Avalide 300/12.5 film coated tablet

Avalide (Bristol-Myers Squibb Company), manufactured drug form of Irbesartan and hydrochlorothiazide, 12.5mg/tablet hydrochlorothiazide ; 300mg/tablet irbesartan film coated tablet, NDC 0087-2876

Available in:

NDC Product ID:

  • 0087-2876

Manufacturer:

Manufactured drug form

Manufactured form of:

Generic drug:

  • No

Label date:

  • Jul 1, 2011

Label link:

Label sections:

Section name Section URI Prominent warning Highlight text Section LOINC code
  • Warning: Use In Pregnancy
  • Yes
  • WARNING: USE IN PREGNANCY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue AVALIDE as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. (5.1)
  • 34066-1
  • Recent Major Changes Section
  • No
  • Warnings and Precautions, Acute Myopia and Secondary Angle-Closure Glaucoma (5.9) 5/2011
  • 43683-2
  • 1 Indications And Usage
  • No
  • AVALIDE is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: In patients not adequately controlled with monotherapy. (1) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1)
  • 34067-9
  • 2 Dosage And Administration
  • No
  • 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 Not controlled on monotherapy: 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) Initial therapy: Initiate with 150/12.5 mg once daily for 1 to 2 weeks and titrate as needed up to maximum of 300/25 mg once daily. (2.4)
  • 34068-7
  • 3 Dosage Forms And Strengths
  • No
  • 150 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3) 300 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3)
  • 43678-2
  • 4 Contraindications
  • No
  • Hypersensitivity to any component of this product (4) Anuria (4) Hypersensitivity to sulfonamide-derived drugs (4)
  • 34070-3
  • 5 Warnings And Precautions
  • No
  • Symptomatic hypotension with intravascular volume- or sodium-depletion. Correct volume-depletion prior to administration. Not recommended as initial therapy in volume-depleted patients. (2.4, 5.2) Impaired hepatic function: Thiazides should be used with caution as minor fluid and electrolyte imbalances may precipitate hepatic coma. (5.7) Impaired renal function: Use with caution. Oliguria or azotemia with acute renal failure and/or death has been reported in medications affecting the renin-angiotensin-aldosterone system. (5.8) Thiazide diuretics may cause an exacerbation or activation of systemic lupus erythematosus. (5.4) Acute myopia and secondary angle-closure glaucoma. (5.9)
  • 43685-7
  • 6 Adverse Reactions
  • No
  • Most common adverse events (≥5% on AVALIDE and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • 34084-4
  • 7 Drug Interactions
  • No
  • Irbesartan (7): NSAIDs and selective COX-2 inhibitors: May lead to increased risk of renal impairment and loss of antihypertensive effect. Monitor renal function periodically. Hydrochlorothiazide (7): Alcohol, Barbiturates, Narcotics: Potentiation of orthostatic hypotension Antidiabetic Drugs: Dosage adjustment of antidiabetic may be required Cholestyramine and colestipol: Reduced absorption of thiazides Corticosteroids, ACTH: Hypokalemia, electrolyte depletion 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. Observe patient closely.
  • 34073-7
  • 8 Use In Specific Populations
  • No
  • Nursing Mothers: Potential for adverse effects in infant. (8.3)
  • 43684-0
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Discontinued:

  • No

Marketing start date:

  • Feb 24, 2011

Patents:

Patent expiry date:

  • Dec 7, 2015

FDA application number:

  • NDA020758

Color:

Shape:

Size:

  • 16 mm (0.63 in )

Scoring:

  • 1

Imprint:

  • 2876
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