PILOCARPINE HYDROCHLORIDE- pilocarpine hydrochloride ophthalmic solution solution/ drops

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Cumpara asta acum

Ingredient activ:

PILOCARPINE HYDROCHLORIDE (UNII: 0WW6D218XJ) (PILOCARPINE - UNII:01MI4Q9DI3)

Disponibil de la:

Somerset Therapeutics, LLC

Calea de administrare:

OPHTHALMIC

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

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].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

                                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
                                
                                Citiți documentul complet
                                
                            

Căutați alerte legate de acest produs