Content on this page requires a newer version of Adobe Flash Player.

Get Adobe Flash player

 
 
 
 
 
 
 
 
 
 

VITONAC SR 500

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 cardiovascular  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 Vitonac SR 500 which contain Nicotinic Acid IP..500 mg


This Vitonac SR 500 contains same active ingredient as SIMCOR from Abbott Pharmaceuticals.

Vitonac SR 500

Double click on above image to view full picture

Zoom Out
Zoom In

Details

                                                     VITONAC SR 500

COMPOSITION:

Each Uncoated Sustained

Release Tablet Contains:

Nicotinic Acid IP                           500 mg

CHEMISTRY: Pyridine-3-carboxylic acid CATEGORY: Antihyperlipidemic agent

PHARMACOLOGY

PHARMACODYNAMICS:

The mechanism by which nicotinic acid alters lipid profiles has not been well defined. It may involve several actions including partial inhibition of release of free fatty acids from adipose tissue and increased lipoprotein lipase activity, which may increase the rate of chylomicron triglyceride removal from plasma. Nicotinic acid decreases the rate of hepatic synthesis of VLDL and LDL and does not appearto affectfecal excretion of fats sterols, or bile acids.

PHARMACOKINETICS:

Absorption

Nicotinic acid is rapidly and extensively absorbed (at least 60 to 76% of dose) when administered orally. To maximize bioavailability and reduce the risk of gastrointestinal (GI) upset, administration of nicotinic acid tablets with a low-fat meal or snack is recommended.

Distribution

Time to reach the maximum nicotinic acid plasma concentrations was about 5 hours following nicotinic acid tablets.

Metabolism

The pharmacokinetic profile of nicotinic acid is complicated due to rapid and extensive first-pass metabolism, which is species and dose-rate specific. In humans, one pathway is through a simple conjugation step with glycine to form nicotinuric acid (NUA). NUA is then excreted in the urine, although there may be a small amount of reversible metabolism backto nicotinic acid.

Elimination

Nicotinic acid and its metabolites are rapidly eliminated in the urine. Following single and multiple doses, approximately 60 to 76% of the nicotinic acid dose administered is recovered in urine as nicotinic acid and metabolites; up to 12% was recovered as unchanged nicotinic acid after multiple dosing. The ratio of metabolites recovered in the urine was dependent on the dose administered.

INDICATIONS:

1. Nicotinic acid tablets are indicated as an adjunct to diet for reduction of elevated TC, LDL-C, Apo B and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidennia, when the response to an appropriate diet has been inadequate.

2. Nicotinic acid tablets in combination with lovastatin is indicated for the treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidennia when treatment with both nicotinic acid tablets and lovastatin is appropriate and as an adjunctto diet.

3. In patients with a history of myocardial infarction and hypercholesterolemia, nicotinic acid is indicated to reduce the risk of recurrent nonfatal myocardial infarction.

4. In patients with a history of coronary artery disease (CAD) and hypercholesterolemia, nicotinic acid, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.

5. Nicotinic acid tablets in combination with a bile acid binding resin is indicated as an adjunct to diet for reduction of elevated IC and LDL-C levels in adult patients with primary hypercholesterolemia,when the response to an appropriate diet or diet plus monotherapy, has been inadequate.

6.Nicotinic acid tablets is also indicated as adjunctive therapy for treatment of adult patients with very high serum triglyceride levels who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.

 

Limitations of Use:

No incremental benefit of nicotinic acid tablets coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for nicotinic acid, simvastatin, or lovastatin monotherapy has been established.

DOSAGE AND ADMINISTRATION:

Nicotinic acid tablets should be taken at bedtime, after a low-fat snack and doses should be individualized according to patient response. Therapy with nicotinic acid tablets must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during earlytherapy.

Recommended Dosing:


 

Week(s)

Daily dose

Nicotinic acid

tablets Dosage

INITIAL TITRATION

SCHEDULE

1 to 4

500 mg

1 nicotinic acid

500 mg tablets at

bedtime

 

5 to 8

1000 mg

2 nicotinic acid

500 mg tablets at

bedtime

 

*

1 500 mg

3 nicotinic acid

500 mg tablets at

bedtime

 

*

2000 mg

4 nicotinic acid

500 mg tablets at

bedtime

 

* After Week 8 titrate to patient response and tolerance. If response to 1000 mg daily is inadequate, increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Daily dose should not be increased more than 500 mg in a 4-week period and doses above 2000 mg daily are not recommended. Women may respond at lower doses than men.

Maintenance Dose:

The daily dosage of nicotinic acid tablets should not be increased by more than 500 mg in any 4-week period. The recommended maintenance dose is 1000 mg (two 500 mg tablets) to 2000 mg (four 500 mg tablets) once daily at bedtime. Doses greater than 2000 mg daily are not recommended. Women may respond at lower nicotinic acid tablets doses than men.

If nicotinic acid tablets therapy is discontinued for an extended period; reinstitution of therapy should include a titration phase.

Nicotinic acid tablets should be taken whole and should not be broken, crushed or chewed before swallowing.

Concomitant Therapy

Concomitant Therapy with Lovastatin or Simvastatin

Patients already receiving a stable dose of lovastatin or simvastatin who require further TG-lowering or HDL-raising, may receive concomitant dosage titration with nicotinic acid per nicotinic acid tablet recommended initial titration schedule. Combination therapy with nicotinic acid and lovastatin or nicotinic acid and simvastatin should not exceed doses of 2000 mg nicotinic acid tablets and 40 mg lovastatin or simvastatin daily.

Dosage in Patients with Renal or Hepatic Insufficiency:

Use of nicotinic acid tablets in patients with renal or hepatic insufficiency has not been studied. Nicotinic acid tablets is contraindicated in patients with significant or unexplained hepatic dysfunction. Nicotinic acid tablets should be used with caution in patients with renal insufficiency.

CONTRAINDICATIONS:

Nicotinic acid tablets is contraindicated in patients with a known hypersensitivity to nicotinic acid or any component of this medication, significant or unexplained hepatic dysfunction, active peptic ulcer disease or arterial bleeding.

WARNINGS:

For patients switching from immediate-release nicotinic acid to nicotinic acid tablets, therapy with nicotinic acid tablets should be initiated with low doses (i.e., 500 mg at bedtime) and the nicotinic acid tablets dose should then be titrated to the desired therapeutic response.

Skeletal Muscle

Physicians contemplating combined therapy with HMG-CoA reductase inhibitors and nicotinic acid tablets should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug.

Liver Dysfunction

Nicotinic acid tablets should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. Active liver diseases or unexplained transaminase elevations are contraindications to the use of nicotinic acid tablets. PRECAUTIONS:

General

Before instituting therapy with nicotinic acid tablets an attempt should be made to control hyperlipidemia with appropriate diet, exercise, and weight reduction in obese patients and to treat other underlying medical problems

Patients with a past history of jaundice, hepatobiliary disease or peptic ulcer should be observed closely during nicotinic acid tablets therapy.

Caution should also be used when nicotinic acid tablets is used in patients with unstable angina or in the acute phase of an MI. Elevated uric acid levels have occurred with nicotinic acid therapy, therefore use with caution in patients predisposed to gout. Nicotinic acid is rapidly metabolized by the liver, and excreted through the kidneys. Nicotinic acid tablets are contraindicated in patients with significant or unexplained hepatic dysfunction.

INTERACTIONS:

Antihypertensive Therapy: Nicotinic acid may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.

Aspirin: Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of this finding is unclear.

Other: Concomitant alcohol or hot drinks may increase the side effects of flushing and pruritus and should be avoided around the time of nicotinic acid tablets ingestion. Vitamins or other nutritional supplements containing large doses of nicotinic acid or related compounds such as nicotinamide may potentiate the adverse effects of nicotinic acid tablets.

PREGNANCY AND LACTATION:

Pregnancy Category C: It is also not known whether nicotinic acid tablets at doses typically used for lipid disorders can cause fetal harm when administered to pregnant women or whether it can affect reproductive capacity. If a woman receiving nicotinic acid tablets for primary hypercholesterolemia (Types Ila or 11b) becomes pregnant, the drug should be discontinued. If a woman being treated with nicotinic acid for hypertriglyceridennia (Types IV or V) conceives, the benefits and risks of continued therapy should be assessed on an individual basis.

Nursing Mothers

Nicotinic acid has been reported to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from lipid-altering doses of nicotinic acid, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. No studies have been conducted with nicotinic acid tablets in nursing mothers.

Pediatric Use

Safety and effectiveness of nicotinic acid therapy in pediatric patients (s 16 years) have not been established. No studies in patients under 21 years of age have been conducted with nicotinic acid tablets.

Geriatric Use

No overall differences in safety and effectiveness were observed between these patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.

ADVERSE DRUG REACTIONS:

Water soluble vitamins seldom cause toxicity in persons with normal renal function. However, flushing or redness of the skin, especially on face and neck; feeling of warmth, headache or an allergic reaction may occur but usually subside in 2 weeks.

At higher doses, diarrhea, dizziness or faintness, dryness of skin or eyes; nausea or vomiting; aggravation of peptic ulcer causing stomach pain; pruritus; hyperglycemia; hyperuricemia; cardiac arrhythnnias and hepatotoxicity are more likelyto occur.

OVERDOSAGE:

Supportive measures should be undertaken in the event of an overdose.

PRESENTATION: Blister of 10 tablets

Storage: Store in a cool and dry place. Protect from light.

Keep out of reach of children. Last Update: December 2012.