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TARO-SIMVASTATIN is a brand name for Simvastatin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TARO-SIMVASTATIN (simvastatin) is indicated in adults as an adjunct to diet for: • Reduction of risk of total mortality, myocardial infarction and ischemic stroke in patients with high risk of coronary events (because of existing Coronary Heart Disease (CHD), occlusive arterial disease, or diabetic over the age of 40)…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Patients should be placed on a standard cholesterol-lowering diet before receiving TARO- SIMVASTATIN, and should continue on this diet during treatment with TARO-SIMVASTATIN. If appropriate, a program of weight control and physical exercise should be implemented.
Prior to initiating therapy with TARO-SIMVASTATIN, secondary causes for elevations in plasma lipid levels should be excluded. A lipid profile should also be performed. After establishing that the elevation in plasma lipids represents a primary disorder not due to underlying conditions such as poorly controlled diabetes mellitus, hypothyroidism, the nephrotic syndrome, liver disease, or dysproteinaemias, it should ideally be determined that patients for whom treatment with simvastatin is being considered have an elevated LDL-C level as the cause for an elevated total serum cholesterol.
The usual dosage is 5 to 40 mg/day. Due to the increased risk of myopathy/rhabdomyolysis, particularly during the first year of treatment, the use of 80 mg/day of TARO-SIMVASTATIN is discouraged (see Musculoskeletal). Therefore, 80 mg/day of TARO-SIMVASTATIN should be restricted to patients who have been taking this dosage chronically with no evidence of muscle toxicity or to patients at high risk for cardiovascular complications who do not tolerate other statins and in whom the benefits are expected to outweigh the potential risks.
In other patients, consider alternative treatment strategies as follows: - Patients unable to achieve their LDL-C goal with the 40-mg dose of TARO-SIMVASTATIN should be switched to alternative LDL-C-lowering treatments with lower risks of muscle toxicity.
- Patients currently tolerating 80 mg/day of TARO-SIMVASTATIN who need an interacting drug that is either contraindicated or associated with an increase of plasma level of TARO- SIMVASTATIN should be switched to an alternative statin with less potential for a drug-drug interaction.
2 Recommended Dose and Dosage Adjustment • Prevention of Cardiovascular Disease in patients at high risk of coronary events, with or without hyperlipidemia, because of existing Coronary Heart Disease (CHD) or other occlusive arterial disease, or being over the age of 40 years with a diagnosis of diabetes: The recommended starting dose is 40 mg/day given as a single dose in the evening.
1 Adverse Reaction Overview Based on experience in a total of over 2300 patients, of whom more than 1200 were treated for one year and over 230 for 2 years or more, simvastatin is generally well tolerated and adverse reactions are usually mild and transient.
5 Post-Market Adverse Reactions). 2 Clinical Trial Adverse Reactions). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 0% of patients were withdrawn due to adverse experiences attributable to simvastatin.
8 *Considered possibly, probably, or definitely drug related as assessed by the investigators. 4 years of the study.
Ophthalmologic:
See 7 WARNINGS AND PRECAUTIONS. 3 Pediatrics; 10 CLINICAL PHARMACOLOGY). 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Marked persistent increases of serum transaminases (ALT, AST) have been noted.
Note that ALT may emanate from muscle, therefore ALT rising with CK may indicate myopathy (see Hepatic/Biliary/Pancreatic, Monitoring and Laboratory Tests and Musculoskeletal). 0% of patients had elevations of creatine phosphokinase (CK) levels three or more times the normal value on one or more occasions.
This was attributable to the noncardiac fraction of CK. 4 Drug-Drug interactions). 5 Post-Market Adverse Reactions The following additional adverse reactions were reported either in uncontrolled clinical studies or in post-marketing experience with simvastatin, regardless of causality assessment.
). • Hepatic Impairment TARO-SIMVASTATIN is contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase levels (see 2 CONTRAINDICATIONS and Hepatic/Biliary/Pancreatic).
• Drug discontinuation If the patient becomes pregnant while taking TARO-SIMVASTATIN, the drug should be discontinued immediately and the patient appraised of the potential harm to the fetus. If hypersensitivity is suspected, TARO-SIMVASTATIN should be discontinued.
TARO-SIMVASTATIN (Simvastatin Tablets) Page 7 of 56 If the transaminase levels show evidence of progression, particularly if they rise to three times the ULN and are persistent, the drug should be discontinued. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of TARO-SIMVASTATIN; if such a condition should develop during therapy, the drug should be discontinued.
If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with TARO-SIMVASTATIN, promptly interrupt therapy. If an alternate etiology is not found, do not restart TARO-SIMVASTATIN. TARO-SIMVASTATIN therapy should be immediately discontinued if markedly elevated CK levels are measured or myopathy is diagnosed or suspected.
, sepsis, hypotension, major surgery, trauma, severe metabolic endocrine and electrolyte disorders, or uncontrolled seizures). 4 Drug-Drug Interactions) Therapy with simvastatin should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes.
4 Administration TARO-SIMVASTATIN is for oral administration. TARO-SIMVASTATIN can be administered as a single dose in the evening with a meal. 5 Missed Dose If a tablet is missed at its usual time, it should be taken as soon as possible.
But if it is too close to the time of the next dose: only the prescribed dose should be taken at the appointed time. A double dose should not be taken. 6 g. All patients recovered without sequelae. Should an overdose occur, institute symptomatic and supportive measures as required.
Simvastatin is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Active liver disease or unexplained persistent elevations of serum transaminases.
• Pregnant and breast-feeding women. 4 Drug-Drug Interactions). 4 Drug-Drug Interactions). ___________________________________________________________________________ † A disorder of lipid metabolism characterized by elevated serum cholesterol levels in association with normal triglyceride levels (Type IIa) or with increased triglyceride levels (Type IIb).
Fredrickson DS, Levy RI, Lees RS. Fat transport in lipoproteins - An integrated approach to mechanisms and disorders. N Engl J Med 1967;276:148-56. TARO-SIMVASTATIN (Simvastatin Tablets) Page 5 of 56
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Drug therapy can be initiated simultaneously with diet and exercise. • Slowing progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions in hypercholesterolemic patients with coronary heart disease: The recommended dosage is 5 -40 mg/day usually given as a single dose in the evening.
• Hyperlipidemia The recommended starting dose is 10 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 TARO-SIMVASTATIN (Simvastatin Tablets) Page 6 of 56 single dose in the evening.
Patients with mild to moderate hypercholesterolemia can be treated with a starting dose of 5 mg of TARO-SIMVASTATIN. Adjustments of dosage, if required, should be made as specified above. • Homozygous familial hypercholesterolemia (HoFH) In HoFH patients taking lomitapide concomitantly with TARO-SIMVASTATIN, the dose of TARO- SIMVASTATIN should not exceed 20 mg/day.
4 Drug-Drug Interactions). • Dosage in Pediatric Patients (10-<18 years of age) with Heterozygous Familial Hypercholesterolemia 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 individualized according to the recommended goal of therapy (see 10 CLINICAL PHARMACOLOGY). • Geriatric (> 65 years of age) No dosage adjustment is necessary for the elderly. 4 Geriatric and Musculoskeletal). Higher dosages required for some patients with severe hypercholesterolemia are associated with increased plasma levels of simvastatin.
4 Drug-Drug Interactions). • Renal Impairment Because TARO-SIMVASTATIN does not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal insufficiency. 4 Drug-Drug Interactions).
TARO-SIMVASTATIN should be started at 5mg/day of simvastatin and be closely monitored Dosages above 10 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see 7 WARNINGS AND PRECAUTIONS). • Hepatic Impairment TARO-SIMVASTATIN is contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase levels (see 2 CONTRAINDICATIONS and Hepatic/Biliary/Pancreatic).
• Drug discontinuation If the patient becomes pregnant while taking TARO-SIMVASTATIN, the drug should be discontinued immediately and the patient appraised of the potential harm to the fetus. If hypersensitivity is suspected, TARO-SIMVASTATIN should be discontinued.
TARO-SIMVASTATIN (Simvastatin Tablets) Page 7 of 56 If the transaminase levels show evidence of progression, particularly if they rise to three times the ULN and are persistent, the drug should be discontinued. Active liver disease or […]
Endocrine disorders:
Increases in fasting glucose and HbA1c levels have been reported with simvastatin. Diabetes mellitus has been reported with statins, including simvastatin.
Eye disorders: ocular myasthenia Gastrointestinal:
Vomiting Hematologic: Anemia Leukopenia Purpura Hepatic/Pancreatic: Hepatitis Fatal and non-fatal hepatic failure with liver transplant outcome have been reported, regardless of the dose.
Jaundice Pancreatitis Laboratory Tests:
Elevated alkaline phosphatase and γ-glutamyl transpeptidase. Increased HbA1c and fasting serum glucose levels.
Musculoskeletal :
Rhabdomyolysis Muscle Cramps Myalgia Myasthenia gravis There have been rare reports of immune-mediated necrotizing myopathy with statins (see Musculoskeletal).
TARO-SIMVASTATIN (Simvastatin Tablets) Page 18 of 56 Neurologic:
Dizziness Paresthesia Peripheral Neuropathy Peripheral neuropathy with muscle weakness or sensory disturbance has been reported. , memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with simvastatin use, regardless of the dose.
These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Pulmonary:
Interstitial lung disease Psychiatric: Depression Insomnia Reproductive system and breast disorders: Erectile dysfunction Sensitivity: An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: • Anaphylaxis • Angioedema • Arthralgia • Arthritis • Dermatomyositis • Dyspnea • Eosinophilia • ESR increased • Fever • Flushing • Lupus-like Syndrome • Malaise • Photosensitivity • Polymyalgia Rheumatica • Thrombocytopenia • Urticaria • Vasculitis Skin: Alopecia Erythema Multiforme including Stevens-Johnson syndrome Lichen planus [Sec.
5-slu-lichen-planus] Pruritus Rash Others: Although the following adverse reactions were not observed in clinical studies with simvastatin, they have been reported following treatment with other HMG-CoA reductase inhibitors: TARO-SIMVASTATIN (Simvastatin Tablets) Page 19 of 56 anorexia, […]
For the management of a suspected drug overdose, contact your regional poison control centre. TARO-SIMVASTATIN (Simvastatin Tablets) Page 8 of 56 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition All Nonmedicinal Ingredients oral tablet 5 mg, 10 mg, 20 mg, 40 mg, 80 mg Ascorbic acid, butylated hydroxy anisole, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide.
TARO-SIMVASTATIN tablets 5 mg, 10 mg, 20 mg, 40 mg and 80 mg also contain iron oxide black, iron oxide red, and iron oxide yellow. TARO-SIMVASTATIN, 5 mg tablets, are buff coloured, film-coated, shield shaped tablets, debossed with ‘SST’ on one side and ‘5’ on other side with intact coating.
Available in HDPE bottles of 30s, 100s and 1000s and blister packages of 30 (3 x 10) tablets. TARO-SIMVASTATIN, 10 mg tablets, are peach coloured, film-coated, shield shaped tablets, debossed with ‘SST’ on one side and ‘10’ on other side with intact coating.
Available in HDPE bottles of 30s, 100s, 500s and 1000s and blister packages of 30 (3 x 10) tablets. TARO-SIMVASTATIN, 20 mg tablets, are tan coloured, film-coated, shield shaped tablets, debossed with ‘SST’ on one side and ‘20’ on other side with intact coating.
Available in HDPE bottles of 30s, 100s, 500s and 1000s and blister packages of 30 (3 x 10) tablets. TARO-SIMVASTATIN, 40 mg tablets, are brick red coloured, film-coated, shield shaped tablets, debossed with ‘SST’ on one side and ‘40’ on other side with intact coating.
Available in HDPE bottles of 30s, 100s, 500s and 1000s and blister packages of 30 (3 x 10) tablets. TARO-SIMVASTATIN, 80 mg tablets, are brick red coloured, film-coated, capsule shaped tablets, debossed with ‘SST’ on one side and ‘80’ on other side with intact coating.
Available in HDPE bottles of 30s, 100s and 1000s and blister packages of 30 (3 x 10) tablets. 7 WARNINGS AND PRECAUTIONS General The patient should be advised to inform health professionals of the prior use of simvastatin or any other lipid-lowering agent.
In primary prevention intervention the effects of simvastatin-induced changes in lipoprotein levels, including reduction of serum cholesterol, on cardiovascular morbidity or mortality or total mortality have not been established. TARO-SIMVASTATIN (Simvastatin Tablets) Page 9 of 56 Carcinogenesis and Mutagenesis See Carcinogenicity Driving and Operating Machinery “Simvastatin has no or negligible influence on the ability to drive and use machines.
However, dizziness has been reported in post market adverse effects for simvastatin. ” Endocrine and Metabolism HMG-CoA reductase inhibitors interfere with cholesterol synthesis and as such might theoretically blunt adrenal and/or gonadal steroid production.
Clinical studies with simvastatin and other HMG-CoA reductase inhibitors have suggested that these agents do not reduce plasma cortisol concentration or impair adrenal reserve and do not reduce basal plasma testosterone concentration.
However, the effects of HMG-CoA reductase inhibitors on male fertility have not been studied in adequate numbers of patients. The effects, if any, on the […]