Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
Desmopressin acetate
Ferring Pharmaceuticals Pty Ltd
Medicine Registered
MINIRIN ® TABLETS _Desmopressin acetate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Minirin Tablets. It does not contain all the available information. It does not replace of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Minirin Tablets 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 MINIRIN IS USED FOR The active ingredient, desmopressin acetate in Minirin Tablets is a synthetic version of a naturally occurring substance produced in the brain called vasopressin. It has a number of different actions on the body including an action on the kidney to reduce the amount of urine produced. This means that Minirin Tablets can be used for several different conditions including: • primary nocturnal enuresis (bedwetting) in patients over 6 years of age who have a normal ability to concentrate urine and who have not responded to treatment with an enuresis alarm or in whom an enuresis alarm is contraindicated or inappropriate • cranial diabetes insipidus (large amounts of urine being produced day and night and constant thirst). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. It is available only with a doctor's prescription. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU TAKE MINIRIN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE MINIRIN TABLETS IF YOU HAVE AN ALLERGY TO: • any medicine containing desmopressin or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or Lire le document complet
PRODUCT INFORMATION 1 #1735-v21A _MINIRIN_ _®_ _ TABLETS _ NAME OF THE MEDICINE: Desmopressin Acetate Synonyms of desmopressin: DDAVP 1-desamino-8-D-Arginine vasopressin. Desamino-cys-1-D-Arginine-8 vasopressin. SCH 2 CH 2 CO-Tyr-Phe-Gln-Asn-Cys-Pro-D-Arg-Gly-NH 2 CAS No. 62357-86-2 (trihydrate) DESCRIPTION: The active substance, desmopressin, (present as the hydrated acetate with variable amounts of acetic acid and water) is a synthetic structural analogue of the natural pituitary hormone arginine vasopressin. The difference lies in the desamination of cysteine and substitution of L-arginine by D-arginine. Minirin Tablets contain desmopressin, lactose, potato starch, povidone and magnesium stearate. PHARMACOLOGY: Actions: Pharmacotherapeutic group: vasopressin and analogues. Compared to vasopressin, desmopressin has a considerably longer duration of action and a complete lack of pressor effect in the dosages clinically used. Pharmacokinetics: The absolute bioavailability of orally administered Minirin 200µg tablets is approximately 0.08% (range 0.029 - 0.115%). Mean maximum plasma concentration is reached within 2 hours. The distribution volume is 0.2 – 0.37 L/kg. Desmopressin does not cross the blood-brain barrier. The oral terminal half-life varies between 2.0 and 3.21 hours. The bioequivalence of the 200 and 400µg Minirin Tablets has not been established. Desmopressin exhibits a moderate to high variability in bioavailability, both within and between subjects. Concomitant intake of food decreases the rate and extent of absorption of Minirin 200µg tablets, administered at a dose of 400µg, by >40%. In vitro in human liver microsome preparations, it has been shown that no significant Lire le document complet