INDICATIONS

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

INSTRUCTIONS

Take Zanaflex exactly as prescribed by your doctor.

A single dose of 8 mg of Tizanidine reduces muscle tone in patients with spasticity for a period of several hours. The effect peaks at approximately 1 to 2 hours and dissipates between 3 to 6 hours. Effects are dose-related.

Although single doses of less than 8 mg have not been demonstrated to be effective in controlled clinical studies, the dose-related nature of tizanidine's common adverse events make it prudent to begin treatment with single oral doses of 4 mg. Increase the dose gradually (2 to 4 mg steps) to optimum effect (satisfactory reduction of muscle tone at a tolerated dose).

The dose can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours. The total daily dose should not exceed 36 mg.

Experience with single doses exceeding 8 mg and daily doses exceeding 24 mg is limited There is essentially no experience with repeated, single, daytime doses greater than 12 mg or total daily doses greater than 36 mg.

Ask your health care provider any questions you may have about how to use Zanaflex.

STORAGE

Store Zanaflex at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)  Dispense in containers with child resistant closure.

MORE INFO:

Active Ingredient: Tizanidine hydrochloride.

Zanaflex can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Dizziness is most likely to occur when you rise from a sitting or lying position. Get up slowly to prevent dizziness and a possible fall. Do not use Zanaflex at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone. Cold or allergy medicine, narcotic pain medicine, sleeping pills, other muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Zanaflex. Tell your doctor if you need to use any of these other medicines together with Zanaflex. Avoid drinking alcohol. It can increase some of the side effects of Zanaflex.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• feeling light-headed, fainting, slow heart rate;
• hallucinations, confusion, unusual thoughts or behavior;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• burning or pain when you urinate.

Less serious Zanaflex side effects may be more likely to occur, such as:

• drowsiness or dizziness;
• feeling anxious or nervous;
• numbness or tingling;
• stomach pain, diarrhea, constipation, vomiting;
• fever;
• dry mouth;
• muscle weakness, back pain;
• increased muscle tone or spasms; or
• sweating or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Do not take Zanaflex if you are also taking the antidepressant fluvoxamine (Luvox), or the antibiotic ciprofloxacin (Cipro). Do not use Zanaflex at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone.

Switching between Zanaflex tablets and capsules, or changing the way you take it with regard to eating, can cause an increase in side effects or a decrease in therapeutic effect. Follow your doctor's instructions carefully. After making any changes in how you take Zanaflex, contact your doctor if you notice any change in how well the medicine works or if it causes increased side effects.

Do not take more than three doses (36 mg) of Zanaflex in a 24-hour period. Too much of this medication can damage your liver. Cold or allergy medicine, narcotic pain medicine, sleeping pills, other muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Zanaflex. Tell your doctor if you need to use any of these other medicines together with Zanaflex. Avoid drinking alcohol. It can increase some of the side effects of Zanaflex.

Do not use Zanaflex if you are allergic to tizanidine, or if you are also taking the antidepressant fluvoxamine (Luvox), or the antibiotic ciprofloxacin (Cipro).

Before using Zanaflex, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• kidney disease;
• high or low blood pressure; or
• a history of "Long QT syndrome."

If you have any of these conditions, you may not be able to use Zanaflex, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Zanaflex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. In older adults, Zanaflex may take much longer to clear from the body. Follow your doctor's instructions about your specific dosage and medication schedule.