atorvastatin reference
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(atorvastatin · DailyMed)
Registered Rwanda · Rwanda FDA

AVAS 40

ATORVASTATIN

Rwanda FDA-HMP-MA-2070 TABLETS 40MG cardiovascular system INN generic

What it does

Atorvastatin is a medication used to lower cholesterol levels in the blood.

Commonly used for: high cholesterol (hyperlipidemia), prevention of heart disease, prevention of stroke

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-2070
Registration date
17/08/2024
Expiry date
16/08/2029
Status
Registered
Active ingredient
ATORVASTATIN
Dosage form
TABLETS
Strength
40MG
Pack size
3x10 Tablets
Therapeutic class
-
ATC class (WHO)
C10BA - Combinations of various lipid modifying agents
RxNorm RxCUI
83367
Manufacturer / MAH
Micro Labs
Applicant / LTR
MICRO LABS LIMITED
Country of origin
INDIA
Manufacturer location
31, Race Course Rd, Madhava Nagar, Gandhi Nagar, Bengaluru, Karnataka 560001, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:06 · updated 2026-09-14 02:30:15

Drug Interactions

127
Check interactions

Pharmacodynamic Warnings

Atorvastatin appears in TABLE 1: Drugs that cause hepatotoxicity

Severe (7)

Atorvastatin - increases exposure

Darolutamide is predicted to increase the exposure to statins (atorvastatin, fluvastatin, rosuvastatin). Avoid.

Severe Theoretical

Atorvastatin - increases exposure

Posaconazole is predicted to increase the exposure to statins (atorvastatin). Avoid.

Severe Anecdotal

Atorvastatin - increases exposure

Tedizolid is predicted to increase the exposure to statins (atorvastatin, fluvastatin, rosuvastatin). Avoid.

Severe Study

Statins - increases exposure

Darolutamide is predicted to increase the exposure to statins (atorvastatin, fluvastatin, rosuvastatin). Avoid.

Severe Theoretical

Statins - increases exposure

Posaconazole is predicted to increase the exposure to statins (atorvastatin). Avoid.

Severe Anecdotal

Statins - increases exposure

Tedizolid is predicted to increase the exposure to statins (atorvastatin, fluvastatin, rosuvastatin). Avoid.

Severe Study

Statins - increases exposure

Voxilaprevir with sofosbuvir and velpatasvir markedly increases the exposure to statins (rosuvastatin). Avoid.

Severe Study

Moderate (40)

Atorvastatin - increases exposure

Amiodarone is predicted to increase the exposure to statins (atorvastatin). Monitor and adjust dose.

Moderate Theoretical

Atorvastatin - increases exposure

Dronedarone slightly increases the exposure to statins (atorvastatin). Monitor and adjust dose.

Moderate Study

Atorvastatin - decreases exposure

Carbamazepine is predicted to decrease the exposure to statins (atorvastatin). Monitor and adjust dose. Also see TABLE 1 p. 1517.

Moderate Study

Atorvastatin - decreases exposure

Eslicarbazepine is predicted to decrease the exposure to statins (atorvastatin). Monitor and adjust dose.

Moderate Theoretical

Atorvastatin - increases exposure

Fluconazole is predicted to increase the exposure to statins (atorvastatin, simvastatin). Monitor and adjust dose. Also see TABLE 1 p. 1517.

Moderate Anecdotal

Unknown (80)

Aliskiren - increases exposure

Atorvastatin slightly to moderately increases the exposure to aliskiren.

Unknown Study

Atorvastatin - decreases exposure

Apalutamide is predicted to decrease the exposure to statins (atorvastatin).

Unknown Study

Atorvastatin - decreases exposure

Enzalutamide is predicted to decrease the exposure to statins (atorvastatin, simvastatin).

Unknown Study

Atorvastatin - decreases exposure

Phenytoin moderately decreases the exposure to statins (atorvastatin).

Unknown Study

Atorvastatin - decreases exposure

Oxcarbazepine is predicted to decrease the exposure to statins (atorvastatin, simvastatin).

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Atorvastatin is a medication used to lower cholesterol levels in the blood.

What it treats

  • high cholesterol (hyperlipidemia)
  • prevention of heart disease
  • prevention of stroke

How it works

Atorvastatin works by blocking a substance your body needs to make cholesterol, which helps reduce the amount of cholesterol in your blood.

Who it's for

It is suitable for adults who have high cholesterol or are at risk of heart disease.

Drug class

Statins

Cautions

  • • Be cautious if you are taking other medications that can harm the liver.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Atorvastatin

BNF-referenced

Atorvastatin is a statin medication used to lower cholesterol levels and reduce the risk of cardiovascular disease. It works by inhibiting HMG-CoA reductase, an enzyme involved in the synthesis of cholesterol in the liver.

Indications

  • Hyperlipidaemia
  • Primary prevention of cardiovascular disease
  • Secondary prevention of cardiovascular events

Dosage

Children: Refer to the BNF for Children for specific dosing information.

Adults: Initial dose is typically 10-20 mg once daily, which can be adjusted based on lipid levels and tolerability. Maximum dose is 80 mg once daily.

Mechanism of action

Atorvastatin competitively inhibits HMG-CoA reductase, leading to decreased cholesterol synthesis and increased uptake of LDL cholesterol from the blood.

Pharmacodynamics

Atorvastatin reduces total cholesterol, LDL cholesterol, and triglycerides while increasing HDL cholesterol. The effects are dose-dependent, and it may also provide vascular protection.

Pharmacokinetics

Atorvastatin is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1 to 2 hours. It undergoes extensive first-pass metabolism in the liver, primarily by CYP3A4. The elimination half-life is approximately 14 hours, and it is excreted mainly in bile.

Contra-indications

  • Active liver disease
  • Unexplained persistent elevations in serum transaminases
  • Pregnancy

Adverse effects

  • Myopathy
  • Rhabdomyolysis
  • Hepatotoxicity
  • Severe cutaneous adverse reactions (SCARs)
  • Hypoglycaemia
  • Peripheral oedema
  • Cough
  • Dyspnoea
  • Weight loss

Interactions

  • darolutamide: Severe (increases exposure)
  • posaconazole: Severe (increases exposure)
  • tedizolid: Severe (increases exposure)
  • amiodarone: Moderate (increases exposure)
  • dronedarone: Moderate (increases exposure)
  • carbamazepine: Moderate (decreases exposure)
  • eslicarbazepine: Moderate (decreases exposure)
  • fluconazole: Moderate (increases exposure)
  • diltiazem: Moderate (increases exposure)
  • cobicistat: Moderate (increases exposure)

Precautions

  • Caution in patients with a history of haemorrhagic stroke
  • Caution in hepatic impairment
  • Patient counselling advised for muscle effects

Pregnancy

Manufacturer advises against use due to potential risk of fetal congenital anomalies.

Breast-feeding

Manufacturer advises to avoid; no information available.

Storage

Store in a cool, dry place away from direct sunlight.

Formulations

  • Atorvastatin 10 mg tablets
  • Atorvastatin 20 mg tablets
  • Atorvastatin 30 mg tablets
  • Atorvastatin 60 mg tablets
  • Atorvastatin 80 mg tablets
BNF for Children 2019-2020 p.156 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Atorvastatin

PubChem CID 60823

Molecular formula: C33H35FN2O5

Mechanism of action

Atorvastatin is a statin medication and a competitive inhibitor of the enzyme HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase, which catalyzes the conversion of HMG-CoA to mevalonate, an early rate-limiting step in cholesterol biosynthesis. Atorvastatin acts primarily in the liver, where decreased hepatic cholesterol concentrations stimulate the upregulation of hepatic low-density lipoprotein (LDL) receptors, which increases hepatic uptake of LDL. Atorvastatin also reduces Very-Low-Density Lipoprotein-Cholesterol (VLDL-C), serum triglycerides (TG) and Intermediate Density Lipoproteins (IDL), as well as the number of apolipoprotein B (apo B) containing particles, but increases High-Density Lipoprotein Cholesterol (HDL-C). _In vitro_ and _in vivo_ animal studies also demonstrate that atorvastatin exerts vasculoprotective effects independent of its lipid-lowering properties, also known as the pleiotropic effects of statins. These effects include improvement in endothelial function, enhanced stability of atherosclerotic plaques, reduced oxidative stress and inflammation, and inhibition of the thrombogenic response. Statins were also found to bind allosterically to β2 integrin function-associated antigen-1 (LFA-1), which plays an essential role in leukocyte trafficking and T cell activation. In animal models, Lipitor lowers plasma cholesterol and lipoprotein levels by inhibiting 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase and cholesterol synthesis in the liver and by increasing the number of hepatic low-density lipoprotein (LDL) receptors on the cell surface to enhance uptake and catabolism of LDL; Lipitor also reduces LDL production and the number of LDL particles. Lipitor reduces LDL-cholesterol (LDL-C) in some patients with homozygous familial hypercholesterolemia (FH), a population that rarely responds to other lipid-lowering medication(s). Lipitor is a selective, competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Cholesterol and triglycerides circulate in the bloodstream as part of lipoprotein complexes. With ultracentrifugation, these complexes separate into HDL (high-density lipoprotein), IDL (intermediate-density lipoprotein), LDL (low-density lipoprotein), and VLDL (very-low-density lipoprotein) fractions. Triglycerides (TG) and cholesterol in the liver are incorporated into VLDL and released into the plasma for delivery to peripheral tissues. LDL is formed from VLDL and is catabolized primarily through the high-affinity LDL receptor. Clinical and pathologic studies show that elevated plasma levels of total cholesterol (total-C), LDL-cholesterol (LDL-C), and apolipoprotein B (apo B) promote human atherosclerosis and are risk factors for developing cardiovascular disease, while increased levels of HDL-C are associated with a decreased cardiovascular risk. Statins are largely used in clinics in the treatment of patients with cardiovascular diseases for their effect on lowering circulating cholesterol. Lectin-like oxidized low-density lipoprotein (LOX-1), the primary receptor for ox-LDL, plays a central role in the pathogenesis of atherosclerosis and cardiovascular disorders. We have recently shown that chronic exposure of cells to lovastatin disrupts LOX-1 receptor cluster distribution in plasma membranes, leading to a marked loss of LOX-1 function. Here we investigated the molecular mechanism of statin-mediated LOX-1 inhibition and we demonstrate that all tested statins /including atorvastatin/ are able to displace the binding of fluorescent ox-LDL to LOX-1 by a direct interaction with LOX-1 receptors in a cell-based binding assay. Molecular docking simulations confirm the interaction and indicate that statins completely fill the hydrophobic tunnel that crosses the C-type lectin-like (CTLD) recognition domain of LOX-1. Classical

Pharmacodynamics

Atorvastatin is an oral antilipemic agent that reversibly inhibits HMG-CoA reductase. It lowers total cholesterol, low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), non-high density lipoprotein-cholesterol (non-HDL-C), and triglyceride (TG) plasma concentrations while increasing HDL-C concentrations. High LDL-C, low HDL-C and high TG concentrations in the plasma are associated with increased risk of atherosclerosis and cardiovascular disease. The total cholesterol to HDL-C ratio is a strong predictor of coronary artery disease, and high ratios are associated with a higher risk of disease. Increased levels of HDL-C are associated with lower cardiovascular risk. By decreasing LDL-C and TG and increasing HDL-C, atorvastatin reduces the risk of cardiovascular morbidity and mortality. Elevated cholesterol levels (and high low-density lipoprotein (LDL) levels in particular) are an important risk factor for the development of CVD. Clinical studies have shown that atorvastatin reduces LDL-C and total cholesterol by 36-53%. In patients with dysbetalipoproteinemia, atorvastatin reduced the levels of intermediate-density lipoprotein cholesterol. It has also been suggested that atorvastatin can limit the extent of angiogenesis, which can be useful in the treatment of chronic subdural hematoma. **Myopathy/Rhabdomyolysis** Atorvastatin, like other HMG-CoA reductase inhibitors, is associated with a risk of drug-induced myopathy characterized by muscle pain, tenderness, or weakness in conjunction with elevated levels of creatine kinase (CK). Myopathy often manifests as rhabdomyolysis with or without acute renal failure secondary to myoglobinuria. The risk of statin-induced myopathy is dose-related, and the symptoms of myopathy are typically resolved upon drug discontinuation. Results from observational studies suggest that 10-15% of people taking statins may experience muscle aches at some point during treatment. **Liver Dysfunction** Statins, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. Persistent elevations (> 3 times the upper limit of normal [ULN] occurring on two or more occasions) in serum transaminases occurred in 0.7% of patients who received atorvastatin in clinical trials. This effect appears to be dose-related. **Endocrine Effects** Statins are associated with a risk of increased serum HbA1c and glucose levels. An _in vitro_ study demonstrated a dose-dependent cytotoxic effect on human pancreatic islet β cells following treatment with atorvastatin. Moreover, insulin secretion rates decreased relative to control. HMG-CoA reductase inhibitors interfere with cholesterol synthesis and may theoretically interfere with the production of adrenal and/or gonadal steroids. Clinical studies with atorvastatin and other HMG-CoA reductase inhibitors have suggested that these agents do not affect plasma cortisol concentrations, basal plasma testosterone concentration, or adrenal reserve. However, the effect of statins on male fertility has not been fully investigated. The effects of statins on the pituitary-gonadal axis in premenopausal women are unknown. **Cardiovascular** Significant decreases in circulating ubiquinone levels in patients treated with atorvastatin and other statins have been observed. The clinical significance of a potential long-term statin-induced deficiency of ubiquinone has not been established. It has been reported that a decrease in myocardial ubiquinone levels could lead to impaired cardiac function in patients with borderline congestive heart failure. **Lipoprotein A** In some patients, the beneficial effect of lowered total cholesterol and LDL-C levels may be partly blunted by the concomitant increase in Lp(a) lipoprotein concentrations. Present knowledge suggests the importance of high Lp(a) levels as an emerging risk factor for coronary heart disease. Further studies have demonstrated statins affect Lp(a) levels diffe

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

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