INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo LORANO™ 10 tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

LORANO™ 10 tablets

COMPOSITION:
Each LORANO 10 tablet contains 10 mg
loratadine.

PHARMACOLOGICAL CLASSIFICATION:
A.5.7.1 Antihistaminics.

PHARMACOLOGICAL ACTION:
Loratadine is a long-acting, tricyclic antihistamine with selective peripheral H
1 - receptor antagonistic activity. Loratadine does not readily cross the blood-brain barrier.
Maximal serum levels were achieved within 1,5 hours. Clinical effect was achieved within 2 hours. Excretion occurred equally via renal and faecal routes.

INDICATIONS:
Loratadine tablets are indicated for the relief of the symptoms associated with seasonal allergic rhinitis and chronic urticaria.

CONTRA-INDICATIONS:
Loratadine tablets are contra-indicated in patients who have shown hypersensitivity or idiosyncrasy to its components.
Safety of loratadine tablets in the elderly has not been established. The safe use of loratadine tablets during pregnancy or lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Adults
: One LORANO tablet once daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Most commonly reported side-effects include fatigue, headache, somnolence, dry mouth, gastro-intestinal disorders such as nausea, gastritis and also allergic symptoms like rash.
Alopecia, anaphylaxis and abnormal hepatic function have been reported rarely.
Precautions
Loratadine tablets lack significant sedative effects. Patients should, however be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants.
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine; an initial dose of 5 mg once daily, or 10 mg every 2nd day is recommended.

MEDICINE / LABORATORY TEST INTERACTIONS:
Loratadine tablets should be discontinued approximately 48 hours prior to skin testing procedures since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
Loratadine is metabolised by cytochrome P450 isoenzymes CYP3A4 and CYP2D6. Concomitant administration of other drugs that inhibit or are metabolised by these hepatic enzymes may result in changes in the plasma concentrations of either drug and, possibly may have adverse effects.
Cimetidine, erythromycin, ketoconazole, quinidine, fluconazole, and fluoxetine are all known to inhibit one or other of these enzymes.
Erythromycin, ketoconazole and cimetidine are all known to inhibit the metabolism of loratadine.
Similarly clarithromycin inhibits the metabolism of loratadine and its active metabolite descarboethoxyloratadine.

KNOWN SYMPTOMS OF OVER-DOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to "Side-effects and special precautions".
Over-dosage Information:
Somnolence, tachycardia and headache have been reported with overdoses. In the event of over-dosage, treatment should be started immediately.
Treatment:
Treatment is symptomatic and supportive. Loratadine is not cleared by haemodialysis to any appreciable extent.

IDENTIFICATION:
The LORANO 10 mg tablets are white, oval, notch and code LT/10 on one side.
Length: 7.5 - 7.9 mm
Width: 4.9 - 5.3 mm

PRESENTATION:
The tablets are packed into white, opaque PVC/aluminium blister strips containing 10 tablets each.
1 (10) blister strip packed into a carton i.e. 10 tablets per carton or
3 (10) blister strip packed into a carton i.e. 30 tablets per carton or
25 (10) blister strips packed into a carton i.e. 250 tablets per carton.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from excessive moisture.
Keep out of reach of children.

REGISTRATION NUMBER:
35/5.7.1/0354

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Hexal Pharma (SA) (Pty) Ltd
46 Mahogany Road
Mahogany Ridge
Pinetown
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11/2002

        LORAP

Updated on this site: October 2005
Source: Community Pharmacy

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