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Diurex 25

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Indications:

Used for the treatment of essential hypertension in patients for whom combination therapy is appropriate. Combination drugs like irbesartan and hydrochlorothiazide are usually only prescribed when treatment with a single medication is not effective at lowering blood pressure sufficiently.

Contraindications:

Contraindicated in patients who are hypersensitive to any component of this product or to other sulfonamide-derived drugs. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria. EPROSARIC is also contraindicated in patients with severe renal impairment, and in women who are more than 12 weeks pregnant.

Adverse reactions:

The most common side effects may include: Dizziness, fatigue, influenza, muscle and bone pain, nausea, swelling due to water retention, and vomiting. Less common side effects may include: Abdominal pain, abnormal urination, allergy, chest pain, cough, diarrhea, dizziness when standing up, headache, indigestion and heartburn, jaundice, muscle cramps, rapid heartbeat, rash, runny nose, sore throat, swelling in the mouth or face, upper respiratory infection, and urinary tract infection.

Interactions:

Concomitant use of alcohol, barbiturates, or narcotics with this drug or Hydrochlorothiazide may increase the effects of this drug. Diuretic agents and other drugs that eliminate sodium reduce the renal clearance of lithium and increase risk of lithium toxicity. Dosage adjustment of the antidiabetic drug (oral agents and insulin) may be required in the presence of diuretics. Concomitant use of other antihypertensive drugs may cause diuretic additive effect or drug potentiation. Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins, such as cholestyramine and colestipol resins. this drug should be taken at least 1 hour before or 4 hours after these medications. Intensified electrolyte depletion, particularly hypokalemia, may occur when corticosteroids are given concomitantly with diuretics. In some patients, the administration of a nonsteroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of thiazide diuretics. Since irbesartan decreases the production of aldosterone, potassium-sparing diuretics or potassium supplements should be given only for documented hypokalemia and with frequent monitoring of serum potassium. Potassium-containing salt substitutes should also be used with caution.

Warnings:

Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal injury and death when administered to pregnant women. When pregnancy is detected, irbesartan should be discontinued as soon as possible. Oligohydramnios has been reported, presumably resulting from decreased fetal renal function. If oligohydramnios is observed, irbesartan should be discontinued unless it is considered life-saving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Infants with histories of in utero exposure to an angiotensin II receptor antagonist should be closely observed for hypotension, oliguria, and hyperkalemia. Thiazides cross the placental barrier and appear in cord blood, the routine use of diuretics in otherwise healthy pregnant women is not recommended and exposes mother and fetus to unnecessary hazard, including fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults. Occasionally, symptomatic hypotension has occurred after administration of irbesartan, in some cases after the dose. It is more likely to occur in patients who are volume depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. In these patients, because of the potential fall in blood pressure, therapy should be started under close medical supervision. Similar considerations apply to patients with ischemic heart or cerebrovascular disease, in whom an excessive fall in blood pressure could result in myocardial infarction or cerebrovascular accident. Sensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma. Use of irbesartan should include appropriate assessment of renal function. Because of the hydrochlorothiazide component, this drug is not recommended in patients with severe renal impairment (creatinine clearance ≤ 30mL/min). Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations in fluid and electrolyte balance may precipitate hepatic coma. Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalemia, hyponatremia and hypochloremic alkalosis). Calcium excretion is decreased by thiazides which may cause intermittent and slight elevation of serum calcium. Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesemia. Hyperuricemia may occur, and an acute attack of gout may precipitated in certain patients receiving thiazide therapy. When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension. This drug should not be used in nursing women. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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