Product Details

PILOCARPINE HCL 4% O/S 15 ML

Manufacturer: SOMERSET THERAPEUTICS, LLC

MFG#: 70069-0201-01

NDC: 70069-0201-01

PID: 322243

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In Stock
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Additional Information

Product NamePilocarpine HCl 4% O/S 15 Ml
ApplicationMiotic Agent
Generic Drug NamePilocarpine HCl
Mechanism of ActionStimulates muscarinic receptors, increases aqueous humor outflow
Strength4%
TypeOphthalmic
Volume15 mL
Onset of Action10-30 minutes
Duration of Action4-8 hours
ContraindicationsUveitis, iritis, uncontrolled asthma, hypersensitivity to pilocarpine
Adverse EffectsBlurred vision, eye irritation, headache, accommodative spasm
PrecautionsUse caution in patients with cardiovascular disease, asthma, or GI disorders
Pregnancy CategoryC (Use if benefits outweigh risks)
Packaging15 mL bottle with dropper
IndicationsOpen-angle glaucoma, acute angle-closure glaucoma, ocular hypertension

Description

Pilocarpine Hydrochloride 4% Ophthalmic Solution is a miotic agent used to reduce intraocular pressure in conditions such as glaucoma and ocular hypertension. It acts as a cholinergic agonist, stimulating muscarinic receptors in the eye to induce pupillary constriction, increase aqueous humor outflow, and lower intraocular pressure.

Each milliliter of the solution contains 40 mg of pilocarpine hydrochloride in a sterile aqueous base. The formulation is intended for ophthalmic use only and should be applied as directed by a healthcare provider. Proper administration technique, including avoiding contamination of the dropper tip, is necessary to maintain sterility and prevent infection.

Adverse effects include ocular irritation, headache, blurred vision, eye pain, and possible accommodative spasm. Systemic absorption may lead to excessive cholinergic effects such as sweating, salivation, nausea, or bradycardia. Caution is required in patients with asthma, cardiovascular disease, or gastrointestinal disorders due to potential systemic effects.

Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind AT
DESI2 Drug Ind AT
Drug Category -
Drug Category -
Drug Type Code N
Drug Type Code N
FDA Approval Date 01/13/2020
FDA Approval Date 01/13/2020
FDA Therap Equiv ML
FDA Therap Equiv ML
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date 1
Unit 15
Unit 15
Units Per Pkg 11/25/2019
Units Per Pkg 11/25/2019
Active Ingredients 1694 pilocarpine HCl 54717
Active Ingredients 1694 pilocarpine HCl 54717
AHFS Class 52402000 MIOTICS
AHFS Class 52402000 MIOTICS
DEA Class NC
DEA Class NC
Dose Form DROPS
Dose Form DROPS
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 7826 pilocarpine HCl OPHTHALMIC DROPS 4 %
Gen Code and Des 7826 pilocarpine HCl OPHTHALMIC DROPS 4 %
Inactive Ingredients 2332 sodium citrate 68042; 3141 benzalkonium chloride 8001545
Inactive Ingredients 2332 sodium citrate 68042; 3141 benzalkonium chloride 8001545
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 4%
Strength 4%
Common Brand Name COMMON BRAND NAME(S): Isopto Carpine, Pilocar
Common Brand Name COMMON BRAND NAME(S): Isopto Carpine, Pilocar
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Allocation Period -
Case Quantity 240
Case Quantity 240
Drug Form Pack Size 15
Drug Form Pack Size 15
Form OPHTHALMIC SOL OR SUSP
Form OPHTHALMIC SOL OR SUSP
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AT Topical products therapeutically equivalent in same dosage form.
Orange Book AT Topical products therapeutically equivalent in same dosage form.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 15
Unit Size 15
How to Use HOW TO USE: To apply eye drops, wash your hands first. To avoid contamination, be careful not to touch the dropper to any surface or let it touch your eye. If you are wearing contact lenses, remove them before using eye drops. Wait at least 15 minutes before replacing your contact lenses. Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Let go of the eyelid and gently close your eyes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure for 1 to 2 minutes. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed or if your dose is for more than 1 drop. Remove extra solution around the eye with a tissue and wash your hands to remove any medicine that may be on them. Do not rinse the dropper. Replace the dropper cap after each use. If you are using another kind of eye medication (such as drops or ointments), wait at least 5 minutes before using the other medication. Use eye drops before ointments to allow the eye drops to enter the eye. If your doctor has prescribed this medication to treat glaucoma or high pressure in the eyes, use it regularly in order to get the most benefit from it. Most people with glaucoma or high pressure in the eyes do not have any symptoms. To help you remember, use it at the same time(s) each day.
How to Use HOW TO USE: To apply eye drops, wash your hands first. To avoid contamination, be careful not to touch the dropper to any surface or let it touch your eye. If you are wearing contact lenses, remove them before using eye drops. Wait at least 15 minutes before replacing your contact lenses. Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Let go of the eyelid and gently close your eyes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure for 1 to 2 minutes. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed or if your dose is for more than 1 drop. Remove extra solution around the eye with a tissue and wash your hands to remove any medicine that may be on them. Do not rinse the dropper. Replace the dropper cap after each use. If you are using another kind of eye medication (such as drops or ointments), wait at least 5 minutes before using the other medication. Use eye drops before ointments to allow the eye drops to enter the eye. If your doctor has prescribed this medication to treat glaucoma or high pressure in the eyes, use it regularly in order to get the most benefit from it. Most people with glaucoma or high pressure in the eyes do not have any symptoms. To help you remember, use it at the same time(s) each day.
Missed Dose MISSED DOSE: If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Missed Dose MISSED DOSE: If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as eye exams) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as eye exams) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: increased saliva or sweating, tremors, slow heartbeat, dizziness.
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: increased saliva or sweating, tremors, slow heartbeat, dizziness.
Phonetic Pronunciation (PYE-loe-KAR-peen)
Phonetic Pronunciation (PYE-loe-KAR-peen)
Precautions PRECAUTIONS: Before using pilocarpine, tell your doctor or pharmacist if you are allergic to it; or to preservatives (such as benzalkonium chloride); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (such as iritis, detached retina). After you apply this drug, your vision may become temporarily blurred. Vision in dim light may be affected. Do not drive (especially at night), use machinery, or do any activity that requires clear vision until you can do it safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this drug should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before using pilocarpine, tell your doctor or pharmacist if you are allergic to it; or to preservatives (such as benzalkonium chloride); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (such as iritis, detached retina). After you apply this drug, your vision may become temporarily blurred. Vision in dim light may be affected. Do not drive (especially at night), use machinery, or do any activity that requires clear vision until you can do it safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this drug should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Temporary irritation/burning/stinging of the eye, temporary blurred vision, poor vision in dim light, headache, or brow ache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: eye pain, vision changes (such as seeing floaters/flashes of light). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Temporary irritation/burning/stinging of the eye, temporary blurred vision, poor vision in dim light, headache, or brow ache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: eye pain, vision changes (such as seeing floaters/flashes of light). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets. If you are using the single-use containers, discard any unused medication immediately after use. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets. If you are using the single-use containers, discard any unused medication immediately after use. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is used alone or with other medications to treat high pressure inside the eye due to glaucoma or other eye diseases (such as ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness, vision loss, and nerve damage. This medication may also be used during certain eye surgeries and to reverse the effects of drugs used to enlarge the pupil (such as during an eye exam). Pilocarpine works by causing the pupil of the eye to shrink and decreasing the amount of fluid within the eye.
Uses USES: This medication is used alone or with other medications to treat high pressure inside the eye due to glaucoma or other eye diseases (such as ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness, vision loss, and nerve damage. This medication may also be used during certain eye surgeries and to reverse the effects of drugs used to enlarge the pupil (such as during an eye exam). Pilocarpine works by causing the pupil of the eye to shrink and decreasing the amount of fluid within the eye.

Frequently Asked Questions (FAQs)

The cost of PILOCARPINE HCL 4% O/S 15 ML is $$0.00

PILOCARPINE HCL 4% O/S 15 ML is manufactured by SOMERSET THERAPEUTICS, LLC.

You can purchase PILOCARPINE HCL 4% O/S 15 ML on our website at https://pkd.pipelinemedical.com/product/detail/pilocarpine-hcl-4-o-s-15-ml-322243