Pronunciation:

pye-loe-KAR-peen

Brand Names:

• Salagen

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Dental Agent

Pharmacologic—

Cholinergic System

Uses of This Medicine:

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. This medicine may help you speak without having to sip liquids. It may also help with chewing, tasting, and swallowing. This medicine 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

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

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Studies on this medicine have been done only in adult patients and there is no specific information comparing use of pilocarpine in children with use in other age groups.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Tegafur

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if 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 condition worse

• Retinal detachment, tendency for, or
• Retinal disease—Pilocarpine may increase the risk of a detached retina

Proper Use of This Medicine:

Take this medicine 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 this medicine 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 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 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 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.

Precautions While Using This Medicine:

This medicine may cause difficulty in reading or other vision problems, especially at night. It may also cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not 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 sweating so you do not lose too much fluid and become dehydrated. Check with your doctor if you are not sure how much extra liquid to drink or if you cannot drink 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 may need medical attention.

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

Symptoms of overdose

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:

More common

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

Less common or rare

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.