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LOVASTATIN MYLAN Tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Lovastatin Mylan.

Qualitative and quantitative composition

Lovastatin 20 mg and 40 mg. For a full list of excipients see section 6.1.

Pharmaceutical form

Tablets. 20 mg: Pale blue, octagonal tablets marked LV/20 on one side and G on the other, with score-line on one side. 40 mg: Green, octagonal tablets marked LV/40 on one side and G on the other, with ...

Therapeutic indications

Severe cases of hypercholesterolaemia when dietary treatment does not have an adequate effect.

Posology and method of administration

The patient should be placed on a standard cholesterol-lowering diet before being given lovastatin. This diet should be continued during treatment with lovastatin. Any cause for secondary hypercholesterolemia ...

Contraindications

Hypersensitivity to lovastatin or to any of the excipients of the medicinal product. Active liver disease or unexplained persistently elevated serum transaminase levels. Cholestasis Myopathy Concomitant ...

Special warnings and precautions for use

Myopathy/Rhabdomyolysis Lovastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above 10X the upper ...

Interaction with other medicinal products and other forms of interaction

CYP3A4 Interactions Interactions associated with cytochrome P450 3A4. Lovastatin has no inhibitory effect on cytochrome P450 3A4. Therefore, lovastatin is not expected to influence the plasma concentrations ...

Pregnancy and lactation

Pregnancy Lovastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with lovastatin have been carried out in pregnant women. There ...

Effects on ability to drive and use machines

Lovastatin has no or negligible influence on the ability to drive and use machines. However, when driving vehicles or operating machines, it should be taken into account that dizziness has been reported ...

Undesirable effects

Lovastatin is generally well tolerated; the adverse reactions of lovastatin have for the most part been mild and transient. The frequency of adverse reactions can be ranged as follows: Very common (≥1/10), ...

Overdose

Until further experience with overdose of lovastatin has been obtained, no specific treatment can be recommended. General measures for overdose should be applied and liver function should be monitored. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Serum lipid reducing agents HMG CoA reductase inhibitors. ATC code: C10AA02 Lovastatin, which is an inactive lactone, is hydrolysed after oral administration to the corresponding ...

Pharmacokinetic properties

In animal studies lovastatin, after oral administration, has displayed high selectivity for the liver, where lovastatin can be measured in far higher concentrations than in other tissues. Lovastatin undergoes ...

Preclinical safety data

The repeated administration of lovastatin in high doses led to toxic effects in various animal species, which were attributable to an excessive pharmacological action. The main target organs were the liver ...

List of excipients

20 mg: Pregelatinised starch Microcrystalline cellulose Magnesium stearate Butylated hydroxyanisole (E320) Indigo carmine (E132) 40 mg: Pregelatinised starch Microcrystalline cellulose Mmagnesium stearate ...

Incompatibilities

Not applicable.

Shelf life

Shelf-life: 2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Aluminium/aluminium blister. Pack sizes: 10, 28, 30, 50, 100. Not all pack sizes may be marketed.

Instructions for use/handling

No special requirements.

Marketing authorization holder

Mylan AB

Marketing authorization number(s)

20 mg: 32379 40 mg: 32380

Date of revision of the text

January 2012

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