granisetron hydrochloride


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granisetron hydrochloride

Granisol, Kytril, Sancuso

Pharmacologic class: 5-hydroxytryptamine3 antagonist

Therapeutic class: Antiemetic

Pregnancy risk category B

Action

Binds to serotonin receptors in chemoreceptor trigger zone and vagal nerve terminals, blocking serotonin release and controlling nausea and vomiting

Availability

Injection: 1 mg/ml

Oral solution: 2 mg/10 ml in 30-ml bottles

Tablets: 1 mg

Transdermal system (patch): 52-cm2 patch (containing 34.3 mg granisetron delivering 3.1 mg/24 hours)

Indications and dosages

To prevent nausea and vomiting caused by chemotherapy

Adults and children ages 2 to 16: For I.V. use, 10 mcg/kg I.V. within 30 minutes before chemotherapy. For P.O. use (adults only), 1 mg P.O. b.i.d., with first dose given at least 1 hour before chemotherapy and second dose given 12 hours later on days when chemotherapy is administered; or 2 mg P.O. daily at least 1 hour before chemotherapy. For transdermal use (adults only), apply patch for up to 7 days.

To prevent nausea and vomiting caused by radiation therapy

Adults: 2 mg P.O. daily within 1 hour of radiation therapy

Acute postoperative nausea and vomiting

Adults: 1 mg I.V. undiluted, administered over 30 seconds

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• pregnant or breastfeeding patients
• children younger than age 18 (safety of P.O. and transdermal use not established)
• children younger than age 2 (safety of I.V. use not established).

Administration

• For I.V. infusion, dilute with 20 to 50 ml of normal saline solution or dextrose 5% in water.
• Infuse I.V. over 5 minutes, starting 30 minutes before chemotherapy.
• For direct I.V. injection, give undiluted over 30 seconds.
• Don't mix I.V. form with other drugs.
• For P.O. use, give first dose 1 hour before chemotherapy and second dose 12 hours after first.
• Apply a single transdermal patch to upper outer arm for 24 to 48 hours before chemotherapy.
• Remove patch a minimum of 24 hours after chemotherapy completion. Patch may be worn up to 7 days depending on duration of chemotherapy.

Adverse reactions

CNS: headache, anxiety, stimulation, weakness, drowsiness, dizziness

CV: hypertension

GI: nausea, vomiting, diarrhea, constipation, abdominal pain

Hematologic: anemia, leukopenia, thrombocytopenia

Skin: alopecia, application site reactions (patch)

Other: altered taste, decreased appetite, fever, chills, shivering

Interactions

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase: increased levels

Electrolytes: altered levels

Hemoglobin, platelets, white blood cells: decreased levels

Drug-herbs.Horehound: enhanced serotonergic effects

Patient monitoring

• Monitor hepatic enzyme levels and CBC with white cell differential.
• Monitor temperature and blood pressure. Have patient use caution when ambulating, to avoid orthostatic hypotension.
• Know that patch may be degraded by direct exposure to natural or artificial sunlight.

Patient teaching

• Instruct patient to apply a single transdermal patch to upper outer arm 24 to 48 hours before chemotherapy.
• Instruct patient to remove patch by gently peeling it off in a minimum of 24 hours after chemotherapy completion.
• Instruct patient to remove patch if a severe or generalized skin reaction (such as rash or itching) occurs.
• Advise patient to avoid direct exposure of application site to natural or artificial sunlight by covering site with clothing while wearing patch and for 10 days after patch removal.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Advise patient to minimize GI upset by eating frequent, small servings of healthy food.
• Tell patient he'll undergo regular blood testing during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests and herbs mentioned above.

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References in periodicals archive ?
Food and Drug Administration (FDA) has approved the Company's two abbreviated New Drug Applications (ANDAs) to market granisetron hydrochloride injection, USP (granisetron), an antiemetic used to prevent nausea and vomiting caused by chemotherapy.
Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Granisetron Hydrochloride Injection, 1 mg/mL, 1 mL single dose, and 1mg/mL, 4mL multiple dose vials, the generic equivalent of Hoffmann-LaRoche's Kytril Injection.
Granisetron Hydrochloride Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high dose cisplatin and radiation cancer therapy.
Food and Drug Administration ("FDA") for its Abbreviated New Drug Application for Granisetron Hydrochloride Tablets USP, 1 mg (base) ("granisetron tablets").
Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride Tablets, 1 mg (base).
Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has launched Granisetron Hydrochloride Injection, 0.
announced today the approval of its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride Tablets, 1mg by the U.
As the first company to file an ANDA with a Paragraph IV patent certification for Granisetron Hydrochloride Injection, 1 mg (base)/mL in 1 mL single-dose vials, Teva has been awarded 180 days marketing exclusivity for this product.
Our increased market penetration for our existing portfolio and the wide acceptance of our newly launched products Granisetron hydrochloride and Alginic Sodium Diester have contributed to the strong growth of our revenue," commented Ms.
Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride Injection, 1 mg/mL, 1 mL vials, USP, the generic equivalent of Hoffmann-La Roche's Kytril([R]) Injection.
Granisetron hydrochloride which was launched in the middle of the second quarter is experiencing encouraging sales.
OB) today announced it had received approval from the Chinese State Food and Drug Administration (SFDA) to manufacture and market its Granisetron Hydrochloride Injection product.