Pilocarpine Hydrochloride Ophthalmic Solution USP (Sterile)

PILOCARPINE HYDROCHLORIDE  - pilocarpine hydrochloride solution/ drops 
Physicians Total Care, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Rx only

DESCRIPTION:

Pilocarpine Hydrochloride is a cholinergic prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structural formula:

Pilocarpine Hydrochloride 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 5 mg (0.5%); INACTIVES: Monobasic Sodium Phosphate, Hypromellose, Sodium Chloride, 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%.

Pilocarpine HCI 3%

EACH mL CONTAINS: ACTIVE: Pilocarpine Hydrochloride 30 mg (3%); INACTIVES: Monobasic Sodium Phosphate, Hypromellose, Edetate Disodium, Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (3.5 - 5.5). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.

Pilocarpine HCI 1%
Pilocarpine HCI 2%
Pilocarpine HCI 6%

EACH mL CONTAINS: ACTIVE: Pilocarpine Hydrochloride 10 mg (1%), 20 mg (2%) or 60 mg (6%); INACTIVES: Monobasic Sodium Phosphate, Hypromellose, 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%.

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%.

CLINICAL PHARMACOLOGY:

The actions of pilocarpine hydrochloride are those of pilocarpine, a cholinergic substance. Its penetration, following topical application to the eye, results in parasympathomimetic reactions by responsive tissues.

INDICATIONS AND USAGE:

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.

CONTRAINDICATIONS:

Parasympathomimetics are contraindicated where miosis is undesirable such as acute iritis or pupillary block glaucoma.

This product is also contraindicated in persons hypersensitive to one or more of the components of this preparation.

WARNINGS:

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.

PRECAUTIONS:

This pilocarpine-induced miosis may cause difficulty in dark adaptation. The patient should exercise caution when involved in night driving or other hazardous activities in poor light.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

There have been no long-term studies done using pilocarpine in animals to evaluate carcinogenic potential.

Pregnancy Category C:

Animal studies have not been conducted with pilocarpine. It is also not known whether pilocarpine can cause fetal harm when administered to a pregnant women or can affect reproduction capacity. Pilocarpine should be given to a pregnant women only if clearly needed.

Nursing Mothers:

It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pilocarpine is administered to a nursing woman.

ADVERSE REACTIONS:

OCULAR: Transient symptoms of stinging and burning may occur. Ciliary spasm, conjunctival vascular congestion, temporal or supraorbital headache, lacrimation and induced myopia may occur. This is especially true in younger individuals who have recently started administration. Reduced visual acuity in poor illumination is frequently experienced by older individuals and individuals with lens opacity. Miotic agents may also cause retinal detachment; thus, care should be exercised with all miotic therapy especially in young myopic patients. Lens opacity may occur with prolonged use of pilocarpine.

SYSTEMIC: Systemic reactions following topical administration, although extremely rare, have included hypertension, tachycardia, bronchiolar spasm, pulmonary edema, salivation, sweating, nausea, vomiting, and diarrhea.

DOSAGE AND ADMINISTRATION:

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.

HOW SUPPLIED

Pilocarpine Hydrochloride Ophthalmic Solution USP is supplied in a plastic squeeze bottle with a controlled drop tip in the following strengths and sizes:

Pilocarpine HCl Ophthalmic Solution USP, 1%
15 mL - NDC 54868-1200-0
Pilocarpine HCl Ophthalmic Solution USP, 4%
15 mL - NDC 54868-1168-1

NOT FOR INJECTION.

FOR OPHTHALMIC USE ONLY.

STORAGE: Store between 15°- 30°C (59°- 86°F).

KEEP OUT OF REACH OF CHILDREN.

Revised August 2007

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated



Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK      74146

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 54868-1200-0

image of 15mL (1%) package label

Rx only

1% - 15 mL

Pilocarpine Hydrochloric Ophthalmic Solution USP, 1% (Sterile)







NDC 54868-1168-1

image of 15mL (4%) package label

Rx only

4% - 15 mL

Pilocarpine hydrochloric Ophthalmic Solution USP, 4% (Sterile)



PILOCARPINE HYDROCHLORIDE 
pilocarpine hydrochloride solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-1200(NDC:24208-676)
Route of AdministrationCONJUNCTIVALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PILOCARPINE HYDROCHLORIDE (PILOCARPINE) PILOCARPINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE 
HYPROMELLOSES 
EDETATE DISODIUM 
WATER 
SODIUM HYDROXIDE 
HYDROCHLORIC ACID 
BENZALKONIUM CHLORIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:54868-1200-01 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
115 mL in 1 BOTTLE, PLASTICThis package is contained within the CARTON (54868-1200-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/15/201001/11/2013

PILOCARPINE HYDROCHLORIDE 
pilocarpine hydrochloride solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-1168(NDC:24208-686)
Route of AdministrationCONJUNCTIVALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PILOCARPINE HYDROCHLORIDE (PILOCARPINE) PILOCARPINE HYDROCHLORIDE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE 
HYPROMELLOSES 
EDETATE DISODIUM 
WATER 
SODIUM HYDROXIDE 
HYDROCHLORIC ACID 
BENZALKONIUM CHLORIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:54868-1168-11 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
115 mL in 1 BOTTLE, PLASTICThis package is contained within the CARTON (54868-1168-1)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other10/07/201101/11/2013

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel, relabel

Revised: 01/2013 Physicians Total Care, Inc.