Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
Zolpidem Tartrate (UNII: WY6W63843K) (zolpidem - UNII:7K383OQI23)
Caraco Pharmaceutical Laboratories, Ltd.
Zolpidem Tartrate
TABLET
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 in pregnant women. Zolpidem tartrate should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Oral studies of zolpidem in pregnant rats and rabbits showed adverse effects on the development of offspri
Zolpidem tartrate tablets, 5 mg, pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘515’ on one side and plain on the other side are available as follows: Zolpidem tartrate tablets, 10 mg, white to off-white colored, oval shaped, biconvex, film coated tablets, debossed with ‘516’ on one side and plain on the other side are available as follows: Store at controlled room temperature 20° to 25°C (68° to 77°F). Dispense in a tight, light-resistant container (USP). Protect from moisture.
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET Caraco Pharmaceutical Laboratories, Ltd. ---------- 17.4 MEDICATION GUIDE MEDICATION GUIDE 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 tablet is a sedative-hypnotic (sleep) medicine. Zolpidem tartrate tablets are used in adults for the short-term treatment of a sleep problem called insomnia. Symptoms of insomnia include: • trouble falling asleep • Zolpidem tartrate tablet is not for children. Zolpidem tartrate tablet is a federally c Lue koko asiakirja
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET CARACO PHARMACEUTICAL LABORATORIES, LTD. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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 (4.1) 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 or discontinuation (5.4, 9.3) CNS depressant effects: Use can impair alertness and motor coordination. If used in combination with other CNS depressants, dose reductions may be needed due to additive effects. Do not use Lue koko asiakirja