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IRBESARTAN AND HYDROCHLOROTHIAZIDE is a brand name for Hydrochlorothiazide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see sections 5.1).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Irbesartan and Hydrochlorothiazide Film-coated tablets can be taken once daily, with or without food. e. irbesartan and hydrochlorothiazide) may be recommended. 5mg Film-coated tablets. Doses higher than 300mg irbesartan / 25mg hydrochlorothiazide once daily are not recommended.
1). Special Populations Renal impairment: due to the hydrochlorothiazide component, Irbesartan and Hydrochlorothiazide Film-coated tablets are not recommended for patients with severe renal dysfunction (creatinine clearance <30 ml/min).
Loop diuretics are preferred to thiazides in this population. 4).
Hepatic impairment:
Irbesartan and Hydrochlorothiazide Film-coated tablets are not indicated in patients with severe hepatic impairment. Thiazides should be used with caution in patients with impaired hepatic function. 3). Older people: no dosage adjustment of Irbesartan and Hydrochlorothiazide Film- coated tablets is necessary in older people.
Paediatric population:
Irbesartan and Hydrochlorothiazide Film-coated tablets are not recommended for use in children and adolescents because the safety and efficacy have not been established. No data are available. Method of Administration For oral use.
5% of the patients experienced adverse reactions. 4%). 1%) were also commonly observed in the trials. Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials. The frequency of adverse reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4) Uncommon: swelling extremityMusculoskeletal and connective tissue disorders: Not known: arthralgia, myalgia Metabolism and nutrition disorders: Not known: hyperkalaemia Vascular disorders: Uncommon: flushing General disorders and administration site conditions: Common: fatigue Immune system disorders: Not known: cases of hypersensitivity reactions such as angioedema, rash, urticaria Uncommon: jaundiceHepatobiliary disorders: Not known: hepatitis, abnormal liver function Reproductive system and breast disorders Uncommon: sexual dysfunction, libido changes Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Irbesartan and Hydrochlorothiazide.
Tables 2 and 3 below detail the adverse reactions reported with the individual components of Irbesartan and Hydrochlorothiazide. 4) Gastrointestinal disorders: Not known: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite Renal and urinary disorders: Not known: interstitial nephritis, renal dysfunction Skin and subcutaneous tissue disorders: Not known: anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria Musculoskeletal and connective tissue disorders: Not known: weakness, muscle spasm Vascular disorders: Not known: postural hypotension General disorders and administration site conditions: Not known: fever Hepatobiliary disorders: Not known: jaundice (intrahepatic cholestatic jaundice) Psychiatric disorders: Not known: depression, sleep disturbances The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
Hypotension - Volume-depleted patients:
Irbesartan and Hydrochlorothiazide Film- coated tablets have been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension. Symptomatic hypotension may be expected to occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Such conditions should be corrected before initiating therapy with Irbesartan and Hydrochlorothiazide Film-coated tablets. Renal artery stenosis - Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists.
While this is not documented with Irbesartan and Hydrochlorothiazide Film-coated tablets, a similar effect should be anticipated. Renal impairment and kidney transplantation: when Irbesartan and Hydrochlorothiazide Film-coated tablets are used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
There is no experience regarding the administration of Irbesartan and Hydrochlorothiazide Film-coated tablets in patients with a recent kidney transplantation. 3). Thiazide diuretic-associated azotemia may occur in patients with impaired renal function.
No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥30 ml/min. However, in patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min but <60 ml/min) this fixed dose combination should be administered with caution.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS):
1. • Severe renal impairment (creatinine clearance ≤ 30 ml/min). • Anuria. • History of angioneurotic oedema associated with previous ACE-inhibitor therapy. • Hereditary or idiopathic angioedema. • Hypersensitivity to sulfonamide-derived drugs.
6). • Severe hepatic impairment. 1).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). 1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy. Hepatic impairment: thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
There is no clinical experience with Irbesartan and Hydrochlorothiazide Film-coated tablets in patients with hepatic impairment. Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin- angiotensin system. Therefore, the use of Irbesartan and Hydrochlorothiazide Film- coated tablets is not recommended.
8). These patients presented with abdominal pain, nausea, vomiting and diarrhoea. Symptoms resolved after discontinuation of angiotensin II receptor antagonists. If intestinal angioedema is diagnosed, irbesartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.
Non-melanoma skin cancer:
An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC. Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions.
Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies.
8). Metabolic and endocrine effects: thiazide therapy may impair glucose tolerance. Latent diabetes mellitus may become manifest during thiazide therapy. Irbesartan may induce hypoglycaemia, particularly in diabetic patients. 5). 5mg dose contained in Irbesartan and Hydrochlorothiazide Film-coated tablets, minimal or no effects were reported.
Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy. Electrolyte imbalance: as for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
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