EDLUAR Tablet (2019)
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Meda Pharmaceuticals
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BOXED WARNING SECTION
<b>WARNING: COMPLEX SLEEP BEHAVIORS</b> <b>Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Edluar. Some ...
1. Indications and Usage
Edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation <em>[see Clinical Studies (14)]</em>. The clinical ...
2. Dosage and Administration
2.1 Dosage in Adults Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with ...
3. Dosage Forms and Strengths
Edluar is available in 5 mg and 10 mg strength tablets for sublingual administration. Tablets are <u>not</u> scored. Edluar 5 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed ...
4. Contraindications
Edluar is contraindicated in patients: who have experienced complex sleep behaviors after taking Edluar <em>[see Warnings and Precautions (5.1)]</em>. with known hypersensitivity to zolpidem. Observed ...
5. Warnings and Precautions
5.1 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 zolpidem. Patients can be seriously ...
6. Adverse Reactions
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors <em>[see Warnings and Precautions (5.1)]</em> CNS-Depressant Effects and ...
6.1. Clinical Trials Experience
Associated with discontinuation of treatment Approximately 4% of 1,701 patients who received zolpidem tartrate at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because ...
7. Drug Interactions
7.1 CNS-active Drugs CNS Depressants Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression <em>[see Warnings and Precautions (5.1, 5.2)]</em>. Zolpidem tartrate ...
8. Use in Specific Populations
8.6 Gender Difference in Pharmacokinetics Women clear zolpidem tartrate from the body at a lower rate than men, C<sub>max</sub> and AUC parameters of zolpidem were approximately 45% higher at the same ...
8.1. Pregnancy
Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation (<em>see Clinical Considerations ...
8.2. Lactation
Risk Summary Limited data from published literature reports the presence of zolpidem in human milk. There are reports of excess sedation in infants exposed to zolpidem through breastmilk (<em>see Clinical ...
8.4. Pediatric Use
Edluar is not recommended for use in children. Safety and effectiveness in pediatric patients have not been established in pediatric patients below the age of 18. In an 8-week controlled study in 201 pediatric ...
8.5. Geriatric Use
A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received oral zolpidem were ≥60 years of age. For a pool of U.S. patients receiving zolpidem ...
9.1. Controlled Substance
Edluar contains the same active substance, zolpidem tartrate, as zolpidem tartrate oral tablets and is classified as a Schedule IV controlled substance by federal regulation.
9.2. Abuse
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 ...
9.3. Dependence
Physical dependence is a state of adaptation 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 ...
10. Overdosage
10.1 Signs and Symptoms In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, ...
11. Description
Edluar contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Edluar is available in 5 mg and 10 mg strength tablets for sublingual administration. ...
12.1. Mechanism of Action
Zolpidem is a GABA<sub>A</sub> receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α<sub>1</sub> ...
12.2. Pharmacodynamics
Zolpidem binds to GABA<sub>A</sub> receptors with a greater affinity for α<sub>1</sub> subunit relative to α<sub>2</sub> and α<sub>3</sub> subunit containing receptors. Zolpidem has no appreciable binding ...
12.3. Pharmacokinetics
Absorption Edluar (zolpidem tartrate) sublingual tablets are bioequivalent to Ambien tablets (Sanofi-Aventis) with respect to C<sub>max</sub> and AUC. Similar to zolpidem tartrate oral tablets, Edluar ...
12.4. Microbiology
Carcinogenesis Zolpidem was administered to mice and rats for 2 years at oral doses of 4, 18, and 80 mg base/kg/day. In mice, these doses are approximately 2.5, 10, and 50 times the maximum recommended ...
14. Clinical Studies
14.1 Transient Insomnia Normal adults experiencing transient insomnia (n=462) during the first night in a sleep laboratory were evaluated in a double-blind, parallel group, single night trial comparing ...
16.1. How Supplied
Edluar is supplied as sublingual tablets in two dosage strengths: Tablets are not scored. Edluar 5 mg sublingual tablets are round white tablets, flat-faced, bevel-edged with debossed V on one side and ...
16.2. Storage and Handling
Store at controlled room temperature 20-25°C (68-77°F). Protect from light and moisture.
17. Patient Counseling Information
<em>See FDA-approved patient labeling (Medication Guide)</em>. Inform patients and their families about the benefits and risks of treatment with Edluar. Inform patients of the availability of a Medication ...