SOSVOMIT^® 8 ODT

COMPOSITION

Each orally disintegrating tablet (ODT) contains:

Ondansetron……………………………8 mg

Excipients: Microcelac 100, Microcrystalline cellulose, Crospovidone, Sodium lauryl sulfate, Sucralose, Oder of ginger, Colloidal anhydrous silica, Magnesium stearate.

INDICATIONS

• Prevention ofnausea and vomiting associated with highly emetogenic cancer  chemotherapy, including cisplatin ≥ 50 mg/m².
• Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
• Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total bodyirradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
• Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, SOSVOMIT^® ODT (Orally disintegrating tablet) is recommended even where the incidenceof postoperative nausea and/or vomiting is low.

Notes: Ondansetron should be prescribed only for young patients (<45 years of age) who are more likely to develop extrapyramidal reactions to high dose metoclopramide and who are received highly emetogenic chemotherapeutic agents.  This drug is still prescribed for elderly patients. Ondansetron should also not be prescribed for chemotherapeutic agents with a low emetogenic potential (e.g bleomycin, busulfan, cyclophosphamide < 1.000 mg, etoposide, 5-fluorouracil, vinblastine, vincristin).

DOSAGE & ADMINISTRATION

Instructions for Use/Handling SOSVOMIT^® 8 ODT Orally Disintegrating Tablets

Do not attempt to push SOSVOMIT^® 8 ODT Tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the SOSVOMIT^® 8 ODT Tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

The recommended adult oral dosage of SOSVOMIT^® 8 ODT is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m². Multiday, single-dose administration of a 24 mg dosage has not been studied.

Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

Geriatric Use: The dosage recommendation is the same as for the general population.

Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: 

The recommended adult oral dosage is one 8-mg SOSVOMIT^® 8 ODT tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg SOSVOMIT^® 8 ODT tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is 4 mg ondansetron given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. 4 mg ondansetron should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

Geriatric Use: The dosage is the same as for the general population.

Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: 

The recommended oral dosage is one 8-mg SOSVOMIT^® 8 ODT tablet given 3 times a day.

For total body irradiation, one 8-mg SOSVOMIT^® 8 ODT tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

For single high-dose fraction radiotherapy to the abdomen, one 8-mg SOSVOMIT^® 8 ODT tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

For daily fractionated radiotherapy to the abdomen, one 8-mg SOSVOMIT^® 8 ODT tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Pediatric Use: There is no experience with the use of SOSVOMIT^® 8 ODT tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

Geriatric Use: The dosage recommendation is the same as for the general population.

Postoperative Nausea and Vomiting

The recommended dosage is 16 mg given as two 8-mg SOSVOMIT^® 8 ODT tablets 1 hour before induction of anesthesia.

Pediatric Use: There is no experience with the use of SOSVOMIT^® 8 ODT tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

Geriatric Use: The dosage is the same as for the general population.

Dosage Adjustment for Patients With Impaired Renal Function

The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

Dosage Adjustment for Patients With Impaired Hepatic Function

In patients with severe hepatic impairment (Child-Pugh 2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

CONTRAINDICATIONS

The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.

Hypersensitivity to ondansetron, other selective 5-HT₃ receptor antagonists (e.g. granisetron, dolasetron) or any component of the preparation.

PRECAUTIONS

Ondansetron should be used on the scheduled basis, not as a “as need” basis, since data supports the use of this drug in the prevention of nausea and vomiting and not in the rescue of nausea and vomiting.

Serotonin Syndrome: Advise patients of the possibility of serotonin syndrome with concomitant use of ondansetron and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms.

Ondansetron prolongs the QT interval in a dose-dependent manner. In addition, post- marketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT syndrome. Ondansetron should be administered with caution to patients who have or may develop prolongation of QTc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation or electrolyte abnormalities.

Ondansetron should be used only in the first 24 - 48 hours of receiving chemotherapy.

Paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function.

Ondansetron should be used with caution in patients with suspected intestinal obstruction and elderly patients with hepatic impairment.

PREGNANT and LACTATING WOMEN

Pregnancy: no data available on crossing the placenta. This drug should be used during pregnancy only if clearly needed.

Lactating women: Ondansetron is excreted in the breast milk of rats. It is not known whether ondansetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ondansetron is administered to a nursing woman.

PRESENTATION: Blisters of 10 tablets, 1 blister/ aluminum pouch/ box, 3 blister/ aluminum pouch/ box or 10 blister/ aluminum pouch/ box.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured and Distributed by: AMPHARCO U.S.A PJSC

Nhon Trach 3 Industrial Park, Hiep Phuoc, Nhon Trach, Dong Nai, Vietnam.

Tel: 02513 566 202    -     Fax: 02513 566 203