Cosmos Pharmaceutical Limited | Lipecos® Tablets
Cosmos Limited is one of the leading manufacturers of pharmaceutical products in Kenya and East Africa. Through our specialized Human Health and Animal Health.
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Lipecos® Tablets

PRESENTATION

Lipecos® 5 Tablets: Yellow, circular, biconvex film coated tablet embossed ‘C’ on one side and plain on the other side. Each film coated tablet contains: Rosuvastatin calcium equivalent to Rosuvastatin 5 mg, Lactose and other excipients. Lipecos® 10 Tablets: Salmon Red, circular, biconvex film coated tablet embossed ‘C’ on one side and plain on the other side. Each film coated tablet contains: Rosuvastatin calcium equivalent to Rosuvastatin 10 mg, Lactose and other excipients.

CLINICAL PHARMACOLOGY

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3- methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol. The primary site of action for Rosuvastatin is the liver, the target organ for cholesterol lowering. Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.

Pharmacokinetics

Rosuvastatin is incompletely absorbed from the gastrointestinal tract, with a bioavailability of about 20%.Peak plasma concentrations are achieved about 5 hours after an oral dose. It is taken up extensively by the liver, its primary site of action, and undergoes limited metabolism, mainly by the cytochrome P450 isoenzyme CYP2C9. Approximately 90% of an oral dose of Rosuvastatin is excreted in the faeces, including absorbed and non-absorbed drug. The remainder is excreted in the urine, about 5% of the dose is excreted unchanged. USES Treatment of hypercholesterolemia Adults, adolescents and children aged 10 years or older with primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) are inadequate. Prevention of cardiovascular events Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.

DOSAGE AND ADMINISTRATION

Usual doses in adults Usual initial dose: 5 mg or 10 mg. The maximum daily dose of Rosuvastatin is 40 mg. In children and adolescents aged 10-17 years The usual starting dose is 5 mg. Your doctor may increase your dose to find the right amount of Rosuvastatin for you. The maximum daily dose of Rosuvastatin is 20 mg. The dose should be taken once a day.

CONTRA-INDICATIONS AND WARNINGS

Talk to your doctor or pharmacist before taking Rosuvastatin. If you have problems with your kidneys. If you have problems with your liver. If you have repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines.
If you regularly drink large amount of alcohol.
If your thyroid gland is not working properly.
If you take other medicine called fibrates to lower your cholesterol.

Precautions:

Do not take Rosuvastatin:
If you have ever had an allergic reaction to Rosuvastatin, or to any of its ingredients.
If you are pregnant or breast-feeding.
If you have severe kidney problems.
If you have repeated or unexplained muscle aches or pains. Adverse Effects: Common possible side effects include: Headache, stomach pain, constipation, feeling sick, muscle pain, feeling weak and dizziness. Interactions: Tell your doctor or pharmacists if you are taking, have recently taken or might take any other medicines. Tell your doctor if you are taking any of the following: ciclosporin (used for example, after organ transplants), warfarin,(or any other drug used for thinning the blood), fibrates(such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol(such as ezetimibe), indigestion remedies(such as neutralize acid in your stomach, erythromycin, an oral contraceptive, hormone replacement therapy or ritonavir with lopinavir and/or atazanavir. The effect of these medicines could be changed by Rosuvastatin or they could change the effects of Rosuvastatin.

PHARMACEUTICAL PRECAUTIONS:

Store in a dry place below 30°C. Protect from light. Keep all medicines out of the reach of children.

LEGAL CATEGORY:

Prescription Only Medicine (POM)

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