Emestop

Emestop40 mg

Capsule

Aprepitant

Incepta Pharmaceuticals Ltd.

Product Code : 5705
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Medicine overview

Indications of Emestop 40 mg

Emestop 40 mg is indicated for- Prevention of postoperative nausea and vomiting (PONV) Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

Theropeutic Class

Anti-emetic drugs

Pharmacology

Emestop 40 mg is a selective high affinity antagonist of human substance P neurokinin 1 (NK1) receptors. When substance P attaches to these receptors, it causes nausea and vomiting. Emestop 40 mg stops substance P from binding to the NK1 receptors. By blocking the receptors, Emestop 40 mg can prevent nausea and vomiting, which often happens after chemotherapy or as a complication of surgery.

Dosage & Administration of Emestop 40 mg

Post Operative Nausea and Vomiting: The recommended oral dosage of Emestop 40 mg is 40 mg within 3 hours prior to induction of anesthesia. Chemotherapy Induced Nausea and Vomiting: Day 1: Emestop 40 mg 125mg orally, Dexamethasone 12 mg orally, 5-HT3 antagonist (Ondansetron): 24 mg 30 minutes before the start of chemotherapy. Day 2: Emestop 40 mg 80 mg orally, Dexamethasone 8 mg orally Day 3: Emestop 40 mg 80 mg orally, Dexamethasone 8 mg orally Day 4: Dexamethasone 8 mg orally Emestop 40 mg is administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. Dexamethasone is administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone accounts for drug interactions.The following regimen should be used for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy: Day 1: Emestop 40 mg 125mg orally, Dexamethasone 12 mg orally, 5-HT3 antagonist (Ondansetron): one 8 mg tablet 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Day 2: Emestop 40 mg 80 mg orally, 5-HT3 antagonist (Ondansetron): 8 mg tablet twice a day Day 3: Emestop 40 mg 80 mg orally, 5-HT3 antagonist (Ondansetron): 8 mg tablet twice a day. Emestop 40 mg is administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. Dexamethasone is administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for drug interactions.Emestop 40 mg may be taken with or without food. No dosage adjustment is necessary for the elderly patients.

Dosage of Emestop 40 mg

Post Operative Nausea and Vomiting: The recommended oral dosage of Emestop 40 mg is 40 mg within 3 hours prior to induction of anesthesia. Chemotherapy-Induced Nausea and Vomiting: ** The following regimen should be used for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy- Day 1: Emestop 40 mg 125 mg orally, Dexamethasone 12 mg orally, 5-HT3 antagonist (Ondansetron): 24 mg 30 minutes before the start of chemotherapy. Day 2: Emestop 40 mg 80 mg orally, Dexamethasone 8 mg orally Day 3: Emestop 40 mg 80 mg orally, Dexamethasone 8 mg orally Day 4: Dexamethasone 8 mg orally Emestop 40 mg is administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. Dexamethasone is administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone accounts for drug interactions.** The following regimen should be used for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy: Day 1: Emestop 40 mg 125 mg orally, Dexamethasone 12 mg orally, 5-HT3 antagonist (Ondansetron): one 8 mg tablet 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Day 2: Emestop 40 mg 80 mg orally, 5-HT3 antagonist (Ondansetron): 8 mg tablet twice a day Day 3: Emestop 40 mg 80 mg orally, 5-HT3 antagonist (Ondansetron): 8 mg tablet twice a day. Emestop 40 mg is administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. Dexamethasone is administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for drug interactions.

Administration of Emestop 40 mg

Emestop 40 mg may be taken with or without food. No dosage adjustment is necessary for the elderly patients.

Interaction of Emestop 40 mg

Emestop 40 mg is a substrate, a weak-to-moderate (dose dependent) inhibitor, and an inducer of CYP3A4. Emestop 40 mg is also an inducer of CYP2C9. Precautions should be taken while coadministering Emestop 40 mg with drugs that use CYP3A4 or CYP2C9, for example- Warfarin, Tolbutamide, Phenytoin, Ketoconazole, Itraconazole, Nefazodone, Troleandomycin, Clarithromycin, Ritonavir, Nelfinavir, Diltiazem, Rifampin, Carbamazepine etc.  Upon coadministration with Emestop 40 mg, the efficacy of hormonal contraceptives during and for 28 days following the last dose of Emestop 40 mg may be reduced. Alternative or back-up methods of contraception should be used during treatment with Emestop 40 mg and for 1 month following the last dose of Emestop 40 mg.

Contraindications

Emestop 40 mg is contraindicated in patients who are hypersensitive to any component of the product. Emestop 40 mg should not be used concurrently with Pimozide, Terfenadine, Astemizole & Cisapride.

Side Effects of Emestop 40 mg

Constipation, Hypotension, Pruritus, Pyrexia

Pregnancy & Lactation

Pregnancy Category B. This drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug based on patient’s importance.

Overdose Effects of Emestop 40 mg

No specific information is available on the treatment of overdosage with Emestop 40 mg. Single doses up to 600 mg of Emestop 40 mg were generally well tolerated in healthy subjects. Drowsiness and headache can be seen due to overdose. In the event of overdose, Emestop 40 mg should be discontinued. General supportive treatment and monitoring should be provided. Because of the antiemetic activity of Emestop 40 mg, medicine-induced emesis may not be effective. Emestop 40 mg cannot be removed by hemodialysis.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Use In Special Populations

Patients with Renal Impairment: No dosage adjustment is necessary for patients with renal impairment or for patients with end stage renal disease (ESRD) undergoing hemodialysis.Patients with Hepatic Impairment: No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. There are no clinical data in patients with severe hepatic impairment .

Drug Classes

Anti-emetic drugs

Mode Of Action

Emestop 40 mg is a selective high affinity antagonist of human substance P neurokinin 1 (NK1) receptors. When substance P attaches to these receptors, it causes nausea and vomiting. Emestop 40 mg stops substance P from binding to the NK1 receptors. By blocking the receptors, Emestop 40 mg can prevent nausea and vomiting, which often happens after chemotherapy or as a complication of surgery.

Pregnancy

Pregnancy Category B. This drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug based on patient’s importance.

Pediatric Uses

Patients with Renal Impairment: No dosage adjustment is necessary for patients with renal impairment or for patients with end-stage renal disease (ESRD) undergoing hemodialysis.Patients with Hepatic Impairment: No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. There are no clinical data in patients with severe hepatic impairment.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.