Drugplain

Irbesartan and Hydrochlorothiazide 12.5 mg/1

Irbesartan and Hydrochlorothiazide · TABLET, FILM COATED · Unichem Pharmaceuticals (USA), Inc.

7 Recalls on Record
Plain English

Irbesartan and Hydrochlorothiazide is a tablet, film coated containing irbesartan and hydrochlorothiazide at 12.5 mg/1, taken oral. Manufactured by Unichem Pharmaceuticals (USA), Inc..

Key Facts

Brand Name
Irbesartan and Hydrochlorothiazide
Generic Name
Irbesartan and Hydrochlorothiazide
NDC Code (Product)
29300-215
Manufacturer
Unichem Pharmaceuticals (USA), Inc.
Strength
12.5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA207018
Drug Class
Thiazide Diuretic [EPC]; Angiotensin 2 Receptor Blocker [EPC]
Marketing Start
09/19/2017

Recall History

7 Recalls on Record
Class II01/18/2019

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.

CompletedVoluntary: Firm initiated
Class II10/12/2021

Lupin Pharmaceuticals Inc.

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

TerminatedVoluntary: Firm initiated
Class II01/18/2019

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.

CompletedVoluntary: Firm initiated
Class II01/18/2019

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.

CompletedVoluntary: Firm initiated
Class III05/30/2016

Prinston Pharmaceutical Inc

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.

TerminatedVoluntary: Firm initiated
Class III10/20/2015

Teva Pharmaceutical Industries

Labeling: Incorrect or Missing Lot AND/OR Exp Date.

TerminatedVoluntary: Firm initiated
Class II10/12/2021

Lupin Pharmaceuticals Inc.

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

dizziness67 reports
fatigue60 reports
hyponatraemia60 reports
nausea51 reports
malaise47 reports
vomiting45 reports
drug ineffective44 reports
dyspnoea44 reports
fall43 reports
asthenia41 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of irbesartan and hydrochlorothiazide as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy. Data from Studies V and VI [see Clinical Studies ( 14.2 )] provide estimates of the probability of reaching a blood pressure goal with irbesa…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION General Considerations • Maximum effects within 2 to 4 weeks after dose change. ( 2.1 ) • Renal impairment: Not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min). ( 2.1 , 5.8 ) Hypertension • Initiate with 150/12.5 mg. Titrate to 300/12.5 mg then 300/25 mg if needed. ( 2.2 ) • Replacement therapy: May be substituted for titrated components. ( 2.3 ) 2.1 General Considerations The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter [see Adverse Reactions ( 6 )]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose. Irbesartan and hydrochlorothiazide may be administered with or without food. Irbesartan and hydrochlorothiazide may be administered with other antihypertensive agents. Renal Impairment The usual regimens of therapy with irbesartan and hydrochlorothiazide may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal …

Contraindications

4 CONTRAINDICATIONS • Irbesartan and hydrochlorothiazide is 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 coadminister aliskiren with irbesartan and hydrochlorothiazide in patients with diabetes [see Drug Interactions ( 7 )]. • Hypersensitivity to any component of this product. ( 4 ) • Anuria. ( 4 ) • Hypersensitivity to sulfonamide-derived drugs. ( 4 ) • Do not coadminister aliskiren with irbesartan and hydrochlorothiazide in patients with diabetes. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • NSAIDs and selective COX-2 inhibitors: Can reduce diuretic, natriuretic of diuretic, may lead to increased risk of renal impairment and reduced antihypertensive effect. Monitor renal function periodically. ( 7 ) • Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. ( 7 ) • Antidiabetic drugs: Dosage adjustment of antidiabetic may be required. ( 7 ) • Cholestyramine and colestipol: Reduced absorption of thiazides. ( 7 ) • Lithium: Increases in serum lithium concentrations and lithium toxicity. ( 7 ) • Carbamazepine: Increased risk of hyponatremia. ( 7 ) 7.1 Nonsteroidal Anti-inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) Irbesartan In patients who are elderly, volume depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including irbesartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Therefore, monitor renal function and blood pressure periodica…

Adverse Reactions

6 ADVERSE REACTIONS • Most common adverse events (≥5% on irbesartan and hydrochlorothiazide and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 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. 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. Irbesartan and Hydrochlorothiazide Irbesartan and hydrochlorothiazide tablets have been evaluated for safety in 1694 patients treated for essential hypertension in 6 clinical trials. In Studies I through IV with irbesartan and hydrochlorothiazide, no adverse events peculiar to this combination drug product have been observed. Adverse events have been limited to those that were reported pr…

Frequently Asked Questions

What is Irbesartan and Hydrochlorothiazide used for?

Irbesartan and Hydrochlorothiazide contains Irbesartan and Hydrochlorothiazide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Irbesartan and Hydrochlorothiazide a controlled substance?

Irbesartan and Hydrochlorothiazide is not classified as a controlled substance by the DEA.

What is the generic name for Irbesartan and Hydrochlorothiazide?

The generic name for Irbesartan and Hydrochlorothiazide is Irbesartan and Hydrochlorothiazide. There are 1 other brand versions of Irbesartan and Hydrochlorothiazide.

What is the NDC code for Irbesartan and Hydrochlorothiazide 12.5 mg/1?

The NDC (National Drug Code) for Irbesartan and Hydrochlorothiazide 12.5 mg/1 is 29300-215, listed by Unichem Pharmaceuticals (USA), Inc..

Product NDC

29300-215

Package NDC

29300-215-10

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

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