Telmisartan HCTZ-WGR

What it is

Telmisartan HCTZ-WGR is a fixed-dose combination tablet containing telmisartan and hydrochlorothiazide. The registered strengths are 40/12.5 mg, 80/12.5 mg, and 80/25 mg.

Approved indications

— Treatment of hypertension.

Dosing overview

Telmisartan HCTZ-WGR is administered once daily, with or without food, in patients whose blood pressure is not adequately controlled by the individual components alone. Dosing should be individualised and dependent on the patient's condition, and the dose may be titrated after 4 weeks depending on blood pressure response.

Key safety warnings

An increased risk of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) with increasing cumulative dose of hydrochlorothiazide has been observed in epidemiological studies, with photosensitising actions of hydrochlorothiazide acting as a possible mechanism. Patients taking hydrochlorothiazide should be informed of this risk and advised to regularly check their skin for new lesions and promptly report suspicious skin lesions, with preventive measures such as limited exposure to sunlight and UV rays recommended. Severe chronic diarrhoea with substantial weight loss has been reported in patients taking the active ingredient months to years after drug initiation, with intestinal biopsies demonstrating villous atrophy; if a patient develops these symptoms, other etiologies should be excluded and discontinuation should be considered where no other etiology is identified. Angioedema, including swelling of the larynx and glottis causing airway obstruction and swelling of the face, lips, pharynx and tongue, has been reported; Telmisartan HCTZ-WGR should be immediately discontinued in patients who develop angioedema and should not be re-administered. Very rare severe cases of acute respiratory distress syndrome have been reported after taking hydrochlorothiazide, with pulmonary oedema typically developing within minutes to hours after intake with symptoms including dyspnoea, fever, pulmonary deterioration and hypotension; if acute respiratory distress syndrome is suspected, the medicine should be withdrawn and appropriate treatment given.

Contraindications

Telmisartan HCTZ-WGR is contraindicated in patients who are hypersensitive to telmisartan, sulfonamide derived drugs such as thiazides, or any other component of the medication, and in pregnancy. It is also contraindicated in patients with anuria or severe renal impairment (creatinine clearance less than 30 mL/min), severe hepatic impairment, cholestasis or biliary obstruction, patients who are breastfeeding, and patients with refractory hypokalaemia, hypercalcaemia, hyponatraemia, and symptomatic hyperuricaemia.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

Telmisartan HCTZ-WGR was first listed on the ARTG on 19 August 2016 in three strengths: 40/12.5 mg, 80/12.5 mg, and 80/25 mg.