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 ?
It was reported on Friday that the contract has been signed for commercialisation and promotion of Sancuso (granisetron transdermal delivery system) in the People's Republic of China excluding Taiwan, Hong Kong, Macau and the Retained Territory.
The EMA has granted approval for ProStrakan Group to market SANCUSO (Granisetron Transdermal System) in the EU, with 3M Drug Delivery Systems as the manufacturer.
ProStraken, based in Galashiels in the Borders, have developed Sancuso, a drug for chemotherapy patients which eases symptoms of nausea and vomiting.
Subsequent approval by the US Food and Drug Administration (FDA), ProStrakan plans to market Rapinyl alongside its other oncology support product, Sancuso for the prevention of chemotherapy-induced nausea & vomiting (CINV), which is currently under consideration for approval by the FDA.
According to Solasia, Sancuso is the first and only commercialised extended release granisetron transdermal product.
M2 EQUITYBITES-3 March 2010-Solasia Pharma and Kyowa Hakko Kirin sign licence agreement forA Sancuso in Asia(C)2010 M2 COMMUNICATIONS http://www.
PROSTRAKAN, a Borders pharmaceutical group, have signed a distribution agreement in South Korea with LG Life Sciences for Sancuso, a patch to prevent chemotherapy-induced nausea and vomiting.