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ZOCOR DRUG INFO ACTIVE INGREDIENT: SIMVASTATIN (SIM-va-stat-in) COMMON BRAND NAME(S): Zocor USES: This medicine is an HMG-CoA reductase inhibitor or "statin" used in combination with a low-cholesterol and low-fat diet to lower cholesterol (LDL) and triglyceride levels and to raise good cholesterol (HDL) levels in your blood. OTHER USES: It may also be used in certain adolescent patients, age 10 to 17 years, who have a genetically caused cholesterol problem. This medicine is not a cure for high cholesterol, but may help to control it. This medicine may also be used in certain patients to reduce the risk of blood vessel blockage, heart attack, stroke, and death due to heart disease. It may also be used to treat other conditions as determined by your doctor. HOW TO USE: The patient should be placed on a standard cholesterol lowering diet before receiving ZOCOR and should continue on this diet during treatment with ZOCOR. Hypercholesterolaemia: The starting dose is usually 10 mg/day as a single dose taken in the evening. Dosage adjustments, if required, can be made at intervals of not less than 4 weeks up to a maximum of 40 mg/day administered in a single dose in the evening. If the levels of cholesterol-LDL fall below 75 mg/dl (1.94 mmol/l) or if the levels of plasma total cholesterol fall below 140 mg/dl (3.6 mmol/l) a reduction in the dosage of ZOCOR should be considered. Coronary heart disease: Patients with coronary heart disease can be treated with a starting dose of 20 mg/day given as a single dose in the evening. Adjustment of dosage, if required, should be made as described in the previous paragraph (see section DOSE, METHOD AND TIME OF ADMINISTRATION - Hypercholesterolaemia). Concomitant therapy: ZOCOR is effective alone or in combination with bile-acid sequestrants. In patients taking concomitant cyclosporin, fibrates or niacin, amiodarone or verapamil with simvastatin, see section PRECAUTIONS FOR USE - Muscle effects. Dosage in renal impairment: Since ZOCOR does not undergo significant renal excretion, no dosage adjustments are required in patients with moderate renal impairment. In patients with severe renal impairment (creatinine clearance less than 30 ml/min), dosages higher than 10 mg/day should be carefully assessed and, if considered necessary, increased with caution. SIDE EFFECTS: Any drug can have unforeseen or undesirable effects, so-called side effects. The majority of side effects were mild and transient in nature. Fewer than 2% of patients abandoned the controlled clinical studies due to undesirable effects attributable to ZOCOR. In all the pre-marketing controlled clinical studies, undesirable effects considered by the investigator as possibly, probably or definitely drug related, occurring with a frequency of 1% or more were: abdominal pain, constipation and flatulence. Other undesirable effects occurring in 0.5-0.9% of patients were weakness and headache. Cases of myopathy (muscle disease) have been reported. Since myopathy can be serious in rare cases, you should contact your doctor immediately in case of pain, tenderness or muscle weakness (see section PRECAUTIONS FOR USE). The following undesirable effects have been reported in uncontrolled clinical studies or with marketed use: nausea, diarrhoea, skin rash, digestive disorders, pruritus, alopecia, dizziness, muscle cramps, muscle pain, pancreatitis, paraesthesia, peripheral neuropathy, vomiting, anaemia. In rare cases, there have been reports of skeletal muscle lesions and liver disease, yellowing of the skin and mucosa. There have been rare reports of apparent hypersensitivity syndrome, including some of the following conditions: swelling of the face, tongue and throat, syndrome similar to SLE, polymyalgia rheumatica (inflammatory disease of the muscles), dermatomyositis (inflammatory disease of the skin and muscles), inflammation of the blood vessels, decreased platelet count, elevated white cell count, eosinophilia, elevated erythrocyte sedimentation rate (ESR), arthritis, joint pain, urticaria, hypersensitivity reaction due to exposure to sunlight, fever, flushing, respiratory difficulties, malaise. Laboratory test findings: As with all cholesterol lowering agents, following treatment with simvastatin, moderate increases of the serum transaminases have been reported (less than 3 times the maximum limit of normal). These changes, which appeared immediately after the start of simvastatin therapy, were frequently transient and were not accompanied by any other symptomatology and, generally speaking, did not require suspension of the treatment. Marked and persistent increases of serum transaminases have been reported infrequently. Elevated alkaline phosphatase and y-glytamyl transpeptidase have been reported. There have been reports of elevated serum creatine-kinase (CK) levels of skeletal muscle origin (see section PRECAUTIONS FOR USE) Muscle effects (myopathy/rhabdomyolysis): The following undesirable events have been reported during ZOCOR treatment, but a causal relationship to therapy with the drug has not been demonstrated: depression, erythema multiforme, including Stevens-Johnson syndrome, leucopenia and purpura. The patient is invited to inform his doctor if any undesirable effects other than those described above are experienced. PRECAUTIONS: Do not take simvastatin without first talking to your doctor if you have liver disease. Before taking simvastatin, tell your doctor if you have kidney disease, drink alcoholic beverages, have a chronic muscular disease, or have a blood disorder. You may not be able to take simvastatin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Simvastatin is in the FDA pregnancy category X. This means that simvastatin is known to cause birth defects if it is taken during pregnancy. Do not take simvastatin if you are pregnant or could become pregnant during treatment. It is not known whether simvastatin passes into breast milk. Do not take simvastatin without first talking to your doctor if you are breast-feeding a baby. DRUG INTERACTIONS: Interactions and risk of myopathy/rhabdomyolysis The risk of myopathy/rhabdomyolysis is increased with the concomitant use of the following drugs: Potent inhibitors of CYP3A4 increase the risk of myopathy by reducing the elimination of simvastatin. Cyclosporin, mibefradil, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors or nefadozone, especially with elevated doses of simvastatin (see section PRECAUTIONS FOR USE). Interactions with lipid lowering drugs that can cause myopathy, even if administered alone.The risk of myopathy is increased also by the following lipid lowering drugs that are not potent inhibitors of CYP3A4 but which can cause myopathy even if used alone: gemfibrozil, other fibrates or niacin administered at lipid lowering dosages (= 1 g/day), especially with elevated doses of simvastatin (see section PRECAUTIONS FOR USE). Other drugs: amiodarone or verapamil, with elevated dosages of simvastatin (See section PRECAUTIONS FOR USE). In a clinical study under way, myopathy was observed in 6% of patients treated with 80 mg of simvastatin and amiodarone. Diltiazem: patients treated concomitantly with simvastatin 80 mg have a slightly increased risk of myopathy. In these patients the risk of myopathy is equivalent to approximately 1%. In clinical studies, the risk of myopathy in patients receiving 40 mg simvastatin therapy and diltiazem, was similar to the risk of patients treated with 40 mg simvastatin without diltiazem (see section PRECAUTIONS FOR USE). Digoxin: Concomitant administration of simvastatin and digoxin to healthy volunteers has caused a slight increase (less than 0.3 ng/ml) in the plasma concentrations of the drug (measured using the radio-immuno-assay method) compared to concomitant administration with the placebo and digoxin. Coumarin derivatives: In two clinical studies one in healthy volunteers and the other in hypercholesterolaemia patients, simvastatin 20-40 mg/day modestly potentiated the effect of coumarin anticoagulants: the prothrombin time, reported as INR (International Normalised Ratio), increased from a baseline of 1.7 to 1.8 in healthy volunteers and 2.6 -3.4 in the hypercholesterolaemia patients. In patients taking coumarin anticoagulants, prothrombin time should be should be determined before starting simvastatin and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs. Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals regularly recommended for patients on coumarin anticoagulants. If the dose of simvastatin is changed, the same procedure should be repeated. Simvastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants. OVERDOSE: If you think you have taken an excessive dose of ZOCOR, contact your doctor immediately. Some cases of overdose have been reported. No specific symptoms have been reported and all patients recovered without sequellae. Symptoms of a simvastatin overdose include nausea, diarrhea, stomach distress, and indigestion. NOTES: ZOCOR should not be used: In patients who are hypersensitive/allergic to the active substance, one of the excipients or substances which are closely related chemically; In patients with active liver disease or persistent transaminase elevations; In case of concomitant therapy with mibefradil, a calcium antagonist belonging to the tetralol class (see also PRECAUTIONS FOR USE and INTERACTIONS. In women who are known or believed to be pregnant or lactating (see also SPECIAL WARNINGS) - Pregnancy and Lactation): In children (see section PRECAUTIONS FOR USE). MISSED DOSE: Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication. STORAGE: Keep this medication in the packet it came in, tightly closed, and out of reach of children. Store below 30ºC. Throw away any medication that is outdated or no longer needed. Expiry: check the expiry date on the pack. The shelf life is quoted for the product in an unopened and correctly stored pack. Talk to your pharmacist about the proper disposal of your medication.
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