INTRA LABS INDIA PVT LTD #43/44 P.S.Lane B.R.D.Building Chickpet Cross Bengaluru 560053
Atorvastatin 10mg/20mg/40mg tablets,
List of Related Indications:
List Of Drugs:
- Atorvastatin @ - Antihyperlipmic- (FDC- List )- (2008-2013)
Indication Type Description:
Dosages/ Overdosage Etc
Interaction with Food
Pregnancy and lactation
Concurrent administration of cyclosporine, fibric acid derivatives, niacin, erthromycin or azole antifungals with atorvastatin increases the risk of myopathy.
Co-administration with contraceptive pill containing ethyl estradiol and norethindone is found to increase the Cmax of ethinyl estyradiol and norethisterone .
Mibefradil, calcium channel blocker is found to supress the activity of liver enzymes. Antacid suspension decreases the plasma concentrations of atorvastatin.
Constipation, Flatulance, Dyspepsia and abdominal pain.,
Pancreatitis, Liver toxicity,
Dizziness, Transaminase elevations
Contraindicated in cases of liver disease or unexplained persistent elevations of serum transaminase.
Discontinue the drug on nursing mothers.
Dosages/ Overdosage Etc:
Initial U.S. Approval: 2013
Hypercholesterolamia . Hypertriglyceridamia
Hyperlipidaemia asociated with hypertension
Type 2 diabetes
Oral: 10mg/day. Can be increased to 80mg/day
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-Approved Patient Labeling (Patient Information)
Patients should be advised to adhere to their National Cholesterol Education Program (NCEP) recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.
1. Muscle Pain- All patients starting therapy with LIPTRUZET should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing LIPTRUZET.
The risk of this occurring is increased when taking certain types of medication or consuming larger quantities (>1 liter) of grapefruit juice.
Patients should discuss all medication, both prescription and over-the-counter, with their physician.
2.Liver Enzymes- It is recommended that liver enzyme tests be performed before the initiation of LIPTRUZET and if signs or symptoms of liver injury occur.
All patients treated with LIPTRUZET should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
3.Pregnancy- Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using LIPTRUZET. Discuss future pregnancy plans with your patients, and discuss when to stop taking LIPTRUZET if they are trying to conceive.
Patients should be advised that if they become pregnant they should stop taking LIPTRUZET and call their healthcare professional.
4. Breast-Feeding- Women who are breast-feeding should be advised to not use LIPTRUZET.
Patients who have a lipid disorder and are breast-feeding should be advised to discuss the options with their healthcare professionals.
5.Important Storage and Administration Instructions- Patients should be advised to see the FDA-Approved Patient Labeling (Patient Information). Tablets should be swallowed whole. Do not crush, dissolve, or chew tablets. If a dose is missed, the patient should not take an extra dose. Just resume the usual schedule.
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Two mechanisms by Atorvastatin, which is a HMG-CoA reductase inhibitor, may exert the same pharmacological effects have been suggested.
Firstly inhibition of MMG - CoA reductase is rate limiting step in the synthesis of mevalonate, a precursor of steroids in the body, by atorvastatin, there by resulting in extensive reduction in cholesterol synthesis by impairment of assembly and secretion of very low density lipoproteins (VLDL).
Secondly, marked reduction in hepatic cholesterol levels leading to increase LDL receptor expression, which in turn brings about reductions in triglyceride levels through increased binding of VLDL remnant particles and LDL.
Following oral administration of atorvastatin it is reportedly absorbed quickly. The mean time of the maximum observed concentration and elimination half-life with food are 5.9hrs and 32h respy, and without food are 2.6h and 35h respy.
The effect of food on bioavailability of the drug on LDL- chlolestrol reduction is not altered, in spite of the food decreasing the rate and the extent of drug absorption by 25%and 9% respy. LDL- cholestrol reduction by the drug is not affected by the presence or absence of food.
Interaction with Food:
Not affected by the presence or absence of food.
Avoid excessive consumption of ( > 1L /day ) of grapefruit juice
Pregnancy and lactation: