Emiset 8mg

Tablet
Ondansetron
Alco Pharma

Other Strength:

Alternative:
- Onsat 8mg
- PERISET 8mg
- Onaseron 8mg
- Ofran 8mg
- Emistat 8mg
- Osetron 8mg
- Emeset 8mg
- Apulset 8mg
- Emeren 8mg



Emiset
Composition:
Emiset 8 Tablet: Each tablet contains Ondansetron 8 mg as Ondansetron Hydrochloride USP.
Emiset Oral Solution: Each 5 ml solution contains Ondansetron 4 mg as Ondansetron Hydrochloride USP.

Pharmacology:
Pharmacokinetics
Absorption
Ondansetron Hydrochloride is well absorbed from the gastrointestinal tract and undergoes some first-pass metabolism. Mean bioavailability in healthy subjects is approximately 56% and bioavailability is also slightly enhanced by the presence of food at higher doses but unaffected by antacids.
Distribution
Ondansetron Hydrochloride is distributed with volume of distribution 1.9-2.6 L/Kg, indicating that much of the drug is taken up by body tissues. Circulating drug also distributes into erythrocytes. Plasma protein binding of Ondansetron Hydrochloride is 70% and crosses membranes readily.
Metabolism
Biotransformation pathways involve the primary metabolic pathway that is hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation.
Elimination
Ondansetron Hydrochloride is excreted in the urine (approximately 65%) and feces (35) after extensive hepatic metabolism. The plasma half-life of Ondansetron Hydrochloride is 3.5 hours.

Indication/Use:
For the prevention and treatment of post-operative nausea and vomiting and for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.

Dosage Guideline:
Prevention of chemotherapy induced nausea & vomiting (CINV):
Adult- tablet and oral solution: The recommended adult oral dosage of Emiset (Ondansetron) is 24 mg given as three 8 mg tablets in highly emetogenic chemotherapy. In case of moderately emetogenic chemotherapy the oral dose is one 8 mg Emiset (Ondansetron) tablet or 10 ml Emiset (Ondansetron) oral solution given twice daily.
Peditric patients- tablet and oral solution: for pediatric patients 4 through 11 years of age the dosage is one 4 mg Emiset tablet or 5 ml of Emiset oral solution should be administered 3 times a day for 1 to 2 days after completion of chemotherapy.
Radiotherapy induced nausea & vomiting:
Adult- tablet and oral solution: The recommended oral dosage is one 8 mg Emiset tablet or 10 ml of Emiset oral solution given 3 times daily.
Post operative nausea & vomiting (PONV):
Adult- tablet and oral solution: The recommended dosage is 16 mg given as two 8 mg Emiset tablets or 20 ml of Emiset oral solution 1 hour before induction of anesthesia.
Dosage adjustment for patients with impaired hepatic function:
Tablet and Oral Solution: The total daily dose of 8 mg should not be exceeded.

Side Effects:
Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported.

Contraindication:
Ondansetron Hydrochloride is contraindicated for patients known to have hypersensitivity to the drug.

Drug Interaction:
Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, 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 of Ondansetron is recommended for patients on these drugs.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.

Use in Pregnancy & Lactation:
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women.
Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing woman.

Precaution:
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.

Therapeutic Class:
Antiemetic

Dosage Form:
Emiset 8 Tablet: Each box contains 3x10 tablets in blister pack.
Emiset Oral Solution: Each bottle contains 50 ml solution in PET bottle.

Storage:
Store in a cool & dry place, protected from light. Keep out of reach of children.


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