Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
Clomipramine hydrochloride
Apotex Pty Ltd
Medicine Registered
TERRY WHITE CHEMISTS CLOMIPRAMINE _Contains the active ingredient, clomipramine (as clomipramine hydrochloride)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE This leaflet answers some common questions about clomipramine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Terry White Chemists Clomipramine. It contains the active ingredient, clomipramine (as clomipramine hydrochloride). It is used to treat: • depression • obsessive compulsive disorders and phobias in adults • cataplexy associated with narcolepsy (sudden muscle weakness associated with an uncontrollable desire to sleep). 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. _HOW IT WORKS_ Clomipramine belongs to a group of medicines called tricyclic antidepressants. These medicines are thought to work by their action on brain chemicals called amines which are involved in controlling mood. _USE IN CHILDREN_ There is not enough information to recommend using this medicine in children and adolescents younger than 18 years. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF: Přečtěte si celý dokument
Product Information – Australia Terry White Chemists Clomipramine Tablets Page 1 TERRY WHITE CHEMISTS CLOMIPRAMINE TABLETS NAME OF THE MEDICINE Clomipramine hydrochloride Chemical Name; 3-chloro-5-[3-(dimethylamino)-propyl]10, 11-dihydro-5H dibenz [b,f] azepine hydrochloride. Structural Formula: Molecular Formula: C 19 H 23 N 2 Cl . HCl Molecular Weight: 351.3 CAS Registry Number: 17321-77-6 DESCRIPTION Clomipramine is the 3-chloro derivative of imipramine. It is a white crystalline powder, soluble in water, slightly soluble in ethanol and insoluble in diethyl ether. PHARMACOLOGY PHARMACODYNAMICS Clomipramine is a tricyclic antidepressant. It inhibits the neuronal re-uptake of noradrenaline (NA) and serotonin (5-HT) released in the synaptic cleft, inhibition of 5-HT uptake being the dominant component of this activity. Clomipramine also has a wide spectrum of pharmacological action, including alpha 1 - adrenolytic, anticholinergic, antihistaminic and antiserotonergic (5-HT-receptor blocking) properties. PHARMACOKINETICS Absorption The active substance is completely absorbed following oral administration, but due to extensive hepatic first pass metabolism to the active metabolite, _N_-desmethylclomipramine, less than 50% of a dose reaches the systemic circulation unchanged. During oral administration of constant daily doses of clomipramine, the steady-state plasma concentrations of clomipramine show wide variations between patients. Administration of the standard dose recommended for treatment of depression, _i.e._ 25 mg clomipramine orally three times daily, produced steady state concentrations ranging from 31 ng/mL to 186 ng/mL. This scatter reflects differences in clomipramine’s distribution volume and clearance bet Přečtěte si celý dokument