Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)
Lake Erie Medical DBA Quality Care Products LLC
ORAL
PRESCRIPTION DRUG
INDICATIONS AND USAGE For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states. CONTRAINDICATIONS Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with a gradual increase in dosage until optimum response is achieved. Amitriptyline hydrochloride should not be given with Cisapride due to the potential for increased QT interval and increased risk for arrhythmia. This drug is not recommended for use during the acute
HOW SUPPLIED 10 mg tablets are blue, round, unscored, film coated tablets, debossed “2101” on one side and debossed “V” on the reverse side. 25 mg tablets are yellow, round, unscored, film coated tablets, debossed “2102” on one side and debossed “V” on the reverse side. 50 mg tablets are beige, round, unscored, film coated tablets, debossed “2103” on one side and debossed “V” on the reverse side. 75 mg tablets are orange, round, unscored, film coated tablets, debossed “2104” and “V”. 100 mg tablets are mauve, round, unscored, film coated tablets, debossed “2105” and “V”. 150 mg tablets are blue, capsule shaped, unscored, film coated tablets, debossed “2106” on one side and debossed “V” on the reverse side. Storage: Store in a well-closed container. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. In addition, amitriptyline tablets must be protected from light and stored in a well-closed, light-resistant container.
Abbreviated New Drug Application
AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED Lake Erie Medical DBA Quality Care Products LLC ---------- AMITRIPTYLINE HYDROCHLORIDE - amitriptyline hydrochloride tablet, film coated Qualitest Pharmaceuticals Medication Guide Antidepressant Medicines, Depression and Other Serious Mental llnesses, and Suicidal Thoughts or Actions Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about: • all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Lue koko asiakirja
AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- AMITRIPTYLINE HYDROCHLORIDE 50 MG DESCRIPTION Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,_d_] cycloheptene-5-ylidene)-N,N-dimethyl-1- propanamine hydrochloride. Its empirical formula is C H N•HCl, and its structural formula is Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Amitriptyline HCl is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg tablets. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate and titanium dioxide. The 10 mg tablets also contain FDandC blue #1 lake. The 25 mg tablets also contain DandC yellow #10 lake and FDandC blue #2 lake. The 50 mg tablets also contain synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. The 75 mg tablets also contain FDandC yellow #6 lake. The 100 mg tablets also contain DandC red #33 lake and FDandC red #40 lake. The 150 mg tablets also contain FDandC blue #2 lake and FDandC yellow #6 lake CLINICAL PHARMACOLOGY CLINICAL PHARMACOLOGY Amitriptyline hydrochloride is an antidepressant with sedative effects. Its mechanism of action in man is not known. It is not a monoamine oxidase inhibitor, and it does not act primarily by stimulation of the central nervous system. Amitriptyline inhibits the membrane pump mechanism responsible for uptake of norepinephrine and serotonin in adrenergic and serotonergic neurons. Pharmacologically this action may potentiate or prolong neuronal activity since reuptake of these biogenic amines is important physiologically in terminating transmitting activity. This interference with the reuptake of norepinephrine and/or serotonin is believed by some to underlie the ant Lue koko asiakirja