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Sunday, March 18, 2012

Thiothixene

Class: Thioxanthenes
VA Class: CN709
Chemical Name: N,N-dimethyl-9-[3-(4-methyl-1-piperazinyl)-propylidene]thioxanthene-2-sulfonamide
Molecular Formula: C₂₃H₂₉N₃O₂S₂
CAS Number: 5591-45-7
Brands: Navane

Special Alerts:

[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .

[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section. For more information visit the FDA website at: , and .

Introduction

Thioxanthene-derivative, conventional (prototypical, first-generation) antipsychotic agent; structurally and pharmacologically related to chlorprothixene (no longer commercially available in the US) and trifluoperazine.^a ^b ^c ^d ^e ^g ^u

Uses for Thiothixene

Psychotic Disorders

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Symptomatic management of psychotic disorders (i.e., schizophrenia).^a ^b ^c ^d ^u

Has been used in the management of refractory or treatment-resistant schizophrenia.^c

Mental Retardation

Efficacy not established for the management of behavioral complications in patients with mental retardation.^a ^b ^c ^u

Thiothixene Dosage and Administration

General

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adjust dosage carefully according to individual requirements and response; use the lowest possible effective dosage.^a ^b ^c ^u

Periodically evaluate patients receiving long-term therapy to determine whether maintenance dosage can be decreased or drug therapy discontinued.^a ^b ^u ^w (See Tardive Dyskinesia under Cautions.)

For symptomatic relief of psychotic disorders, initial therapeutic response to antipsychotic therapy usually occurs within 2–4 weeks and optimum therapeutic response occurs within 6 months or longer.^d ^w

Administration

Oral Administration

Thiothixene is administered orally once daily or in divided doses 2 or 3 times daily.^a ^b ^c ^k ^t ^u Thiothixene hydrochloride has been given orally and parenterally, but no longer is commercially available in the US.^a ^c ^h ^v

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Pediatric Patients

Psychotic Disorders

Oral

Children ≥12 years of age: Initially, 2 mg 3 times daily for mild to moderate psychotic disorders; may gradually increase dosage, if necessary, up to 15 mg daily.^a ^b ^c ^u

For more severe psychotic disorders in children ≥12 years of age: Initially, 5 mg twice daily; may then increase dosage until satisfactory response obtained.^a ^b ^c ^u

Optimal maintenance dosage usually 20–30 mg daily; may be increased up to 60 mg daily, if necessary; once-daily administration may be adequate.^a ^b ^c ^k ^u

Daily dosages >60 mg rarely provide additional therapeutic effect.^a ^b ^c ^u

Adults

Psychotic Disorders

Oral

For mild to moderate psychotic disorders: Initially, 2 mg 3 times daily; may gradually increase dosage, if necessary, up to 15 mg daily.^a ^b ^c ^u

For more severe psychotic disorders: Initially, 5 mg twice daily; may then increase dosage until satisfactory response obtained.^a ^b ^c ^u

Optimal maintenance dosage usually 20–30 mg daily; may be increased up to 60 mg daily, if necessary; once-daily administration may be adequate.^a ^b ^c ^k ^u

Daily dosages >60 mg rarely provide additional therapeutic effect.^a ^b ^c ^u

Prescribing Limits

Pediatric Patients

Psychotic Disorders

Oral

Children ≥12 years of age: Maximum 60 mg daily.^a ^b ^c ^u

Adults

Psychotic Disorders

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Oral

Maximum 60 mg daily.^a ^b ^c ^u

Special Populations

Geriatric Patients

No specific dosage recommendations for geriatric patients, but generally select dosage at the lower end of recommended range; increase dosage more gradually and monitor closely.^a ^b ^d ^h ^u ^w (See Geriatric Use under Cautions and see Special Populations under Pharmacokinetics.)

Cautions for Thiothixene

Contraindications

Circulatory collapse.^a ^b ^c ^u

Comatose states or CNS depression from any cause.^a ^b ^c ^u (See Specific Drugs and Laboratory Tests under Interactions.)

Blood dyscrasias.^a ^b ^c ^u

Known hypersensitivity to thiothixene.^a ^b ^c ^u Not known if cross-sensitivity exists between thioxanthenes and phenothiazines; consider possibility that cross-sensitivity may occur.^a ^b ^c ^u

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Shares the toxic potentials of other antipsychotic agents (e.g., phenothiazines); observe the usual precautions associated with therapy with these agents.^a ^b ^c ^u

Tardive Dyskinesia

Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements, may develop in patients receiving antipsychotic agents, including thiothixene.^a ^b ^c ^d ^u ^w Consider reducing thiothixene dosage or discontinuing drug and switching to a second-generation (atypical) antipsychotic agent.^a ^b ^c ^d ^u ^w

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, has been reported with antipsychotic agents, including thiothixene.^a ^b ^c ^u ^w

CNS Depression

May impair mental and/or physical abilities, especially during the first few days of therapy; use caution with activities requiring alertness (e.g., operating vehicles or machinery).^a ^b ^u

Response to CNS depressants and alcohol may be potentiated.^a ^b ^u (See Specific Drugs and Laboratory Tests under Interactions.)

Sensitivity Reactions

Hypersensitivity and Cross-sensitivity

Possible sensitivity reactions reported with thiothixene (e.g., rash, pruritus, urticaria, anaphylactoid reactions) and related drugs (e.g., agranulocytosis, pancytopenia, thrombocytopenic purpura, jaundice, biliary stasis).^a ^b ^c ^u ^w

Not known if cross-sensitivity exists between thioxanthenes and phenothiazines; consider possibility that cross-sensitivity may occur.^a ^b ^u

Photosensitivity

Photosensitivity may occur; avoid excessive exposure to sunlight during therapy.^a ^b ^u ^w

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Seizures

Possible risk of seizures; may lower seizure threshold.^a ^b ^c ^u Use with extreme caution in patients with a history of seizures or during alcohol withdrawal.^a ^b ^c ^u (See Specific Drugs and Laboratory Tests under Interactions.)

Cardiovascular Effects

Possible hypotension, tachycardia, nonspecific ECG changes, dizziness, and/or syncope; use with caution in patients with cardiovascular disease.^a ^b ^c ^u

If severe hypotension occurs, administer norepinephrine or phenylephrine; epinephrine or dopamine should not be used.^a ^b ^c ^u ^w (See Specific Drugs and Laboratory Tests under Interactions.)

Anticholinergic Effects

Possible anticholinergic effects (e.g., dry mouth, blurred vision, constipation, increased perspiration, urinary retention, impotence).^a ^b ^c ^u

Use with caution in patients with glaucoma or prostatic hypertrophy.^c (See Specific Drugs and Laboratory Tests under Interactions.)

Ocular Effects

Pigmentary retinopathy and lenticular pigmentation reported with prolonged therapy with antipsychotic agents, including thiothixene.^a ^b ^c ^u Observe carefully.^a ^b ^c ^u

Prolactin Secretion

Elevated prolactin concentrations reported; elevation persists during chronic administration.^a ^b ^c ^u ^w

Clinical significance unknown; consider that approximately one-third of human breast cancers are prolactin dependent when prescribing thiothixene in patients with previously detected breast cancer.^a ^b ^c ^u ^w

Galactorrhea, amenorrhea, gynecomastia, and impotence reported.^a ^b ^c ^u ^w

Regulation of Body Temperature

Use with caution in patients exposed to extreme heat or cold.^a ^b ^c ^u ^w

Other Precautions

Antiemetic effects may mask signs of overdosage of other drugs (e.g., antineoplastic agents) or obscure cause of vomiting in various disorders (e.g., intestinal obstruction, Reye’s syndrome, brain tumor).^a ^b ^c ^u ^w

Specific Populations

Pregnancy

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Category C.^e

Lactation

Not known but considered likely to distribute into human milk; possible effects on nursing infant unknown.^e ^h ⁿ ^o ^r ^s Caution if used in nursing women; carefully assess potential benefits and risks.^e ⁿ ^o

Pediatric Use

Safety not established in children <12 years of age.^a ^b ^c ^u

Geriatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Geriatric patients appear to be particularly sensitive to adverse CNS (e.g., tardive dyskinesia, parkinsonian manifestations, akathisia, sedation), anticholinergic, and cardiovascular (e.g., orthostatic hypotension) effects of antipsychotic agents.^a ^b ^d ^h ⁱ ^u ^w

Use with caution.^h (See Geriatric Patients under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Common Adverse Effects

Drowsiness or sedation, extrapyramidal reactions (e.g., Parkinson-like symptoms, dystonia, akathisia, tardive dyskinesia), anticholinergic effects (e.g., dry mouth, blurred vision), hypotension.^a ^b ^c ^u

Interactions for Thiothixene

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction (increased or decreased plasma thiothixene concentrations) with concomitant use of CYP enzyme inhibitors or inducers.^a ^b ^h ^j ^l ^u (See Specific Drugs and Laboratory Tests under Interactions.)

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Alcohol	Potential additive CNS effects and hypotension^a ^b ^u ^w	Use with caution^a ^b ^h ^u ^w
Anticholinergic drugs (e.g., atropine)	Possible potentiation of anticholinergic effects^a ^b ^c ^u	Use with caution^a ^b ^u
Anticonvulsants (e.g., carbamazepine, phenobarbital, phenytoin)	Anticonvulsants may decrease plasma thiothixene concentrations^a ^h ^j ^l Thiothixene may lower seizure threshold^a ^b ^c ^u Barbiturates: Thiothixene does not appear to potentiate the anticonvulsant activity of barbiturates^a ^b ^c ^u	Observe for signs and symptoms of reduced thiothixene effectiveness^a Dosage adjustments of anticonvulsants may be necessary ⁱ Barbiturates: Do not reduce anticonvulsant dosage during concurrent use^a ^b ^c ^u
Antidepressants, tricyclic (TCAs)	Possible increased plasma concentrations of thiothixene^j ^l
β-Blockers (e.g., propranolol)	Possible decreased thiothixene clearance^j ^l
Cimetidine	Possible decreased thiothixene clearance^h ^j ^l
CNS depressants (e.g., antihistamines, barbiturates, general anesthetics, opiate analgesics, sedative/hypnotics)	Possible additive CNS effects and hypotension^a ^b ^u	Use with caution to avoid excessive sedation or CNS depression; carefully adjust dosages of both agents as necessary^a ^b ^h ^u
Epinephrine or dopamine	Possible further lowering of BP^a ^b ^c ^u ^w	Do not use epinephrine or dopamine for thiothixene-induced hypotension^a ^b ^c ^u ^w (see Cardiovascular Effects under Cautions)
Hypotensive agents	Possible additive hypotensive effect^a ^c	Observe closely for signs of excessive hypotension^a ^c
Isoniazid	Possible decreased thiothixene clearance^l
Lithium	An acute encephalopathic syndrome reported occasionally, especially when high serum lithium concentrations present ^h ^w	Observe patients receiving combined therapy for evidence of adverse neurologic effects; promptly discontinue if such signs or symptoms appear^w
Paroxetine	Pharmacokinetic interaction unlikely^m
Smoking	Possible decreased plasma thiothixene concentrations ^h ^j ^l
Tests for pregnancy	False-positive results reported in some patients receiving phenothiazines; less likely to occur when serum test is used^a ^b ^u

Thiothixene Pharmacokinetics

Absorption

Bioavailability

Rapidly and well absorbed from GI tract following oral administration.^c ⁱ ^k Peak plasma concentrations usually occur within 1–3 hours.ⁱ ^k ^t

Onset

Antipsychotic effects usually are apparent within 2–4 weeks after initiation of oral therapy and optimum therapeutic response usually occurs within 6 months or longer.^c ^d ^w

Plasma Concentrations

Optimal therapeutic plasma concentrations not well defined, but clinical improvement associated with peak plasma concentrations of 2–15 mcg/L.^t ^y

Distribution

Extent

Widely distributed into body tissues.^c ⁱ

Crosses placenta in animals; considered likely to cross placenta in humans.^p ^x Not known if distributed into human milk but distribution into breast milk considered likely.^e ^h ^o ^r

Plasma Protein Binding

>99%.ⁱ

Elimination

Metabolism

Principally metabolized in the liver; undergoes extensive oxidative first-pass metabolism to form thiothixene sulfoxide and N-desmethylthiothixene.^c ^h ⁱ ^j

Elimination Route

Excreted mainly in feces via biliary elimination as unchanged drug and as demethyl, sulfoxide, demethylated sulfoxide, and hydroxylated metabolites.^c ⁱ

Unlikely to be removed by hemodialysis and peritoneal dialysis.^a ^b ^u ^w

Half-life

34–35 hours.^d ⁱ ^k ^m ^t

Special Populations

Clearance is reduced in females and in patients >50 years of age.^h

Stability

Storage

Oral

Capsules

Tight, light-resistant containers at 20–25°C; protect from light and moisture.^b ^c ^u

ActionsActions

Produces pharmacologic effects similar to those of other conventional antipsychotic agents (e.g., phenothiazines, butyrophenones, chlorprothixene).^a ^b ^c ^u ^w

Precise mechanism(s) of antipsychotic action not determined, but may be principally related to antidopaminergic effects.^w Acts principally at subcortical levels on the reticular formation, hypothalamus, and limbic system.^c ^w

Exhibits weak anticholinergic, antihistaminic, α-adrenergic, and sedative effects and strong extrapyramidal effects; appears to possess antiemetic activity.^a ^b ^c ^h ^u

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.^a ^b ^c ^h ^u

Importance of clinicians informing patients in whom chronic use is contemplated of risk of tardive dyskinesia, taking into account clinical circumstances and competency of patient to understand information provided.^a ^b ^u

Importance of clinicians informing patients of risk of extrapyramidal reactions and providing reassurance that these reactions usually can be controlled by administration of antiparkinsonian drugs (e.g., benztropine) and by subsequent dosage reduction.^a ^b ^c ^u ^w

Advise patients to avoid excessive sunlight.^a ^b ^u ^w

Importance of avoiding exposure to temperature extremes.^a ^b ^c ^w

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^a ^b ^u

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^a ^b ^u

Importance of informing patients of other important precautionary information.^a ^b ^u (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Thiothixene
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	1 mg*	Navane	Pfizer
			Thiothixene Capsules	Mylan, Sandoz
		2 mg*	Navane	Pfizer
			Thiothixene Capsules	Mylan, Sandoz
		5 mg*	Navane	Pfizer
			Thiothixene Capsules	Mylan, Sandoz
		10 mg*	Navane	Pfizer
			Thiothixene Capsules	Mylan, Sandoz
		20 mg	Navane	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Navane 10MG Capsules (PFIZER U.S.): 90/$189.99 or 270/$565.95

Navane 2MG Capsules (PFIZER U.S.): 90/$92.99 or 270/$266.98

Navane 20MG Capsules (PFIZER U.S.): 90/$266 or 270/$779.99

Navane 5MG Capsules (PFIZER U.S.): 90/$139.99 or 270/$409.96

Thiothixene 1MG Capsules (SANDOZ): 90/$22.99 or 270/$49.97

Thiothixene 2MG Capsules (MYLAN): 90/$26.99 or 270/$71.97

Thiothixene 5MG Capsules (SANDOZ): 90/$25.99 or 270/$59.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 15, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. Roerig, Division of Pfizer Inc. Navane (thiothixene) capsules and solution, concentrate prescribing information. New York, NY. 2008 Mar.

b. Sandoz Inc. Thiothixene capsules prescribing information. Princeton, NJ. 2007 Feb.

c. AHFS drug information 2008. McEvoy GK, ed. Thiothixene. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2516-7.

d. American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia, second edition. From the APA website

e. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Baltimore, MD: Williams & Wilkins; 2005:1577-8.

f. American Academy of Pediatrics. Use of psychoactive medication during pregnancy and possible effects on the fetus and newborn. Pediatrics. 2000; 105:880-87. [PubMed 10742343]

g. The United States Pharmacopeial Convention, Inc. USAN and the USP Dictionary drug names. Rockville, MD: United States Pharmacopeial Convention, Inc; 2007:853.

h. AMA Division of Drugs. AMA drug evaluations. Chicago: American Medical Association; 1994:2:1-2:29.

i. Balant-Gorgia AE, Balant L. Antipsychotic drugs: clinical pharmacokinetics of potential candidates for plasma concentration monitoring. Clin Pharmacokinet. 1987: 13:65-90.

j. Ereshefsky L, Saklad SR, Watanabe MD, et al. Thiothixene pharmacokinetic interactions: a study of hepatic enzyme inducers, clearance inhibitors, and demographic variables. J Clin Psychopharmacol. 1991; 11:296-301. [PubMed 1765572]

k. Hobbs DC, Welch WM, Short MJ, et al. Pharmacokinetics of thiothixene in man. Clin Pharmacol Ther. 1974; 16:473-8. [PubMed 4415039]

l. Ereshefsky L, Jann MW, Saklad SR, et al. Bioavailability of psychotropic drugs: historical perspective and pharmacokinetic overview. J Clin Psychiatry. 1986; 47 (Suppl):6-15. [PubMed 3528134]

m. Guthrie SK, Hariharan M, Kumar AA, et al. The effect of paroxetine on thiothixene pharmacokinetics. J Clin Pharm Ther. 1997; 22:221-6. [PubMed 9447478]

n. Webb RT, Howard L, Abel KM. Antipsychotic drugs for non-affective psychosis during pregnancy and postpartum. Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.: CD004411. DOI: 10.1002/14651858.CD004411.pub2.

o. Cohen LS, Heller VL, Rosenbaum JF. Treatment guidelines for psychotropic drug use in pregnancy. Psychosomatics. 1989; 30:25-33. [PubMed 2643809]

p. Altshuler LL, Cohen L, Szuba MP, et al. Pharmacologic management of psychiatric illness during pregnancy: dilemmas and guidelines. Am J Psychiatry. 1996; 153:592-606. [PubMed 8615404]

q. Mortola JF. The use of psychotropic agents in pregnancy and lactation. Psychiatr Clin North Am. 1989; 12:69-87. [PubMed 2652114]

r. Goldberg H, Nissim R. Psychotropic drugs in pregnancy and lactation. Int J Psychiatry Med. 1994; 24:129-49. [PubMed 7960421]

s. Calabrese JR, Gulledge AD. Psychotropics during pregnancy and lactation: a review. Psychosomatics. 1985; 26:413-26. [PubMed 2859631]

t. Milton GV, Jann MW. Emergency treatment of psychotic symptoms: pharmacokinetic considerations for antipsychotic drugs. Clin Pharmacokinet. 1995; 28:494-504. [PubMed 7656507]

u. Mylan Pharmaceuticals Inc. Thiothixene capsules prescribing information. Morgantown, WV; 2003 Oct.

v. Roerig, Division of Pfizer Inc. Navane (thiothixene hydrochloride) intramuscular for injection prescribing information. New York, NY. 2008 Jan.

w. AHFS drug information 2008. McEvoy GK, ed. Phenothiazines general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008: 2497-508.

x. Schmidt MH, Lee T. Investigation of striatal dopamine D2 receptor acquisition following prenatal neuroleptic exposure. Psychiatry Res. 1991; 36:319-28. [PubMed 1676523]

y. Mavroidis ML, Kanter DR, Hirschowitz J et al. Clinical relevance of thiothixene plasma levels.J Clin Psychopharmacol. 1984; 4:155-7. [PubMed 6736276]

More Thiothixene resources

Thiothixene Side Effects (in more detail)
Thiothixene Dosage
Thiothixene Use in Pregnancy & Breastfeeding
Drug Images
Thiothixene Drug Interactions
Thiothixene Support Group
3 Reviews for Thiothixene - Add your own review/rating

Thiothixene Professional Patient Advice (Wolters Kluwer)

Thiothixene Prescribing Information (FDA)

Thiothixene MedFacts Consumer Leaflet (Wolters Kluwer)

thiothixene Concise Consumer Information (Cerner Multum)

thiothixene Advanced Consumer (Micromedex) - Includes Dosage Information

Navane Advanced Consumer (Micromedex) - Includes Dosage Information

Navane Prescribing Information (FDA)

Compare Thiothixene with other medications

Psychosis

Testolactone

Generic Name: testolactone (test O lack tone)

Brand Names: Teslac

What is testolactone?

Testolactone blocks the production of the hormone estrogen. Certain types of breast cancer require estrogen to grow.

Testolactone is used to treat some types of breast cancer.

Testolactone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about testolactone?

Testolactone should not be used for the treatment of men with breast cancer or in patients with a history of allergic reactions to the drug.

What should I discuss with my healthcare provider before taking testolactone?

Testolactone should not be used for the treatment of men with breast cancer or in patients with a history of allergic reactions to the drug.

Testolactone is in the FDA pregnancy category C. This means that it is not known whether testolactone will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. Testolactone passes into breast milk in small amounts and may affect a nursing baby. Do not take testolactone without first talking to your doctor if you are breast-feeding a baby.

How should I take testolactone?

Take testolactone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass (8 ounces) of water.

It is important to take testolactone regularly to get the most benefit.

Your doctor may want you to have breast exams (or to perform self breast exams), mammograms, blood tests, or other medical evaluations during treatment with testolactone to monitor progress and side effects.

Store testolactone at room temperature away from moisture and heat. Keep this product out of the reach of children.

See also: Testolactone dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless your doctor directs otherwise.

What happens if I overdose?

Call an emergency room or a poison control center for advice if you suspect an overdose.

Symptoms of a testolactone overdose are unknown, but nausea, vomiting, seizures, tremor, or dizziness may be expected.

What should I avoid while taking testolactone?

There are no restrictions on food, beverages, or activity during treatment with testolactone unless otherwise directed by your doctor.

Testolactone side effects

Stop taking testolactone and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

new breast lumps;

bone pain;

menstrual changes, abnormal vaginal bleeding, vaginal discharge, or pelvic pain or pressure; or

excessive nausea, vomiting, or thirst.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Testolactone Dosing Information

Usual Adult Dose for Breast Cancer--Palliative:

For use as adjunctive therapy in the palliative treatment of advanced or disseminated breast cancer in postmenopausal women when hormonal therapy is indicated or in women who were diagnosed as having had disseminated breast carcinoma when premenopausal, in whom ovarian function has been subsequently terminated: 250 mg 4 times a day.

What other drugs will affect testolactone?

Before taking testolactone, tell your doctor if you are taking

an estrogen such as Premarin, Ogen, Estratest, Estraderm, Vivelle, Climara, and others;

a birth control pill that contains estrogen;

warfarin (Coumadin) or another blood thinner.

You may not be able to take testolactone or you may require special monitoring or a dosage adjustment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with testolactone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More testolactone resources

Testolactone Side Effects (in more detail)
Testolactone Dosage
Testolactone Use in Pregnancy & Breastfeeding
Testolactone Drug Interactions
Testolactone Support Group
0 Reviews for Testolactone - Add your own review/rating

testolactone Advanced Consumer (Micromedex) - Includes Dosage Information

Testolactone MedFacts Consumer Leaflet (Wolters Kluwer)

Teslac Prescribing Information (FDA)

Compare testolactone with other medications

Breast Cancer, Palliative

Where can I get more information?

Your pharmacist has additional information about testolactone written for health professionals that you may read.

What does my medication look like?

Testolactone is available with a prescription under the brand name Teslac. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

See also: testolactone side effects (in more detail)

Saturday, March 17, 2012

Norvir

Generic Name: ritonavir (Oral route)

rit-OH-na-vir

Oral route(Capsule, Liquid Filled;Solution;Tablet)

Coadministration of ritonavir with sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs .

Commonly used brand name(s)

In the U.S.

Norvir

Available Dosage Forms:

Capsule, Liquid Filled

Tablet

Solution

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Protease Inhibitor

Uses For Norvir

Ritonavir is used alone or in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Ritonavir will not cure HIV infection or prevent AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Ritonavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using Norvir

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ritonavir in infants younger than 1 month old. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of ritonavir have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of ritonavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving ritonavir.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Alfuzosin

Amiodarone

Astemizole

Bepridil

Cisapride

Colchicine

Conivaptan

Dihydroergotamine

Dronedarone

Encainide

Eplerenone

Ergoloid Mesylates

Ergonovine

Ergotamine

Flecainide

Lovastatin

Methylergonovine

Methysergide

Midazolam

Pimozide

Propafenone

Quinidine

Ranolazine

Sildenafil

Silodosin

Simvastatin

St John's Wort

Terfenadine

Tolvaptan

Triazolam

Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone

Aprepitant

Bosentan

Brentuximab Vedotin

Cabazitaxel

Crizotinib

Dasatinib

Digoxin

Docetaxel

Etravirine

Everolimus

Fentanyl

Fluticasone

Fusidic Acid

Garlic

Iloperidone

Ixabepilone

Lapatinib

Methylenedioxymethamphetamine

Nilotinib

Oxycodone

Pazopanib

Pitavastatin

Quinine

Rifabutin

Rifampin

Rivaroxaban

Romidepsin

Ruxolitinib

Salmeterol

Sunitinib

Tamoxifen

Tamsulosin

Temsirolimus

Ticagrelor

Topotecan

Toremifene

Vemurafenib

Venlafaxine

Vinblastine

Vincristine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Alprazolam

Amitriptyline

Amlodipine

Amprenavir

Bupropion

Carbamazepine

Cerivastatin

Clarithromycin

Clonazepam

Clozapine

Cyclosporine

Dalfopristin

Delavirdine

Desipramine

Desogestrel

Dexamethasone

Didanosine

Dienogest

Diltiazem

Disopyramide

Drospirenone

Dutasteride

Efavirenz

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etonogestrel

Fluoxetine

Fosamprenavir

Imipramine

Indinavir

Itraconazole

Ketoconazole

Lamotrigine

Levonorgestrel

Levothyroxine

Maraviroc

Medroxyprogesterone Acetate

Meperidine

Mestranol

Methadone

Methamphetamine

Metoprolol

Mexiletine

Nefazodone

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Paroxetine

Phenobarbital

Phenytoin

Posaconazole

Prednisone

Quinupristin

Rifapentine

Risperidone

Tacrolimus

Tadalafil

Tenofovir Disoproxil Fumarate

Theophylline

Trazodone

Valproic Acid

Verapamil

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Norvir

Take this medicine exactly as directed by your doctor. Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

It is important that ritonavir be taken with food.

Swallow the tablet whole. Do not break, crush, or chew it.

For patients taking the oral liquid:

Shake the bottle well before using.

Use a specially marked measuring syringe or cup to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

You can mix the oral liquid with chocolate milk or nutritional drinks (such as Ensure® or Advera®) to make it taste better. You should drink this medicine within one hour of mixing.

This medicine works best when there is a constant amount in the blood. To help keep blood levels constant, do not miss any doses. It is best to take the doses at evenly spaced times, day and night. For example, if you are to take two doses each day, the doses should be spaced about 12 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.

Ritonavir must be taken with other medicines. Tell your doctor about all of the medications you are taking since the dose of ritonavir or other medications you take may need to be adjusted.

If you are taking ritonavir with a medication called didanosine (Videx®), take the ritonavir 2 hours and 30 minutes before or after the didanosine.

Read and carefully follow the patient information leaflet before starting ritonavir treatment and each time you refill. Ask your doctor or pharmacist if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For treatment of HIV infection:
- For oral dosage forms (capsules, solution, or tablets):
  - Adults—600 milligrams (mg) two times per day.
  - Children 1 month of age and older—Dose is based on body size and must be determined by your doctor. The dose is usually 350 to 400 milligrams per square meter (mg/[m]2) of body size two times per day. However, the dose is usually not more than 600 mg two times per day.
  - Children younger than 1 month of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the capsules in the refrigerator or at room temperature in a closed container. If stored at room temperature, use the medicine within 30 days. Keep away from heat and direct light.

Store the oral liquid or tablets in a closed container at room temperature, away from heat and direct light. Do not refrigerate.

Precautions While Using Norvir

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (e.g., St. John's wort) or vitamin supplements.

Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), amiodarone (Cordarone®), astemizole (Hismanal®), bepridil (Vascor®), cisapride (Propulsid®), ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, or Ergomar®), flecainide (Tambocor®), lovastatin (Altocor®, Mevacor®), oral midazolam (Versed®), pimozide (Orap®), propafenone (Rythmol®), quinidine (Quinaglute®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), terfenadine (Seldane®), triazolam (Halcion®), or voriconazole (Vfend®). Using these medicines together with ritonavir may increase your chance of having serious side effects.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Pancreatitis may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may decrease the effects of some birth control pills. To avoid getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; fever; chills; cough; diarrhea; itching; joint or muscle pain; rash; red skin lesions, often with a purple center; sore throat; sores, ulcers, or white spots in the mouth or on the lips; swelling of your hands, face, tongue, or throat; or unusual tiredness or weakness.

This medicine may increase the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to lower the cholesterol and fats. Talk to your doctor if you or your child have concerns.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

Norvir Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Fainting

feeling faint, dizzy, or lightheaded

feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

headache

sweating

Rare

Confusion

dehydration

dry or itchy skin

fruity mouth odor

increased hunger

increased thirst

increased urination

nausea

vomiting

weight loss

Incidence not known

Bloating

chills

constipation

convulsions

cough

darkened urine

decreased urination

difficulty with breathing

dry mouth

fast heartbeat

fever

hives or welts

increase in heart rate

indigestion

itching

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

loss of bladder control

muscle spasm or jerking of all extremities

noisy breathing

pains in the stomach, side, or abdomen, possibly radiating to the back

rapid breathing

redness of the skin

shortness of breath

skin rash

sudden loss of consciousness

sunken eyes

thirst

tightness in the chest

unusual tiredness or weakness

wheezing

wrinkled skin

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in sense of taste

diarrhea

dizziness

general feeling of discomfort or illness

heartburn

lack or loss of strength

sleepiness or unusual drowsiness

sleeplessness

trouble sleeping

unable to sleep

weakness

Less common

Body aches or pain

congestion

delusions

dementia

difficulty with moving

discouragement

dryness or soreness of the throat

excess air or gas in the stomach or intestines

fear

feeling sad or empty

full feeling

hoarseness

increased urge to urinate during the night

irritability

lack of appetite

loss of interest or pleasure

mood or mental changes

muscle pain or stiffness

nervousness

pain in the joints or in unspecified location

passing gas

runny nose

tender, swollen glands in the neck

throat irritation

tiredness

trouble concentrating

trouble with swallowing

voice changes

waking to urinate at night

Incidence not known

Gaining weight around your neck, upper back, breast, face, or waist

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Norvir side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Norvir resources

Norvir Side Effects (in more detail)
Norvir Use in Pregnancy & Breastfeeding
Drug Images
Norvir Drug Interactions
Norvir Support Group
0 Reviews for Norvir - Add your own review/rating

Norvir Prescribing Information (FDA)

Norvir Consumer Overview

Norvir Monograph (AHFS DI)

Norvir MedFacts Consumer Leaflet (Wolters Kluwer)

Ritonavir Professional Patient Advice (Wolters Kluwer)

Compare Norvir with other medications

HIV Infection

Friday, March 16, 2012

Synarel

Generic Name: nafarelin (Nasal route)

naf-a-REL-in

Commonly used brand name(s)

In the U.S.

Synarel

Available Dosage Forms:

Spray

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

Uses For Synarel

Nafarelin is a man-made version of a hormone that is similar to the one normally released from the hypothalamus gland in the brain. Nafarelin nasal spray is used for the treatment of:

Central precocious puberty (CPP), a condition that causes early puberty in boys (before 9 years of age) and in girls (before 8 years of age).

Endometriosis, a painful condition caused by extra tissue growing inside or outside of the uterus (womb).

When given regularly to boys and girls experiencing early puberty, nafarelin slows down the development of genital areas in both sexes and breast development in girls. This medicine delays puberty in a child only as long as the child continues to take it.

When given regularly to women, nafarelin prevents the growth of tissue caused by endometriosis in adult women during treatment and for 6 months after treatment is discontinued. Reducing the amount of estrogen in the body is one way of treating endometriosis.

Suppressing estrogen can cause thinning of the bones or slowing of growth. This is a problem for adult women whose bones are no longer growing like the bones of children. Slowing the growth of bones is a positive effect for girls and boys whose bones grow too fast when puberty begins too early. Boys and girls may benefit by adding inches to their adult height when nafarelin causes their bones to grow at the proper and expected rate for children.

This medicine is available only with your doctor's prescription.

Before Using Synarel

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nafarelin nasal spray in children. Nafarelin will stop having an effect on a child treated for central precocious puberty soon after the child stops using it, and puberty will advance normally. It is not known if using nafarelin nasal spray around the time of puberty causes changes in boys' and girls' future abilities to have babies. Their chances of having children later are thought to be normal. It is especially important that you discuss with the child's doctor the benefit of this medicine as well as the risk of using it.

Appropriate studies have not been performed on the relationship of age to the effects of nafarelin nasal spray for the treatment of endometriosis in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of nafarelin nasal spray in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Proper Use of Synarel

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the amount that is absorbed from the nose and the chance of unwanted effects. Do not change your dose or stop using this medicine without checking with your doctor first.

This medicine comes with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is only used in the nose. Do not get it in your eyes. If it does get in the eyes, rinse them with water right away and call your doctor.

To use nafarelin spray:

Before you use each new bottle of nafarelin, the spray pump needs to be started. To do this, point the bottle away from you and pump the bottle firmly about 7 times. This only needs to be done once for each new bottle of nafarelin. Be careful not to breathe in this spray. You could inhale extra doses of nafarelin, since the medicine is dissolved in the spray.

Before you take your daily doses of nafarelin, blow your nose gently. Hold your head forward a little. Put the spray tip into one nostril. Aim the tip toward the back and outside of your nostril. You do not need to put the tip too far into your nose.

Close your other nostril off by pressing on the outside of your nose with a finger. Then, sniff in the spray as you pump the bottle once.

Take the spray bottle out of your nose. Tilt your head back for 30 seconds, to let the spray get onto the back of your nose.

Repeat these steps for each dose of medicine.

Each time you use the spray bottle, wipe off the tip with a clean tissue or cloth. Keep the white safety clip and plastic cap on the bottle when you are not using it.

Be sure to clean the tip of the spray bottle before and after every use. To do this, hold the bottle sideways. Rinse the tip with warm water, while wiping the tip with your finger or a soft cloth for about 15 seconds. Dry the tip with a soft cloth or tissue. Replace the cap right after use. Be careful not to get water into the bottle, since this could dilute the medicine.

Do not try to make the tiny hole in the spray tip larger. Doing so, may deliver a wrong dose of the medicine.

If you are also using a topical nasal decongestant, do not use it at the same time you are using this medicine. Wait at least 2 hours after using nafarelin spray before using the nasal decongestant.

It is important to avoid sneezing when spraying and immediately after using the medicine. If you sneeze, the medicine may not be absorbed as well.

Many boys and girls who have central precocious puberty will not feel sick or will not understand the importance of taking the medicine regularly. It is very important that the medicine is used exactly as directed and that the proper amount is used at the proper time. It works best when there is a constant amount in the blood. To help keep the amount constant, nafarelin must be given on a regular schedule.

Dosing

For nasal dosage form (spray):
- For treatment of central precocious puberty:
  - Children—Two sprays in each nostril two times a day, taken in the morning and in the evening. This provides a total dose of 8 sprays a day. Some patients may need a larger dose by using 3 sprays in alternating nostrils three times a day to provide a total of 9 sprays per day.
- For treatment of endometriosis:
  - Adults—One spray in one nostril in the morning and one spray into the other nostril in the evening, taken for 6 months. Begin your treatment on Day 2, 3, or 4 of your menstrual period.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After you prime the bottle, there will only be 60 doses or sprays. Keep track of the number of sprays you use. Throw the bottle away after you use 60 sprays (for 30 days) even if some liquid remains in the bottle.

Precautions While Using Synarel

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects. Be sure to keep all appointments.

For female patients: You should not take this medicine if you are pregnant or may become pregnant. Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

For children using nafarelin spray for central precocious puberty: The medicine can cause a brief increase in blood levels of some hormones. During this time, you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls. If your child's symptoms do not improve within 4 weeks, or if they get worse, call your doctor.

For adult women using nafarelin spray for endometriosis:

For the first few days of treatment, the symptoms of your condition may get worse. This is normal. Do not stop using this medicine. Talk with your doctor if you have concerns about this.

During the time you are receiving nafarelin, your menstrual period may not be regular or you may not have a menstrual period at all. This is to be expected when being treated with this medicine. If regular menstruation does not begin within 2 to 3 months after you stop using this medicine, check with your doctor.

During the time you are using nafarelin spray, you should use birth control methods that do not contain hormones, such as condoms, IUD, a diaphragm or a cervical cap with a spermicide. If you have any questions about this, check with your doctor.

Use a water-based vaginal lubricant product if dryness of the vagina causes problems, such as pain during sexual intercourse. Make sure the lubricant you choose can be used with a latex birth control device if you are using one. Some lubricants contain oils, which can break down the latex rubber of condoms, a cervical cap, or a diaphragm, and cause them to rip or tear.

If you suspect you may have become pregnant, stop using this medicine and check with your doctor. There is a chance that continued use of nafarelin during pregnancy could cause birth defects or a miscarriage.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Synarel Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More commonFor adults (female)

Breast enlargement

light vaginal bleeding between regular menstrual periods called spotting

longer or heavier menstrual periods

vaginal bleeding between regular menstrual periods called breakthrough bleeding

For children (male)

Body odor

growth of pubic hair

For children (female)

Body odor

breast enlargement

growth of pubic hair

light vaginal bleeding between regular menstrual periods called spotting

longer or heavier menstrual periods

vaginal bleeding between regular menstrual periods called breakthrough bleeding

Less common

Chest pain

hives or welts

itching skin

redness of the skin

skin rash

shortness of breath

Less common or rareFor adults (female)

Fast or irregular heartbeat

numbness or tingling of the hands or feet

pain in the eyes or joints

patchy brown or dark brown discoloration of the skin

pelvic bloating or tenderness

unexpected or excess milk flow from breasts

unusual tiredness or weakness

For children (male and female)

Chest pain

hives

shortness of breath

Incidence not known

Anxiety or mental depression

changes in vision

chest pain or discomfort

cold, clammy, or pale skin

confusion

convulsions

headache

irregular heartbeats

nightmares or unusually vivid dreams

slow heart rate

vomiting

weakness

Incidence not known - For adults (female)

Cough

difficulty with speaking

dizziness or lightheadedness

double vision

fainting

fast heartbeat

inability to move the arms, legs, or facial muscles

inability to speak

nausea

pain or discomfort in the arms, jaw, back, or neck

pain, redness, or swelling in the arm or leg

slow speech

sudden shortness of breath or troubled breathing

sweating

vomiting

yellow eyes or skin

More commonFor adults (female)

Acne

dandruff

hot flashes

increase or decrease in sexual desire

increased hair growth, often abnormally distributed

mood swings

muscle pain

oily skin

pain during sexual intercourse

rapid weight gain

reduced breast size

stopping of menstrual periods

swelling of the feet or lower legs

vaginal dryness

For children (male)

Acne

dandruff

mood swings

oily skin

For children (female)

Acne

dandruff

hot flashes

mood swings

oily skin

Less common or rareFor adults (female)

Breast pain

headache (mild and transient)

irritated or runny nose

mental depression (mild and transient)

skin rash

For children (male)

Irritated or runny nose

For children (female)

Irritated or runny nose

white or brownish vaginal discharge

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Synarel side effects (in more detail)

More Synarel resources

Synarel Side Effects (in more detail)
Synarel Use in Pregnancy & Breastfeeding
Synarel Support Group
2 Reviews for Synarel - Add your own review/rating

Synarel Prescribing Information (FDA)

Synarel Concise Consumer Information (Cerner Multum)

Synarel Monograph (AHFS DI)

Synarel MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Synarel with other medications

Endometriosis
Precocious Puberty

Thursday, March 15, 2012

Stromectol

Pronunciation: EYE-ver-MEK-tin
Generic Name: Ivermectin
Brand Name: Stromectol

Stromectol is used for:

Treating infections caused by certain parasites.

Stromectol is an anthelmintic. It works by killing sensitive parasites.

Do NOT use Stromectol if:

you are allergic to any ingredient in Stromectol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Stromectol:

Some medical conditions may interact with Stromectol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have any other parasite infection (eg, Loa loa infection) or you have recently traveled to areas where parasite infection is likely

if you have asthma or a weakened immune system (eg, HIV infection)

Some MEDICINES MAY INTERACT with Stromectol. Tell your health care provider if you are taking any other medicines, especially any of the following:

Warfarin because the risk of its side effects may be increased by Stromectol.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Stromectol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Stromectol:

Use Stromectol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Stromectol by mouth on an empty stomach with water.

Some patients who take Stromectol will need repeated follow-up and retreatment to make sure the infection is cleared up completely. Follow your doctor's instructions. Be sure to keep all doctor and lab appointments.

Stromectol is usually given as a single dose. If you forget to take Stromectol, take it as soon as your remember.

Ask your health care provider any questions you may have about how to use Stromectol.

Important safety information:

Stromectol may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Stromectol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Stromectol may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Rarely, some patients taking Stromectol who have also had a certain other parasite infection (loiasis) have developed a serious and sometimes fatal brain problem. Tell your doctor if you have any other parasite infection. Tell your doctor if you have been in an area where Loa loa infection is likely (eg, West or Central Africa). Tell your doctor at once if you have symptoms such as unusual back pain, eye bleeding, shortness of breath, failure to control bladder or bowel, trouble walking or standing, mental changes (eg, confusion), unusual weakness, or seizures.

Lab tests, including stool examinations, may be performed while you use Stromectol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Stromectol should be used with extreme caution in CHILDREN weighing less than 33 pounds (15 kilograms); safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Do not use Stromectol if you are pregnant. If you think you may be pregnant, contact your doctor right away. Stromectol is found in breast milk. If you are or will be breast-feeding while you use Stromectol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Stromectol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eye pain, swelling, or redness; fainting; fast heartbeat; fever; joint pain; red, swollen, blistered, or peeling skin; seizures; severe dizziness or lightheadedness; swelling of the skin, arms, legs, ankles, or feet; tender or swollen lymph glands (eg, in the neck, groin, underarms); vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Stromectol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal skin sensations; diarrhea; loss of coordination; nausea; seizures; severe headache or dizziness; stomach pain; swelling; trouble breathing; unusual weakness; vomiting.

Proper storage of Stromectol:

Store Stromectol at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Stromectol out of the reach of children and away from pets.

General information:

If you have any questions about Stromectol, please talk with your doctor, pharmacist, or other health care provider.

Stromectol is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Stromectol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Stromectol resources

Stromectol Side Effects (in more detail)
Stromectol Use in Pregnancy & Breastfeeding
Drug Images
Stromectol Drug Interactions
Stromectol Support Group
2 Reviews for Stromectol - Add your own review/rating

Stromectol Prescribing Information (FDA)

Stromectol Advanced Consumer (Micromedex) - Includes Dosage Information

Stromectol Concise Consumer Information (Cerner Multum)

Stromectol Monograph (AHFS DI)

Ivermectin Prescribing Information (FDA)

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Thyroid

THYE-roid

Oral route(Tablet)

In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects .

Commonly used brand name(s)

In the U.S.

Armour Thyroid

Nature-Throid NT-1

Nature-Throid NT-1/2

Nature-Throid NT-2

Nature-Throid NT-3

Nature-Thyroid

Westhroid

Available Dosage Forms:

Tablet

Capsule

Therapeutic Class: Thyroid Supplement

Uses For thyroid

Thyroid is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. It is also used to help decrease the size of enlarged thyroid glands (known as goiter) and to treat thyroid cancer .

Thyroid is also used in some medical tests to help diagnose problems with the thyroid gland .

thyroid is available only with your doctor's prescription .

Before Using thyroid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For thyroid, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to thyroid or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of thyroid in children .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of thyroid in the elderly. However, elderly patients are more likely to have age-related heart and blood vessel problems, which may require caution in patients receiving thyroid .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	A	Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

Breast Feeding

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking thyroid, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using thyroid with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Anisindione

Dicumarol

Kelp

Phenindione

Phenprocoumon

Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of thyroid

thyroid usually needs to be taken for life. Do not stop taking thyroid or change your doses without first checking with your doctor. It may take several weeks before you start to notice an improvement in your symptoms .

Dosing

The dose of thyroid will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of thyroid. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (tablet):
- For the treatment of hypothyroidism:
  - Adults—At first, 30 milligrams (mg) once a day. Then, your doctor may increase your dose a little at a time up to the usual maintenance dose of 60 to 120 mg a day. A lower starting dose of 15 mg/day may be given to patients for certain conditions.
  - Children 0 to 6 months of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 15 to 30 mg once a day.
  - Children 6 to 12 months of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 30 to 45 mg once a day.
  - Children 1 to 5 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 45 to 60 mg once a day.
  - Children 6 to 12 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 60 to 90 mg once a day.
  - Children over 12 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is over 90 mg once a day .

Missed Dose

If you miss a dose of thyroid, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

DRUG: GENERAL, STORAGE DRUG: GENERAL, STORAGE

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Precautions While Using thyroid

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects .

Thyroid should not be used for the treatment of obesity or for the purpose of losing weight. thyroid is ineffective for weight reduction and when taken in larger amount, it may cause more serious medical conditions .

Hypothyroidism can sometimes cause infertility in men and women. Thyroid should not be used for the treatment of infertility unless it is caused by hypothyroidism .

Call your doctor right away if you start to have chest pain, fast, irregular, pounding, or racing heartbeat or pulse, excessive sweating, heat intolerance, nervousness, or any other unusual medical condition .

For patients with diabetes, it is very important that you keep track of your blood or urine sugar levels as instructed by your doctor. Check with your doctor immediately if you notice any changes in your sugar levels .

A temporary loss of hair may occur during the first few months of thyroid therapy. Ask your doctor about this if you have any concerns .

thyroid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following symptoms of overdose occur:

Changes in appetite

changes in menstrual periods

chest pain

diarrhea

fast or irregular heartbeat

fever

hand tremors

headache

irritability

leg cramps

nervousness

sensitivity to heat

shortness of breath

sweating

trouble sleeping

vomiting

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: thyroid side effects (in more detail)

More thyroid resources

Thyroid Side Effects (in more detail)
Thyroid Use in Pregnancy & Breastfeeding
Drug Images
Thyroid Drug Interactions
Thyroid Support Group
53 Reviews for Thyroid - Add your own review/rating

Armour Thyroid Prescribing Information (FDA)

Armour Thyroid Concise Consumer Information (Cerner Multum)

Armour Thyroid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare thyroid with other medications

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Monday, March 12, 2012

Sumavel DosePro injection

Generic Name: sumatriptan (injection) (soo ma TRIP tan)

Brand Names: Alsuma, Imitrex, Imitrex Statdose, Imitrex Statdose Refill, Sumavel DosePro Needle-free System

What is sumatriptan injection?

Sumatriptan is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Sumatriptan is used to treat migraine headaches and cluster headaches. Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Sumatriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

Sumatriptan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sumatriptan injection?

You should not use this medication if you are allergic to sumatriptan, if you have any history of heart disease, or if you have coronary heart disease, angina, blood circulation problems, lack of blood supply to the heart, uncontrolled high blood pressure, severe liver disease, ischemic bowel disease, a history of a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches. Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including sumatriptan tablets or nasal spray, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), rizatriptan (Maxalt), naratriptan (Amerge), zolmitriptan (Zomig), or ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine). Do not use sumatriptan if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

Before using sumatriptan, tell your doctor if you have liver or kidney disease, seizures, high blood pressure, a heart rhythm disorder, or coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Also tell your doctor if you are taking an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

After using a sumatriptan injection, you must wait one (1) hour before using a second injection. Do not use more than two injections in 24 hours.

What should I discuss with my health care provider before using sumatriptan injection?

You should not use this medication if you are allergic to sumatriptan, or if you have:

coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

a history of heart disease, heart attack, or stroke, including "mini-stroke";

severe or uncontrolled high blood pressure;

severe liver disease;

ischemic bowel disease; or

a headache that seems different from your usual migraine headaches.

Do not use sumatriptan if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

To make sure you can safely use sumatriptan, tell your doctor if you have any of these other conditions:

liver disease;

kidney disease;

epilepsy or other seizure disorder;

high blood pressure, a heart rhythm disorder; or

coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category C. It is not known whether sumatriptan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Your name may need to be listed on a sumatriptan pregnancy registry when you start using this medication.

Sumatriptan can pass into breast milk and may harm a nursing baby. Do not breast-feed within 12 hours after using a sumatriptan injection. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby. This medicine should not be given to anyone under 18 or over 65 years of age.

How should I use sumatriptan injection?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Overuse of migraine headache medicine can actually make your headaches worse.

Sumatriptan is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use sumatriptan as soon as you notice headache symptoms, or after an attack has already begun.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to see if you have any serious side effects.

Sumatriptan injection comes in a vial (bottle), in a prefilled cartridge to be loaded into an auto-injector syringe (Imitrex Statdose), or in a needle-free injector device (Sumavel DosePro Needle-free System). Each vial, cartridge, or needle-free device is for one use only.

After using an injection: If your headache does not completely go away after the injection, call your doctor before using a second sumatriptan injection. If your headache goes away and then comes back, you may use a second injection if it has been at least one hour since your first injection. Do not use more than two (2) injections in 24 hours. If your symptoms do not improve, contact your doctor before using any more injections.

Store at room temperature away from moisture, heat, and light. Throw away any unused medicine after the expiration date on the label has passed.

What happens if I miss a dose?

Since sumatriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using sumatriptan.

After using a sumatriptan injection, you must wait one (1) hour before using a second injection. Do not use more than two (2) injections in 24 hours.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include tremors or shaking, skin redness, breathing problems, blue-colored lips or fingernails, vision problems, watery eyes or mouth, weakness, lack of coordination, or seizure (convulsions).

What should I avoid while using sumatriptan injection?

Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including:

sumatriptan tablets or nasal spray, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig); or

ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Sumatriptan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Sumatriptan injection side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using sumatriptan and call your doctor if you have a serious side effect such as:

feeling of pain or tightness in your jaw, neck, or throat;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden and severe stomach pain and bloody diarrhea;

seizure (convulsions);

numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or

(if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

mild headache (not a migraine);

pressure or heavy feeling in any part of your body;

discomfort in your nose or throat;

dizziness, spinning sensation;

muscle pain, neck pain or stiffness;

warmth, redness, or mild tingling under your skin; or

pain, redness, bleeding, swelling, or bruising where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sumatriptan injection?

Tell your doctor about all other medicines you use, especially:

an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

This list is not complete and other drugs may interact with sumatriptan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Sumavel DosePro resources

Sumavel DosePro Side Effects (in more detail)
Sumavel DosePro Use in Pregnancy & Breastfeeding
Sumavel DosePro Drug Interactions
14 Reviews for Sumavel DosePro - Add your own review/rating

Compare Sumavel DosePro with other medications

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Migraine

Where can I get more information?

Your pharmacist can provide more information about sumatriptan.

See also: Sumavel DosePro side effects (in more detail)