Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL Solution/ Drops — NDC 60219-2649-1 (Billing 60219-2649-01)
This is a package of Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL Solution/ Drops from Amneal Pharmaceuticals NY LLC, marketed since Sep 2025 and currently FDA-listed; retail pharmacies pay about $19.39 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 60219-2649-1 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 60219 labeler · 2649 product · 1 package
- Package marketed since
- Sep 1, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0360219264915, 0360219236622
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 082789
- GCN: 51425
- GPI-14 (Medi-Span): 86501030102017
- HICL (First Databank): 005198
- AHFS class code: 12:04.00.00
- RxCUI (RxNorm): 2584552
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Cholinergic Receptor Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Pilocarpine ophthalmic is used to treat glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision) and ocular hypertension (a condition which causes increased pressure in the eye). Pilocarpine ophthalmic is also used to prevent or reduce increased pressure in the eye during and after certain types of laser eye surgery. It is also used during an eye exam to constrict (close) the pupil (the black part of the eye through which you see). Pilocarpine ophthalmic (Vuity, Qlosi) is used to treat presbyopia (a condition in which the lens of the eye loses its abilit...
Read the full MedlinePlus article ↗- It depends on the product. Eye drops are used for glaucoma, raised eye pressure or presbyopia, depending on the brand. Tablets treat dry mouth from head and neck radiation or Sjogr...
- Eye drops go in the eye and tablets are swallowed. Schedules vary by product, so follow your prescriber and your label. For dry mouth, it can take weeks to know if the tablets are...
- With tablets, sweating is the most common, along with nausea, runny nose, diarrhea and chills. Eye forms can blur your vision, especially at night. Call your doctor if effects are...
- Use extra caution. Tablets should not be used with uncontrolled asthma. With controlled asthma, COPD, chronic bronchitis or significant heart disease, you would need close supervis...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $19.391 | $96.96 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $18.47 | $92.35 / 5 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 60219-2649-01 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER | 2025-09-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mLthis 60219-2649-01 | Amneal | 1 bottle | $19.391 | — | Availability likely | — |
| Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL 60219-2366-02 | Amneal | 1 bottle | $24.740 | — | Availability likely | +28% |
| Vuity 12.5 mg/mL 00074-7098-01 | AbbVie | 1 bottle | — | — | Discontinued | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Pilocarpine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII R57ZHV85D4
Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Amneal Pharmaceuticals NY LLC labeler code 60219
- Deflazacort 36 mg Tablet NDC 60219-2285-1
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- prednisolone acetate 10 mg/mL Suspension/ Drops NDC 60219-2550-1
- prednisolone acetate 10 mg/mL Suspension/ Drops NDC 60219-2551-1
- prednisolone acetate 10 mg/mL Suspension/ Drops NDC 60219-2552-1
- Sildenafil 10 mg/mL Powder, For Suspension NDC 60219-2651-1
- Fosfomycin Tromethamine 3 g Granule, For Solution NDC 60219-3955-1
- Fenofibrate 54 mg Tablet NDC 60219-5511-9
- Fenofibrate 160 mg Tablet NDC 60219-5522-5
- Pilocarpine Hydrochloride 5 mg Tablet, Film Coated NDC 60219-5922-1
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Pilocarpine hydrochloride ophthalmic solution is indicated for the treatment of presbyopia in adults. Pilocarpine hydrochloride is a cholinergic muscarinic receptor agonist indicated for the treatment of presbyopia in adults. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended dosage of pilocarpine hydrochloride ophthalmic solution is one drop in each eye once daily. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart. Instill one drop of pilocarpine hydrochloride ophthalmic solution 1.25% in each eye once daily. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Pilocarpine hydrochloride ophthalmic solution, USP is a clear, colorless, sterile ophthalmic solution containing 1.25% (12.5 mg/mL) of pilocarpine hydrochloride. Ophthalmic solution containing pilocarpine hydrochloride USP, 1.25%. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Pilocarpine hydrochloride ophthalmic solution is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients. Hypersensitivity. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Blurred Vision : Patients should be advised not to drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous activities in poor illumination. ( 5.1 ) Risk of Retinal Detachment : Rare cases of retinal detachment and retinal tear have been reported with miotics, including pilocarpine hydrochloride ophthalmic solution.
Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters or vision loss.
( 5.2 ) Iritis : Caution is advised in patients with iritis. ( 5.3 )
5.1Blurred Vision Miotics, including pilocarpine hydrochloride ophthalmic solution, may cause accommodative spasm. Patients should be advised not to drive or operate machinery if vision is not clear (e.g., blurred vision). In addition, patients may experience temporary dim or dark vision with miotics, including pilocarpine hydrochloride ophthalmic solution.
Patients should be advised to exercise caution in night driving and other hazardous activities in poor illumination.
5.2Risk of Retinal Detachment Rare cases of retinal detachment and retinal tear have been reported with miotics, including pilocarpine hydrochloride ophthalmic solution. Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to the initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters or vision loss.
5.3Iritis Pilocarpine hydrochloride ophthalmic solution is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and the lens.
5.4Use with Contact Lenses 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.
5.5Potential for Eye Injury or Contamination To prevent eye injury or contamination, care should be taken to avoid touching the dispensing bottle to the eye or to any other surface.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Contraindications ( 4) ] Most common adverse reactions (> 5%) are headache, conjunctival hyperemia and eye irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials 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. Pilocarpine hydrochloride ophthalmic solution dosed once daily was evaluated in 375 participants with presbyopia in two randomized, double-masked, vehicle-controlled studies (GEMINI 1 and GEMINI 2) of 30 days duration. The most common adverse reactions reported in > 5% of participants were headache and conjunctival hyperemia.
Ocular adverse reactions reported in 1% to 5% of participants were blurred vision, eye pain, visual impairment, eye irritation and increased lacrimation.
6.2Post-marketing Experience The following adverse reactions have been identified during post-approval use of pilocarpine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to pilocarpine hydrochloride ophthalmic solution exposure. Eye disorders: vitreous detachment, vitreomacular traction, retinal tear, retinal detachment.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of pilocarpine hydrochloride ophthalmic solution administration in pregnant women to inform a drug-associated risk. Oral administration of pilocarpine to pregnant rats throughout organogenesis and lactation did not produce adverse effects at clinically relevant doses. Data Human Data No adequate and well-controlled trials of pilocarpine hydrochloride ophthalmic solution have been conducted in pregnant women.
In a retrospective case series of 15 women with glaucoma, 4 patients used ophthalmic pilocarpine either pre-pregnancy, during pregnancy or postpartum. There were no adverse effects observed in patients or in their infants. Animal Data In embryofetal development studies, oral administration of pilocarpine to pregnant rats throughout organogenesis produced maternal toxicity, skeletal anomalies and reduction in fetal body weight at 90 mg/kg/day (approximately 485-fold higher than the maximum human ophthalmic dose [MHOD] of 0.015 mg/kg/day, on a mg/m 2 basis).
In a peri-/postnatal study in rats, oral administration of pilocarpine during late gestation through lactation increased stillbirths at a dose of 36 mg/kg/day (approximately 195-fold higher than the MHOD). Decreased neonatal survival and reduced mean body weight of pups were observed at ≥ 18 mg/kg/day (approximately 100 times the maximum human ophthalmic dose of pilocarpine hydrochloride ophthalmic solution).
8.2Lactation Risk Summary There is no information regarding the presence of pilocarpine in human milk, the effects on the breastfed infants or the effects on milk production to inform risk of pilocarpine hydrochloride ophthalmic solution to an infant during lactation. Pilocarpine and/or its metabolites are excreted in the milk of lactating rats. Systemic levels of pilocarpine following topical ocular administration are low [see Clinical Pharmacology ( 12.3) ] and it is not known whether measurable levels of pilocarpine would be present in maternal milk following topical ocular administration.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pilocarpine hydrochloride ophthalmic solution and any potential adverse effects on the breastfed child from pilocarpine hydrochloride ophthalmic solution. Data Animal Data Following a single oral administration of 14 C-pilocarpine to lactating rats, the radioactivity concentrations in milk were similar to those in plasma.
8.4Pediatric Use Presbyopia does not occur in the pediatric population.
8.5Geriatric Use Clinical studies of pilocarpine hydrochloride ophthalmic solution did not include participants aged 65 and over to determine whether they respond differently from younger participants. Other reported clinical experience with ophthalmic pilocarpine solutions have not identified overall differences in safety between elderly and younger participants.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of pilocarpine hydrochloride ophthalmic solution administration in pregnant women to inform a drug-associated risk. Oral administration of pilocarpine to pregnant rats throughout organogenesis and lactation did not produce adverse effects at clinically relevant doses. Data Human Data No adequate and well-controlled trials of pilocarpine hydrochloride ophthalmic solution have been conducted in pregnant women.
In a retrospective case series of 15 women with glaucoma, 4 patients used ophthalmic pilocarpine either pre-pregnancy, during pregnancy or postpartum. There were no adverse effects observed in patients or in their infants. Animal Data In embryofetal development studies, oral administration of pilocarpine to pregnant rats throughout organogenesis produced maternal toxicity, skeletal anomalies and reduction in fetal body weight at 90 mg/kg/day (approximately 485-fold higher than the maximum human ophthalmic dose [MHOD] of 0.015 mg/kg/day, on a mg/m 2 basis).
In a peri-/postnatal study in rats, oral administration of pilocarpine during late gestation through lactation increased stillbirths at a dose of 36 mg/kg/day (approximately 195-fold higher than the MHOD). Decreased neonatal survival and reduced mean body weight of pups were observed at ≥ 18 mg/kg/day (approximately 100 times the maximum human ophthalmic dose of pilocarpine hydrochloride ophthalmic solution).
🧒 Pediatric Use ▾
8.4Pediatric Use Presbyopia does not occur in the pediatric population.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of pilocarpine hydrochloride ophthalmic solution did not include participants aged 65 and over to determine whether they respond differently from younger participants. Other reported clinical experience with ophthalmic pilocarpine solutions have not identified overall differences in safety between elderly and younger participants.
🆘 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. Accidental ingestion 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Pilocarpine hydrochloride is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle. Pilocarpine hydrochloride contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light. Pilocarpine hydrochloride also contracts the ciliary muscle and may shift the eye to a more myopic state.
12.3Pharmacokinetics Systemic exposure to pilocarpine was evaluated in 22 participants with presbyopia who were administered 1 drop of pilocarpine hydrochloride ophthalmic solution in each eye once daily for 30 days (GEMINI 1). The mean (SD) C max and AUC values from time 0 to last measurable concentration over 10-hour period post-last dose on Day 30 were 1.95 (0.98) ng/mL and 4.14 (2.16) ng·hr/mL, respectively. The median T max value on Day 30 was 0.3 hours post-dose with a range from 0.2 hours to 0.5 hours post-dose.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Pilocarpine hydrochloride is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle. Pilocarpine hydrochloride contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light. Pilocarpine hydrochloride also contracts the ciliary muscle and may shift the eye to a more myopic state.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Pilocarpine Hydrochloride Ophthalmic Solution USP, 1.25% is supplied as a sterile, clear, colorless solution filled in low density polyethylene white opaque bottle and low density polyethylene white opaque nozzle with, dark green colored high density polyethylene cap. It is available as follows: 2.5 mL in 5 mL Bottle (Filled to 1/2 Capacity): NDC 60219-2366-2 5 mL in 5 mL Bottle: NDC 60219-2649-1 Storage Store at 15° to 25°C (59° to 77°F). After opening, pilocarpine hydrochloride ophthalmic solution, USP can be used until the expiration date on the bottle.
📋 Description ▾
11 DESCRIPTION Pilocarpine hydrochloride ophthalmic solution USP, 1.25% is a cholinergic muscarinic receptor agonist prepared as an isotonic, clear, colorless, sterile ophthalmic solution containing 1.25% of pilocarpine hydrochloride, USP. The chemical name for pilocarpine hydrochloride, USP is (3S,4R)-3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]-oxolan-2-one hydrochloride. Its molecular weight is 244.72 g/mol and its molecular formula is C 11 H 16 N 2 O 2 · HCl.
Its structural formula is: Pilocarpine hydrochloride, USP is a white or almost white, crystalline powder or colorless crystals hygroscopic. It is very soluble in water and freely soluble in alcohol, slightly soluble in chloroform and insoluble in ether. Each mL of Pilocarpine Hydrochloride Ophthalmic Solution, USP contains: Active: Pilocarpine hydrochloride USP, 1.25% (12.5 mg) equivalent to 1.06% (10.6 mg) pilocarpine free-base.
Preservative: Benzalkonium chloride, 0.0075%. Inactives: Boric acid, sodium citrate dihydrate, sodium chloride, water for injection and may also include hydrochloric acid and/or sodium hydroxide for pH adjustment to between 3.5 and 5.5, if necessary. 1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Night Driving Pilocarpine hydrochloride ophthalmic solution may cause temporary dim or dark vision. Advise patients to exercise caution with night driving and when hazardous activities are undertaken in poor illumination [see Warnings and Precautions (5.1) ] . Accommodative Spasm Temporary problems when changing focus between near and distant objects may occur.
Advise patients not to drive or use machinery if vision is not clear (e.g., blurred vision) [see Warnings and Precautions (5.1) ] . When to Seek Physician Advice Advise patients to seek immediate medical care with sudden onset of flashing lights, floaters or vision loss [see Warnings and Precautions (5.2) ] . 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 [see Warnings and Precautions ( 5.4) ] . Avoiding Contamination of the Product Do not touch dropper tip to any surface, as this may contaminate the contents [see Warnings and Precautions ( 5.5) ] . Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.
Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.
06-2025-01
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Systemic exposure to pilocarpine was evaluated in 22 participants with presbyopia who were administered 1 drop of pilocarpine hydrochloride ophthalmic solution in each eye once daily for 30 days (GEMINI 1). The mean (SD) C max and AUC values from time 0 to last measurable concentration over 10-hour period post-last dose on Day 30 were 1.95 (0.98) ng/mL and 4.14 (2.16) ng·hr/mL, respectively. The median T max value on Day 30 was 0.3 hours post-dose with a range from 0.2 hours to 0.5 hours post-dose.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The efficacy of pilocarpine hydrochloride ophthalmic solution dosed once daily for the treatment of presbyopia was demonstrated in two 30-Day Phase 3, randomized, double-masked, vehicle-controlled studies, namely GEMINI 1 (NCT03804268) and GEMINI 2 (NCT03857542). A total of 750 participants aged 40 years to 55 years old with presbyopia were randomized (375 to pilocarpine hydrochloride ophthalmic solution group) in two studies and participants were instructed to administer one drop of pilocarpine hydrochloride ophthalmic solution or vehicle once daily in each eye.
In both studies, the proportion of participants gaining 3 lines or more in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA), without losing more than 1 line (5 letters) of corrected distance visual acuity (CDVA) with the same refractive correction was statistically significantly greater in the pilocarpine hydrochloride group compared to the vehicle group at Day 30, Hour 3 (see Table 1). Table 1: Primary Efficacy Results from GEMINI 1 and GEMINI 2 Studies (Intent-to-Treat Population) GEMINI 1 GEMINI 2 Pilocarpine Hydrochloride Ophthalmic Solution N=163 Vehicle N=160 p-value Pilocarpine Hydrochloride Ophthalmic Solution N=212 Vehicle N=215 p-value Proportion of participants gaining 3-lines or more in mesopic DCNVA, without losing more than 1 line (5 letters) of CDVA at Day 30, Hour 3 31% 8% p < 0.01 26% 11% p <
0.01Figures 1 and 2 present the proportion of participants who gained 3-lines or more in mesopic DCNVA at Day 30. Figure 1: Proportion of Participants Achieving 3-Lines or More Improvement in Mesopic, High Contrast, Binocular DCNVA at Day 30 in GEMINI 1 (Intent-to-Treat Population) Figure 2: Proportion of Participants Achieving 3-lines or More Improvement in Mesopic, High Contrast, Binocular DCNVA at Day 30 in GEMINI 2 (Intent-to-Treat Population) 1 2
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Pilocarpine did not induce tumors in mice at any dosage level studied (up to 30 mg/kg/day; approximately 80-times the MHOD). In rats, an oral dose of 18 mg/kg/day (approximately 100 times the MHOD), resulted in a statistically significant increase in the incidence of benign pheochromocytomas in both male and female rats and a statistically significant increase in the incidence of hepatocellular adenomas in female rats. Mutagenesis Pilocarpine did not show any potential to cause genetic toxicity in a series of studies that included: 1) bacterial assays (Salmonella and E. coli) for reverse gene mutations.
2) an in vitro chromosome aberration assay in a Chinese hamster ovary cell line. 3) an in vivo chromosome aberration assay (micronucleus test) in mice; and 4) a primary DNA damage assay (unscheduled DNA synthesis) in rat hepatocyte primary cultures. Impairment of Fertility Pilocarpine oral administration to male and female rats at a dosage of 18 mg/kg/day (100 times the MHOD) resulted in impaired reproductive function, including reduced fertility, decreased sperm motility and morphologic evidence of abnormal sperm.
It is unclear whether the reduction in fertility was due to effects on males, females or both. In dogs, exposure to pilocarpine at a dosage of 3 mg/kg/day for 6 months resulted in evidence of impaired spermatogenesis (approximately 55 times the MHOD).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Pilocarpine did not induce tumors in mice at any dosage level studied (up to 30 mg/kg/day; approximately 80-times the MHOD). In rats, an oral dose of 18 mg/kg/day (approximately 100 times the MHOD), resulted in a statistically significant increase in the incidence of benign pheochromocytomas in both male and female rats and a statistically significant increase in the incidence of hepatocellular adenomas in female rats. Mutagenesis Pilocarpine did not show any potential to cause genetic toxicity in a series of studies that included: 1) bacterial assays (Salmonella and E. coli) for reverse gene mutations.
2) an in vitro chromosome aberration assay in a Chinese hamster ovary cell line. 3) an in vivo chromosome aberration assay (micronucleus test) in mice; and 4) a primary DNA damage assay (unscheduled DNA synthesis) in rat hepatocyte primary cultures. Impairment of Fertility Pilocarpine oral administration to male and female rats at a dosage of 18 mg/kg/day (100 times the MHOD) resulted in impaired reproductive function, including reduced fertility, decreased sperm motility and morphologic evidence of abnormal sperm.
It is unclear whether the reduction in fertility was due to effects on males, females or both. In dogs, exposure to pilocarpine at a dosage of 3 mg/kg/day for 6 months resulted in evidence of impaired spermatogenesis (approximately 55 times the MHOD).
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 60219-2366-2 Pilocarpine Hydrochloride Ophthalmic Solution USP, 1.25% (2.5 mL) Rx onl y Amneal Pharmaceuticals LLC NDC 60219-2649-1 Pilocarpine Hydrochloride Ophthalmic Solution USP, 1.25% (5 mL) Rx onl y Amneal Pharmaceuticals LLC 1 1 1 1