| Application: | Internal Medicine |
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| Usage Mode: | For oral administration |
| Suitable for: | Elderly, Children, Adult |
| State: | Solid |
| Shape: | Tablet |
| Type: | Organic Chemicals |
| Samples: |
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| Customization: |
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Audited Supplier Simvastatin tablet 10mg 20mg
| Specification | 10mg 20mg 10x10's/Box |
| Shelf life | 3Years |
| Storage | Store in a cool and dry place below 25ºC, protect from light |
Therapeutic indications
Patients at high risk of coronary heart disease (CHD) or with existing CHD
Patients with hyperlipidaemia
Paediatric patients with heterozygous familial hypercholesterolaemia
Dose and method of administration
Dose
The dosage range for simvastatin is 5-80 mg/day, given as a single dose in the evening. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day given as a single dose in the evening. The 80 mg dose of simvastatin is only recommended in patients at high risk for cardiovascular complications who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks
Patients at high risk of coronary heart disease (CHD) or with existing CHD
The usual starting dose of simvastatin is 40 mg/day given as a single dose in the evening in patients at high risk of CHD (with or without hyperlipidaemia) i.e., patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD.
Patients with hyperlipidaemia (who are not in the risk categories above)
The usual starting dose is 20 mg/day given as a single dose in the evening. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg/day given as a single dose in the evening. Patients who require only a moderate reduction of LDL-C may be started at 10 mg. Adjustments of dosage including starting dose, if required, should be made as specified above.
Patients with homozygous familial hypercholesterolaemia
The recommended dosage for patients with homozygous familial hypercholesterolaemia is simvastatin 40 mg/day in the evening or 80 mg/day in 3 divided doses of 20 mg, 20 mg, and an evening dose of 40 mg.
Concomitant therapy
Simvastatin is effective alone or in combination with bile acid sequestrants.
In patients taking amiodarone, verapamil, diltiazem, amlodipine, ≥ 1 g/day of niacin, or products containing elbasvir or grazoprevir concomitantly with simvastatin, the dose of simvastatin should not exceed 20 mg/day
Special populations
Dosage in renal insufficiency
Because simvastatin does not undergo significant renal excretion, modification of dosage should not be necessary in patients with moderate renal insufficiency.In patients with severe renal insufficiency (creatinine clearance <30 mL/min), dosages above 10 mg/day should be carefully considered and, if deemed necessary, implemented cautiously.
Dosage in paediatric patients (10 to 17 years of age) with heterozygous familial
hypercholesterolaemia
The recommended usual starting dose is 10 mg once a day in the evening. The recommended dosing range is 10-40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualised according to the recommended goal of therapy
Method of administration
Simvastatin Mylan tablets may be taken with or without food.
****Follow all directions given to you by your doctor and pharmacist carefully
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