Products Description

 

Product name

Simvalip

Composition

 

Each tablet contains : Simvastatin . 10mg, 20mg, 40mg

 

 

 

 Indications

 

Description :

-  Simvalip (Simvastatin) is an oral antilipemic agent, it is a prodrug that require hydrolysis for activation.

-   Simvalip (Simvastatin) is used in the treatment of primary hypercholesterolemia and is effective in reducing the total cholesterol, LDL- cholesterol, triglycerides and apolipoprotein B.

-  Simvalip(Simvastatin) in combination with diet control prevents myocardial infarction in patients with hypercholesterolemia and preexisting coronary artery disease.

 

Mechanism of action :

- The increase of the level of lipids and cholesterols in some patients is due to the activity of the hepatic microsomal enzyme HMG-COA reductase which converts HMG-COA to mevalonic acid, the precursor of sterols including total cholesterol, LDL-cholesterol as well as triglycerides and a polipoprotein B.

- Simvastatin is a prodrug activated by hydrolysis to several active metabolites mainly mevinolinic acid which is structurally similar to HMG-COA (Hydroxy Methyl Glutaryl COA), due to this similarity it competes for the conjugation with the hepatic microsomal enzyme HMG-COA Reductase instead of HMG-COA.

This interference with the activity of this enzyme reduces the quantity of mevalonic acid subsequently reduces total cholesterol and LDL-cholesterol as well as triglycerides and a polipoprtien B.

 

Indications :

- Simvalip (Simvastatin) is indicated for: atherosclerosis and with concomitant to specific diet system for reduction of elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides in patients with primary hypercholesterolemia, myocardial infarction prophylaxis, stroke  prophylaxis and in familial hypercholesterolemia (Heterozygous variant) or combined (mixed) hyperlipidemia corresponding to type II a and II b in conjunction with dietary control.

 

Dosage & Administration

 

Dosage & administration :

- The patient should be placed on a standard diet before, during and after treatment with 

- Patients requiring ≥ 20% reduction of cholesterol level: the usual starting dose is 10mg once at evening, the dose can be increased by the physician according to the cholesterol level and goal therapy into 20mg once daily.

- Adjustment of the dose should be made at interval of 4 weeks.

For patients with homozygous familial hypercholesterolemia :

The recommended dose is 40mg/day in the evening or 80mg/day divided in 3 doses per day of 20mg, 20mg and evening of 40mg.

 Contraindications :

- Simvalip (Simvastatin) is contraindicated in:

* Hypersensitivity to Simvastatin.

* Seizure disorder.

* During pregnancy and breast feeding.

Precautions :

-  Simvalip (Simvastatin) should be used with caution in :

* Patient with active liver disease (serum transaminase > 3 times the upper limit of normal).

* Patient with mayopathy (CPK ≥ 10 times of the upper limit of normal).

* Patient who consume substantial quantities of alcohol.

Drug interactions :

Simultaneous use of    with :

* Erythromycin : may increase the serum concentration of Simvastatin.

* Oral contraceptives : may increase the serum concentration of norethindrone and ethinyl oestradiol.

* Colestipol : may decrease the serum concentration of Simvastatin .

* Digoxin : may increase the serum concentration of Digoxin by about 20%.

* Cyclosporine, fibric acid derivatives : increase the risk of myopathy.

* Antacids : may decrease the serum concentration of Simvastatin.

* Warfarin : minimal decrease in prothrombin time may occur.

 Side effects :

- Most commonly reported are :

Abdominal pain, constipation and flatulence.

- Less common side effects are :

headache and weakness.

- The following side effects have been reported rarely:

nausea, vomiting, diarrhea, muscle pain, muscular weakness, tenderness of the muscles, alopecia, pancreatitis, paresthesia, peripheral neuropathy, pruritis, rash, liver problems, dizziness or fatigue. Also rarely, a hypersensitivity (allergic) reaction may occur including one or more of the following features: swelling or flushing of the face, fever, urticaria, shortness of breath, blood disorders, joint pain, inflammation of the joints or blood vessels. If you have these complaints or complaints that are not listed in the packet insert, you should contact your physician or pharmacist.

 Instructions to the patients :

-  Simvalip (simvastatin) tablets should be swallowed with a drink of water.

Simvalip (simvastatin) tablets work best if taken with food, if you take the tablet once daily take it with evening meal.

Simvalip (simvastatin) is only part of total cholesterol lowering program.  Your doctor or dietician can suggest a low cholesterol and low fat diet, that will reduce your risk of getting heart and blood vessel disease.

- Tell your physician about all other medicines your are taking including non prescription drugs.

- Tell your doctor about any side effects from                  .

- Visit your doctor for regular checks especially for your liver functions.

Pregnancy and lactation :

Not used in pregnancy and lactation.

 

 

Presentation

 

Simvalip 10 mg pack of 2 blisters X 14 tablets.

Simvalip 20 mg pack of 2 blisters X 14 tablets.

 Simvalip  40 mg pack of 2 blisters X 14 tablets.

Hospital packs of different sizes.

 

 

 

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