Amlodipine besylate and Atorvastatin calcium 2.5 mg/1
Amlodipine besylate and Atorvastatin calcium · TABLET, FILM COATED · Dr. Reddy's Laboratories Inc
Amlodipine besylate and Atorvastatin calcium is a tablet, film coated containing amlodipine besylate and atorvastatin calcium at 2.5 mg/1, taken oral. Manufactured by Dr. Reddy's Laboratories Inc.
Key Facts
- Brand Name
- Amlodipine besylate and Atorvastatin calcium
- Generic Name
- Amlodipine besylate and Atorvastatin calcium
- NDC Code (Product)
43598-317- Manufacturer
- Dr. Reddy's Laboratories Inc
- Strength
- 2.5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203874
- Marketing Start
- 03/17/2014
Recall History
Dr. Reddy's Laboratories, Inc.
Subpotent drug
Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Dr. Reddy's Laboratories, Inc.
Subpotent drug
Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Dr. Reddy's Laboratories, Inc.
Subpotent drug
Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Dr. Reddy's Laboratories, Inc.
Subpotent drug
Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine Amlodipine besylate and atorvastatin calcium tablets are a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG CoA-reductase inhibitor, indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure (1.1). Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Amlodipine is indicated for the treatment of Coronary Artery Disease (1.2). Atorvastatin is indicated as an adjunct therapy to diet for prevention of cardiovascular disease (1.3) and hyperlipidemia (1.4). 1.1 Hypertension Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs fr…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Amlodipine besylate and atorvastatin calcium Dosage of amlodipine besylate and atorvastatin calcium must be individualized on the basis of both effectiveness and tolerance for each individual component in the treatment of hypertension/angina and hyperlipidemia. Select doses of amlodipine and atorvastatin independently. Amlodipine besylate and atorvastatin calcium may be substituted for its individually titrated components. Patients may be given the equivalent dose of amlodipine besylate and atorvastatin calcium or a dose of amlodipine besylate and atorvastatin calcium with increased amounts of amlodipine, atorvastatin, or both for additional antianginal effects, blood pressure lowering, or lipid-lowering effect. Amlodipine besylate and atorvastatin calcium may be used to provide additional therapy for patients already on one of its components. Amlodipine besylate and atorvastatin calcium may be used to initiate treatment in patients with hyperlipidemia and either hypertension or angina. Amlodipine The usual initial antihypertensive oral dose of amlodipine is 5 mg once daily, and the maximum dose is 10 mg once daily. Pediatric (age > 6 years), small adult…
Contraindications
4 CONTRAINDICATIONS • 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 )
Drug Interactions
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 atorvastatin increased by 18% (90% confidence interval: 109 to 127%) in the presence of amlodipine, which is not clinically meaningful. No drug interaction studies have been conducted with amlodipine besylate and atorvastatin calcium and other drugs, although studies have been conducted in the individual amlodipine and atorvastatin components, as described below: Amlodipine Increased Risk of Myopathy and Rhabdomyolysis ( 2 , 5.1 , 7.3 , 12.3 ) Cyclosporine, tipranavir plus ritonavir, glecaprevir plus pibrentasvir Avoid atorvastatin Clarithromycin, itraconazole, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir,letermovir Do not exceed 20 mg atorvastatin daily Nelfinavir Do not exceed 40 mg atorvastatin daily Lopinavir plus r…
Adverse Reactions
6 ADVERSE REACTIONS 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 Laboratories, Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium has been evaluated for safety in 1,092 patients in double-blind placebo-controlled studies treated for co-morbid hypertension and dyslipidemia. In general, treatment with amlodipine besylate and atorvastatin calcium was…
Frequently Asked Questions
What is Amlodipine besylate and Atorvastatin calcium used for?
Amlodipine besylate and Atorvastatin calcium contains Amlodipine besylate and Atorvastatin calcium. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Amlodipine besylate and Atorvastatin calcium a controlled substance?
Amlodipine besylate and Atorvastatin calcium is not classified as a controlled substance by the DEA.
What is the generic name for Amlodipine besylate and Atorvastatin calcium?
The generic name for Amlodipine besylate and Atorvastatin calcium is Amlodipine besylate and Atorvastatin calcium. There are 1 other brand versions of Amlodipine besylate and Atorvastatin calcium.
What is the NDC code for Amlodipine besylate and Atorvastatin calcium 2.5 mg/1?
The NDC (National Drug Code) for Amlodipine besylate and Atorvastatin calcium 2.5 mg/1 is 43598-317, listed by Dr. Reddy's Laboratories Inc.
Other Amlodipine besylate and Atorvastatin calcium Dosages
- Amlodipine besylate and Atorvastatin calcium5 mg/143598-322
- Amlodipine besylate and Atorvastatin calcium10 mg/143598-315
- Amlodipine besylate and Atorvastatin calcium10 mg/143598-318
- Amlodipine besylate and Atorvastatin calcium5 mg/143598-319
- Amlodipine besylate and Atorvastatin calcium2.5 mg/143598-320
- Amlodipine besylate and Atorvastatin calcium10 mg/143598-313
- Amlodipine besylate and Atorvastatin calcium5 mg/143598-316
- Amlodipine besylate and Atorvastatin calcium2.5 mg/143598-323
- Amlodipine besylate and Atorvastatin calcium5 mg/143598-314
- Amlodipine besylate and Atorvastatin calcium10 mg/143598-321
Other Amlodipine Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)