CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

CHLORDIAZEPOXIDE

Composition:

CHLORDIAZEPOXIDE 5 mg

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 tablets 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 tablets are 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 inhibitor with chlordiazepoxide and amitriptyline hydrochloride tablets, a minimum of 14 days should be allowed to elapse after the former is discontinued. Chlordiazepoxide and amitriptyline hydrochloride tablets should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. This drug is contraindicated during the acute recovery phase following myocardial infarction. Chlordiazepoxide and amitriptyline hydrochloride tablets contain chlordiazepoxide, a Schedule IV controlled substance. Chlordiazepoxide and amitriptyline hydrochloride tablets are a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see WARNINGS: Abuse, Misuse, and Addiction). The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol). Chlordiazepoxide and amitriptyline hydrochloride tablets may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see WARNINGS: Dependence and Withdrawal Reactions). To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide and amitriptyline hydrochloride tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of Chlordiazepoxide and Amitriptyline Hydrochloride Tablets and WARNINGS: Dependence and Withdrawal Reactions). Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. Tolerance to chlordiazepoxide and amitriptyline hydrochloride tablets may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of chlordiazepoxide and amitriptyline hydrochloride tablets may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Product summary:

Chlordiazepoxide and Amitriptyline Hydrochloride Tablets, USP are available containing 5 mg of chlordiazepoxide, USP and 14 mg of amitriptyline hydrochloride, USP equivalent to 12.5 mg of amitriptyline or 10 mg of chlordiazepoxide, USP and 27.98 mg of amitriptyline hydrochloride, USP equivalent to 25 mg of amitriptyline. The 5 mg/12.5 mg tablets are green, film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 211 on the other side. They are available as follows: NDC 0378-0211-01 bottles of 100 tablets NDC 0378-0211-05 bottles of 500 tablets The 10 mg/25 mg tablets are white, film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 277 on the other side. They are available as follows: NDC 0378-0277-01 bottles of 100 tablets NDC 0378-0277-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store in a dry place. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

HYDROCHLORIDE TABLET, FILM COATED
Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Chlordiazepoxide and Amitriptyline Hydrochloride Tablets, USP CIV
(klorʺ dye azʺ e poxʹ ide amʺ i tripʹ ti leen hyeʺ droe klorʹ
ide)
What is the most important information I should know about
chlordiazepoxide and amitriptyline
hydrochloride tablets?
•
Chlordiazepoxide 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:
o
shallow or slowed breathing
o
breathing stops (which may lead to the heart stopping)
o
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
chlordiazepoxide and
amitriptyline hydrochloride tablets with opioids affect 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.
o
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.
o
You can develop an addiction even if you take chlordiazepoxide and
amitriptyline
hydrochloride tablets exactly as prescribed by your healthcare
provider.
o
Take chlordiazepoxide and amitriptyline hydrochloride tablets exactly
as your healthcare
provider prescribed.
o
Do not share your chlordiazepoxide and amitriptyline hydrochloride
tablets with other
people.
o
Keep chlordiazepoxide and ami

Summary of Product characteristics

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE- CHLORDIAZEPOXIDE
AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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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 THE DOSAGE (SEE DOSAGE AND
ADMINISTRATION AND WARNINGS).
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND
BEHAVIORS IN PEDIAT