Donepezil Hydrochloride

DONEPEZIL HYDROCHLORIDE- donepezil hydrochloride tablet, film coated
NCS HealthCare of KY, Inc dba Vangard Labs

1 INDICATIONS AND USAGE

Donepezil hydrochloride 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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing in Mild to Moderate Alzheimer’s Disease

The recommended starting dosage of donepezil hydrochloride tablets are 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 tablets are 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 Information

Donepezil hydrochloride tablets should be taken in the evening, just prior to retiring. Donepezil hydrochloride tablets can be taken with or without food. The donepezil hydrochloride 23 mg tablet should not be split, crushed, or chewed.

Allow donepezil hydrochloride orally disintegrating tablets to dissolve on the tongue and follow with water.

3 DOSAGE FORMS AND STRENGTHS


Donepezil hydrochloride tablets, USP are supplied as film-coated, round tablets containing either 5 mg or 10 mg of donepezil hydrochloride USP.
• The 5 mg tablets are white to off white, round, biconvex, film-coated tablets debossed with ‘ML 89’ on one side and plain on the other side.
• The 10 mg tablets are yellow, round, biconvex, film-coated tablets debossed with ‘ML 88’ on one side and plain on the other side.

Donepezil hydrochloride 23 mg tablets are supplied as film-coated, round tablets containing 23 mg of donepezil hydrochloride USP.

• The 23 mg tablets are red, round, biconvex, film-coated tablets debossed with “C 26” on one side, and plain on the other side.
Donepezil hydrochloride orally disintegrating tablets, USP are supplied as round tablets containing either 5 mg or 10 mg of donepezil hydrochloride USP.
• The 5 mg orally disintegrating tablets are yellow, circular, flat face, beveled edge uncoated tablets debossed with “CL 31” on one side and plain on the other side.
• The 10 mg orally disintegrating tablets are yellow, circular, flat face, beveled edge uncoated tablets debossed with “CL 32” on one side and plain on the other side.

4 CONTRAINDICATIONS

Donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.

5 WARNINGS AND PRECAUTIONS

5.1 Anesthesia


Donepezil hydrochloride as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.

5.2 Cardiovascular Conditions

Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes. This effect may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil hydrochloride.

5.3 Nausea and Vomiting


Donepezil hydrochloride, as a predictable consequence of its pharmacological properties, has been shown to produce diarrhea, nausea, and vomiting. These effects, when they occur, appear more frequently with the 10 mg/day dose than with the 5 mg/day dose, and more frequently with the 23 mg dose than with the 10 mg dose. Specifically, in a controlled trial that compared a dose of 23 mg/day to 10 mg/day in patients who had been treated with donepezil 10 mg/day for at least three months, the incidence of nausea in the 23 mg group was markedly greater than in the patients who continued on 10 mg/day (11.8% vs. 3.4%, respectively), and the incidence of vomiting in the 23 mg group was markedly greater than in the 10 mg group (9.2% vs. 2.5%, respectively). The percent of patients who discontinued treatment due to vomiting in the 23 mg group was markedly higher than in the 10 mg group (2.9% vs. 0.4%, respectively).

Although in most cases, these effects have been transient, sometimes lasting one to three weeks, and have resolved during continued use of donepezil hydrochloride, patients should be observed closely at the initiation of treatment and after dose increases.

5.4 Peptic Ulcer Disease and GI Bleeding


Through their primary action, cholinesterase inhibitors may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers, e.g., those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of donepezil hydrochloride in a dose of 5 mg/day to 10 mg/day have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Results of a controlled clinical study with 23 mg/day showed an increase, relative to 10 mg/day, in the incidence of peptic ulcer disease (0.4% vs. 0.2%) and gastrointestinal bleeding from any site (1.1% vs. 0.6%).

5.5 Weight Loss

Weight loss was reported as an adverse reaction in 4.7% of patients assigned to donepezil hydrochloride in a dose of 23 mg/day compared to 2.5% of patients assigned to 10 mg/day. Compared to their baseline weights, 8.4% of patients taking 23 mg/day were found to have a weight decrease of ≥ 7% by the end of the study, while 4.9% of patients taking 10 mg/day were found to have weight loss of ≥ 7% at the end of the study.

5.6 Genitourinary Conditions

Although not observed in clinical trials of donepezil hydrochloride, cholinomimetics may cause bladder outflow obstruction.

5.7 Neurological Conditions: Seizures

Cholinomimetics are believed to have some potential to cause generalized convulsions. However, seizure activity also may be a manifestation of Alzheimer’s disease.

5.8 Pulmonary Conditions


Because of their cholinomimetic actions, cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

6 ADVERSE REACTIONS

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)]

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