Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
Novel Laboratories, Inc.
ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE 1.75 mg
SUBLINGUAL
PRESCRIPTION DRUG
Zolpidem Tartrate Sublingual Tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitations of Use : Zolpidem Tartrate Sublingual Tablet is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking. Zolpidem Tartrate Sublingual Tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema [see Warnings and Precautions (5.3)]. Pregnancy Category C There are no adequate and well-controlled studies of zolpidem in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS-depressants. Children born to mothers taking
Each Zolpidem Tartrate Sublingual Tablet is individually packaged in a blister inside a unit-dose pouch. Zolpidem Tartrate Sublingual Tablets 1.75 mg are white to off white, round, flat faced beveled edged debossed with "N2" on one side and plain on the other side and supplied as: NDC 40032-762-30: Carton of 30 unit-dose pouches Zolpidem Tartrate Sublingual Tablets 3.5 are white to off white, round, flat faced beveled edged debossed with "NP" on one side and plain on the other side and supplied as: NDC 40032-761-30: Carton of 30 unit-dose pouches Storage and Handling Store between 20°C to 25°C (68°F to 77°F), [see USP Controlled Room Temperature]. Protect from moisture. The patient should be instructed not to remove the blister from the unit-dose pouch until the patient is ready to consume the sublingual tablet inside. Do not use if blister seal is broken or missing.
Abbreviated New Drug Application
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET Novel Laboratories, Inc. ---------- MEDICATION GUIDE Zolpidem Tartrate (ZOL-pi-dem TAR-trate or zole-PI-dem TAR-trate) Sublingual Tablet CIV Phenylketonurics Phenylalanine is a component of aspartame. Each 3.5 mg and 1.75 mg Zolpidem Tartarate Sublingual Tablets contains 4.48 mg and 2.24 mg of phenylalanine. Read the Medication Guide that comes with Zolpidem Tartrate Sublingual 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 Sublingual Tablet? Follow the Instructions for Use at the end of this Medication Guide when you take Zolpidem Tartrate Sublingual Tablet. If you do not follow the Instructions for Use, you might be drowsy in the morning without knowing it. • Only take one Tablet a night, if needed. • Only take Zolpidem Tartrate Sublingual Tablet if you have at least 4 hours of bedtime left. Zolpidem Tartrate Sublingual Tablet may cause serious side effects, including: • After taking Zolpidem Tartrate Sublingual Tablet, 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 drank alcohol that day or take other medicines that make you sleepy with Zolpidem Tartrate Sublingual Tablet. Reported activities include: • driving a car ("sleep-driving") • making and eating food • talking on the phone • having sex • sleep-walking Call your healthcare provider right away if you find out that you have done any of the above activities after taking Zolpidem Tartrate Sublingual Tablet. Important: 1. Take Zolpidem Tartrate Sublingual Tablet exactly as prescribed 2. Do not take Zolpidem Tartrate Sublingual Tablet if you: • drank alcohol that Lesen Sie das vollständige Dokument
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET NOVEL LABORATORIES, INC. ---------- 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 FOR SUBLINGUAL USE. INITIAL U.S. APPROVAL: 1992 INDICATIONS AND USAGE Zolpidem Tartrate is a GABA agonist indicated for use as needed for the treatment of insomnia when a middle-of-the- night awakening is followed by difficulty returning to sleep (1) Limitation of Use: Not indicated for the treatment of middle-of-the night awakening when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking (1) DOSAGE AND ADMINISTRATION Take only if 4 hours of bedtime remain before the planned time of waking (2.1, 5.1) Zolpidem Tartrate Sublingual Tablets should be placed under the tongue and allowed to disintegrate completely before swallowing. The tablet should not be swallowed whole. (2.1) The effect of Zolpidem Tartrate Sublingual Tablets may be slowed if taken with or immediately after a meal (2.1) Recommended dose is 1.75 mg for women and 3.5 mg for men, taken only once per night if needed (2.2) Lower doses of CNS depressants may be necessary when taken concomitantly with Zolpidem Tartrate Sublingual Tablets (2.3) Co-administration with CNS depressants: Recommended dose is 1.75 mg for men and women (2.3) Geriatric patients and patients with hepatic impairment: Recommended dose is 1.75 mg for men and women (2.4,2.5) DOSAGE FORMS AND STRENGTHS 1.75 mg and 3.5 mg sublingual tablets (3) CONTRAINDICATIONS Known hypersensitivity to zolpidem (4) WARNINGS AND PRECAUTIONS CNS depressant effects: Impairs alertness and motor coordination. Instruct patients on correct use (5.1) Evaluate for co-morbid diagnoses: Re-evaluate if insomnia persists after 7 to 10 days of use (5.2) Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not re-chal Lesen Sie das vollständige Dokument