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DANTRIUM DESCRIPTION

Dantrium® (Dantrolene Sodium) - Capsule

Dantrium is manufactured by Procter & Gamble Pharmaceuticals Inc. This medicine is a muscle relaxant used to treat muscle spasms caused by stroke, cerebral palsy, spinal cord injury, or multiple sclerosis. It may also be used to treat other conditions as determined by your doctor.

Dantrium® (dantrolene sodium) capsules' peripheral action on the skeletal muscle can help preserve your patients' cognitive function.

Dantrium is the only drug indicated for the treatment of spasticity with action directly on the skeletal muscle.

In a clinical study comparing Dantrium and diazepam in the treatment of spasticity, drowsiness, imbalance, and incoordination worsened significantly more often in patients on diazepam when compared to patients on Dantrium.1,2,†

In Dantrium clinical trials, when drowsiness or dizziness occurred, it was generally transient and seldom lasted more than 3-4 days. Dantrium is the only drug indicated for and proven effective in the treatment of spasticity in all of the following disorders:
stroke
multiple sclerosis
cerebral palsy
spinal cord injury
Dantrium capsules are indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (i.e., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis).

Most common side effects of Dantrium are drowsiness, dizziness and weakness.* These are generally transient, occurring early in treatment, and can often be obviated by beginning with a low dose and increasing dosage gradually until an optimal regimen is established. A central nervous system effect occurs, with drowsiness, dizziness and generalized weakness occasionally present. Although Dantrium does not appear to directly affect the central nervous system, the extent of its indirect effect is unknown. Dantrium is contraindicated in active hepatic disease (hepatitis and cirrhosis). Symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels. Use Dantrium only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. Before prescribing, please see full prescribing information including the Warnings. In chronic spasticity, it is important that Dantrium capsules be titrated to the lowest effective dose. If no benefits are observed after 45 days, therapy should be discontinued. Please refer to the Dosing and Administration section of the prescribing information.

The effects of Dantrium sodium and diazepam were compared in a double-blind, cross-over study involving 42 patients with moderate or severe spasticity. Each patient was evaluated under two control and four treatment conditions, at consecutive two week intervals. Worsening of the following symptoms occurred significantly more often with diazepam compared to Dantrium; respectively, when excluding those patients whose symptoms worsened on both drugs: drowsiness (56% vs 9%, p<0.01), imbalance (23% vs 0%, p<0.01) and incoordination (25% vs 5%, p<0.05).

Population included stroke, spinal cord injury, multiple sclerosis and unclassified patients.
Schmidt RT et al. Comparison of Dantrium sodium and diazepam in the treatment of spasticity. Journal of Neurology, Neurosurgery, and Psychiatry 1976; 39: 350-356.
Schmidt RT et al. Treatment of spasticity in Multiple Sclerosis: Comparison of Dantrium Sodium and Diazepam. Transactions of the American Neurological Association 1975; 100: 235-237.
Data on file, Procter & Gamble Pharmaceuticals.
Dantrium (Dantrium sodium) capsules Package Insert, Procter & Gamble Pharmaceuticals.
Brand Name
Dantrium Capsules

Common Name
Dantrium

How does Dantrium work? What will it do for me?

Dantrium belongs to a group of medicines known as muscle relaxants. Dantrium capsules are used to treat people with chronic muscle spasms caused by conditions such as cerebral palsy, multiple sclerosis, stroke, or spinal cord injury. Dantrium helps these symptoms by preventing contractions or spasms of the muscles.

Dantrium capsules may also be used before surgery for people at risk of malignant hyperthermia and for follow-up treatment of this condition. Malignant hyperthermia is a syndrome of muscle rigidity and greatly increased body temperature that can be caused by a reaction to certain anaesthetics. If left untreated, malignant hyperthermia can lead to death.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

How should I use Dantrium?

The usual starting dose for adults is 25 mg once daily. The dose is then increased gradually until the best dose is found, based on individual response and needs. The best dose is the lowest dose that will control the muscle spasms. Most people respond to doses of 400 mg daily (given in divided doses, usually as 100 mg four times daily) or less. Children's dosing is based on body weight. Children should not be given doses higher than 100 mg four times daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is very important that this medication be used on a regular schedule as prescribed by the doctor. If you miss a dose of this medication, check with your health care professional. Do not double-up on doses.

What form(s) does Dantrium come in?

Dantrium® Capsules are available in strengths of 25 mg and 100 mg.

25 mg: Each orange and brown capsule, coded with one black bar and "DANTRIUM 25 mg 0149 0030", contains Dantrium 25 mg.

100 mg: Each orange and brown capsule, coded with three black bars and "DANTRIUM 100 mg 0149 0033", contains Dantrium 100 mg.

Nonmedicinal ingredients: edible black ink, gelatin, lactose, magnesium stearate, starch, talc, titanium dioxide, carnauba wax, iron oxide red, FD&C Yellow No. 6, iron oxide yellow; may contain one or more of the following: FD&C Blue No. 2, D&C Red No. 33.

Who should NOT take this medication?

Dantrium capsules should not be used by people who:

have poor lung function
have active liver disease (such as hepatitis or cirrhosis)
have a particular type of muscle spasm (one that, in the doctor's opinion, may actually help increase or maintain the person's ability to function)
are allergic to Dantrium or any ingredients of the medication
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