pilocarpine hydrochloride
Pilocarpine Hydrochloride is a cholinergic receptor agonist used to treat Head and Neck Neoplasms, Xerostomia, Angle-Closure Glaucoma, Mydriasis.
Cholinergic Receptor Agonist · by Somerset Theraps LLC
Generic of Isopto Carpine
Key facts
- Active ingredient
- Pilocarpine Hydrochloride
- Drug class
- Cholinergic Receptor Agonist
- Form
- Drops, Tablet
- Strength
- Pilocarpine Hydrochloride 1% · Pilocarpine Hydrochloride 2% · Pilocarpine Hydrochloride 4%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Somerset Theraps LLC
- What the pharmacy pays
- ~$0.38 per ml — not your price
- FDA application
- ANDA210384
What is Pilocarpine Hydrochloride?
From the FDA label:Pilocarpine hydrochloride ophthalmic solution is a cholinergic agonist prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure: Molecular 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 • HCl Molecular Weight: 244.72. Each mL of pilocarpine hydrochloride ophthalmic solution 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, 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 has a pH of 3.5 to 5.5 and an osmolality of 290 to 350 mOsm/kg (1% and 2% products) and 500 to 600 mOsm/kg (4% product). Image
How to use
Pilocarpine Hydrochloride is sold in more than one form (Drops and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA210384 — follow the label that came with the product you were actually prescribed.
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-naïve 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 and 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…
Side effects
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%, two or three times daily. The most frequently reported adverse reactions occurring in ≥ 5% of patients in the pilocarpine 2% populations were: headache/browache, accommodative change, blurred vision, eye irritation, visual impairment (dim, dark, or "jumping" 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. Most common adverse reactions are headache/browache, accommodative change, eye irritation, eye pain, blurred vision, and/or visual impairment (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at…
Warnings
Important safety information
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 susceptible 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.
Who should not take Pilocarpine Hydrochloride
None. None.
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
How this class works, per Muscarinic Agonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Pilocarpine Hydrochloride ranks — best-rated cholinergic receptor agonist for:
Dosage forms
Drops and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Pilocarpine Hydrochloride treat?
- Pilocarpine Hydrochloride (Pilocarpine Hydrochloride) may be used to treat head and neck neoplasms, xerostomia, angle-closure glaucoma, mydriasis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Pilocarpine Hydrochloride work?
- Pilocarpine Hydrochloride is a cholinergic receptor agonist. Cholinergic receptor agonists mimic acetylcholine and switch on its receptors, triggering the body's "rest and digest" responses. This boosts effects like saliva and tear flow, bladder and bowel emptying, and pupil constriction.
- How much does Pilocarpine Hydrochloride cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.38 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Pilocarpine Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Pilocarpine Hydrochloride. To pay less, Pilocarpine Hydrochloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Pilocarpine Hydrochloride?
- Pilocarpine Hydrochloride is marketed by Somerset Theraps LLC. You can see Somerset Theraps LLC's full profile, rating, and other products on pharmaranks.
- Is Pilocarpine Hydrochloride a brand-name or generic drug?
- Pilocarpine Hydrochloride is a generic medication; its active ingredient is Pilocarpine Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Pilocarpine Hydrochloride available over the counter?
- No. Pilocarpine Hydrochloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Pilocarpine Hydrochloride come in?
- Pilocarpine Hydrochloride is currently marketed as drops and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Pilocarpine Hydrochloride?
- Pilocarpine Hydrochloride is classified as cholinergic receptor agonist, per the FDA's Established Pharmacologic Class.
- Is Pilocarpine Hydrochloride FDA-registered?
- Pilocarpine Hydrochloride is on record with the U.S. FDA under application number ANDA210384. You can verify this on its official FDA label.
- Is Pilocarpine Hydrochloride safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Pilocarpine Hydrochloride. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Pilocarpine Hydrochloride?
- Pilocarpine Hydrochloride's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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