Salagen

Pilocarpine comes as a tablet to take by mouth. When pilocarpine is used to treat dry mouth caused by radiotherapy in people who have head and neck cancer, it is usually taken three times a day. When pilocarpine is used to treat dry mouth in people who have Sjogren's syndrome, it is usually taken four times a day. Take pilocarpine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pilocarpine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on an average dose of pilocarpine and adjust your dose depending on how well your symptoms are controlled and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with pilocarpine.

Pilocarpine will control your symptoms but will not cure your condition. Continue to take pilocarpine even if you feel well. Do not stop taking pilocarpine without talking to your doctor.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Salagen^®

Oral pilocarpine usually is taken three or four times daily. The recommended dose for radiation induced xerostomia is 5 to 10 mg three times daily.

The dose for xerostomia associated with Sjögren's syndrome is 5 mg four times daily. The maximum effect occurs in approximately one hour but may occur later if it is taken with food. The effects last three to five hours.

Tablets: 5 and 7.5 mg.

Tablets should be stored at room temperature, 15 C - 30 C (59 F - 86 F).

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using pilocarpine and call your doctor at once if you have:

• shortness of breath;
• fast or slow heart rate;
• severe headache, pounding in your neck or ears;
• confusion, tremors; or
• a light-headed feeling, like you might pass out.

Common side effects may include:

• increased sweating, urinating more than usual;
• chills, or flushing (warmth, redness, or tingly feeling);
• headache, dizziness, weakness;
• nausea, vomiting, diarrhea;
• blurred vision, watery eyes; or
• runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Flushing.
• Upset stomach.
• Passing urine more often.
• Runny nose.
• Loose stools (diarrhea).
• Chills.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Salagen, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Salagen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Salagen.

Review Date: October 4, 2017

Applies to pilocarpine: oral tablet

Along with its needed effects, pilocarpine (the active ingredient contained in Salagen) 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 while taking pilocarpine:

• 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 of pilocarpine 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

General

Pilocarpine hydrochloride is available in the following dosage form(s) and strength(s):

Tablets: 5 mg. Each tablet contains 5 mg pilocarpine hydrochloride.1

Tablets: 7.5 mg. Each tablet contains 7.5 mg pilocarpine hydrochloride.1

Dosage

Adults

Head and Neck Cancer Patients: The recommended initial dose of pilocarpine hydrochloride tablets is 5 mg taken three times a day. Dosage should be titrated according to therapeutic response and tolerance. The usual dosage range is up to 15–30 mg per day (not to exceed 10 mg per dose). Although early improvement may be realized, at least 12 weeks of uninterrupted therapy with pilocarpine hydrochloride tablets may be necessary to assess whether a beneficial response will be achieved. The incidence of the most common adverse events increases with dose. The lowest dose that is tolerated and effective should be used for maintenance.1

Sjogren’s Syndrome Patients: The recommended dose of pilocarpine hydrochloride tablets is 5 mg taken four times a day. Efficacy was established by 6 weeks of use.1

Special Populations

Hepatic Impairment: Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended.1