AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Buy It Now

Active ingredient:

AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)

Available from:

AvPAK

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 Infarc

Product summary:

Amitriptyline hydrochloride tablets, USP for oral administration are available as: 10 mg: Pink colored, round shaped, film-coated tablets, debossed with "60" on one side and "U" on the other side, and supplied as NDC 50268-037-15 (10 tablets per card, 5 cards per carton). 25 mg: Yellow colored, round shaped, film-coated tablets, debossed with "420" on one side and "U" on the other side, and supplied as NDC 50268-038-15 (10 tablets per card, 5 cards per carton). 50 mg: Brown colored, round shaped, film-coated tablets, debossed with "421" on one side and "U" on the other side, and supplied as NDC 50268-039-15 (10 tablets per card, 5 cards per carton). 75 mg: Yellow colored, round shaped, film-coated tablets, debossed with "422" on one side and "U" on the other side, and supplied as NDC 50268-040-15 (10 tablets per card, 5 cards per carton). 100 mg: Orange colored, round shaped, film-coated tablets, debossed with "423" on one side and "U" on the other side, and supplied as NDC 50268-041-15 (10 tablets per card, 5 cards per carton). 150 mg: Green colored, Capsule shaped, film-coated tablets, debossed with "424" on one side and "U" on the other side. Dispensed in Unit Doese Package. For Institutional Use. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. KEEP OUT OF THE REACH OF CHILDREN. METABOLISM Studies in man following oral administration of 14 C-labeled drug indicated that amitriptyline is rapidly absorbed and metabolized. Radioactivity of the plasma was practically negligible, although significant amounts of radioactivity appeared in the urine by 4 to 6 hours and one-half to one-third of the drug was excreted within 24 hours. Amitriptyline is metabolized by N-demethylation and bridge hydroxylation in man, rabbit, and rat. Virtually the entire dose is excreted as glucuronide or sulfate conjugate of metabolites, with little unchanged drug appearing in the urine. Other metabolic pathways may be involved.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

                                AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
AvPAK
----------
MEDICATION GUIDE
Amitriptyline Hydrochloride Tablets , USP
(a-mee-TRIP-ti-leen)
Antidepressant Medicines , Depression and other Serious Mental
Illnesses , 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 t
                                
                                Read the complete document
                                
                            

Summary of Product characteristics

                                AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
AVPAK
----------
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 hydrochloride, USP, a dibenzocycloheptadiene derivative,
is a white, or
practically white, odorless, crystalline compound which is freely
soluble in water and
alcohol.
It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5
_H_-dibenzo[a, d]
cycloheptene-Δ
, γ-propylamine hydrochloride. It has the following structural
formula:
5
C
H
N.HCl
M.W. 313.90
Each tablet for oral administration contains 10, 25, 50, 75, 100, or
150 mg amitriptyline
hydrochloride, USP. Inactive ingredients include lactose monohydrate,
microcrystalline
cellulose, croscarmellose 
                                
                                Read the complete document
                                
                            

Search alerts related to this product