CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

CHLORDIAZEPOXIDE HYDROCHLORIDE (UNII: MFM6K1XWDK) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR), CLIDINIUM BROMIDE (UNII: 91ZQW5JF1Z) (CLIDINIUM - UNII:BO76JF850N)

Commercializzato da:

Bryant Ranch Prepack

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Chlordiazepoxide hydrochloride and clidinium bromide capsules is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Chlordiazepoxide hydrochloride and clidinium bromide capsules is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide. Controlled Substance Chlordiazepoxide hydrochloride and clidinium bromide capsules contains chlordiazepoxide hydrochloride, a Schedule IV controlled substance and clidinium bromide, which is not a controlled substance. Chlordiazepoxide hydrochloride and clidinium bromide capsules is exempted from Schedule IV and is not controlled under the Controlled Substances Act. Abuse Chlordiazepoxide hydrochloride, a component of chlordiazepoxide hydrochloride and clidinium bromide capsules, is 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 ). 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). Dependence Physical Dependence Chlordiazepoxide hydrochloride and clidinium bromide capsules 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 ). To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride and clidinium bromide capsules or reduce the dosage (see WARNINGS and DOSAGE AND ADMININSTRATION ). Acute Withdrawal Signs and Symptoms 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 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 Tolerance to chlordiazepoxide hydrochloride and clidinium bromide capsules 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 effects of chlordiazepoxide hydrochloride and clidinium bromide capsules may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Dettagli prodotto:

Chlordiazepoxide hydrochloride and clidinium bromide capsules is available in green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide in bottles of 100 (63629-8859) with “CDP/CD” imprinted on the cap and 5/2.5” imprinted on the body of the capsule. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]; Dispense in Tight Containers. Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
Bryant Ranch Prepack
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MEDICATION GUIDE
CHLORDIAZEPOXIDE HYDROCHLORIDE
(klor-dye-az-e-POX-ide hye-droe-KLOR-ide)
AND
CLIDINIUM BROMIDE (kli DIN ee um BRO mide) CAPSULES
for oral use
What is the most important information I should know about
chlordiazepoxide hydrochloride and clidinium bromide capsules?
•
Chlordiazepoxide hydrochloride and clidinium bromide capsules contains
a benzodiazepine medicine. Taking
chlordiazepoxide hydrochloride and clidinium bromide capsules 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 takingchlordiazepoxide
hydrochloride and clidinium bromide capsules with opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines, including
chlordiazepoxide hydrochloride and clidinium bromide capsules, which
can lead to overdose or death.
•
Serious side effects including coma and death have happened in people
who have abused or misused benzodiazepines,
including chlordiazepoxide hydrochloride and clidinium bromide
capsules. 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
hydrochloride and clidinium bromide capsules as
prescribed by your healthcare provider.
•
Take chlordiazepoxide hydrochloride and clidinium bromide capsules
exactly as your healthcare provider prescribed.
•
Do not share your chlordia

Scheda tecnica

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE-
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
BRYANT RANCH PREPACK
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CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES USP FOR
ORAL
USE
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF THESE DRUGS IN 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 AND PRECAUTIONS, DRUG INTERACTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING CHLODIAZEPOXIDE HYDROCHLORIDE,
A COMPONENT OF CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
CAPSULES, USP, 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 HYDROCHLORIDE AND CLIDINIUM BROMIDE
CAPSULES, USP AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK
FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS)_._
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE
HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES, USP, 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 HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES, USP
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
HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES