Drugplain

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE 10 mg/1

amlodipine besylate valsartan hydrochlorothiazide · TABLET, FILM COATED · Strides Pharma Science Limited

3 Recalls on RecordCurrently in Shortage
Plain English

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE is a tablet, film coated containing amlodipine besylate valsartan hydrochlorothiazide at 10 mg/1, taken oral. Manufactured by Strides Pharma Science Limited.

Key Facts

Brand Name
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
Generic Name
amlodipine besylate valsartan hydrochlorothiazide
NDC Code (Product)
64380-201
Manufacturer
Strides Pharma Science Limited
Strength
10 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA201087
Drug Class
Thiazide Diuretic [EPC]; Angiotensin 2 Receptor Blocker [EPC]
Marketing Start
06/27/2022

Recall History

3 Recalls on Record
Class II08/08/2013

Novartis Pharmaceuticals Corp.

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

TerminatedVoluntary: Firm initiated
Class II08/08/2013

Novartis Pharmaceuticals Corp.

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

TerminatedVoluntary: Firm initiated
Class II08/08/2013

Novartis Pharmaceuticals Corp.

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

basal cell carcinoma2 reports
blood triglycerides increased2 reports
bronchitis2 reports
claudication of jaw muscles2 reports
completed suicide2 reports
condition aggravated2 reports
death2 reports
depression2 reports
drug ineffective2 reports
drug interaction2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Amlodipine/valsartan/hydrochlorothiazide 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 from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine/valsartan/hydrochlorothiazide. 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 1 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, fro…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Dose once-daily. Titrate up to a maximum dose of 10/320/25 mg. (2.1) Amlodipine/valsartan/hydrochlorothiazide may be used as add-on/switch therapy for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. (2.2) Amlodipine/valsartan/hydrochlorothiazide may be substituted for its individually titrated components. (2.3) 2.1 General Considerations Dose once-daily. The dosage may be increased after 2 weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of amlodipine/valsartan/hydrochlorothiazide. The maximum recommended dose of amlodipine/valsartan/hydrochlorothiazide is 10/320/25 mg. 2.2 Add-on/Switch Therapy Amlodipine/valsartan/hydrochlorothiazide may be used for patients not adequately controlled on any 2 of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of amlodipine/valsartan/hydrochlorothiazide m…

Contraindications

4 CONTRAINDICATIONS Do not use in patients with anuria, hypersensitivity to other sulfonamide-derived drugs, or hypersensitivity to any component of this product. Do not coadminister aliskiren with amlodipine/valsartan/hydrochlorothiazide in patients with diabetes [see Drug Interactions (7)]. Anuria (4) Hypersensitivity to sulfonamide-derived drugs (4) Known hypersensitivity to any component (4) Do not coadminister aliskiren with amlodipine/valsartan/hydrochlorothiazide in patients with diabetes (4)

Drug Interactions

7 DRUG INTERACTIONS No drug interaction studies have been conducted with amlodipine/valsartan/hydrochlorothiazide and other drugs, although studies have been conducted with the individual components. A pharmacokinetic drug-drug interaction study has been conducted to address the potential for pharmacokinetic interaction between the triple combination, amlodipine/valsartan/hydrochlorothiazide, and the corresponding 3 double combinations. No clinically relevant interaction was observed. Amlodipine Impact of Other Drugs on Amlodipine CYP3A Inhibitors Coadministration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology (12.3)]. CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is coadministered with CYP3A inducers (e.g., rifampicin, St. John's Wort). Sildenafil Monitor for hypotension when sildenafil is coadministered with amlodipi…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse events (≥2% incidence) are dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea and nasopharyngitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc at 1-877-244-9825 and/or www.strides.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. In the controlled trial of amlodipine/valsartan/hydrochlorothiazide, where only the maximum dose (10/320/25 mg) was evaluated, safety data were obtained in 582 patients with hypertension. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall frequency of adverse reactions was similar between men and women, younger (< 65 years) and older (≥ 65 years) patients, and black and white patients. In the active controlled clinical trial, discontinuation because of …

Frequently Asked Questions

What is AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE used for?

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE contains amlodipine besylate valsartan hydrochlorothiazide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE a controlled substance?

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE is not classified as a controlled substance by the DEA.

What is the generic name for AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE?

The generic name for AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE is amlodipine besylate valsartan hydrochlorothiazide. There are no other listed brand versions of amlodipine besylate valsartan hydrochlorothiazide.

What is the NDC code for AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE 10 mg/1?

The NDC (National Drug Code) for AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE 10 mg/1 is 64380-201, listed by Strides Pharma Science Limited.

Product NDC

64380-201

Package NDC

64380-201-01

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

Data from openFDA · Public domain (CC0 1.0)