Pilocarpine (Oral)

Pilocarpine tablets are used to treat dryness in the mouth and throat caused by a decrease in saliva, which can happen after radiation treatment for head and neck cancer or in patients with Sjogren's syndrome. This medicine may help you speak without needing to sip liquids. It can also assist with chewing, tasting, and swallowing. This medicine may lower your need for other oral comfort products, like hard candy, sugarless gum, or artificial saliva.

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.

This medicine may make it hard to read or cause other vision problems, especially at night. It may also make some people feel dizzy or lightheaded. Make sure you know how this medicine affects you 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 effects are especially bothersome, talk to your doctor.

This medicine may make you sweat more than usual. If this happens, it is important to drink extra liquids to replace the lost fluids so you do not become dehydrated. Talk to your doctor if you are unsure how much extra liquid to drink or if you cannot drink as much as you should.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits. This is a decision you and your doctor will make together. 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 inform your health care professional about any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Although some medicines should not be used together at all, in other cases, two different medicines may be used together even if there might be an interaction. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on 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 necessary 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

Interactions with Food/Tobacco/Alcohol

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

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

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

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.

In the U.S.

• Salagen

Available Dosage Forms:

• Tablet

Therapeutic Class: Dental Agent

Pharmacologic Class: Cholinergic System

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.