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Donepezil Hydrochloride (Donepezil Hydrochloride)

Trade Name : Donepezil Hydrochloride

Bryant Ranch Prepack

TABLET, FILM COATED

Strength 10 mg/1

DONEPEZIL HYDROCHLORIDE Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Donepezil Hydrochloride (Donepezil Hydrochloride) which is also known as Donepezil Hydrochloride and Manufactured by Bryant Ranch Prepack. It is available in strength of 10 mg/1 per ml. Read more

Donepezil Hydrochloride (Donepezil Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • None
  • Donepezil hydrochlorideu00a0is indicated for the treatment of dementia of the Alzheimeru2019s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimeru2019s disease.
  • Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimeru2019s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimeru2019s Disease ()
  • No data
  • Mild to Moderate Alzheimeru2019s Disease: 5 mg to 10 mg once daily ()
  • Moderate to Severe Alzheimeru2019s Disease: 10 mg to 23 mg once daily () u00a0
  • Donepezil hydrochloride tablets, USP are supplied as film-coated, round tablets containing either 5 mg or 10 mg of donepezil hydrochloride USP. u2022u00a0The 5 mg tablets are white to off white, round, biconvex, film-coated tablets debossed with u2018ML 89u2019 on one side and plain on the other side. u2022u00a0The 10 mg tablets are yellow, round, biconvex, film-coated tablets debossed with u2018ML 88u2019 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.
  • u2022u00a0The 23 mg tablets are red, round, biconvex, film-coated tablets debossed with u201cC 26u201d on one side, and plain on the other side.n Donepezil hydrochloride orally disintegrating tablets, USP are supplied as round tablets containing either 5 mg or 10 mg of donepezil hydrochloride USP. u2022u00a0The 5 mg orally disintegrating tablets are yellow, circular, flat face, beveled edge uncoated tablets debossed with u201cCL 31u201d on one side and plain on the other side. u2022u00a0The 10 mg orally disintegrating tablets are yellow, circular, flat face, beveled edge uncoated tablets debossed with u201cCL 32u201d on one side and plain on the other side.
  • Tablets: 5mg,10mg and 23 mgu00a0()
  • Orally Disintegrating Tablets : 5 mg and 10 mg ()u00a0
  • Donepezil hydrochlorideu00a0is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.
  • Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives ()
  • No data
  • Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia ()
  • Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block ()
  • Donepezil hydrochloride can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases ()u00a0
  • Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers ()
  • The use of donepezil hydrochloride tablets in a dose of 23 mg once daily is associated with weight loss ()
  • Cholinomimetics may cause bladder outflow obstructions ()
  • Cholinomimetics are believed to have some potential to cause generalized convulsions ()
  • Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease ()u00a0u00a0
  • The following serious adverse reactions are described below and elsewhere in the labeling: u2022u00a0Cardiovascular Conditions u2022u00a0Nausea and Vomiting u2022u00a0Peptic Ulcer Disease and GI Bleeding n n u00a0Weight Lossu2022u00a0Genitourinary Conditions u2022u00a0Neurological Conditions: Seizures u2022u00a0Pulmonary Conditions n
  • Most common adverse reactions in clinical studies of donepezil hydrochloride are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia (6.1)
  • u00a0n n n
  • No data
  • Cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications ()
  • A synergistic effect may be expected withu00a0 concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists ()
  • Pregnancy: Based on animal data, donepezil hydrochloride may cause fetal harm ()
  • Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug.
  • As in any case of overdose, general supportive measures should be utilized. Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse, and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. Tertiary anticholinergics such as atropine may be used as an antidote for donepezil hydrochloride overdosage. Intravenous atropine sulfate titrated to effect is recommended: an initial dose of 1.0 to 2.0 mg IV with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics such as glycopyrrolate. It is not known whether donepezil hydrochloride and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration).
  • Dose-related signs of toxicity in animals included reduced spontaneous movement, prone position, staggering gait, lacrimation, clonic convulsions, depressed respiration, salivation, miosis, tremors, fasciculation, and lower body surface temperature.
  • u00a0Donepezil hydrochloride USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (u00b1)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1-inden-1-one hydrochloride. Donepezil hydrochloride USP is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C2HNOHCl and a molecular weight of 415.96. Donepezil hydrochloride USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane.
  • Donepezil hydrochloride tablets, USPu00a0are available for oral administration in film-coated tablets containing 5,10, or 23 mg of donepezil hydrochloride. n Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, pregelatinised starch, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. The film coating contains talc,u00a0propylene glycol, hypromellose and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent.
  • Inactive ingredients in 23 mg tablets include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and hypromellose. The film coating includes ferric oxide red, hypromellose, polyethylene glycol 8000, talc and titanium dioxide. USP Dissolution Test pending.
  • Donepezil hydrochlorideu00a0orally disintegrating tabletsu00a0USP are available for oral administration. Each donepezil hydrochlorideu00a0orally disintegrating tabletsu00a0contain 5 or 10 mg of donepezil hydrochloride USP. Inactive ingredients are mannitol, crospovidone, sucralose, sodium chloride, ferric oxide yellow and magnesium stearate.
  • No data
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  • Product: 71335-0416
  • NDC: 71335-0416-1 30 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-0416-2 60 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-0416-3 90 TABLET, FILM COATED in a BOTTLE
  • Advise the patient to read the FDA-approved patient labeling (Patient Information). Instruct patients and caregivers to take donepezil hydrochloride tablets only once per day, as prescribed.
  • Instruct patients and caregivers that donepezil hydrochloride can be taken with or without food. Donepezil hydrochloride 23 mg tablets should be swallowed whole without the tablets being split, crushed or chewed. Donepezil hydrochlorideu00a0orally disintegrating tabletsu00a0should not be swallowed whole, but be allowed to dissolve on the tongue and followed with water.
  • Advise patients and caregivers that donepezil hydrochloride may cause nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and decreased appetite. Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant.n n n n n
  • Donepezil Hydrochloride Tabletsn n- Donepezil Hydrochlorideu00a0Orally Disintegrating Tablets
  • Whatu00a0is donepezil hydrochloride? n
  • Donepezil hydrochloride is a prescription medicine to treat mild, moderate, and severe Alzheimeru2019s disease. Donepezil hydrochloride can help with mental function and with doing daily tasks. Donepezil hydrochloride does not work the same in all people. Some people may: u2022u00a0Seem much better u2022u00a0Get better in small ways or stay the same u2022u00a0Get worse over time but slower than expected u2022u00a0Not change and then get worse as expected u00a0
  • Donepezil hydrochloride does not cure Alzheimeru2019s disease. All patients with Alzheimeru2019s disease get worse over time, even if they take donepezil hydrochloride. u00a0
  • Donepezil hydrochloride has not been approved as a treatment for any medical condition in children. u00a0
  • Who should not take donepezil hydrochloride?
  • What should I tellu00a0my doctor before taking donepezil hydrochloride?n- Tell the doctor about all of your present or past health problems and conditions.
  • Tellu00a0your doctor about all the medicines you take,
  • Donepezil hydrochloride taken with certain medicines used for anesthesia may cause side effects. Tell the responsible doctor or dentist that you take donepezil hydrochloride before you have: u2022u00a0surgery u2022u00a0medical procedures u2022u00a0dental surgery or procedures. u00a0
  • Know the medicines that you take. Keep a list of all your medicines. Show it tou00a0your doctor or pharmacist before you start a new medicine. n
  • How should the patient take donepezil hydrochloride? n
  • Whatu00a0are the possible side effects of donepezil hydrochloride?n- Donepezil hydrochloride may cause the following serious side effects: n
  • Callu00a0your doctor if you have: n
  • The most common side effects of donepezil hydrochloride are: n
  • u2022u00a0muscle cramps u2022u00a0feeling tired u2022u00a0not wanting to eat
  • These side effects may get better after you take donepezil hydrochloride for a while. This is not a complete list of side effects with donepezil hydrochloride. For more information, asku00a0youru00a0doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. u00a0
  • How should donepezil hydrochloride tablets be stored? n
  • Keep donepezil hydrochloride tablets and all medicines out of the reach of children. n
  • General information about donepezil hydrochloride
  • This leaflet summarizes the most important information about donepezil hydrochloride. If you would like more information talk with the patientu2019s doctor. You can ask your pharmacist or doctor for information about donepezil hydrochloride tablets that is written for health professionals. For more information call 1-888-943-3210. u00a0
  • What are the ingredients in donepezil hydrochloride tablets?
  • Active ingredient:
  • Inactive ingredients: Donepezil hydrochloride tablets 5 mg and 10 mg film-coated tablets:
  • Donepezil hydrochloride 23 mg film-coated tablets:
  • Donepezil hydrochlorideu00a0orally disintegrating tablets 5 mg and 10 mg:
  • u00a0n Macleods Pharma USA, INC, Plainsboro, NJ 08536
  • Manufactured by:n
  • March 2019n n
  • No data

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