Livostin Nasal Spray (Levocabastine HClallergic rhinitis)



Levocabastine HCl

Histamine H1-antagonist

Action And Clinical Pharmacology: Levocabastine is a potent, fast-acting and highly selective histamine H1-antagonist with a sustained duration of action.

Within 10 minutes of topical application to the nose, levocabastine inhibits sneezing, itchy nose and rhinorrhea induced by nasal provocation with allergens.

Orally-administered levocabastine provides a dose dependent inhibition of skin reactions to intradermal histamine. After repeated topical application to the nose, topical and systemic antihistamine effects contribute to overall clinical outcome. Although systemic effects may contribute to the therapeutic effects of levocabastine nasal spray, this is not accompanied by any sedative effects.

Levocabastine nasal spray (2 sprays/nostril 3 times daily), under acute and steady state conditions, is devoid of CNS effects, as evaluated by objective and subjective psychoperformance tests and measures of general CNS activity.

Following topical application to the nose, the absorption of levocabastine was incomplete and the absolute bioavailability of levocabastine administered in the nose could be estimated at 60 to 80% in healthy volunteers and in patients with allergic rhinitis.

Indications And Clinical Uses: The symptomatic treatment of allergic rhinitis (sneezing, itchy nose, runny nose).

Contra-Indications: In patients with hypersensitivity to any of the ingredients.

Manufacturers’ Warnings In Clinical States: Pregnancy and Lactation: There are no clinical trials on the use of levocabastine nasal spray in pregnant or nursing women, therefore, levocabastine nasal spray should not be used during pregnancy, except if the potential benefit justifies the potential risk to the fetus.

Children: Levocabastine nasal spray is not recommended for use in children under the age of 12 years except on the advice of a physician. Clinical experience with nasal levocabastine is absent in children under 5 years of age.

Occupational Hazards: Effects on Driving Ability and Use of Machinery: Levocabastine will generally not cause clinically relevant sedation nor does it impair psychomotor performance as compared with placebo. Levocabastine nasal spray, therefore, would not be expected to interfere with the ability to drive a car or operate machinery. Should drowsiness occur, caution is advised.

Precautions: Since levocabastine is excreted renally, caution should be exercised when administering levocabastine nasal spray to patients with renal impairment.

Geriatrics: The safety and efficacy of topical levocabastine has not been established in patients greater than 65 years of age.

Drug Interactions: Interaction with alcohol or any other drug was never reported in clinical trials. In specially designed studies, there was no evidence of potentiation of alcohol or diazepam by levocabastine nasal spray used in normal dosages.

Adverse Reactions: The most frequent side effect encountered with levocabastine nasal spray is nasal irritation. In post-marketing experience, allergic reactions have rarely been reported. Most side effects are transient and rarely necessitate discontinuation of therapy.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: There have not been any reports of overdosage of levocabastine nasal spray. Some sedation after accidental intake of the contents of the bottle cannot be excluded.

In the case of accidental ingestion, the patient should be advised to drink plenty of fluids in order to accelerate the renal elimination of levocabastine. Treatment should include general supportive measures.

Dosage And Administration: Adults and children (12 to 65 years old): 2 sprays (50 µg/spray)/nostril, 2 times daily. The dose may be increased to 2 sprays 3 to 4 times daily.

It is not useful to continue the treatment for more than 3 days if no improvement is seen. There are no clinical studies to support continuous treatment durations of greater than 10 weeks.

As levocabastine nasal spray is available as a microsuspension, the bottle should be shaken before each application. 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.

Availability And Storage: Each mL of white microsuspension contains: levocabastine HCl equivalent to levocabastine 0.5 mg. Nonmedicinal ingredients: benzalkonium chloride, disodium edetate, disodium phosphate, hypromellose, monosodium phosphate, polysorbate 80, propylene glycol and water. pH 6 to 8. Plastic bottles of 15 mL containing 15 mL of microsuspension. Store at room temperature (15 to 30°C).

LIVOSTIN® NASAL SPRAY Janssen-Ortho Levocabastine HCl Histamine H1-antagonist

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