CLORAZEPATE DIPOTASSIUM tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

CLORAZEPATE DIPOTASSIUM (UNII: 63FN7G03XY) (CLORAZEPIC ACID - UNII:D51WO0G0L4)

Disponible des:

ANI Pharmaceuticals, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal. Clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma. Clorazepate dipotassium tablets contains clorazepate, a Schedule IV controlled substance. Clorazepate dipotassium is 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). Physical Dependence Clorazepate dipotassium 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 clorazepate dipotassium or reduce the dosage (see DOSAGE and ADMINISTRATION: Discontinuation or Dosage Reduction of Clorazepate Dipotassium and WARNINGS: Dependence and Withdrawal Reactions). 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 to clorazepate dipotassium 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 clorazepate dipotassium may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Resumen del producto:

Clorazepate Dipotassium Tablets, USP 3.75 mg are supplied as blue round tablet debossed with “N” above the score and 159 below the score on one side of the tablet and plain on the other side. NDC 70954-159-30                                                                Bottle of 30 tablets (Unit-of-use) Clorazepate Dipotassium Tablets, USP 7.5 mg are supplied as peach round tablet debossed with “N” above the score and 158 below the score on one side of the tablet and plain on the other side. NDC 70954-158-30                                                                Bottle of 30 tablets (Unit-of-use) Clorazepate Dipotassium Tablets, USP 15 mg are supplied as white to off-white round tablet debossed with “N” above the score and 157 below the score on one side of the tablet and plain on the other side. NDC 70954-157-20                                                                Bottle of 30 tablets (Unit-of-use) Recommended storage: Protect from moisture. Keep the bottle tightly closed in a dry place with the desiccant enclosed. Store at 20°-25°C (68°-77°F). See USP controlled room temperature. All trademarks are the property of their respective owners. Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Issued: 02/2024 LB4538-04

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

ANI Pharmaceuticals, Inc.
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SPL MEDGUIDE
MEDICATION GUIDE
Clorazepate Dipotassium Tablets, USP CIV
(klor az' e pate dye" poe tas' ee um)
What is the most important information I should know about clorazepate
dipotassium?
•
Clorazepate dipotassium 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
clorazepate dipotassium and opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines including
clorazepate dipotassium 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 clorazepate dipotassium. 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 clorazepate dipotassium
as prescribed by your healthcare
provider
•
Take clorazepate dipotassium exactly as your healthcare provider
prescribed.
•
Do not share your clorazepate dipotassium with other people.
•
Keep clorazepate dipotassium in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Clorazepate dipotassium
can cause physical dependence and
withdrawal reactions.
•
Do not suddenly stop taking clorazepate dipotassium. Stopping
clorazepate dipotassium suddenly can cause
serious and life-threate

Fitxa tècnica

CLORAZEPATE DIPOTASSIUM - CLORAZEPATE DIPOTASSIUM TABLET
ANI PHARMACEUTICALS, INC.
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CLORAZEPATE DIPOTASSIUM TABLETS, USP CIV
RX ONLY
BOXED WARNING
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). THE USE OF BENZODIAZEPINES, INCLUDING CLORAZEPATE DIPOTASSIUM,
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
CLORAZEPATE DIPOTASSIUM AND THROUGHOUT OUT TREATMENT, ASSESS EACH
PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS). THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CLORAZEPATE
DIPOTASSIUM, 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 CLORAZEPATE DIPOTASSIUM 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 CLORAZEPATE DIPOTASSIUM OR REDUCE THE DOSAGE
(SEE DOSAGE AND ADMINISTRATION AND WARNINGS).
DESCRIPTION
Chemically, clorazepate dipotassium is a benzodiazepine. The empirical
formula is
C
H
ClK N O ; the molecular weight is 408.92; 1_H_-1, 4
Benzodiazepine-3-carboxylic
acid, 7-chloro-2, 3-dihydro-2-oxo-5-phenyl-, potassium salt compound
with potassium
hydroxide (1:1) and the str