AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

AbsorptionAmlodipine: After oral administration of therapeutic doses of amlodipine alone, absorption produces peak plasma concentrations between 6 and 12 hours. Absolute bioavailability has been estimated to be between 64% and 90%. Atorvastatin: After oral administration alone, atorvastatin is rapidly absorbed; maximum plasma concentrations occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin dose. The absolute bioavailability of atorvastatin (parent drug) is ...

14.1 Amlodipine for Hypertension Adult Patients The antihypertensive efficacy of amlodipine has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving 800 patients on amlodipine and 538 on placebo. Once daily administration produced statistically significant placebo-corrected reductions in supine and standing blood pressures at 24 hours postdose, averaging about 12/6 mmHg in the standing position and 13/7 mmHg in the supine position in patients with mild to moderate hypertension. Maintenance of the blood pressure effect over the 24-hour dosing interva...

The following serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 ) ] Liver enzyme abnormalities [see Warnings and Precautions ( 5.3 ) ] Most common adverse reaction (3% greater than placebo) to amlodipine is edema ( 6.1 ). Most common adverse reactions leading to atorvastatin discontinuation were myalgia and diarrhea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratori...

• Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels
• Pregnancy [see Use in Specific Populations ( 8.1 ) ]
• Lactation [see Use in Specific Populations ( 8.2 ) ] Active liver disease ( 4 ) Pregnancy ( 4 ) Lactation ( 4 )

Myopathy and Rhabdomyolysis: Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness. Amlodipine besylate and atorvastatin calcium therapy should be discontinued if myopathy is diagnosed or suspected ( 2 , 5.1 , 8.5 ). Immune-Mediated Necrotizing Myopathy (IMNM): Monitor for myalgia and treat ( 5.2 ). Hepatic Transaminitis: Monitor liver enzymes before and during treatment ( 5.3 ). Symptomatic hypotension is possible, particularly ...

7 DRUG INTERACTIONS Data from a drug-drug interaction study involving 10 mg of amlodipine and 80 mg of atorvastatin in healthy subjects indicate that the pharmacokinetics of amlodipine are not altered when the drugs are co-administered. The effect of amlodipine on the pharmacokinetics of atorvastatin showed no effect on the C max : 91% (90% confidence interval: 80 to 103%), but the AUC of atorvast...