Avalide (Irbesartan and Hydrochlorothiazide) Drug Information

  • Why is this medication prescribed?

    AVALIDE® (irbesartan-hydrochlorothiazide) Tablets is indicated for the treatment of hypertension.

    AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy.

    AVALIDE may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals

  • How should this medicine be used?

    AVALIDE® (irbesartan-hydrochlorothiazide) 150/12.5 mg and 300/12.5 mg tablets are peach, biconvex, and oval with a heart debossed on one side and "2775" or "2776" on the reverse side. The 300/25 mg film-coated tablet is pink, biconvex, and oval with a heart debossed on one side and "2788" on the reverse side.

    The usual starting dose is AVALIDE 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 300/25 mg tablet once daily as needed to control blood pressure

  • Other uses for this medicine

    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

  • What special precautions should I follow?

    Before taking Irbesartan and Hydrochlorothiazide:

    • Symptomatic hypotension with intravascular volume- or sodium-depletion. Correct volume-depletion prior to administration. Not recommended as initial therapy in volume-depleted patients
    • Impaired hepatic function: Thiazides should be used with caution as minor fluid and electrolyte imbalances may precipitate hepatic coma
    • 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
    • Thiazide diuretics may cause an exacerbation or activation of systemic lupus erythematosus
  • What special dietary instructions should I follow?

    AVALIDE may be administered with or without food.

  • What should I do if I forget a dose?

    Ask your doctor for missed dosed instructions

  • What side effects can this medication cause?

    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
    • Special Senses: transient blurred vision, xanthopsia
  • What storage conditions are needed for this medicine?

    Store at 25C (77F); excursions permitted to 15C-30C (59F-86F) [see USP Controlled Room Temperature].

  • In case of emergency/overdose

    The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

  • What other information should I know?

    Keep all appointments with your doctor.

    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

  • Brand Names

    • Alvalide