IRBESARTAN AND HYDROCHLOROTHIAZIDE
-
irbesartan and
hydrochlorothiazide tablet, film coated
Macleods Pharmaceuticals Limited
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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)* |
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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 |
|
|
|
|
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 |
|
|
|
|
Dizziness |
8 |
4 |
6 |
5 |
Dizziness Orthostatic |
1 |
0 |
1 |
1 |
Renal/Genitourinary |
|
|
|
|
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
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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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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA202414 | 09/27/2012 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE
irbesartan and hydrochlorothiazide tablet, film coated |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA202414 | 09/27/2012 |
Labeler - Macleods Pharmaceuticals Limited (862128535) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Macleods Pharmaceuticals Limited | 918608365 | ANALYSIS, ANALYSIS, MANUFACTURE, MANUFACTURE, LABEL, LABEL, PACK, PACK |
Revised: 09/2012 Macleods Pharmaceuticals Limited