FDA records indicate that there are no current recalls for this drug.
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Pilocarpine Hydrochloride Solution/ Drops Recall
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Questions & Answers
Side Effects & Adverse Reactions
Not for internal use. To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Pilocarpine hydrochloride can be used in the medical management of glaucoma, especially open-angle glaucoma, in those cases in which the intraocular pressure can be controlled adequately by the topical administration of pilocarpine. In acute (closed-angle) glaucoma, pilocarpine hydrochloride may be used alone, or in combination with other cholinergic agents or carbonic anhydrase inhibitors, to relieve tension prior to emergency surgery.
Patients may be maintained on pilocarpine hydrochloride as long as intraocular pressure is controlled and there is no deterioration in the visual fields. The choice of concentration should be determined by the severity of the condition and the response of the patient. Pilocarpine hydrochloride is also indicated to counter the effects of cycloplegics and mydriatics following surgery or ophthalmoscopic examination.
History
There is currently no drug history available for this drug.
Other Information
Pilocarpine Hydrochloride is a cholinergic prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structural formula:
C11H16N2O2•HCl
Mol. Wt. 244.72
2(3H)-Furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl] - monohydrochloride, [3S-cis] -
Pilocarpine HCI 0.5%
EACH mL CONTAINS: ACTIVE: Pilocarpine Hydrochloride 10 mg (1%); INACTIVES: Hypromellose, boric acid, sodium citrate, sodium chloride, Purified Water. Sodium Hydroxide (added to adjust pH).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
Pilocarpine HCI 4%
EACH mL CONTAINS: ACTIVE: Pilocarpine Hydrochloride 40 mg (4%); INACTIVES: Hypromellose, Monobasic Sodium Phosphate, Edetate Disodium, Dibasic Sodium Phosphate, Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (3.5 - 5.5). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
Sources
Pilocarpine Hydrochloride Solution/ Drops Manufacturers
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Rebel Distributors Corp
Pilocarpine Hydrochloride Solution/ Drops | Rebel Distributors Corp
The initial dose is one or two drops in the affected eye(s). This may be repeated up to three or four times daily or as directed by a physician. The frequency of instillation and concentration of pilocarpine hydrochloride ophthalmic solution are determined by the severity of the glaucoma and miotic response of the patient. Individuals with heavily pigmented irides may require higher strengths.
During acute phases, the miotic must be instilled into the unaffected eye to prevent an attack of angle-closure glaucoma.
DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.
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