amlodipine,valsartan and hydrochlorothiazide 5 mg/1
amlodipine,valsartan and hydrochlorothiazide · TABLET, FILM COATED · Macleods Pharmaceuticals Limited
amlodipine,valsartan and hydrochlorothiazide is a tablet, film coated containing amlodipine,valsartan and hydrochlorothiazide at 5 mg/1, taken oral. Manufactured by Macleods Pharmaceuticals Limited.
Key Facts
- Brand Name
- amlodipine,valsartan and hydrochlorothiazide
- Generic Name
- amlodipine,valsartan and hydrochlorothiazide
- NDC Code (Product)
33342-285- Manufacturer
- Macleods Pharmaceuticals Limited
- Strength
- 5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207299
- Drug Class
- Thiazide Diuretic [EPC]; Angiotensin 2 Receptor Blocker [EPC]
- Marketing Start
- 01/06/2025
Recall History
Torrent Pharma Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Teva Pharmaceuticals USA
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Torrent Pharma Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Torrent Pharma Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Teva Pharmaceuticals USA
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Teva Pharmaceuticals USA
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Teva Pharmaceuticals USA
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Torrent Pharma Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Torrent Pharma Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE Amlodipine, valsartan and hydrochlorothiazide tablets are 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 and hydrochlorothiazide tablets. 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 an…
Dosage & Administration
2 DOSAGE & ADMINISTRATION • Dose once-daily. Titrate up to a maximum dose of 10/320/25 mg ( 2.1 ) • Amlodipine, valsartan and hydrochlorothiazide tablets 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 and hydrochlorothiazide tablets 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 and hydrochlorothiazide tablets. The maximum recommended dose of amlodipine, valsartan and hydrochlorothiazide tablets is 10/320/25 mg. 2.2 Add-on / Switch Therapy Amlodipine, valsartan and hydrochlorothiazide tablets 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 …
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 and hydrochlorothiazide tablets 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 and hydrochlorothiazide tablets in patients with diabetes ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No drug interaction studies have been conducted with amlodipine, valsartan and hydrochlorothiazide tablets 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 and hydrochlorothiazide tablets, 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 co…
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 Macleods Pharma USA, Inc., at 1-888-943-3210 or or 1-855-926-3384 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 and hydrochlorothiazide tablets, 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, discontinua…
Frequently Asked Questions
What is amlodipine,valsartan and hydrochlorothiazide used for?
amlodipine,valsartan and hydrochlorothiazide contains amlodipine,valsartan and hydrochlorothiazide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is amlodipine,valsartan and hydrochlorothiazide a controlled substance?
amlodipine,valsartan and hydrochlorothiazide is not classified as a controlled substance by the DEA.
What is the generic name for amlodipine,valsartan and hydrochlorothiazide?
The generic name for amlodipine,valsartan and hydrochlorothiazide is amlodipine,valsartan and hydrochlorothiazide. There are no other listed brand versions of amlodipine,valsartan and hydrochlorothiazide.
What is the NDC code for amlodipine,valsartan and hydrochlorothiazide 5 mg/1?
The NDC (National Drug Code) for amlodipine,valsartan and hydrochlorothiazide 5 mg/1 is 33342-285, listed by Macleods Pharmaceuticals Limited.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)