Pilopine HS

DRUG DESCRIPTION

PILOPINE HS® (pilocarpine hydrochloride ophthalmic gel) 4% is a sterile topical ophthalmic aqueous gel which contains more than 90% water and employs carbopol 940, a synthetic high molecular weight cross-linked polymer of acrylic acid, to impart a high viscosity. The active ingredient, pilocarpine hydrochloride, is a cholinergic agent and is represented by the chemical structure:

PILOPINE HS® (pilocarpine hydrochloride) Structural Formula Illustration

Established name: Pilocarpine Hydrochloride

Chemical name: 2(3H)-Furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)-methyl]-, monohydrochloride, (3S-cis)-.

PILOPINE HS® (pilocarpine hydrochloride ophthalmic gel) 4% - Each Gram Contains: Active: pilocarpine hydrochloride 4% (40 mg). Preservative: benzalkonium chloride 0.008%. Inactives: carbopol 940, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.

What are the possible side effects of pilocarpine ophthalmic (Pilocar, Pilopine-HS, Pilostat)?

Stop using pilocarpine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe stinging, burning, swelling, or redness of your eye;
  • vision changes;
  • eye pain or increased watering; or
  • crusting or drainage around your eye.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Pilopine HS »

What are the precautions when taking pilocarpine hydrochloride ophthalmic gel (Pilopine HS)?

Before using pilocarpine, tell your doctor or pharmacist if you are allergic to it; or to preservatives (e.g., 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: asthma, other eye problems (e.g., iritis, detached retina), heart disease (e.g., heart failure, recent heart attack), low or high blood pressure, overactive thyroid (hyperthyroidism), Parkinsonism, stomach/intestinal problems (e.g., ulcers, spasms).

After you apply pilocarpine, your vision may become temporarily blurred or unstable. Vision in dim light may be affected....

Read All Potential Precautions of Pilopine HS »


Pilopine HS Consumer (continued)

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 persist or worsen, contact your doctor or pharmacist promptly. (See also Precautions section.)

Crusting of the gel on the eyelids or eyelashes may occur overnight, causing them to stick together. If this occurs, wash them with water.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: eye pain, flushing, diarrhea, nausea, stomach/abdominal pain or cramps, increased saliva, unusual sweating, vision changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using pilocarpine, tell your doctor or pharmacist if you are allergic to it; or to preservatives (e.g., 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: asthma, other eye problems (e.g., iritis, detached retina), heart disease (e.g., heart failure, recent heart attack), low or high blood pressure, overactive thyroid (hyperthyroidism), Parkinsonism, stomach/intestinal problems (e.g., ulcers, spasms).

After you apply pilocarpine, your vision may become temporarily blurred or unstable. 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 are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this drug should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Pilopine HS Patient Information Including Side Effects

Brand Names: Pilocar, Pilopine-HS, Pilostat

Generic Name: pilocarpine ophthalmic (Pronunciation: pie low CAR peen off THAL mik)

  • What is pilocarpine ophthalmic (Pilopine HS)?
  • What are the possible side effects of pilocarpine ophthalmic (Pilopine HS)?
  • What is the most important information I should know about pilocarpine ophthalmic (Pilopine HS)?
  • What should I discuss with my healthcare provider before using pilocarpine ophthalmic (Pilopine HS)?
  • How should I use pilocarpine ophthalmic (Pilopine HS)?
  • What happens if I miss a dose (Pilopine HS)?
  • What happens if I overdose (Pilopine HS)?
  • What should I avoid while using pilocarpine ophthalmic (Pilopine HS)?
  • What other drugs will affect pilocarpine ophthalmic (Pilopine HS)?
  • Where can I get more information?

What is pilocarpine ophthalmic (Pilopine HS)?

Pilocarpine reduces the amount of fluid in the eye, which decreases pressure inside the eye.

Pilocarpine ophthalmic (for the eyes) is used to treat glaucoma or ocular hypertension (high pressure inside the eye).

Pilocarpine ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of pilocarpine ophthalmic (Pilopine HS)?

Stop using pilocarpine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe stinging, burning, swelling, or redness of your eye;
  • vision changes;
  • eye pain or increased watering; or
  • crusting or drainage around your eye.

Less serious side effects may include:

  • mild burning, stinging, or discomfort of your eyes;
  • blurred vision; or
  • trouble seeing in dark light.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about pilocarpine ophthalmic (Pilopine HS)?

You should not use this medication if you are allergic to pilocarpine, or if you have uveitis or pupillary block glaucoma.

Before using pilocarpine ophthalmic, tell your doctor if you are allergic to any drugs.

Pilocarpine can cause side effects that can make it harder for you to see at night or in low light. Be careful if you drive or do anything that requires you to be able to see clearly.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Avoid using any other eye medications your doctor has not prescribed.

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