Vilasta Ophthmalmic Solution-Lastacraft- @-Ophthalmic product (July 2010)
Drug Name:Vilasta Ophthmalmic Solution-Lastacraft- @-Ophthalmic product (July 2010)
List Of Brands:
Indication Type Description:
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Indication:
Proprietary Name- Lastacraft
Established Name - Vilasta Ophthalmic solution
Applicant- Vistakon Pharmaceuticals LLC
Indication-
Indication for prevention of itching Associated with Allergic conjunctivitis
Approved by FDA on 28-7-2010 (Ref- FDA approved List- 2010)
Adverse Reaction:
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 drug and
may not reflect the rates observed in clinical practice.
Contra-Indications:
CONTRAINDICATIONS
LASTACAFT® is contraindicated in patients with hypersensitivity to any componen
in the product.
WARNINGS AND PRECAUTIONS
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
tip of the bottle. Keep bottle tightly closed when not in use.
2 Contact Lens Use
Patients should be advised not to wear a contact lens if their eye is red.
LASTACAFT® should not be used to treat contact lens-related irritation.
LASTACAFT® should not be instilled while wearing contact lenses.
Remove contact lenses prior to instillation of LASTACAFT®.
The preservative in LASTACAFT®, benzalkonium chloride,
may be absorbed by soft contact lenses.
Lenses may be reinserted after 10 minutes following administration of LASTACAFT
Dosages/ Overdosage Etc:
Indication-
Indication for prevention of itching Associated with Allergic conjunctivitis
INDICATIONS AND USAGE
LASTACAFT® is an H1 histamine receptor antagonist indicated for the prevention
of itching associated with allergic conjunctivitis.
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.
DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution containing alcaftadine, 0.25% (2.5 mg/mL).
Patient Information:
PATIENT COUNSELING INFORMATION
Potential for Eye Injury and Sterility of Dropper Tip
To minimize eye injury and contamination of the dropper tip and solution, patients
should be advised to not touch the eyelids or surrounding areas with the dropper tip,
as this may contaminate the contents.
Concomitant Use with other Ophthalmic Products or Contact Lenses
If more than one topical ophthalmic drug is being used, the drugs should be
administered at least five minutes apart.
Patients should be advised not to wear a contact lens if their eye is red.
Patients should be advised that LASTACAFT® should not be used to
treat contact lens-related irritation. Patients should also be advised
to remove contact lenses prior to instillation of LASTACAFT®.
The preservative in LASTACAFT®, benzalkonium chloride, may be absorbed
by soft contact lenses. Lenses may be reinserted after 10 minutes
following administration of LASTACAFT®.
Pharmacology/ Pharmacokinetics:
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.
2. 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 occurred at 15 minutes.
Plasma concentrations of alcaftadine were below the lower limit of
quantification (10 pg/mL) by 3 hours after dosing.
The mean Cmax of the active carboxylic acid metabolite was
approximately 3 ng/mL and occurred at 1 hour after dosing.
Plasma concentrations of the carboxylic acid metabolite were below
the lower limit of quantification (100 pg/mL) by 12 hours after dosing.
There was no indication of systemic accumulation or changes in plasma exposure
of alcaftadine or the active metabolite following daily topical ocular administration.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Pregnancy Category B. Reproduction studies performed in rats and rabbits
revealed no evidence of impaired female reproduction or harm to the fetus
due to alcaftadine. Oral doses in rats and rabbits of 20 and 80 mg/kg/day, respectively,
produced plasma exposure levels approximately 200 and 9000 times the
plasma exposure at the recommended human ocular dose.
There are however, no adequate and well controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response,
this drug should be used during pregnancy only if clearly needed.
2. Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when
LASTACAFT® is administered to a nursing woman.
3. Pediatric Use
Safety and effectiveness in pediatric patients below the age of 2 years
have not been established.
4. Geriatric Use
No overall differences in safety or effectiveness were observed between
elderly and younger subjects.
