Donepezil Hydrochloride 5 mg/1
Donepezil Hydrochloride · TABLET, FILM COATED · Aurobindo Pharma Limited
Donepezil Hydrochloride is a tablet, film coated containing donepezil hydrochloride at 5 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.
Key Facts
- Brand Name
- Donepezil Hydrochloride
- Generic Name
- Donepezil Hydrochloride
- NDC Code (Product)
65862-325- Manufacturer
- Aurobindo Pharma Limited
- Strength
- 5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090056
- Marketing Start
- 05/31/2011
Recall History
Sandoz Inc
Subpotent Drug: out of specification results for assay test.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Donepezil hydrochloride tablet is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease ( 1 ). Donepezil hydrochloride tablet is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Mild to Moderate Alzheimer's Disease: 5 mg to 10 mg once daily ( 2.1 ) Moderate to Severe Alzheimer's Disease: 10 mg to 23 mg once daily ( 2.2 ) 2.1 Dosing in Mild to Moderate Alzheimer’s Disease The recommended starting dosage of donepezil hydrochloride tablet is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablets in patients with mild to moderate Alzheimer's disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. 2.2 Dosing in Moderate to Severe Alzheimer’s Disease The recommended starting dosage of donepezil hydrochloride tablet is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablets in patients with moderate to severe Alzheimer's disease is 23 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months. 2.3 Administration In…
Contraindications
4 CONTRAINDICATIONS Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives ( 4 ) Donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.
Drug Interactions
7 DRUG INTERACTIONS Cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications ( 7.1 ). A synergistic effect may be expected with concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists ( 7.2 ). 7.1 Use with Anticholinergics Because of their mechanism of action, cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications. 7.2 Use with Cholinomimetics and Other Cholinesterase Inhibitors A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions in clinical studies of donepezil hydrochloride are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch . The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Conditions [ see Warnings and Precautions ( 5.2 ) ]. Nausea and Vomiting [ see Warnings and Precautions ( 5.3 ) ]. Peptic Ulcer Disease and GI Bleeding [ see Warnings and Precautions ( 5.4 ) ]. Weight Loss [ see Warnings and Precautions ( 5.5 ) ]. Genitourinary Conditions [ see Warnings and Precautions ( 5.6 ) ]. Neurological Conditions: Seizures [ see Warnings and Precautions ( 5.7 ) ]. Pulmonary Conditions [ see Warnings and Precautions ( 5.8 ) ]. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Donepezil hydroc…
Frequently Asked Questions
What is Donepezil Hydrochloride used for?
Donepezil Hydrochloride contains Donepezil Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Donepezil Hydrochloride a controlled substance?
Donepezil Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Donepezil Hydrochloride?
The generic name for Donepezil Hydrochloride is Donepezil Hydrochloride. There are 7 other brand versions of Donepezil Hydrochloride.
What is the NDC code for Donepezil Hydrochloride 5 mg/1?
The NDC (National Drug Code) for Donepezil Hydrochloride 5 mg/1 is 65862-325, listed by Aurobindo Pharma Limited.