Drugplain

Amlodipine and atorvastatin 10 mg/1

Amlodipine and atorvastatin · TABLET, FILM COATED · Mylan Pharmaceuticals Inc.

No Recall HistoryCurrently in Shortage
Plain English

Amlodipine and atorvastatin is a combination tablet that contains a blood pressure medication and a cholesterol-lowering medication, used together to help manage high blood pressure and high cholesterol. This prescription medication is taken by mouth and combines two drugs to reduce your risk of heart disease and stroke.

Key Facts

Brand Name
Amlodipine and atorvastatin
Generic Name
Amlodipine and atorvastatin
NDC Code (Product)
0378-4519
Manufacturer
Mylan Pharmaceuticals Inc.
Strength
10 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA200465
Marketing Start
02/11/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue35 reports
death27 reports
diarrhoea27 reports
cough22 reports
dyspnoea22 reports
pneumonia20 reports
dizziness18 reports
nausea18 reports
asthenia17 reports
weight decreased17 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine Hypertension Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Amlodipine and Atorvastatin Tablets Dosage of amlodipine and atorvastatin tablets 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 and atorvastatin tablets may be substituted for its individually titrated components. Patients may be given the equivalent dose of amlodipine and atorvastatin or a dose of amlodipine and atorvastatin with increased amounts of amlodipine, atorvastatin, or both for additional antianginal effects, blood pressure lowering, or lipid-lowering effect. Amlodipine and atorvastatin tablets may be used to provide additional therapy for patients already on one of its components. Amlodipine and atorvastatin tablets may be used to initiate treatment in patients with hyperlipidemia and either hypertension or angina. Important Dosage Information Take amlod ipine and atorvastatin tablets orally once daily at any time of the day, with or without food. Amlodipine The usual initial antihypertensive oral dosage of amlodipine is 5 mg once daily, and the maximum dose i…

Contraindications

4 CONTRAINDICATIONS Acute liver failure or decompensated cirrhosis [see Warnings and Precautions ( 5.3 )]. Hypersensitivity to amlodipine, atorvastatin or any excipients in amlodipine and atorvastatin tablets. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported [see Adverse Reactions ( 6.2 )]. Acute liver failure or decompensated cirrhosis (4). Hypersensitivity to amlodipine, atorvastatin or any excipient in amlodipine and atorvastatin tablets (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 and atorvastatin and other drugs, although studies have been conducted in the individual amlodipine and atorvastatin components, as described below: Amlodipine See full prescribing information for details regarding concomitant use of amlodipine and atorvastatin tablets with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis (2.5, 7.3 ). Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with atorvastatin ( 7.4 ) Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting a…

Adverse Reactions

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.6 )] Most common adverse reaction to amlodipine is edema which occurred in a dose related manner ( 6.1 ). Most common adverse reactions (incidence ≥5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection to atorvastatin ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800- 706-5575 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, the 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 and Atorvastatin Amlodipine and atorvastatin has been evaluated for safety in 1,092 patients i…

Frequently Asked Questions

What is Amlodipine and atorvastatin used for?

Amlodipine and atorvastatin is a combination tablet that contains a blood pressure medication and a cholesterol-lowering medication, used together to help manage high blood pressure and high cholesterol. This prescription medication is taken by mouth and combines two drugs to reduce your risk of heart disease and stroke.

Is Amlodipine and atorvastatin a controlled substance?

Amlodipine and atorvastatin is not classified as a controlled substance by the DEA.

What is the generic name for Amlodipine and atorvastatin?

The generic name for Amlodipine and atorvastatin is Amlodipine and atorvastatin. There are 11 other brand versions of Amlodipine and atorvastatin.

What is the NDC code for Amlodipine and atorvastatin 10 mg/1?

The NDC (National Drug Code) for Amlodipine and atorvastatin 10 mg/1 is 0378-4519, listed by Mylan Pharmaceuticals Inc..

Product NDC

0378-4519

Package NDC

0378-4519-93

Other Amlodipine and atorvastatin Dosages

Other Amlodipine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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