Streptozocin

Class: Antineoplastic Agents
VA Class: AN200
Chemical Name: 2-Deoxy-2-[[(methylnitrosoamino)carbonyl]amino]-d-glucose
Molecular Formula: C₈H₁₅N₃O₇
CAS Number: 18883-66-4
Brands: Zanosar

• Experience of Supervising Clinician


• 
  

  Administer only under supervision of qualified clinicians experienced in use of cytotoxic therapy.⁴ Hospitalization not required; however, adequate diagnostic and treatment facilities should be readily available to monitor drug tolerance and to manage complications.⁴

  
  

• Major Toxicities


• 
  

  Renal toxicity is dose related and cumulative; may be severe or fatal.⁴

  
  


• 
  

  Nausea and vomiting may be severe and/or treatment limiting.⁴

  
  


• 
  

  Hepatic dysfunction, diarrhea, and hematologic changes observed in some patients.⁴

  
  


• 
  

  Streptozocin is mutagenic.⁴ When given parenterally, found to be tumorigenic or carcinogenic in some rodents.⁴

  
  


• 
  

  Weigh benefits against known toxic effects; clinician must be familiar with prescribing information before beginning therapy.⁴

  
  

Introduction

Antineoplastic agent; a nitrosourea-derivative alkylating antibiotic.^{1 2 3 4 5 6 7 8 14 15 16 17 a}

Uses for Streptozocin

Pancreatic Islet Cell Carcinoma

Treatment of metastatic islet cell carcinoma of the pancreas;^{4 136} used alone^{3 13 26 33 34 35 36 37 38 40 41 42 43 71 72} or in combination with other antineoplastic agents (e.g., doxorubicin, fluorouracil).^{36 37 39 136}

Effective in patients with functional^{4 13 33 34 35 36 37 38 40 41 42 43 48 49 50 51 52 71 72 73 84 85 86 87 88 89 99 100 101 102} or nonfunctional^{4 33 37 39} and beta^{13 33 34 35 36 37 38 40 41 42 43 48 49 50 51 52 71 72} or non-beta^{37 73 84 85 86 87 88 89 99 100 101 102 103 104 105} islet cell tumors. Appears to be equally effective against functional or nonfunctional islet cell tumors.^{33 37}

Currently the most active single agent for treatment of metastatic islet cell carcinoma of the pancreas.^{3 26 33 34 35 36 37 38 40} Combination therapy with fluorouracil associated with higher overall and complete response rates; however, effect on survival not established.^{36 37 81 85 100}

Because tumor may be indolent,^{37 61 122} and because of streptozocin’s nephrotoxic^{4 33} and emetogenic¹²² potential, limit use to symptomatic or progressive metastatic disease.^{4 33 122}

Carcinoid Tumor and Syndrome

Palliative treatment of metastatic carcinoid tumor† or syndrome†.^{3 13 36 39 43 59 63 92 93 94 106 136}

Used alone^{36 43 59 106} or in combination with other antineoplastic agents^{3 63 94 136} (e.g., cyclophosphamide,⁹⁴ fluorouracil,^{94 136} cyclophosphamide with fluorouracil and doxorubicin³ ).

When used alone, objective responses were partial and of short duration.^{36 43 59 106} Exact role in combination chemotherapy not established.^{3 94}

Pancreatic Adenocarcinoma

Treatment of pancreatic adenocarcinoma†.^{3 36 40 43 59 62 69 70 74 75 76 77 78 110 111}

Minimally effective as single agent.^{36 40 43 59} Role in combination chemotherapy regimens not yet determined.^{3 76 77 122}

Streptozocin Dosage and Administration

General

• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastics.⁴

  
  


• 
  

  Use protective gloves during handling of streptozocin powder and preparation of solutions; topical contact may be carcinogenic hazard.⁴ (See Dermatologic Effects under Cautions.)

  
  


• 
  

  If skin or mucosal contact occurs, wash affected area(s) immediately and thoroughly with soap and water.⁴

  
  


• 
  

  Use antiemetic therapy to prevent acute and delayed emesis.¹³⁷ (See GI Effects under Cautions.)

  
  


• 
  

  Measure response to therapy by monitoring for decrease or disappearance of signs or symptoms of disease.^{3 13 33 34 35 36 37 38 40 41 42 43 48 49 50 51 52 55 71 72 79 80 81 82 83 84 85 86 87 88 89 91 99 101 103 104 105} For functional or nonfunctional islet cell tumors, monitor for reductions in tumor size and/or organomegaly (e.g., pancreatic and/or extrapancreatic masses).^{4 33 34 35 36 37 38 40 41 42 43 48 49 50 51 52 63 71 72 79 80 81 82 83 84 85 86 87 88 89 99 100 101 102 103 104 105} For functional tumors, also may monitor appropriate polypeptide hormone concentrations (e.g., insulin, gastrin).^{4 33 34 35 36 37 38 40 41 42 43 48 49 50 51 52 63 71 72 79 80 81 82 83 84 85 86 87 88 89 99 100 101 102 103 104 105}

  
  

Administration

Administer by direct IV injection^{3 4 32 35 37 40 43 70 73 74 77 79 83} or by IV infusion.^{3 4 13 35 38 40 42 60 81} Intra-arterial† infusion not recommended.^{3 4 33 35 71 73 79 80 89 118} (See Intra-arterial Infusion under Dosage and Administration.)

Contains no preservatives; vials not intended for multiple-dose withdrawal.⁴

IV Injection

For solution and drug compatibility information, see Compatibility under Stability.

Reconstitution

Reconstitute vial containing 1 g of streptozocin with 9.5 mL of 5% dextrose or 0.9% sodium chloride injection to provide a solution containing 100 mg/mL.⁴

Rate of Administration

Administer by rapid IV injection.^{4 32 35 37 40 70 74 77}

IV Infusion

For solution and drug compatibility information, see Compatibility under Stability.

Reconstitution

Reconstitute vial containing 1 g of streptozocin with 9.5 mL of 5% dextrose or 0.9% sodium chloride injection to provide a solution containing 100 mg/mL.⁴

Dilution

For IV infusion, may further dilute in 5% dextrose or 0.9% sodium chloride injection⁴ or in 5% dextrose and 0.9% sodium chloride injection.^{121 132}

Rate of Administration

Administer over a short or prolonged period.⁴

Usually administered as intermittent IV infusions over 15 minutes to 6 hours.^{13 35 38 40 42 43 73 78 81 83}

Continuous 5-day IV infusions may be associated with increased CNS toxicity.⁶⁰ (See CNS Effects under Cautions.)

Intra-arterial Infusion†

Not recommended by manufacturer pending evaluation of possibility that adverse renal effects may be evoked more rapidly.^b (See Renal Effects under Cautions.)

Administered via an appropriately placed catheter using a controlled-infusion device.^{35 71 73 79 80 118}

Dilution

Dilute in 5% dextrose or 0.9% sodium chloride injection.^{35 71 73 79 80 118}

Rate of Administration

Infuse over 1–2 hours.^{35 71 73 79 80 118}

Dosage

Optimize results and minimize adverse effects by basing dosage on clinical, renal, hematologic, and hepatic responses and tolerance of the patient.^{3 4 33}

Consult published protocols for dosages of streptozocin and other chemotherapeutic agents and for method and sequence of administration.^a

Do not administer repeat course until renal, hematologic, and hepatic functions are within acceptable limits.^{4 33} (See Renal Effects, Hematologic Effects, and also Hepatic Effects under Cautions.)

Adults

Pancreatic Islet Cell Carcinoma

Consecutive-Day Regimen

IV

500 mg/m² daily for 5 consecutive days; repeat every 6 weeks until optimal benefit or treatment-limiting toxicity occurs.⁴ Do not exceed 500 mg/m² daily.⁴

May produce more severe nausea and vomiting than weekly regimen; however, may be more tolerable and acceptable because of the longer interval between periods of treatment-induced nausea and vomiting.³⁷

Ideal duration of maintenance therapy unknown.⁴

Weekly Regimen

IV

Initially, 1 g/m² once weekly for two weeks; then, may increase dose if therapeutic response is not achieved and no clinically important drug-related toxicity occurs.⁴ Do not exceed single dose of 1.5 g/m²; higher dosages may cause azotemia.⁴

Median time to onset of therapeutic response is approximately 17 days;^{4 33} median total cumulative dose to onset of response is 2 g/m².^{4 33}

Median time to maximum therapeutic response is approximately 35 days;^{4 33} median total cumulative dose to achieve maximum response is 4 g/m².^{4 33}

Ideal duration of maintenance therapy unknown.⁴

Intra-arterial Regimen†

Intra-arterial

1–4 g/m² once every 1–6 weeks for at least 1–4 courses of therapy.^{33 35 71 73 79 80 89 118} Safety not established.^{4 33} (See Intra-arterial Infusion under Dosage and Administration.)

Prescribing Limits

Adults

Pancreatic Islet Cell Carcinoma

Consecutive-Day Regimen

IV

Maximum 500 mg/m² daily.⁴

Weekly Regimen

IV

Maximum 1.5 g/m² once weekly.⁴

Special Populations

Renal Impairment

Cl_cr 10–50 mL/minute: 75% of usual dosage.¹²⁰

Cl_cr <10 mL/minute: 50% of usual dosage.¹²⁰

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.⁴ Start at lower end of dosage range.⁴ (See Geriatric Use under Cautions.)

Cautions for Streptozocin

Warnings/Precautions

Warnings

Highly toxic, with low therapeutic index; therapeutic response not likely to occur without some evidence of toxicity.^{3 4 8 13 33} (See Boxed Warning.)

Renal Effects

Renal toxicity occurs in 25–75% of patients.^{3 13 33 43 59} Dose limiting and cumulative; may be severe or fatal.^{3 4 13 33 43 53 54 55 56 57 58 59}

Renal toxicity may manifest as azotemia, anuria, proteinuria, hypophosphatemia, hyperchloremia, and proximal renal tubular acidosis (possibly associated with Fanconi-like syndrome [e.g., glycosuria, acetonuria, aminoaciduria]).^{3 4 8 13 32 33 40 43 53 54 55 56 57 58 59} Hypokalemia and hypocalcemia also have occurred.³

Hypophosphatemia^{8 13 53 56} or mild proteinuria^{4 13 33 40 59} may be earliest sign of nephrotoxicity and may indicate impending further deterioration of renal function.^{3 4 40 53} Increased BUN and S_cr may occur later if streptozocin is continued.¹³

Mild adverse renal effects (e.g., mild proteinuria) may be reversible if streptozocin is discontinued; ^{3 13} however, nephrotoxicity may be irreversible or fatal if drug is continued despite nephrotoxic manifestations.^{3 13 33 39 56 57 58}

Intra-arterial† administration may increase risk and/or precipitate more rapid development of nephrotoxicity.^{33 b} (See Intra-arterial Infusion under Dosage and Administration.)

Nephrogenic diabetes insipidus reported rarely.^{4 135}

Long-term effects on renal function not fully known.⁵⁸ Cumulative, delayed nephrotoxicity and chronic renal failure reported rarely following discontinuance of streptozocin.⁵⁸

Manufacturer recommends obtaining serial urinalyses, Cl_cr, BUN, S_cr, and electrolyte concentrations prior to and at least weekly during streptozocin therapy and then weekly for 4 weeks after discontinuance of drug.⁴ Alternatively, some clinicians suggest that assessment of renal function prior to each course of therapy is sufficient in most patients.¹²² Serial urinalysis is particularly important for early detection of proteinuria; if proteinuria is detected, quantify with a 24-hour urine collection.⁴

Adequate hydration may help reduce risk of nephrotoxicity to renal tubular epithelium by decreasing renal and urinary concentrations of streptozocin and/or metabolites;^{4 8 13} however, role of hydration not clearly established.^{13 122}

Reduce dosage or discontinue streptozocin if substantial renal toxicity occurs.⁴

Use in patients with impaired renal function only when benefits outweigh known risk of nephrotoxicity.⁴ (See Renal Impairment under Cautions.)

Do not use in combination or concomitantly with other potential nephrotoxins.⁴ (See Nephrotoxic Drugs under Interactions.)

Dermatologic Effects

Possible carcinogenic hazard from topical exposure if improperly handled.^{4 132}

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and embryolethality demonstrated in animals.⁴ Use during pregnancy only when potential benefits justify possible risks to fetus.⁴

Major Toxicities

GI Effects

Severe nausea and vomiting occur in most patients (>90%),¹³⁷ usually beginning 1–4 hours following administration; may persist for ≥24 hours.^{3 13 33} May require discontinuance of streptozocin.^{3 4 13 33 37 137}

Incidence and/or severity of nausea and vomiting may be reduced with 5-day continuous IV infusions compared with rapid, intermittent IV administration.⁶⁰

Aggressive antiemetic therapy during early courses of emetogenic chemotherapy is the best way to prevent anticipatory nausea and vomiting.¹³⁷ Behavioral therapy may be useful; benzodiazepines also may be useful, although evidence is lacking.¹³⁷

To prevent acute emesis associated with highly emetogenic chemotherapy (e.g., streptozocin), ASCO recommends premedication with a 3-drug antiemetic regimen (a selective 5-HT₃ receptor antagonist, dexamethasone, and aprepitant);¹³⁷ currently available selective 5-HT₃ receptor antagonists (e.g., dolasetron, granisetron, ondansetron, palonosetron) are comparably effective.¹³⁷

To prevent delayed emesis, ASCO recommends administration of a 2-drug regimen (dexamethasone and aprepitant) following administration of highly emetogenic chemotherapy.¹³⁷

Diarrhea has occurred occasionally.^{3 4 33} Duodenal ulcer reported rarely; however, not directly associated with streptozocin.⁴⁰

Hematologic Effects

Mild to moderate myelosuppression (e.g., leukopenia, thrombocytopenia, anemia [decreased hematocrit and hemoglobin]) reported; ^{3 4 13 33} severe myelosuppression (e.g., substantial leukopenia and thrombocytopenia) leading to sepsis and death reported rarely.^{4 13 33} Cumulative and usually reversible;^{3 4 13 33} may be more severe in patients previously treated with other antineoplastic agents or radiation therapy.^{3 13 67 68} Leukocyte and platelet nadirs usually occur at 1–2 weeks after administration.¹³

Asymptomatic eosinophilia also reported; disappears following discontinuance of streptozocin.^{13 43 60}

Monitor CBC at least weekly.⁴ Adjust dosage or discontinue streptozocin as needed.⁴

Hepatic Effects

Minimal, transient increases in serum AST, ALT, LDH, and/or alkaline phosphatase concentrations reported.^{4 13 32 33 37} Increased serum bilirubin concentration³³ and hypoalbuminemia also reported.⁴ Severe and fatal hepatic effects reported rarely.⁶¹

Manufacturer recommends performing liver function tests at least weekly;⁴ alternatively, some clinicians recommend monitoring liver function just prior to initiating each course of therapy.¹³³ Adjust dosage or discontinue streptozocin as needed.⁴

Metabolic Effects

Mild to moderate, reversible abnormalities of glucose tolerance reported in some patients.^{3 4 32 33 43} Insulin shock with severe hypoglycemia, requiring treatment with IV dextrose, has occurred rarely in patients with insulinomas,^{4 8 33 61} usually within 24 hours after administration.³³

Glycosuria without hyperglycemia reported in some patients.^{32 33 40 43}

Local Effects

Manifestations of local inflammation (e.g., edema, erythema, burning, tenderness), usually resolving the same day or within a few days, reported following extravasation of streptozocin.⁴ Severe tissue lesions and necrosis also reported following extravasation.^{4 62}

Burning sensation, extending from site of injection up the arm, reported in some patients, especially following rapid IV injection.^{3 33 40}

CNS Effects

Confusion, lethargy, and depression reported with continuous IV infusion for 5 days;^{4 60} not associated with other methods of administration.³

General Precautions

Adequate Patient Evaluation and Monitoring

Monitor closely, particularly for evidence of adverse renal, hematologic, and hepatic effects.⁴ (See Renal Effects, Hematologic Effects, and also Hepatic Effects under Cautions.)

Do not administer repeat course until renal, hematologic, and hepatic functions are within acceptable limits.^{4 33}

Specific Populations

Pregnancy

Category D.⁴ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether streptozocin is distributed into milk.⁴ Discontinue nursing because of potential risk to nursing infants.^b

Pediatric Use

Safety and efficacy not established.^{63 132}

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; clinical experience has not revealed age-related differences.⁴ Select dosage with caution, usually starting at low end of dosage range. ⁴ (See Geriatric Patients under Dosage and Administration.)

Renal Impairment

Weigh benefit against risk of serious renal damage.⁴ (See Renal Effects under Cautions.) Dosage adjustments necessary based on degree of renal impairment.¹²⁰ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Severe nausea and vomiting,^{3 4 13 33 37 137} nephrotoxicity,^{3 4 13 53 54 55 56 57 58} myelosuppression.^{3 4 13 33}

Interactions for Streptozocin

Drugs that Decrease Hematopoiesis

Possible increased risk of hematologic toxicity.¹³²

Nephrotoxic Drugs

Possible cumulative nephrotoxicity; avoid combination or concomitant use.⁴

Specific Drugs

Drug	Interaction	Comments
Antineoplastics	Possible additive adverse effects (e.g., myelosuppression)4
Antineoplastics, nitrosoureas (e.g., carmustine)	Possible synergistic adverse hematologic effects; mechanism unknown3 68
Doxorubicin	Possible increased half-life of doxorubicin, resulting in severe myelosuppression4 61 67	Decrease doxorubicin dosage if used concurrently4 61 67
Phenytoin	Possible decreased cytotoxic effects of streptozocin on beta cells3 4 66	Avoid concomitant administration66

Streptozocin Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed following oral administration.^{7 126} Not active orally; must be administered IV.⁴

Distribution

Extent

Following IV or intraperitoneal administration in animals, rapidly distributed into liver, kidneys, intestine, and pancreas; lower concentrations in skeletal muscle, spleen, lungs, heart, and thymus.^{44 124 125}

Does not appear to cross the blood-brain barrier; however, metabolites readily distribute into CSF.⁴⁵

Readily crosses the placenta in monkeys.⁴ Not known whether streptozocin crosses the placenta or is distributed into milk in humans.⁴

Elimination

Metabolism

Extensively metabolized, probably in the liver and kidneys.^{3 4 44 45 46 47}

Elimination Route

Excreted principally in urine as unchanged drug (10%) and metabolites (60–70%).^{3 5 8 44 45 46 47} May be excreted in expired air (5%) or in feces (<1%).^{45 46}

Half-life

Biphasic;^{8 45 46} terminal half-life is approximately 35–40 minutes for streptozocin or >40 hours for metabolites.^{45 46}

Stability

Storage

Parenteral

Powder for Injection

2–8°C; protect from light.⁴ Store in carton.⁴

Reconstituted or diluted solution (i.e., diluted with 5% dextrose and 0.9% sodium chloride injection to final concentration of 2 mg/mL) stable for 48 hours at room temperature or for ≥96 hours at 2–8°C.^{121 123} However, because product contains no preservatives, manufacturer recommends discarding reconstituted or diluted solution within 12 hours after preparation.⁴

Compatibility

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

Drug Compatibility

Y-Site CompatibilityHID

Compatible

Amifostine

Etoposide phosphate

Filgrastim

Gemcitabine HCl

Granisetron HCl

Melphalan HCl

Ondansetron HCl

Teniposide

Thiotepa

Vinorelbine tartrate

Incompatible

Allopurinol sodium

Aztreonam

Cefepime HCl

Piperacillin sodium–tazobactam sodium

ActionsActions

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  Active against gram-positive and gram-negative bacteria;^{1 2 7 8} cytotoxicity precludes use as an anti-infective agent.^{3 15 16 17 18 19 20}

  
  


• 
  

  Precise mechanism unknown.^{4 5} Alkylates DNA, causing interstrand cross-linking.^{3 9 23 24 25} Weak alkylator compared with other nitrosoureas.^{3 12}

  
  


• 
  

  Inhibits DNA synthesis in bacterial and mammalian cells.^{3 4 9 10 12 15 21 22} Blocks progression of cells into mitosis;¹⁵ however, cycle-phase nonspecific.^{4 8 15} Does not inhibit RNA or protein synthesis.^{15 17 22}

  
  


• 
  

  Marked specificity for pancreatic beta and exocrine cells.^{8 18 26 28}

  
  

Advice to Patients

• 
  

  Risk of adverse renal, GI, hematologic, and hepatic effects.⁴ Importance of adherence to medical and laboratory appointment schedules.⁴

  
  


• 
  

  Possible confusion, lethargy, and depression if receiving continuous IV infusion for 5 days.⁴ Potential risk in driving or using complex machinery.⁴

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., renal disease).⁴

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.⁴

  
  


• 
  

  Importance of informing patients of other precautionary information.⁴ (See Cautions.)

  
  

Preparations

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

Streptozocin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	1 g	Zanosar (with anhydrous citric acid 220 mg)	Sicor

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 entir

Tussi-12D

Pronunciation: car-beta-PEN-tane/fen-ill-EF-rin/peer-IL-a-meen
Generic Name: Carbetapentane/Phenylephrine/Pyrilamine
Brand Name: Tussi-12D

Tussi-12D is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Tussi-12D is a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing, while the cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Tussi-12D if:

• you are allergic to any ingredient in Tussi-12D


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Tussi-12D:

Some medical conditions may interact with Tussi-12D. 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 a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Tussi-12D. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Tussi-12D may be increased


• Digoxin or droxidopa because risk of irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because side effects ma y be increased by Tussi-12D


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Tussi-12D

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tussi-12D 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 Tussi-12D:

Use Tussi-12D as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tussi-12D may be taken with or without food.


• If you miss a dose of Tussi-12D, 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 Tussi-12D.

Important safety information:

• Tussi-12D may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tussi-12D. Using Tussi-12D alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take diet or appetite control medicines while you are taking Tussi-12D without checking with your doctor.


• Tussi-12D contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Tussi-12D for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Tussi-12D may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tussi-12D. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• If you are scheduled for allergy skin testing, do not take Tussi-12D for several days before the test because it may decrease your response to the skin tests.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tussi-12D.


• Use Tussi-12D with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Tussi-12D in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tussi-12D, discuss with your doctor the benefits and risks of using Tussi-12D during pregnancy. It is unknown if Tussi-12D is excreted in breast milk. Do not breast-feed while taking Tussi-12D.

Possible side effects of Tussi-12D:

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:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

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: Tussi-12D 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Tussi-12D:

Store Tussi-12D at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tussi-12D out of the reach of children and away from pets.

General information:

• If you have any questions about Tussi-12D, please talk with your doctor, pharmacist, or other health care provider.


• Tussi-12D 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 Tussi-12D. 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 Tussi-12D resources

• Tussi-12D Side Effects (in more detail)
• Tussi-12D Use in Pregnancy & Breastfeeding
• Tussi-12D Drug Interactions
• Tussi-12D Support Group
• 0 Reviews for Tussi-12D - Add your own review/rating

• Tussi-12D Concise Consumer Information (Cerner Multum)

Compare Tussi-12D with other medications

• Cough and Nasal Congestion

Tracleer

Generic Name: bosentan (boe SEN tan)

Brand Names: Tracleer

What is Tracleer (bosentan)?

Bosentan prevents thickening of the blood vessels, especially those in the lungs and heart. Bosentan also lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Bosentan is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

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

What is the most important information I should know about Tracleer (bosentan)?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Your doctor may have you take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

Do not use this medication if you are allergic to bosentan, or if you are also taking cyclosporine (Sandimmune, Neoral, Gengraf), glyburide (Micronase, DiaBeta, Glynase Pres Tab), or HIV/AIDS medication that contains lopinavir or ritonavir (Kaletra, Norvir). Bosentan can cause severe liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking bosentan, and again each month during your treatment. Do not stop taking bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely.

What should I discuss with my healthcare provider before taking Tracleer (bosentan)?

Do not use this medication if you are allergic to bosentan, or if you:

• 
  

  are also taking HIV/AIDS medication that contains lopinavir or ritonavir (Kaletra, Norvir);

  
  


• 
  

  are also taking using glyburide (Micronase, DiaBeta, Glynase Pres Tab);

  
  


• 
  

  are pregnant or might become pregnant during treatment; or

  
  


• 
  

  are also using cyclosporine (Sandimmune, Neoral, Gengraf).

  
  

Bosentan can cause severe liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking bosentan, and again each month during your treatment. FDA pregnancy category X. This medication can cause birth defects. Do not use bosentan if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Your doctor may have you take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

It is not known whether bosentan passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

How should I take Tracleer (bosentan)?

Take bosentan exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

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

Bosentan can be taken with or without food.

Bosentan is usually taken twice a day, morning and evening.

Do not stop taking bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store bosentan at room temperature away from moisture and heat.

See also: Tracleer dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause headache, nausea, vomiting, increased heart rate and fainting or dizziness (low blood pressure).

What should I avoid while using Tracleer (bosentan)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using bosentan.

Tracleer (bosentan) 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. Call your doctor at once if you have any of these serious side effects:

• 
  

  nausea, stomach pain, loss of appetite;

  
  


• 
  

  dark urine, clay-colored stools; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  flushing;

  
  


• 
  

  swelling of the feet, ankles, or legs;

  
  


• 
  

  dizziness;

  
  


• 
  

  upset stomach;

  
  


• 
  

  fatigue; 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 Tracleer (bosentan)?

Do not take bosentan without first talking to your doctor if you are taking any of the following medicines:

• 
  

  amiodarone (Cordarone, Pacerone);

  
  


• 
  

  diltiazem (Tiazac, Cartia, Cardizem);

  
  


• 
  

  erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  tacrolimus (Prograf);

  
  


• 
  

  an antifungal medication such as ketoconazole (Nizoral), fluconazole (Diflucan), or itraconazole (Sporanox);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin); or

  
  


• 
  

  a cholesterol-lowering medicine such as simvastatin (Zocor), lovastatin (Mevacor), or atorvastatin (Lipitor).

  
  

This list is not complete and there may be other drugs not listed that can affect bosentan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Tracleer resources

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

• Tracleer Prescribing Information (FDA)


• Tracleer MedFacts Consumer Leaflet (Wolters Kluwer)


• Tracleer Monograph (AHFS DI)


• Tracleer Advanced Consumer (Micromedex) - Includes Dosage Information


• Bosentan Professional Patient Advice (Wolters Kluwer)

Compare Tracleer with other medications

• Pulmonary Arterial Hypertension

Where can I get more information?

• Your doctor or pharmacist can provide more information about bosentan.

See also: Tracleer side effects (in more detail)

Simponi SmartJect

Generic Name: golimumab (goe LIM ue mab)

Brand Names: Simponi, Simponi SmartJect

What is Simponi SmartJect (golimumab)?

Golimumab is a tumor necrosis factor (TNF) blocker. It works by reducing the effects of a substance in the body that can cause inflammation.

Golimumab is used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Golimumab is sometimes used with another medication called methotrexate (Rheumatrex, Trexall).

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

What is the most important information I should know about Simponi SmartJect (golimumab)?

You should not use this medication if you are allergic to golimumab, or if you are already using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), or infliximab (Remicade). Some people using golimumab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using golimumab or similar medicines to treat Crohn's disease or ulcerative colitis. Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Golimumab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with golimumab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, stomach pain, diarrhea, or muscle aches.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Tell your doctor about all of your medical conditions, especially if you have hepatitis, congestive heart failure, lupus, diabetes, cancer, HIV or a weak immune system, or multiple sclerosis.

Before using golimumab, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, if you have recently been vaccinated with BCG, or if you have recently traveled to an area where tuberculosis is common.

Before you start treatment with golimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Do not receive a "live" vaccine while you are being treated with golimumab.

What should I discuss with my healthcare provider before using Simponi SmartJect (golimumab)?

You should not use this medication if you are allergic to golimumab, or if you are already using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), or infliximab (Remicade). Some people using golimumab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using golimumab or similar medicines to treat Crohn's disease or ulcerative colitis.

However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.

Before using golimumab, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

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

• 
  

  an active or recent infection;

  
  


• 
  

  hepatitis B;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  lupus;

  
  


• 
  

  diabetes;

  
  


• 
  

  cancer, HIV, or a weak immune system;

  
  


• 
  

  an allergy to latex rubber;

  
  


• 
  

  a disease that affects the nerves or muscles, such as multiple sclerosis;

  
  


• 
  

  if you have recently been vaccinated with BCG (Bacille Calmette-Guerin); or

  
  


• 
  

  if you are scheduled to receive any vaccines.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether golimumab passes into breast milk. Do not use golimumab without first talking to your doctor if you are breast-feeding a baby.

How should I use Simponi SmartJect (golimumab)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Golimumab is usually given once per month. Follow the directions on your prescription label.

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

Before you start treatment with golimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Golimumab 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.

Do not shake the golimumab prefilled syringe. Vigorous shaking can ruin the medicine. Do not use the medication if it has changed colors, is cloudy, or has any particles in it. Call your doctor for a new prescription.

Use a different place on your stomach, thigh, or upper arm each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Avoid injecting golimumab into skin that is scarred, bruised, red, tender, or hard.

Each single-use pre-filled syringe of golimumab is for one use only. Throw away the auto-injector after one use, even if there is still some medicine left in it after injecting your dose.

Throw away used needles and syringes in a puncture-proof container. If your medicine does not come with such a container, ask your pharmacist where you can get one. Keep this container out of the reach of children and pets. Your pharmacist can tell you how to properly dispose of the container.

Golimumab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with golimumab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, stomach pain, diarrhea, or muscle aches.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using golimumab. Visit your doctor regularly.

Store this medication in the refrigerator but do not allow it to freeze. Keep the medication in its original carton and protect from light. You may take the prefilled syringe or autoinjector out of the refrigerator and place it at room temperature for 30 minutes before giving your injection. Do not warm the medication with water or heat.

What happens if I miss a dose?

Use the medication as soon as you remember, and then go back to your regular injection schedule. Do not use 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.

What should I avoid while using Simponi SmartJect (golimumab)?

Do not receive a "live" vaccine while you are being treated with golimumab.

Simponi SmartJect (golimumab) 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 golimumab and call your doctor right away if you have any of these symptoms of lymphoma:

• 
  

  fever, night sweats, weight loss, tiredness;

  
  


• 
  

  feeling full after eating only a small amount;

  
  


• 
  

  pain in your upper stomach that may spread to your shoulder;

  
  


• 
  

  easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Stop using golimumab and call your doctor at once if you have any of these other serious side effects:

• 
  

  signs of infection (fever, chills, sore throat, flu symptoms, stomach pain, diarrhea, muscle aches);

  
  


• 
  

  shortness of breath with swelling of your ankles or feet;

  
  


• 
  

  chest pain, ongoing cough, coughing up mucus or blood;

  
  


• 
  

  cold sores;

  
  


• 
  

  vision changes, neck stiffness, seizure;

  
  


• 
  

  numbness or tingly feeling, weakness in your legs;

  
  


• 
  

  loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or

  
  


• 
  

  patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

  
  

Less serious side effects may include:

• 
  

  cold symptoms such as stuffy nose, sneezing, sore throat;

  
  


• 
  

  dizziness; or

  
  


• 
  

  redness 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 Simponi SmartJect (golimumab)?

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

• 
  

  abatacept (Orencia);

  
  


• 
  

  anakinra (Kineret);

  
  


• 
  

  rituximab (Rituxan);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  digoxin (digitalis, Lanoxin, Lanoxicaps);

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene); or

  
  


• 
  

  a heart rhythm medication such as disopyramide (Norpace), procainamide (Procan, Pronestyl), or quinidine (Quin-G).

  
  

This list is not complete and other drugs may interact with golimumab. 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 Simponi SmartJect resources

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

• Golimumab Professional Patient Advice (Wolters Kluwer)


• Golimumab Monograph (AHFS DI)


• golimumab Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information


• Golimumab MedFacts Consumer Leaflet (Wolters Kluwer)


• Simponi Prescribing Information (FDA)


• Simponi Consumer Overview

Compare Simponi SmartJect with other medications

• Ankylosing Spondylitis
• Psoriatic Arthritis
• Rheumatoid Arthritis

Where can I get more information?

• Your pharmacist can provide more information about golimumab.

See also: Simponi SmartJect side effects (in more detail)

Spectazole Topical

Generic Name: econazole (Topical route)

e-KON-a-zole

Commonly used brand name(s)

In the U.S.

• Spectazole

Available Dosage Forms:

• Cream


• Powder


• Solution

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For Spectazole

Econazole belongs to the family of medicines called antifungals, which are used to treat infections caused by a fungus. They work by killing the fungus or preventing its growth.

Econazole cream is applied to the skin to treat fungus infections. These include:

• ringworm of the body (tinea corporis);


• ringworm of the foot (tinea pedis; athlete's foot);


• ringworm of the groin (tinea cruris; jock itch);


• tinea versicolor (sometimes called ``sun fungus''); and


• certain other fungus infections, such as Candida (Monilia) infections.

Econazole is available only with your doctor's prescription.

Before Using Spectazole

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

Although there is no specific information comparing use of this medicine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of econazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 Spectazole

Apply enough econazole to cover the affected and surrounding skin areas, and massage in gently.

Keep this medicine away from the eyes.

When econazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over the medicine. To do so may cause irritation of the skin. Do not apply an airtight covering over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, it is very important that you keep using econazole for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .

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 topical dosage form (cream):
  
  • For fungus infections:
    
    • Adults and children—Apply to the affected skin and surrounding areas, one or two times a day, for two to four weeks. If you have to use the cream two times a day, apply it in the morning and evening.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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.

Precautions While Using Spectazole

If your skin problem does not improve within 2 weeks or more, or if it becomes worse, check with your doctor.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required.

• For patients using econazole for ringworm of the groin (tinea cruris; jock itch):
  
  • Avoid wearing underwear that is tight-fitting or made from synthetic materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.
  
  
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder (for example, tolnaftate) on the skin. It is best not to use econazole cream or any other antifungal cream at the same time that you use the powder.
  
  

These measures will help reduce chafing and irritation and will also help keep the groin area cool and dry.

• For patients using econazole for ringworm of the foot (tinea pedis; athlete's foot):
  
  • Carefully dry the feet, especially between the toes, after bathing.
  
  
  • Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if the feet sweat freely.
  
  
  • Wear well-ventilated shoes (for example, shoes with holes) or sandals.
  
  
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder (for example, tolnaftate) between the toes, on the feet, and in socks and shoes freely once or twice a day. It is best not to use econazole cream or any other antifungal cream at the same time that you use the powder.
  
  
  
  These measures will help keep the feet cool and dry.

If you have any questions about this, check with your health care professional.

Spectazole 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 as soon as possible if any of the following side effects occur:

Less common

• Burning, itching, stinging, redness, or other sign of irritation not present before use of this medicine

Rare

• Skin rash with itching

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: Spectazole Topical 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 Spectazole Topical resources

• Spectazole Topical Side Effects (in more detail)
• Spectazole Topical Use in Pregnancy & Breastfeeding
• Spectazole Topical Support Group
• 3 Reviews for Spectazole Topical - Add your own review/rating

Compare Spectazole Topical with other medications

• Cutaneous Candidiasis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Sodium Ferric Gluconate

Class: Iron Preparations
Molecular Formula: C₁₂H₂₂FeO₁₄
CAS Number: 299-29-6
Brands: Ferrlecit

Introduction

Hematinic agent;^{1 8 28} stable macromolecular complex composed of ferric oxide hydrate directly bonded to sucrose and chelated with gluconate.^{1 2 3}

Uses for Sodium Ferric Gluconate

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

Treatment of iron deficiency anemia in adult and pediatric hemodialysis patients receiving epoetin alfa therapy.^{1 15}

National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI) guidelines recommend regular use of IV iron to prevent functional (and absolute) iron deficiency and improve erythropoiesis in most hemodialysis patients receiving epoetin alfa therapy.⁵

Available data suggest that iron sucrose and sodium ferric gluconate may be associated less frequently with serious adverse effects (e.g., hypersensitivity reactions) than iron dextran.^{2 3 100 101}

Safety and efficacy not established for the prevention and/or treatment of iron deficiency anemia not associated with CRF (e.g., HIV- or cancer-related anemia).^{44 97}

Sodium Ferric Gluconate Dosage and Administration

General

• 
  

  Goal of iron therapy in patients with CFR is to achieve and maintain a transferrin saturation (TSAT) of at least 20% and a serum ferritin concentration of at least 100 ng/mL.⁵

  
  


• 
  

  Monitor maintenance iron status by measuring TSAT and serum ferritin concentration every 3 months.⁵

  
  

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer (diluted) by slow IV infusion or (undiluted) by slow IV injection.^{1 2 19}

Dilution

For IV infusion, dilute recommended adult or pediatric dosage in 100 or 25 mL of 0.9% sodium chloride, respectively.¹

Use immediately after dilution.¹

Rate of Administration

IV infusion: slowly (e.g., over 1 hour).^{1 3}

IV injection (adults): slowly, up to 12.5 mg/minute^{1 2} at the end of dialysis.^{6 7 16 21}

Dosage

Dosage is expressed in terms of mg of elemental iron.¹ Sodium ferric gluconate injection contains the equivalent of 12.5 mg of elemental iron per mL.¹

Pediatric Patients

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

1.5 mg/kg (up to 125 mg/dose) administered at or during hemodialysis for 8 sequential dialysis sessions.^a

Adults

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

125 mg administered at sequential dialysis sessions or during the dialysis session itself.^{1 3} Most patients will require a minimum cumulative dose of 1000 mg of elemental iron, administered over 8 sessions at or during sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response.^{1 3 5}

Once patients achieve TSAT levels ≥20% or serum ferritin concentrations ≥100 ng/mL, continue IV iron therapy at the lowest dose necessary to maintain target hematocrit/hemoglobin levels and iron stores within acceptable limits.¹ Weekly maintenance dosage of 25–100 mg of elemental iron for 10 weeks may be appropriate in hemodialysis patients once optimal hematocrit/hemoglobin stores are attained.⁵

If TSAT ≥50% or serum ferritin concentrations ≥800 ng/mL, withhold iron therapy for up to 3 months.⁵ IV iron therapy may be resumed at a dosage that is 33-50% of the previous iron dosage when TSAT and serum ferritin concentration have decreased to <50% and <800 ng/mL, respectively.⁵

Prescribing Limits

Pediatric Patients

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

Maximum dose: 125 mg per session.^a

Cautions for Sodium Ferric Gluconate

Contraindications

• 
  

  Known hypersensitivity to sodium ferric gluconate or any ingredient in the formulation.¹

  
  


• 
  

  Evidence of iron overload.¹

  
  


• 
  

  Anemias not associated with iron deficiency.¹

  
  

Warnings/Precautions

Warnings

Iron Overload

Not easily eliminated from the body (not dialyzable) and accumulation can be toxic; avoid unwarranted therapy.¹

Excess storage of iron may possibly result in a syndrome similar to hemosiderosis, particularly in patients whose anemia is not attributable to iron deficiency (e.g. those with hemoglobinopathies or other refractory anemias that might be erroneously diagnosed as iron deficiency anemia).^{1 8}

Sensitivity Reactions

Hypersensitivity Reactions

Potentially fatal sensitivity (e.g. anaphylactic or anaphylactoid) reactions possible; use with caution, particularly in patients with a history of allergic reactions to iron dextran.¹

If serious anaphylactoid reactions occur, institute appropriate resuscitative measures.¹

Major Toxicities

Overdose

Excessive dosing may lead to iron accumulation and hemosiderosis. Manifestations of acute toxicity in animals included decreased activity, staggering ataxia, increased respiratory rate, tremor and seizures. Not dialyzable.

General Precautions

Hypotension

Possible hypotension accompanied by flushing, lightheadedness, malaise, fatigue, weakness, or severe pain in the chest, back, flanks, or groin.¹ Such reactions are not associated with sensitivity and usually resolve within 1–2 hours.^{1 2} May require volume expansion if symptomatic.

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether sodium ferric gluconate is distributed into milk; use with caution in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <6 years of age.¹

Contains benzyl alcohol; not recommended for use in neonates.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; use caution in dosage selection and adjustment.¹

Titrate dosage carefully.¹

Common Adverse Effects

Hypotension, nausea, vomiting and/or diarrhea, pain, hypertension, allergic reaction, chest pain, pruritus, back pain.¹

Interactions for Sodium Ferric Gluconate

No formal drug interaction studies to date.¹

Specific Drugs

Drug	Interaction	Comment
ACE inhibitors	Possible potentiation of adverse effects (e.g., hypotension, sensitivity reactions) associated with IV iron therapy14	Use concomitantly with caution14
Iron, oral	Reduced absorption of oral iron1	Concomitant use not recommended1

Sodium Ferric Gluconate Pharmacokinetics

Distribution

Extent

Ferric iron in plasma combines with transferrin and is carried to the bone marrow and incorporated into hemoglobin.^{9 27 29 30 31}

Elimination

Half-life

Following IV administration, terminal elimination half-life of drug-bound iron was approximately 1 hour in healthy iron-deficient adults.¹

Following IV administration of 1.5 or 3 mg/kg, terminal elimination half-life was was 2 or 2.5 hours, respectively, in iron-deficient pediatric patients.^a

Special Populations

In vitro, <1% of the iron species in a single dose was removed during hemodialysis periods of up to 270 minutes using membranes with pore sizes corresponding to 12,000–14,000 daltons.⁹⁹

Stability

Storage

Parenteral

Injection

20–25°C (may be exposed to temperatures ranging from 15–30°C).¹ Do not freeze.¹

Compatibility

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

Parenteral

Sodium ferric gluconate should not be mixed with other drugs or added to parenteral nutrition solutions for IV infusion.¹

Solution Compatibility¹

Compatible
Sodium Chloride 0.9%

ActionsActions

• 
  

  Replenishs and maintains total body content of iron and has pharmacologic actions similar to those of iron dextran.^{1 8 28}

  
  


• 
  

  Unlike iron dextran, sodium ferric gluconate is free of ferrous ion and dextran polysaccharides and may be associated with fewer sensitivity reactions.^{1 2 3 10}

  
  

Advice to Patients

• 
  

  Risk of hypersensitivity (e.g., anaphylactoid) reactions.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 Cautions.)

  
  

Preparations

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

Sodium Ferric Gluconate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV use	equivalent to iron 12.5 mg/mL	Ferrlecit (with benzyl alcohol 0.9% and sucrose 20% w/v)	Watson

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 July 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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3. Nissenson AR, Lindsay RM, Swan S et al. Sodium ferric gluconate in sucrose is safe and effective in hemodialysis patients: North American clinical trial. Am J Kidney Dis. 1999; 33(3):471-82. [IDIS 424841] [PubMed 10070911]

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8. St. Peter WL, Lewis MJ. Chronic renal insufficiency and end stage renal disease. In: DiPiro JT, Talbert RL, Yee GC et al., eds. Pharmacotherapy: a pathophysiologic approach. 4th ed. Stamford: Appleton and Lange; 1999:752-7.

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