Trisenox

Generic Name: Arsenic Trioxide
Class: Antineoplastic Agents
VA Class: AN900
CAS Number: 1327-53-3

• Experience of Supervising Clinician


• 
  

  Use under the supervision of a qualified clinician experienced in the management of acute leukemia.¹

  
  

• Acute Promyelocytic Leukemia (APL) Differentiation Syndrome


• 
  

  Risk of developing potentially fatal APL differentiation syndrome.¹

  
  


• 
  

  If signs or symptoms suggestive of APL differentiation syndrome (e.g., unexplained fever, dyspnea, weight gain, abnormal chest auscultatory findings, radiographic abnormalities) occur, initiate high-dose corticosteroid therapy (e.g., dexamethasone phosphate 10 mg IV twice daily for 3 days or longer until symptoms resolve) immediately regardless of the patient's leukocyte count; discontinuance of arsenic trioxide generally is not required.¹

  
  

• ECG Abnormalities


• 
  

  Risk of potentially fatal atypical ventricular tachycardia (torsades de pointes) and complete atrioventricular block,^{1 4 6 8 10} particularly in patients with a history of torsades de pointes, CHF, or preexisting QT interval prolongation, and in those receiving drugs that might prolong the QT interval or produce electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia).¹

  
  

• ECG and Electrolyte Monitoring


• 
  

  Prior to initiation of therapy, perform baseline ECG and determine serum electrolyte (potassium, calcium, and magnesium) and creatinine concentrations.^{1 6 7}

  
  


• 
  

  If baseline QT_c interval >500 msec, institute appropriate corrective measures and reassess with serial ECGs prior to considering arsenic trioxide therapy.¹

  
  


• 
  

  Correct preexisting electrolyte abnormalities; if possible, discontinue drugs known to prolong the QT interval.¹

  
  


• 
  

  During therapy, maintain serum potassium concentrations >4 mEq/L and serum magnesium concentrations >1.8 mg/dL and monitor ECGs weekly (more frequently in clinically unstable patients).^{1 10}

  
  


• 
  

  If QT interval >500 msec during therapy, correct any concomitant risk factors immediately and weigh the risks/benefits of continued therapy.^{1 11}

  
  


• 
  

  If syncope and/or rapid or irregular heartbeat occurs, hospitalize patient for careful monitoring; discontinue arsenic trioxide until QT_c interval decreases to <460 msec, electrolyte abnormalities are corrected, and syncope and irregular heartbeat resolve.¹

  
  

Introduction

Antineoplastic agent.¹

Uses for Trisenox

Refractory or Relapsed Acute Promyelocytic Leukemia

Induction of remission and consolidation of acute promyelocytic leukemia (APL) that is refractory to retinoid and anthracycline therapy or has relapsed following such therapy;^{1 4 16 17} used in patients whose disease is characterized by the presence of the t(15;17) translocation or promyelocytic leukemia-retinoic acid receptor (PML-RAR)-α gene expression.^{1 5}

Actuarial 18-month relapse-free survival rate: 56%.¹⁷

Newly Diagnosed Acute Promyelocytic Leukemia

As a component of therapy for newly diagnosed APL† in combination with other agents and consolidation chemotherapy.^{17 20 25}

Combination therapy with arsenic trioxide and tretinoin has been used as an alternative to chemotherapy for induction and postremission therapy in newly diagnosed APL†; may consider use of these regimens in select patients who cannot tolerate standard anthracycline-containing chemotherapy (e.g., geriatric patients with poor performance or patients with cardiac dysfunction).^{27 28 29}

Trisenox Dosage and Administration

General

• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.¹

  
  

Administration

Administer by IV infusion.¹

IV Administration

For solution compatibility information, see Compatibility under Stability.

IV solutions of the drug contain no preservatives; discard any unused portion of single-use ampul.¹

Do not mix with other drugs.¹

Dilution

Immediately after withdrawing the appropriate dose of the drug from the ampul, dilute with 100–250 mL of 5% dextrose injection or 0.9% sodium chloride injection.¹

Rate of Administration

Administer by IV infusion over 1–2 hours; if acute vasomotor reactions occur, longer infusion periods (e.g., up to 4 hours) may be used.¹

Dosage

Pediatric Patients

Acute Promyelocytic Leukemia

Induction Therapy

IV

In children ≥5 years of age, 0.15 mg/kg daily.¹ Continue until bone marrow remission occurs or for a maximum of 60 doses.¹

Consolidation Therapy

IV

In children ≥5 years of age, 0.15 mg/kg daily for 25 doses, administered over a period of up to 5 weeks.¹ Initiate 3–6 weeks after completion of induction therapy.¹

Adults

Acute Promyelocytic Leukemia

Induction Therapy

IV

0.15 mg/kg daily.¹ Continue until bone marrow remission occurs or for a maximum of 60 doses.¹

Consolidation Therapy

IV

0.15 mg/kg daily for 25 doses, administered over a period of up to 5 weeks.¹ Initiate 3–6 weeks after completion of induction therapy.¹

Cautions for Trisenox

Contraindications

• 
  

  Known hypersensitivity to arsenic trioxide or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

For warnings regarding experience of supervising clinician, APL differentiation syndrome, ECG abnormalities, and ECG and electrolyte monitoring, see Boxed Warning.

Hyperleukocytosis

Possible hyperleukocytosis (leukocyte count ≥10,000/mm³).^{1 11}

Carcinogenicity

Carcinogenicity studies not performed using IV arsenic trioxide; however, arsenic trioxide is a human carcinogen.¹

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; avoid pregnancy during therapy.¹ If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.¹

General Precautions

Adequate Patient Monitoring

Perform hematologic and coagulation tests and determine serum electrolyte concentrations at least twice weekly during induction therapy (more frequently in clinically unstable patients) and at least weekly during consolidation therapy.¹

Monitor ECG weekly (more frequently in clinically unstable patients) during induction and consolidation therapy.¹

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Arsenic is distributed into milk in humans;¹ discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children <5 years of age.¹

Used in 7 children 5–16 years of age with APL in one study and in 13 children and young adults 4–21 years of age with refractory or relapsed APL in another study; 5 and 11 achieved complete responses, respectively.^{1 11 26}

Hepatic Impairment

Not studied in patients with hepatic impairment.¹

Renal Impairment

Not studied in patients with renal impairment.¹

Potential for prolonged elimination.¹ Use with caution in patients with renal failure.¹

Common Adverse Effects

Leukocytosis, GI effects (nausea, vomiting, diarrhea, abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, dizziness.¹

Interactions for Trisenox

Extensively metabolized in the liver.¹ Methyltransferases involved in metabolism of arsenic trioxide are not CYP isoenzymes.¹

Has no inhibitory effects on metabolism of substrates of major CYP isoenzymes (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11).¹

No formal drug interaction studies to date.¹

Drugs that Prolong the QT Interval

Potential pharmacologic interaction (additive effects on prolongation of the QT interval).^{14 15}

Drugs that May be Associated with Electrolyte Abnormalities

Potential pharmacologic interaction (additive effects on prolongation of the QT interval).¹

Specific Drugs

Drug	Interaction	Comments
Amphotericin B	Additive effects on prolongation of QT interval1	Use with caution1
Antiarrhythmics producing QT-interval prolongation	Additive effects on prolongation of QT interval1	Use with caution1
Diuretics (potassium-wasting)	Additive effects on prolongation of QT interval1	Use with caution1
Pimozide	Additive effects on prolongation of QT interval14 15	Concomitant use not recommended14 15
Thioridazine	Additive effects on prolongation of QT interval1	Use with caution1
Ziprasidone	Additive effects on prolongation of QT interval14 15	Concomitant use not recommended14 15

Trisenox Pharmacokinetics

Pharmacokinetics of trivalent arsenic have not been characterized.¹

Distribution

Extent

Arsenic is stored mainly in liver, kidney, heart, lung, hair, and nails.¹

Inorganic arsenical preparations cross the placenta in animals.¹

Elimination

Metabolism

Arsenic trioxide is extensively metabolized via reduction by arsenate reductase and methylation (mainly in the liver) by methyltransferases.¹

Elimination Route

Trivalent arsenic is excreted in urine.¹

Stability

Storage

Parenteral

Solution

25°C (may be exposed to 15–30°C).¹ Do not freeze.¹

Chemically and physically stable after dilution for 24 hours at room temperature and 48 hours when refrigerated.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible1
Dextrose 5% in water
Sodium chloride 0.9%

ActionsActions

• 
  

  Mechanism of action not fully elucidated.^{1 5}

  
  


• 
  

  Believed to induce apoptosis (programmed cell death) of promyelocytic leukemia cells.^{1 5}

  
  

Advice to Patients

• 
  

  Importance of informing clinicians if unexplained fever, dyspnea, or weight gain occurs.¹

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Boxed Warning and see Cautions.)

  
  

Preparations

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

Arsenic Trioxide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV use only	1 mg/mL (10 mg)	Trisenox	Cephalon

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 January 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

1. Cephalon. Trisenox (arsenic trioxide) injection prescribing information. Frazer, PA; 2006 Jul.

2. Food and Drug Administration. Labeling and prescription drug advertising; content and format for labeling for human prescription drugs. 21 CFR Parts 201 and 202. Final Rule. [Docket No. 75N-0066] Fed Regist. 1979; 44:37434-67.

3. Department of Health and Human Services, Food and Drug Administration. Subpart B—Labeling requirements for prescription drugs and/or insulin. (21 CFR Ch. 1 (4-1-87 ed.). 1987:18-24.

4. Anon. FDA approves arsenic trioxide for leukemia treatment in record time for a cancer drug development program. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2000 Sep 26.

5. Soignet SL, Maslak P, Wang ZG et al. Complete remission after treatment of acute promyelocytic leukemia with arsenic trioxide. N Engl J Med. 1998; 339:1341-8. [IDIS 430941] [PubMed 9801394]

6. Food and Drug Administration. Torsades de pointes arrhythmia and sudden death associated with the use of arsenic trioxide. Medwatch safety information summaries 2001. Rockville, MD; March 2001. From FDA website ()

7. Food and Drug Administration: Healthcare providers reminded to closely monitor patients on arsenic trioxide. Medwatch safety information summaries 2001. Rockville, MD; March 2001. From FDA website () Correction.

8. Dear health care provider letter regarding the importance of close monitoring of patients on arsenic trioxide. Seattle, WA: Cell Therapeutics; 2001 March.

9. Unnikrishnan D, Dutcher JP, Varshneya N et al. Torsades de pointes in 3 patients with leukemia treated with arsenic trioxide. Blood. 2001; 97:1514-6. [IDIS 459938] [PubMed 11222403]

10. Ohnishi K, Yoshida H, Shigeno K et al. Prolongation of the QT interval and ventricular tachycardia in patients treated with arsenic trioxide for acute promyelocytic leukemia. Ann Intern Med. 2000; 133:881-5. [IDIS 456624] [PubMed 11103058]

11. Cell Therapeutics, Seattle, WA: Personal communication.

12. Westervelt P, Brown RA, Adkins DR et al. Sudden death among patients with acute promyelocytic leukemia treated with arsenic trioxide. Blood. 2001; 98:266-71. [IDIS 466692] [PubMed 11435292]

13. Dear doctor letter commenting on the report of sudden death in 3 patients receiving arsenic trioxide. Seattle, WA: Cell Therapeutics; 2001 Jul 24.

14. Food and Drug Administration. MedWatch—Safety-related drug labeling changes: Geodon (ziprasidone) capsules [February 15, 2002]. From FDA web site .

15. Food and Drug Administration. MedWatch—Safety-related drug labeling changes: Omap (pimozide) [November 14, 2002]. From FDA web site .

16. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52. [PubMed 15529105]

17. Adult acute myeloid leukemia. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 Aug 8.

18. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97[[030]]414). Rockville, MD; [May 5, 2003]. From FDA web site .

19. Soignet SL, Frankel SR, Douer D et al. United States multicenter study of arsenic trioxide in relapsed acute promyelocytic leukemia. J Clin Oncol. 2001; 19:3852-60. [IDIS 469715] [PubMed 11559723]

20. Childhood acute myeloid leukemia/other myeloid malignancies. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 Aug 18.

21. Shen ZX, Shi ZZ, Fang J et al. All-trans retinoic acid/As2O3 combination yields a high quality remission and survival in newly diagnosed acute promyelocytic leukemia. Proc Natl Acad Sci U S A. 2004; 101:5328-35. [PubMed 15044693]

22. Hussein MA, Saleh M, Ravandi F et al. Phase 2 study of arsenic trioxide in patients with relapsed or refractory multiple myeloma. Br J Haematol. 2004; 125:470-6. [PubMed 15142117]

23. Munshi NC, Tricot G, Desikan R et al. Clinical activity of arsenic trioxide for the treatment of multiple myeloma. Leukemia. 2002; 16:1835-7. [PubMed 12200700]

24. Sekeres MA. Arsenic trioxide as a treatment for myelodysplastic syndrome. Curr Hematol Rep. 2005; 4:59-63. [PubMed 15610661]

25. Powell BL, Moser B, Stock W et al. Effect of consolidation with arsenic trioxide (As₂O₃) on event-free survival (EFS) and overall survival (OS) among patients with newly diagnosed acute promyelocytic leukemia (APL): North American Intergroup Protocol C9710. Proc ASCO. 2007; Abstract No. 2..

26. Fox E, Razzouk BI, Widemann BC et al. Phase I trial and pharmacokinetic study of arsenic trioxide in children and adolescents with refractory or relapsed acute leukemia, including acute promyelocytic leukemia or lymphoma. Blood. 2008; 111:566-73. [PubMed 17959855]

27. Estey E, Garcia-Manero G, Ferrajoli A et al. Use of all-trans retinoic acid plus arsenic trioxide as an alternative to chemotherapy in untreated acute promyelocytic leukemia. Blood. 2006; 107:3469-73. [PubMed 16373661]

28. Mathews V, George B, Lakshmi KM et al. Single-agent arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia: durable remissions with minimal toxicity. Blood. 2006; 107:2627-32. [PubMed 16352810]

29. Douer D. ATO: the forefront of APL treatment? Blood. 2006; 107:2588-2589.

HID. Trissel LA. Handbook on injectable drugs. 14th ed; Bethesda, MD: American Society of Health-System Pharmacists; 2007:171.

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• Trisenox Side Effects (in more detail)
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• Trisenox Drug Interactions
• Trisenox Support Group
• 0 Reviews for Trisenox - Add your own review/rating

• Trisenox Prescribing Information (FDA)


• Trisenox MedFacts Consumer Leaflet (Wolters Kluwer)


• Trisenox Concise Consumer Information (Cerner Multum)


• Trisenox Advanced Consumer (Micromedex) - Includes Dosage Information


• Arsenic Trioxide Professional Patient Advice (Wolters Kluwer)

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• Acute Promyelocytic Leukemia

Sulfoxyl Strong

Generic Name: benzoyl peroxide and sulfur topical (BEN zoe ill per OX ide and SULL fur)

Brand Names: NuOx, Sulfoxyl Regular, Sulfoxyl Strong

What is Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect that decreases oiliness of the skin.

When sulfur is applied topically, it causes drying and peeling of the skin. This allows excess oils and dirt to be easily washed away.

Benzoyl peroxide and sulfur topical is used to treat acne.

Benzoyl peroxide and sulfur topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Do not use benzoyl peroxide and sulfur topical on sunburned, windburned, dry, chapped, or irritated skin or on an open wound.

Avoid abrasive, harsh, or drying soaps and cleansers while using benzoyl peroxide and sulfur topical.

Avoid contact with clothing and hair. Benzoyl peroxide may cause bleaching.

Avoid combining PABA-containing sunscreens and benzoyl peroxide and sulfur topical. Temporary skin discoloration may occur if they are used together.

Who should not use Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Do not use benzoyl peroxide and sulfur topical on sunburned, windburned, dry, chapped, or irritated skin. It could make these conditions much worse. Also avoid using benzoyl peroxide and sulfur topical in wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Do not use benzoyl peroxide and sulfur topical during treatment with tretinoin (Retin-A). The combination could lead to severe skin irritation.

It is not known whether benzoyl peroxide and sulfur topical will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether benzoyl peroxide and sulfur topical passes into breast milk. Do not use benzoyl peroxide and sulfur topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Use benzoyl peroxide and sulfur topical exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after applying this medication.

Clean and dry the area of skin where you will apply benzoyl peroxide and sulfur topical. Apply the medication to the affected area. When applying benzoyl peroxide and sulfur topical, avoid your eyes, the inside of your nose and mouth, your lips, and areas where the skin is broken to prevent excessive irritation. If you get medication in any of these areas, rinse it off with water. Do not cover the affected area after applying benzoyl peroxide and sulfur topical. Doing so could cause too much medicine to be absorbed by your body and could be harmful. It may take several weeks or more to see the effects of this drug. Do not stop using benzoyl peroxide and sulfur topical if you do not see results immediately.

Apply benzoyl peroxide and sulfur topical less often if you experience excessive burning, dryness, or irritation.

Store benzoyl peroxide and sulfur topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only your next regularly scheduled dose.

What happens if I overdose?

An overdose of benzoyl peroxide and sulfur topical is unlikely to occur. If you do suspect an overdose, or if benzoyl peroxide and sulfur topical has been ingested, call a poison control center or an emergency room for advice.

What should I avoid while using Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Do not use benzoyl peroxide and sulfur topical on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid using other topical products on the same area at the same time unless directed to do so by your doctor. They may interfere with the effects or absorption of benzoyl peroxide and sulfur topical.

Do not cover the area after applying benzoyl peroxide and sulfur topical. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area you are treating.

Avoid contact with clothing and hair. Benzoyl peroxide may cause bleaching.

Avoid combining PABA-containing sunscreens and benzoyl peroxide and sulfur topical. Temporary skin discoloration may occur if they are used together.

Sulfoxyl Strong (benzoyl peroxide and sulfur topical) side effects

Serious side effects are not likely to occur. Stop using benzoyl peroxide and sulfur topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

You may experience some burning, stinging, tingling, itching, redness, dryness, peeling, or irritation while you are using benzoyl peroxide topical. If these side effects are excessive, apply benzoyl peroxide and sulfur topical less often.

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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Do not use benzoyl peroxide and sulfur topical during treatment with tretinoin (Retin-A). The combination could lead to severe skin irritation.

Do not use other topical prescription or over-the-counter products unless directed to do so by your doctor. They may interfere with your treatment or increase irritation to your skin.

Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area you are treating.

Drugs other than those listed here may also interact with benzoyl peroxide and sulfur topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

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Compare Sulfoxyl Strong with other medications

• Acne

Where can I get more information?

• Your pharmacist has additional information about benzoyl peroxide and sulfur topical written for health professionals that you may read.

See also: Sulfoxyl Strong side effects (in more detail)

Soloxine

Dosage Form: FOR ANIMAL USE ONLY
Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

Description

Each Soloxine® (Levothyroxine Sodium, USP) Tablet provides synthetic crystalline levothyroxine sodium (L-thyroxine).

The structural formula for levothyroxine sodium is:

Levothyroxine Sodium Action

Levothyroxine sodium acts, as does endogenous thyroxine, to stimulate metabolism, growth, development and differentiation of tissues. It increases the rate of energy exchange and increases the maturation rate of the epiphyses. Levothyroxine sodium is absorbed rapidly from the gastrointestinal tract after oral administration. Following absorption, the compound becomes bound to the serum alpha globulin fraction. For purposes of comparison, 0.1 mg of levothyroxine sodium elicits a clinical response approximately equal to that produced by one grain (65 mg) of desiccated thyroid.

Indications

Provides thyroid replacement therapy in all conditions of inadequate production of thyroid hormones. Hypothyroidism is the generalized metabolic disease resulting from deficiency of the thyroid hormones levothyroxine (T4) and liothyronine (T3). Soloxine (levothyroxine sodium) will provide levothyroxine (T4) as a substrate for the physiologic deiodination to liothyronine (T3). Administration of levothyroxine sodium alone will result in complete physiologic thyroid replacement.

Canine hypothyroidism is usually primary, i.e., due to atrophy of the thyroid gland. In the majority of cases the atrophy is associated with lymphocytic thyroiditis and in the remainder it is non-inflammatory and as of yet unknown etiology. Less than 10 percent of cases of hypothyroidism are secondary, i.e., due to deficiency of thyroid stimulating hormone (TSH). TSH deficiency may occur as a component of congenital hypopituitarism or as an acquired disorder in adult dogs, in which case it is invariably due to the growth of a pituitary tumor.

Hypothyroidism in the Dog

Hypothyroidism usually occurs in middle-aged and older dogs although the condition will sometimes be seen in younger dogs of the larger breeds. Neutered animals of either sex are also frequently affected, regardless of age. The following are clinical signs of hypothyroidism in dogs:

 

Lethargy, lack of endurance, increased sleeping

 

Reduced interest, alertness and excitability

 

Slow heart rate, weak apex beat and pulse, low voltage on ECG

 

Preference for warmth, low body temperature, cool skin

 

Increased body weight

 

Stiff and slow movements, dragging of front feet

 

Head tilt, disturbed balance, unilateral facial paralysis

 

Atrophy of epidermis, thickening of dermis

 

Surface and follicular hyperkeratosis, pigmentation

 

Puffy face, blepharoptosis, tragic expression

 

Dry, coarse, sparse coat, slow regrowth after clipping

 

Retarded turnover of hair (carpet coat of boxers)

 

Shortening or absence of estrus, lack of libido

 

Dry feces, occasional diarrhea

 

Hypercholesterolemia

 

Normochromic, normocytic anemia

 

Elevated serum creatinine phosphokinase

Contraindications

Levothyroxine sodium therapy is contraindicated in thyrotoxicosis, acute myocardial infarction and uncorrected adrenal insufficiency. Use in pregnant bitches has not been evaluated.

Precautions

The effects of levothyroxine sodium therapy are slow in being manifested. Overdosage of any thyroid drug may produce the signs and symptoms of thyrotoxicosis including, but not limited to: polydipsia, polyuria, polyphagia, reduced heat tolerance and hyperactivity or personality change. Administer with caution to animals with clinically significant heart disease, hypertension or other complications for which a sharply increased metabolic rate might prove hazardous.

Adverse Reactions

There are no particular adverse reactions associated with levothyroxine sodium therapy at the recommended dosage levels. Overdosage will result in the signs of thyrotoxicosis listed above under precautions.

Dosage

The initial recommended dose is 0.1 mg/10 lb. (4.5 kg) body weight twice daily. Dosage is then adjusted by monitoring the thyroid blood levels of the dog every four weeks until an adequate maintenance dose is established. The usual maintenance dose is 0.1 mg/10 lb. (4.5 kg) once daily.

A maximum of 0.8 mg to 1.0 mg total daily dose will be sufficient in most dogs over 80 pounds in body weight.

Administration

Soloxine tablets may be administered orally or placed in the food.

Dosage forms available

0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg and 1.0 mg tablets in bottles of 250 and 1,000.

Storage

Store at controlled room temperature 15°C to 30°C (59°F to 86°F).

References

1. Evinger, J.V. and Nelson, R.W.; JAVMA 314. 1984, pg 185, 314-316.


2. Richard Nelson, DVM; Current Veterinary Therapy X. Edited by R. W. Kirk, W. B. Saunders, Co., Philadelphia, PA 1989, pg 994.


3. Edward Feldman, DVM and Richard Nelson, DVM; Canine and Feline Endocrinology and Reproduction. W. B. Saunders 1987, pg 82.

Virbac AH, Inc.

Fort Worth, TX 76137

For More Information Call

1-800-338-3659

11/09

301787-02

PRINCIPAL DISPLAY PANEL - 0.1 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-831-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.1 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-832-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.2 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.3 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-833-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.3 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.4 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-834-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.4 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-835-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.5 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.6 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-836-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.6 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.7 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-837-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.7 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.8 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-838-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.8 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 1.0 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-830-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

1.0 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-831 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.1 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;1 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-831-10 1000 TABLET In 1 BOTTLE None 2 51311-831-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-832 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.2 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PINK Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-832-10 1000 TABLET In 1 BOTTLE None 2 51311-832-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-833 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.3 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color GREEN Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;3 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-833-10 1000 TABLET In 1 BOTTLE None 2 51311-833-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-834 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.4 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color RED (Maroon) Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;4 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-834-10 1000 TABLET In 1 BOTTLE None 2 51311-834-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-835 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.5 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;5 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-835-10 1000 TABLET In 1 BOTTLE None 2 51311-835-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-836 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.6 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PURPLE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;6 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-836-10 1000 TABLET In 1 BOTTLE None 2 51311-836-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-837 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.7 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color ORANGE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;7 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-837-10 1000 TABLET In 1 BOTTLE None 2 51311-837-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-838 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.8 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BLUE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;8 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-838-10 1000 TABLET In 1 BOTTLE None 2 51311-838-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-830 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 1 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN (Beige) Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 1 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-830-10 1000 TABLET In 1 BOTTLE None 2 51311-830-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Labeler - Virbac AH, Inc. (131568396)

Establishment
Name	Address	ID/FEI	Operations
Virbac Bridgeton		808558100	MANUFACTURE

Revised: 12/2009Virbac AH, Inc.

Sporanox Solution

Pronunciation: IT-ra-KON-a-zole
Generic Name: Itraconazole
Brand Name: Sporanox

Sporanox Solution has been shown to cause decreased heart function. Contact your doctor immediately if you experience symptoms of congestive heart failure such as swelling of the hands, ankles, feet, or abdomen; bloating; shortness of breath; fast or irregular heartbeat; severe or persistent nausea; or confusion.

Use of Sporanox Solution along with certain other medicines may increase your risk of serious and sometimes fatal heart problems, including irregular heartbeat. Do not take Sporanox Solution if you are also taking cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl).

Sporanox Solution is used for:

Treating fungal infections. It may also be used for other conditions as determined by your doctor.

Sporanox Solution is an azole antifungal. It kills sensitive fungi by interfering with the formation of the fungal cell membrane.

Do NOT use Sporanox Solution if:

• you are allergic to any ingredient in Sporanox Solution


• you are taking an aldosterone blocker (eg, eplerenone), alprazolam, astemizole, cisapride, conivaptan, dofetilide, an ergot alkaloid (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), levacetylmethadol (levomethadyl), oral midazolam, nevirapine, nisoldipine, pimozide, a quinazoline (eg, alfuzosin), quinidine, rifabutin, rifampin, terfenadine, triazolam, or certain 5-HT receptor agonists (eg, eletriptan)

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

Before using Sporanox Solution:

Some medical conditions may interact with Sporanox Solution. 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 are allergic to other azole antifungals (eg, ketoconazole)


• if you have HIV infection, a weakened immune system, low white blood cell levels, cystic fibrosis, kidney or liver problems, abnormal liver function tests, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), low stomach acid (eg, hypochlorhydria), nerve problems, or problems with swelling or retaining fluid


• if you have an irregular heartbeat or other heart problems (eg, congestive heart failure, coronary artery disease, heart valve problems)


• if you have had serious liver problems caused by Sporanox Solution or other medicines

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

• Many prescription and nonprescription medicines (eg, used for infections, HIV, seizures, anxiety, sleep, heartburn, diabetes, high cholesterol, heart problems, high blood pressure, allergies, irregular heartbeat, pain, blood thinning, asthma, migraines, mood or mental problems, cancer, prostate problems, immune system suppression, erectile dysfunction, urinary problems, or birth control [eg, birth control pills]), multivitamin products, and herbal or dietary supplements may interact with Sporanox Solution, increasing the risk of serious side effects


• Nevirapine, rifabutin, or rifampin because they may decrease Sporanox Solution's effectiveness


• Astemizole, cisapride, dofetilide, levacetylmethadol (levomethadyl), nisoldipine, pimozide, quinidine, or terfenadine because the risk of severe heart effects may be increased


• Alprazolam, midazolam, or triazolam because their actions and the risk of their side effects may be increased by Sporanox Solution, resulting in increased risk of sedation and breathing difficulties


• Aldosterone blockers (eg, eplerenone), calcium channel blockers (eg, verapamil), conivaptan, ergot alkaloids (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), 5-HT receptor agonists (eg, eletriptan), or quinazolines (eg, alfuzosin) because the risk of their side effects may be increased by Sporanox Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sporanox Solution 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 Sporanox Solution:

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

• Take Sporanox Solution on an empty stomach at least 1 hour before or 2 hours after eating.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you are using Sporanox Solution to treat a mouth or throat infection, swish Sporanox Solution in your mouth for several seconds before swallowing, unless directed otherwise by your doctor.


• Do not take antacids within 1 hour before or 2 hours after taking Sporanox Solution.


• Take Sporanox Solution at least 2 hours before proton pump inhibitors (eg, omeprazole).


• To clear up your infection completely, take Sporanox Solution for the full course of treatment. Keep taking it even if you feel better in a few days. Do not miss any doses.


• Sporanox Solution works best if it is taken at the same time each day.


• If you miss a dose of Sporanox Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Sporanox Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Sporanox Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Rarely, Sporanox Solution has been associated with serious, sometimes fatal liver damage. Contact your doctor right away if you notice dark urine, pale stools, a swollen or tender stomach, or yellowing of the skin or eyes.


• Sporanox Solution only works against fungi; it does not treat viral infections (eg, the common cold).


• Be sure to use Sporanox Solution for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Do not switch between the capsule and oral solution forms of Sporanox Solution without checking with your doctor. Effectiveness and side effects of these forms of Sporanox Solution may be different even at the same dose.


• Diabetes patients - Sporanox Solution may increase the risk of low blood sugar from your diabetes medicine. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Sporanox Solution. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• If you are using Sporanox Solution to treat a certain type of fungal infection (onychomycosis), you should use an effective form of birth control while you are taking Sporanox Solution and for 2 months after you have stopped treatment. Talk with your doctor about effective forms of birth control.


• Tell your doctor or dentist that you take Sporanox Solution before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including liver function, may be performed while you use Sporanox Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Sporanox Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially loss of hearing.


• Sporanox Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Sporanox Solution can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sporanox Solution while you are pregnant. Sporanox Solution is found in breast milk. If you are or will be breast-feeding while you use Sporanox Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sporanox Solution:

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; gas; headache; nausea; runny nose; stomach pain or upset; unpleasant taste; vomiting.

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); bloating; chest pain; confusion; coughing up white or pink mucus; dark urine; decreased sexual ability; depression; fast or irregular heartbeat; fever, chills, or sore throat; hair loss; increased or uncontrolled urination; joint pain; loss of appetite; loss of hearing; muscle pain, weakness, or cramping; numbness, burning, or tingling of the hands, arms, legs, or feet; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; sensitivity to sunlight; severe or persistent nausea; severe or persistent vomiting; severe stomach or back pain; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender stomach abdomen; trouble sleeping; unusual tiredness or fatigue; vision problems (eg, blurred vision, double vision); yellowing of the skin or eyes.

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: Sporanox 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.

Proper storage of Sporanox Solution:

Store Sporanox Solution below 77 degrees F (25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sporanox Solution out of the reach of children and away from pets.

General information:

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


• Sporanox Solution 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 Sporanox Solution. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Sporanox resources

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

Compare Sporanox with other medications

• Aspergillosis, Aspergilloma
• Blastomycosis
• Candida Infections, Systemic
• Candida Urinary Tract Infection
• Coccidioidomycosis
• Cryptococcosis
• Dermatophytosis
• Esophageal Candidiasis
• Febrile Neutropenia
• Histoplasmosis
• Onychomycosis, Fingernail
• Onychomycosis, Toenail
• Oral Thrush
• Paracoccidioidomycosis
• Sporotrichosis
• Tinea Capitis
• Tinea Versicolor
• Vaginal Yeast Infection

Suphedrin

Generic Name: pseudoephedrine (SOO doe ee FED rin)

Brand Names: Chlor Trimeton Nasal Decongestant, Contac Cold, Drixoral Decongestant Non-Drowsy, Elixsure Decongestant, Entex, Genaphed, Kid Kare Drops, Nasofed, Seudotabs, Silfedrine, Sudafed, Sudafed 12-Hour, Sudafed 24-Hour, Sudafed Children's Nasal Decongestant, Sudodrin, SudoGest, SudoGest 12 Hour, Suphedrin, Triaminic Softchews Allergy Congestion, Unifed

What is Suphedrin (pseudoephedrine)?

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pseudoephedrine is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

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

What is the most important information I should know about Suphedrin (pseudoephedrine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant. Do not use pseudoephedrine 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. A dangerous drug interaction could occur, leading to serious side effects.

What should I discuss with my healthcare provider before taking Suphedrin (pseudoephedrine)?

Do not use pseudoephedrine 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. A dangerous drug interaction could occur, leading to serious side effects. Do not use this medication if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

Ask a doctor or pharmacist if it is safe for you to take pseudoephedrine if you have:

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a thyroid disorder.

  
  

FDA pregnancy category C. It is not known whether pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Suphedrin (pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. You may need to shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one. Do not take pseudoephedrine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. If you need surgery, tell the surgeon ahead of time that you are using pseudoephedrine. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since pseudoephedrine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include feeling restless or nervous.

What should I avoid while taking Suphedrin (pseudoephedrine)?

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant.

Suphedrin (pseudoephedrine) 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 pseudoephedrine and call your doctor at once if you have a serious side effect such as:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness or anxiety;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).

  
  

Less serious side effects may include:

• 
  

  loss of appetite;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  feeling restless or excited (especially in children);

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  skin rash or itching.

  
  

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 Suphedrin (pseudoephedrine)?

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

• 
  

  blood pressure medications;

  
  


• 
  

  a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with pseudoephedrine. 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 Suphedrin resources

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

• Suphedrin MedFacts Consumer Leaflet (Wolters Kluwer)


• Pseudoephedrine Monograph (AHFS DI)


• Cenafed Advanced Consumer (Micromedex) - Includes Dosage Information


• Dimetapp Decongestant Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Drixoral Non-Drowsy Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex Consumer Overview


• Sudafed Consumer Overview


• Tylenol Simply Stuffy Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Suphedrin with other medications

• Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about pseudoephedrine.

See also: Suphedrin side effects (in more detail)

Serpazide

Generic Name: hydralazine/hydrochlorothiazide/reserpine (hye DRAL a zeen/hye droe klor oh THYE a zide/re SER peen)

Brand Names: Diuretic Ap-Es, Hydrap-ES, Ser-Ap-Es, Serpazide, Tri-Hydroserpine, Uni Serp

What is Serpazide (hydralazine/hydrochlorothiazide/reserpine)?

Hydralazine is a vasodilator. It lowers blood pressure by relaxing (widening) blood vessels (veins and arteries) and making it easier for your heart to pump.

Hydrochlorothiazide is a thiazide diuretic (water pill). It helps to lower your blood pressure and decrease edema (swelling or water retention) by increasing the amount of salt and water you lose in your urine.

Reserpine lowers blood pressure by decreasing the levels of certain chemicals in your blood. This allows your blood vessels (veins and arteries) to relax and your heart to beat more slowly and easily.

The combination, hydralazine/hydrochlorothiazide/reserpine, is used to lower high blood pressure.

Hydralazine/hydrochlorothiazide/reserpine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Serpazide (hydralazine/hydrochlorothiazide/reserpine)?

Stand up slowly from a sitting or lying position. Hydralazine/hydrochlorothiazide/reserpine may make you feel dizzy. Do not stop taking hydralazine/hydrochlorothiazide/reserpine suddenly. Even if you feel better, you need this medication to control your condition. Stopping suddenly could cause severely high blood pressure, anxiety, and other dangerous side effects. Use caution when driving, operating machinery, or performing other hazardous activities. Hydralazine/hydrochlorothiazide/reserpine may cause dizziness. If you experience dizziness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking this medication.

What should I discuss with my healthcare provider before taking Serpazide (hydralazine/hydrochlorothiazide/reserpine)?

Do not take hydralazine/hydrochlorothiazide/reserpine without first talking to your doctor if you

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  have an allergy to sulfa-based drugs such as sulfa antibiotics;

  
  


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  have coronary heart disease or mitral valvular rheumatic heart disease;

  
  


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  have peptic ulcer disease (stomach ulcers);

  
  


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  have ulcerative colitis;

  
  


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  are suffering from depression (especially if you have suicidal thoughts);

  
  


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  are receiving electroconvulsive shock therapy; or

  
  


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  have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

  
  

You may not be able to take hydralazine/hydrochlorothiazide/reserpine if you have any of the conditions listed above.

Before taking this medication, tell your doctor if you

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  have gallstones,

  
  


• have kidney or liver disease,


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  have diabetes,

  
  


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  have gout,

  
  


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  have a collagen vascular disease such as systemic lupus erythematosus,

  
  


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  have pancreatitis,

  
  


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  have asthma,

  
  


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  have any type of heart disease,

  
  


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  have had a stroke or a transient ischemic attack (mini-stroke),

  
  


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  have high cholesterol or high levels of fat in your blood, or

  
  


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  have pulmonary hypertension (a type of lung disease).

  
  

You may require a dosage adjustment or special monitoring during therapy with hydralazine/hydrochlorothiazide/reserpine if you have any of the conditions listed above.

Hydralazine/hydrochlorothiazide/reserpine is in the FDA pregnancy category C. This means that it is not known whether hydralazine/hydrochlorothiazide/reserpine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Hydralazine/hydrochlorothiazide/reserpine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from hydralazine/hydrochlorothiazide/reserpine therapy. You may require a lower dose of this medication.

How should I take Serpazide (hydralazine/hydrochlorothiazide/reserpine)?

Take the medication exactly as directed. 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 of water. Take the medication with food or milk if it upsets your stomach.

Do not suddenly stop taking hydralazine/hydrochlorothiazide/reserpine. Stopping suddenly could make your condition much worse or cause very serious side effects. Talk to your doctor before you stop taking this medication.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an overdose include low blood pressure (fainting, dizziness, weakness), slow pulse or an irregular heartbeat, low body temperature, diarrhea, increased urination, vomiting, headache, flushing of the skin, and slow breathing.

What should I avoid while taking Serpazide (hydralazine/hydrochlorothiazide/reserpine)?

Use caution when driving, operating machinery, or performing other hazardous activities. This medicine may cause dizziness. If you experience dizziness, avoid these activities. Avoid alcohol while taking hydralazine/hydrochlorothiazide/reserpine. Alcohol may increase the drowsiness caused by this medication and may increase dizziness. Use caution even with small amounts of alcohol. Use caution when rising from a sitting or lying position, especially first thing in the morning. You may become dizzy while taking hydralazine/hydrochlorothiazide/reserpine, and you may fall and injure yourself.

Do not let yourself become overheated in hot weather or during exercise, and use caution if you have a fever. Dehydration may increase the effects of hydralazine/hydrochlorothiazide/reserpine, and you may become very dizzy.

Avoid prolonged exposure to sunlight. Hydrochlorothiazide may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Serpazide (hydralazine/hydrochlorothiazide/reserpine) side effects

If you experience any of the following serious side effects, stop taking hydralazine/hydrochlorothiazide/reserpine and seek emergency medical attention:

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

  
  


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  irregular or fast heartbeats or a fluttering feeling in your chest;

  
  


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  new or worsening chest pain;

  
  


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  heart failure (shortness of breath, swelling of ankles or legs, sudden weight gain of 2 pounds in one day or 5 pounds in one week);

  
  


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  unusual fatigue or confusion;

  
  


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  abnormal bleeding or bruising;

  
  


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  yellow skin or eyes;

  
  


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  blood in your urine or stools;

  
  


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  little or no urine;

  
  


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  numbness, tingling, pain, or weakness of your arms or legs; or

  
  


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  fainting.

  
  

Other, less serious side effects are more likely to occur. Continue to take hydralazine/hydrochlorothiazide/reserpine and talk to your doctor if you experience

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  mild fatigue, drowsiness, or dizziness;

  
  


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  headache;

  
  


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  water retention (swelling of the hands, feet, or ankles);

  
  


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  anxiety, depression, or nightmares;

  
  


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  diarrhea, nausea, vomiting , abdominal pain;

  
  


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  stuffy nose or a dry mouth;

  
  


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  muscle weakness or cramps;

  
  


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  increased hunger, thirst, or urination;

  
  


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  a rash;

  
  


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  sensitivity to sunlight; or

  
  


• impotence or difficulty ejaculating.

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.

What other drugs will affect Serpazide (hydralazine/hydrochlorothiazide/reserpine)?

Do not take this medication if you have taken a monoamine oxidase inhibitor (MAOI), such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate), in the last 14 days.

Before taking this medication, tell your doctor if you are taking any of the following drugs:

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  digoxin (Lanoxin, Lanoxicaps);

  
  


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  quinidine (Cardioquin, others);

  
  


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  lithium (Lithobid, Eskalith, others);

  
  


• a tricyclic antidepressant such as amitriptyline (Elavil, Endep), imipramine (Tofranil), nortriptyline (Pamelor), doxepin (Sinequan), and others;


• a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Anaprox, Aleve), and others;


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  an antidiabetic medicine such as glipizide (Glucotrol), glyburide (Micronase, Glynase, Diabeta), and others; or

  
  


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  a steroid medicine such as prednisone (Orasone, Deltasone), prednisolone (Delta Cortef, Prelone), methylprednisolone (Medrol), and others.

  
  

You may not be able to take hydralazine/hydrochlorothiazide/reserpine, or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

Also, before taking hydralazine/hydrochlorothiazide/reserpine, tell your doctor if you are taking any medicine to treat high blood pressure, water retention, heart problems, prostate problems, or another condition. Some medicines used to treat these conditions may interact with hydralazine/hydrochlorothiazide/reserpine, and the interaction may increase the effects on your heart.

Hydralazine/hydrochlorothiazide/reserpine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

Drugs other than those listed here may also interact with hydralazine/hydrochlorothiazide/reserpine or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Serpazide resources

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

• Ser-Ap-Es Prescribing Information (FDA)

Compare Serpazide with other medications

• High Blood Pressure

Where can I get more information?

• Your pharmacist has additional information about hydralazine/hydrochlorothiazide/reserpine written for health professionals that you may read.

What does my medication look like?

Hydralazine/hydrochlorothiazide/reserpine is available with a prescription under the brand name Ser-Ap-Es. 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.

Hydralazine/hydrochlorothiazide/reserpine strengths are as follows:

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  Ser-Ap-Es (25 mg/15 mg/0.1mg)--round, salmon-pink, dry-coated tablets

  
  

See also: Serpazide side effects (in more detail)