IRBESARTAN AND HYDROCHLOROTHIAZIDE - irbesartan and hydrochlorothiazide tablet, film coated
Macleods Pharmaceuticals Limited
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets USP safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets USP.
Irbesartan and Hydrochlorothiazide Tablets USP Initial U.S. Approval: 1997 WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue Irbesartan and hydrochlorothiazide tablets as soon as possible (5.1). • Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. (5.1) RECENT MAJOR CHANGESINDICATIONS AND USAGEIrbesartan and hydrochlorothiazide tablet USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: DOSAGE AND ADMINISTRATIONGeneral 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). DOSAGE FORMS AND STRENGTHSCONTRAINDICATIONSWARNINGS AND PRECAUTIONSADVERSE REACTIONSMost common adverse events (≥5% on Irbesartan and hydrochlorothiazide tablets and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch DRUG INTERACTIONSIrbesartan (7) • NSAIDS and selective COX-2 inhibitors: May lead to increased risks of renal impairment and loss of antihypertensive effect. Monitor renal function periodically. • Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. Hydrochlorothiazide (7): • Antidiabetic Drugs: Dosage adjustment of antidiabetic may be required • Cholestyramine and colestipol: Reduced absorption of thiazides • Lithium: Reduced renal clearance and high risk of lithium toxicity when used with diuretics. Should not be given with diuretics. • NSAIDs: Can reduce diuretic, natriuretic, and antihypertensive effects of diuretics and increase risk of renal impairment. • Carbamazepine: Increased risk of hyponatremia. USE IN SPECIFIC POPULATIONS• Nursing Mothers: Potential for adverse effects in infant (8.3). See 17 for PATIENT COUNSELING INFORMATION. Revised: 11/2012 |
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Figure 1a: Probability of Achieving SBP <140 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)* | Figure 1b: Probability of Achieving SBP <130 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)* |
Figure 2a: Probability of Achieving DBP <90 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)* | Figure 2b: Probability of Achieving DBP <80 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)* |
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Irbesartan/ HCTZ (n=898) (%) |
Placebo (n=236) (%) |
Irbesartan (n=400) (%) |
HCTZ (n=380) (%) |
Body as a Whole |
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Chest Pain |
2 |
1 |
2 |
2 |
Fatigue |
6 |
3 |
4 |
3 |
Influenza |
3 |
1 |
2 |
2 |
Cardiovascular |
|
|
|
|
Edema |
3 |
3 |
2 |
2 |
Tachycardia |
1 |
0 |
1 |
1 |
Gastrointestinal |
|
|
|
|
Abdominal Pain |
2 |
1 |
2 |
2 |
Dyspepsia/heartburn |
2 |
1 |
0 |
2 |
Nausea/vomiting |
3 |
0 |
2 |
2 |
Immunology |
|
|
|
|
Allergy |
1 |
0 |
1 |
1 |
Musculoskeletal |
|
|
|
|
Musculoskeletal Pain |
6 |
5 |
6 |
10 |
Nervous System |
|
|
|
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Dizziness |
8 |
4 |
6 |
5 |
Dizziness Orthostatic |
1 |
0 |
1 |
1 |
Renal/Genitourinary |
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|
|
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Abnormality Urination |
2 |
1 |
1 |
2 |
The following adverse events were also reported at a rate of 1% or greater, but were as, or more, common in the placebo group: headache, sinus abnormality, cough, URI, pharyngitis, diarrhea, rhinitis, urinary tract infection, rash, anxiety/nervousness, and muscle cramp.
Adverse events occurred at about the same rates in men and women, older and younger patients, and black and non-black patients.
Adverse events in Studies V and VI were similar to those described above in Studies I through IV.
Irbesartan
Other adverse events that have been reported with irbesartan, without regard to causality, are listed below:
Body as a Whole: fever, chills, orthostatic effects, facial edema, upper extremity edema
Cardiovascular: flushing, hypertension, cardiac murmur, myocardial infarction, angina pectoris, hypotension, syncope, arrhythmic/conduction disorder, cardiorespiratory arrest, heart failure, hypertensive crisis
Dermatologic: pruritus, dermatitis, ecchymosis, erythema face, urticaria
Endocrine/Metabolic/Electrolyte Imbalances: sexual dysfunction, libido change, gout
Gastrointestinal: diarrhea, constipation, gastroenteritis, flatulence, abdominal distention
Musculoskeletal/Connective Tissue: musculoskeletal trauma, extremity swelling, muscle cramp, arthritis, muscle ache, musculoskeletal chest pain, joint stiffness, bursitis, muscle weakness
Nervous System: anxiety/nervousness, sleep disturbance, numbness, somnolence, vertigo, emotional disturbance, depression, paresthesia, tremor, transient ischemic attack, cerebrovascular accident
Renal/Genitourinary: prostate disorder
Respiratory: cough, upper respiratory infection, epistaxis, tracheobronchitis, congestion, pulmonary congestion, dyspnea, wheezing
Special Senses: vision disturbance, hearing abnormality, ear infection, ear pain, conjunctivitis
Hydrochlorothiazide
Other adverse events that have been reported with hydrochlorothiazide, without regard to causality, are listed below:
Body as a Whole: weakness
Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation
Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia
Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions
Metabolic: hyperglycemia, glycosuria, hyperuricemia
Musculoskeletal: muscle spasm
Nervous System/Psychiatric: restlessness
Renal: renal failure, renal dysfunction, interstitial nephritis
Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis
Tablet Strength (irbesartan and hydrochlorothiazide) | Film-Coated Tablet Color/Shape | Tablet Markings | Package Size | NDC Code |
150 mg/12.5 mg | peach, oval-shaped | ML; 34 debossed on one side and plain on the reverse | Bottles of 30 Bottles of 90 Bottles of 500 Blister pack of 30s (3 x 10s unit-dose blister) Blister pack of 90s (9 x 10s unit-dose blister) |
33342-057-07 33342-057-10 33342-057-15 33342-057-06 33342-057-39 |
300 mg/12.5 mg | peach, oval-shaped | ML; 33 debossed on one side and plain on the reverse | Bottles of 30 Bottles of 90 Bottles of 500 Blister pack of 30s (3 x 10s unit-dose blister) Blister pack of 90s (9 x 10s unit-dose blister) |
33342-058-07 33342-058-10 33342-058-15 33342-058-06 33342-058-39 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE
irbesartan and hydrochlorothiazide tablet, film coated |
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IRBESARTAN AND HYDROCHLOROTHIAZIDE
irbesartan and hydrochlorothiazide tablet, film coated |
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Labeler - Macleods Pharmaceuticals Limited (862128535) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Macleods Pharmaceuticals Limited | 918608365 | ANALYSIS(33342-057, 33342-058), LABEL(33342-057, 33342-058), MANUFACTURE(33342-057, 33342-058), PACK(33342-057, 33342-058) |