Dantrolene Sodium Oral capsule

What is this medicine?

DANTROLENE (DAN troe leen) helps to relieve spasms and stiffness of muscles in conditions such as multiple sclerosis, cerebral palsy, stroke, or injury to the spine. This medicine can also help prevent and treat a condition called malignant hyperthermia, which may occur after surgery or anesthesia.

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

What should I tell my health care provider before I take this medicine?

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

• heart disease

• liver disease

• lung or breathing disease, like asthma

• an unusual or allergic reaction to dantrolene, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

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 medicine?

• female hormones, like estrogens or progestins and birth control pills

• medicines for angina or high blood pressure

• medicines for anxiety or sleeping problems, such as diazepam or temazepam

• medicines for pain

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 medicine?

Visit your doctor or health care professional for regular checks on your progress.

You may get drowsy or dizzy. Muscle weakness may occur. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. Be careful walking down stairs. Use caution to reduce the risk of dizzy or fainting spells or falls. Alcohol can make you more drowsy. Avoid alcoholic drinks.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• black, or tarry stools

• breathing problems

• chest pain

• confusion, depression, nervousness

• dark urine

• diarrhea

• fever

• seizures

• stomach pain, nausea, vomiting

• swelling of feet or legs

• yellowing of eyes or skin

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

• constipation

• loss of appetite

• slurred speech

• trouble sleeping

• weak or tired

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 medicine?

Keep out of the reach of children.

Store at room temperature below 40 degrees C (104 degrees F). Throw away any unused medicine after the expiration date.

Dantrolene Sodium Solution for injection

What is this medicine?

DANTROLENE (DAN troe leen) is a muscle relaxant. It is used to prevent and to treat a condition called malignant hyperthermia.

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

What should I tell my health care provider before I take this medicine?

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

• heart disease

• liver disease

• lung or breathing disease, like asthma

• an unusual or allergic reaction to dantrolene, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine 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?

This does not apply.

What may interact with this medicine?

• alcohol

• female hormones, like estrogens or progestins and birth control pills

• medicines for anxiety or sleep like diazepam, temazepam

• medicines for heart disease like verapamil

• medicines for pain

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 medicine?

Your condition will be monitored carefully while you are receiving this medicine.

You may get drowsy or dizzy. Muscle weakness may occur. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. Be careful walking down stairs. Use caution to reduce the risk of dizzy or fainting spells or falls. Alcohol can make you more drowsy. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain

• confusion, depression, nervousness

• fever

• swelling of feet or legs

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

• drowsy, dizzy

• loss of appetite

• muscle weakness for up to 48 hours after treatment

• slurred speech

• trouble sleeping

• unusually weak or tired

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 medicine?

This drug is given in a hospital or clinic and will not be stored at home.