Miostat
.1 mg/mL · Solution
- Prescription only
- Cholinergic Receptor Agonist
- Active substance
- Carbachol
- Made by
- Alcon Laboratories, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2023-02-10
Cholinergic Receptor Agonist
- 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.
Should not be used in those persons showing hypersensitivity to any of the components of this preparation.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- 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.
From the official label · 2023-02-10 · DailyMed
How it works
From this product’s own US prescribing label.
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 carbachol lowers IOP is not precisely known.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-02-10
Do not take it if
Should not be used in those persons showing hypersensitivity to any of the components of this preparation.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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.
Quoted from the official label, section “Dosage & Administration”.
Other 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.
- Use only if the container is undamaged.
- Carcinogenesis:
- Studies in animals to evaluate the carcinogenic potential have not been conducted.
- Pregnancy: There are no adequate and well-controlled studies in pregnant women.
- Nursing Mothers: It is not known if this medication is excreted in breast milk.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- 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 risk to the fetus.
- It is not known if this medication is excreted in breast milk. Exercise caution when administering to a nursing woman.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
Safety and efficacy in pediatric patients have not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Quoted from the official label, section “Geriatric Use”.
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) 0.01% 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.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- 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). © 2021 Alcon Inc.
- Distributed by: Alcon Laboratories, Inc.
- Fort Worth, Texas 76134 300048977-0621
Quoted from the official label, section “How Supplied”.
What is in it
- 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: C 6 H 15 CIN 2 O 2 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. chemical
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | Alcon Laboratories, Inc. |
|---|---|
| Active substance | Carbachol |
| Strength | .1 mg/mL |
| Form | Solution |
| Route | Ophthalmic |
| Packs | 12 VIAL, GLASS in 1 CARTON / 1.5 mL in 1 VIAL, GLASS |
| NDC | 0065-0023 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).