Edluar
Loading...Edluar Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Edluar (zolpidem tartrate) sublingual tablet is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
The clinical trials performed with Zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment [see Clinical Studies (14)].
History
There is currently no drug history available for this drug.
Other Information
Edluar (zolpidem tartrate) sublingual tablet is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for sublingual administration.
Chemically, zolpidem tartrate is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:
Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88.
Each Edluar tablet includes the following inactive ingredients: mannitol, colloidal silicon dioxide, silicified microcrystalline cellulose, croscarmellose sodium, saccharin sodium, and magnesium stearate.
Sources
Edluar Manufacturers
-
Meda Pharmaceuticals
![Edluar (Zolpidem Tartrate) Tablet [Meda Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Edluar | Meda Pharmaceuticals
The dose of Edluar should be individualized.
2.1 Dosage in adultsThe recommended dose for Edluar for adults is 10 mg once daily immediately before bedtime. The total Edluar daily dose should not exceed 10 mg.
2.2 Special populationsElderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Edluar in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.3 Use with CNS depressantsDosage adjustment may be necessary when Edluar is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 AdministrationThe effect of Edluar may be slowed by ingestion with or immediately after a meal. Edluar should not be given with or immediately after a meal.
Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.
-
Meda Pharmaceuticals Inc.
Edluar | Lannett Company, Inc.
2.1 Recommended DoseThe recommended dose of letrozole tablets, USP is one 2.5 mg tablet administered once a day, without regard to meals.
2.2 Use in Adjuvant Treatment of Early Breast CancerIn the adjuvant setting, the optimal duration of treatment with letrozole is unknown. The planned duration of treatment in the study was 5 years with 73% of the patients having completed adjuvant therapy. Treatment should be discontinued at relapse [see Clinical Studies (14.1)].
2.3 Use in Extended Adjuvant Treatment of Early Breast CancerIn the extended adjuvant setting, the optimal treatment duration with letrozole tablets, USP is not known. The planned duration of treatment in the study was 5 years. In the final updated analysis, conducted at a median follow-up of 62 months, the median treatment duration was 60 months. Seventy-one percent of patients were treated for at least 3 years and 58% of patients completed at least 4.5 years of extended adjuvant treatment. The treatment should be discontinued at tumor relapse [see Clinical Studies (14.2)].
2.4 Use in First and Second-Line Treatment of Advanced Breast CancerIn patients with advanced disease, treatment with letrozole tablets, USP should continue until tumor progression is evident. [see Clinical Studies (14.4, 14.5)].
2.5 Use in Hepatic ImpairmentNo dosage adjustment is recommended for patients with mild to moderate hepatic impairment, although letrozole tablets, USP blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole tablets, USP in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [see Warnings and Precautions (5.3)]. The recommended dose of letrozole tablets, USP for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on letrozole tablets, USP exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined.
2.6 Use in Renal ImpairmentNo dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥ 10 mL/min. [see Clinical Pharmacology (12.3)].
![Edluar (Zolpidem Tartrate) Tablet [Meda Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=eb9ef121-71c7-436f-85d0-aa3649852915&name=letrozole-tablets-usp-7.jpg)
Login To Your Free Account