U.S. BRAND NAMES — Miochol®-E
PHARMACOLOGIC CATEGORY
Cholinergic Agonist
Ophthalmic Agent, Miotic
DOSING: ADULTS — To produce miosis: Intraocular: 0.5-2 mL of 1% injection (5-20 mg) instilled into anterior chamber before or after securing one or more sutures
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Powder for solution, intraocular, as chloride:
Miochol®-E: 1:100 [20 mg; packaged with diluent (2 mL)]
DOSAGE FORMS: CONCISE
Powder for intraocular solution:
Miochol®-E: 1:100 [20 mg; packaged with diluent (2 mL)]
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Open under aseptic conditions only. Attach filter before irrigating eye.
USE — Produces complete miosis in cataract surgery, keratoplasty, iridectomy, and other anterior segment surgery where rapid miosis is required
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Cardiovascular: Bradycardia, flushing, hypotension
Central nervous system: Headache
Ocular: Clouding, corneal edema, decompensation
Respiratory: Dyspnea
Miscellaneous: Diaphoresis
CONTRAINDICATIONS — Hypersensitivity to acetylcholine chloride or any component of the formulation; acute iritis and acute inflammatory disease of the anterior chamber
WARNINGS / PRECAUTIONS
Disease-related concerns: Diseases affected by systemic effects: Systemic effects rarely occur but can cause problems for patients with asthma, GI spasm, acute heart failure, hyperthyroidism, Parkinson's disease, peptic ulcer disease, and or urinary tract obstruction.
Special populations: Pediatrics: Safety and efficacy have not been established in children.
Other warnings/precautions: Aseptic conditions: Open under aseptic conditions only. Cataract surgery: During cataract surgery, use only after lens is in place.
DRUG INTERACTIONS
Acetylcholinesterase Inhibitors: May enhance the adverse/toxic effect of Cholinergic Agonists. Risk C: Monitor therapy
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Acetylcholine is used primarily in the eye and there are no reports of its use in pregnancy. Because it is ionized at physiologic pH, transplacental passage would not be expected.
CANADIAN BRAND NAMES — Miochol®-E
INTERNATIONAL BRAND NAMES — Acetilcolina Colirio (AR); Acetilcolina Cusi (ES); Miochol (FI, GR, LU, NL, NZ); Miochol-E (AU, BE, CH, CN, DE, DK, FI, GB, HK, ID, IE, IL, IT, KP, NL, NO, SE, ZA); Miochole (FR); Miovisin (IT); OQ-Miot (CO)
MECHANISM OF ACTION — Causes contraction of the sphincter muscles of the iris, resulting in miosis and contraction of the ciliary muscle, leading to accommodation spasm
PHARMACODYNAMICS / KINETICS
Onset of action: Rapid
Duration: ~10 minutes
PATIENT INFORMATION — Do not touch dropper to eye. May sting on instillation. Use caution while driving at night or performing hazardous tasks.
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Tuesday, May 18, 2010
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