Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
Aidarex Pharmaceuticals LLC
ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE 5 mg
ORAL
PRESCRIPTION DRUG
Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP 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 justifies the potential risk to the fetus. Administration of zolpidem to pregnant rats and rabbits resul
Zolpidem tartrate 5 mg tablets, USP are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as: NDC Number Size 33261-172-10 bottle of 10 33261-172-12 bottle of 12 33261-172-14 bottle of 14 33261-172-15 bottle of 15 33261-172-20 bottle of 20 33261-172-30 bottle of 30 33261-172-42 bottle of 42 33261-172-60 bottle of 60 33261-172-90 bottle of 90 33261-172-120 bottle of 120 Zolpidem tartrate 10 mg tablets, USP are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as: NDC Number Size 33261-173-10 bottle of 10 33261-173-12 bottle of 12 33261-173-14 bottle of 14 33261-173-15 bottle of 15 33261-173-20 bottle of 20 33261-173-30 bottle of 30 33261-173-42 bottle of 42 33261-173-60 bottle of 60 33261-173-90 bottle of 90 33261-173-120 bottle of 120 Store at 20°-25°C (68°-77°F); excursions permitted to 15° - 30°C (59°- 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET Aidarex Pharmaceuticals LLC ---------- Zolpidem Tartrate Tablets, USP C-IV 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 are zolpidem tartrate tablets? Zolpidem tartrate tablets are 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 tablets are not for children. Zolpidem tartrate is a federally controlled substance (C-IV) because it can be abused Přečtěte si celý dokument
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET AIDAREX PHARMACEUTICALS LLC ---------- 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, USP -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, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP 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 Přečtěte si celý dokument