What is Salagen used for?
Salagen is a prescription medicine that is used to treat dry mouth.
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 non-polar solvents. Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyl-dihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl] mono-hydrochloride, has a molecular weight of 244.72.
Each 5 mg SALAGEN® 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, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide and other ingredients.
Each 7.5 mg SALAGEN® 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, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide, FD&C blue#2 aluminum lake, and other ingredients.
Before taking Salagen, tell your doctor:
- If you are allergic to Salagen; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have any of these health problems: Asthma, glaucoma, liver disease, or swelling in parts of the eye.
- If you are breast-feeding or plan to breast-feed.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Salagen with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Salagen?
- Tell all of your health care providers that you take Salagen. This includes your doctors, nurses, pharmacists, and dentists.
- Use care when driving or doing other tasks that call for clear eyesight.
- Use care when driving at night or doing other tasks in lowered lighting.
- Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
- It may take several weeks to see the full effects.
- If you are 65 or older, use Salagen with care. You could have more side effects.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Salagen while you are pregnant.
How is Salagen best taken?
Use Salagen as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Keep taking Salagen as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
What are the side effects of Salagen that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Shortness of breath.
- Fast or slow heartbeat.
- A heartbeat that does not feel normal.
- Very upset stomach or throwing up.
- Change in eyesight, eye pain, or very bad eye irritation.
- More tears.
- Sweating a lot.
- Severe diarrhea.
- Feeling confused.
- Belly pain.
What are some other side effects of Salagen?
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:
- Upset stomach.
- Passing urine more often.
- Runny nose.
- 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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
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.
How do I store and/or throw out Salagen?
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
PRINCIPAL DISPLAY PANEL
- NDA 59212-705-10
100 film coated tablets – 5 mg each
PRINCIPAL DISPLAY PANEL
- NDA 59212-775-10
100 film coated tablets – 7.5 mg each
SRC: NLM .