SOSVOMIT 8

COMPOSITION

Each tablet contains: Ondansetron 8 mg

Excipients: Mannitol, Low-substituted hydroxypropyl cellulose, Microcrystalline cellulose 101, Erythorsine dye, Sucralose, Peppermint oil, Xylitol, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate, Talc q.s. 1 tablet

INDICATIONS

• Prevention of cancer chemotherapy-induced nausea and vomiting (in particular induced by cisplatin), for the patients who had proved resistant or had a lot of side effects to conventional antiemetic therapy.
• Prevention of nausea and vomiting associated with radiotherapy.
• Prevention of postoperative nausea and/or vomiting.

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 < 1000 mg, etoposide, 5-fluorouracil, vinblastine, vincristin).

DOSAGE & ADMINISTRATION

Prevention of chemotherapy and radiotherapy-induced nausea and vomiting

• Adults: The emetogenic potential of chemotherapy varies according to the different chemotherapy, depending on the doses, therapy combinations and individual sensitivity. The dose of ondansetron, therefore, must be individualized between 8 – 32 mg/ 24 hours intravenously or per-orally.

Usual dose of 8 mg (1 tablet of SOSVOMIT 8 or 2 tables of SOSVOMIT 4) is given 1 - 2 hours before chemotherapy or radiotherapy, followed by 8 mg orally 12 hourly. To protect against delayed or prolonged emesis after the first 24 hours, SOSVOMIT should be continued orally, 8 mg twice daily, 4 hours apart, for up to 5 days after a course of treatment.

• Children 4-12 years: Starting with ondansetron, one dose of 5 mg/m²body surface area (or15 mg/kg) is given intravenous immediately before chemotherapy, followed by 4 mg orally every 12 hours (1 tablet SOSVOMIT 4), for up to 5 days.

Little information is available about the dosage for the children 3 years of age or younger.

Prevention of Postoperative Nausea and Vomiting:

• Adults: a single dose of 16 mg ondansetron (4 tablets of SOSVOMIT 4 or 2 tablets of SOSVOMIT 8) given orally 1 hour before induction of anesthesia.
• Pediatric Use: There is no experience with the use of oral ondansetron in the prevention of post-operative nausea and vomiting in pediatric patients.
• Patients with liver impairment: maximum daily dose is 8 mg in cirrhotic patients and severe hepatic diseases.
• Elderly patients: The dosage recommendation is the same as for the general population.
• Patients with impaired renal function: no specific studies have been conducted.

CONTRAINDICATIONS

Hypersensitivity to 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.

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: no data available. Caution should be exercised when the drug is administered to a nursing woman.

PRESENTATION: Blisters of 10 tablets, box of 3 blisters.

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 JSPC

Nhon Trach 3 Industrial Park, Nhon Trach, Dong Nai.

Tel: 02513 566 202    -     Fax: 02513 566 203