TELTARTAN Tablet Ref.[51084] Active ingredients: Telmisartan

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2023  Publisher: Arrotex Pharmaceuticals Pty Ltd, 15 – 17 Chapel Street, Cremorne, Victoria 3121

4.1. Therapeutic indications

TELTARTAN is indicated for:

  • Treatment of hypertension in adults
  • Prevention of cardiovascular morbidity and mortality in adults 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage (see Section 5.1 PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS).

4.2. Posology and method of administration

Telmisartanmay be administered with or without food.

Treatment of hypertension

Adults

The recommended dose is 40 mg once daily. In cases where the target blood pressure is not achieved, telmisartan dose can be increased to 80 mg once daily. When considering raising the dose, it must be borne in mind that, while reduction in blood pressure is achieved after the first dose, the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment. Telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide or calcium-channel blockers such as amlodipine, which have been shown to have an additive blood pressure lowering effect with telmisartan.

Prevention of cardiovascularmorbidity and mortality

The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan are effective in preventing cardiovascularmorbidity and mortality.

When initiating telmisartan therapy for the prevention of cardiovascular morbidity and mortality, monitoring of blood pressure is recommended, and if appropriate, adjustment of medicationsthat lower blood pressure may be necessary.

Special Populations

Elderly

No dose adjustment is necessary.

Renal impairment

No dose adjustment is required for patients with renal impairment, including those on haemodialysis. Telmisartan is not removed from blood by haemofiltration and is not dialysable.

Hepatic impairment

In patients with mild to moderate hepatic impairment, this medicine should be administered with caution. For telmisartan, the dosage should not exceed 40 mg once daily (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

4.9. Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

Limited information is available with regard to overdose in humans. The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia also occurred. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by haemofiltration or haemodialysis.

6.3. Shelf life

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.

6.4. Special precautions for storage

Store TELTARTAN tablets below 300°C. Protect from light and moisture.

Due to the hygroscopic property of TELTARTAN tablets, they should not be removed from their foil pack until required for administration.

6.5. Nature and contents of container

TELTARTAN tablets are available in blister packs containing 28 tablets.

6.6. Special precautions for disposal and other handling

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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