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Apulset

Ondansetron Hydrochloride

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.

Product Details

Presentation

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.

Pharmacology

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.

Indication

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:
Prevention of nausea & vomiting associated with chemotherapy: 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.
Prevention of nausea & vomiting associated with radiotherapy: Total body irradiation: 8 mg 1-2 hours before each fraction of radiotherapy administered each day. Single high-dose fraction radiotherapy to abdomen: 8 mg 1-2 hours before radiotherapy, then 8 mg every 8 hours after 1st dose for 1-2 days after radiation completed. Daily fractionated radiotherapy to abdomen: 8 mg 1-2 hours before radiotherapy, then 8 mg every 8 hours after 1st dose for each day of radiotherapy.
Prevention of post-operative nausea & vomiting: 16 mg 1 hour before induction of anesthesia.

For children:
Prevention of nausea & vomiting associated with highly emetogenic chemotherapy, radiotherapy, or <4 yrs of age: not recommended. Prevention of nausea & vomiting associated with moderately emetogenic chemotherapy (4-11 yrs): 4 mg every 4 hours for 3 doses beginning 30 minutes before chemotherapy, then 4 mg every 8 hours for 1-2 days after chemotherapy completed.

Injection:
For adults:
Prevention of nausea & vomiting associated with chemotherapy: Infuse over 15 minutes. 0.15 mg/kg (max 16 mg/dose) IV every 4 hours for 3 doses beginning 30 minutes before chemotherapy.
Prevention of post-operative nausea & vomiting: Infuse in not less than 30 seconds, preferably over 2-5 minutes: 4 mg IV as single dose immediately before induction of anesthesia; or shortly post-operative if nausea or vomiting occurs. Or, may use 4 mg IM undiluted as a single injection.
For children:
Prevention of nausea & vomiting associated with chemotherapy: Infuse over 15 minutes. 6 months-18 yrs: 0.15 mg/kg (max 16 mg/dose) IV for 3 doses every 4 hours beginning 30 minutes before chemotherapy.
Prevention of post-operative nausea & vomiting: Infuse in not less than 30 seconds, preferably over 2-5 minutes. 1 month-12 yrs (<40 kg): 0.1 mg/kg; 40 kg: 4 mg. Give IV as single dose immediately before induction of anesthesia; or shortly post-op if nausea or vomiting occurs.

Dosage adjustment for patients with impaired hepatic function:
The dosage recommendation is the same as for the general population. For severe hepatic dysfunction a total daily dose of 8 mg should not be exceeded.

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.

Warning & Precautions

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.

Side effects

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

Drug 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.

Use in special groups

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.

Packing

Apulset-4 Tablet: Each box contains 30 tablets in blister/strip pack.
Apulset-8 Tablet: Each box contains 30 tablets in blister/strip pack.
Apulset Oral Solution: Each bottle contains 50 ml oral solution.
Apulset IV/IM Injection: Each box contains 5 ampoules in blister pack.

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