Pilocarpine

Before taking pilocarpine,

• tell your doctor and pharmacist if you are allergic to pilocarpine (Pilopine HS, Salagen)or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: ambenonium (Mytelase); antihistamines; atropine (Motofen, in Lomotil, in Lonox); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); bethanechol (Urecholine); cevimeline (Evoxac); donepezil (Aricept); galantamine (Razadyne); ipratropium (Atrovent, in Combivent, in Duoneb); medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; neostigmine (Prostigmin); physostigmine (Mestinon); rivastigmine (Exelon) and tacrine (Cognex). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have asthma, acute iritis (uveitis; swelling and irritation inside the eye), or glaucoma (an eye disease).Your doctor may tell you not to take pilocarpine.
• tell your doctor if you have or have ever had chronic bronchitis or another type of chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema); kidney stones; gallstones; mental illness; any condition that affects your ability to think; or gallbladder, heart, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pilocarpine, call your doctor.
• you should know that pilocarpine may cause decreased fertility in men and women. Talk to your doctor before you take pilocarpine if you or your partner would like to become pregnant.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pilocarpine.
• you should know that pilocarpine may cause changes in vision, especially at night, or when there is not enough light. Be careful when driving at night, or when performing dangerous activities in low lighting.
• you should know that pilocarpine may cause you to sweat a great deal, which can cause dehydration.Be sure to drink plenty of water and call your doctor right away if you are having difficulty drinking enough fluid or if you think you may be dehydrated.

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You should not use pilocarpine if you are allergic to it, or if you have:

• untreated or uncontrolled asthma; or

• narrow-angle glaucoma.

To make sure pilocarpine is safe for you, tell your doctor if you have:

• asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD), or other breathing disorder;

• glaucoma or vision problems;

• liver disease;

• kidney disease;

• heart disease;

• gallbladder problems;

• mental illness;

• if you take heart or blood pressure medicine; or

• if you use a bronchodilator to treat a breathing disorder.

FDA pregnancy category C. It is not known whether pilocarpine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether pilocarpine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take pilocarpine with or without food.

Drink plenty of liquids while you are taking pilocarpine. This medicine can cause increased sweating and you may get dehydrated easily.

Use pilocarpine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Usual Adult Dose for Xerostomia:

Initial - Head and Neck cancer patients:
5 mg three times a day. Titrate upwards, not to exceed 10 mg per dose, to a maximum of 30 mg per day.

Sjögren's syndrome patients:
5 mg four times a day.

Pilocarpine tablets are used to treat dryness of the mouth and throat caused by a decrease in the amount of saliva that may occur after radiation treatment for cancer of the head and neck or in patients with Sjogren's syndrome. pilocarpine may help you speak without having to sip liquids. It may also help with chewing, tasting, and swallowing. pilocarpine may reduce your need for other oral comfort agents, such as hard candy, sugarless gum, or artificial saliva agents.

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

pilocarpine is available only with your doctor's prescription.

Take pilocarpine only as directed. Do not take it more often and do not take a larger dose than directed. To do so may increase the chance of side effects.

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

Dosing

The dose of pilocarpine 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 pilocarpine. 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 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 pilocarpine, 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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:

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

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:

• Chills
• cough
• diarrhea
• feeling of warmth or heat
• fever
• flushing or redness of skin especially on 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

• fast heartbeat
• headache
• holding more body water
• swelling of face, fingers, ankles, or feet
• trembling or shaking
• trouble swallowing
• trouble seeing
• unusual weak feeling
• voice change
• vomiting

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.

Fatal overdosage with Pilocarpine has been reported in the scientific literature at doses presumed to be greater than 100 mg in two hospitalized patients. 100 mg of Pilocarpine is considered potentially fatal. Overdosage should be treated with atropine titration (0.5 mg to 1.0 mg given subcutaneously or intravenously) and supportive measures to maintain respiration and circulation. Epinephrine (0.3 mg to 1.0 mg, subcutaneously or intramuscularly) may also be of value in the presence of severe cardiovascular depression or bronchoconstriction. It is not known if Pilocarpine is dialyzable.

Initial: 5 mg twice daily, in patients with moderate hepatic insufficiency.

No dosage adjustments are required in patients with mild hepatic insufficiency (Child-Pugh score of 5 to 6).