国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
St Marys Medical Park Pharmacy
ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE 12.5 mg
ORAL
PRESCRIPTION DRUG
Zolpidem tartrate extended-release tablets are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14) ] . Zolpidem tartrate extended-release 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 extended-release tablets in pregnant women. Zolpidem tartrate extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk
Zolpidem tartrate extended-release tablets, 12.5 mg are available as white to off-white round film coated tablets engraved with “A116” on one side and plain on the other side. They are supplied as follows: NDC 60760-116-30 BOTTLES OF 30 *Store at 20°C to 25°C (68°F to 77°F) [see USP controlled room temperature].
Abbreviated New Drug Application
St Marys Medical Park Pharmacy ---------- Revised: 10/2018 Document Id: 77e68d0b-c9f6-b796-e053-2991aa0a3918 34391-3 Set id: de7a700d-2757-40c2-8e50-9a6b106ab011 Version: 4 Effective Time: 20181010 St Marys Medical Park Pharmacy 阅读完整的文件
ZOLPIDEM TARTRATE EXTENDED RELEASE- ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE ST MARYS MEDICAL PARK PHARMACY ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZOLPIDEM TARTRATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM TARTRATE. ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE FOR ORAL USE. INITIAL U.S. APPROVAL: 1992 RECENT MAJOR CHANGES Indications and Usage ( 1) 12/2007 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) 04/2007 INDICATIONS AND USAGE Zolpidem tartrate extended-release tablets are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ( 1) DOSAGE AND ADMINISTRATION Adult dose: 12.5 mg once daily immediately before bedtime ( 2.1) Elderly/debilitated/hepatically impaired patients: 6.25 mg once daily immediately before bedtime ( 2.2) Tablets to be swallowed whole, not to be crushed, divided or chewed. Should not be taken with or immediately after a meal ( 2.4) DOSAGE FORMS AND STRENGTHS 6.25 mg and 12.5 mg extended-release 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 diagnoses: Revaluate 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, 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 occ 阅读完整的文件