LEVOCETIRIZINE Adults & children ≥ 12 years old ………………….

5
mg
DIHYDROCHLORIDE (1 film-coated tablet)

5 mg Film-coated Tablet For children aged 2 to 6 years, no adjusted dosage is

Elderly:
FORMULATION Adjustment of the dose is recommended in elderly
Each film-coated tablet contains: patients with moderate to severe renal impairment
Levocetirizine dihydrochloride ………………....…5 (see Renal impairment below).
mg
Renal impairment:
DESCRIPTION OF THE PRODUCT The dosing intervals must be based on the renal
Levocetirizine dihydrochloride is a white oval film function. Refer to the following table and adjust the
coated biconvex tablet with one side having an dose as indicated.
embossed G breakline G and the other side having a
plain appearance. Group Clcr (ml/min) Dosage and frequency
Normal ≥80 1 tablet once daily
Mild 50 – 79 1 tablet once daily
PHARMACODYNAMICS Moderate 30 – 49 1 tablet once every 2 days
Levocetirizine is a potent and selective antagonist of Severe < 30 1 tablet once every 3 days
peripheral histamine H1-receptors, with a long End-stage renal < 10- Contra-indicated
disease - Patients
duration of action and is used to significantly improve undergoing dialysis
various allergic symptoms, including nasal
obstruction. To use this dosing table, an estimate of the patient's
creatinine clearance (CLcr) in ml/min is needed. The
PHARMACOKINETICS CLcr (ml/min) may be estimated from serum
The extent of absorption of Levocetirizine is not creatinine (mg/dl) determination using the following
reduced with food but it can be absorbed rapidly and formula:
extensively following oral administration. This drug is
poorly metabolized with an extent of less than 14%
CLcr ( ml / min )=
[ 140−age ( years ) ] x weight (kg) (x 0.85 for w
so interaction with other substances is unlikely. Urine
is the major route of excretion, but it may also be 72 x serum creatinine (mg/ dl)
excreted via feces.
For pediatric patients suffering from renal impairment,
INDICATIONS the dose will have to be adjusted on an individual
basis based on the renal clearance of the patient and
Levocetirizine dihydrochloride 5 mg film-coated his body weight. There is no specific data for children
tablets are indicated for the symptomatic treatment of with renal impairment.
allergic rhinitis (including persistent allergic rhinitis)
and urticaria in adults and children aged > 6 years WARNINGS AND PRECAUTIONS
old.
Do not exceed the stated dose.
CONTRAINDICATIONS Precaution is recommended with concurrent intake of
The use of Levocetirizine is contraindicated in alcohol. Caution should be taken in patients with
patients with hypersensitivity to the active substance, predisposing factors of urinary retention (e.g. spinal
to cetirizine, to hydroxyzine, to any other piperazine cord lesion, prostatic hyperplasia) since levocetirizine
derivatives or to any of the other excipients, and may increase the risk of urinary retention. Caution is
patients with severe renal impairment at less than 10 also advised in patients with epilepsy and patients at
ml/min creatinine clearance. risk of convulsion as this medication may cause
seizure aggravation.
DOSAGE AND ADMINISTRATION
Wash-out period (of 3 days) is required prior to
Levocetirizine is intended to be taken orally, allergy skin testing as antihistamines are known to
swallowed whole with water, and may be taken with inhibit response to the said test.
or without food. It is recommended to take the daily
dose in one single intake. Patients with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-
galactose malabsorption should not take this your doctor. Hypersensitivity reaction symptoms may
medicine. include swelling of the mouth, tongue, face and/or
throat, breathing or swallowing difficulties (chest
Rarely, discontinuation may cause pruritus (intense tightness or wheezing), hives, or sudden fall in blood
itching) even if those symptoms were not present pressure leading to collapse or shock, which may be
before treatment initiation. The symptoms may fatal.
resolve spontaneously. In some cases, the symptoms OVERDOSAGE, SYMPTOMS AND ANTIDOTE
may be intense and may require treatment to be
restarted. The symptoms should resolve when the If Levocetirizine is taken more than the
treatment is restarted. For further questions, ask your recommended dose, adults may experience
doctor or pharmacist. drowsiness while children may experience agitation
and restlessness at first then followed by drowsiness.
Pediatric population No specific antidote for levocetirizine is known. When
The use of the film-coated tablet formulation is not experiencing such symptoms, immediately
recommended in children aged less than 6 years. discontinue the medication and seek for medical
advice.
USE DURING PREGNANCY AND LACTATION
STORAGE CONDITIONS
Pregnancy
There aren’t enough well-controlled studies with the This medicinal product does not require any special
use of Levocetirizine in pregnant women. However, storage conditions. Store product at temperatures
for cetirizine, the racemate of levocetirizine, a large between 20 - 25°C. Keep it out of sight and reach of
amount of data (more than 1000 pregnancy children.
outcomes) on pregnant women indicates no
malformative or feto/neonatal toxicity. With this, the DOSAGE FORMS AND PACKAGING AVAILABLE
use of this medication may be considered during Levocetirizine 5 mg is a film-coated tablet that is
pregnancy, if necessary. Consultation with medical available in aluminum/PVC blister pack x 10’s, Box of
practitioner is recommended. 30’s. Levocetirizine 5 mg is also available in pack
sizes ranging from 7, 10, 20, 21, 28, 30, 50, 90 and
Breast-feeding 100 tablets.
Caution is advised when prescribing levocetirizine to
lactating women since the excretion of levocetirizine
in human milk is likely and adverse reactions may be INSTRUCTIONS ON PROPER DISPOSAL
observed in breastfed infants.
Any unused medicinal product or waste material
should be disposed of in accordance with local
DRUG INTERACTIONS
requirements.
No interaction studies have been performed with
Levocetirizine. Studies with the racemate compound CAUTION STATEMENT
cetirizine demonstrated that there were no clinically
Foods, Drugs, Devices, and Cosmetics Act prohibits
relevant adverse interactions (with antipyrine,
dispensing without prescription
azithromycin, cimetidine, diazepam, erythromycin,
glipizide, ketoconazole and pseudoephedrine).
ADR REPORTING STATEMENT
The extent of absorption of levocetirizine is not For suspected adverse drug reaction, report to the
reduced with food, but the rate of absorption is FDA: www. fda.gov.ph
decreased.
NAME AND ADDRESS OF MARKETING
In sensitive patients, the concurrent administration of
AUTHORIZATION HOLDER
cetirizine or levocetirizine and alcohol or other CNS
depressants may cause additional reductions in ABC Pharmaceutical Corp.
alertness and impairment of performance 34 Maharlika Street, Greenpark Village
Pasig City, Philippines 
ADVERSE DRUG REACTIONS
NAME AND ADDRESS OF MANUFACTURER
Like all medicines, Levocetirizine may cause side
effects, but not everybody gets them. Common side XYZ Manufacturing Inc.
effects include dry mouth, headache, tiredness, and 345 Waterloo Road Industrial Park NSW 1112, India
drowsiness. Rare side effects include exhaustion
and/or abdominal pain.
At the first signs of a hypersensitivity reaction, stop
taking Levocetirizine 5mg film-coated tablets and tell
Registration Number: DR-XY12345
Batch Number: ABC-321
Manufacture Date: 03/2022
Expiration Date: 03/2025
Date of First Authorization: 19/07/2012
Date of Latest Revision: 12/2019