Miostat

What is Miostat used for?

Miostat is a prescription medicine that is used during eye surgery.

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 Name: Carbachol
Chemical Name: Ethanaminium, 2-[(aminocarbonyl)oxy]-N,N,Ntrimethyl-, chloride.
Molecular Formula: C6H15CIN2O2
Molecular Weight: 182.65

Each mL of MIOSTAT* (carbachol intraocular solution, USP) 0.01%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 dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH) and Water for Injection. pH range is 6.5-7.5.

Before taking Miostat, tell your doctor:

• If you are allergic to Miostat; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Miostat with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Miostat?

• Tell all of your health care providers that you take Miostat. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for clear eyesight while your pupils are dilated.
• If you have a latex allergy, talk with your doctor. Some products have latex.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Miostat best taken?

Use Miostat as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the eye.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Miostat that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Flushing.
• Headache.
• Passing urine more often.
• Sweating a lot.
• Stomach pain.
• Stomach cramps.

What are some other side effects of Miostat?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Miostat?

• If you need to store Miostat at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL

 

• NDC 0065-0023-15
• MIOSTAT* (CARBACHOL INTRAOCULAR SOLUTION, USP) 0.01%
• TWELVE 1.5 mL Sterile Glass Vials
  Alcon Laboratories, Inc., Fort Worth, Texas 76134 USA
  * a trademark of Novartis
  ©2004, 2013, 2015 Novartis
• Alcon®
  a Novartis company
  USUAL DOSAGE: 0.5 mL
• STORAGE: Store at 15 – 30C (59 – 86F).
• Rx Only

 

• MIOSTAT®
  (carbachol intraocular solution, USP) 0.01%
• Alcon®
• © 2001, 2018 Alcon, Inc.
• H15348-0718
• LOT:  EXP.:

SRC: NLM .