Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
ZALEPLON (UNII: S62U433RMH) (ZALEPLON - UNII:S62U433RMH)
Bryant Ranch Prepack
ZALEPLON
ZALEPLON 10 mg
ORAL
PRESCRIPTION DRUG
Zaleplon capsules are indicated for the short-term treatment of insomnia. Zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment. Zaleplon is contraindicated in patients: - who have experienced complex sleep behaviors after taking zaleplon (see WARNINGS ) - with hypersensitivity to zaleplon or any excipients in the formulation (see PRECAUTIONS ) Zaleplon is classified as a Schedule IV controlled substance by federal regulation. Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with ot
Zaleplon capsules USP 10 mg are available as hard gelatin capsules with dark blue cap and dark blue body imprinted with "U" on cap and "132" on the body in black ink along the horizontal axis. NDC: 63629-3405-1: 15 Capsules in a BOTTLE NDC: 63629-3405-2: 30 Capsules in a BOTTLE NDC: 63629-3405-3: 60 Capsules in a BOTTLE NDC: 63629-3405-4: 90 Capsules in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Abbreviated New Drug Application
ZALEPLON- ZALEPLON CAPSULE Bryant Ranch Prepack ---------- MEDICATION GUIDE Zaleplon Capsules USP C-IV (zal' e plon) Read this Medication Guide before you start taking zaleplon capsules 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. You and your doctor should talk about zaleplon capsules when you start taking it and at regular checkups. What is the most important information I should know about zaleplon capsules? Zaleplon capsules may cause serious side effects including complex sleep behaviors that may cause serious injury and death.. After taking zaleplon capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with zaleplon capsules whether or not you drink alcohol or take other medicines that make you sleepy. Reported activities include: • driving a car ("sleep-driving") • making and eating food • talking on the phone • having sex • sleep-walking Important: 1. Take zaleplon capsules exactly as prescribed • Do not take more zaleplon capsules than prescribed. • Take zaleplon capsules right before you get in bed, not sooner. 2. Do not take zaleplon capsules if you: • have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone or having sex while not fully awake) after taking zaleplon capsules • 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 zaleplon capsules with your other medicines • cannot get a full night's sleep 3. Stop taking zaleplon capsules and call your doctor right away if you find out that you have done any of the above activities after taking zaleplon capsules. What are zaleplon capsules? Zaleplon ca Perskaitykite visą dokumentą
ZALEPLON- ZALEPLON CAPSULE BRYANT RANCH PREPACK ---------- ZALEPLON CAPSULES USP CIV WARNING: COMPLEX SLEEP BEHAVIORS COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND ENGAGING IN OTHER ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF ZALEPLON. SOME OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH. DISCONTINUE ZALEPLON IMMEDIATELY IF A PATIENT EXPERIENCES A COMPLEX SLEEP BEHAVIOR (SEE CONTRAINDICATIONS AND COMPLEX SLEEP BEHAVIORS UNDER WARNINGS). DESCRIPTION Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N- ethylacetamide. Its molecular formula is C H N O, and its molecular weight is 305.34. The structural formula is shown below. ZALEPLON Zaleplon is a white to off-white powder that is practically insoluble in water and sparingly soluble in alcohol or propylene glycol. Its partition coefficient in octanol/water is constant (log PC = 1.23) over the pH range of 1 to 7. Zaleplon capsules USP contain zaleplon as the active ingredient. Inactive ingredients consist of microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate, lactose, gelatin, titanium dioxide, FD&C blue #1, FD&C red #40 and black iron oxide. The 5 mg capsules also contain FD&C yellow #5. 17 15 5 Meets USP Dissolution Test 2. CLINICAL PHARMACOLOGY PHARMACODYNAMICS AND MECHANISM OF ACTION While zaleplon is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties, it interacts with the gamma-aminobutyric acid-benzodiazepine (GABA-BZ) receptor complex. Subunit modulation of the GABA-BZ receptor chloride channel macromolecular complex is hypothesized to be responsible for some of the pharmacological properties of benzodiazepines, which include sedative, anxiolytic, muscle relaxant, and anticonvulsive effects in animal models. Other nonclinical studies have also shown Perskaitykite visą dokumentą