Vietnam Product

Lolip Tablets

Lolip Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Hypercholesterolaemia
Lolip is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C),
LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Lolip is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Prevention of cardiovascular disease
Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

Side effects:
In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 Lolip vs. 7311 placebo) patients treated for a mean period of 53 weeks, 5.2% of patients on atorvastatin discontinued due to adverse reactions compared to 4.0% of the patients on placebo.
Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse reaction profile for Lolip.
Estimated frequencies of reactions are ranked according to the following convention: common ( 1/100, < 1/10); uncommon ( 1/1,000, < 1/100); rare ( 1/10,000, < 1/1,000); very rare ( 1/10,000).
Infections and infestations:
Common: Nasopharyngitis.
Blood and lymphatic system disordersbr> Rare:
Thrombocytopenia.
Immune system disorders
Common:
Allergic reactions.
Very rare:
Anaphylaxis.
Metabolism and nutrition disorders
Common:
Hyperglycaemia.
Uncommon:
Hypoglycaemia, weight gain, anorexia Psychiatric disorders
Uncommon:
Nightmare, insomnia.
Nervous system disorders<br> Common:
Headache.
Uncommon:
Dizziness, paraesthesia, hypoesthesia, dysgeusia, amnesia.
Rare:
Peripheral neuropathy.
Eye disorders
Uncommon:
vision blurred.
Rare:
Visual disturbance.
Ear and labyrinth disorders
Uncommon:
tinnitus
Very rare: hearing loss.
Respiratory, thoracic and mediastinal disorders
Common:
Pharyngolaryngeal pain, epistaxis.

Common:
Constipation, flatulence, dyspepsia, nausea, diarrhoea.
Uncommon:
Vomiting, abdominal pain upper and lower, eructation, pancreatitis.
Hepatobiliary disorders
Uncommon:
Hepatitis.
Rare:
Cholestasis.
Very rare:
Hepatic failure.
Skin and subcutaneous tissue disorders
Uncommon:
urticaria, skin rash, pruritus, alopecia.
Rare: angioneurotic oedema, dermatitis bullous including erythema multiforme, Stevens- Johnson syndrome and toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders
Common:
Myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain.
Uncommon: neck pain, muscle fatigue.
Rare:
Myopathy, myositis, rhabdomyolysis, tendonopathy, sometimes complicated by rupture.
Reproductive system and breast disorders
Very rare:
Hynecomastia.
General disorders and administration site conditions
Uncommon:
Malaise, asthenia, chest pain, peripheral oedema, fatigue, pyrexia. Investigations
Common:
liver function test abnormal, blood creatine kinase increased.
Uncommon:
White blood cells urine positive.
As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving Lolip. These changes were usually mild, transient, and did not require interruption of treatment. Clinically important (> 3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on Lolip. These elevations were dose related and were reversible in all patients.
Elevated serum creatine kinase (CK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on Lolip, similar to other HMG-CoA reductase inhibitors in clinical trials. Levels above 10 times the normal upper range occurred in 0.4% Lolip-treated patients.

Paediatric Population
The clinical safety database includes safety data for 249 paediatric patients who received atorvastatin, among which 7 patients were < 6 years old, 14 patients were in the age range of 6 to 9, and 228 patients were in the age range of 10 to 17.
Nervous system disorders Common:
Headache
Gastrointestinal disorders
Common:
Abdominal pain
Investigations
Common:
Alanine aminotransferase increased, blood creatine phosphokinase increased Based on the data available, frequency, type and severity of adverse reactions in children are expected to be the same as in adults. There is currently limited experience with respect to long-term safety in the paediatric population.
The following adverse events have been reported with some statins:
• Sexual dysfunction.
• Depression.
• Exceptional cases of interstitial lung disease, especially with long term therapy.
Adverse Drug reaction*:
"Inform doctors about unexpected reactions after using drugs".

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Lolip is contraindicated in patients:
 With hypersensitivity to the active substance or to any of the excipients of this medicinal product
 With active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal
 During pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures.

What to do if you accidentally take too much (overdose) of the medicine?

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Storage conditions:
Store below 30°C.

Shelf-life:
2 years.
Package:
14 tablets are packed in a blister and 2 such blisters are packed in a carton along with pack insert.
Manufacturer:
Kusum Healthcare Pvt. Ltd.

Address:
SP 289 (A), RIICO INDL. AREA, CHOPANKI, BHIWADI (Raj.), (INDIA)

Drug Description

Composition:
Active substance:
Atorvastatin calcium;

Each film-coated tablet contains:
Atorvastatin calcium equivalent to Atorvastatin…………10 mg/20 mg Additional ingredients: Lactose monohydrate, Microcrystalline cellulose, calcium carbonate, Povidone (K 30), Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate, Opadry Pink 03F84827, Isopropyl alcohol, Purified water

Indications and dosage.

Indications:
Hypercholesterolaemia
Lolip is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C),
LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Lolip is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Prevention of cardiovascular disease
Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.

Administration and Dosage:
The patient should be placed on a standard cholesterol-lowering diet before receiving Lolip and should continue on this diet during treatment with Lolip.
The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response.
The usual starting dose is 10 mg once a day. Adjustment of dose should be made at intervals of 4 weeks or more. The maximum dose is 80 mg once a day.
Lolip is for oral administration. Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.

Side effects and drug interactions.

Side effects:
In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 Lolip vs. 7311 placebo) patients treated for a mean period of 53 weeks, 5.2% of patients on atorvastatin discontinued due to adverse reactions compared to 4.0% of the patients on placebo.
Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse reaction profile for Lolip.
Estimated frequencies of reactions are ranked according to the following convention: common ( 1/100, < 1/10); uncommon ( 1/1,000, < 1/100); rare ( 1/10,000, < 1/1,000); very rare ( 1/10,000).
Infections and infestations:
Common: nasopharyngitis.
Blood and lymphatic system disorders
Rare:
Thrombocytopenia.
Immune system disorders
Common:
Allergic reactions.
Very rare:
Anaphylaxis.
Metabolism and nutrition disorders
Common:
Hyperglycaemia.
Uncommon:
Hypoglycaemia, weight gain, anorexia Psychiatric disorders
Uncommon:
Nightmare, insomnia.
Nervous system disorders
Common:
Neadache.
Uncommon:
Dizziness, paraesthesia, hypoesthesia, dysgeusia, amnesia.
Rare:
Peripheral neuropathy.
Eye disorders
Uncommon:
Vision blurred.
Rare:
Visual disturbance.
Ear and labyrinth disorders
Uncommon:
Tinnitus
Very rare: hearing loss.
Respiratory, thoracic and mediastinal disorders
Common:
pharyngolaryngeal pain, epistaxis.
Gastrointestinal disorders
Common:
Constipation, flatulence, dyspepsia, nausea, diarrhoea.
Uncommon:
Vomiting, abdominal pain upper and lower, eructation, pancreatitis.
Hepatobiliary disorders
Uncommon:
Hepatitis.
Rare:
Cholestasis.
Very rare:
Hepatic failure.
Skin and subcutaneous tissue disorders
Uncommon:
Urticaria, skin rash, pruritus, alopecia.
Rare: Angioneurotic oedema, dermatitis bullous including erythema multiforme, Stevens- Johnson syndrome and toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders
Common:
Myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain.
Uncommon: neck pain, muscle fatigue.
Rare:
Myopathy, myositis, rhabdomyolysis, tendonopathy, sometimes complicated by rupture.
Reproductive system and breast disorders
Very rare:
Gynecomastia.
General disorders and administration site conditions
Uncommon:
Malaise, asthenia, chest pain, peripheral oedema, fatigue, pyrexia. Investigations
Common:
Iiver function test abnormal, blood creatine kinase increased.
Uncommon:
White blood cells urine positive.
As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving Lolip. These changes were usually mild, transient, and did not require interruption of treatment. Clinically important (> 3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on Lolip. These elevations were dose related and were reversible in all patients.
Elevated serum creatine kinase (CK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on Lolip, similar to other HMG-CoA reductase inhibitors in clinical trials. Levels above 10 times the normal upper range occurred in 0.4% Lolip-treated patients.
Paediatric Population
The clinical safety database includes safety data for 249 paediatric patients who received atorvastatin, among which 7 patients were < 6 years old, 14 patients were in the age range of 6 to 9, and 228 patients were in the age range of 10 to 17.
Nervous system disorders

Common:
Headache Gastrointestinal disorders
Common:
Abdominal pain
Investigations
Common:
Alanine aminotransferase increased, blood creatine phosphokinase increased Based on the data available, frequency, type and severity of adverse reactions in children are expected to be the same as in adults. There is currently limited experience with respect to long-term safety in the paediatric population.
The following adverse events have been reported with some statins:
• Sexual dysfunction.
• Depression.
• Exceptional cases of interstitial lung disease, especially with long term therapy.
Adverse Drug reaction*:
"Inform doctors about unexpected reactions after using drugs".

Drug Interactions:
Effect of co-administered medicinal products on Atorvastatin
Atorvastatin is metabolized by cytochrome P450 3A4 (CYP3A4) and is a substrate to transport proteins e.g. the hepatic uptake transporter OATP1B1. Concomitant administration of medicinal products that are inhibitors of CYP3A4 or transport proteins may lead to increased plasma concentrations of atorvastatin and an increased risk of myopathy. The risk might also be increased at concomitant administration of atorvastatin with other medicinal products that have a potential to induce myopathy, such as fibric acid derivates and ezetimibe.
CYP3A4 inhibitors
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Co-administration of potent CYP3A4 inhibitors (e.g. ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.) should be avoided if possible. In cases where coadministration of these medicinal products with atorvastatin cannot be avoided lower starting and maximum doses of atorvastatin should be considered and appropriate clinical monitoring of the patient is recommended.
Moderate CYP3A4 inhibitors (e.g. erythromycin, diltiazem, verapamil and fluconazole) may increase plasma concentrations of atorvastatin. An increased risk of myopathy has been observed with the use of erythromycin in combination with statins. Interaction studies evaluating the effects of amiodarone or verapamil on atorvastatin have not been conducted. Both amiodarone and verapamil are known to inhibit CYP3A4 activity and coadministration with atorvastatin may result in increased exposure to atorvastatin. Therefore, a lower maximum dose of atorvastatin should be considered and appropriate clinical monitoring of the patient is recommended when concomitantly used with moderate CYP3A4 inhibitors. Appropriate clinical monitoring is recommended after initiation or following dose adjustments of the inhibitor.
CYP3A4 inducers
Concomitant administration of atorvastatin with inducers of cytochrome P450 3A (e.g. efavirenz, rifampin, St. John's Wort) can lead to variable reductions in plasma concentrations of atorvastatin. Due to the dual interaction mechanism of rifampin, (cytochrome P450 3A induction and inhibition of hepatocyte uptake transporter OATP1B1), simultaneous co-administration of atorvastatin with rifampin is recommended, as delayed administration of atorvastatin after administration of rifampin has been associated with a significant reduction in atorvastatin plasma concentrations. The effect of rifampin on atorvastatin concentrations in hepatocytes is, however, unknown and if concomitant administration cannot be avoided, patients should be carefully monitored for efficacy. Transport protein inhibitors
Inhibitors of transport proteins (e.g. ciclosporin) can increase the systemic exposure of atorvastatin (see Table 1). The effect of inhibition of hepatic uptake transporters on atorvastatin concentrations in hepatocytes is unknown. If concomitant administration cannot be avoided, a dose reduction and clinical monitoring for efficacy is recommended. Gemfibrozil / fibric acid derivatives
The use of fibrates alone is occasionally associated with muscle related events, including rhabdomyolysis. The risk of these events may be increased with the concomitant use of fibric acid derivatives and atorvastatin. If concomitant administration cannot be avoided, the lowest dose of atorvastatin to achieve the therapeutic objective should be used and the patients should be appropriately monitored.
Ezetimibe
The use of ezetimibe alone is associated with muscle related events, including rhabdomyolysis. The risk of these events may therefore be increased with concomitant use of ezetimibe and atorvastatin. Appropriate clinical monitoring of these patients is recommended.
Colestipol
Plasma concentrations of atorvastatin and its active metabolites were lower (by approx. 25%) when colestipol was co-administered with Lolip. However, lipid effects were greater when Lolip and colestipol were co-administered than when either medicinal product was given alone.
Fusidic acid
Interaction studies with atorvastatin and fusidic acid have not been conducted. As with other statins, muscle related events, including rhabdomyolysis, have been reported in postmarketing experience with atorvastatin and fusidic acid given concurrently. The mechanism of this interaction is not known. Patients should be closely monitored and temporary suspension of atorvastatin treatment may be appropriate.
Effect of atorvastatin on co-administered medicinal products
Digoxin
When multiple doses of digoxin and 10 mg atorvastatin were co-administered, steady-state digoxin concentrations increased slightly. Patients taking digoxin should be monitored appropriately.
Oral contraceptives
Co-administration of Lolip with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Warfarin
In a clinical study in patients receiving chronic warfarin therapy, coadministration of atorvastatin 80 mg daily with warfarin caused a small decrease of about 1.7 seconds in prothrombin time during the first 4 days of dosing which returned to normal within 15 days of atorvastatin treatment. Although only very rare cases of clinically significant anticoagulant interactions have been reported, prothrombin time should be determined before starting atorvastatin in patients taking coumarin anticoagulants and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs. Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of atorvastatin is changed or discontinued, the same procedure should be repeated. Atorvastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants.
Paediatric population
Drug-drug interaction studies have only been performed in adults. The extent of interactions in the paediatric population is not known.

Warnings and precautions


Precautions in usage:
Liver effects
Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develop any signs or symptoms suggestive of liver injury should have liver function tests performed. Patients who develop increased transaminase levels should be monitored until the abnormalities resolve. Should an increase in transaminases of greater than 3 times the upper limit of normal (ULN) persist, reduction of dose or withdrawal of Lolip is recommended.
Lolip should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL)
In a post-hoc analysis of stroke subtypes in patients without coronary heart disease (CHD) who had a recent stroke or transient ischemic attack (TIA) there was a higher incidence of hemorrhagic stroke in patients initiated on atorvastatin 80 mg compared to placebo. The increased risk was particularly noted in patients with prior hemorrhagic stroke or lacunar infarct at study entry. For patients with prior hemorrhagic stroke or lacunar infarct, the balance of risks and benefits of atorvastatin 80 mg is uncertain, and the potential risk of hemorrhagic stroke should be carefully considered before initiating treatment.
Skeletal muscle effects
Atorvastatin, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, a potentially life-threatening condition characterised by markedly elevated creatine kinase (CK) levels (> 10 times ULN), myoglobinaemia and myoglobinuria which may lead to renal failure.
Before the treatment
Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis. A CK level should be measured before starting statin treatment in the following situations:
 Renal impairment
 Hypothyroidism
 Personal or familial history of hereditary muscular disorders
 Previous history of muscular toxicity with a statin or fibrate
 Previous history of liver disease and/or where substantial quantities of alcohol
are consumed  In elderly (age > 70 years), the necessity of such measurement should be considered, according to the presence of other predisposing factors for Rhabdomyolysis
 Situations where an increase in plasma levels may occur, such as interactions and special populations including genetic subpopulations.
 In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended.  If CK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started.
Creatine kinase measurement
Creatine kinase (CK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CK increase as this makes value interpretation difficult. If CK levels are significantly elevated at baseline (> 5 times ULN), levels should be remeasured within 5 to 7 days later to confirm the results.

Concomitant treatment with other medicinal products
Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicinal products that may increase the plasma concentration of atorvastatin such as potent inhibitors of CYP3A4 or transport proteins (e.g. ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc). The risk of myopathy may also be increased with the concomitant use of gemfibrozil and other fibric acid derivates, erythromycin, niacin and ezetimibe. If possible, alternative (non-interacting) therapies should be considered instead of these medicinal products.
In cases where co-administration of these medicinal products with atorvastatin is necessary, the benefit and the risk of concurrent treatment should be carefully considered. When patients are receiving medicinal products that increase the plasma concentration of atorvastatin, a lower maximum dose of atorvastatin is recommended. In addition, in the case of potent CYP3A4 inhibitors, a lower starting dose of atorvastatin should be considered and appropriate clinical monitoring of these patients is recommended. The concurrent use of atorvastatin and fusidic acid is not recommended, therefore, temporary suspension of atorvastatin may be considered during fusidic acid therapy. Paediatric use
Developmental safety in the paediatric population has not been established. Interstitial lung disease
Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy. Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.

Overdosage and Contraindications

Contraindications:
Lolip is contraindicated in patients:
 With hypersensitivity to the active substance or to any of the excipients of this medicinal product
 With active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal
 During pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures.

Overdosage:
Specific treatment is not available for Lolip overdose. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.

Clinical pharmacology.

Pharmaceutical Form: Tablets.
Pharmacotherapeutic group: Lipid lowering agent
ATC code: C10AA05
Pharmacologic properties:
Pharmacodynamics:
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Triglycerides and cholesterol in the liver are incorporated into very low-density lipoproteins (VLDL) and released into the plasma for delivery to peripheral tissues. Low-density lipoprotein (LDL) is formed from VLDL and is catabolized primarily through the receptor with high affinity to LDL (LDL receptor).
Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
Atorvastatin reduces LDL production and the number of LDL particles. Atorvastatin produces a profound and sustained increase in LDL receptor activity coupled with a beneficial change in the quality of circulating LDL particles. Atorvastatin is effective in reducing LDL-C in patients with homozygous familial hypercholesterolaemia, a population that has not usually responded to lipid-lowering medicinal products.
Reductions in total-C, LDL-C, and apolipoprotein B have been proven to reduce risk for cardiovascular events and cardiovascular mortality.
Pharmacokinetics:
Absorption
Atorvastatin is rapidly absorbed after oral administration; maximum plasma concentrations (Cmax) occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin dose. After oral administration, atorvastatin film-coated tablets are 95% to 99% bioavailable compared to the oral solution. The absolute bioavailability of atorvastatin is approximately 12% and the systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%. The low systemic availability is attributed to presystemic clearance in gastrointestinal mucosa and/or hepatic first-pass metabolism Distribution
Mean volume of distribution of atorvastatin is approximately 381 l. Atorvastatin is 98% bound to plasma proteins.
Biotransformation
Atorvastatin is metabolized by cytochrome P450 3A4 to ortho- and parahydroxylated derivatives and various beta-oxidation products. Apart from other pathways these products are further metabolized via glucuronidation. In vitro, inhibition of HMG-CoA reductase by ortho- and parahydroxylated metabolites is equivalent to that of atorvastatin. Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites.
Excretion
Atorvastatin is eliminated primarily in bile following hepatic and/or extrahepatic metabolism. However, atorvastatin does not appear to undergo significant enterohepatic recirculation. Mean plasma elimination half-life of atorvastatin in humans is approximately 14 hours. The half-life of inhibitory activity for HMG-CoA reductase is approximately 20 to 30 hours due to the contribution of active metabolites.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780