CO-DIOVAN

What it is

CO-DIOVAN is a film-coated tablet combining valsartan and hydrochlorothiazide in five strengths: 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. Valsartan is an orally active, potent and specific angiotensin II receptor antagonist that acts selectively on the AT1 receptor subtype, which is responsible for the known actions of angiotensin II. Hydrochlorothiazide is structurally related to the thiazide group of diuretics.

Approved indications

— Treatment of hypertension.

Dosing overview

The recommended dose of CO-DIOVAN is one tablet per day. When clinically appropriate, CO-DIOVAN 80/12.5, 160/12.5 or 320/12.5 may be used. CO-DIOVAN 160/12.5 mg may be administered in patients whose blood pressure is not adequately controlled after 4 weeks of treatment by valsartan 160 monotherapy. Treatment with CO-DIOVAN 160/25 mg is limited to those patients who do not show adequate blood pressure reduction with CO-DIOVAN 160/12.5 mg after at least 4 weeks of treatment. CO-DIOVAN 320/12.5 mg may be administered in patients whose blood pressure is not adequately controlled after 4 weeks of treatment by valsartan 320 monotherapy. Treatment with CO-DIOVAN 320/25 mg is limited to those patients with more severe hypertension who do not show adequate blood pressure reduction with CO-DIOVAN 320/12.5 mg after at least 4 weeks of treatment.

Key safety warnings

Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other drugs that may increase potassium levels should be used with caution. Thiazide diuretics can precipitate new onset hypokalaemia or exacerbate pre-existing hypokalaemia. Potassium and magnesium serum concentrations should be checked periodically. All patients receiving thiazide diuretics should be monitored for imbalances in electrolytes, particularly potassium. Regular monitoring of serum sodium concentrations is recommended. Treatment with thiazide diuretics, including hydrochlorothiazide, has been associated with hyponatraemia and hypochloraemic alkalosis. Hyponatraemia, accompanied by neurological symptoms (nausea, progressive disorientation, apathy) has been observed in isolated cases. Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx and/or tongue has been reported in patients treated with valsartan. CO-DIOVAN should be immediately discontinued in patients who develop angioedema, and should not be re-administered. Hydrochlorothiazide, a sulfonamide, has been associated with an idiosyncratic reaction resulting in choroidal effusion with visual field defect, acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to week of a drug initiation. Untreated acute-angle closure glaucoma can lead to permanent vision loss. An increased risk of non-melanoma skin cancer [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry. The risk for non-melanoma skin cancer appears to increase with long-term use. Patients taking hydrochlorothiazide should be informed of the risk of non-melanoma skin cancer and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome (ARDS) have been reported after taking hydrochlorothiazide. Pulmonary oedema typically develops within minutes to hours after hydrochlorothiazide intake. At the onset, symptoms include dyspnoea, fever, pulmonary deterioration and hypotension. If diagnosis of ARDS is suspected, CO-DIOVAN should be withdrawn and appropriate treatment given.

Contraindications

Hypersensitivity to valsartan, hydrochlorothiazide, other sulfonamide-derived medicinal products or to any of the excipients of CO-DIOVAN; pregnancy; severe hepatic impairment; biliary cirrhosis and cholestasis; anuria; severe renal impairment (creatinine clearance < 30 mL/min); refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia; and concomitant use with aliskiren in patients with Type 2 diabetes mellitus.

PBS listing

Information on PBS listing is not contained in the provided source documents.

Regulatory history

CO-DIOVAN 80/12.5, 160/12.5 and 160/25 were first registered on the ARTG on 31 May 2005, whilst CO-DIOVAN 320/12.5 and 320/25 were first registered on 22 May 2008.