Ontralfy

Ontralfy is a medicine used in adults to relax tight or stiff muscles caused by spasticity.

Ontralfy may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

Ontralfy is usually taken up to 3 times a day. Allow 6 to 8 hours between doses. Do not take more than three doses (36 mg) in a 24-hour period. Taking too much of this medicine can harm your liver.

You may take Ontralfy with or without food, but take it the same way each time. Changing between taking this medicine with food and without food can make the medicine less effective or cause more side effects.

Measure liquid medicine with the provided measuring device (not a kitchen spoon).

Switching between Ontralfy tablets and capsules may result in changes in side effects or how well the medicine works.

• Taking the tablets with food can increase your blood levels of Ontralfy.
• Taking the capsules with food can decrease your blood levels of Ontralfy.

If you change how you take Ontralfy, tell your doctor if you notice any change in side effects or in how well the medicine works.

Ontralfy is a short-acting medication, and its effects will be most noticeable between 1 and 3 hours after you take it. You should take this medicine only for daily activities that require relief from muscle spasms.

You will need regular blood tests to check your liver function.

You should not stop using Ontralfy suddenly. Follow your doctor's instructions about decreasing your dose.

Store at room temperature away from moisture and heat.

You should not take Ontralfy if you are also taking fluvoxamine or ciprofloxacin.

Do not use Ontralfy when you need muscle tone for safe balance and movement during certain activities.

You should not use Ontralfy if you are allergic to it, or if you:

• take the antidepressant fluvoxamine (Luvox); or
• take the antibiotic ciprofloxacin (Cipro).

Tell your doctor if you have or have ever had:

• low blood pressure; or
• liver or kidney disease.

Ontralfy may harm an unborn baby. Tell your doctor if you are pregnant.

Ask a doctor if it is safe to breastfeed while using Ontralfy.

Not approved for use by anyone younger than 18 years old.

Older adults may be more sensitive to the effects of this medication.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Ontralfy may cause serious side effects. Call your doctor right away if you have:

• a light-headed feeling, as if you might faint;
• weak or shallow breathing;
• liver problems—loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• confusion, hallucinations; or
• pain or burning when you urinate.

Common side effects of Ontralfy may include:

• drowsiness, dizziness, weakness;
• feeling anxious;
• blurred vision;
• flu-like symptoms;
• dry mouth, difficulty speaking;
• abnormal liver function tests;
• runny nose, sore throat;
• urination problems, painful urination;
• vomiting, constipation; or
• uncontrolled muscle movements.

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 FDA at 1-800-FDA-1088.

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include weakness, drowsiness, confusion, slow heart rate, shallow breathing, feeling light-headed, or fainting.

Do not use Ontralfy at a time when you need muscle tone for safe balance and movement during certain activities. In some situations, it may be dangerous for you to have reduced muscle tone.

Drinking alcohol with Ontralfy can cause side effects.

Avoid driving or doing dangerous activities until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Taking Ontralfy with other medications that cause drowsiness or slow your breathing can lead to serious side effects or even death. Always check with your doctor before using opioid medications, sleeping pills, muscle relaxers, or medications for anxiety or seizures.

Inform your doctor about all the other medicines you are taking, especially:

• acyclovir;
• ticlopidine;
• zileuton;
• birth control pills;
• an antibiotic-- levofloxacin, moxifloxacin, or ofloxacin;
• blood pressure medicine-- clonidine, guanfacine, methyldopa;
• heart rhythm medicine-- amiodarone, mexiletine, propafenone, verapamil; or
• stomach acid medicine-- cimetidine, famotidine.

This list is not exhaustive. Other medications may also interact with Ontralfy, including prescription and over-the-counter drugs, vitamins, and herbal products. Not all possible drug interactions are included here.