Aproxi80 mg

Aproxi 80 mg is indicated for- Prevention of postoperative nausea and vomiting (PONV) Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

Anti-emetic drugs

Aproxi 80 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. Aproxi 80 mg stops substance P from binding to the NK1 receptors. By blocking the receptors, Aproxi 80 mg can prevent nausea and vomiting, which often happens after chemotherapy or as a complication of surgery.

Post Operative Nausea and Vomiting: The recommended oral dosage of Aproxi 80 mg is 40 mg within 3 hours prior to induction of anesthesia. Chemotherapy Induced Nausea and Vomiting: Day 1: Aproxi 80 mg 125mg orally, Dexamethasone 12 mg orally, 5-HT3 antagonist (Ondansetron): 24 mg 30 minutes before the start of chemotherapy. Day 2: Aproxi 80 mg 80 mg orally, Dexamethasone 8 mg orally Day 3: Aproxi 80 mg 80 mg orally, Dexamethasone 8 mg orally Day 4: Dexamethasone 8 mg orally Aproxi 80 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: Aproxi 80 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: Aproxi 80 mg 80 mg orally, 5-HT3 antagonist (Ondansetron): 8 mg tablet twice a day Day 3: Aproxi 80 mg 80 mg orally, 5-HT3 antagonist (Ondansetron): 8 mg tablet twice a day. Aproxi 80 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.Aproxi 80 mg may be taken with or without food. No dosage adjustment is necessary for the elderly patients.

Post Operative Nausea and Vomiting: The recommended oral dosage of Aproxi 80 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: Aproxi 80 mg 125 mg orally, Dexamethasone 12 mg orally, 5-HT3 antagonist (Ondansetron): 24 mg 30 minutes before the start of chemotherapy. Day 2: Aproxi 80 mg 80 mg orally, Dexamethasone 8 mg orally Day 3: Aproxi 80 mg 80 mg orally, Dexamethasone 8 mg orally Day 4: Dexamethasone 8 mg orally Aproxi 80 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: Aproxi 80 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: Aproxi 80 mg 80 mg orally, 5-HT3 antagonist (Ondansetron): 8 mg tablet twice a day Day 3: Aproxi 80 mg 80 mg orally, 5-HT3 antagonist (Ondansetron): 8 mg tablet twice a day. Aproxi 80 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.

Aproxi 80 mg may be taken with or without food. No dosage adjustment is necessary for the elderly patients.

Aproxi 80 mg is a substrate, a weak-to-moderate (dose dependent) inhibitor, and an inducer of CYP3A4. Aproxi 80 mg is also an inducer of CYP2C9. Precautions should be taken while coadministering Aproxi 80 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 Aproxi 80 mg, the efficacy of hormonal contraceptives during and for 28 days following the last dose of Aproxi 80 mg may be reduced. Alternative or back-up methods of contraception should be used during treatment with Aproxi 80 mg and for 1 month following the last dose of Aproxi 80 mg.

Aproxi 80 mg is contraindicated in patients who are hypersensitive to any component of the product. Aproxi 80 mg should not be used concurrently with Pimozide, Terfenadine, Astemizole & Cisapride.

Constipation, Hypotension, Pruritus, Pyrexia

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.

No specific information is available on the treatment of overdosage with Aproxi 80 mg. Single doses up to 600 mg of Aproxi 80 mg were generally well tolerated in healthy subjects. Drowsiness and headache can be seen due to overdose. In the event of overdose, Aproxi 80 mg should be discontinued. General supportive treatment and monitoring should be provided. Because of the antiemetic activity of Aproxi 80 mg, medicine-induced emesis may not be effective. Aproxi 80 mg cannot be removed by hemodialysis.

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

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 .

Anti-emetic drugs

Aproxi 80 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. Aproxi 80 mg stops substance P from binding to the NK1 receptors. By blocking the receptors, Aproxi 80 mg can prevent nausea and vomiting, which often happens after chemotherapy or as a complication of surgery.

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.

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.