Megalex Silymarin Liver Support Tablets

Megalex Tablets
Silymarin 70 mg Liver support

 

Composition

Each tablet contains:

Silymarin 70 mg

 

Properties

The liver has several vital functions to perform in the human body: e.g. it plays a dominate role in metabolism (sugar, protein and fats), in digestion (bile secretion) and in the detoxication of waste products.

Every form of liver damage causes changes in the membranes of the liver cell and in this way impairs the functional capacity of the liver.

 

Pharmacodynamics

Silyimarin is of plant origin. It acts as a cell membrane stabilizer and is capable of protecting the liver against deleterious agents, which can cause toxic liver disease and accelerates the regenerative capacity of the damaged liver. These effects are reflected in improvement in general condition, relief of digestive symptoms, improvement of signs of liver disease and normalization of liver function test.

The mode of action of Silymarin is summarized as follows:

1- Silymarin modifies the structure of the exterior  cell membrane of the hepatocytes preventing hepatic toxins from penetrating into the interior of the cell.

2- Silymarin stimulates the activity of nuclear polymerase A, hence increasing ribosomal synthesis at proteins and resulting in a stimulation of the regenerating capacity of the liver and of the formation of new hepatocytes.

3- Silymarin also has an antioxidant effect preventing the formation of free radicals, which are often formed in the liver, such as reactive metabolites, as a result of the intake of toxins and they are responsible for cell membrane damage. Treatment of hepatic diseases resulting from biharziasis, viral hepatitis and amoebiasis has not yet been substantiated.

 

Pharmacokinetics

After the oral administration of Silymarin, the plasma concentration is insignificant; the main constituent measured is silibinin. Maximum concentration is attained after 2 hours on average.

Only about 1% of the administered dose is excreted in the urine 24 hours following the administration of the drug. On the contrary, a relatively high percentage of silibinin is detectable in bile in free and conjugated forms, permitting the estimation of the total quantity of silibinin found in bile, which is approximately 20 to 40% of the administered dose. The biliary half-life (the time of biliary half-elimination) is about 4 hours, while the total stay of the drug in the body is about 8 hours on average. The time of biliary elimination is relatively long bringing to belief that the silibinin remains long enough in the liver and/or takes part in the entero-hepatic circulation; this was proven with animal studies.

The excretion of silibinin takes place essentially through the bile as sulphate and glucuronide, as well as a small portion unchanged. On the other hand, urinary elimination is very little. Other metabolites cannot be lactated in appreciable concentrations.

 

Indications and Usage

Megalex Tablets are used for liver support only, in toxic and inflammatory hepatic disease.

 

Side Effects

A moderate laxative effect has been observed in isolated cases.

 

Contra – Indications

None are known.

 

Warnings and Precautions

None are known.

 

Drug Interactions

The concomitant use of Silymarin and butyrophenones or phenothiazines results in a reduction of lipid peroxidation.

Silymarin has an antagonistic effect with yohimbine and phentolamine when given simultaneously.

 

Pregnancy and Lactation

– No known clinical studies concerning the drug’s use in pregnant women exist.

– Animal studies have revealed no toxicity, neither direct nor indirect, having an effect on pregnancy, on embryonic development and post-natal development.

–  The potential risk on the foetus is unknown.

– The drug should he used with caution during pregnancy.

– The drug should not be administered during pregnancy except when absolutely necessary.

 

Effect on driving ability and on the use of machinery

Megalex does not have any influence on the driving ability or on the use of machinery.

 

Overdosage

There are no known specific antidotes. In cases of enetual urgency, treatment is symptomatic.

 

Dosage and Administration

As directed by the physician or as follows:

The daily dosage has been effective and well tolerated at 140 to 420 mg divided in 2 to 3 doses.

Initial dose (or in severe cases): 420 mg/day equivalent to 2 tablets 3 times daily.

Maintenance dose (or in moderate cases): reduce the dose to 3 tablets per day.

Swallow the tablets without crunching them, independently of meals, with some liquid.

 

Packing

Carton box contains 4 or 100 (pvc/al) strips each of 10 tablets.

 

Storage Conditions

Store below 25oC. Protect from light.

 

NAFDAC Reg. No.: B4 -4405

 

– Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.

– Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sells the medicament.

– The doctor and the pharmacist are experts in medicine, its benefits and risks.

– Do not by yourself interrupt the period of treatment prescribed for you.

– Do not repeat the same prescription without consulting your doctor.

– Keep medicament out of reach of children.

 

Produced by

Alexandria Co. for Pharmaceuticals and Chemical Industries

Gamila Bohreid Road-Awayed-Alex,

Misr Station Alexandria-Egypt.

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