Evoxac

Evoxac (cevimeline) is used to treat dry mouth symptoms caused by Sjögren's syndrome (also called Sjögren's disease) in adults. It is a cholinergic agonist that binds to muscarinic receptors in the exocrine glands, which increases the body's natural secretions, such as saliva. This helps relieve the dry mouth that is common in Sjögren's.

Evoxac comes in two forms: a 30 mg oral capsule and a 30 mg/5 mL oral solution, which is a raspberry-flavored liquid. Both are taken by mouth three times a day. The oral solution gives an option for people who have trouble swallowing capsules.

The active ingredient in Evoxac is cevimeline hydrochloride, and it is distributed by Cosette Pharmaceuticals, Inc. Generic cevimeline capsules are also available.

Evoxac (cevimeline) received FDA approval on January 11, 2000.

Use Evoxac exactly as prescribed. Follow all directions on your prescription label, and do not use more or less than recommended.

The usual dose is 30 mg three times a day:

• Capsule: take one 30 mg capsule three times a day, with or without food.
• Oral solution: take 30 mg (5 mL) three times a day with a glass of water, with or without food. Measure the liquid with the device provided or a dose-measuring syringe, not a household spoon.

Drink plenty of liquids while you are taking Evoxac. This helps keep your kidneys working properly and can help prevent dehydration.

Store Evoxac at room temperature between 68°F and 77°F (20°C and 25°C). Brief exposure between 59°F and 86°F (15°C and 30°C) is allowed. Keep the container tightly closed.

You should not use Evoxac if you have uncontrolled asthma, narrow-angle (angle-closure) glaucoma, or an eye condition called acute iritis.

Evoxac can affect your heart rate and heart rhythm, make breathing problems worse, and cause blurred vision. It can also lower your ability to sweat, which can lead to overheating and dehydration. Tell your doctor right away if you have a fast or irregular heartbeat, trouble breathing, or signs of dehydration.

You should not use Evoxac if you are allergic to cevimeline, or if you have:

• uncontrolled asthma;
• narrow-angle (angle-closure) glaucoma; or
• an eye condition called acute iritis.

To make sure Evoxac is safe for you, tell your doctor if you have:

• asthma, chronic bronchitis, or chronic obstructive pulmonary disease (COPD);
• heart disease, chest pain (angina), or a history of heart attack;
• a heart rhythm disorder, such as atrial fibrillation;
• high blood pressure (hypertension);
• liver or kidney disease; or
• a history of kidney stones or gallstones.

It is not known whether Evoxac will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding is not recommended while you use Evoxac and for 1 day after your last dose. Talk to your doctor about the best way to feed your baby during treatment.

Evoxac is not approved for use by anyone younger than 18 years old.

If the oral solution is prescribed, note that each 5 mL dose contains about 10 mg of sodium and also contains sorbitol and the preservatives methylparaben and propylparaben. Tell your doctor if you need a low-sodium diet or have had a reaction to these ingredients.

Get emergency medical help if you have signs of an allergic reaction (hives; difficult breathing; swelling of your face, lips, tongue, or throat). Serious allergic reactions, including anaphylaxis and a severe skin reaction called Stevens-Johnson syndrome, have been reported.

Evoxac may cause serious side effects. Stop using Evoxac and call your doctor at once if you have:

• a fast, slow, or uneven heart rate, or a fluttering feeling in your chest;
• wheezing, chest tightness, or trouble breathing;
• severe pain in your stomach, side, or lower back (a possible gallbladder or kidney problem);
• painful or difficult urination;
• a light-headed feeling, like you might pass out; or
• dehydration symptoms, such as feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Common side effects of Evoxac may include:

• increased sweating;
• nausea or vomiting;
• sinus infection (sinusitis), or a stuffy or runny nose;
• upper respiratory tract infection, cough, or bronchitis;
• stomach (abdominal) pain or diarrhea;
• urinary tract infection;
• headache;
• back pain or joint pain; or
• feeling tired.

In clinical studies, the most common side effect was excessive sweating, which occurred in about 19% of people taking Evoxac 30 mg three times a day.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Evoxac has been shown to improve the symptoms of dry mouth and to increase saliva production in adults with Sjögren's syndrome. In a 6-week study, 76% of people taking Evoxac 30 mg three times a day reported that their dry mouth was better, compared with 35% of people taking a placebo. A separate 12-week study also found a significant improvement in dry mouth symptoms and an increase in saliva flow with the 30 mg three-times-daily dose compared with placebo.

Taking more than the recommended amount (for example, 60 mg three times a day) did not work better than the 30 mg dose. The effectiveness of the oral solution is based on these capsule studies, because the oral solution delivers a similar amount of medicine to the body.

Evoxac works as a cholinergic agonist. Its active ingredient, cevimeline, binds to muscarinic receptors on the exocrine glands, such as the salivary and sweat glands. Stimulating these receptors increases the glands' natural secretions, which boosts saliva and helps relieve dry mouth. Because these same receptors are found elsewhere in the body, cevimeline can also increase the tone of smooth muscle in the gastrointestinal and urinary tracts. This is why it can cause side effects such as sweating, nausea, and a more frequent need to urinate.

Take the missed dose as soon as you remember. If it is less than 4 hours until your next scheduled dose, skip the missed dose. Do not take extra medicine to make up for a missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include headache, vision problems, confusion, sweating, tremors, vomiting, diarrhea, shortness of breath, and an irregular heartbeat.

Evoxac may cause blurred vision, especially at night, and may slow your reactions. Be careful if you drive or do anything that requires you to see clearly and stay alert.

Avoid becoming overheated or dehydrated during exercise or in hot weather. Evoxac can reduce sweating, which may raise your risk of heat stroke.

Tell your doctor about all your current medicines and any you start or stop, especially:

• beta-blockers and other heart or blood pressure medicines, which may affect your heart rhythm when combined with Evoxac;
• medicines with anticholinergic effects, such as some treatments for overactive bladder, allergies, or stomach problems;
• other cholinergic medicines, such as pilocarpine; or
• medicines that block the liver enzymes CYP2D6 or CYP3A4, which can raise Evoxac levels, including some antidepressants, antifungals, and antivirals for HIV or hepatitis C.

This list is not complete. Other drugs may interact with cevimeline, including prescription and over-the-counter medicines, vitamins, and herbal products.

Active ingredient: cevimeline hydrochloride. Each 30 mg of cevimeline hydrochloride is equivalent to 25.4 mg of cevimeline.

Inactive ingredients (capsule): hydroxypropyl cellulose, lactose monohydrate, and magnesium stearate.

Inactive ingredients (oral solution): anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, a masking flavor, methylparaben, propylparaben, propylene glycol, purified water, raspberry flavor, sodium citrate dihydrate, sodium thiosulfate, sorbitol solution 70%, and sucralose. Each 5 mL of the oral solution contains about 10 mg of sodium.