Drugplain

Moexipril Hydrochloride 7.5 mg/1

Moexipril Hydrochloride · TABLET, FILM COATED · Teva Pharmaceuticals USA, Inc.

1 Recall on Record
Plain English

Moexipril Hydrochloride is a tablet, film coated containing moexipril hydrochloride at 7.5 mg/1, taken oral. Manufactured by Teva Pharmaceuticals USA, Inc..

Key Facts

Brand Name
Moexipril Hydrochloride
Generic Name
Moexipril Hydrochloride
NDC Code (Product)
0093-0017
Manufacturer
Teva Pharmaceuticals USA, Inc.
Strength
7.5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA076204
Marketing Start
05/08/2003

Recall History

1 Recall on Record
Class II12/14/2017

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

asthenia8 reports
dyspnoea6 reports
nausea5 reports
blood pressure decreased4 reports
cerebrovascular accident4 reports
cough4 reports
dehydration4 reports
diarrhoea4 reports
drug ineffective4 reports
flushing4 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Moexipril hydrochloride tablets are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using moexipril hydrochloride tablets, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that moexipril hydrochloride tablets do not have a similar risk (see WARNINGS ). In considering use of moexipril hydrochloride tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema ).

Dosage & Administration

DOSAGE AND ADMINISTRATION

Warnings

WARNINGS

Contraindications

CONTRAINDICATIONS Moexipril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Do not co-administer aliskiren with moexipril hydrochloride tablets in patients with diabetes (see PRECAUTIONS, Drug Interactions ).

Adverse Reactions

ADVERSE REACTIONS Moexipril hydrochloride tablets have been evaluated for safety in more than 2500 patients with hypertension; more than 250 of these patients were treated for approximately one year. The overall incidence of reported adverse events was only slightly greater in patients treated with moexipril hydrochloride tablets than patients treated with placebo. Reported adverse experiences were usually mild and transient, and there were no differences in adverse reaction rates related to gender, race, age, duration of therapy, or total daily dosage within the range of 3.75 mg to 60 mg. Discontinuation of therapy because of adverse experiences was required in 3.4% of patients treated with moexipril hydrochloride tablets and in 1.8% of patients treated with placebo. The most common reasons for discontinuation in patients treated with moexipril hydrochloride tablets were cough (0.7%) and dizziness (0.4%). All adverse experiences considered at least possibly related to treatment that occurred at any dose in placebo-controlled trials of once-daily dosing in more than 1% of patients treated with moexipril hydrochloride tablets alone and that were at least as frequent in the moexipril

Frequently Asked Questions

What is Moexipril Hydrochloride used for?

Moexipril Hydrochloride contains Moexipril Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Moexipril Hydrochloride a controlled substance?

Moexipril Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Moexipril Hydrochloride?

The generic name for Moexipril Hydrochloride is Moexipril Hydrochloride. There are no other listed brand versions of Moexipril Hydrochloride.

What is the NDC code for Moexipril Hydrochloride 7.5 mg/1?

The NDC (National Drug Code) for Moexipril Hydrochloride 7.5 mg/1 is 0093-0017, listed by Teva Pharmaceuticals USA, Inc..

Product NDC

0093-0017

Package NDC

0093-0017-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)