DE-HISTAMINE (syr)
-
Chemical Name:
Loratadine -
Therapeutic Category:
Respiratory tract drugs -
Pharmacologic Category:
Histamine H1 Antagonist, Second Generation -
Pharmaceutical Form:
Syrup -
Composition:
Loratadine 5mg/5ml
DE HISTAMINE
Tablets - Syrup
Loratadine
Long-Acting, Non-Sedating Antihistamine
1.PHARMACOPLOGY:
DE HISTAMINE is a potent long-acting tricyclic antihistamine with selective peripheral H1- receptor antagonistic activity.
2.INDICATIONS:
DE HISTAMINE is used in the treatment of allergic disorders such as :
- Allergic rhinitis, rhinorrhea, itching, ocular itching and burning.
- Chronic urticaria.
- Allergic dermatologic disorders.
3.CONTRAINDICATIONS:
- Hypersensitivity to any of the components.
- Children under 2 years.
4.PRECAUTIONS:
- An initial dose of 5 mg (0.25 ml) daily should be administered to patients with severe liver impairment.
- Use in pregnant women only if clearly needed.
- Loratadine is excreted in breast milk. Caution should be taken if it is administered to nursing women.
5.SIDE EFFECTS :
DE HISTAMINE has no sedative properties or antimuscarinic effect in comparison with other antihistamine drugs.
The other side effects such as : fatigue, dry mouth, gastrointestinal disturbances have been rarely reported.
6.DRUG INTERACTIONS:
- Increase in plasma concentrations of Loratadine have been reported after concomitant use with: Ketoconazole, Erythromycin, Cimetidine, Ranitidine.
- Loratadine should be discontinued 48 hours prior to skin testing procedures.
7.DOSAGE & ADMINSTRATION:
Children from 2 to 12 years:
Body weight < 30 kgs: 5 mg (½ tablet) or 5 mL (one teaspoonful) once daily.
Body weight >30 kgs: 10 mg (1 tablet) or 10 mL (two teaspoonfuls) once daily.
Adult: 10 mg (1 tablet) or 10 ml (two teaspoonfuls) once daily.
8.PACKAGING & COMPOSITION:
- DE HISTAMINE - Tablets: A pack of 10 or 20 tablets in blister. Each tablet contains Loratadine 10 mg.
- DE HISTAMINE - Syrup: A pack of glass bottle of 100 mL. Each 5 mL of the syrup contains Loratadine micronized 5 mg.
9. STORAGE CONDITIONS:
Store DE HISTAMINE – Tablets and Syrup at temperature between (20-25)°C.