PILOCARPINE (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Salagen

In Canada?

• Salagen

? Not commercially available in Canada.

Category

• Cholinergic

Description

Pilocarpine (pye-loe-KAR-peen) tablets are used to treat dryness of themouth and throat caused by a decrease in the amount of saliva that may occurafter radiation treatment for cancer of the head and neck or in patients withSjogren's syndrome. This medicine may help you speak without having to sipliquids. It may also help with chewing, tasting, and swallowing. This medicinemay reduce your need for other oral comfort agents, such as hard candy, sugarlessgum, or artificial saliva agents.

Pilocarpine may also be used to treat dryness of the eyes caused by Sjogren'ssyndrome

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Oral
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of using the medicine must be weighed against the good it will do.This is a decision you and your doctor will make. For pilocarpine, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to pilocarpine taken by mouth or used in the eye. Also tellyour health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Pilocarpine has not been studied in pregnant women.However, studies in animals have shown that pilocarpine, when given in veryhigh doses, may cause birth defects. Before using this medicine, make sureyour doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?It is not known whether pilocarpine passes intothe breast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are takingthis medicine and who wish to breast-feed should discuss this with their doctor..

Children?Studies on this medicine have been done only in adultpatients and there is no specific information comparing use of pilocarpinein children with use in other age groups.

Older adults?This medicine has been tested and has not been shownto cause different side effects or problems in older people than it does inyounger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are usingpilocarpine, it is especially important that your health care professionalknow if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Anticholinergics (medicine for abdominal or stomach spasms or cramps)or
• Antidepressants (medicine for depression) or
• Antidyskinetics (medicine for Parkinson's disease or other conditionsaffecting control of muscles) or
• Antihistamines or
• Antipsychotics (medicine for mental illness) or
• Buclizine (e.g., Bucladin) or
• Carbamazepine (e.g., Tegretol) or
• Cyclizine (e.g., Marezine) or
• Cyclobenzaprine (e.g., Flexeril) or
• Disopyramide (e.g., Norpace) or
• Flavoxate (e.g., Urispas) or
• Ipratropium (e.g., Atrovent) or
• Meclizine (e.g., Antivert) or
• Methylphenidate (e.g., Ritalin) or
• Orphenadrine (e.g., Norflex) or
• Oxybutynin (e.g., Ditropen) or
• Procainamide (e.g., Pronestyl) or
• Promethazine (e.g., Phenergan) or
• Quinidine (e.g., Quinidex) or
• Trimeprazine (e.g., Temaril)?Pilocarpine may reduce the effectof these medicines or these medicines may reduce the effects of pilocarpine

• Antimyasthenics (ambenonium [e.g., Mytelase], neostigmine [e.g.,Prostigmin], pyridostigmine [Mestinon]) or
• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol[e.g., Tenormin], betaxolol [e.g., Kerlone], carteolol [e.g., Cartrol], labetalol[e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard],oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken],propranolol [e.g., Inderal], sotalol [e.g., Sotacor], timolol [e.g., Blocadren])or
• Bethanecol (e.g., Urecholine) or
• Ophthalmic beta-adrenergic blocking agents (betaxolol [e.g., Betoptic],carteolol [e.g., Ocupress], levobunolol [e.g., Betagan], metipranolol [e.g.,OptiPranolol], timolol [e.g., Timoptic])?Pilocarpine may increase theside effects of these medicines

• Carbachol (e.g., Isopto Carbachol) or
• Demecarium (e.g., Humorsol) or
• Echothiophate (e.g., Phospholine Iodide) or
• Isoflurophate (e.g., Floropryl) or
• Physostigmine (e.g., Isopto Eserine) or
• Pilocarpine (ophthalmic) (e.g., Isopto Carpine)?Pilocarpinemay increase the effects of these ophthalmic glaucoma medicines

Other medical problems?The presence of other medicalproblems may affect the use of pilocarpine. Make sure you tell your doctorif you have any other medical problems, especially:

• Asthma, bronchitis, or other breathing problems, or
• Gallbladder problems or
• Glaucoma, angle closure, or
• Heart or blood vessel disease or
• Iritis (inflammation of the iris [colored part] of the eye) or
• Kidney problems or
• Mental problems or
• Peptic ulcer disease, acute?Pilocarpine may make the conditionworse

• Retinal detachment, tendency for, or
• Retinal disease?Pilocarpine may increase the risk of a detachedretina

Proper Use of This Medicine

Take this medicine only as directed. Do not take it more often and do nottake a larger dose than directed. To do so may increase the chance of sideeffects.

It is important that you visit your dentist regularly even though thismedicine may make your dry mouth feel better. Having a dry mouth conditionmakes you more likely to have dental and other mouth problems.

Dosing?The dose of pilocarpine will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage dose of pilocarpine. If your dose is different,do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For dryness of eyes:
    • Adults?5 milligrams (mg) three or four times a day.
  • For dryness of mouth and throat:
    • Adults?5milligrams (mg) three or four times a day.
    • Children?Use and dose must be determined by your doctor.

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

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Thismedicine may cause difficulty in reading or other vision problems, especiallyat night. It may also cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before youdrive, use machines, or do anything else that could be dangerous if you arenot alert or able to see well. If these reactions are especially bothersome,check with your doctor.

This medicine may cause you to sweat more than is usual. If you do, it is important that you drink extra liquids to offset this sweatingso you do not lose too much fluid and become dehydrated. Check withyour doctor if you are not sure how much extra liquid to drink or if you cannotdrink as much liquid as you should.

Side Effects of This Medicine

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 mayneed medical attention.

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

Symptoms of overdose

Chest pain; confusion; diarrhea (continuing or severe); fainting; fast, slow, or irregular heartbeat (continuingor severe); headache (continuing or severe); nausea or vomiting (continuing or severe); shortness of breath or troubled breathing; stomachcramps or pain; tiredness or weakness (continuingor severe); trembling or shaking (continuing or severe); trouble seeing (continuing or severe)

Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:

More common

Chills; cough; diarrhea; feeling of warmth or heat; fever; flushing or redness of skin especiallyon face and neck; increased need to urinate; indigestion; joint pain; muscle aches and pains; nausea; passing urine more often; runny nose; unusual tiredness or weakness; Sweating

Less common or rare

fast heartbeat; headache; holding more body water; swelling offace, fingers, ankles, or feet; trembling or shaking; trouble swallowing; troubleseeing; unusual weak feeling; voice change; vomiting

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.