Miostat

Other Miotics-Antiglaucoma Agents

Ophthalmic solution drops:
For topical ophthalmic use only. Not for injection.
Instruct patient on proper instillation of eye solution.
Do not touch the tip of the dropper to the eye, fingertips, or other surface since this may contaminate the solution.
Wash hands before and after use.
Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. Close eyes to spread drops. To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 1—2 minutes following application to the eye.
If more than one topical ophthalmic drug product is being used, the drugs should be administered at least 5 minutes apart.
To avoid contamination or the spread of infection, do not use dropper for more than one person.

Intraocular Administration
Intraocular solution for injection, USP:
Using aseptic technique, remove sterile vial from 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.
Gently instill prepared dosage into the anterior chamber.
The solution may be instilled before or after securing sutures.
Discard unused portion after each use; vials are single-use only.

bronchospasm / Rapid / 0-1.0
night blindness / Delayed / Incidence not known
corneal opacification / Delayed / Incidence not known
visual impairment / Early / Incidence not known
retinal detachment / Delayed / Incidence not known

urinary retention / Early / 0-1.0
blurred vision / Early / 5.0
corneal edema / Early / Incidence not known
ciliary body spasm / Rapid / Incidence not known
keratopathy / Delayed / Incidence not known
conjunctival hyperemia / Early / Incidence not known
iritis / Delayed / Incidence not known
ocular inflammation / Early / Incidence not known
sinus tachycardia / Rapid / Incidence not known
hypotension / Rapid / Incidence not known

headache / Early / 1.0-5.0
flushing / Rapid / 0-1.0
hyperhidrosis / Delayed / 0-1.0
urinary urgency / Early / 0-1.0
ocular irritation / Rapid / 5.0
ocular pain / Early / Incidence not known
miosis / Early / Incidence not known
diarrhea / Early / Incidence not known
abdominal pain / Early / Incidence not known
vomiting / Early / Incidence not known
hypersalivation / Early / Incidence not known
syncope / Early / Incidence not known

Isopto Carbachol, Miostat

Rx

Direct-acting ophthalmic miotic agent.
Used to lower intraocular pressure (IOP) in glaucoma, induce miosis during surgery, and reduce IOP after cataract surgery.
Eye preparations can produce systemic cholinergic side effects, even with intact epithelium.

Gently instill up to 0.5 mL into the anterior chamber for the production of satisfactory miosis. The solution may be instilled before or after securing sutures. Miosis is usually maximal within 2 to 5 minutes after application.

Instill 2 drops topically in the affected eye(s) up to 3 times per day or as directed.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are necessary.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are necessary.

There are no drug interactions associated with Carbachol products.

Carbachol/Isopto Carbachol Ophthalmic Sol: 1.5%, 3%
Miostat Intraocular Inj Sol: 0.01%

Intraocular injection (Miostat): 0.5 mL/dose intraocularly for induction of miosis.
Ophthalmic solution: 6 drops/day per affected eye.

Intraocular injection (Miostat): 0.5 mL/dose intraocularly for induction of miosis.
Ophthalmic solution: 6 drops/day per affected eye.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Carbachol is a potent, direct-acting parasympathomimetic agent with muscarinic effects. Clinically, constriction of the iris and ciliary body occur, with a subsequent decrease in intraocular pressure.

Carbachol is administered via the ophthalmic route.

Ophthalmic Route
Miosis is usually maximal within 2—5 minutes after application of the intraocular solution for injection. Systemic effects have been reported following topical ophthalmic or systemic application of carbachol, indicating some systemic absorption is possible.

No adequate and well-controlled studies have been conducted with carbachol in pregnant women, and its ability to cause fetal harm or affect reproduction is unknown. The manufacturer recommends use during pregnancy only if the benefits to the mother outweigh the potential risks to the fetus. Following ophthalmic administration, carbachol is ionized at a physiologic pH and transplacental passage is not expected.

Data are limited regarding use of carbachol during breast-feeding, and its excretion into breast milk is unknown. The manufacturer advises caution when administering to nursing women. Following ophthalmic administration, clinically significant systemic concentrations are unlikely; transfer to breast-milk is not expected. To minimize the amount of drug that reaches systemic circulation, and potentially breast milk, apply pressure over the tear duct in the corner of the eye for 1 to 2 minutes after ophthalmic administration. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.