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Logo DAZIT TABLETS (tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

DAZIT TABLETS (tablets)

COMPOSITION:
Each film-coated tablet contains 5 mg
desloratadine.

PHARMACOLOGICAL CLASSIFICATION
A.5.7.1 Antihistaminic

PHARMACOLOGICAL ACTION
Desloratadine is the major, long acting, active metabolite of loratadine, a non-sedating second-generation H1antagonist. It selectively blocks peripheral histamine H1 receptors since it is blocked from entering the central nervous system (CNS). Except for its anti-histaminic activity, studies also indicated inhibition of events leading to allergic-inflammation.
Pharmacokinetics
Desloratadine is rapidly absorbed from the gastro-intestinal tract and reaches maximum plasma concentrations in 3 hours. There is no evidence of drug accumulation and food has no influence on the absorption of desloratadine. The percentage desloratadine bound to plasma proteins is an average of 85%. The mean elimination half-live for desloratadine is 28 hours.

INDICATIONS
DAZIT TABLETS is indicated for the relief of symptoms associated with seasonal allergic rhinitis.

CONTRA-INDICATIONS
Hypersensitivity to DAZIT TABLETS or to any ingredients of this preparation.
Cross sensitivity to other antihistamines.
Porphyria.

WARNINGS
Safety of DAZIT TABLETS in the elderly has not been established.
Safety of DAZIT TABLETS in children under two years of age has not been established.
DAZIT TABLETS should be used with caution in patients with:
Severe liver impairment, as reduced clearance of desloratadine may occur. Dosage adjustment may be needed (see DOSAGE AND DIRECTIONS FOR USE).
Renal impairment - A lower starting dose should be used. In patients with chronic renal impairment (creatinine clearance of 30 mL/minute or less), both oral bioavailability and peak plasma concentrations of desloratadine may be increased.
DAZIT TABLETS lack significant sedative effects (see PHARMACOLOGICAL ACTION).

INTERACTIONS
Concomitant used of DAZIT TABLETS with:
Inhibitors of cytochrome P-450 enzyme system such as cimetidine, ketoconazole, clarithromycin and erythromycin may increase the plasma concentration of DAZIT TABLETS.

PREGNANCY AND LACTATION
Safety and efficacy in pregnancy and lactation has not been established. Desloratadine has been detected in breast milk. Small amounts of DAZIT TABLETS entering breast milk may cause drowsiness or excitement in the infants.

DOSAGE AND DIRECTIONS FOR USE
Adults (>12 years): One tablet orally, once daily.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side Effects
Central nervous system
Frequent: Headache.
Less frequent: Fatigue, somnolence, sedation, nervousness, blurred vision, confusion and nightmares.
Gastro-intestinal
Frequent: Dry mouth, gastro-intestinal disorder such as nausea and gastritis.
Liver
Less frequent: Abnormal hepatic function.
Skin
The following was reported but the frequency is unknown: Rash, alopecia.
Other
Less frequent: Allergic reactions.
The following was reported but the frequency is unknown: Anaphylaxis.

Special Precautions
DAZIT TABLETS should be discontinued prior to skin tests allergen extracts as it may inhibit the cutaneous histamine response, thus producing false-negative results.
DAZIT TABLETS should be discontinued at least 48 hours before test.
DAZIT TABLETS should be used with caution when then following medical caution exists and/or patients using other medication metabolised by the cytochrome P-450 system:
Emphysema, prostatic hypertrophy, narrow angle glaucoma, cardiovascular disorder, epilepsy or during acute attacks of asthma.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
(See SIDE EFFECTS AND SPECIAL PRECAUTIONS)
Symptoms of overdose
Somnolence, tachycardia and headaches have been reported. In children, extrapyramidal manifestations and palpitations have been reported.
Treatment of overdose
Treatment is symptomatic and supportive. After overdose of DAZIT TABLETS, the stomach should be emptied immediately by inducing emesis or by gastric lavage. Administration of activated charcoal after emesis may be useful in preventing absorption of DAZIT TABLETS.
Saline cathartics may be of value to rapidly dilute bowel contents. DAZIT TABLETS is not cleared by haemodialysis.

IDENTIFICATION
DAZIT TABLETS are blue coloured circular shaped, biconvex, film-coated tablets debossed with “5”on one side and plain on the other side.

PRESENTATION
DAZIT TABLETS are packed in white round HDPE bottle with polypropylene cap and liner. Each bottle contains 30 tablets.

STORAGE INSTRUCTIONS
Store below 25°C in a well closed container.
Protect from moisture.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER
41/5.7.1/0448

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Pharmaplan (Pty) Ltd
106 16th Road
Midrand

DATE OF PUBLICATION OF THE PACKAGE INSERT
30 November 2007

New addition to this site: February 2008
Source: Pharmaceutical Industry

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