cevimeline (Oral route)

se-VI-me-leen

Commonly used brand name(s)

In the U.S.

  • Evoxac

Available Dosage Forms:

  • Capsule

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Cholinergic

Uses For cevimeline

Cevimeline is used to treat the symptoms of dry mouth often experienced by patients with Sjogren's syndrome. It works by causing certain mouth glands to produce more saliva.

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cevimeline is available only with your doctor's prescription.

Before Using cevimeline

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cevimeline, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cevimeline or any other medicines. Also tell your health care professional if you have 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 cevimeline have been done only in adult patients, and there is no specific information comparing use of cevimeline in children with use in other age groups.

Geriatric

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of cevimeline in the elderly with use in other age groups, cevimeline is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 cevimeline. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma, uncontrolled, or
  • Cholelithiasis (gallstones), or
  • Heart disease, or
  • Nephrolithiasis (kidney stones), or
  • Eye conditions in which contraction of the pupils is undesirable (e.g., acute iritis and narrow-angle glaucoma), or
  • Pulmonary disease other than asthma

Proper Use of cevimeline

Dosing

The dose of cevimeline 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 cevimeline. 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 (capsules):
    • For the treatment of dry mouth in patients with Sjogren's syndrome:
      • Adults—30 milligrams three times a day
      • Children—Use and dose must be determined by your doctor.

Missed 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 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using cevimeline

If you will be taking cevimeline for a long time, it is very important that your doctor check you at regular visits for signs of your receiving too much medicine.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

cevimeline may cause some people to become drowsy, dizzy, or less alert than they are normally. cevimeline may also cause a change in vision that could cause you to see less well at night. Make sure you know how you react to cevimeline before you drive, use machines, or do anything else that could be dangerous if you are unable to see well, or if you are dizzy or are not alert.

cevimeline Side Effects

Along with its needed effects, a medicine 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 immediately if any of the following side effects occur:

Less common
  • Difficulty breathing
  • fast heartbeat
  • itching
Rare
  • Chest pain
  • fainting or light-headedness when getting up from a lying or a sitting position
  • swelling of gums or tongue
Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

  • Blurring or loss of vision
  • chest pain
  • cold, clammy skin
  • diarrhea, continuous and severe
  • disturbed color vision
  • dizziness, faintness, or light-headedness when getting up from a lying or sitting position
  • difficult or labored breathing
  • fast, pounding, slow, or irregular heartbeat
  • fast, weak pulse
  • headache
  • mental confusion
  • nausea
  • pounding in ears
  • shaking or trembling of hands or feet
  • shortness of breath
  • stomach cramps or pain
  • sweating
  • tearing of the eyes

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

Less common
  • Bloody or cloudy urine
  • blurred vision
  • chest pain
  • cough
  • cracks in skin
  • difficult, burning , or painful urination
  • dizziness
  • dry or itching eyes
  • earache
  • feeling of constant movement of self or surroundings
  • itching of vagina, genital, or other skin area
  • lower back pain
  • redness or pain in eye
  • ringing or buzzing in the ears
  • scaling of skin
  • shortness of breath
  • skin rash
  • soreness or redness of skin
  • sores, ulcers, or white spots on tongue, lips, or inside of mouth
  • stiffness of muscles
  • swelling of hands, ankles, feet, or lower legs
  • swelling on side of face and jaw, with or without pain
  • tense muscles

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
  • Excessive sweating
  • nausea
  • runny or stuffy nose
Less common
  • Abdominal pain
  • belching
  • bloating or swelling of face, hands, feet, or lower legs
  • bloody nose
  • bone or joint pain
  • burning, dry, or itching feeling in eye
  • change in vision
  • chills
  • constipation
  • cough, mucus-producing
  • decreased touch sensation
  • depression
  • diarrhea
  • dry mouth
  • eye pain
  • feelings of warmth in face, neck, arms, and occasionally, chest
  • fever
  • heartburn
  • hiccups
  • injury
  • itching
  • leg cramps
  • loss of appetite
  • migraine headache
  • mood or mental changes
  • muscle aches, pain, or stiffness
  • pain and swelling of eye, eyelid, or inner lining of eye
  • pain on side of face and jaw
  • pain, swelling, or redness of joints
  • postoperative pain
  • rapid weight gain
  • shortness of breath
  • skin disorder
  • tightness in chest
  • tooth disorders or pain
  • trembling or shaking of hands or feet
  • trouble in sleeping
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • watering of mouth
  • weight loss
Rare
  • Abnormal crying
  • deep, dark, purple bruise
  • swelling or puffiness of face
  • temperature sensation changes

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.

See also: Side effects (in more detail)

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