国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
APREPITANT
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
APREPITANT
3 (1x125mg & 2x80mg)capsule Capsules
Alkermes Pharma Ireland Limited
CONSUMER MEDICATION INFORMATION LE AFLET (RIMUP) EMEND ® CAPSULE Aprepitant (80 mg, 125 mg) _____________________________________________________________________________________________ _____________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What EMEND is taken for 2. How EMEND works 3. Before you take EMEND 4. How to take EMEND 5. While you are taking EMEND 6. Side effects 7. Storage and Disposal of EMEND 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT EMEND IS TAKEN FOR EMEND is taken ALONG WITH OTHER MEDICINES to prevent and control nausea (sick feeling ) and vomiting caused by your cancer chemotherapy treatment. HOW EMEND WORKS EMEND is a member of a class of medicines called neurokinin 1 (NK 1 ) receptor antagonists works by blocking signals to the area of the brain that controls nausea and vomiting. BEFORE YOU TAKE EMEND - When you must not take it Do not take EMEND if you are allergic to any of its ingredients. - Before you start to take it Tell your doctor about any of the following that apply to you: any past or present medical problems. any allergies. all medicines that you are taking or plan to take, even those you can get without a prescription or herbal products. Any intolerance to some sugars as this medicine contains sucrose. USE IN CHILDREN Usage of EMEND has not been adequately studied in childr en. Therefore, EMEND should not be given to children under 18 years old. USE IN THE ELDERLY EMEND works equally well in and is equally well - tolerated by older and younger adult s. No dosage adjustment is necessary in the elderly. - Taking other medicines Do not take EMEND with medicines containing pimozide (used to treat psychiatric illness) , terfenadine, astemizole (used for hay fever and other allergic conditions), or cisapride (used for treating digestive problems) . Taking EMEND with these me dications could result in SERIOUS OR LIFE- THREATENING PROBLEMS . Your d 完全なドキュメントを読む
LPC-MK0869-C-042021b-Malaysia LOCAL PRODUCT CIRCULAR Capsules EMEND ® (aprepitant, MSD) I. THERAPEUTIC CLASS EMEND ® (aprepitant, MSD), is a substance P neurokinin 1 (NK 1 ) receptor antagonist. II. CLINICAL PHARMACOLOGY IIa. Mechanism of Action Aprepitant has a unique mode of action; it is a selective high affinity antagonist at human substance P neurokinin 1 (NK 1 ) receptors. Counter-screening assays showed that aprepitant was at least 3,000-fold selective for the NK 1 receptor over other enzyme, transporter, ion channel and receptor sites including the dopamine and serotonin receptors that are targets for existing chemotherapy induced nausea and vomiting (CINV). NK 1 -receptor antagonists have been shown pre-clinically to inhibit emesis induced by cytotoxic chemotherapeutic agents, such as cisplatin, via central actions. Preclinical and human Positron Emission Tomography (PET) studies with aprepitant have shown that it is brain penetrant and occupies brain NK 1 receptors. Preclinical studies show that aprepitant has a long duration of central activity, inhibits both the acute and delayed phases of cisplatin-induced emesis, and augments the antiemetic activity of the 5-HT 3 -receptor antagonist ondansetron and the corticosteroid dexamethasone against cisplatin-induced emesis. IIb. Pharmacokinetics IIb-1. Absorption The mean absolute oral bioavailability of aprepitant is approximately 60 to 65% and the mean peak plasma concentration (C max ) of aprepitant occurred at approximately 4 hours (T max ). Oral administration of the capsule with a standard breakfast had no clinically meaningful effect on the bioavailability of aprepitant. The pharmacokinetics of aprepitant are non-linear across the clinical dose range. In healthy young adults, the increase in AUC 0-∞ was 26% greater than dose proportional between 80- mg and 125-mg single doses administered in the fed state. A separate clinical study in healthy young adults demonstrated that there is no clinically important effect of food on the pharmacokinetics of 完全なドキュメントを読む