Metaxalone Tablets; Capsaicin Cream

What is this medication?

METAXALONE; CAPSAICIN (me TAX a lon; kap SAY sin) treats muscle pain and stiffness. Metaxalone works by calming overactive nerves in your body, which helps your muscles relax. Capsaicin works by making your skin feel warm or cool, which blocks pain signals going to the brain. This product contains a muscle relaxant.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Metaxall CP

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Large areas of burned or damaged skin
• Liver disease
• Low red blood cell levels (anemia)
• Skin conditions
• An unusual or allergic reaction to capsaicin, hot peppers, metaxalone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Metaxalone tablets

Take this medication by mouth with water. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 13 years for selected conditions, precautions do apply.

Capsaicin cream

This medication is for external use only. Do not take by mouth. Wash your hands before and after use. If you are treating your hands, only wash your hands before use. Do not get it in your eyes. If you do, rinse your eyes with plenty of cool tap water. Use it as directed on the label at the same time every day. Do not use it more often than directed. Keep using it unless your care team tells you to stop.

Apply a thin film of the medication to the affected area. Do not apply to burned or damaged skin. Do not cover the area with a bandage.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Metaxalone Tablets

• Alcohol
• Benzodiazepines, such as alprazolam, diazepam, lorazepam
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that help you fall asleep
• Opioids for pain or cough
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Some antihistamines
• Some medications for depression, such as amitriptyline or trazodone
• Some medications for seizures, such as phenobarbital or primidone

Capsaicin cream

Interactions are not expected. Do not use any other skin products on the same area of skin without talking to your care team.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Metaxalone may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Warm water, sweating, and open pores can increase the amount of medication your body absorbs from capsaicin cream. This may cause an intense burning sensation. Avoid hot tubs, saunas, electric blankets, heated waterbeds, or tanning lamps. Do not use a hairdryer or heating pad on or near the area where the cream is applied. If severe discomfort occurs, remove the excess cream with a soft cloth and cooking oil.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Agitation, feeling irritable or restless
• Dizziness
• Drowsiness
• Headache
• Mild skin irritation, redness, or dryness
• Nausea
• Upset stomach
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

Capsaicin cream is flammable. Avoid exposure to heat, fire, flame, and smoking.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.