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    Anti-doping test hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test. Ace-inhibitors and angiotensin ii receptor blockers should not be used concomitantly in patients with diabetic nephropathy. Hypokalaemia may result in muscle spasms andor accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.

    Irbesartan and hydrochlorothiazide are orally active agents and do not require biotransformation for their activity. Adequate monitoring of serum potassium in patients at risk is recommended (see section 4. The following changes, observed in rats and macaques receiving the irbesartanhydrochlorothiazide combination at 10 mgkgday, were also seen with one of the two medicinal products alone andor were secondary to decreases in blood pressure (no significant toxicologic interactions were observed) kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasiahypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit) stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mgkgday, hydrochlorothiazide 90 mgkgday, and irbesartanhydrochlorothiazide 1010 mgkgday.

    Healthcare professionals are asked to report any suspected adverse reactions via no specific information is available on the treatment of overdose with irbesartan hydrochlorothiazide. In non-clinical safety studies, high doses of irbesartan ( 250 mgkgday in rats and 100 mgkgday in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit). Available pharmacodynamictoxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see 5.

    Epidemiological studies have shown that long term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity. Irbesartan hydrochlorothiazide 300 mg25 mg may be administered in patients insufficiently controlled by irbesartan hydrochlorothiazide 300 mg12. Tables 2 and 3 below detail the adverse reactions reported with the individual components of irbesartan hydrochlorothiazide.

    A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. Since irbesartanhidroclorotiazide milpharm contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.

    Co administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol thiazide diuretics may increase serum calcium levels due to decreased excretion. These lesions were not observed in macaques decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan. When assessed by ambulatory blood pressure monitoring, the combination 150 mg irbesartan and 12. Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers. The frequency of adverse reactions listed below is defined using the following convention very common ( 110) common ( 1100 to 110) uncommon ( 11,000 to 1100) rare ( 110,000 to 11,000) very rare ( 110,000)not known (cannot be estimated from the available data).


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    Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide. ..... of irbesartan/hydrochlorothiazide (range: 37.5 mg/6.25 mg to 300 mg/25 mg) ... Within each frequency grouping, undesirable effects are presented in order ..... Limited accumulation of irbesartan (< 20%) is observed in plasma upon ...

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    Buy now Coreg 6.25mg 20 pills in Milton Keynes Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses in patients without risk of electrolyte imbalance (see sections 4. These findings were also observed with lower doses of this other angiotensin-ii antagonist when given in combination with hydrochlorothiazide. Hypokalaemia may result in muscle spasms andor accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products. The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide. The most likely manifestations of irbesartan overdose are expected to be hypotension and tachycardia bradycardia might also occur. Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloremia, hyponatraemia) and dehydration resulting from excessive diuresis. Carvedilol 6. Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity (see section 5.
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    In long-term follow-up studies, the effect of irbesartanhydrochlorothiazide was maintained for over one year. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischemic cardiopathy or ischemic cardiovascular disease could result in a myocardial infarction or stroke. After either oral or intravenous administration of 14c irbesartan, about 20 of the radioactivity is recovered in the urine, and the remainder in the faeces. In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome p450 enzyme cyp2c9 isoenzyme cyp3a4 has negligible effect. In patients not adequately controlled on 25 mg hydrochlorothiazide alone, the addition of irbesartan gave an added placebo-subtracted systolicdiastolic mean reduction of 11.

    Hydrochlorothiazide crosses the placental but not the blood-brain barrier, and is excreted in breast milk. No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is 30 mlmin (see sections 4. The concomitant use of irbesartan hydrochlorothiazide with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (gfr 60 mlmin1. Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease. Epidemiological studies have shown that long term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.

    Irbesartan does not inhibit ace (kininase-ii), an enzyme which generates angiotensin-ii and also degrades bradykinin into inactive metabolites. The effects of cyp2c9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. Because no information is available regarding the use of irbesartan hydrochlorothiazide during breast-feeding, irbesartan hydrochlorothiazide is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used. Irbesartan hydrochlorothiazide is administered with medicinal products affected by serum potassium disturbances (e. In the months before this episode she had experienced recurrent attacks of dizziness and palpitations and occasional episodes of anginal chest pain. Healthcare professionals are asked to report any suspected adverse reactions via no specific information is available on the treatment of overdose with irbesartan hydrochlorothiazide. Conversely, based on the experience with the use of other medicinal products that blunt the renin sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e. In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required. Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials.

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