LASTACAFT Solution (Drops) (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Allergan, Inc.

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1. Indications and Usage

LASTACAFT is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.

2. Dosage and Administration

Instill one drop in each eye once daily. If more than 1 topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.

3. Dosage Forms and Strengths

Ophthalmic solution containing alcaftadine 0.25% (2.5 mg/mL).

4. Contraindications

LASTACAFT is contraindicated in patients with hypersensitivity to any component in the product.

5. Warnings and Precautions

5.1 Potential for Eye Injury and Contamination To minimize eye injury and contamination of the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of LASTACAFT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

8.1. Pregnancy

Risk Summary There are no adequate and well-controlled studies with LASTACAFT in pregnant women to inform a drug associated risk. There are limited data with the use of alcaftadine eye drops in pregnant ...

8.2. Lactation

Risk Summary There is no information regarding the presence of LASTACAFT in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of LASTACAFT to an infant ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

8.5. Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger subjects.

11. Description

LASTACAFT (alcaftadine ophthalmic solution) is an H1 receptor antagonist, in a sterile ophthalmic solution for topical ophthalmic use. Alcaftadine is a white to yellow powder with an empirical formula ...

12.1. Mechanism of Action

Alcaftadine is an H1 histamine receptor antagonist and inhibitor of the release of histamine from mast cells. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated. ...

12.3. Pharmacokinetics

Absorption Following bilateral topical ocular administration of alcaftadine ophthalmic solution, 0.25%, the mean plasma Cmax of alcaftadine was approximately 60 pg/mL and the median Tmax ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis The carcinogenic potential of alcaftadine has not been evaluated in long-term animal studies. Mutagenesis Alcaftadine was not mutagenic or genotoxic in the Ames test, the mouse lymphoma ...

14. Clinical Studies

Clinical efficacy was evaluated in conjunctival allergen challenge (CAC) studies. LASTACAFT was more effective than its vehicle in preventing ocular itching in patients with allergic conjunctivitis induced ...

16.1. How Supplied

LASTACAFT (alcaftadine ophthalmic solution) 0.25% is supplied in an opaque, white low-density polyethylene bottle with a white polystyrene cap. 3 mL fill in 5 mL bottle NDC 0023-4290-03

16.2. Storage and Handling

Store at 15°C to 25°C (59°F to 77°F). After opening, LASTACAFT can be used until the expiration date on the bottle.

17. Patient Counseling Information

Potential for Eye Injury and Sterility of Dropper Tip To minimize eye injury and contamination of the dropper tip and solution, advise patients to not touch the eyelids or surrounding areas with the dropper ...