Cevimeline

Uses

What is Cevimeline used for?

Cevimeline is commonly used to treat symptoms of dry mouth due to a certain immune disease (Sjogren’s syndrome). Cevimeline belongs to a class of drugs known as cholinergic agonists. It works by stimulating certain nerves to increase the amount of saliva you produce, making it easier and more comfortable to speak and swallow.

How should I take Cevimeline?

Take this medication by mouth with or without food, usually 3 times daily or as directed by your doctor.

Dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

You may continue to drink water or use saliva substitutes as needed for moisture in your mouth.

You may start to feel some benefit in 1 to 2 weeks. However, it may take up to 6 weeks to feel the full benefit. Tell your doctor if your condition persists or worsens.

How do I store Cevimeline?

Cevimeline is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Cevimeline in the bathroom or the freezer. There may be different brands of Cevimeline that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Cevimeline down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Cevimeline?

Before taking cevimeline, 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).

This drug may make you dizzy or cause vision problems, especially at night. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision, especially at night, until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

If cevimeline 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 right away.

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

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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Cevimeline during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Cevimeline. This Cevimeline is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk,
• B=No risk in some studies,
• C=There may be some risk,
• D=Positive evidence of risk,
• X=Contraindicated,
• N=Unknown

Side effects

What side effects can occur from Cevimeline?

Sweating, nausea, runny nose, 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. 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 right away if any of these unlikely but serious side effects occur: slow/fast/irregular 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Cevimeline?

Some products that may interact with this drug include: beta blockers (such as metoprolol, atenolol).

Other medications can affect the removal of cevimeline from your body, which may affect how cevimeline works. Examples include cimetidine, amiodarone, ritonavir, fluoxetine, among others.

Cevimeline may cause drugs with “drying’ effects (some antihistamines, anticholinergics such as certain drugs for asthma, over-active bladder, and Parkinson’s) to work less well. Examples of affected drugs include chlorpheniramine, diphenhydramine, atropine, belladonna alkaloids, benztropine, ipratropium, and tolterodine. These medications can also worsen dry mouth, causing cevimeline to work less well. Consult your doctor or pharmacist for more information.

Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients that could have a drying effect. Ask your pharmacist for more details.

Cevimeline may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Cevimeline?

Cevimeline may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Cevimeline?

Cevimeline may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

should ALWAYS consult with your doctor or pharmacist before using this Cevimeline.

What is the dose of Cevimeline for an adult?

Usual Adult Dose for Sjogren’s Syndrome

30 mg orally three times a day

Comments:

-There is insufficient safety information and insufficient evidence for additional efficacy to support doses greater than 30 mg three times a day.

Use: Treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.

Other Comments

Patient advice:

-Patients should be aware that this drug may cause visual disturbances, especially at night, that could affect their ability to drive safely.

-If a patient sweats excessively while taking this drug, dehydration may occur. The patient should drink extra water and consult a health care provider.

What is the dose of Cevimeline for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Cevimeline available?

Cevimeline is available in the following dosage forms and strengths:

• Capsule

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Cevimeline, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.