"By Kathleen Doheny
WebMD Health News
Reviewed by Michael W. Smith, MD
Dec. 30, 2013 -- The FDA has rejected the new multiple sclerosis drug Lemtrada, saying the drugmaker didn't show the drug's benefits outweigh some s"...
(dantrolene sodium) Capsules
Dantrium (dantrolene sodium) has a potential for hepatotoxicity, and should not be used in conditions other than those recommended. Symptomatic hepatitis (fatal and nonfatal) has been reported at various dose levels of the drug. The incidence reported in patients taking up to 400 mg/day is much lower than in those taking doses of 800 mg or more per day. Even sporadic short courses of these higher dose levels within a treatment regimen markedly increased the risk of serious hepatic injury. Liver dysfunction as evidenced by blood chemical abnormalities alone (liver enzyme elevations) has been observed in patients exposed to Dantrium for varying periods of time. Overt hepatitis has occurred at varying intervals after initiation of therapy, but has been most frequently observed between the third and twelfth month of therapy. The risk of hepatic injury appears to be greater in females, in patients over 35 years of age, and in patients taking other medication(s) in addition to Dantrium (dantrolene sodium). Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving Dantrium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of Dantrium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.
The chemical formula of Dantrium (dantrolene sodium) is hydrated 1-[[[5-(4-nitrophenyl)-2furanyl]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 (3-1/2 moles) and has a molecular weight of 399. The structural formula for the hydrated salt is:
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
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 of the skin or eyes);
- black, bloody, or tarry...
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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as hepatitis, cirrhosis), breathing problems (such as 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...
Last reviewed on RxList: 7/25/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Dantrium Capsules Information
Dantrium Capsules - User Reviews
Dantrium Capsules User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
Get the latest treatment options.