LEVOZIN Syrup 2.5

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Levocetrizine Dihydrochloride

Available from:

Lincoln Pharmaceuticals Limited, INDIA

ATC code:

Antihistamines For Systemic Use, Piperazine deriva

INN (International Name):

Levocetrizine Dihydrochloride

Dosage:

2.5

Pharmaceutical form:

Syrup

Manufactured by:

Lincoln Pharmaceuticals Limited, INDIA

Product summary:

Physical description: Clear colourless to pale yellow coloured liquid; Local technical representative: Heko Pharmacy Limited (7718)

Authorization status:

Registered/Compliant

Authorization date:

2022-09-21

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Levocetirizine Dihydrochloride Syrup 2.5 mg/5 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levocetirizine Dihydrochloride USP EXCIPIENTS WITH KNOWN EFFECT:
Sucrose…2000 mg/5ml
Methyl Hydroxy benzoate…6.750 mg/5ml
Propyl Hydroxy benzoate….0.750 mg/5ml
For full list of Excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral liquid, syrup
A Clear colourless to pale yellow coloured liquid filled.
4.
CLINICAL PARTICULARS
1. THERAPEUTIC INDICATIONS
It is indicated for symptomatic treatment of allergic rhinitis
(including persistent allergic
rhinitis) and urticaria in adults and children aged 2 years and above.
2.
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: For oral administration only.
The appropriate volume of oral solution should be measured with
measuring cup. Poured
oral solution in a measuring cup up to mark or in a glass of water. It
must be taken orally
immediately after dilution, and may be taken with or without food or
as directed by
physician.
DURATION OF USE:
Intermittent or in case of persistent allergic rhinitis (symptoms
experienced for less than
four days a week or for less than four weeks a year) has to be treated
according to the
disease and its history or continuous therapy can be proposed to the
patient during the
period of exposure to allergens. The use of levocetirizine for
treatment periods of at least 6
months. In chronic urticaria and chronic allergic rhinitis: use of
cetirizine (racemate) for up
to one year. It can be stopped once the symptoms have disappeared and
can be restarted
again when symptoms reappear.
ADULTS AND ADOLESCENTS 12 YEARS AND ABOVE: The recommended dose is (5
mg) 10 ml.
ELDERLY: Recommended dose need to adjustment for in elderly patients
with moderate to
severe renal impairment.
RENAL IMPAIRMENT: The dosing intervals must be individualized
according to renal function.
Dose adjust as indicated, an estimate of the patient's creatinine
clearance (CLcr) in ml/min
is needed.
The CLcr (ml/min) may be estimated from seru