LEVOCABASTINE HYDROCHLORIDE Eye drops, Nasal spray (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Levocabastine hydrochloride.
2. Qualitative and quantitative composition
Zyrtec eye drops Active ingredients: levocabastine hydrochloride equivalent to levocabastine 0.5 mg/mL Excipients with known effect: benzalkonium chloride and disodium edetate (both 0.15 mg/mL) as preservatives ...
3. Pharmaceutical form
Eye drops: a sterile white ophthalmic microsuspension (pH 6-8) Nasal spray: a white microsuspension (pH 6-8).
4.1. Therapeutic indications
Eye Drops: Symptomatic treatment of seasonal allergic conjunctivitis. Nasal Spray: Symptomatic treatment of seasonal or perennial allergic rhinitis.
4.2. Posology and method of administration
As ZYRTEC eye drops and nasal spray are available as a microsuspension, the bottle should be shaken before each application. Eye Drops As with all ophthalmic preparations containing benzalkonium chloride, ...
4.3. Contraindications
Hypersensitivity to any of the ingredients.
4.4. Special warnings and precautions for use
Mental Alertness In clinical trials there was no significant difference in the incidence of slowed patient reactions with ZYRTEC compared to placebo and active comparator drugs. ZYRTEC, therefore, would ...
4.5. Interaction with other medicinal products and other forms of interaction
No interactions have been seen with ZYRTEC eye drops. With ZYRTEC nasal spray there were no reports of interaction with alcohol in clinical trials. In psychomotor performance studies there was no significant ...
4.6. Pregnancy and lactation
Use in pregnancy Pregnancy Category B3. In pregnant rats, levocabastine readily crossed the placental barrier and was distributed extensively in foetal tissues. Reproductive studies in mice and rats showed ...
4.7. Effects on ability to drive and use machines
The effects of this medicine on a persons ability to drive and use machines were not assessed as part of its registration.
4.8. Undesirable effects
Clinical Trial Data Eye Drops The safety of ZYRTEC eye drops was evaluated in 508 subjects who participated in 4, placebocontrolled clinical trials and one open-label clinical trial. All adverse drug reactions ...
4.9. Overdose
There has been no experience with overdose of ZYRTEC eye drops or nasal spray to date. After accidental intake of the contents of the bottle, sedation may occur. In case of overdose, the patient should ...
5.1. Pharmacodynamic properties
Mechanism of action ZYRTEC eye drops contain levocabastine, a potent, fast-acting and highly selective histamine H1-antagonist with a sustained duration of action. After topical application to the eyes, ...
5.2. Pharmacokinetic properties
Absorption After intranasal and ocular application, the absorption of levocabastine is incomplete with a systemic bioavailability ranging from 60 to 80% for the nasal spray and from 30 to 60% for the eye ...
5.3. Preclinical safety data
Genotoxicity No data available Carcinogenicity In female mice, dietary administration of levocabastine for 20 months stimulated the development of pituitary adenomas and mammary adenocarcinomas. The no-effect ...
6.1. List of excipients
Refer to Section 2 Qualitative and quantitative composition
6.2. Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine. Refer to section 4.5: Interactions with other medicines and other forms of interactions.
6.3. Shelf life
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
ZYRTEC eye drops: 4 mL in 5 mL bottle. ZYRTEC nasal spray: 10 mL in 15 mL bottle.
6.6. Special precautions for disposal and other handling
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
7. Marketing authorization holder
Johnson & Johnson Pacific, AUSTRALIA NEW ZEALAND, 45 Jones Street, Ultimo NSW 2007, Registered Trademark Consumer Care Centre Australia: 1800 029 979, New Zealand: 0800 446 147, Overseas Customers: +61 ...
9. Date of first authorization / renewal of the authorization
March 1994
10. Date of revision of the text
June 2020
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