ELAVIL Tablet (2018)
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Περιεχόμενα
Name of the medicinal product
ELAVIL Amitriptyline hydrochloride tablets USP.
Indications and clinical use
ELAVIL (amitriptyline hydrochloride) is indicated in the drug management of depressive illness. ELAVIL may be used in depressive illness of psychotic or endogenous nature and in selected patients with ...
Contraindications
ELAVIL (amitriptyline hydrochloride) is contraindicated in: Patients who are hypersensitive to amitriptyline hydrochloride or to any ingredient in the formulation (see PHARMACEUTCIAL INFORMATION, Composition) ...
Warnings and precautions
Warnings Amitriptyline should be used with caution in patients with a history of seizures, impaired liver function or blood dyscrasias. Due to its anticholinergic activity, amitriptyline should be used ...
Adverse reactions
Note: Included in the listing which follows are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs ...
Dosage and administration
Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. <u>Outpatient Adults:</u> The recommended initial dose for ambulatory ...
Overdosage
Symptoms High doses may cause temporary confusion, disturbed concentration, or transient visual hallucinations. Overdosage may cause drowsiness, hypothermia, tachycardia and other arrhythmic abnormalities, ...
Action and clinical pharmacology
Amitriptyline hydrochloride is a tricyclic antidepressant with sedative properties. Its mechanism of action in man is not known. Amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake ...
Storage and stability
Store at room temperature (15°C to 30°C). Keep in a tightly closed container.
Dosage forms, composition and packaging
<u>ELAVIL 10 mg:</u> Each blue, round, biconvex, film coated tablet, engraved 10 on one side contains 10 mg of amitriptyline hydrochloride. Available in bottles of 100 and 1000, unit dose packages of 100 ...
Pharmaceutical information
Drug substance Proprietary Name: ELAVIL Proper/Common Name: Amitriptyline Hydrochloride USP Chemical Name: 1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]-cyclohepten-5- ylidene)-N,N-dimethyl-, hydrochloride ...
Detailed pharmacology
Amitriptyline has qualitatively similar pharmacologic actions to other tricyclic antidepressants in experimental animals. It is more sedative than imipramine, reducing spontaneous motor activity at lower ...
Toxicology
Acute SPECIES ROUTE SEX LD<sub>50</sub> (mg of base/kg) 95% FUDUCIAL LIMITS Mice PO F 289 (249-335) IP F 76 (71-81) SO F 328 (279-386) Rats PO F 464 (370-583) PO M 600 (403-872) IP F 67 (59-76) ...
Marketing authorization holder
AA PHARMA INC., 1165 Creditstone Road Unit #1, Vaughan, ON, L4K 4N7
Submission control number
217626
Date of revision
August 29, 2018
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