Pilopine-HS

The following adverse experiences associated with pilocarpine therapy have been reported: lacrimation, burning or discomfort, temporal or periorbital headache, ciliary spasm, conjunctival vascular congestion, superficial keratitis and induced myopia. Systemic reactions following topical administration are extremely rare, but occasional patients are peculiarly sensitive to develop sweating and gastrointestinal overactivity following suggested dosage and administration. Ocular reactions usually occur during initiation of therapy and often will not persist with continued therapy. Reduced visual acuity in poor illumination is frequently experienced in older individuals and in those with lens opacity. A subtle corneal granularity was observed in about 10% of patients treated with PILOPINE HS® (pilocarpine hydrochloride ophthalmic gel) . Cases of retinal detachment have been reported during treatment with miotic agents; especially in young myopic patients. Lens opacity may occur with prolonged use of pilocarpine.

Pilopine HS® (pilocarpine hydrochloride ophthalmic gel) 4% is a miotic (parasympathomimetic) used to control intraocular pressure. It may be used in combination with other miotics, beta-blockers, carbonic anhydrase inhibitors, sympathomimetics or hyperosmotic agents.

The following adverse experiences associated with pilocarpine therapy have been reported: lacrimation, burning or discomfort, temporal or periorbital headache, ciliary spasm, conjunctival vascular congestion, superficial keratitis and induced myopia. Systemic reactions following topical administration are extremely rare, but occasional patients are peculiarly sensitive to develop sweating and gastrointestinal overactivity following suggested dosage and administration. Ocular reactions usually occur during initiation of therapy and often will not persist with continued therapy. Reduced visual acuity in poor illumination is frequently experienced in older individuals and in those with lens opacity. A subtle corneal granularity was observed in about 10% of patients treated with Pilopine HS®. Cases of retinal detachment have been reported during treatment with miotic agents; especially in young myopic patients. Lens opacity may occur with prolonged use of pilocarpine.

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.

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.

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.

Pilocarpine is used to treat glaucoma and other eye conditions.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain pilocarpine. It may not be specific to Pilopine-HS. Please read with care.

To use the eye drop form of pilocarpine:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To use the eye gel form of pilocarpine:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of gel into this space. A 1½-cm (approximately ½-inch) strip of gel is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• Immediately after using the eye gel, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye gel, wipe the tip of the gel tube with a clean tissue and keep the tube tightly closed.

To use the eye insert form of pilocarpine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.
• If you think this medicine unit may be damaged, do not use it. If you have any questions about this, check with your health care professional.
• If the unit seems to be releasing too much medicine into your eye, remove it and replace with a new unit. If you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For eye drop dosage form:
  • For chronic glaucoma:
    • Adults and children—One drop one to four times a day.
  • For acute angle-closure glaucoma:
    • Adults and children—One drop every five to ten minutes for three to six doses. Then one drop every one to three hours until eye pressure is reduced.
• For eye gel dosage form:
  • For glaucoma:
    • Adults and teenagers—Use once a day at bedtime.
    • Children—Use and dose must be determined by your doctor.
• For eye insert dosage form:
  • For glaucoma:
    • Adults and children—Insert one ocular system every seven days.
    • Infants—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the eye system form of this medicine in the refrigerator. Keep from freezing. Store the 3.5-gram size (of the gel form) at room temperature.

Your doctor should check your eye pressure at regular visits.

For patients using the eye drop or gel form of this medicine:

• For a short time after you use this medicine, your vision may be blurred or there may be a change in your near or far vision, especially at night. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.

For patients using the eye insert form of this medicine:

• For the first several hours after you insert this unit in the eye, your vision may be blurred or there may be a change in your near or far vision, especially at night. Therefore, insert this unit in the eye at bedtime, unless otherwise directed by your doctor. If this unit is inserted in the eye at any other time of the day, make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Increased sweating
• muscle tremors
• nausea, vomiting, or diarrhea
• troubled breathing or wheezing
• watering of mouth

• Eye pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blurred vision or change in near or far vision
• decrease in night vision

• Eye irritation
• headache or browache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.