Generic Name: Avalide
What is Avalide?
However, in clinical studies the consequences of concomitant irbesartan on the pharmacodynamics of warfarin were negligible. Concomitant nifedipine or hydrochlorothiazide had no effect on irbesartan pharmacokinetics. Based on in vitro data, no interaction would be expected with drugs whose metabolism is dependent upon cytochrome P450 isoenzymes 1A1, 1A2, 2A6, 2B6, 2D6, 2E1, or 3A4.
In separate studies of patients receiving maintenance doses of warfarin, hydrochlorothiazide, or digoxin, irbesartan administration for 7 days had no effect on the pharmacodynamics of warfarin prothrombin time or the pharmacokinetics of digoxin. The pharmacokinetics of irbesartan were not affected by coadministration of nifedipine or hydrochlorothiazide. Surviving females receiving this dose about 1. Irbesartan was found to cross the placental barrier in rats and rabbits.
The antihypertensive effects of irbesartan were examined in 7 major placebo-controlled, 8- to 12-week trials in patients with baseline diastolic blood pressures of 95 to 110 mmHg.
Doses of 1 to 900 mg were included in these trials in order to fully explore the dose-range of irbesartan. Two of the 7 placebo-controlled trials identified above and 2 additional placebo-controlled studies examined the antihypertensive effects of irbesartan and hydrochlorothiazide in combination.
The 7 studies of irbesartan monotherapy included a total of 1915 patients randomized to irbesartan 1 to 900 mg and 611 patients randomized to placebo. No further increase in effect was seen at dosages greater than 300 mg.
Pediatric Use Neonates With A history Of In Utero Exposure To AVALIDE: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion.
Safety and effectiveness in pediatric patients have not been established. Geriatric Use Of 1694 patients receiving AVALIDE in controlled clinical studies of hypertension, 264 15. Hydrochlorothiazide 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.
Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
Hydrochlorothiazide Hydrochlorothiazide is a thiazide diuretic. Pharmacodynamics Irbesartan In healthy subjects, single oral irbesartan doses of up to 300 mg produced dose-dependent inhibition of the pressor effect of angiotensin II infusions. Hydrochlorothiazide After oral administration of hydrochlorothiazide, diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours. Drug Interactions Hydrochlorothiazide Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.
Pharmacokinetics Irbesartan Irbesartan is an orally active agent that does not require biotransformation into an active form. Irbesartan exhibits linear pharmacokinetics over the therapeutic dose range. Hydrochlorothiazide When plasma levels have been followed for at least 24 hours, the plasma half-life has been observed to vary between 5.
Metabolism And Elimination Irbesartan Irbesartan is metabolized via glucuronide conjugation and oxidation. Hydrochlorothiazide Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney.
How should I take Avalide?
Clinical studies of AVALIDE irbesartan-hydrochlorothiazide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. AVALIDE has been evaluated for safety in 898 patients treated for essential hypertension. In clinical trials with AVALIDE, no adverse experiences peculiar to this combination drug product have been observed. The overall incidence of adverse experiences reported with the combination was comparable to placebo.
What should I avoid while taking Avalide?
Closely monitor blood pressure, renal function, and electrolytes in patients on AVALIDE and other agents that affect the RAS. Coadministration of AVALIDE with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe. Monitor serum potassium in such patients. Dosage adjustment of the antidiabetic drug may be required when coadministered with hydrochlorothiazide. Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Avalide side effects
What questions should I ask my doctor about. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. Avalide is a drug marketed by Sanofi Aventis Us and is included in one NDA. The drug profiles in this unique consumer handbook are based on the Physicians' Desk Reference R -- the trusted guide to safe, effective drug therapy that healthcare professionals have employed for more than sixty years.
The simple, A-to-Z listing of brand-name medications -- with convenient generic cross-references -- in The PDR R Pocket Guide to Prescription Drugs TM provides all the most important information about the benefits, risks, and side effects associated with each method of treatment.
Common Avalide ide effects may include:
Therefore, when AVALIDE irbesartan-hydrochlorothiazide Tablets and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Hypersensitivity Reaction Hydrochlorothiazide Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Avalide can be taken with or without food.
It is important to take this medication regularly and to follow your doctor's instructions regarding monitoring blood pressure to ensure that you receive the maximum benefit from the medication.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. This product may contain inactive ingredients, which can cause allergic reactions or other problems.
Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: gout, kidney disease, liver disease, lupus, severe loss of body water and minerals dehydration.
Where can I get more information?
Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.
The physician should inform the patient about potential risks to the fetus based on the time of gestational exposure to AVALIDE first trimester only or later.