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Loratadine (Afrab-Chem)

Afrab-Chem Ltd
No. 22, Abimbola Street, Isolo Industrial Estate, Isolo, P.O. Box 1647, Lagos, Nigeria.
Email: info@afrabchem.com
Tel: 234-1-2700057
Fax: 234-1-4520328
Website: http://afrabchem.com/

Brand Name

Loratadine (Afrab-Chem)

Manufacturer

Afrab Chem Limited, 22 Abimbola Street, Isolo Ind. Est., Isolo, Lagos.

Therapeutic Class

Antihistamines, Systemic

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN:A4-7347): Loratadine 10 mg.

Pack size: Blister pack of 2 x 10 and 10 x 10.

 Loratadine tab   Loratadine tabb

Syrup (NRN:A4-7551): Loratadine 5 mg

Pack size: 60 mL Plastic bottle.

Loratadine syrup

Pharmacology

Mechanism of action: Competitively antagonizes histamine at the H 1-receptor site.

Pharmacokinetics: Rapidly absorbed following oral administration. Tmax is 1.3 h for loratadine and 2.5 h for its metabolite. Food increases bioavailability (AUC) approximately 40%; however, Tmax is delayed 1 h. Steady state is reached by approximately the fifth dosing day.

Distribution: 97% protein bound.

Metabolism: Metabolite is descarboethoxyloratadine. Metabolized by CYP-450 3A4 and P450 2D6. Undergoes extensive first-pass metabolism.

Elimination: Approximately 80% equally distributed between urine and feces in the form of metabolic products within 10 days. The t½ for loratadine is 8.4 h (3 to 20 h). The t½ for descarboethoxyloratadine is 28 h (8.8 to 92 h).

Indications

Loratidine is used for the symptomatic relief of allergic conditions such as sneezing, rhinorrhea and itching, and ocular itching and burning.

Also indicated for the relief of chronic urticaria and other allergic dermatological disorders.

Contra-indications

Risk-benefit ratio should be considered when the following medical problems exist: bladder neck obstruction, prostatic hypertrophy, urinary retention, glaucoma, or sensitivity to Loratadine.

Precautions/Warnings

  • 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
  • Safe use of loratadine in pregnancy has not been established

Interactions

No drug-drug interaction that is considered serious. However, it should not be taken with with alcoholic drinks.

Adverse Effects

Sedative and anticholinergic effects are not likely. Headache, nausea and fatigue have been reported. Those that have been reported rarely include hair loss, changes in liver function and severe allergic reactions.

Dosage & Administration

Adult and children over 6 years: 10 mg daily.

Children 2 – 5 years: One teaspoonful (5 mg) daily.

Patients with severe liver impairment should take one tablet every other day.

Or as directed by the Physician.

Storage/Handling Recommendations

Store protected from light.

Keep in a cool dry place and away from children.

Review Date

2017-09-30 02:15:43