Description and Brand Names

Drug information provided by: Merative, 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.

Portions of this document last updated: Feb. 01, 2024

Original article: https://www.mayoclinic.org/es-es/drugs-supplements/cevimeline-oral-route/side-effects/drg-20062661