INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo LIVOSTIN® N.S. nasal spray

SCHEDULING STATUS
Schedule 2.

PROPRIETARY NAME
(and dosage form)

LIVOSTIN® N.S. nasal spray

COMPOSITION
Each mL of the microsuspension contains
levocabastine hydrochloride equivalent to 0,5 mg levocabastine. Preservative: Benzalkonium chloride 0,015% m/v and Disodium edetate 0,015% m/v.
Each spray contains approximately 50 micrograms levocabastine.

PHARMACOLOGICAL CLASSIFICATION
A.5.7.1 Antihistaminics.

PHARMACOLOGICAL ACTION
Livostin N.S. nasal spray contains levocabastine, a selective histamine H1-antagonist with a prolonged elimination half-life of 30-40 hours.
After intranasal application, about 30-40 micrograms levocabastine per puff is absorbed and predominantly excreted in the urine as unchanged drug (about 70% of the absorbed dose).
Typical systemic antihistaminic effects have been observed in human volunteers after oral administration of therapeutically effective doses of levocabastine following histamine provocation.

INDICATIONS
Short term symptomatic treatment of seasonal allergic rhinitis e.g. sneezing, itchy nose, rhinorrhoea.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
Safety in pregnancy and lactation has not been established.
In mice and rats, Livostin, at high systemic doses did reveal embryotoxic and teratogenic effects.

WARNINGS
Since elimination of levocabastine is prolonged in patients with renal impairment, caution should be exercised when administering Livostin N.S. nasal spray to patients with renal impairment.

DOSAGE AND DIRECTIONS FOR USE
As Livostin N.S. nasal spray is available as a microsuspension, the bottle should be shaken before each application.
ADULTS AND CHILDREN OVER 5 YEARS:
The usual dose is 2 puffs of Livostin N.S. nasal spray per nostril, twice daily for up to 8 weeks.
CHILDREN 6 MONTHS TO 5 YEARS: The usual dose is 1 puff of LIVOSTIN nasal spray per nostril, twice daily for up to 4 weeks.
Patients should be instructed to clear the nasal passages prior to administering the spray and to inhale through the nose during spraying. Before using the pump delivery system for the first time, the pump reservoir should be filled up by priming until a fine spray is delivered.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Local irritation (nasal stinging and burning) immediately after instillation of Livostin N.S. nasal spray may occur.
Headache, dry mouth, somnolence, tiredness have occurred. Epitaxis has been reported less frequently. Allergic reactions with local swelling, bronchospasm and urticaria have been reported. In children between 6 months and 5 years, otitis media and pharyngitis have been observed.
Livostin N.S. lacks significant sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by the simultaneous intake of alcohol and other central nervous system depressants.
Interaction with alcohol or any other drug was never reported in clinical trials. In a specially designed psycho-performance study, an interaction with diazepam was not observed but a slight interaction with alcohol could not be excluded.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Treatment is symptomatic and supportive.

IDENTIFICATION
A white homogenous microsuspension.

PRESENTATION
Livostin N.S. nasal spray is available in 15 mL containers, containing 10 mL or 15 mL Livostin N.S. suspension.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light. Shake well before use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
X/5.7.1/230

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN-CILAG
Janssen Pharmaceutica (Pty) Ltd
(Reg. No. 1980/11122/07)
15th Road
HALFWAY HOUSE
1685
www.janssencilag.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT
26 April 1994

© J-C 2002        ZA - 238762/V1        V

Updated on this site: November 2002        Source: Pharmaceutical Industry

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