MIMS August prescribing update

NEW PRODUCTS

• Zoledronic acid (Aclasta) is a bisphosphonate used in the treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures, and patients older than 50 years with a history of at least one low trauma hip fracture, to reduce the incidence of further fractures.

It is contraindicated in patients with hypersensitivity to any bisphosphonate; hypocalcaemia; renal impairment (creatinine clearance <35 mL/min); current or recent uveitis, or a history of bisphosphonate-associated uveitis. It is also contraindicated in pregnancy and lactation.

The recommended dose is a single intravenous infusion of 5 mg administered once a year. Supplemental calcium and vitamin D intake is recommended. 

Aclasta is available on a private prescription as 5 mg/100 ml infusion.

• Valsartan (Diovan) is an angiotensin II receptor antagonist indicated for the treatment of hypertension or heart failure (NYHA class II-IV) in patients receiving usual therapy (e.g. diuretics, digitalis) who are intolerant to ACE inhibitors, and to improve survival following myocardial infarction in clinically stable patients with clinical or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction.

Valsartan is contraindicated in pregnancy; severe hepatic impairment; biliary cirrhosis and cholestasis.

Recommended starting dose is 80 mg once daily (hypertension) or 40 mg twice daily (heart failure). In postmyocardial infarction, treatment may be initiated as early as 12 hours after a myocardial infarction. After an initial dose of 20 mg twice daily, valsartan therapy should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks.

Diovan is available on private prescription as 40, 80, 160 and 320 mg tablets (packs of 28).

• Co-Diovan (valsartan + hydrochlorothiazide) is indicated for the treatment of hypertension.

It is contraindicated in patients with hypersensitivity to sulfonamide derivatives; pregnancy; severe renal (creatinine clearance <30 mL/min) and hepatic impairment; biliary cirrhosis and cholestasis; anuria; refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.

Initial dose is one tablet of 80 mg/12.5 mg daily. It is available on private prescription as 80/12.5 mg, 160/12.5 mg and 160/25 mg tablets in packs of 28.

• Exforge (valsartan + amlodipine) is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

It is contraindicated in patients with hypersensitivity to dihydropyridine derivatives; severe hepatic impairment; biliary cirrhosis and cholestasis; severe renal impairment (GFR <30 ml/min/1.73 m²) and patients undergoing dialysis. It is also contraindicated during pregnancy.

A patient whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy may be switched to combination therapy with Exforge. The recommended dose is one tablet per day.

Exforge is available on a private prescription as 5/80 mg, 5/160 mg or 10/160 mg tablets (packs of 28).

SAFETY-RELATED CHANGES

• In the event of intolerable headaches during initial treatment with Asasantin SR (aspirin + dipyridamole), switch to one capsule at bedtime and low-dose aspirin (for example, 75-150 mg) in the morning.

Because there are no long-term, clinical outcome data with this regimen and headaches become less of a problem as treatment continues, patients should return to the usual regimen (one capsule twice daily) as soon as possible, usually within one week.

• The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series of Infanrix Penta to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.

As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

This list is a summary of only some of the changes that have occurred over the last month. Before prescribing always refer to the full Product Information.