LOVASTATIN MYLAN Tablets (2012)
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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