国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
PILOCARPINE HYDROCHLORIDE (UNII: 0WW6D218XJ) (PILOCARPINE - UNII:01MI4Q9DI3)
Somerset Therapeutics, LLC
OPHTHALMIC
PRESCRIPTION DRUG
Pilocarpine hydrochloride ophthalmic solution, is indicated for the: None. Pregnancy. Category C. Animal reproduction studies have not been conducted with pilocarpine hydrochloride. It is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pilocarpine hydrochloride ophthalmic solution should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pilocarpine hydrochloride ophthalmic solution is administered to a nursing woman. Safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Pilocarpine hydrochloride ophthalmic solution USP, 1%, 2% and 4% is clear colorless solution supplied sterile in natural LDPE bottles plugged with natural LDPE nozzle and green coloured HDPE cap. 15 mL in 15 mL bottles 1%: NDC 70069-181 -01 2%: NDC 70069-191 -01 4%: NDC 70069-201 -01 STORAGE: Store between 15º to 25ºC (59º to 77ºF) and protect from freezing; [see USP Controlled Room Temperature].
Abbreviated New Drug Application
PILOCARPINE HYDROCHLORIDE - PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION SOLUTION/ DROPS SOMERSET THERAPEUTICS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION. PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION INITIAL U.S. APPROVAL: 1974 INDICATIONS AND USAGE Pilocarpine hydrochloride ophthalmic solution, USP is a muscarinic cholinergic agonist indicated for (1) The reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension (1.1) The management of acute angle-closure glaucoma (1.2) The prevention of postoperative elevated IOP associated with laser surgery (1.3) The induction of miosis (1.4) DOSAGE AND ADMINISTRATION Instill one drop in the eye(s) up to four times daily (2). DOSAGE FORMS AND STRENGTHS Solution containing 1% (10 mg/mL), 2% (20 mg/mL) or 4% (40 mg/mL) pilocarpine hydrochloride (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Poor illumination: Exercise caution in night driving and other hazardous occupations in poor illumination (5.1). Pre-existing retinal disease: Rare cases of retinal detachment have been reported; a thorough examination of the retina including funduscopy is advised in all patients prior to the initiation of therapy (5.2). Iritis: Caution is advised in patients with iritis. (5.3) Congenital glaucoma: Caution is advised in pediatric patients with primary congenital glaucoma for control of IOP as cases of a paradoxical increase in IOP have been reported. (5.4) ADVERSE REACTIONS Most common adverse reactions are headache/browache, accommodative change, eye irritation, eye pain, blurred vision, and/or visual impairment (6.1). (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOMERSET THERAPEUTICS, LLC AT 1-800- 417-9175 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH (6) SEE 17 FOR PATIENT COUNSELING INFORMA 阅读完整的文件