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VANADON

Quick Overview

Our aim is to reach out to the globe within shortest possible time frame. 


To promote this objective, not only we distribute and market our CNS  range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as VANADON which contains Donepezil Hydrochloride USP….. 10 mg.

Vanadon-10

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Details

Each film coated tablet contains:

Donepezil Hydrochloride USP….. 10 mg

Excipients     q.s.
Colour : Yellow Oxide of Iron and Titanium Dioxide

CHEMISTRY: ( ± )-2 [(1-Benzy1-4- pip eridyl)methyl] -5,6-dimethoxy-1- indanone hydrochloride

CATEGORY: Reversible inhibitor of acetyl cholinesterase.

PHARMACOLOGY

Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimer's disease attribute some of them to a deficiency of cholinergic neurotransmission.

PHARMACODYNAM ICS:

Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase. There is no evidence that donepezil alters the course of the underlying dementing process.

PHARMACOKINETICS:

Absorption

Pharmacokinetics of donepezil is linear over a dose range of 1 mg to 10 mg given once daily. The rate and extent of absorption of donepezil hydrochloride tablets are not influenced by food.

Distribution

The steady state volume of distribution is 12 to 16 Ukg. Donepezil is approximately 96% bound to human plasma proteins, mainly to albumins (about 75%) and alpha1 - acid glycoprotein (about 21%).

Metabolism

Following multiple dose administration, donepezil accumulates in plasma by 4 to 7 fold, and steady state is reached within 15 days. Extensively metabolized to four major metabolites, two of which are known to be active, and a number of minor metabolites, not all of which have been identified. Donepezil is metabolized by CYP 450 is enzymes 2D6 and 3A4 and undergoes glucuronidation.

Excretion

The elimination half-life of donepezil is about 70 hours, and the mean apparent plasma clearance (Cl/F) is 0.13 to 0.19 Uhr/kg. Donepezil is both excreted in the urine.

INDICATIONS:

Donepezil hydrochloride tablets are 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 AND ADMINISTRATION:

Mild to Moderate Alzheimer's Disease -5 mg or 10 mg administered once daily. Severe Alzheimer's disease - 10 mg administered once daily.

Titration

The recommended starting dose of donepezil hydrochloride tablets is 5 mg once daily. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg.

CONTRAINDICATIONS:

Donepezil hydrochloride tablets are contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piper dine derivatives.

WARNINGS AND PRECAUTIONS:

Anesthesia

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

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 tablets.

Nausea and Vomiting

Donepezil hydrochloride tablets, 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.

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 antiinflammatory drugs (NSAIDs).

Genitourinary Conditions

Although no studies have been reported of donepezil hydrochloride tablets, cholinomimetics may cause bladder outflow obstruction.

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.

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.

INTERACTIONS:

Effect of Donepezil Hydrochloride tablets on the Metabolism of Other Drugs Whether donepezil hydrochloride tablets has any potential for enzyme induction is not known. Studies reported on the potential of donepezil hydrochloride tablets for interaction with theophylline, cimetidine, warfarin, digoxin and ketoconazole show no effects of donepezil hydrochloride tablets on the pharmacokinetics of these drugs.

Effect of Other Drugs on the Metabolism of Donepezil Hydrochloride

Formal pharmacokinetic studies reported that the metabolism of donepezil hydrochloride tablets is not significantly affected by concurrent administration of digoxin or cimetidine.

Use with Anticholinergics

Because of their mechanism of action, cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications.

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.

PREGNANCY AND LACTATION:

Pregnancy

Pregnancy Category C:

There are no adequate or well-controlled studies in pregnant women. Donepezil hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether donepezil is excreted in human milk. Caution should be exercised when donepezil hydrochloride tablets are administered to a nursing woman.

USE IN SPECIFIC POPULATIONS:

Pediatric Use

The safety and effectiveness of donepezil hydrochloride tablets in children have not been established.

Geriatric Use

There were no clinically significant differences in most adverse events reported by patient groups 65 years old and <65 years old.

Effect to Drive & Use the Machine: None

ADVERSE DRUG REACTIONS:

The most common adverse reactions of donepezil hydrochloride tablets are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia.

Body as a Whole:

Frequent: abdominal pain, asthenia, fungal infection, flu syndrome; Infrequent: allergic reaction, cellulltis, malaise, sepsis, face edema, hernia.

Cardiovascular System:

Frequent: hypotension, bradycardia, ECG abnormal, heart failure;

Infrequent: myocardial infarction, angina pectoris, atrial fibrillation, congestive heart failure, peripheral vascular disorder, supraventricular extrasystoles, ventricular extrasystoles, cardiomegaly.

Digestive System:

Frequent: constipation, gastroenteritis, fecal incontinence, dyspepsia; Infrequent: gamma glutamyl transpeptidase increase, gastritis, dysphagia, periodontltis, stomach ulcer, periodontal abscess, flatulence, liver function tests abnormal, eructation, esophagitis, rectal hemorrhage.

Endocrine System:

Infrequent: diabetes mellitus. Hemic and Lymphatic System: Frequent: anemia; leukocytosis.

Metabolic and Nutritional Disorders: Frequent: weight loss, peripheral edema, edema, lactic dehydrogenase increased, alkaline phosphatase increased; Infrequent hypercholesteremia, hypokalemia, hypoglycemia, weight gain, bilirubinemia, BUN increased, B12 deficiency anemia, cachwda, creatinine increased, gout, hyponatremia, hypoproteinemia, iron deficiency anemia, SGOT increased, SGPT increased.

Musculoskeletal System: Frequent: arthritis; Infrequent: arthrosis, bone fracture, arthralgia, leg cramps, osteoporosis, myalgia.

Nervous System: Frequent: agitation, anxiety, tremor, convulsion, wandering, abnormal gaff; Infrequent: apathy, vertigo, delusions, abnormal dreams, cerebrovascular accident, increased salivation, ataxia, euphoria, vasodilatation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, extrapyramidal syndrome, grand mal convulsion, hemiplegia, hypertonia, hypokinesia.

Respiratory System: Frequent: pharyngitis, pneumonia, cough increased, bronchitis; Infrequent: dyspnea, rhinitis, asthma.

Skin and Appendages: Frequent: rash, skin ulcer, pruritus; Infrequent: psoriasis, skin discoloration, herpes zoster, dry skin, sweating, urticaria, vesiculobullous rash.

Special Senses: Infrequent: conjunctivitis, glaucoma, abnormal vision, ear pain, lacrimation disorder.

Urogenital System: Frequent: urinary tract infection, cystitis, hematuria, glycosuria; Infrequent: vaginitis, dysuria, urinary frequency, albuminuria.

OVERDOSAGE:

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.

It is not known whether donepezil hydrochloride tablets 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 gaff, lacrimation, clonic convulsions, depressed respiration, salivation, miosis, tremors, fasciculation and lower body surface temperature.

PRESENTATION: Blister of 10 tablets

STORAGE: Store below 30°C.

Keep out of reach of children.

 

 

 
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