Enalapril maleate and hydrochlorothiazide 5 mg/1
Enalapril maleate and hydrochlorothiazide · TABLET · Dr. Reddy's Laboratories Limited
This medication combines an ACE inhibitor and a diuretic to help lower blood pressure in patients with hypertension. It works by relaxing blood vessels and reducing fluid buildup in the body.
Key Facts
- Brand Name
- Enalapril maleate and hydrochlorothiazide
- Generic Name
- Enalapril maleate and hydrochlorothiazide
- NDC Code (Product)
55111-133- Manufacturer
- Dr. Reddy's Laboratories Limited
- Strength
- 5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075909
- Drug Class
- Thiazide Diuretic [EPC]
- Marketing Start
- 10/15/2001
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Enalapril maleate and hydrochlorothiazide is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION ). In using enalapril maleate and hydrochlorothiazide, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril does not have a similar risk (see WARNINGS ). In considering use of enalapril maleate and hydrochlorothiazide, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Head and Neck Angioedema ).
Dosage & Administration
DOSAGE AND ADMINISTRATION Enalapril and hydrochlorothiazide are effective treatments for hypertension. The usual dosage range of enalapril is 10 to 40 mg per day administered in a single or two divided doses; hydrochlorothiazide is effective in doses of 12.5 to 50 mg daily. The side effects (see WARNINGS ) of enalapril 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 enalapril and hydrochlorothiazide will be associated with both sets of dose-independent side effects but the addition of enalapril 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 Titration Guided by Clinical Effect A patient whose blood pressure is not adequately controlled with either enalapril or hydrochlorothiazide monotherapy may be given enalapril maleate and hydrochlorothiazide 5/12…
Warnings
WARNINGS General Enalapril Maleate Hypotension Excessive hypotension was rarely seen in uncomplicated hypertensive patients but is a possible consequence of enalapril use in severely salt/volume depleted persons such as those treated vigorously with diuretics or patients on dialysis. Syncope has been reported in 1.3 percent of patients receiving enalapril maleate and hydrochlorothiazide. In patients receiving enalapril alone, the incidence of syncope is 0.5 percent. The overall incidence of syncope may be reduced by proper titration of the individual components (see PRECAUTIONS, Drug Interactions , ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION ). In patients with severe congestive heart failure, with or without associated renal insufficiency, excessive hypotension has been observed and may be associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death. Because of the potential fall in blood pressure in these patients, therapy should be started under very close medical supervision. Such patients should be followed closely for the first two weeks of treatment and whenever the dose of enalapril and/or diuretic is increased. Similar consider…
Contraindications
CONTRAINDICATIONS Enalapril maleate and hydrochlorothiazide is 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. Enalapril maleate and hydrochlorothiazide is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate and hydrochlorothiazide within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS ). Do not co-administer aliskiren with enalapril maleate and hydrochlorothiazide in patients with diabetes (see PRECAUTIONS, Drug Interactions ).
Drug Interactions
Drug Interactions Neprilysin Inhibitors Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema (see WARNINGS ). Enalapril Maleate Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on enalapril maleate and hydrochlorothiazide and other agents that affect the RAS. Do not coadminister aliskiren with enalapril maleate and hydrochlorothiazide in patients with diabetes. Avoid use of aliskiren with enalapril maleate and hydrochlorothiazide in patients with renal impairment (GFR <60 mL/min). Hypotension – Patients on Diuretic Therapy Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduc…
Adverse Reactions
ADVERSE REACTIONS Enalapril maleate and hydrochlorothiazide has been evaluated for safety in more than 1500 patients, including over 300 patients treated for one year or more. In clinical trials with enalapril maleate and hydrochlorothiazide 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 enalapril or hydrochlorothiazide. The most frequent clinical adverse experiences in controlled trials were: dizziness (8.6 percent), headache (5.5 percent), fatigue (3.9 percent) and cough (3.5 percent). Generally, adverse experiences were mild and transient in nature. Adverse experiences occurring in greater than two percent of patients treated with enalapril maleate and hydrochlorothiazide in controlled clinical trials are shown below. Percent of Patients in Controlled Studies Enalapril maleate and hydrochlorothiazide (n=1580) Incidence (discontinuation) Placebo (n=230) Incidence Dizziness 8.6 (0.7) 4.3 Headache 5.5 (0.4) 9.1 Fatigue 3.9 (0.8) 2.6 Cough 3.5 (0.4) 0.9 Muscle Cramps 2.7 (0.2) 0.9 Nausea 2.5 (0.4) 1.7 Asthenia 2.4 (0.3) 0.9 Orthostatic Effects 2.3 …
Frequently Asked Questions
What is Enalapril maleate and hydrochlorothiazide used for?
This medication combines an ACE inhibitor and a diuretic to help lower blood pressure in patients with hypertension. It works by relaxing blood vessels and reducing fluid buildup in the body.
Is Enalapril maleate and hydrochlorothiazide a controlled substance?
Enalapril maleate and hydrochlorothiazide is not classified as a controlled substance by the DEA.
What is the generic name for Enalapril maleate and hydrochlorothiazide?
The generic name for Enalapril maleate and hydrochlorothiazide is Enalapril maleate and hydrochlorothiazide. There are 3 other brand versions of Enalapril maleate and hydrochlorothiazide.
What is the NDC code for Enalapril maleate and hydrochlorothiazide 5 mg/1?
The NDC (National Drug Code) for Enalapril maleate and hydrochlorothiazide 5 mg/1 is 55111-133, listed by Dr. Reddy's Laboratories Limited.