Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2022 Publisher: Novartis Pharmaceuticals Australia Pty Limited, ABN 18 004 244 160, 54 Waterloo Road, Macquarie Park NSW 2113
Co-Diovan is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.
The recommended dose of Co-Diovan is one tablet per day. When clinically appropriate either Co-Diovan 80/12.5,160/12.5 or 320/12.5 may be used.
Co-Diovan160/12.5 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.
Co-Diovan should be administered consistently with or without food (see Section 5.2 Pharmacokinetic properties).
Renal or Hepatic Impairment: No dosage adjustment is required for patients with mild to moderate renal impairment (creatinine clearance >30 mL/min). In patients with mild to moderate hepatic impairment without cholestasis the daily dose of valsartan should not exceed 80 mg (see Section 4.4 Special warnings and precautions for use).
Patients with severe renal or hepatic impairment, biliary cirrhosis or cholestasis must not take Co-Diovan (see Section 4.3 Contraindications).
Overdose with valsartan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock. In addition, the following signs and symptoms may occur due to an overdose of the hydrochlorothiazide component: dizziness, nausea, somnolence, hypovolaemia, hypotension and electrolyte disturbances associated with cardiac arrhythmias and muscle spasms.
If the ingestion is recent, a sufficient amount of activated charcoal should be administered. Otherwise, the usual treatment would be intravenous infusion of normal saline solution.
Valsartan cannot be eliminated by means of haemodialysis because it is strongly bound to plasma proteins. The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
Keep in the original package. Protect from moisture. Store below 30°C.
Co-Diovan 80/12.5: PA/Al/PVC/Al blister packs of 7, 14, 28, 30 and 56.
Co-Diovan 160/12.5: PA/Al/PVC/Al blister packs of 7, 14, 28, 30 and 56.
Co-Diovan 160/25: PA/Al/PVC/Al blister packs of 7, 14, 28, 30 and 56.
Co-Diovan 320/12.5: PA/Al/PVC/Al blister packs of 7, 14, 28, 30 and 56.
Co-Diovan 320/25: PA/Al/PVC/Al blister packs of 7, 14, 28, 30 and 56.
Not all strengths and pack sizes may be marketed.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
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