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Human

Apulset

Tablet

4 mg

GENERIC NAMEOndansetron Hydrochloride

MANUFACTURED BYAristopharma Ltd.

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Available Pack Sizes:4 Sizes

Purchase Option:Full Pack

Maximum Retail Price (MRP):

Quantity

৳ 6.00/ 30's

(Unit: ৳ 6.00 / 1 Tablet)

16263

Composition

Apulset-4 Tablet: Each tablet contains Ondansetron Hydrochloride USP equivalent to Ondansetron 4 mg.

Apulset-8 Tablet: Each tablet contains Ondansetron Hydrochloride USP equivalent to Ondansetron 8 mg.

Apulset Oral Solution: Each 5 ml solution contains Ondansetron Hydrochloride USP equivalent to Ondansetron 4 mg.

Apulset IV/IM Injection: Each 4 ml Injection contains Ondansetron Hydrochloride USP equivalent to Ondansetron 8 mg.

Description

Ondansetron is a selective 5-HT3 receptor antagonist. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. It is not certain whether ondansetron's antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine.

Indications

Apulset is indicated for the prevention and treatment of post-operative nausea and vomiting and for the management of nausea and vomiting induced by cytotoxic chemotherapy and nausea and vomiting associated with radiotherapy, either total body irradiation or single dose fraction or daily fractions to the abdomen. It is also used for the prevention and treatment of nausea and vomiting associated with pregnancy and gastroenteritis.

Dosage & Administration

Tablet & Oral Solution:

For adults:

Highly emetogenic chemotherapy: 24 mg once, 30 minutes before start of single-day chemotherapy.

Moderately emetogenic chemotherapy: 8 mg every 8 hours for 2 doses beginning 30 minutes before chemotherapy, then 8 mg every 12 hours for 1–2 days after chemotherapy completed.

Radiotherapy (Total body irradiation): 8 mg 1–2 hours before each fraction each day.

Radiotherapy (Single high-dose fraction to abdomen): 8 mg 1–2 hours before radiotherapy, then 8 mg every 8 hours for 1–2 days after completion.

Radiotherapy (Daily fractionated to abdomen): 8 mg 1–2 hours before radiotherapy, then 8 mg every 8 hours for each day of radiotherapy.

Post-operative nausea & vomiting: 16 mg 1 hour before induction of anesthesia.

For children:

Moderately emetogenic chemotherapy (4–11 years): 4 mg every 4 hours for 3 doses beginning 30 minutes before chemotherapy, then 4 mg every 8 hours for 1–2 days after completion.

Injection:

For adults:

Chemotherapy-induced: Infuse over 15 minutes: 0.15 mg/kg (max 16 mg/dose) IV every 4 hours for 3 doses beginning 30 minutes before chemotherapy.

Post-operative: Infuse over 2–5 minutes (not less than 30 seconds): 4 mg IV as single dose immediately before induction of anesthesia, or shortly post-operatively; or 4 mg IM undiluted.

For children:

Chemotherapy-induced (6 months–18 years): Infuse over 15 minutes: 0.15 mg/kg (max 16 mg/dose) IV for 3 doses every 4 hours beginning 30 minutes before chemotherapy.

Post-operative (1 month–12 years): <40 kg: 0.1 mg/kg; ≥40 kg: 4 mg IV as a single dose.

Hepatic impairment: For severe hepatic dysfunction, do not exceed a total daily dose of 8 mg.

Interaction

Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of ondansetron. On the basis of available data, no dosage adjustment is recommended for patients on these drugs.

Contraindications

Ondansetron is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the components of the preparation.

Side Effects

The most common side effects reported after taking Ondansetron may include headache, diarrhea, fatigue, constipation, dizziness, drowsiness, hypoxia, pyrexia, pruritus etc.

Pregnancy & Lactation

Use in pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.

Use in nursing mothers: It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing woman.

Pediatric use: Can be given in children 1 month of age and above.

Geriatric use: No dosage adjustment is necessary in the elderly.

Precautions & Warnings

Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

Apulset • 30's

৳ 6.00