Miostat

What is Miostat and how is it used?

Miostat is a prescription medicine used to treat the symptoms of Glaucoma and Inhibition of Perioperative Intraocular Pressure. Miostat may be used alone or with other medications.

Miostat belongs to a class of drugs called Miotics, Direct-Acting; Antiglaucoma, Miotics.

What are the possible side effects of Miostat?

Miostat may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• new or sudden vision problems,
• seeing “floaters” in your vision, and
• urination problems

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Miostat include:

• blurred vision,
• flushing (warmth, redness, or tingly feeling),
• stomach pain,
• headache, and
• a tight feeling in your bladder

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Miostat. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

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

Established name: Carbachol

Chemical name: Ethanaminium, 2-[(aminocarbonyl)oxy]-N,N,Ntrimethyl-, chloride.

Molecular Formula: C₆H₁₅CIN₂O₂

Molecular Weight: 182.65

Each mL contains: Active: carbachol 0.01%.

Inactives: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dehydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dehydrate 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH) and Water for Injection. pH range is 6.5-7.5.

INDICATIONS

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

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 with an atraumatic cannula prior to intraocular instillation. No more than one-half milliliter should be gently instilled into the anterior chamber for the production of satisfactory miosis. It may be instilled before or after securing sutures. Miosis is usually maximal within two to five minutes after application.

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

Storage

Store at 15° - 30°C (59° - 86°F).

Distributed by: Alcon Laboratories , Inc., Fort Worth, Texas 76134 USA. Revised: Mar 2016

SIDE EFFECTS

Ocular: Corneal clouding, persistent bullous keratopathy, retinal detachment and postoperative iritis following cataract extraction have been reported.

Systemic: Side effects such as flushing, sweating, epigastric distress, abdominal cramps, tightness in

urinary bladder, and headache have been reported with topical or systemic application of carbachol.

The following additional reactions have been identified during post-approval use of MIOSTAT (carbachol intraocular solution, USP) in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to MIOSTAT, or a combination of these factors, include: corneal edema, drug effect prolonged (miosis), eye inflammation, eye pain, intraocular pressure increased, ocular hyperemia, vision blurred, visual impairment, and vomiting.

DRUG INTERACTIONS

No information provided.

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, G.I. spasm, urinary tract obstruction and Parkinson's disease.

The vial stopper contains natural rubber (latex) which may cause severe allergic reactions.

PRECAUTIONS

Use only if the container is undamaged.

Carcinogenesis

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

Pregnancy

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

Nursing Mothers

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

Pediatric Use

Safety and efficacy in pediatric patients have not been established.

Geriatric Use

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

OVERDOSE

No information provided.

CONTRAINDICATIONS

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

CLINICAL PHARMACOLOGY

Carbachol is a potent cholinergic (parasympathomimetic) agent which produces constriction of the iris and ciliary body resulting in reduction in intraocular pressure. The exact mechanism by which carbachol lowers intraocular pressure is not precisely known.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.