Pilocarpine Hydrochloride

Akorn
Human Prescription Drug
NDC 17478-223

Pilocarpine Hydrochloride is a human prescription drug labeled by 'Akorn'. National Drug Code (NDC) number for Pilocarpine Hydrochloride is 17478-223. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Pilocarpine Hydrochloride drug includes Pilocarpine Hydrochloride - 10 mg/mL . The currest status of Pilocarpine Hydrochloride drug is Active.

Drug Information:

Drug NDC:	17478-223
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Pilocarpine Hydrochloride
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Pilocarpine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Akorn
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution/ Drops
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	PILOCARPINE HYDROCHLORIDE - 10 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	OPHTHALMIC
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	28 Sep, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	21 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA204398
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Akorn
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1000647 1000862 1000897
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0317478226123 0317478224129 0317478223122
UPC stands for Universal Product Code.
UNII:	0WW6D218XJ
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Cholinergic Agonists [MoA] Cholinergic Muscarinic Agonists [MoA] Cholinergic Receptor Agonist [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
17478-223-12	1 BOTTLE, DROPPER in 1 CARTON (17478-223-12) / 15 mL in 1 BOTTLE, DROPPER	28 Sep, 2017	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Pilocarpine Hydrochloride

Tablet, Film Coated
American Health Packaging
NDC: 68084-928

Isopto Carpine

Pilocarpine Hydrochloride

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Alcon Laboratories, Inc.
NDC: 0998-0203

Pilocarpine Hydrochloride

Tablet, Film Coated
Actavis Pharma, Inc.
NDC: 0228-2837

Salagen

Isopto Carpine

Pilocarpine Hydrochloride

Solution/ Drops
Alcon Laboratories, Inc.
NDC: 0998-0204

Product Elements:

Pilocarpine hydrochloride pilocarpine hydrochloride pilocarpine hydrochloride pilocarpine hypromellose, unspecified boric acid sodium chloride sodium citrate, unspecified form hydrochloric acid sodium hydroxide water benzalkonium chloride pilocarpine hydrochloride pilocarpine hydrochloride pilocarpine hydrochloride pilocarpine hypromellose, unspecified boric acid sodium citrate, unspecified form hydrochloric acid sodium hydroxide water benzalkonium chloride pilocarpine hydrochloride pilocarpine hydrochloride pilocarpine hydrochloride pilocarpine hypromellose, unspecified boric acid sodium citrate, unspecified form hydrochloric acid sodium hydroxide water benzalkonium chloride

Indications and Usage:

1 indications and usage pilocarpine hydrochloride ophthalmic solution is indicated for the: pilocarpine hydrochloride ophthalmic solution is a muscarinic cholinergic agonist indicated for 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 ) 1.1 reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension 1.2 management of acute angle-closure glaucoma 1.3 prevention of postoperative elevated iop associated with laser surgery 1.4 induction of miosis

Warnings and Cautions:

5 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 ). 5.1 poor illumination patients should be advised to exercise caution in night driving and other hazardous occupations in poor illumination. in addition, miotics may cause accommodative spasm. patients should be advised not to drive or use machinery if vision is not clear. 5.2 pre-existing retinal disease as with all miotics, rare cases of retinal detachment have been reported when used in certain su Read more...

sceptible individuals and those with pre-existing retinal disease; therefore, a thorough examination of the retina including funduscopy is advised in all patients prior to the initiation of therapy. 5.3 iritis pilocarpine hydrochloride ophthalmic solution is not recommended to be used when iritis is present. 5.4 primary congenital glaucoma caution is advised when using pilocarpine hydrochloride ophthalmic solution in pediatric patients with primary congenital glaucoma for control of intraocular pressure (iop) as cases of a paradoxical increase in iop have been reported. in addition, the use of pilocarpine hydrochloride ophthalmic solution is not recommended in pediatric patients diagnosed with glaucoma secondary to anterior segment dysgenesis or uveitis (especially if uveitis is active). 5.5 contact lens wear contact lens wearers should be advised to remove their lenses prior to the instillation of pilocarpine hydrochloride ophthalmic solution and to wait 10 minutes after dosing before reinserting their contact lenses.

Dosage and Administration:

2 dosage and administration instill one drop in the eye(s) up to four times daily ( 2 ). 2.1 reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension one drop of pilocarpine hydrochloride ophthalmic solution 1%, 2% or 4% should be applied topically in the eye(s) up to four times daily. pilocarpine-naÃ¯ve patients should be started on the 1% concentration as higher concentrations are often not tolerated initially. the frequency of instillation and concentration of pilocarpine hydrochloride ophthalmic solution are determined by the severity of the elevated intraocular pressure and miotic response of the patient. to limit systemic exposure to pilocarpine, patients may be instructed to perform punctal occlusion for 2 minutes after instillation of pilocarpine hydrochloride ophthalmic solution. 2.2 management of acute angle-closure glaucoma prior to pilocarpine hydrochloride ophthalmic solution use, treatment with secretory suppressants a Read more...

nd hyperosmotic agents may be needed to lower iop below 50 mmhg and relieve iris ischemia. for initial management of acute angle-closure glaucoma, one drop of pilocarpine hydrochloride ophthalmic solution 1% or 2% may be applied topically in the eye(s) up to three times over a 30-minute period. if laser iridoplasty or iridomy is used to break the attack, one drop of pilocarpine hydrochloride ophthalmic solution 4% should be administered prior to the procedure. following laser iridoplasty, one drop of pilocarpine hydrochloride ophthalmic solution 1% should be administered four times daily until an iridotomy can be performed. 2.3 prevention of postoperative elevated iop associated with laser surgery one drop of pilocarpine hydrochloride ophthalmic solution 1%, 2% or 4% (or two drops administered five minutes apart) should be applied topically in the eye(s) 15 to 60 minutes prior to surgery. 2.4 induction of miosis one drop of pilocarpine hydrochloride ophthalmic solution 1%, 2% or 4% (or two drops administered five minutes apart) should be applied topically in the eye(s). 2.5 use with other topical ophthalmic medications pilocarpine hydrochloride ophthalmic solution may be used in combination with beta-blockers, carbonic anhydrase inhibitors, sympathomimetics or hyperosmotic agents. if more than one topical ophthalmic drug is being used, the drugs should be administered at least five ( 5 ) minutes apart. 2.6 use in pediatric patients in children under 2 years of age, one drop of pilocarpine hydrochloride ophthalmic solution 1% should be applied topically in the eye(s) three times daily. children 2 years of age and over should be dosed as for adults. for the induction of miosis prior to goniotomy or trabeculotomy in children, one drop of pilocarpine hydrochloride ophthalmic solution 1% or 2% should be applied topically in the eye 15 to 60 minutes prior to surgery.

Dosage Forms and Strength:

3 dosage forms and strengths bottle filled with 15 ml of 1% (10 mg/ml), 2% (20 mg/ml) or 4% (40 mg/ml) pilocarpine hydrochloride sterile ophthalmic solution. solution containing 1% (10 mg/ml), 2% (20 mg/ml) or 4% (40 mg/ml) pilocarpine hydrochloride ( 3 )

Contraindications:

4 contraindications none. none.

Adverse Reactions:

6 adverse reactions most common adverse reactions are headache/browache, accommodative change, eye irritation, eye pain, blurred vision, and/or visual impairment ( 6 ). to report suspected adverse reactions, contact akorn operating company llc at 1-800-932-5676 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. clinical studies experience because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. the safety data described below reflect exposure in four controlled clinical trials of 90 days to 2 years duration in 317 patients diagnosed with open-angle glaucoma or ocular hypertension. in the four clinical trials, patients were treated with pilocarpine hydrochloride ophthalmic solution 2%, two to four times daily or with pilocarpine 1%, 1.75% or 2% in fixed combination with betaxolol 0.25 Read more...

%, two or three times daily. the most frequently reported adverse reactions occurring in â¥ 5% of patients in the pilocarpine 2% populations were: headache/browache, accommodative change, blurred vision, eye irritation, visual impairment (dim, dark, or âjumpingâ vision), and eye pain. the adverse reaction profile reported for the use of pilocarpine hydrochloride ophthalmic solution in pediatric patients is comparable to that seen in adult patients.

Use in Specific Population:

8 use in specific populations 8.1 pregnancy 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. 8.3 nursing mothers 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. 8.4 pediatric use safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established. 8.5 geriatric use no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Use in Pregnancy:

8.1 pregnancy 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.

Pediatric Use:

8.4 pediatric use safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established.

Geriatric Use:

8.5 geriatric use no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Overdosage:

10 overdosage systemic toxicity following topical ocular administration of pilocarpine is rare, but occasionally patients who are sensitive may develop sweating and gastrointestinal overactivity following the suggested dosage and administration. overdosage can produce sweating, salivation, nausea, tremors and slowing of the pulse and a decrease in blood pressure. in moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration. for patients demonstrating severe poisoning, atropine, the pharmacologic antagonist to pilocarpine, should be used.

Description:

11 description pilocarpine hydrochloride ophthalmic solution, usp is a cholinergic agonist prepared as a sterile topical ophthalmic solution. the active ingredient is represented by the chemical structure: established name: pilocarpine hydrochloride chemical name: 2(3 h )-furanone, 3-ethyldihydro-4-[(1-methyl-1 h -imidazol-5-yl)-methyl]-monohydrochloride, (3s- cis )-. molecular formula: c 11 h 16 n 2 o 2 â¢ hcl molecular weight: 244.72 each ml of pilocarpine hydrochloride ophthalmic solution, usp contains: active: pilocarpine hydrochloride 1% (10 mg/ml), 2% (20 mg/ml), or 4% (40 mg/ml). preservative: benzalkonium chloride 0.01%. inactives: hypromellose (2910) 5 mg (0.5%), boric acid, sodium citrate, sodium chloride (present in 1% only); hydrochloric acid and/or sodium hydroxide (to adjust ph); water for injection. pilocarpine hydrochloride ophthalmic solution, usp has a ph of 3.5 to 5.5 and an osmolality of 270 to 350 mosm/kg (1% product), 290 to 350 mosm/kg (2% product) and 500 to 600 mosm/kg (4% product). structural formula

Clinical Pharmacology:

12 clinical pharmacology 12.1 mechanism of action pilocarpine hydrochloride is a direct acting cholinergic parasympathomimetic agent which acts through direct stimulation of muscarinic receptors and smooth muscle such as the iris and secretory glands. pilocarpine contracts the ciliary muscle, causing increased tension on the scleral spur and opening of the trabecular meshwork spaces to facilitate outflow of aqueous humor. outflow resistance is reduced, lowering intraocular pressure (iop). pilocarpine also produces miosis through contraction of the iris sphincter muscle. miosis relieves appositional angle narrowing and closure, which lowers iop in certain types of angle-closure glaucoma. 12.3 pharmacokinetics systemic exposure to pilocarpine was evaluated in 14 healthy subjects administered 2 drops of pilocarpine hydrochloride ophthalmic solution 4% to both eyes four times daily for eight days. a comparison of c max values on days 5 and 8 indicated that pilocarpine concentrations in pla Read more...

sma reached steady-state following topical administration of pilocarpine hydrochloride ophthalmic solution 4%. the mean (sd) c max and auc 0-last values on day 8 were 3.7 (3.2) ng/ml and 7.7 (8.4) ngÃhour/ml, respectively. the t max values on day 8 ranged from 0.5 to 1 hour.

Mechanism of Action:

12.1 mechanism of action pilocarpine hydrochloride is a direct acting cholinergic parasympathomimetic agent which acts through direct stimulation of muscarinic receptors and smooth muscle such as the iris and secretory glands. pilocarpine contracts the ciliary muscle, causing increased tension on the scleral spur and opening of the trabecular meshwork spaces to facilitate outflow of aqueous humor. outflow resistance is reduced, lowering intraocular pressure (iop). pilocarpine also produces miosis through contraction of the iris sphincter muscle. miosis relieves appositional angle narrowing and closure, which lowers iop in certain types of angle-closure glaucoma.

Pharmacokinetics:

12.3 pharmacokinetics systemic exposure to pilocarpine was evaluated in 14 healthy subjects administered 2 drops of pilocarpine hydrochloride ophthalmic solution 4% to both eyes four times daily for eight days. a comparison of c max values on days 5 and 8 indicated that pilocarpine concentrations in plasma reached steady-state following topical administration of pilocarpine hydrochloride ophthalmic solution 4%. the mean (sd) c max and auc 0-last values on day 8 were 3.7 (3.2) ng/ml and 7.7 (8.4) ngÃhour/ml, respectively. the t max values on day 8 ranged from 0.5 to 1 hour.

Nonclinical Toxicology:

13 nonclinical toxicology 13.1 carcinogenesis, mutagenesis, impairment of fertility there have been no long-term studies done using pilocarpine hydrochloride in animals to evaluate carcinogenic potential.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

13.1 carcinogenesis, mutagenesis, impairment of fertility there have been no long-term studies done using pilocarpine hydrochloride in animals to evaluate carcinogenic potential.

Clinical Studies:

14 clinical studies in clinical trials reported in the medical literature, pilocarpine ophthalmic solution reduced intraocular pressure (iop) by 3 to 7 mmhg in patients with open-angle glaucoma. pilocarpine ophthalmic solution has also been shown to be effective in the induction of miosis, in the prevention of postoperative elevated iop, and in the management of acute angle-closure glaucoma.

How Supplied:

16 how supplied/storage and handling pilocarpine hydrochloride ophthalmic solution, usp 1%, 2% and 4% is supplied sterile in white low density polyethylene plastic ophthalmic bottles and natural low density polyethylene tips with green polypropylene caps. 15 ml in 15 ml bottles 1% - ndc 17478-223-12 2% - ndc 17478-224-12 4% - ndc 17478-226-12 storage: store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. protect from freezing. keep tightly closed.

Information for Patients:

17 patient counseling information 17.1 avoiding contamination of the product do not touch dropper tip to any surface, as this may contaminate the contents. 17.2 night driving caution is advised with night driving and when hazardous activities are undertaken in poor illumination. 17.3 accommodative spasm pilocarpine hydrochloride ophthalmic solution may cause problems when changing focus between near objects and distant objects. do not drive or use machinery if vision is not clear. 17.4 contact lens wear contact lens should be removed prior to the instillation of pilocarpine hydrochloride ophthalmic solution. wait 10 minutes after dosing before reinserting contact lenses. 17.5 concomitant topical ocular therapy if more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. 17.6 systemic exposure to limit exposure to pilocarpine to the eye alone, close eyes gently and apply pressure with finger to the corner of eye by the nose f Read more...

or 2 minutes after instillation of pilocarpine hydrochloride ophthalmic solution. rx only akorn distributed by: akorn operating company llc gurnee, il 60031 pc00n rev. 03/22

Package Label Principal Display Panel:

Principal display panel text for container label: ndc 17478-223-12 pilocarpine hcl ophthalmic solution, usp 1% for use in the eyes only eye logo rx only principal display panel text for container label

Principal display panel text for carton label: ndc 17478-223-12 pilocarpine hydrochloride ophthalmic solution, usp 1% for use in the eyes only eye logo sterile 15 ml rx only akorn logo principal display panel text for carton label

Principal display panel text for container label: ndc 17478-224-12 pilocarpine hcl ophthalmic solution, usp 2% for use in the eyes only eye logo rx only principal display panel text for container label

Principal display panel text for carton label: ndc 17478-224-12 pilocarpine hydrochloride ophthalmic solution, usp 2% for use in the eyes only eye logo sterile 15 ml rx only akorn logo principal display panel text for carton label

Principal display panel text for container label: ndc 17478-226-12 pilocarpine hcl ophthalmic solution, usp 4% for use in the eyes only eye logo rx only principal display panel text for container label

Principal display panel text for carton label: ndc 17478-226-12 pilocarpine hydrochloride ophthalmic solution, usp 4% for use in the eyes only eye logo sterile 15 ml rx only akorn logo principal display panel text for carton label

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