PHARMACOLOGICAL CLASSIFICATION: Antihistamines & Antiallergics

CONTENTS: Acrivastine.

PRESENTATION: Cap 8 mg x 24's, 84's, 500's.

ACTIONS: Acrivastine provides symptomatic relief in conditions believed to depend wholly or partly upon the triggered release of histamine. It is a potent competitive histamine Hi-receptor antagonist which lacks significant anticholinergic effects, and has a low potential to penetrate the central nervous system.

INDICATIONS: Semprex is an antihistamine indicated for the symptomatic relief of allergic rhinitis, including hay fever & histamine-mediated dermatoses eg chronic idiopathic urticaria, symptomatic dermographism, cholinergic urticaria, idiopathic acquired cold urticaria and the itching of atopic eczema.

DOSAGE & ADMINISTRATION:

Adults & children over 12 years: 1 cap 3 times daily.

Children under 12 years: There is as yet no information on the use of Semprex in children.

Elderly: Although clinical studies have shown that no special precautions are required when using Semprex in elderly individuals, it may be advisable to monitor renal function.

CONTRAINDICATIONS: Semprex is contraindicated in patients with known hypersensitivity to acrivastine or triprolidine. The main route of excretion is via the renal system, thus until specific studies have been carried out, Semprex should not be given to patients with significant renal impairment (creatinine clearance < 50 mL/min or serum creatinine 150 umol/L).

PRECAUTIONS: Most patients do not experience drowsiness with Semprex. Nevertheless, as there is individual variation in response to all medication, it is sensible to caution all patients about engaging in activities requiring mental alertness, eg driving a car or operating machinery, until patients are familiar with their own response to the drug. It is usual to advise patients not to undertake tasks requiring mental alertness whilst under the influence of alcohol or other central nervous system (CNS) depressants. Concomitant administration of acrivastine may, in some individuals, produce additional impairment.

Use in pregnancy & lactation: No information is available on the effects of administration if Semprex is used during human pregnancy. Acrivastine, like most medicines, should not be used during pregnancy unless the potential benefits outweigh any possible risk.

No information is available on levels of acrivastine which may appear in human milk following administration of Semprex.

SIDE EFFECTS: Reports of drowsiness attributable to SEMPREX are extremely rare. In clinical trials, the sedative effect of SEMPREX was no greater than that of placebo. For the great majority of patients, treatment with SEMPREX is not associated with clinically significant anticholinergic or sedative side effects.

Launching Date: September 1991.