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

• 
  

  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

Flagyl I.V.

Generic Name: metronidazole (Oral route)

met-roe-NYE-da-zole

Oral route(Tablet;Tablet, Extended Release;Capsule)

Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided. Its use should be reserved only for conditions for which it is approved .

Commonly used brand name(s)

In the U.S.

• Flagyl


• Flagyl ER

Available Dosage Forms:

• Tablet, Extended Release


• Capsule


• Tablet


• Suspension

Therapeutic Class: Antibiotic

Chemical Class: Nitroimidazole

Uses For Flagyl I.V.

Metronidazole is used to treat bacterial infections in different areas of the body. The extended-release tablets are used to treat women with vaginal infections (bacterial vaginosis).

Metronidazole belongs to the class of medicines known as antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, metronidazole is used in certain patients with the following medical conditions:

• Clostridium difficile diarrhea or colitis (antibiotic-associated colitis).


• Crohn's disease (inflammatory bowel disease).


• Gastritis or stomach ulcers due to Helicobacter pylori.


• Giardiasis (parasite infection in the intestines).

Before Using Flagyl I.V.

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of metronidazole to treat bacterial infections in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of metronidazole in children with amebiasis.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metronidazole in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution and an adjustment in the dose for patients receiving metronidazole.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

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

• Amprenavir


• Disulfiram

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

• Amiodarone


• Busulfan


• Fluorouracil


• Mycophenolate Mofetil


• Warfarin

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

• Carbamazepine


• Cholestyramine


• Cyclosporine


• Lithium


• Milk Thistle


• Tacrolimus

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Leukopenia (low white blood cells), history of or


• Optic neuropathy (eye disease with vision changes), history of or


• Oral thrush (Candida infection) or


• Peripheral neuropathy (nerve disease with pain, numbness, or tingling), history of or


• Seizures, history of or


• Vaginal yeast infection (Candida infection)—Use with caution. May make these conditions worse.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of metronidazole

This section provides information on the proper use of a number of products that contain metronidazole. It may not be specific to Flagyl I.V.. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

The regular tablet or capsule can be taken with or without food. If the medicine upsets your stomach, it is best to take it with a meal or snack.

The extended–release tablet must be taken without food, one hour before or two hours after a meal.

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

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop using this medicine too soon, your infection may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times during the day. If you need help planning the best times to take your medicine, check with your doctor.

If you have taken a medicine called disulfiram (Antabuse®) within the last 2 weeks, do not take metronidazole until you talk to your doctor. Disulfiram is used to help people who have a drinking problem. If these 2 medicines are taken close together, serious unwanted effects may occur.

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 oral dosage forms (capsules or tablets):
  
  • For amebiasis infections:
    
    • Adults and teenagers—500 or 750 milligrams (mg) 3 times per day for 5 to 10 days.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 35 to 50 milligrams (mg) per kilogram (kg) of body weight per day, divided and given in 3 doses, for 10 days.
    
    
  
  
  • For bacterial infections:
    
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 milligrams (mg) per kilogram (kg) of body weight, up to a maximum dose of 1 gram, every 6 hours for 7 to 10 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For trichomoniasis infections:
    
    • Adults and teenagers—The tablet can be given 3 different ways: as a single dose of 2 grams; or as 1 gram 2 times per day for 1 day; or as 250 milligrams (mg) 3 times per day for 7 days. The capsule dose is 375 mg 2 times per day for 7 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (extended-release tablets):
  
  • For bacterial vaginosis:
    
    • Adults and teenagers—750 milligrams (mg) once a day for 7 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Flagyl I.V.

It is important that your doctor check your progress after you finish taking this medicine. This is to make sure that the infection is cleared up. Blood tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days after you start this medicine or if they become worse, check with your doctor.

Drinking alcoholic beverages while using this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (e.g., elixirs, cough syrups, tonics) may also cause problems. These problems may last for at least one day after you stop using metronidazole. This medicine may also cause alcoholic beverages to taste different. You should not drink alcoholic beverages or take other alcohol-containing preparations while you are using this medicine and for at least 3 days after stopping it.

Using this medicine while you are pregnant (especially during the first 3 months of pregnancy) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you are using this medicine for trichomoniasis (an infection of the sex organs in men or women), your doctor may want to treat your sexual partner at the same time you are being treated, even if he or she has no symptoms. Also, it may be desirable to use a condom (rubber) during sexual intercourse. These measures will help to keep you from getting the infection back again from your partner. If you have any questions about this, check with your doctor.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Check with your doctor right away if you have dizziness, problems with muscle control or coordination, shakiness or an unsteady walk, slurred speech, or trouble with speaking. These may be symptoms of a serious brain condition called encephalopathy.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

Metronidazole may cause dry mouth, an unpleasant or sharp metallic taste, and a change in taste sensation. For temporary relief of dry mouth, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. If your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

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

Flagyl I.V. Side Effects

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

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

More common

• Agitation


• back pain


• blindness


• blurred vision


• burning, numbness, tingling, or painful sensations in the hands or feet


• changes in speech patterns


• confusion


• convulsions


• decreased vision


• depression


• dizziness


• drowsiness


• eye pain


• fever


• hallucinations


• headache


• irritability


• lack of coordination


• mood or mental changes


• nausea


• seizures


• shakiness and unsteady walk


• slurred speech


• stiff neck or back


• trouble with speaking


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual tiredness or weakness


• vomiting


• weakness in the arms, hands, legs, or feet

Less common

• Black, tarry stools


• blood in the urine or stools


• body aches or pain


• chills


• clumsiness or unsteadiness


• difficulty with breathing


• ear congestion


• feeling of pelvic pressure


• frequent or painful urination


• loss of voice


• nasal congestion


• pinpoint red spots on the skin


• runny nose


• skin rash, hives, redness, or itching


• sneezing


• stomach and back pain (severe)


• unusual bleeding or bruising


• vaginal irritation, discharge, or dryness not present before taking the medicine

Rare

• Bleeding gums


• bloating


• chest pain


• constipation


• cough


• dark-colored urine


• fast heartbeat


• indigestion


• loss of appetite


• painful or difficult urination


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


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• yellow eyes or skin

Incidence not known

• Blistering, peeling, or loosening of the skin


• bloody or cloudy urine


• burning while urinating


• continuing diarrhea


• continuing stomach pain


• diarrhea


• feeling of warmth


• increased volume of pale, dilute urine


• joint or muscle pain


• loss of bladder control


• red irritated eyes


• red skin lesions, often with a purple center


• redness of the face, neck, arms, and occasionally, upper chest


• redness of the skin

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

More common

• Abdominal or stomach cramps


• dizziness or lightheadedness


• feeling of constant movement of self or surroundings


• heartburn


• sensation of spinning


• sleeplessness


• trouble sleeping


• unable to sleep


• weight loss

Less common or rare

• Change in taste sensation


• congestion


• dry mouth


• pain or tenderness around the eyes and cheekbones


• stuffy nose


• tender, swollen glands in the neck


• trouble with swallowing


• unpleasant or sharp metallic taste


• voice changes

Incidence not known

• Decreased interest in sexual intercourse


• inability to have or keep an erection


• loss in sexual ability, desire, drive, or performance


• painful sexual intercourse

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: Flagyl I.V. 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 Flagyl I.V. resources

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

• Flagyl Prescribing Information (FDA)


• Flagyl Consumer Overview


• Flagyl Monograph (AHFS DI)


• Flagyl MedFacts Consumer Leaflet (Wolters Kluwer)


• Flagyl ER Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Flagyl ER Prescribing Information (FDA)


• Metronidazole Prescribing Information (FDA)


• Metronidazole Professional Patient Advice (Wolters Kluwer)


• Metronidazole MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Flagyl I.V. with other medications

• Amebiasis
• Aspiration Pneumonia
• Bacteremia
• Bacterial Infection
• Bone infection
• Clostridial Infection
• Crohn's Disease, Acute
• Crohn's Disease, Maintenance
• Deep Neck Infection
• Dental Abscess
• Diverticulitis
• Dracunculiasis
• Endocarditis
• Giardiasis
• Helicobacter Pylori Infection
• Intraabdominal Infection
• Joint Infection
• Meningitis
• Pelvic Inflammatory Disease
• Peritonitis
• Pneumonia
• Pseudomembranous Colitis
• Skin Infection
• Surgical Prophylaxis
• Trichomoniasis

Triprolidine/Chlophedianol Liquid

Pronunciation: trye-PROE-li-deen/KLOE-fe-DYE-a-nol
Generic Name: Triprolidine/Chlophedianol
Brand Name: Prohist CF

Triprolidine/Chlophedianol Liquid is used for:

Relieving cough and other symptoms, such as runny nose and sneezing, due to colds, hay fever, or allergies. It may also be used for other conditions as determined by your doctor.

Triprolidine/Chlophedianol Liquid is an antihistamine and cough suppressant combination. The antihistamine works by blocking histamine, which reduces allergy symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Triprolidine/Chlophedianol Liquid if:

• you are allergic to any ingredient in Triprolidine/Chlophedianol Liquid


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


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (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 Triprolidine/Chlophedianol Liquid:

Some medical conditions may interact with Triprolidine/Chlophedianol Liquid. 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, tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; a stroke; glaucoma or increased pressure in the eyes; a blockage of your stomach, intestines, or bladder; ulcers; trouble urinating; an enlarged prostate; seizures; or an overactive thyroid


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

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

• Furazolidone, linezolid, MAOIs (eg, phenelzine), or sodium oxybate (GHB) because the risk of serious side effects, such as severe low blood pressure, severe drowsiness, breathing problems, fever, severe muscle problems, and possibly death, may be increased by Triprolidine/Chlophedianol Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triprolidine/Chlophedianol Liquid 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 Triprolidine/Chlophedianol Liquid:

Use Triprolidine/Chlophedianol Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Triprolidine/Chlophedianol Liquid by mouth with or without food.


• 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 miss a dose of Triprolidine/Chlophedianol Liquid and you are taking it regularly, 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 Triprolidine/Chlophedianol Liquid.

Important safety information:

• Triprolidine/Chlophedianol Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Triprolidine/Chlophedianol Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Triprolidine/Chlophedianol Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not drink alcohol while you are taking Triprolidine/Chlophedianol Liquid.


• Do NOT exceed the recommended dose or take Triprolidine/Chlophedianol Liquid for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days, if they become worse, if they go away and then come back, or if new symptoms occur, check with your doctor.


• If your symptoms occur along with a fever, rash, or persistent headache, check with your doctor.


• Do not use Triprolidine/Chlophedianol Liquid for cough with a lot of mucus. Do not use for long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Triprolidine/Chlophedianol Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Triprolidine/Chlophedianol Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Triprolidine/Chlophedianol Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Triprolidine/Chlophedianol Liquid for a few days before the tests.


• Tell your doctor or dentist that you take Triprolidine/Chlophedianol Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Triprolidine/Chlophedianol Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Triprolidine/Chlophedianol Liquid in CHILDREN; they may be more sensitive to its effects.


• Triprolidine/Chlophedianol Liquid should not be used in CHILDREN younger than 6 years without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Triprolidine/Chlophedianol Liquid while you are pregnant. Triprolidine/Chlophedianol Liquid is found in breast milk. If you are or will be breast-feeding while you take Triprolidine/Chlophedianol Liquid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Triprolidine/Chlophedianol Liquid:

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; 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, light-headedness, 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.

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, light-headedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Triprolidine/Chlophedianol Liquid:

Store Triprolidine/Chlophedianol Liquid 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 Triprolidine/Chlophedianol Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Triprolidine/Chlophedianol Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Triprolidine/Chlophedianol Liquid 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 Triprolidine/Chlophedianol Liquid. 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 Triprolidine/Chlophedianol resources

• Triprolidine/Chlophedianol Use in Pregnancy & Breastfeeding
• Triprolidine/Chlophedianol Drug Interactions
• Triprolidine/Chlophedianol Support Group
• 0 Reviews · Be the first to review/rate this drug

Stalevo 75

Generic Name: carbidopa, entacapone, and levodopa (Oral route)

lee-voe-DOE-pa, kar-bi-DOE-pa, en-TAK-a-pone

Commonly used brand name(s)

In the U.S.

• Stalevo 100


• Stalevo 125


• Stalevo 150


• Stalevo 50


• Stalevo 75

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Dopamine Precursor

Uses For Stalevo 75

Carbidopa, entacapone, and levodopa combination is used to treat Parkinson's disease, sometimes called shaking palsy. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord).

Dopamine is a naturally occurring substance in the brain that helps provide control of movement and activities such as walking and talking. In patients with Parkinson's disease, there is not enough dopamine in some parts of the brain. Levodopa (a component of this medicine) enters the brain and helps replace the missing dopamine, which allows people to function better. By increasing the amount of dopamine in the brain, levodopa helps control symptoms and helps you to perform daily activities such as dressing, walking, and handling utensils.

This medicine is a combination of three different medicines. This medicine is known as a levodopa therapy. The difference between this medicine and other levodopa treatments is that this medicine contains entacapone. Entacapone helps levodopa last longer by blocking a substance called COMT enzyme. This enzyme breaks down levodopa before it reaches the brain. When less levodopa is broken down, more is available to the brain. Increased availability of levodopa may lead to smoother and steadier levels of dopamine in the brain, which may provide better symptom control for longer periods each day. This may lead to improvement in daily activities.

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

Before Using Stalevo 75

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of carbidopa, entacapone, and levodopa combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date in elderly patients up to age 75 years have not demonstrated geriatrics-specific problems that would limit the usefulness of carbidopa, entacapone, and levodopa combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, and cardiovascular insufficiency, which may require extra caution.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Clorgyline


• Iproniazid


• Isocarboxazid


• Linezolid


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Selegiline


• Toloxatone


• Tranylcypromine

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

• Apomorphine


• Bitolterol


• Desipramine


• Dobutamine


• Dopamine


• Epinephrine


• Iproniazid


• Isocarboxazid


• Isoetharine


• Isoniazid


• Isoproterenol


• Linezolid


• Methyldopa


• Moclobemide


• Nialamide


• Norepinephrine


• Pargyline


• Phenelzine


• Procarbazine


• Tranylcypromine


• Venlafaxine

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

• Bromperidol


• Bupropion


• Droperidol


• Ferric Ammonium Citrate


• Fosphenytoin


• Indinavir


• Iron


• Kava


• Metoclopramide


• Phenylalanine


• Phenytoin


• Spiramycin


• Tyrosine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• High Protein Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Biliary obstruction or blockage or


• Colitis (inflammation of the colon) or


• Depression, history of or


• Dyskinesia (abnormal muscle movements) or


• Endocrine or metabolic disease or


• Heart attack, history of or


• Heart or blood vessel disease, severe or


• Heart rhythm problems (e.g., ventricular tachycardia) or


• Hypotension (low blood pressure) or


• Kidney disease or


• Liver disease or


• Lung disease, severe or


• Psychosis (mental disorder), or history of or


• Wide-angle glaucoma (eye pressure problem)—Use with caution. May make these conditions worse.

• Melanoma (skin tumor), history of or


• Narrow–angle glaucoma (eye pressure problem) or


• Skin lesions, undiagnosed (rashes that involve changes in color or texture of the skin)—Should not be used in patients with these conditions.

• Peptic ulcer, history of—May increase risk of stomach or bowel hemorrhage.

Proper Use of carbidopa, entacapone, and levodopa

This section provides information on the proper use of a number of products that contain carbidopa, entacapone, and levodopa. It may not be specific to Stalevo 75. Please read with care.

Take this medicine exactly as directed, and every time that you are supposed to take it. It is important that you do not stop taking your medicine unless ordered by your doctor. It is also important to not start taking other medicines for your Parkinson's disease without first talking with your doctor.

Since protein may interfere with the body's response to levodopa, high protein diets should be avoided. Intake of normal amounts of protein should be spaced equally throughout the day, or taken as directed by your doctor.

You may experience a “wearing-off” effect towards the end of the dosing interval. You should tell your doctor if you have problems with this that affect your every day life. Your doctor may want to adjust your dose.

This medicine begins to release its ingredients 30 minutes after you take it.

If you are taking multivitamin tablets or plan to start taking them, discuss this first with your doctor. Iron salts (in vitamins) may keep this medicine from working properly.

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 oral dosage forms (capsules or tablets):
  
  • For Parkinson's disease:
    
    • Adults—The starting dose is usually the same as the current dose you are taking. If you are starting this medicine for the first time, your doctor may want to start you on a carbidopa and levodopa combination with entacapone and gradually switch you over to this combination.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Stalevo 75

It is very important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects.

Do not take this medicine if you have taken a monoamine oxidase (MAO) inhibitor (e.g. phenelzine [Nardil®] or tranylcypromine [Parnate®]) in the past 2 weeks.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Check with your doctor right away if you are having convulsions (seizures); difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause dizziness, trouble in controlling movements, or trouble in concentrating or seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Dizziness, lightheadedness, or fainting may occur with this medicine, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may also help. If this problem continues or gets worse, check with your doctor.

This medicine may cause diarrhea, and in some cases it can be severe. It can occur months after starting this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Check with your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These may be symptoms of a condition called rhabdomyolysis.

Stop using this medicine and check with your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while being treated with this medicine.

It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.

It is possible that a dark color (red, brown, or black) may appear in saliva, urine, or sweat after taking this medicine. The color may cause some of your garments to become discolored. This is normal and nothing to worry about.

It is possible that you may become nauseous, especially when you are first starting your medicine.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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

Stalevo 75 Side Effects

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

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

More common-Entacapone

• Twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Incidence not known-Carbidopa and Levodopa and/or Levodopa alone

• Bleeding gums


• bloody or black, tarry stools


• bloody or cloudy urine


• change in size, shape, or color of an existing mole


• changes in skin color


• chest pain, discomfort, or tightness


• constipation


• constricted pupil


• convulsions


• cough


• difficult or labored breathing


• difficulty with speaking


• drooling


• drooping eyelid (ptosis)


• facial dryness


• fast, irregular, or pounding heartbeat


• fever with or without chills


• general feeling of illness


• hallucinations (seeing, hearing, or feeling things that are not there)


• hoarseness


• high or low blood pressure


• large, flat, blue, or purplish patches in the skin


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


• loss of appetite


• loss of bladder control


• lower abdominal or stomach pain


• lower back or side pain


• mole that leaks fluid or bleeds


• muscle cramps or spasms


• muscle pain or stiffness


• muscle trembling, jerking, or stiffness


• nausea


• pain


• painful or difficult urination


• pinpoint red spots on the skin


• raised red swellings on the skin, the buttocks, legs, or ankles


• restlessness


• seizures


• severe mental changes


• shakiness and unsteady walk


• shuffling walk


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• sweating


• swollen glands


• trembling, or other problems with muscle control or coordination


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting

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

More common-Entacapone

• Absence of or decrease in body movement


• diarrhea


• dizziness


• urine discoloration

Less common-Entacapone

• Acid or sour stomach


• anxiety


• belching


• bitter, sour, or unusual taste in the mouth


• bloated


• burning feeling in the chest or stomach


• dry mouth


• excess air or gas in the stomach or intestines


• fear


• full feeling


• heartburn


• hyperventilation


• increased sweating


• indigestion


• irritability


• lack or loss of strength


• nervousness


• passing gas


• restlessness


• sleepiness or unusual drowsiness


• stomach discomfort or upset


• swollen mouth and tongue


• tenderness in the stomach area


• trouble sleeping


• urge to have bowel movement


• wheezing

Incidence not known-Carbidopa and Levodopa and/or Levodopa alone

• Being forgetful


• bladder pain


• blurred vision


• body aches or pain


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


• burning and upper abdominal or stomach pain


• burning sensation of the tongue


• clenching, gnashing, or grinding teeth


• confusion about identity, place, and time


• dark saliva


• dark sweat


• decreased mental acuity


• difficulty swallowing


• discouragement


• double vision


• ear congestion


• enlarged pupils


• excessive watering of the mouth


• fainting


• false or unusual sense of well-being


• feeling like you will pass out


• feeling of warmth


• feeling sad or empty


• flushing


• hair loss


• headache


• hiccups


• hives or welts


• increased blinking


• increased interest in sexual ability, desire, drive, or performance


• increased interest in sexual intercourse


• lack of appetite


• large, hard skin blisters


• leg pain


• loss of voice


• muscle spasm, especially of the neck and back


• nasal congestion


• nightmares


• numbness


• pain in the chest below the breastbone


• painful or prolonged erection of the penis


• pharyngeal pain


• pounding in the ears


• problems with memory or speech


• redness of the face, neck, arms, and occasionally upper chest


• runny nose


• sense of stimulation


• skin rash


• sleeplessness


• slow movement


• slow or fast heartbeat


• slow reflexes


• sneezing


• swelling


• tremor, increased


• trouble concentrating


• trouble recognizing objects


• trouble thinking and planning


• urinary frequency


• urinary retention


• weight gain


• weight loss

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

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

See also: Stalevo 75 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.

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