Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
DIAZEPAM (UNII: Q3JTX2Q7TU) (DIAZEPAM - UNII:Q3JTX2Q7TU)
Mylan Institutional Inc.
DIAZEPAM
DIAZEPAM 5 mg
ORAL
PRESCRIPTION DRUG
Diazepam 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. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodi
Diazepam Tablets, USP are available containing 2 mg, 5 mg or 10 mg of diazepam, USP. The 2 mg tablets are white, round, scored tablets debossed with MYLAN over 271 on one side and scored on the other side. They are available as follows: NDC 51079-284-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 5 mg tablets are orange, round, scored tablets debossed with MYLAN over 345 on one side and scored on the other side. They are available as follows: NDC 51079-285-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 10 mg tablets are green, round, scored tablets debossed with MYLAN over 477 on one side and scored on the other side. They are available as follows: NDC 51079-286-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
Mylan Institutional Inc. ---------- MEDICATION GUIDE Diazepam Tablets, USP (dye az' e pam) What is the most important information I should know about diazepam tablets? • Diazepam tablets are 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 diazepam tablets with opioids affect you. What are diazepam tablets? • Diazepam tablets are a prescription medicine used: • to treat anxiety disorders • for the short-term relief of the symptoms of anxiety • to relieve the symptoms of alcohol withdrawal including agitation, shakiness (tremor), sudden and severe mental or nervous system changes (delirium tremens) and seeing or hearing things that others do not see or hear (hallucinations) • along with other medicines for the relief of muscle spasms • along with other medicines to treat seizure disorders • Diazepam tablets are a federal controlled substance (C-IV) because they contain diazepam that can be abused or lead to dependence. Keep diazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away diazepam tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs. • It is not known if diazepam tablets are safe and effective in children under 6 months of age. • It is not known if diazepam tablets are safe and effective for use longer than 4 months. Do not take diazepam tablets if you: • are allergic to diazepam or any of the ingredients in diazepam tablets. See the end of this Medication Guide for a complete list of ingredie Läs hela dokumentet
DIAZEPAM- DIAZEPAM TABLET MYLAN INSTITUTIONAL INC. ---------- 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 DIAZEPAM 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 DIAZEPAM TABLETS AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS) _._ _ _ THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING DIAZEPAM 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 DIAZEPAM 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 DIAZEPAM TABLETS OR REDUCE THE DOSAGE (SEE DOSAGE AND ADMINISTRATION AND WARNINGS) _._ DESCRIPTION Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-Chloro- 1,3-dihydro-1-methyl-5-phenyl-2 _H_-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The molecular formula is C H ClN O and the molecular weight is 284.74. The structural formula is as follows: 16 13 2 Diazepam is available for oral administration as tablets contain Läs hela dokumentet