White, oblong uncoated tablet, shallow convex, scored on one face and “H 10” embossed on the same face.
Eeach tablet contains Loratadine 10 mg.
ACTIONS AND PHARMACOLOGY
Loratadine, a pipendine derivative related to azatadine, is a long-acting, non-sedating tricyclic antihistamine with selective peripheral H1 -receptor antagonist activity, with no significant sedative or antimuscarinic activity. Loratadine is rapidly absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are being attained in about one hour. Loratadine, which is 98%, bound to plasma protein, undergoes extensive metabolism, mainly to descarboethoxyloratadine, which has potent antihistamine activity. However, descarboethoxyloratadine is less extensively bound to plasma protein. Loratadine and descarboethoxyloratadine have half-lives of 8.4 hours and 28 hours respectively. Most of a dose is excreted equally in the urine and faeces, mainly in the form of metabolites.
For relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge (rhinorrhea) and itching, and ocular itching and burning.
Also indicated for relief of symptoms and signs of chronic urticaria and other allergic dermatological disorders.
Risk-benefit should be considered when the following medical problems exist: bladder neck obstruction, prostatic hypertrophy, urinary retention, glaucoma, or sensitivity to loratadine.
WARNING AND PRECAUTIONS
• Precaution should be exercised when administering loratadine to patients with severe hepatic impairment as reduced clearance of loratadine may occur.
• Patients sensitive to one of the antihistamines may be sensitive to others.
USE IN PREGNANCY & LACTATION
The safe use of loratadine in pregnancy has not been established. Small amounts of loratadine are excreted in breast milk and therefore risk-benefit should be considered due to the increased risk of antihistamines on infants.
MAIN SIDE I ADVERSE EFFECTS
Sedative and anticholinergic effects are not likely. Events of fatigue, nausea and headache were reported rarely. Spontaneous adverse events reported rarely include alopecia, anaphylaxis, and abnormal hepatic function.
Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450, 3A4 and/or 2D6, may elevate plasma concentrations of either drug and adverse effects might result. Increased plasma concentrations of loratadine have been reported when used concomitantly with ketoconazole, erythromycin and cimetidine.
Symptoms of overdosage, i.e. somnolence, tachycardia and headache have been reported.
Treatment of overdosage
In the event of overdosage, treatment which should be started immediately is symptomatic and supportive. The patient should be induced to vomit, even if emesis has occurred spontaneously, but not in patients with impaired consciousness. Administration of activated charcoal as a slurry with water may be attempted following emesis. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed.
DOSAGE AND ADMINISTRATION
• Usual adult and adolescent dose: Oral; 10 mg once daily.
• Usual geriatric dose: Oral; 10 mg once daily.
(Note: Geriatric patients may be more sensitive to the effects of the adult dose)
Patients with severe liver impairment: Due to the possibility of a reduced clearance of loratadine, a lower dose should be administered, i.e. an initial dose of 5 mg once daily, or 10 mg on alternate days is recommended.
Note: The information given here is limited. For further information consult your doctor or pharmacist.
Store below 25°C. Protect from moisture.
Plastic bottles of 100’s, 500’s; Blisters of 2x 10’s, 10 x 10’s
121, Jalan Tunku Abdul Rahman, 30010 Ipoh, Malaysia.
Revised date: December 2014.