LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5 mg/1
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE · TABLET, FILM COATED · Granules Pharmaceuticals Inc.
Losartan Potassium and Hydrochlorothiazide is a prescription tablet that combines two blood pressure-lowering medications to help treat high blood pressure. It works by relaxing blood vessels and removing excess salt and water from the body.
Key Facts
- Brand Name
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Generic Name
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- NDC Code (Product)
70010-187- Manufacturer
- Granules Pharmaceuticals Inc.
- Strength
- 12.5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA218015
- Drug Class
- Thiazide Diuretic [EPC]
- Marketing Start
- 09/29/2023
Recall History
Torrent Pharma Inc.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Lupin Pharmaceuticals Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Macleods Pharma Usa Inc
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Sandoz, Inc
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Torrent Pharma Inc.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Jubilant Cadista Pharmaceuticals Inc.
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
AVKARE Inc.
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Lupin Pharmaceuticals Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
MACLEODS PHARMA USA, INC
Presence of foreign substance: plastic-like substance.
Torrent Pharma Inc.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
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 Losartan potassium and hydrochlorothiazide tablets are a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) 1.1 Hypertension Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking ce…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Hypertension Usual starting dose: 50 mg/12.5 mg once daily. ( 2.1 ) Titrate as needed to a maximum dose of 100 mg/25 mg. ( 2.1 ) Hypertensive Patients with Left Ventricular Hypertrophy Not controlled on monotherapy: Initiate with 50 mg/12.5 mg. Titrate as needed to a maximum of 100 mg/25 mg. ( 2.2 ) 2.1 Hypertension The usual starting dose of losartan potassium and hydrochlorothiazide tablets is 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. The dosage can be increased after 3 weeks of therapy to a maximum of 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily as needed to control blood pressure [see Clinical Studies ( 14.2 )]. Initiate a patient whose blood pressure is not adequately controlled with losartan 50 mg monotherapy with losartan potassium and hydrochlorothiazide tablets 50/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dosage may be increased to two tablets of losartan potassium and hydrochlorothiazide tablets 50/12.5 once daily or one tablet of losartan potassium and hydrochlorothiazide tablets 100/25 once daily. Initiate a patient whose blood pressure is not adequately…
Contraindications
4 CONTRAINDICATIONS Losartan potassium and hydrochlorothiazide tablets are contraindicated: In patients who are hypersensitive to any component of this product. In patients with anuria For coadministration with aliskiren in patients with diabetes Hypersensitivity to any component of losartan potassium and hydrochlorothiazide tablets. ( 4 ) Anuria. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Agents increasing serum potassium: Risk of hyperkalemia. ( 7.1 ) Lithium: Risk of lithium toxicity. ( 7.2 ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects. ( 7.3 ) Dual inhibition of the renin-angiotensin system: increased risk of renal impairment, hypotension, syncope, and hyperkalemia. ( 7.4 ) Antidiabetic drugs: dosage adjustment of antidiabetic may be required. ( 7.5 ) Cholestyramine and colestipol: Reduced absorption of thiazides. ( 7.5 ) 7.1 Agents Increasing Serum Potassium Coadministration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of angiotensin II receptor antagonists or thiazide diuretics. Monitor lithium levels in patients receiving losartan potassium and hydrochlorothiazide tablets and lithium. 7.3 Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors Losartan Potassium In patients who are elderly, volume-depleted (in…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2% and greater than placebo) are dizziness, upper respiratory infection, cough, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 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. Losartan potassium-hydrochlorothiazide has been evaluated for safety in 858 patients treated for essential hypertension and 3,889 patients treated for hypertension and left ventricular hypertrophy. Most adverse reactions have been mild and transient in nature and have not required discontinuation of therapy. In controlled clinical trials, discontinuation of therapy due to clinical adverse events was required in only 2.8% and 2.3% of patients treated with the combination and placebo, respectively. In these double-blind controlled clinical trials, adverse reactions occurring in greater than 2% o…
Frequently Asked Questions
What is LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE used for?
Losartan Potassium and Hydrochlorothiazide is a prescription tablet that combines two blood pressure-lowering medications to help treat high blood pressure. It works by relaxing blood vessels and removing excess salt and water from the body.
Is LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE a controlled substance?
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE is not classified as a controlled substance by the DEA.
What is the generic name for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE?
The generic name for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE is LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE. There are 12 other brand versions of LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE.
What is the NDC code for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5 mg/1?
The NDC (National Drug Code) for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 12.5 mg/1 is 70010-187, listed by Granules Pharmaceuticals Inc..
Other Losartan Brands
See all →- Losartan potassium and Hydrochlorothiazide12.5 mg/133342-051
- Losartan Potassium and Hydrochlorothiazide25 mg/150090-7821
- Losartan Potassium and Hydrochlorothiazide25 mg/159746-339
- Losartan Potassium and Hydrochlorothiazide12.5 mg/170518-3398
- losartan potassium and hydrochlorothiazide25 mg/171610-671
- Losartan Potassium and Hydrochlorothiazide12.5 mg/182804-103
- Losartan Potassium and Hydrochlorothiazide12.5 mg/182804-239
- Losartan Potassium and Hydrochlorothiazide25 mg/10093-7368
- losartan potassium and hydrochlorothiazide12.5 mg/129300-190
- Losartan Potassium and Hydrochlorothiazide25 mg/143547-424
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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