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IRBESARTAN/HYDROCHLOROTHIAZIDE is a brand name for Irbesartan. 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 section 5.1).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Irbesartan/Hydrochlorothiazide Tablets can be taken once daily, with or without food. e. irbesartan and hydrochlorothiazide) may be recommended. 5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.
5). Special Population Renal impairment: due to the hydrochlorothiazide component, Irbesartan/Hydrochlorothiazide Tablets is 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/Hydrochlorothiazide Tablets is 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/Hydrochlorothiazide Tablets is necessary in older people.
Paediatric population:
Irbesartan/Hydrochlorothiazide Tablets is 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 Hepatobiliary disorders: Uncommon: Not known: jaundice 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/Hydrochlorothiazide Tablets.
Tables 2 and 3 below detail the adverse reactions reported with the individual components of Irbesartan/Hydrochlorothiazide Tablets. 4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides Cardiac disorders: Not known: cardiac arrhythmias Blood and lymphatic system disorders: Not known: aplastic anaemia, bone marrow depression, neutropenia/ agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia Nervous system disorders: Not known: vertigo, paraesthesia lightheadedness, restlessness Eye disorders: Not known: transient blurred vision, xanthopsia, acute myopia and secondary acute angle- closure glaucoma, choroidal effusion Respiratory, thoracic and mediastinal disorders: Not known: respiratory distress (including pneumonitis and pulmonary oedema) 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 Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known: Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma) The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
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/Hydrochlorothiazide should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.
Hypotension-Volume-depleted patients: the combination of irbesartan / hydrochlorothiazide has 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/Hydrochlorothiazide 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/Hydrochlorothiazide Tablets, a similar effect should be anticipated.
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.
5 ).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1). Reporting of suspected adverse reaction Reporting suspected adverse reaction 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.
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). Renal impairment and kidney transplantation: when Irbesartan/Hydrochlorothiazide Tablets is 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/Hydrochlorothiazide 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-aldosteron system (RAAS):
Dual blockade of the RAAS by combining Irbesartan/Hydrochlorothiazide Tablets with aliskiren is not recommended since there is an increased risk of hypotension , hyperkalaemia, and changes in renal function. 5 ). 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/Hydrochlorothiazide 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 reninangiotensin system. Therefore, the use of Irbesartan/Hydrochlorothiazide Tablets is not recommended.
Metabolic and endocrine effects: thiazide therapy may impair glucose tolerance. In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required. Latent diabetes mellitus may become manifest during thiazide therapy.
5 mg dose contained in Irbesartan/Hydrochlorothiazide 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.
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalaemia, hyponatraemia, and hypochloremic alkalosis). Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting.
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with irbesartan may reduce diuretic-induced hypokalaemia. The risk of hypokalaemia is […]