Zanaflex

Pregnancy category: C

Lactation: May be excreted in breast milk due to lipophilic nature; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Zanaflex

Tizanidine is a short-acting muscle relaxer. It works by blocking nerve impulses (pain sensations) that are sent to your brain.

Tizanidine is used to treat spasticity by temporarily relaxing muscle tone.

Tizanidine may also be used for purposes other than those listed in this medication guide.

Zanaflex is a prescription medication used to relieve spasms and increased muscle tone caused by multiple sclerosis, stroke, or brain or spinal injury. Zanaflex belongs to a group of drugs called skeletal muscle relaxants, which work by slowing action in the brain and nervous system to allow the muscles to relax.

This medication comes in tablet and capsule forms and is taken up to 3 times a day, with or without food. It should always be taken consistently with food or without food, though.

Common side effects of Zanaflex include dry mouth, weakness, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how Zanaflex affects you.

Zanaflex is a prescription medication used to relieve spasms and increased muscle tone caused by multiple sclerosis, stroke, or brain or spinal injury.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before taking Zanaflex, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Zanaflex or to any of its ingredients
• have liver problems
• have kidney problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Zanaflex falls into category C. In animals studies, pregnant animals were given this medication and had some babies born with problems. There are no well-controlled studies that have been done in humans with Zanaflex though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Spasticity

Management of spasticity associated with cerebral or spinal injury, alone or in conjunction with other standard therapies (e.g., baclofen).1 2 5

• Importance of advising patients that clinical experience with long-term or high-dose tizanidine therapy is limited.1

• Risk of marked orthostatic hypotension; importance of exercising caution when moving from a supine to a fixed upright position.1

• Risk of sedation, which may be additive when taken in conjunction with alcohol or other CNS depressants; importance of exercising caution when performing activities requiring alertness, including driving a motor vehicle or operating machinery.1

• Importance of advising patients of potential changes in absorption profile and resulting changes in efficacy and adverse effect profile when taken with food.1 (See Pharmacokinetics.)

• Importance of not discontinuing abruptly because of potential for rebound hypertension and tachycardia.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses, and of informing clinicians or pharmacists whenever any drug is added or discontinued.1 Importance of not taking tizanidine concomitantly with either ciprofloxacin or fluvoxamine.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of advising patients of other important precautionary information.1 (See Cautions.)

In the U.S.

• Comfort Pac w/Tizanidine
• Zanaflex
• Zanaflex Capsule

Available Dosage Forms:

• Capsule
• Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

• If you have an allergy to tizanidine or any other part of Zanaflex (tizanidine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking any of these drugs: Ciprofloxacin or fluvoxamine.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Zanaflex with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Zanaflex affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not stop taking this medicine all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop Zanaflex, you will want to slowly stop it as ordered by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Do not change from the capsule to the tablet or from the tablet to the capsule.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Zanaflex while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Applies to tizanidine: oral capsule, oral tablet

Along with its needed effects, tizanidine (the active ingredient contained in Zanaflex) 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 while taking tizanidine:

• Chest pain or discomfort
• fever or chills
• nausea or vomiting
• nervousness
• pain or burning while urinating
• unusual tiredness

• Blurred vision
• flu-like symptoms
• irregular heartbeat
• itching skin
• kidney stones
• right upper stomach tenderness
• seeing things that are not there
• shortness of breath
• weight gain

• 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 while taking tizanidine:

• 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
• sleepiness or unusual drowsiness
• slow or irregular heartbeat
• sweating
• unusual tiredness or weakness

Some side effects of tizanidine 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:

• Dizziness or lightheadedness, especially when getting up from a lying or sitting position
• drowsiness
• dry mouth
• fatigue
• sleepiness
• weakness

• Constipation
• nervousness
• sore throat