L-Cet Tablets / Film-coated

Levocetrizine Dihydrochloride 0.1%

5mg

Oman Pharmaceutical Products

Pack size	20's (10's Blister x 2)
Dispensing mode	POM
Source	OMAN
Agent	Muscat Pharmaceutical Trading L.L.C.
Retail Price	13.50 AED

Available as:

0.5mg/ml - Solution (Oral)

Indications

L-Cet 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

L-Cet 5mg Tablets / Film-coated manufactured by Oman Pharmaceutical Products. Its generic name is Levocetrizine Dihydrochloride 0.1%. L-Cet is availble in United Arab Emirates. Farmaco UAE drug index information on L-Cet Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Levocetrizine Dihydrochloride 0.1% :

Tablets / Film-coated

Zolix ^{5 mg}

TABUK PHARMACEUTICAL MANUFACTURING CO

Solution (Oral)

Zolix ^0.5mg/ml

TABUK PHARMACEUTICAL MANUFACTURING CO

Tablets / Film-coated

Xyzal ^5mg

UCB FARCHIM SA

Tablets / Film-coated

Omcet-L ^{5 mg}

National Pharmaceutical industries Co. (SAOG)

Tablets / Film-coated

Evocet ^5mg

Neobiocon