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.
