MIOSTAT Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Alcon Laboratories, Inc.

Λέξεις κλειδιά

0065-0023

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1. Description

MIOSTAT (carbachol intraocular solution, USP) 0.01% is a sterile balanced salt solution of carbachol for intraocular injection. The active ingredient is represented by the chemical structure: Established ...

2. Clinical Pharmacology

Carbachol is a potent cholinergic (parasympathomimetic) agent which produces constriction of the iris and ciliary body resulting in reduction in intraocular pressure (IOP). The exact mechanism by which ...

3. Indications and Usage

Intraocular use for obtaining miosis during surgery. In addition, MIOSTAT (carbachol intraocular solution, USP) 0.01% reduces the intensity of IOP elevation in the first 24 hours after cataract surgery. ...

4. Contraindications

Should not be used in those persons showing hypersensitivity to any of the components of this preparation.

5. Warnings

For single-dose intraocular use only. Discard unused portion. Intraocular carbachol 0.01% should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, ...

6. Precautions

Use only if the container is undamaged.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies in animals to evaluate the carcinogenic potential have not been conducted.

6.7. Pregnancy

There are no adequate and well-controlled studies in pregnant women. MIOSTAT (carbachol intraocular solution, USP) 0.01% should be used during pregnancy only if the potential benefit justifies the potential ...

6.9. Nursing Mothers

It is not known if this medication is excreted in breast milk. Exercise caution when administering to a nursing woman.

6.10. Pediatric Use

Safety and efficacy in pediatric patients have not been established.

6.11. Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

7. Adverse Reactions

<u>Ocular:</u> Corneal clouding, persistent bullous keratopathy, retinal detachment and postoperative iritis following cataract extraction have been reported. <u>Systemic:</u> Side effects such as flushing, ...

10. Dosage and Administration

Aseptically remove the sterile vial from the blister package by peeling the backing paper and dropping the vial onto a sterile tray. Withdraw the contents into a dry sterile syringe, and replace the needle ...

11. How Supplied

In a 2.0 mL glass vial with a 1.5 mL fill, grey butyl stopper and aluminum seal packaged twelve to a carton. NDC 0065-0023-15 Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134

12. Storage and Handling

Store at 15°-30°C (59°-86°F).