Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
TROPICAMIDE (UNII: N0A3Z5XTC6) (TROPICAMIDE - UNII:N0A3Z5XTC6)
Sandoz Inc
TROPICAMIDE
TROPICAMIDE 5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
For mydriasis and cycloplegia for diagnostic procedures. Contraindicated in persons showing hypersensitivity to any component of this preparation.
Tropicamide ophthalmic solution, USP, 0.5% is supplied in an LDPE plastic bottle with a dropper tip as: STORAGE Store at 8° to 25°C (46° to 77°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. After opening, this product can be used until the expiration date on the bottle.
Abbreviated New Drug Application
TROPICAMIDE- TROPICAMIDE SOLUTION/ DROPS SANDOZ INC ---------- TROPICAMIDE OPHTHALMIC SOLUTION, USP RX ONLY DESCRIPTION Tropicamide Ophthalmic Solution, USP, 0.5% is an anticholinergic prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure: Established name: Tropicamide ophthalmic solution Chemical name: Benzeneacetamide, _N_-ethyl-α-(hydroxymethyl)-_N_-(4-pyridinylmethyl)-. EACH ML CONTAINS: ACTIVE: tropicamide 0.5%. PRESERVATIVE: benzalkonium chloride 0.01%. INACTIVES: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water. pH 4.0 - 5.8. CLINICAL PHARMACOLOGY This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil (mydriasis). The stronger preparation (1%) also paralyzes accommodation. This preparation acts in 15 to 30 minutes, and the duration of activity is approximately 3 to 8 hours. Complete recovery from mydriasis in some individuals may require 24 hours. The weaker strength may be useful in producing mydriasis with only slight cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides. INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures. CONTRAINDICATIONS Contraindicated in persons showing hypersensitivity to any component of this preparation. WARNINGS For topical ophthalmic use only. Not for injection. This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered. Mydriatics may produce a transient elevation of intraocular pressure. Remove contact lenses before using. PRECAUTIONS GENERAL The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. INFORMATION FOR PATIENTS Do not touch dropper Soma hati kamili