PILOCAR^® (pilocarpine hydrochloride) ophthalmic solution is a sterile solution for ophthalmic administration having the following composition:

Plastic Squeeze Bottle

Pilocarpine Hydrochloride 5, 10, 20, 30, 40, or 60 mg/mL (cholinergic/parasympathomimetic) in a buffered solution of boric acid, potassium chloride, hydroxypropylmethyl cellulose, sodium carbonate, edetate disodium and purified water, preserved with benzalkonium chloride.

Dropperettes^® Applicator

Pilocarpine Hydrochloride 10, 20 or 40 mg/mL (cholinergic/parasympathomimetic) in an isotonic, buffered solution of boric acid, potassium chloride, sodium carbonate and purified water, preserved with benzalkonium chloride.

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

Last updated on RxList: 12/8/2004

PILOCAR^® ophthalmic solution is indicated for the treatment of primary open-angle glaucoma and also to lower intraocular pressure prior to surgery for acute angle-closure glaucoma. It may be used in combination with other miotics, beta adrenergic blocking agents, carbonic anhydrase inhibitors, hyperosmotic agents, or epinephrine.

The initial dose is one or two drops. This may be repeated up to six times daily. The frequency of instillation and concentration of PILOCAR^® ophthalmic solution are determined by the severity of the glaucoma and miotic response of the patient.

During acute phases, the miotic must be instilled into the unaffected eye to prevent an attack of angle-closure glaucoma.

0.5%, 1%, 2%, 3%, 4%, and 6% solution: in 15 mL plastic dropper-tip squeeze bottles.

0.5%, 1%, 2%, 3%, 4%, and 6% solution: in a Twin Pack of 2 x 15 mL plastic dropper-tip squeeze bottles.

1%, 2%, and 4%: 1mL DROPPERETTES^® applicators package of 12.

Keep tightly closed. Store at controlled room temperature. 15°- 30° C (59°- 86° F)

CAUTION: Federal (U.S.) law prohibits dispensing without prescription.

Last updated on RxList: 12/8/2004

Ocular

Ciliary spasm, conjunctival vascular congestion, temporal or supraorbital headache, lacrimation, and induced myopia may occur. This is especially true in younger individuals who have recently started administration. Reduced visual acuity in poor illumination is frequently experienced by older individuals and individuals with lens opacity. Miotic agents may also cause retinal detachment; thus, care should be exercised with all miotic therapy especially in young myopic patients. Lens opacity may occur with prolonged use of pilocarpine.

Systemic

Systemic reactions following topical administration, although extremely rare, have included hypertension, tachycardia, bronchiolar spasm, pulmonary edema, salivation, sweating, nausea, vomiting, and diarrhea.

No information provided.

Last updated on RxList: 12/8/2004

No information provided.

The pilocarpine-induced miosis may cause difficulty in dark adaptation. The patient should exercise caution when involved in night driving or other hazardous activities in poor light.

Not for internal use. To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies done using pilocarpine in animals to evaluate carcinogenic potential.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with pilocarpine. It is also not known whether pilocarpine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pilocarpine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pilocarpine is administered to a nursing woman.

Last updated on RxList: 12/8/2004

No information provided.

When constriction is undesirable such as in acute iritis and in persons hypersensitive to one or more of the components of this preparation.

Last updated on RxList: 12/8/2004

Pilocarpine is a direct acting cholinergic (parasympathomimetic) agent causing pupillary constriction and reduction of intraocular pressure.

Last updated on RxList: 12/8/2004

See PRECAUTIONS and CONTRAINDICATIONS.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

PILOCARPINE SOLUTION - OPHTHALMIC

(pie-low-KAR-peen)

COMMON BRAND NAME(S): Akarpine, Isopto Carpine, Pilocar, Piloptic-1

USES: This medication is used alone or with other medications to treat high pressure inside the eye due to glaucoma or other eye diseases (e.g., 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 (e.g., during an eye exam). Pilocarpine works by causing the pupil of the eye to shrink and decreasing the amount of fluid within the eye.

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 (e.g., 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.

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.)

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, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call 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.

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. Use caution while driving (especially at night), using machinery, or doing any activity that requires clear vision. 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.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: other eye medications.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center. Symptoms of overdose may include: increased saliva, slow heartbeat, nausea, diarrhea, increased sweating.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., eye exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

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 and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 46-80 degrees F (8-27 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

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 for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.