Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Evoxac

Descriptions


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

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Capsule

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Appropriate studies have not been performed on the relationship of age to the effects of cevimeline in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cevimeline in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution for patients receiving this medicine.

Breastfeeding

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.

Drug Interactions

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.

Other Interactions

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Acute iritis (swelling of the colored ring around your eye's pupil) or
  • Asthma, uncontrolled, or
  • Narrow-angle glaucoma—Should not be used in patients with these conditions.
  • Angina (chest pain), history of or
  • Heart attack, history of or
  • Heart or blood vessel disease, history of—Use with caution. May cause side effects to become worse.
  • Asthma, controlled or
  • Bronchitis, chronic or
  • Cholelithiasis (gallbladder stones), history of or
  • Chronic obstructive pulmonary disease (COPD) or
  • Eye problems or
  • Nephrolithiasis (kidney stones), history of—Use with caution. May make these conditions worse.

Proper Use

Dosing

The dose of this medicine 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 this medicine. 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 dry mouth in patients with Sjögren's syndrome:
      • Adults—30 milligrams 3 times a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

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

This medicine may worsen the condition of patients with heart disease or heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain. You might also feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

This medicine may cause blurred or decreased vision, especially at night and in patients with eye problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause kidney or gallbladder problems. Check with your doctor right away if you have severe nausea or vomiting, indigestion, stomach pain, itchy skin, light-colored stools, yellow eyes or skin, bloody or cloudy urine, or pain in the lower back or side.

Drink plenty of water, especially if you have excessive sweating, to prevent dehydration.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Check with your doctor or nurse immediately if any of the following side effects occur:

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Bladder pain
  2. bloody or cloudy urine
  3. body aches or pain
  4. chills
  5. cough
  6. difficult, burning, or painful urination
  7. difficulty in breathing
  8. dryness or soreness of the throat
  9. ear congestion
  10. frequent urge to urinate
  11. headache
  12. hoarseness
  13. loss of voice
  14. lower back or side pain
  15. runny or stuffy nose
  16. sneezing
  17. tender, swollen glands in the neck
  18. trouble in swallowing
  19. unusual tiredness or weakness
  20. voice changes

Less common

  1. Accumulation of pus
  2. bloating or swelling of the face, arms, hands, lower legs, or feet
  3. blurred vision or other change in vision
  4. burning, dry, or itching eyes
  5. chest pain
  6. cough producing mucus
  7. diarrhea
  8. discharge, excessive tearing
  9. dizziness
  10. earache
  11. excessive muscle tone
  12. eye pain
  13. fast, irregular, pounding, or racing heartbeat or pulse
  14. feeling unusually cold
  15. fever
  16. general feeling of discomfort or illness
  17. headache, severe and throbbing
  18. heartburn
  19. hives, skin rash
  20. joint pain
  21. loss of appetite
  22. muscle pain, stiffness, tension, or tightness
  23. nausea
  24. nosebleed
  25. pale skin
  26. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  27. rapid weight gain
  28. redness or swelling in the ear
  29. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  30. sensitivity of the eye to light
  31. shivering
  32. sore throat
  33. swollen, red, tender area of the infection site
  34. tightness in the chest
  35. tingling of the hands or feet
  36. tremor
  37. trouble sleeping
  38. unusual bleeding or bruising
  39. unusual weight gain or loss
  40. vomiting
  41. weight loss

Rare

  1. Anxiety
  2. black, tarry stools
  3. bleeding after defecation
  4. bleeding gums
  5. blisters
  6. bloating
  7. blood in the urine or stools
  8. blood in vomit
  9. bloody nose
  10. blue or pale skin
  11. burning feeling in the chest or stomach
  12. burning feeling while urinating
  13. burning, numbness, pain, or tingling in all fingers, except the smallest finger
  14. burning, tingling, numbness or pain in the hands, arms, feet, or legs
  15. changes in skin color
  16. chest discomfort
  17. chest pain, possibly moving to the left arm, neck, or shoulder
  18. choking
  19. clumsiness or unsteadiness
  20. cold sweats
  21. collection of blood under the skin
  22. confusion
  23. constipation
  24. cool, pale skin
  25. coughing or spitting up blood
  26. cracked lips
  27. decreased urination
  28. deep, dark purple bruise
  29. depressed mood
  30. difficulty controlling your bladder or bowels
  31. difficulty walking
  32. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  33. dry mouth
  34. dry skin and hair
  35. dry, puffy skin
  36. extra heartbeat
  37. fainting
  38. feeling cold
  39. forgetfulness
  40. frequent urge to defecate
  41. fruit-like breath odor
  42. gaseous abdominal pain
  43. heart murmur
  44. heavier menstrual periods
  45. husky voice
  46. incoherent speech
  47. increase in heart rate
  48. increased hunger
  49. increased thirst
  50. increased volume of pale, dilute urine
  51. indigestion
  52. involuntary muscle contractions
  53. irregular heartbeat
  54. irritation or soreness of the mouth
  55. itching, pain, redness, swelling, tenderness, or warmth on the skin
  56. joint stiffness or swelling
  57. lightheadedness
  58. loss of bladder control
  59. loss of consciousness
  60. lower back, side, or stomach pain
  61. metallic taste
  62. mood changes
  63. muscle cramps or weakness
  64. nerve pain
  65. nervousness
  66. nightmares
  67. noisy breathing
  68. numbness or tingling in the face, hands, feet, or lips
  69. pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
  70. pain or burning in the throat
  71. pain or discomfort in the arms, jaw, back, or neck pain, warmth, or burning in the fingers, toes, and legs
  72. painful blisters on the trunk of the body
  73. painful cold sores or blisters on the lips, nose, eyes, or genitals
  74. pale, bluish-colored, or cold hands or feet
  75. pinpoint red spots on the skin
  76. pounding in the ears
  77. rapid, shallow breathing
  78. rectal bleeding
  79. recurrent fever
  80. redness and swelling of the gums
  81. redness, soreness, or itching skin
  82. redness, swelling, or soreness of the tongue
  83. seizures
  84. sensation of pins and needles
  85. severe constipation
  86. severe cramping
  87. severe or continuing stomach pain
  88. severe stomach pain
  89. severe vomiting
  90. shakiness
  91. slow heartbeat
  92. slurred speech
  93. sores, ulcers, or white spots on the lips or tongue or inside the mouth
  94. stabbing pain
  95. stomach bloating, burning, cramping, or pain
  96. stomach tenderness or discomfort
  97. stomach upset or fullness
  98. straining while passing stool
  99. sudden decrease in the amount of urine
  100. sunken eyes
  101. sweating
  102. swelling around the eyes
  103. swelling of the front part of the neck
  104. swelling or inflammation of the mouth
  105. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  106. trouble in holding urine
  107. uncomfortable swelling around the anus
  108. unexplained weight loss
  109. voice changes
  110. vomiting of blood or material that looks like coffee grounds
  111. weak or absent pulses in the legs
  112. weight gain
  113. wrinkled skin
  114. yellow eyes or skin

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

Symptoms of Overdose

  1. Blurred or loss of vision
  2. chest pain or discomfort
  3. cold, clammy skin
  4. confusion
  5. disturbed color perception
  6. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  7. double vision
  8. fainting fast, pounding, or irregular heartbeat or pulse
  9. fast, weak pulse
  10. halos around lights
  11. nervousness
  12. night blindness
  13. overbright appearance of lights
  14. pounding in the ears
  15. pounding, slow heartbeat
  16. stomach cramps or pain
  17. tearing of the eyes
  18. tightness in the chest
  19. tremor
  20. troubled breathing
  21. tunnel vision
  22. unusual tiredness or weakness

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:

Less common

  1. Back pain
  2. belching
  3. bloated, full feeling
  4. bone pain
  5. change in the color, amount, or odor of vaginal discharge
  6. difficulty in moving
  7. discouragement
  8. excess air or gas in stomach or bowels
  9. feeling of constant movement of self or surroundings
  10. feeling of warmth feeling sad or empty
  11. hiccup
  12. increased watering of the mouth
  13. irritability
  14. itching of the vagina or genital area
  15. leg cramps
  16. loss of interest or pleasure
  17. overactive reflexes, followed by underactive reflexes
  18. pain during sexual intercourse
  19. passing gas
  20. redness of the face, neck, arms, and occasionally, upper chest
  21. salivary gland enlargement or pain
  22. sensation of spinning
  23. thick, white vaginal discharge with no odor or with a mild odor
  24. tooth disorder
  25. toothache
  26. trouble concentrating

Rare

  1. Abnormal crying
  2. abnormal dreaming
  3. absence of menstruation
  4. acne
  5. agitation
  6. change in tongue color
  7. changes in menstrual periods
  8. decreased sexual ability in males
  9. difficulty in speaking
  10. discoloration of the fingernails or toenails
  11. false beliefs that cannot be changed by facts
  12. feeling of unreality
  13. hair loss or thinning of hair
  14. increase in body movements
  15. increased appetite
  16. increased sensitivity of skin to sunlight
  17. lack or loss of strength
  18. painful menstruation
  19. poor insight and judgment
  20. problems with memory or speech
  21. seeing, hearing, or feeling things that are not there
  22. sense of detachment from self or body
  23. severe sunburn
  24. sleepiness or unusual drowsiness
  25. trouble recognizing objects
  26. trouble thinking and planning
  27. trouble walking

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.