HYDROCHLOROTHIAZIDE 12.5 mg/1
hydrochlorothiazide · TABLET · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Hydrochlorothiazide is a thiazide diuretic tablet taken by mouth that is commonly used to treat high blood pressure and reduce excess fluid in the body. Your doctor will determine the right dose for your specific condition.
Key Facts
- Brand Name
- HYDROCHLOROTHIAZIDE
- Generic Name
- hydrochlorothiazide
- NDC Code (Product)
23155-764- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Strength
- 12.5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA085182
- Drug Class
- Increased Diuresis [PE]; Thiazide Diuretic [EPC]
- Marketing Start
- 05/02/2023
Recall History
Unichem Pharmaceuticals USA Inc.
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Calvin Scott & Company, Inc.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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 Pharmaceuticals Inc.
Subpotent Drug
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.
Prinston Pharmaceutical 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.
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.
Apotex Inc.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Torrent Pharma Inc.
Superpotent; Hydrochlorothiazide
Lupin Pharmaceuticals Inc.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Lisinopril 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 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 lisinopril 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 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, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity a…
Dosage & Administration
DOSAGE AND ADMINISTRATION Lisinopril monotherapy is an effective treatment of hypertension in once-daily doses of 10 mg to 80 mg, while hydrochlorothiazide monotherapy is effective in doses of 12.5 mg to 50 mg per day. In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10 mg to 80 mg and hydrochlorothiazide doses of 6.25 mg to 50 mg, the antihypertensive response rates generally increased with increasing dose of either component. The side effects (see WARNINGS ) of lisinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of lisinopril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but addition of lisinopril in clinical trials blunted the hypokalemia normally seen with diuretics. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy. Dose Titra…
Warnings
WARNINGS General Lisinopril Anaphylactoid and Possibly Related Reactions: Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including lisinopril and hydrochlorothiazide tablets) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin converting enzyme inhibitors, including lisinopril. This may occur at any time during treatment. ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients. In such cases lisinopril and hydrochlorothiazide tablets should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred. Even in those instances where swelling of only the tongue is involved, without respiratory distress, patients may require prolonged observation since treatment with antihistamines and corticosteroids may not be sufficient. Very ra…
Contraindications
CONTRAINDICATIONS Lisinopril and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Lisinopril and hydrochlorothiazide tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer lisinopril and hydrochlorothiazide tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS ). Do not coadminister aliskiren with lisinopril and hydrochlorothiazide tablets in patients with diabetes.
Drug Interactions
Drug Interactions Lisinopril Hypotension - Patients on Diuretic Therapy: Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with lisinopril. The possibility of hypotensive effects with lisinopril can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with lisinopril. If it is necessary to continue the diuretic, initiate therapy with lisinopril at a dose of 5 mg daily, and provide close medical supervision after the initial dose for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS , and DOSAGE AND ADMINISTRATION .) When a diuretic is added to the therapy of a patient receiving lisinopril, an additional antihypertensive effect is usually observed (See DOSAGE AND ADMINISTRATION .) Non-steroidal Anti-inflammatory Agents Including Selective Cyclooxygenase-2 (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 …
Adverse Reactions
ADVERSE REACTIONS Lisinopril and hydrochlorothiazide tablets have been evaluated for safety in 930 patients including 100 patients treated for 50 weeks or more. In clinical trials with lisinopril and hydrochlorothiazide tablets no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with lisinopril or hydrochlorothiazide. The most frequent clinical adverse experiences in controlled trials (including open label extensions) with any combination of lisinopril and hydrochlorothiazide tablets were: dizziness (7.5%), headache (5.2%), cough (3.9%), fatigue (3.7%) and orthostatic effects (3.2%) all of which were more common than in placebo-treated patients. Generally, adverse experiences were mild and transient in nature; but see WARNINGS regarding angioedema and excessive hypotension or syncope. Discontinuation of therapy due to adverse effects was required in 4.4% of patients principally because of dizziness, cough, fatigue and muscle cramps. Adverse experiences occurring in greater than one percent of patients treated with lisinopril plus hydrochlorothiazide in contr…
Frequently Asked Questions
What is HYDROCHLOROTHIAZIDE used for?
Hydrochlorothiazide is a thiazide diuretic tablet taken by mouth that is commonly used to treat high blood pressure and reduce excess fluid in the body. Your doctor will determine the right dose for your specific condition.
Is HYDROCHLOROTHIAZIDE a controlled substance?
HYDROCHLOROTHIAZIDE is not classified as a controlled substance by the DEA.
What is the generic name for HYDROCHLOROTHIAZIDE?
The generic name for HYDROCHLOROTHIAZIDE is hydrochlorothiazide. There are 12 other brand versions of hydrochlorothiazide.
What is the NDC code for HYDROCHLOROTHIAZIDE 12.5 mg/1?
The NDC (National Drug Code) for HYDROCHLOROTHIAZIDE 12.5 mg/1 is 23155-764, listed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..
Other Hydrochlorothiazide Brands
See all →- Hydrochlorothiazide25 mg/170518-4113
- OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE12.5 mg/133342-174
- Valsartan and Hydrochlorothiazide25 mg/142291-969
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5 mg/172189-129
- Exforge HCT10 mg/10078-0563
- OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE25 mg/133342-175
- Losartan Potassium and Hydrochlorothiazide12.5 mg/163187-394
- olmesartan medoxomil-hydrochlorothiazide12.5 mg/142291-924
- Triamterene and Hydrochlorothiazide50 mg/170518-4351
- Lisinopril and Hydrochlorothiazide25 mg/171335-1783
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)