PRAVASTATIN-ELSaad 10
-
Chemical Name:
Pravastatin Sodium -
Therapeutic Category:
Cardiovascular drugs -
Pharmacologic Category:
Antilipemic Agent, HMG-CoA Reductase Inhibitor -
Pharmaceutical Form:
Tablets -
Composition:
Pravastatin Sodium 10mg
PRAVASTATIN ELSaad
Tablets
Pravastatin Sodium
1.PHARMACOLOGY:
Pravastatin sodium is one of a new class of Lipid – lowering compounds, unlike Simvastatin or Lovastatin it is active in its administrated form.
Pravastatin sodium is a cholesterol lowering agent.
Pravastatin sodium is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG – CoA) reductase, and as a consequence, it first effects modest reduction in intracellular pools of cholesterol, and the second is the inhibition of LDL production by inhibiting hepatic synthesis of precursor of LDL which is VLDL.
Treatment with Pravastatin sodium reduces Total-C, LDL-C, apolipoprotein, TG and produces an increase in HDL-C and apolipoprotein A.
2.PHARMACOKINETICS:
Absorption: Pravastatin sodium is rapidly absorbed from the gastro – intestinal tract. It undergoes extensive first - pass metabolism in the liver, its primary site of action. Approximately 50 % of the circulating Pravastatin sodium is bound to plasma proteins.
Elimination: The Plasma elimination half-life of Pravastatin sodium in 1.5 to 2 hours. Pravastatin sodium is excreted mainly in faeces via the bile with a smaller proportion excreted in the urine.
3.INDICATIONS:
Pravastatin is indicated to those individuals at risk for atherosclerosis- related clinical events as a function of cholesterol level, the presence or absence of coronary cardiac disease & other risk factors.
Primary prevention of coronary events:
In hypercholesterolemic patients without clinically evident coronary heart disease, Pravastatin is indicated to reduce the risk of myocardial infraction, undergoing myocardial revascularization procedures, cardiovascular mortality with no increase in death from non cardiovascular causes.
Secondary prevention of cardiovascular events:
In patients with clinically evident coronary cardiac disease, Pravastatin is indicated to reduce the risk of:
- Total mortality by reducing coronary death.
- Myocardial infraction.
- Undergoing myocardial revascularization procedure.
- Stroke and stroke/transient ischemic attack.
And to slow the progression of coronary atherosclerosis.
Hyperlipidemia:
- Pravastatin is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB and TG-levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb).
- Pravastatin is indicated as adjunctive therapy to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV).
- Pravastatin is indicated for the treatment of patients with primary dysbetalipoprotenmia (Fredrickson Type III) who don't respond to diet adequately.
4. CONTRAINDICATIONS:
- Hypersensitivity to the product.
- Active liver disease or unexplained, persistent elevations of serum transaminases.
- Pregnancy and lactation.
5.PRECAUTIONS:
It is recommended that liver function tests be performed prior to the initiation of therapy, prior to the elevation of the dose and when otherwise clinically indicated.
Skeletal muscle:
Rare cases of rhabdomylysis with acute renal failure secondary to myoglobinuria are reported with pravastatin and other drugs in this class. Uncomplicated myalgia has been reported in Pravastatin-treated patients. Patients should be advised to report promptly any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Pravastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
Pravastatin therapy should be also being temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to Rhabdomylosis e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine or electrolyte disorders or uncontrolled epilepsy.
Homozygous Familial Hypercholesterolemia:
It has been reported that HMG-CoA reductase inhibitors are less effective because the patients lack functional LDL-receptors.
Renal Insufficiency:
Patients with renal impairment who are receiving Pravastatin should be closely monitored.
Endocrine functions:
Patients with Pravastatin who display clinical evidence of endocrine dysfunction should be evaluated appropriately. Caution should be also taken if HMG-CoA reductase inhibitors or other agents used to lower cholesterol levels are administered to patients also receiving other drugs e.g. Ketoconazole, Spironolactone, Cimetidine that may diminish the levels of steroid hormones activity.
6.SIDE EFFECTS:
Pravastatin sodium is well tolerated; it may rarely cause mild and transient side effects such as: Abdominal pain, constipation, diarrhea, nausea, headache, skin rashes and myopathy.
7.DRUG INTERACTIONS:
- Pravastatin should be taken one hour before or four hours after Cholestyramine or Colestipol when these drugs are used concomitantly.
- There are no drug interactions with the following products: Warfarine, Cimetidine, Digoxine, Aspirin.
- The concomitant use with some products like: Erythromycin, Cyclosporine, Niacin or Fibrates may increase the risk of myopathy.
8.DOSAGE AND ADMINISTRATION:
The patient should be placed on a cholesterol lowering diet and it is recommended that this diet should be continued during treatment.
Adult Patients:
The recommended starting dose is 40 mg once daily. If this dose does not achieve desired cholesterol levels, 80 mg once daily is recommended. In patients with a history of significant renal or hepatic dysfunction, a starting dose of 10 mg daily is recommended.
Adolescents Patients (Ages 14 to 18 Years):
The recommended dose is 40 mg once daily. Doses greater than 40 mg have not been studied in this patient population.
Children Patients (Ages 8 to 13 Years, Inclusive):
The recommended dose is 20 mg once daily. Doses greater than 20 mg have not been studied in this patient population.
9.PACKAGING & COMPOSITION:
- PRAVASTATIN ELSaad 10 – Tablets: A pack of 10 or 30 tablets. Each tablet contains Pravastatin Sodium 10 mg.
- PRAVASTATIN ELSaad 20 – Tablets: A pack of 20 tablets. Each tablet contains Pravastatin Sodium 20 mg.
- PRAVASTATIN ELSaad 40 – Tablets: A pack of 10 tablets. Each tablet contains Pravastatin Sodium 40 mg.
- PRAVASTATIN ELSaad 80 – Tablets: A pack of 10 or 20 tablets. Each tablet contains Pravastatin Sodium 80 mg.
10.STORAGE CONDITIONS:
Store PRAVASTATIN ELSaad – Tablets at temperature between (15-30)°C. Protect from light and moisture.
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