AKTEN- lidocaine hydrochloride gel

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Lidocaine Hydrochloride Anhydrous (UNII: EC2CNF7XFP) (Lidocaine - UNII:98PI200987)

Доступно од:

Akorn

Пут администрације:

OPHTHALMIC

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

AKTEN® is indicated for ocular surface anesthesia during ophthalmologic procedures. None. Reproduction studies for lidocaine have been performed in both rats and rabbits. There was no evidence of harm to the fetus at subcutaneous doses up to 50 mg/kg lidocaine (more than 800 fold greater than the human dose on a body weight basis) in the rat model. 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 in pregnancy only if clearly needed. Lidocaine is secreted in human milk. The clinical significance of this observation is unknown. Although no systemic exposure is expected with administration of AKTEN® , caution should be exercised when AKTEN® is administered to a nursing woman. Safety and efficacy in pediatric patients have been extrapolated from studies in older subjects and studies in pediatric patients using different formulations of lidocaine. No overall clinical differences

Резиме производа:

AKTEN® (lidocaine hydrochloride ophthalmic gel) 3.5% is supplied as a clear gel for single-patient use as follows: Storage Store at 15°C to 25°C (59°F to 77°F). Keep container closed and protected from light in the original carton until use. Discard after use. AKORN Manufactured by: Akorn Operating Company LLC Lake Forest, IL 60045 *Made in Switzerland Patent Pending AE00N        Revised 2/2022

Статус ауторизације:

New Drug Application

Карактеристике производа

AKTEN- LIDOCAINE HYDROCHLORIDE GEL
AKORN
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AKTEN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AKTEN .
AKTEN (LIDOCAINE HYDROCHLORIDE OPHTHALMIC GEL), FOR TOPICAL OPHTHALMIC
USE
INITIAL U.S. APPROVAL: 1972
RECENT MAJOR CHANGES
Warnings and Precautions (5.3)
7/2021
INDICATIONS AND USAGE
AKTEN is a local anesthetic indicated for ocular surface anesthesia
during ophthalmologic procedures. (1)
DOSAGE AND ADMINISTRATION
The recommended dose of AKTEN is 2 drops applied to the ocular surface
in the area of the planned
procedure. Additional anesthesia may be reapplied as needed. (2)
DOSAGE FORMS AND STRENGTHS
AKTEN 3.5% (35 mg/mL) Ophthalmic Gel. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
For Topical Ophthalmic Use. Not for Injection. (5.1)
Corneal Opacification-prolonged use of a topical ocular anesthetic may
produce permanent corneal
opacification and ulceration with accompanying visual loss. (5.2)
For Administration by Healthcare Provider: AKTEN is not intended for
patient self-administration. (5.3)
ADVERSE REACTIONS
Most common adverse reactions are conjunctival hyperemia, corneal
epithelial changes, headache, and
burning upon instillation. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AKORN OPERATING COMPANY
LLC AT 1-
800-932-5676 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
REVISED: 11/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 For Topical Ophthalmic Use
5.2 Corneal Opacification
5.3 For Administration by Healthcare Provider
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
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8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment