ALISTIM 20 Tablets/Film-coated

What is ALISTIM 20

ALISTIM 20 mg contains **simvastatin**, a lipid-lowering medication classified as an HMG‑CoA reductase inhibitor (statin). It comes in film-coated tablets, typically packaged as 28 tablets in two 14‑tablet blisters.

• Therapeutic class: Statin – used to reduce cholesterol production in the liver :contentReference[oaicite:1]{index=1}.
• Indications:
  • Treatment of primary hyperlipidemia and mixed dyslipidemia.
  • Prevention of cardiovascular disease in high-risk individuals.
  • Primary and secondary prevention of atherosclerotic events in patients with coronary heart disease or diabetes :contentReference[oaicite:2]{index=2}.
• Benefits: Lowers LDL (“bad”) cholesterol by up to 50%, lowers triglycerides, and modestly raises HDL (“good”) cholesterol :contentReference[oaicite:3]{index=3}.
• Evidence: Clinical trials show simvastatin reduces heart attacks, strokes, and related mortality by 18–34% over several years :contentReference[oaicite:4]{index=4}.
• Formulation: Available in doses from 5 to 40 mg; 20 mg considered a moderate-intensity statin suitable for many patients :contentReference[oaicite:5]{index=5}.

How to use ALISTIM 20

Proper use of simvastatin maximizes efficacy and safety. Follow your healthcare provider’s guidance.

• Administration: Take orally once daily in the evening, with or without food—optimal LDL-lowering occurs when dosed at night :contentReference[oaicite:6]{index=6}.
• Typical dosing range: 5–40 mg/day; 20 mg is standard for LDL targets and moderate-intensity therapy :contentReference[oaicite:7]{index=7}.
• Missed doses: Take as soon as remembered, unless it's within 12 hours of the next dose; never double up :contentReference[oaicite:8]{index=8}.
• Duration: Usually lifelong therapy, alongside diet and lifestyle changes. May pause temporarily for surgeries or medical procedures :contentReference[oaicite:9]{index=9}.
• Monitoring:
  • Lipid profile at baseline, 4–12 weeks after initiation or dose change, and every 3–12 months.
  • Liver enzymes (ALT/AST) at baseline, possibly at 12 weeks, then as indicated.
  • Creatine kinase (CK) if unexplained muscle pain arises :contentReference[oaicite:10]{index=10}.
• Lifestyle advice: Maintain a low-fat diet, regular exercise, healthy weight, and avoid smoking/alcohol—together with simvastatin, these improve outcomes :contentReference[oaicite:11]{index=11}.

Mode of Action ALISTIM 20

Simvastatin helps lower cholesterol and protect against cardiovascular disease via the following mechanisms:

• HMG‑CoA reductase inhibition: Competitively blocks the rate-limiting enzyme in cholesterol synthesis, reducing hepatic cholesterol production :contentReference[oaicite:12]{index=12}.
• Increased LDL receptors: Decreased cholesterol prompts the liver to upregulate LDL receptors, improving clearance of LDL from circulation.
• Cholesterol reduction: Significantly lowers LDL, modestly lowers triglycerides, and slightly raises HDL levels :contentReference[oaicite:13]{index=13}.
• Pleiotropic effects: Anti-inflammatory and anti-atherogenic beyond lipid lowering—benefits include improved endothelial function and plaque stabilization :contentReference[oaicite:14]{index=14}.
• Onset of action: LDL reductions begin within 1 week, with maximum effect after approximately 4–6 weeks :contentReference[oaicite:15]{index=15}.

ALISTIM 20 Interactions ALISTIM 20

Simvastatin is extensively metabolized by CYP3A4, and its levels can be affected by various drugs:

• Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, HIV protease inhibitors): Contraindicated due to high risk of myopathy/rhabdomyolysis :contentReference[oaicite:16]{index=16}.
• Moderate inhibitors (e.g., amiodarone, verapamil, diltiazem): Limit simvastatin to ≤20 mg daily :contentReference[oaicite:17]{index=17}.
• Fibrates (gemfibrozil, fenofibrate) & high-dose niacin ≥1g/day: High risk of muscle toxicity—avoid or use with caution :contentReference[oaicite:18]{index=18}.
• Cyclo-sporine, danazol: Muscle toxicity risk—concurrent use contraindicated :contentReference[oaicite:19]{index=19}.
• Grapefruit juice: Increases simvastatin levels markedly—avoid entirely :contentReference[oaicite:20]{index=20}.
• Others (e.g., colchicine, digoxin, warfarin): Potential interactions—monitor CK, INR, and drug levels closely :contentReference[oaicite:21]{index=21}.
• CYP3A4 inducers (e.g., rifampin, carbamazepine): Increase metabolism and reduce efficacy—monitor lipid levels :contentReference[oaicite:22]{index=22}.

Dosage of ALISTIM 20

• Standard dose: 20 mg once daily in the evening.
• Intensity: 20 mg is considered **moderate-intensity**, reducing LDL by ~30–50% :contentReference[oaicite:23]{index=23}.
• Dose adjustment:
  • Increase up to 40 mg based on LDL targets and tolerance.
  • Do **not** exceed 20 mg/day if also taking amiodarone, amlodipine, verapamil, or diltiazem :contentReference[oaicite:24]{index=24}.
  • Contraindicated with strong CYP3A4 inhibitors :contentReference[oaicite:25]{index=25}.
• Elderly & comorbidities: Use caution in elderly, hypothyroid, renal/hepatic impairment; monitor more closely :contentReference[oaicite:26]{index=26}.
• Pediatric use: Approved use from age ≥10 for familial hypercholesterolemia; dose individualized :contentReference[oaicite:27]{index=27}.

Possible side effects of ALISTIM 20

Simvastatin is usually well tolerated, but side effects can arise:

• Common (≥1%): Headache, GI upset, constipation, nausea, muscle cramps, mild elevations in liver enzymes :contentReference[oaicite:28]{index=28}.
• Muscle-related (rare but serious):
  • Myopathy (pain, tenderness) with CK >10× ULN; risk increases with dose and interacting medications :contentReference[oaicite:29]{index=29}.
  • Rhabdomyolysis (<0.1% at 20 mg; increases at 80 mg) – characterized by muscle breakdown and potential kidney injury :contentReference[oaicite:30]{index=30}.
  • Immune-mediated necrotizing myopathy (rare) requiring immunosuppression :contentReference[oaicite:31]{index=31}.
• Hepatic: Elevated AST/ALT; severe hepatotoxicity is rare :contentReference[oaicite:32]{index=32}.
• Endocrine: Slight increase in blood glucose; higher risk of new-onset diabetes in predisposed individuals :contentReference[oaicite:33]{index=33}.
• Cognitive: Rare reversible memory loss/confusion :contentReference[oaicite:34]{index=34}.
• Hypersensitivity: Rare allergic skin reactions like rash, urticaria :contentReference[oaicite:35]{index=35}.

Discontinue misuse if muscle symptoms occur, and test CK and renal function promptly. Monitor LFTs per guidelines.

ALISTIM 20 Contraindications ALISTIM 20

• Absolute:
  • Active liver disease or unexplained elevated transaminases :contentReference[oaicite:36]{index=36}.
  • Hypersensitivity to simvastatin or excipients.
  • Pregnancy and breastfeeding—statins are teratogenic and contraindicated :contentReference[oaicite:37]{index=37}.
  • Concurrent use of strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, protease inhibitors) :contentReference[oaicite:38]{index=38}.
  • Co-administration with gemfibrozil, ciclosporin, danazol—contraindicated due to toxicity risk :contentReference[oaicite:39]{index=39}.
• Relative:
  • Renal or hepatic impairment—dose carefully and monitor.
  • History of myopathy/muscle disorders.
  • Elderly and hypothyroidism—correct thyroid function before starting.

Storage of ALISTIM 20

• Temperature: Store at room temperature, 20–25 °C; brief excursions between 15–30 °C acceptable :contentReference[oaicite:40]{index=40}.
• Packaging: Keep tablets in original blister packs, away from light and moisture.
• Safety: Keep out of reach of children.
• Disposal: Do not flush; dispose according to local pharmaceutical regulations :contentReference[oaicite:41]{index=41}.