Valsartan and Hydrochlorothiazide 25 mg/1
Valsartan and Hydrochlorothiazide · TABLET, FILM COATED · Proficient Rx LP
Valsartan and hydrochlorothiazide is a combination tablet used to treat high blood pressure and contains two types of medications—an angiotensin II receptor blocker and a thiazide diuretic. This prescription medication works by relaxing blood vessels and reducing fluid in the body to help lower blood pressure.
Key Facts
- Brand Name
- Valsartan and Hydrochlorothiazide
- Generic Name
- Valsartan and Hydrochlorothiazide
- NDC Code (Product)
71205-015- Manufacturer
- Proficient Rx LP
- Strength
- 25 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA201662
- Drug Class
- Thiazide Diuretic [EPC]; Angiotensin 2 Receptor Blocker [EPC]
- Marketing Start
- 05/20/2016
Recall History
Mylan Laboratories Limited, (Nashik FDF)
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Mylan Laboratories Limited, (Nashik FDF)
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Mylan Laboratories Limited, (Nashik FDF)
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Prinston Pharmaceutical 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.
Avkare Incorporated
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Teva Pharmaceuticals USA
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Avkare Incorporated
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Teva Pharmaceuticals USA
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Teva Pharmaceuticals USA
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 AND USAGE 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 hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with 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 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 a…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dose once daily. Titrate as needed to a maximum dose of 320 mg/25 mg. (2) May be used as add-on/switch therapy for patients not adequately controlled on any of the components (valsartan or HCTZ). (2) May be substituted for titrated components. (2.3) 2.1 General Considerations The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2) ]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose. 2.2 Add-On Therapy A patient whose blood pressure is not adequately controlled with valsartan (or another ARB) alone or hydrochlorothiazide alone may be switched to combination therapy with valsartan and hydrochlorothiazide tablets. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan a…
Contraindications
4 CONTRAINDICATIONS Valsartan and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not co-administer aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes [see Drug Interactions (7) ] . Anuria; Hypersensitivity to any sulfonamide-derived drugs or any component; Do not co-administer aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes. (4)
Drug Interactions
7 DRUG INTERACTIONS Valsartan and Hydrochlorothiazide: Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or thiazides. Monitor lithium levels in patients taking valsartan and hydrochlorothiazide. Valsartan: Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable. Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including val…
Adverse Reactions
6 ADVERSE REACTIONS The most common reasons for discontinuation of therapy with valsartan and hydrochlorothiazide were headache and dizziness. The only adverse experience that occurred in ≥ 2% of patients treated with valsartan and hydrochlorothiazide and at a higher incidence than placebo was nasopharyngitis (2.4% vs. 1.9%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 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 reactions 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 practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension Valsartan and hydrochlorothiazide has been evaluated for safety in more than 5,700 patients, including over 990 treated for over 6 months, and over 370 for over 1 year. Adverse experiences have generally been mild and transient in nature and hav…
Frequently Asked Questions
What is Valsartan and Hydrochlorothiazide used for?
Valsartan and hydrochlorothiazide is a combination tablet used to treat high blood pressure and contains two types of medications—an angiotensin II receptor blocker and a thiazide diuretic. This prescription medication works by relaxing blood vessels and reducing fluid in the body to help lower blood pressure.
Is Valsartan and Hydrochlorothiazide a controlled substance?
Valsartan and Hydrochlorothiazide is not classified as a controlled substance by the DEA.
What is the generic name for Valsartan and Hydrochlorothiazide?
The generic name for Valsartan and Hydrochlorothiazide is Valsartan and Hydrochlorothiazide. There are 4 other brand versions of Valsartan and Hydrochlorothiazide.
What is the NDC code for Valsartan and Hydrochlorothiazide 25 mg/1?
The NDC (National Drug Code) for Valsartan and Hydrochlorothiazide 25 mg/1 is 71205-015, listed by Proficient Rx LP.
Other Valsartan and Hydrochlorothiazide Dosages
- Valsartan and Hydrochlorothiazide12.5 mg/142291-968
- Valsartan and Hydrochlorothiazide12.5 mg/146708-454
- Valsartan and Hydrochlorothiazide25 mg/151655-243
- Valsartan and Hydrochlorothiazide25 mg/165162-849
- Valsartan and Hydrochlorothiazide12.5 mg/10378-6322
- Valsartan and Hydrochlorothiazide12.5 mg/171205-042
- Valsartan and Hydrochlorothiazide12.5 mg/171205-258
- Valsartan and Hydrochlorothiazide12.5 mg/150090-5570
Other Valsartan 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)