Pronunciation:

tye-ZAN-i-deen

Brand Names:

• Zanaflex

Dosage Forms:

• Capsule
• Tablet

Classifications:

Therapeutic—

Skeletal Muscle Relaxant, Centrally Acting

Uses of This Medicine:

Tizanidine is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis or certain injuries to the spine. Tizanidine does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.

Tizanidine acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of the medicine's side effects.

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

Before Using This Medicine:

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.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of tizanidine in children with use in other age groups.

Older adults—

Studies in older adults show that tizanidine stays in the body a little longer than it does in younger adults. Your doctor will consider this when deciding on your dose.

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.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ciprofloxacin
• Fluvoxamine

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:

• Kidney disease or
• Liver disease—The chance of side effects may be increased; higher blood levels of tizanidine may result and a smaller dose may be needed

Proper Use of This Medicine:

When you take the different dosage forms (tablets, capsules, capsule contents sprinkled over applesauce) of tizanidine with food, it effects the amount of the medicine absorbed into your blood differently. Follow your doctor's instructions for when to take this medicine and whether or not you should take it with food.

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

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 and tablets):
  • For muscle relaxation:
    • Adults—The dose is 8 milligrams (mg) every six to eight hours as needed. No more than 36 mg should be taken within a twenty-four-hour period.
    • 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.

Precautions While Using This Medicine:

Your doctor should check your progress at regular visits, especially during the first few weeks of treatment with this medicine. During this time the amount of medicine you are taking may have to be changed often to meet your individual needs.

Do not suddenly stop taking this medicine. Unwanted effects may occur if the medicine is stopped suddenly. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using tizanidine.

This medicine may cause dizziness, drowsiness, lightheadedness, clumsiness or unsteadiness, or vision problems in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see well.

Tizanidine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Side Effects of This Medicine:

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 as soon as possible if any of the following side effects occur:

More common

Chest pain or discomfort

fever

loss of appetite

lower back or side pain

nausea and/or vomiting

nervousness

pain or burning while urinating

painful or difficult urination

sores on the skin

tingling, burning, or prickling sensations

unusual tiredness

yellow eyes or skin

Less common

Black, tarry stools

bloody vomit

blurred vision

chills or sore throat

coldness

convulsions (seizures)

cough or hoarseness

dark urine

dry, puffy skin

eye pain

fainting

influenza (flu)-like symptoms

irregular heartbeat

kidney stones

persistent anorexia

pruritus

right upper quadrant tenderness

seeing things that are not there

shortness of breath

slow or irregular heartbeat

unusual tiredness or weakness

weight gain

Incidence not known

Continuing vomiting

general feeling of tiredness or weakness

headache

light-colored stools

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

Symptoms of overdose

Blurred vision

change in consciousness

chest pain or discomfort

confusion

decreased awareness or responsiveness

difficult or troubled breathing

dizziness, faintness or lightheadedness when getting up from a lying position

irregular, fast or slow, or shallow breathing

lightheadedness, dizziness or fainting

loss of consciousness

pale or blue lips, fingernails, or skin

severe sleepiness

shortness of breath

sleepiness or unusual drowsiness

slow or irregular heartbeat

sweating

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:

More common

Anxiety

back pain

constipation

depression

diarrhea

difficulty in speaking

dizziness or lightheadedness, especially when getting up from a lying or sitting position

drowsiness

dry mouth

heartburn

increased sweating

increased muscle spasms or tone

muscle weakness

pain or burning in throat

runny nose

skin rash

sleepiness

stomach pain

uncontrolled movements of the body

Less common

Difficulty swallowing

dry skin

general feeling of discomfort or illness

increased need to urinate

joint or muscle pain or stiffness

loss of hair

migraine headache

mood changes

neck pain

passing urine more often

shivering

swelling of feet or lower legs

swollen area that feels warm and tender

trembling or shaking

trouble sleeping

unusual feeling of well-being

unusual tiredness or weakness

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.