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RX ITEM-Zaleplon 5Mg Cap 100 By Teva Pharma

NDC 00093-5268-01 UPC/GTIN No.3-00935-26801-9 Mfg.Part No.526801BRAND: ZALEPLON NDC: 00093-5268-01,93526801 UPC: 3-00935-26801-9,300935268019 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Zaleplon 5Mg Cap 100 By Teva Pharma

$368.74$109.75

item No.:DEA638383 NDC No.93526801 UPC No.:300935268019 NDC No.00093-5268-01 UPC/GTIN No.3-00935-26801-9 MPN 526801 Only Physician,Pharmacy or Licensed Facility-must be Licensed by DEA can order this Rx Item No.DEA638383 Zaleplon 5mg Cap 100 by Teva Pharma Item No.8638383 NDC No.00093526801 UPC No.300935268019 Other Name Zaleplon, Sonata Oral Capsule 5 M Therapeutic Code282492 Therapeutic Class Sonata,Zaleplon Item Class Rx Controlled Drug Case Qnty:48 Common Group Zaleplon Oral Capsule 5 M Unit

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SONATA- zaleplon capsule
Pfizer Laboratories Div Pfizer Inc
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 empirical formula is C17 H15 N5 O, and its molecular weight is 305.34.
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.
Sonata® capsules contain zaleplon as the active ingredient. Inactive ingredients consist of microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, magnesium stearate, lactose, gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1, FD&C green #3, and FD&C yellow #5.
CLINICAL PHARMACOLOGY
Pharmacodynamics and Mechanism of Action
While Sonata (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.
INDICATIONS AND USAGE
Sonata is indicated for the short-term treatment of insomnia. Sonata has 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.
CONTRAINDICATIONS
Hypersensitivity to zaleplon or any excipients in the formulation
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class
Sonata is classified as a Schedule IV controlled substance by federal regulation.
Abuse, Dependence, and Tolerance
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 other psychoactive substances. Physical dependence is a state of adaption that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.
Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.
Abuse
Two studies assessed the abuse liability of Sonata at doses of 25 mg, 50 mg, and 75 mg in subjects with known histories of sedative drug abuse. The results of these studies indicate that Sonata has an abuse potential similar to benzodiazepine and benzodiazepine-like hypnotics.
DOSAGE AND ADMINISTRATION
The dose of Sonata should be individualized. The recommended dose of Sonata for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Sonata appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.


NDC 00093-5268-01 UPC/GTIN No.3-00935-26801-9 Mfg.Part No.526801
RX ITEM-Zaleplon 5Mg Cap 100 By Teva Pha
NDC 00093-5268-01 UPC/GTIN No.3-00935-26801-9 Mfg.Part No.526801

BRAND: ZALEPLON NDC: 00093-5268-01,93526801 UPC: 3-00935-26801-9,300935268019
Zaleplon 5Mg Cap 100 By Teva Pharma
BRAND: ZALEPLON NDC: 00093-5268-01,93526801 UPC: 3-00935-26801-9,300935268019

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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