Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
RedPharm Drug Inc.
ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE 5 mg
ORAL
PRESCRIPTION DRUG
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)] . The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.2)] . Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. Zolpidem tartrate tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Administration of zolpidem to pregnant rats and rabbits resulted
Zolpidem Tartrate Tablets are available as: 5 mg, pink, film-coated, capsule-shaped, unscored, debossed "6468" on one side and debossed "V" on the reverse side, in bottles of 10, 20, 30, 100, 500 and 1000. 10 mg, white, film-coated, capsule-shaped, unscored, debossed "6469" on one side and debossed "V" on the reverse side, in bottles of 10, 15, 20, 30, 60, 90, 100, 500 and 1000. Store at controlled room temperature 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ZOLPIDEM TARTRATE - ZOLPIDEM TARTRATE TABLET, FILM COATED RedPharm Drug Inc. ---------- MEDICATION GUIDE CIV ZOLPIDEM TARTRATE TABLETS Read the Medication Guide that comes with zolpidem tartrate tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. What is the most important information I should know about zolpidem tartrate tablets? After taking zolpidem tartrate tablets, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with zolpidem tartrate tablets. Reported activities include: • driving a car ("sleep-driving") • making and eating food • talking on the phone • having sex • sleep-walking Call your doctor right away if you find out that you have done any of the above activities after taking zolpidem tartrate tablets. Important: 1. Take zolpidem tartrate tablets exactly as prescribed • Do not take more zolpidem tartrate tablets than prescribed. • Take zolpidem tartrate tablets right before you get in bed, not sooner. 2. Do not take zolpidem tartrate tablets if you: • drink alcohol • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take zolpidem tartrate tablets with your other medicines. • cannot get a full night's sleep What is zolpidem tartrate tablets? Zolpidem tartrate tablets is a sedative-hypnotic (sleep) medicine. Zolpidem tartrate tablets is used in adults for the short-term treatment of a sleep problem called insomnia. Symptoms of insomnia include: • trouble falling asleep. Zolpidem tartrate tablets is not for children. Zolpidem tartrate tablets is a federally controlled substance (C-IV) becaus Διαβάστε το πλήρες έγγραφο
ZOLPIDEM TARTRATE - ZOLPIDEM TARTRATE TABLET, FILM COATED REDPHARM DRUG INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZOLPIDEM TARTRATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM TARTRATE TABLETS ZOLPIDEM TARTRATE TABLETS CIV INITIAL U.S. APPROVAL: 1992 RECENT MAJOR CHANGES Indications and Usage (1) 03/2007 Warnings and Precautions Severe anaphylactic and anaphylactoid reactions (5.2) 03/2007 Abnormal thinking and behavioral changes (5.3) 03/2007 Special populations (5.6) 03/2007 INDICATIONS AND USAGE Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies (1) DOSAGE AND ADMINISTRATION Adult dose: 10 mg once daily immediately before bedtime (2.1) Elderly/debilitated patients/hepatically impaired: 5 mg once daily immediately before bedtime (2.2) Downward dosage adjustment may be necessary when used with CNS depressants (2.3) Should not be taken with or immediately after a meal (2.4) DOSAGE FORMS AND STRENGTHS 5 mg and 10 mg tablets. Tablets not scored (3) CONTRAINDICATIONS Known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation (4) WARNINGS AND PRECAUTIONS Need to evaluate for co-morbid diagnosis: Reevaluate if insomnia persists after 7 to 10 days of use (5.1) Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur (5.2) Abnormal thinking, behavioral changes and complex behaviors: May include "sleep-driving" and hallucinations. Immediately evaluate any new onset behavioral changes (5.3) Depression: Worsening of depression or, suicidal thinking may occur. Prescribe the least amount feasible to avoid intentional overdose (5.3, 5.6) Withdrawal effects: Symptoms may occur with rapid dose reduction Διαβάστε το πλήρες έγγραφο