Simvastatin-Teva

Simvastatin-Teva

simvastatin

Manufacturer:

Teva

Distributor:

KLN Pharma
Concise Prescribing Info
Contents
Simvastatin
Indications/Uses
Reduction of cholesterol & triglyceride levels. Prevention of CHD.
Dosage/Direction for Use
Adult (including the elderly) Hypercholesterolemia Initially 10-20 mg daily as a single dose each evening. When large reduction in cholesterol is required: Initially 20-40 mg daily as a single dose each evening. Max: 80 mg daily. HoFH 40 mg daily in the evening, or 80 mg daily in divided doses (20 mg, 20 mg, & evening dose of 40 mg). Prevention of CHD 20-40 mg daily as a single dose in the evening.
Administration
Swallow whole w/ water.
Contraindications
Hypersensitivity. Concomitant use w/ itraconazole, ketoconazole, posaconazole or voriconazole; delavirdine or HIV PIs (eg, ritonavir or indinavir); HCV PIs (eg, boceprevir or telaprevir); erythromycin, clarithromycin or telithromycin; nefazodone; gemfibrozil; cyclosporine; danazol. Patients w/ liver disease. Pregnancy & lactation.
Special Precautions
Risk of muscle problems, which may be serious, including muscle breakdown which can result in kidney damage. Perform LFTs before treatment initiation & thereafter when clinically indicated. Reports of increases in HbA1c & fasting serum glucose levels. Rare post-marketing reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion). Use 80-mg dose only in patients who have been taking this dose for ≥12 mth w/o evidence of muscle toxicity. Do not start 80-mg dose in new patients, including patients already taking lower doses. Caution in patients w/ severe resp failure; kidney problems; history of liver disease; underactive thyroid; any inherited muscular problems, or family history of such problems; previous muscular problems after taking any other medicines that lower cholesterol or lipid levels; problems w/ alcohol abuse; sugar intolerance. Do not drive or operate machinery if dizziness occurs. Prescribe a lower dose in patients w/ severe kidney problems. Not recommended for childn & adolescents <18 yr.
Adverse Reactions
Sleep disturbances (including insomnia & nightmares); memory loss; sexual difficulties; depression; breathing problems (including persistent cough &/or shortness of breath or fever). Rarely, allergic reaction; muscle pain, cramp, wasting; headache, dizziness, lethargy; constipation, abdominal pain, indigestion, wind, diarrhoea; feeling or being sick; pins-&-needles or numbness, loss of sensation; yellowing of skin & whites of eyes; hepatitis; anaemia (causing unusual tiredness or weakness); hair loss; rashes or itching.
Drug Interactions
Caution w/ other lipid-lowering drugs (eg, bezafibrate, fenofibrate, or ≥1 g/day niacin or nicotinic acid); amiodarone, verapamil or diltiazem; coumarin derivatives (eg, warfarin). Do not exceed 20 mg simvastatin daily w/ amiodarone, amlodipine & ranolazine. Do not exceed 10 mg simvastatin daily w/ verapamil, diltiazem & other fibrates (except fenofibrate). Closely monitor when taking w/ fusidic acid. Risk of myopathy/rhabdomyolysis w/ niacin (lipid-modifying dose); colchicine. Avoid grapefruit juice. Keep alcohol intake to a min.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Simvastatin-Teva FC tab 10 mg
Packing/Price
30's
Form
Simvastatin-Teva FC tab 20 mg
Packing/Price
30's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in