INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
AP LORATADINE SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

AP LORATADINE SYRUP

COMPOSITION
Each 5 mL of AP LORATADINE SYRUP contains:
5 mg of Loratadine as active
0,1% m/v Sodium Benzoate as preservative

PHARMACOLOGICAL CLASSIFICATION
A.5.7.1 Antihistaminics

PHARMACOLOGICAL ACTION
Loratadine is a second generation histamine (H1)-receptor antagonist. Loratadine exerts its action by competing with histamine for H1-receptor sites on effector cells.
It prevents, but does not reverse responses mediated by histamine. Loratadine does not cross the blood-brain barrier to any extent.
Pharmacokinetics:
After oral administration, loratadine is well absorbed from the gastrointestinal tract and peak plasma concentrations are reached within 1,5 hours. Ingestion of food may enhance the absorption of loratadine. Loratadine undergoes extensive first pass metabolism via the cytochrome P-450 system.
The major metabolite, desloratadine, is active. Loratadine is 97% protein bound, while desloratadine is less extensively protein bound (73% to 77%). The mean elimination half-lives for loratadine and desloratadine are 8,4 and 28 hours respectively.

INDICATIONS
AP LORATADINE SYRUP is indicated for the relief of symptoms associated with seasonal allergic rhinitis and chronic urticaria.

CONTRA-INDICATIONS
Hypersensitivity to AP LORATADINE SYRUP or to any ingredients of this preparation.
Cross sensitivity to other antihistamines.
Porphyria.

WARNINGS
Safety of AP LORATADINE SYRUP in the elderly has not been established.
Safety of AP LORATADINE SYRUP in children under two years of age has not been established.
AP LORATADINE SYRUP should be used with caution in patients with:

•	Severe liver impairment, as reduced clearance of loratadine may occur. Dosage adjustment may be needed (See Dosage & 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 loratadine may be increased, however, the elimination half-life of loratadine and its active metabolite appear to be similar to those individuals with normal renal function.

AP LORATADINE SYRUP may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other nervous system depressants (e.g. sedatives and tranquillisers). Caution should be used when driving a motor vehicle or operating machinery or performing potentially dangerous tasks, where loss of concentration may lead to accidents.

INTERACTIONS
Concomitant use of AP LORATADINE SYRUP with:

•	Inhibitors of cytochrome P-450 enzyme system such as cimetidine, ketoconazole, clarithromycin and erythromycin may increase the plasma concentration of AP LORATADINE SYRUP.

PREGNANCY AND LACTATION
Safety and efficacy in pregnancy and lactation have not been established. Loratadine and its metabolites have been detected in breast milk. Small amounts of AP LORATADINE SYRUP entering breast milk may cause drowsiness or excitement in infants.

DOSAGE AND DIRECTIONS FOR USE
Shake well before use.
Children 2 to 12 years of age:
Body weight less than or equal to 30 kg: 5 mg once daily.
Body weight more than 30 kg: 10 mg once daily.
Adults and children over 12 years of age: 10 mg once daily.
Adults with severe liver function impairment: initial dose is 5 mg once daily or 10 mg on alternate days.
Use of AP LORATADINE SYRUP should be limited to 14 days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side effects:
Frequently occurring:
Nervous system disorders

•	Fatigue
•	Headache
•	Somnolence
•	Blurred vision
•	Confusion
•	Nightmares

Gastrointestinal disorders

•	Dry mouth
•	Nausea
•	Gastritis

Less-frequently occurring:
Nervous system disorders

•	Sedation
•	Nervousness

Hepatobiliary disorders

•	Abnormal hepatic function

Skin and subcutaneous tissue disorders

•	Rash
•	Alopecia

Immune system disorders

•	Allergic reactions
•	Anaphylaxis

Special precautions
AP LORATADINE SYRUP should be discontinued prior to skin tests using allergen extracts as it may inhibit the cutaneous histamine response, thus producing false-negative results.
AP LORATADINE SYRUP should be discontinued at least 48 hours before the test.
AP LORATADINE SYRUP should be used with caution when the following medical conditions exist and/or in patients using other medication metabolised by the cytochrome P-450 system:

•	Emphysema; prostatic hypertrophy; narrow angle glaucoma; cardiovascular disorder; epilepsy; and 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 AP LORATADINE SYRUP, 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 AP LORATADINE SYRUP. Saline cathartics may be of value to rapidly dilute bowel contents. AP LORATADINE SYRUP is not cleared by haemodialysis.

IDENTIFICATION
A clear, colourless to light yellow solution.

PRESENTATION
AP LORATADINE SYRUP is available in 150 mL amber glass bottles.

STORAGE INSTRUCTIONS
Store below 25°C in tightly closed containers.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
AP LORATADINE SYRUP - 38/5.7.1/0083

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT
16 March 2005

        574987/050401 68459
        UNIPRINT

New addition to this site: September 2005
Source: Pharmaceutical Industry
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