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Miostat (Carbachol Intraocular Solution): Side Effects, Uses, Dosage, Interactions, Warnings

Miostat

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 10/8/2024

Drug Summary

What Is Miostat?

Miostat (carbachol intraocular solution) is a cholinergic agent that reduces the pressure in the eye by increasing the amount of fluid that drains from the eye and is used to treat glaucoma by lowering the pressure inside the eye.

What Are 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.

Common side effects of Miostat include:

  • burning,
  • stinging, or
  • tearing eyes,
  • eye irritation,
  • decreased vision in poor light,
  • headache,
  • watering mouth,
  • increased sweating,
  • increased urination,
  • nausea,
  • vomiting,
  • stomach cramps,
  • diarrhea,
  • dizziness,
  • feeling faint,
  • flushing (warmth, redness, or tingly feeling, especially in the face), and
  • irregular heartbeat.

Tell your doctor if you have serious side effects of Miostat including:

  • vision problems,
  • seeing "floaters" in your vision,
  • feeling like you might pass out,
  • fast or slow heartbeats,
  • wheezing,
  • trouble breathing, or
  • severe burning, stinging, or eye irritation after using the eye drops.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Miostat

Miostat is usually used during surgery and a physician will determine the dose.

What Drugs, Substances, or Supplements Interact with Miostat?

Miostat may interact with other eye medications, especially nonsteroidal anti-inflammatory drugs (NSAIDs). Do not use other eye medications during treatment with Miostat ophthalmic unless your doctor tells you to do so. Tell your doctor all medications and supplements you use.

Miostat During Pregnancy or Breastfeeding

During pregnancy, Miostat should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Miostat (carbachol intraocular solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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Description for Miostat

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:

MIOSTAT
(Carbachol) Structural Formula Illustration

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.

Uses for Miostat

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 for Miostat

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 for Miostat

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 for Miostat

No information provided.

Warnings for Miostat

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 for Miostat

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 Information for Miostat

No information provided.

Contraindications for Miostat

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

Clinical Pharmacology for Miostat

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 for Miostat

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

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.