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Altoprev

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Overview

What is Altoprev?

Altoprev lovastatin extended-release tablets contain a cholesterol-lowering agent isolated from a strain of . After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol.

Lovastatin is [1 -[1α(),3α,7β,8β(2 ,4 ),8aβ]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is CHO and its molecular weight is 404.55. Its structural formula is:

Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile.

Altoprev extended-release tablets are designed for once-a-day oral administration and deliver 20 mg, 40 mg, or 60 mg of lovastatin. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: acetyltributyl citrate; butylated hydroxy anisole; candellila wax; cellulose acetate; confectioner’s sugar (contains corn starch); F D & C yellow # 6; glyceryl monostearate; hypromellose; hypromellose phthalate; lactose; methacrylic acid copolymer, type B; polyethylene glycols (PEG 400, PEG 8000); polyethylene oxides; polysorbate 80; propylene glycol; silicon dioxide; sodium chloride; sodium lauryl sulfate; synthetic black iron oxide; red iron oxide; talc; titanium dioxide and triacetin.



What does Altoprev look like?



What are the available doses of Altoprev?

20, 40, and 60 mg tablets ()

What should I talk to my health care provider before I take Altoprev?

How should I use Altoprev?

Therapy with lipid-altering agents should be one component of multiple risk factor intervention in individuals who require modifications of their lipid profile. Drug therapy is recommended as an adjunct to a diet restricted in saturated fat and cholesterol only when the response to diet and other non-pharmacological measures has been inadequate.

The recommended dosing range is 20-60 mg/day, in single doses taken in the evening at bedtime. 


What interacts with Altoprev?

Sorry No Records found


What are the warnings of Altoprev?

Sorry No Records found


What are the precautions of Altoprev?

Sorry No Records found


What are the side effects of Altoprev?

Sorry No records found


What should I look out for while using Altoprev?

The use of Altoprev is contraindicated in the following conditions:  


What might happen if I take too much Altoprev?

After oral administration of lovastatin immediate-release to mice the median lethal dose observed was >15 g/m.

Five healthy human volunteers have received up to 200 mg of lovastatin as a single dose without clinically significant adverse experiences. A few cases of accidental overdosage with lovastatin immediate-release have been reported; no patients had any specific symptoms, and all patients recovered without sequelae. The maximum dose taken was 5 g to 6 g.

Until further experience is obtained, no specific treatment of overdosage with Altoprev can be recommended.

The dialyzability of lovastatin and its metabolites in man is not known at present.


How should I store and handle Altoprev?

Store at 20° to 25°C (68° to 77°F)Protect from moisture.Store at 20° to 25°C (68° to 77°F)Protect from moisture.Altoprev lovastatin extended-release tablets are supplied as round, convex shaped tablets containing 20 mg, 40 mg and 60 mg of lovastatin.NDC NDC NDC StorageStore at 20º-25°C (68º-77°F) - Excursions Permitted to 15°-30°C (59° -86°F) [See USP Controlled Room Temperature]. Avoid excessive heat and humidity.Altoprev lovastatin extended-release tablets are supplied as round, convex shaped tablets containing 20 mg, 40 mg and 60 mg of lovastatin.NDC NDC NDC StorageStore at 20º-25°C (68º-77°F) - Excursions Permitted to 15°-30°C (59° -86°F) [See USP Controlled Room Temperature]. Avoid excessive heat and humidity.Altoprev lovastatin extended-release tablets are supplied as round, convex shaped tablets containing 20 mg, 40 mg and 60 mg of lovastatin.NDC NDC NDC StorageStore at 20º-25°C (68º-77°F) - Excursions Permitted to 15°-30°C (59° -86°F) [See USP Controlled Room Temperature]. Avoid excessive heat and humidity.Altoprev lovastatin extended-release tablets are supplied as round, convex shaped tablets containing 20 mg, 40 mg and 60 mg of lovastatin.NDC NDC NDC StorageStore at 20º-25°C (68º-77°F) - Excursions Permitted to 15°-30°C (59° -86°F) [See USP Controlled Room Temperature]. Avoid excessive heat and humidity.Altoprev lovastatin extended-release tablets are supplied as round, convex shaped tablets containing 20 mg, 40 mg and 60 mg of lovastatin.NDC NDC NDC StorageStore at 20º-25°C (68º-77°F) - Excursions Permitted to 15°-30°C (59° -86°F) [See USP Controlled Room Temperature]. Avoid excessive heat and humidity.Altoprev lovastatin extended-release tablets are supplied as round, convex shaped tablets containing 20 mg, 40 mg and 60 mg of lovastatin.NDC NDC NDC StorageStore at 20º-25°C (68º-77°F) - Excursions Permitted to 15°-30°C (59° -86°F) [See USP Controlled Room Temperature]. Avoid excessive heat and humidity.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Lovastatin is a lactone that is readily hydrolyzed to the corresponding β-hydroxyacid, a strong inhibitor of HMG-CoA reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate. The conversion of HMG-CoA to mevalonate is an early step in the biosynthetic pathway for cholesterol.

Non-Clinical Toxicology
The use of Altoprev is contraindicated in the following conditions:  

Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including Altoprev.

There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.

All patients starting therapy with Altoprev, or whose dose of Altoprev is being increased, should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing Altoprev.   Altoprev therapy should be discontinued immediately if myopathy is diagnosed or suspected.

Altoprev therapy should be discontinued if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected. Altoprev therapy should also be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; dehydration; major surgery; trauma; severe metabolic, endocrine, and electrolyte disorders; or uncontrolled epilepsy.

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Contraindications (); Clinical Pharmacology (); Drug Interactions ()

Contraindications (); Drug Interactions ()

Gemfibrozil:

 

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Drug Interactions ()

Prescribing recommendations for interacting agents are summarized in .

The following serious adverse reactions are discussed in greater detail in other sections of the label:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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