Edluar label

Edluar

Edluar Recall

Get an alert when a recall is issued.

Add Info

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Add Info

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Add Info

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

Add Info

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Add Info

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)].

Add Info

History

There is currently no drug history available for this drug.

Add Info

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:

Image from Drug Label Content

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.

Add Info
Add to My Alerts
Report Side Effect
Leave a Review
Navigate to :
Edluar Recall
Side Effects & Adverse Reactions
Legal Issues
FDA Safety Alerts
Manufacturer Warnings
FDA Labeling Changes
Uses
History
Other Information
Manufacturers
Trending Topics

Edluar Manufacturers

  • Meda Pharmaceuticals
    Edluar | Meda Pharmaceuticals
    No Recall

    Edluar | Meda Pharmaceuticals

    Edluar | Meda Pharmaceuticals

    The dose of Edluar should be individualized.

    2.1 Dosage in adults

    The 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 populations

    Elderly 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 depressants

    Dosage 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 Administration

    The 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.
    No Recall

    Edluar | Lannett Company, Inc.

    Edluar | Lannett Company, Inc.
    2.1 Recommended Dose

    The 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 Cancer

    In 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 Cancer

    In 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 Cancer

    In 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 Impairment

    No 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 Impairment

    No dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥ 10 mL/min. [see Clinical Pharmacology (12.3)]. 

Login To Your Free Account