Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)
MedVantx, Inc.
AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states. 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 recovery phase following myocardial infa
10 mg tablets are blue, round, unscored, film coated tablets, debossed “2101” on one side and debossed “V” on the reverse side. They are supplied as follows: 25 mg tablets are yellow, round, unscored, film coated tablets, debossed “2102” on one side and debossed “V” on the reverse side. They are supplied as follows: 50 mg tablets are beige, round, unscored, film coated tablets, debossed “2103” on one side and debossed “V” on the reverse side. They are supplied as follows: 75 mg tablets are orange, round, unscored, film coated tablets, debossed “2104” and “V”. They are supplied as follows: 100 mg tablets are mauve, round, unscored, film coated tablets, debossed “2105” and “V”. They are supplied as follows: 150 mg tablets are blue, capsule shaped, unscored, film coated tablets, debossed “2106” on one side and debossed “V” on the reverse side. They are supplied as follows:
Abbreviated New Drug Application
AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED MedVantx, Inc. ---------- MEDICATION GUIDE ANTIDEPRESSANT MEDICINES, DEPRESSION AND OTHER SERIOUS MENTAL LLLNESSES, 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. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, Olvassa el a teljes dokumentumot
AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED MEDVANTX, INC. ---------- AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP RX ONLY SUICIDALITY AND ANTIDEPRESSANT DRUGS ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL THINKING AND BEHAVIOR (SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM STUDIES OF MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE CONSIDERING THE USE OF AMITRIPTYLINE HYDROCHLORIDE TABLETS OR ANY OTHER ANTIDEPRESSANT IN A CHILD, ADOLESCENT, OR YOUNG ADULT MUST BALANCE THIS RISK WITH THE CLINICAL NEED. SHORT-TERM STUDIES DID NOT SHOW AN INCREASE IN THE RISK OF SUICIDALITY WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS BEYOND AGE 24; THERE WAS A REDUCTION IN RISK WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS AGED 65 AND OLDER. DEPRESSION AND CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES ASSOCIATED WITH INCREASES IN THE RISK OF SUICIDE. PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY SHOULD BE MONITORED APPROPRIATELY AND OBSERVED CLOSELY FOR CLINICAL WORSENING, SUICIDALITY, OR UNUSUAL CHANGES IN BEHAVIOR. FAMILIES AND CAREGIVERS SHOULD BE ADVISED OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER. AMITRIPTYLINE HYDROCHLORIDE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC USE.) 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, Olvassa el a teljes dokumentumot