NDC 0023-4290 Lastacaft

Alcaftadine

NDC Product Code 0023-4290

NDC 0023-4290-01

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 1 mL in 1 BOTTLE, PLASTIC

NDC 0023-4290-03

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 3 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Lastacaft with NDC 0023-4290 is a a human prescription drug product labeled by Allergan, Inc.. The generic name of Lastacaft is alcaftadine. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Allergan, Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Lastacaft Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALCAFTADINE 2.5 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Allergan, Inc.
Labeler Code: 0023
FDA Application Number: NDA022134 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-01-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Alcaftadine Ophthalmic

Alcaftadine Ophthalmic is pronounced as (al kaf' ta deen)

Why is alcaftadine ophthalmic medication prescribed?
Ophthalmic alcaftadine is used to relieve the itching of allergic pinkeye. Alcaftadine is in a class of medications called antihistamines. It works by blocking histamine,...
[Read More]

* Please review the disclaimer below.

Lastacaft Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

Topical 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.

5.1 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.

5.2 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®.

6 Adverse Reactions

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.

6.1 Clinical Studies Experience

The most frequent ocular adverse reactions, occurring in less than 4% of eyes treated with LASTACAFT®, were eye irritation, burning and/or stinging upon instillation, eye redness and eye pruritus.

6.2 Non-Ocular Adverse Reactions

The most frequent non-ocular adverse reactions, occurring in less than 3% of subjects with eyes treated with LASTACAFT®, were nasopharyngitis and headache. Some of these events were similar to the underlying disease being studied.

6.3 Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of LASTACAFT® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions include eye discharge, eye swelling, erythema of eyelid, eyelid edema, lacrimation increased, vision blurred, hypersensitivity reactions including swelling of the face or allergic dermatitis, and somnolence.

8.1 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.

8.3 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.

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® is a sterile, topically administered H1 receptor antagonist containing alcaftadine for ophthalmic use.
Alcaftadine is a white to yellow powder with an empirical formula of C19H21N3O and a molecular weight of 307.39.
Contains:Active: alcaftadine 0.25% (2.5 mg/mL)Inactives: benzalkonium chloride 0.005% as a preservative; edetate disodium; sodium phosphate, monobasic; purified water; sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH)
Chemical Name: 6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-imidazo[2,1-b] [3] benzazepine-3-carboxaldehyde
Structural Formula:The drug product has a pH of approximately 7 and an osmolality of approximately 290 mOsm/kg.

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.

Other

AbsorptionFollowing 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.

DistributionThe protein binding of alcaftadine and the active metabolite are 39.2% and 62.7%, respectively.

MetabolismThe metabolism of alcaftadine is mediated by non-CYP450 cytosolic enzymes to the active carboxylic acid metabolite. In vitro studies showed that neither alcaftadine nor the carboxylic acid metabolite substantially inhibited reactions catalyzed by major CYP450 enzymes.

ExcretionThe elimination half-life of the carboxylic acid metabolite is approximately 2 hours following topical ocular administration. Based on data following oral administration of alcaftadine, the carboxylic acid metabolite is primarily eliminated unchanged in the urine.

Potential for Eye Injury and Sterility of Dropper TipTo 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 LensesIf 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®.
© 2016 Allergan. All rights reserved. Irvine, CA 92612, U.S.A.All trademarks are the property of their respective owners. Made in the U.S.A.Patented. See: www.allergan.com/products/patent_notices
72468US13

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Alcaftadine was not mutagenic or genotoxic in the Ames test, the mouse lymphoma assay or the mouse micronucleus assay.
Alcaftadine was found to have no effect on fertility of male and female rats at oral doses up to 20 mg/kg/day (approximately 200 times the plasma exposure at the recommended human ocular dose).

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 by an ocular allergen challenge, both at 3 minutes post-dosing and at 16 hours post-dosing of LASTACAFT®.
The safety of LASTACAFT® was evaluated in a randomized clinical study of 909 subjects over a period of 6 weeks.

16 How Supplied/Storage And Handling

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

Storage And Handling

Storage: Store at 15°-25°C (59°-77°F).

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