CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE- chlordiazepoxide and amitriptyline hydrochloride tablet CHLORDIAZEPOXIDE AND

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Patient Information leaflet (PIL)

19-01-2023

Summary of Product characteristics (SPC)

19-01-2023

Active ingredient:

AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K), CHLORDIAZEPOXIDE (UNII: 6RZ6XEZ3CR) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR)

Available from:

Micro Labs Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablet occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia. Chlordiazepoxide and amitriptyline hydrochloride tablet is contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants. It should not be given concomitantly with a monoamine oxidase inhibitor. Hyperpyretic crises, severe convulsions and deaths have occurred in patients receiving a tricyclic antidepressant and a monoamine oxidase inhibitor simultaneously. When it is desired to replace a monoamine oxidase inhibito

Product summary:

The 5 mg/12.5 mg tablets are green, round, biconvex, film-coated tablets, debossed "CA 1" on one side and plain on the other side. They are available as follows: Bottles of 100 NDC 42571-302-01 Bottles of 500 NDC 42571-302-05 The 10 mg/25 mg tablets are white, round, biconvex, film-coated tablets, debossed "CA2"on one side, plain on the other side. They are available as follows:� Bottles of 100 NDC 42571-303-01 Bottles of 500 NDC 42571-303-05 Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature.] Store in a dry place. Keep in a tightly closed, child-resistant container and out of the light. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Revised: 01/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE - CHLORDIAZEPOXIDE
AND
AMITRIPTYLINE HYDROCHLORIDE TABLET
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE- CHLORDIAZEPOXIDE AND
AMITRIPTYLINE HYDROCHLORIDE TABLET
Micro Labs Limited
----------
MEDICATION GUIDE
Chlordiazepoxide and Amitriptyline Hydrochloride
(KLOR-dye-AZ-e-POX-ide/A-mi-TRIP-ti-leen hye-droe-klor-ide)
Tablets, USP C-IV
What is the most important information I should know about
chlordiazepoxide and amitriptyline
hydrochloride tablets?
•
Chlordiazepoxide and amitriptyline hydrochloride tablet is a
benzodiazepine medicine. Taking
benzodiazepines with opioid medicines, alcohol, or other central
nervous system (CNS)
depressants (including street drugs) can cause severe drowsiness,
breathing problems (respiratory
depression), coma and death. Get emergency help right away if any of
the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
chlordiazepoxide and amitriptyline
hydrochloride tablets with opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including chlordiazepoxide and amitriptyline
hydrochloride tablets, which can
lead to overdose and serious side effects including coma and death.
•
Serious side effects including coma and death have happened in people
who have abused
or misused benzodiazepines, including chlordiazepoxide and
amitriptyline hydrochloride
tablets. These serious side effects may also include delirium,
paranoia, suicidal thoughts or
actions, seizures, and difficulty breathing. Call your healthcare
provider or go to the
nearest hospital emergency room right away if you get any of these
serious side effects.
•
You can develop an addiction even if you take chlordiazepoxide and
amitriptyline
hydrochloride tablets exactly as prescribed by your healthcare
provider.
•
Take chlordiazepoxide and a

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Summary of Product characteristics

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE - CHLORDIAZEPOXIDE
AND AMITRIPTYLINE HYDROCHLORIDE TABLET
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE- CHLORDIAZEPOXIDE
AND AMITRIPTYLINE HYDROCHLORIDE TABLET
MICRO LABS LIMITED
----------
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP CIV
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; DEPENDENCE AND WITHDRAWAL REACTIONS;
AND SUICIDAL THOUGHTS AND BEHAVIORS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF THESE DRUGS FOR PATIENTS FOR WHOM
ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. LIMIT DOSAGES AND
DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS AND
SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION (SEE WARNINGS
AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE AND
AMITRIPTYLINE HYDROCHLORIDE TABLETS, EXPOSES USERS TO RISKS OF ABUSE,
MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. ABUSE
AND MISUSE OF BENZODIAZEPINES COMMONLY INVOLVE CONCOMITANT USE OF
OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT SUBSTANCES, WHICH IS
ASSOCIATED WITH AN INCREASED FREQUENCY OF SERIOUS ADVERSE OUTCOMES.
BEFORE PRESCRIBING CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
TABLETS AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR
ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE AND
AMITRIPTYLINE HYDROCHLORIDE TABLETS, MAY LEAD TO CLINICALLY
SIGNIFICANT
PHYSICAL DEPENDENCE. THE RISKS OF DEPENDENCE AND WITHDRAWAL
INCREASE WITH LONGER TREATMENT DURATION AND HIGHER DAILY DOSE. ABRUPT
DISCONTINUATION OR RAPID DOSAGE REDUCTION OF CHLORDIAZEPOXIDE AND
AMITRIPTYLINE HYDROCHLORIDE TABLETS AFTER CONTINUED USE MAY
PRECIPITATE ACUTE WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING.
TO REDUCE THE RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO
DISCONTINUE CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS
OR REDUCE

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