Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
aprepitant
Merck Sharp & Dohme (Australia) Pty Ltd
Aprepitant
Registered
EMEND ® _Aprepitant_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EMEND. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking EMEND against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EMEND IS USED FOR _CHEMOTHERAPY INDUCED_ _NAUSEA AND VOMITING_ EMEND, in combination with other medicines, is used to prevent nausea (feeling sick) and vomiting associated with cancer chemotherapy. _POST-OPERATIVE NAUSEA AND_ _VOMITING_ EMEND is used to prevent nausea (feeling sick) and vomiting which can occur after surgery. EMEND belongs to a group of medicines called neurokinin 1 (NK1) receptor antagonists. It works by blocking the actions of substances in your brain, called substance P neurokinins, that cause nausea and vomiting. Your doctor may have prescribed EMEND for another reason. Ask your doctor if you have any questions about why EMEND has been prescribed for you. The safety and effectiveness of EMEND in children and teenagers under the age of 18 years have not been established. EMEND is not addictive. BEFORE YOU TAKE EMEND _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE EMEND IF YOU HAVE AN ALLERGY TO EMEND OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT TAKE EMEND IF YOU ARE TAKING: • cisapride, used to treat stomach reflux • pimozide, used to treat psychotic conditions • terfenadine (Teldane*) and astemizole (Hismanal*), antihistamines used for allergic conditions, including hayfever * not available in Australia • St Johns Wort - a herb used to treat depression Taking EMEND with these medicines may cause serious or life- threatening reactions. DO NOT TAKE EMEND IF YOU HAVE A RARE HEREDITARY PROBLEM OF FRUCTOSE INTOLERANCE, GLUCOSE- G Lesen Sie das vollständige Dokument
A140917 Page 1 of 28 PRODUCT INFORMATION EMEND CAPSULE NAME OF THE MEDICINE aprepitant CHEMICAL STRUCTURE Aprepitant is chemically described as 5-[[(2_R_,3_S_)-2-[(1_R_)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]- 3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3_H_-1,2,4-triazol-3-one. Molecular formula: C 23 H 21 F 7 N 4 O 3 Molecular mass: 534.43 CAS NUMBER CAS number: 170729-80-3 DESCRIPTION EMEND is a substance P neurokinin 1 (NK1) receptor antagonist. Aprepitant is a white to off-white crystalline solid. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each capsule of EMEND for oral administration contains 40 mg, 80 mg, 125 mg or 165 mg of aprepitant. Each capsule of EMEND contains the following inactive ingredients: sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The hard gelatin capsules contain the following inactive ingredients: gelatin and titanium dioxide CI 77891, and may also contain sodium lauryl sulfate and silicon dioxide. The 40-mg capsule shell also contains iron oxide yellow CI 77492, the 125-mg capsule shell also contains iron oxide red CI 77491 and iron oxide yellow CI 77492, and the 165-mg capsule shell also contains indigo carmine. The capsules are printed with ink containing iron oxide black CI 77499. PHARMACOLOGY MECHANISM OF ACTION Aprepitant is a selective high affinity antagonist at human substance-P neurokinin-1 (NK 1 ) receptors. Aprepitant showed at least 3,000-fold selectivity for the NK 1 receptor over other enzyme, transporter, ion-channel and receptor sites, including the dopamine and serotonin (5HT 3 ) receptors that are targets for existing chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV) therapies. N O O CF 3 CF 3 F N NH NH O CH 3 A140917 Page 2 of 28 Aprepitant has been shown in animal models to inhibit emesis induced by cytotoxic chemotherapeutic agents, such as cisplatin, via central actions. Pr Lesen Sie das vollständige Dokument