Salagen

DRUG DESCRIPTION

SALAGEN® Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in most nonpolar solvents. Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl) methyl] monohydrochloride, has a molecular weight of 244. 72.

SALAGEN® (pilocarpine hydrochloride) Structural Formula Illustration

Each 5 mg SALAGEN® (pilocarpine hydrochloride) Tablet for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet's film coating, and polishing are: carnauba wax, hydroxypropyl methylcellulose, microcrystalline cellulose, stearic acid, titanium dioxide and other ingredients.

Each 7. 5 mg SALAGEN® (pilocarpine hydrochloride) Tablet for oral administration contains 7. 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet's film coating, and polishing are: carnauba wax, hydroxypropyl methylcellulose, microcrystalline cellulose, stearic acid, titanium dioxide, FD&C blue#2 aluminum lake, and other ingredients.

What are the possible side effects of pilocarpine (Salagen)?

Stop taking pilocarpine and seek emergency medical attention if you experience any of the following uncommon but serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • difficulty breathing;
  • irregular heartbeats;
  • eye pain; or
  • confusion or changes in mental status or behavior.

Other, less serious side effects may also occur. Continue to take pilocarpine and talk to your doctor if you...

Read All Potential Side Effects and See Pictures of Salagen »

What are the precautions when taking pilocarpine hydrochloride (Salagen)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic bronchitis, chronic obstructive pulmonary disease-COPD), certain eye conditions (such as night blindness, acute iritis, narrow-angle glaucoma), heart disease (such as chest pain, heart failure, heart attack, slow heartbeat), low or high blood pressure, liver problems, gallbladder disease (such as gallstones), kidney stones, mental/mood disorders (such as depression, psychoses,...

Read All Potential Precautions of Salagen »


Salagen Consumer (continued)

SIDE EFFECTS: See also Precautions.

Sweating, nausea, runny nose, chills, flushing, frequent urge to urinate, dizziness, weakness, diarrhea, and blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This medication may cause an increase in tears. This can be helpful if you have dry eyes (such as with Sjogren's syndrome). Tell your doctor if runny eyes become a problem.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/fast heartbeat, shakiness (tremor), fainting, lung problems (such as increased wheezing/cough/phlegm), mental/mood changes (such as confusion, agitation), severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic bronchitis, chronic obstructive pulmonary disease-COPD), certain eye conditions (such as night blindness, acute iritis, narrow-angle glaucoma), heart disease (such as chest pain, heart failure, heart attack, slow heartbeat), low or high blood pressure, liver problems, gallbladder disease (such as gallstones), kidney stones, mental/mood disorders (such as depression, psychoses, thinking/understanding problems like dementia, Alzheimer's), stomach problems (such as chronic heartburn, ulcer).

Pilocarpine may make you dizzy and cause vision problems, especially at night. Do not drive, use machinery, or do any activity that requires alertness or clear vision, especially at night, until you are sure you can perform such activities safely. Limit alcoholic beverages.

If pilocarpine makes you sweat heavily, drink plenty of fluids so that you do not become dehydrated. If you are unable to drink enough fluids, talk with your doctor immediately.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness, diarrhea, and increased urge to urinate.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.


Salagen Patient Information Including Side Effects

Brand Names: Salagen

Generic Name: pilocarpine (Pronunciation: pie low CAR peen)

  • What is pilocarpine (Salagen)?
  • What are the possible side effects of pilocarpine (Salagen)?
  • What is the most important information I should know about pilocarpine (Salagen)?
  • What should I discuss with my healthcare provider before taking pilocarpine (Salagen)?
  • How should I take pilocarpine (Salagen)?
  • What happens if I miss a dose (Salagen)?
  • What happens if I overdose (Salagen)?
  • What should I avoid while taking pilocarpine (Salagen)?
  • What other drugs will affect pilocarpine (Salagen)?
  • Where can I get more information?

What is pilocarpine (Salagen)?

Pilocarpine is an agent that affects the nervous system. Pilocarpine increases saliva secretion in the mouth.

Pilocarpine is used in the treatment of dry mouth.

Pilocarpine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of pilocarpine (Salagen)?

Stop taking pilocarpine and seek emergency medical attention if you experience any of the following uncommon but serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • difficulty breathing;
  • irregular heartbeats;
  • eye pain; or
  • confusion or changes in mental status or behavior.

Other, less serious side effects may also occur. Continue to take pilocarpine and talk to your doctor if you experience

  • changes in vision;
  • increased sweating;
  • dizziness;
  • headache;
  • runny nose;
  • nausea;
  • redness of the face and neck;
  • chills; or
  • an increased urge to urinate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about pilocarpine (Salagen)?

Pilocarpine may cause changes in vision, especially at night. Use caution when driving, operating machinery, or performing other hazardous activities. If you experience changes in vision, avoid these activities.

Dehydration may be more likely to occur during treatment with pilocarpine, due to increased sweating. Use caution when exercising and when exposed to hot weather. Drink plenty of fluid to maintain adequate hydration.

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