Omcet-L Tablets / Film-coated
Levocetrizine Dihydrochloride 0.1%
5 mg
National Pharmaceutical industries Co. (SAOG)
| Pack size | 20's (10's Blister x 2) |
|---|---|
| Dispensing mode | POM |
| Source | OMAN |
| Agent | NEW MEDICAL CENTRE |
| Retail Price | 15.50 AED |
Indications
Omcet-L Tablets / Film-coated is used for:
Allergic rhinitis, Chronic idiopathic urticaria
Adult Dose
Oral
Seasonal allergic rhinitis, Chronic idiopathic urticaria
Adult: 5mg once daily
Child Dose
Oral
Seasonal allergic rhinitis, Chronic idiopathic urticaria
Children 12 years of age and older: 5mg once daily
Children 6 to 11 years of age: 2.5mg (1/2 tablet or 1 teaspoon oral solution) once daily
Children 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) once daily
Renal Dose
>12 years
CrCl: 50-80 mL/min: 2.5 mg PO qDay
CrCl: 30-50 mL/min: 2.5 PO qODay
CrCl: 10-30 mL/min: 2.5 mg every 3-4 days
CrCl: <10 mL/min, hemodialysis: Contraindicated
Administration
May be taken with or without food.
Contra Indications
Lactation. End-stage renal disease (CrCl <10 ml/min) or haemodialysis patients. Child 6-11 yr with renal impairment.
Precautions
Renal impairment. May impair ability to drive or operate machinery.
Lactation: expected to be excreted in breast milk, avoid
Pregnancy-Lactation
Pregnancy
Available data from published literature and postmarketing experience in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes
Animal data
In animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by oral route to pregnant rats and rabbits, during period of organogenesis, at doses up to 390 times and 470 times, respectively, maximum recommended human dose (MRHD) in adults
Rats treated during late gestation and lactation period, had no effects on pup development at oral doses up to approximately 60 times the MRHD in adults; in mice treated during late gestation and lactation period, drug administered by oral route to dams had no effects on pup development at a dose that was approximately 25 times the MRHD in adults; however, lower pup weight gain during lactation was observed at a dose that was 95 times MRHD in adults
Lactation
There are no data on presence of levocetirizine in human milk, effects on breastfed infant, or on milk production; however, drug has been reported to be present in human breast milk; in mice and beagle dogs, studies indicated cetirizine was excreted in milk; when a drug is present in animal milk, it is likely the drug will be present in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Interactions
Possible additive adverse CNS effects w/ CNS depressants (e.g. sedatives, tranquilizers).
Adverse Effects
Side effects of Levocetrizine Dihydrochloride 0.1% :
1-10%
Dry mouth, Fatigue, Nasopharyngitis, Pharyngitis
Frequency Not Defined
Somnolence, dizziness, pyrexia, cough, epistaxis, diarrhoea, vomiting, constipation, otitis media, dysuria, urinary retention, blurred vision, angioedema, paraesthesia, dystonia, oculogyric crisis, myoclonus, extrapyramidal symptoms.
Mechanism of Action
Levocetirizine is an active isomer of cetirizine which selectively competes w/ histamine for H1-receptor sites on effector cells in the GI tract, blood vessels and resp tract.
Note
Omcet-L 5 mg Tablets / Film-coated manufactured by National Pharmaceutical industries Co. (SAOG). Its generic name is Levocetrizine Dihydrochloride 0.1%. Omcet-L is availble in United Arab Emirates.
Farmaco UAE drug index information on Omcet-L Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.