Dantrium Capsules

DRUG DESCRIPTION

The chemical formula of Dantrium (dantrolene sodium) is hydrated 1-[[[5-(4- nitrophenyl)-2-furanyl]methylene]amino]-2, 4-imidazolidinedione sodium salt. It is an orange powder, slightly soluble in water, but due to its slightly acidic nature the solubility increases somewhat in alkaline solution. The anhydrous salt has a molecular weight of 336. The hydrated salt contains approximately 15% water (3-? moles) and has a molecular weight of 399. The structural formula for the hydrated salt is:

<b>Dantrium</b> (dantrolene sodium)  structural formula illustration

Dantrium is supplied in capsules of 25 mg, 50 mg, and 100 mg.

Inactive Ingredients: Each capsule contains edible black ink, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, starch, synthetic iron oxide red, synthetic iron oxide yellow, talc, and titanium dioxide.

What are the possible side effects of dantrolene (Dantrium)?

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

Call your doctor at once if you have a serious side effect such as:

  • severe diarrhea or constipation;
  • weak or shallow breathing;
  • pale skin, easy bruising or bleeding;
  • trouble swallowing, especially if it causes choking;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing...

Read All Potential Side Effects and See Pictures of Dantrium Capsules

What are the precautions when taking dantrolene sodium capsules (Dantrium Capsules)?

Before taking dantrolene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver problems (e.g., hepatitis, cirrhosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., chronic obstructive pulmonary disease-COPD), heart problems.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure...

Read All Potential Precautions of Dantrium Capsules


Dantrium Capsules Consumer (continued)

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, weakness, tiredness, nausea, and diarrhea may occur as your body adjusts to this medication and usually lessen after several days. Headache, constipation, slurred speech, and drooling may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: sunburn (sun sensitivity), vision changes, black/tarry stools, vomit that looks like coffee grounds, mental/mood changes, trouble swallowing, problems with urination, severe/persistent constipation, seizures, fast heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (e.g., fever, chills, persistent sore throat), chest pain, swelling of the ankles/feet, trouble breathing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking dantrolene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver problems (e.g., hepatitis, cirrhosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., chronic obstructive pulmonary disease-COPD), heart problems.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Dantrium Capsules Patient Information Including Side Effects

Brand Names: Dantrium

Generic Name: dantrolene (oral) (Pronunciation: DAN troe leen)

  • What is dantrolene (Dantrium Capsules)?
  • What are the possible side effects of dantrolene (Dantrium Capsules)?
  • What is the most important information I should know about dantrolene (Dantrium Capsules)?
  • What should I discuss with my healthcare provider before taking dantrolene (Dantrium Capsules)?
  • How should I take dantrolene (Dantrium Capsules)?
  • What happens if I miss a dose (Dantrium Capsules)?
  • What happens if I overdose (Dantrium Capsules)?
  • What should I avoid while taking dantrolene (Dantrium Capsules)?
  • What other drugs will affect dantrolene (Dantrium Capsules)?
  • Where can I get more information?

What is dantrolene (Dantrium Capsules)?

Dantrolene is a muscle relaxant.

Dantrolene is used to treat muscle spasticity (stiffness and spasms) caused by conditions such as a spinal cord injury, stroke, cerebral palsy, or multiple sclerosis.

Dantrolene is also used to prevent muscle stiffness and spasms caused by malignant hyperthermia (a rapid rise in body temperature) that can occur during surgery with certain types of anesthesia.

Dantrolene may also be used for other purposes not listed in this medication guide.

What are the possible side effects of dantrolene (Dantrium Capsules)?

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

Call your doctor at once if you have a serious side effect such as:

  • severe diarrhea or constipation;
  • weak or shallow breathing;
  • pale skin, easy bruising or bleeding;
  • trouble swallowing, especially if it causes choking;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • seizure (black-out or convulsions); or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • drowsiness, dizziness, weakness, tired feeling;
  • mild diarrhea or constipation;
  • mild nausea, vomiting, stomach pain;
  • problems with speech, balance, or walking;
  • headache, confusion, vision problems;
  • sleep problems (insomnia);
  • sweating, drooling; or
  • urinating more than usual.

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.

What is the most important information I should know about dantrolene (Dantrium Capsules)?

You should not take this medication if you are allergic to dantrolene, or if you have liver disease such as hepatitis or cirrhosis.

You may be more likely to develop liver problems while taking dantrolene if you are a woman, or if you are older than 35. Talk with your doctor about your individual risk.

Do not use dantrolene 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.

Before taking dantrolene, tell your doctor if you have a history of liver disease, a breathing disorder such as COPD, heart disease, or a history of heart attack.

Dantrolene 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.

Dantrolene can cause muscle weakness, which can affect your ability to swallow. Use caution to prevent choking while you are eating meals. Talk with your doctor if you are unable to eat because of this side effect.

Avoid drinking alcohol. It can increase some of the side effects of dantrolene.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

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