Dantrium

IV Compatibilities

Sterile water for injection (SWI)

IV Incompatibilities

Dextrose solutions

0.9% NaCl

Other acidic solutions

IV Preparation

Ryanodex

• Reconstitute each 250 mg vial by adding 5 mL of SWI (not bacteriostatic water for injection)
• Shake the vial to ensure an orange-colored uniform suspension Visually inspect the vial for particulate matter and discoloration prior to administration

Dantrium, Revonto

• Reconstitute each 20 mg vial by adding 60 mL of SWI (not bacteriostatic water for injection)
• Shake vial for about 20 seconds or until solution is clear
• Do not transfer reconstituted solutions to large glass bottles for prophylactic infusion due to precipitate formation
• May transfer to larger volume sterile IV empty plastic bag

IV Administration

Therapeutic or emergency dose can be administered with rapid IV push

Follow-up doses should be administered over 2-3 min

36 vials (20 mg/vial) are needed for adequate hyperthermia therapy

Ryanodex

• Administer the reconstituted suspension either:
• -Into the IV catheter while an IV infusion of 0.9% NaCal or 5% dextrose injection is freely running; or
• -Into the indwelling catheter after assuring its patency without a freely running infusion
• Flush the IV line to assure that there is no residual drug that remains in the catheter

Storage

Unreconstituted vials

• Store controlled room temperature 20-25° C (68-77° F)
• Avoid prolonged exposure to light

Reconstituted vials

• Should be used immediately, but reconstituted solution may be stored at controlled room temperature 20-25° C (68-77° F) and used within 6 hr
• Protect from direct light

Dantrium is a prescription medication used to relieve spasms and increased muscle tone caused by multiple sclerosis, stroke, or brain or spinal injury. Dantrium belongs to a group of drugs called muscle relaxants. Dantrium causes muscle relaxation by interfering with calcium release within the muscle.

This medication comes in the form of a capsule and a liquid for injection. The capsule is usually taken by mouth 3 or 4 times daily. The injection is given directly into a vein (IV) by a healthcare provider.

Common side effects include diarrhea, drowsiness, and dizziness. Do not drive or operate machinery until you know how it affects you. It is best to avoid alcohol while taking Dantrium.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Dantrium falls into category C. There are no adequate and well-controlled studies in pregnant women. Dantrolene should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Dantrium has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Dantrium, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Dantrolene is a muscle relaxer.

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 and severe muscle contractions) that can occur during surgery with certain types of anesthesia.

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

Taking dantrolene with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Liver problems may be more likely in women over 35 who use estrogen. Tell your doctor if you use hormone replacement medicine, or hormonal birth control (pills, injections, implants, skin patches, or vaginal rings).

Other drugs may interact with dantrolene, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

General

Spasticity

• Establish therapeutic goal before initiating therapy.109 Use lowest possible effective dosage.109 Discontinue drug if beneficial effects are not attained within 45 days.109 (See Boxed Warning.)

• Subjective impressions of improvement may sometimes be confirmed by withdrawal of the drug for 2–4 days.109

Malignant Hyperthermia Crisis

• Immediately discontinue all anesthetic agents and institute IV dantrolene as soon as malignant hyperthermia crisis is recognized.108

• Monitor vital signs; employ the usual precautions associated with surgery in susceptible patients, since malignant hyperthermia may only be attenuated rather than prevented.108

Administration

Administer orally or by continuous IV infusion or rapid IV injection.108 109

Oral Administration

Administer orally 1–4 times daily.109

To prepare oral suspension containing 25 mg of dantrolene sodium per 5 mL, empty 5 100-mg capsules in 50 mL of Syrup NF, then add a solution containing 150 mg of citric acid in 10 mL of water followed by a sufficient volume of Syrup NF to make 100 mL.c Mix thoroughly before use.c

IV Administration

For solution compatibility information, see Compatibility under Stability.

For IV infusion, transfer reconstituted solution from the appropriate number of vials to plastic infusion bag.109 Do not use large glass containers; precipitate formation observed with some glass containers.108

Avoid extravasation (injection has high pH).108

Add 60 mL of sterile water for injection (without bacteriostatic agent) to vial containing 20 mg of dantrolene sodium.108 Shake vial until solution is clear.108

Although reconstituted solutions are stable for 6 hours,108 infusions preferably should be prepared immediately before use.a

Preoperative prophylaxis: Infuse IV over approximately 1 hour beginning about 1.25 hours before anticipated anesthesia.108

Treatment of malignant hyperthermia syndrome: Rapid IV injection.108

Dosage

Available as dantrolene sodium; dosage expressed in terms of the salt.108 109

Pediatric Patients

Children ≥5 years of age: 0.5 mg/kg once daily for 7 days, followed by 0.5 mg/kg 3 times daily for 7 days, then 1 mg/kg 3 times daily for 7 days, and then 2 mg/kg 3 times daily, if necessary.109 Some patients may require doses 4 times daily.109

If no additional benefit is observed at the next higher dosage, decrease dosage to the previous (lower) dosage.109

4–8 mg/kg daily in 3 or 4 divided doses for 1–2 days prior to surgery; give the last dose approximately 3–4 hours before surgery with small amount of water.109

2.5 mg/kg infused over approximately 1 hour beginning about 1.25 hours before anticipated anesthesia; may give additional individualized doses intraoperatively, if necessary.108

Initially, 1 mg/kg or more by rapid IV injection.108 Repeat dose as necessary until physiologic and metabolic abnormalities subside or a maximum total dosage of 10 mg/kg is reached.108

Average total dosage: 2.5 mg/kg.a

Repeat regimen if physiologic and metabolic abnormalities reappear.108

4–8 mg/kg daily in 4 divided doses for up to 3 days after the crisis.109

Initially, 1 mg/kg or more as clinically indicated.108 Individualize subsequent doses.108

Adults

Initially, 25 mg once daily for 7 days, followed by 25 mg 3 times daily for 7 days, then 50 mg 3 times daily for 7 days, and then 100 mg 3 times daily, if necessary.109 Some patients may require doses 4 times daily.109

If no additional benefit is observed at the next higher dosage, decrease dosage to the previous (lower) dosage.109

4–8 mg/kg daily in 3 or 4 divided doses for 1–2 days prior to surgery; give the last dose approximately 3–4 hours before surgery with small amount of water.109

2.5 mg/kg infused over approximately 1 hour beginning about 1.25 hours before anticipated anesthesia; may give additional individualized doses intraoperatively, if necessary.108

Initially, 1 mg/kg or more by rapid IV injection.108 Repeat dose as necessary until physiologic and metabolic abnormalities subside or a maximum total dosage of 10 mg/kg is reached.108

Average total dosage: 2.5 mg/kg.a

Repeat regimen if physiologic and metabolic abnormalities reappear.108

4–8 mg/kg daily in 4 divided doses for up to 3 days after the crisis.109

Initially, 1 mg/kg or more as clinically indicated.108 Individualize subsequent doses.108

Prescribing Limits

Pediatric Patients

Maximum 100 mg 4 times daily.109

Maximum 10 mg/kg.108

Adults

Maximum 100 mg 4 times daily.109

Maximum 10 mg/kg.108

Dantrolene may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For prevention or treatment of malignant hyperthermia:
    • Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 4 to 8 milligrams (mg) per kilogram (kg) of body weight each day, and is divided in 3 or 4 doses. Your doctor will tell you exactly when and how often to take your medicine.
    • Children—Use and dose must be determined by your doctor.
  • To relieve muscle spasms:
    • Adults—At first, 25 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg four times a day.
    • Children—Dose is based on body weight and must be determined by your doctor. At first, 0.5 milligram (mg) per kilogram (kg) of body weight twice a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 3 mg per kg four times a day or 100 mg four times a day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Dantrium (dantrolene sodium) is available in:

Store between 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Rx Only.

Dist. by:
Par Pharmaceutical
Chestnut Ridge, NY 10977 U.S.A.

Mfg. by:
Par Formulations Private Limited
1/58 Pudupakkam, Kelambakkam – 603 103

Made in India

SE7583/00

I10/15

OS124J-01-90-01

Applies to dantrolene: oral capsule

Other dosage forms:

• intravenous powder for solution, intravenous powder for suspension

Along with its needed effects, dantrolene (the active ingredient contained in Dantrium) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Serious side effects are very rare when dantrolene is taken for a short time, for example, when it is used for a few days before, during, or after surgery or anesthesia to prevent or treat malignant hyperthermia. However, serious side effects may occur, especially when the medicine is taken for a long time.

Check with your doctor immediately if any of the following side effects occur while taking dantrolene:

• Bloody or black, tarry stools
• bloody or dark urine
• bluish color changes in skin color
• changes in speech
• chest pain
• confusion
• constipation
• convulsions (seizures)
• decrease in frequency of urination
• decrease in urine volume
• difficult urination
• difficulty in moving
• difficulty in passing urine (dribbling)
• difficulty in swallowing
• fast, pounding, or irregular heartbeat or pulse
• increased frequency of urination
• increased urge to urinate during the night
• joint pain
• light-colored stools
• lightheadedness
• loss of bladder control
• mental depression
• muscle aching or cramping
• muscle pains or stiffness
• muscle spasm or jerking of all extremities
• nausea and vomiting
• pain in lower back
• pain or burning while urinating
• pain, tenderness, or changes in skin color
• painful urination
• severe stomach pain
• shortness of breath
• skin rash, hives, or itching
• slow or troubled breathing
• sudden decrease in amount of urine
• sudden loss of consciousness
• swelling of foot or leg
• swollen joints
• unusual tiredness or weakness
• upper right abdominal pain
• vomiting of blood or material that looks like coffee grounds
• waking to urinate at night
• yellow eyes or skin

Some side effects of dantrolene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• dizziness
• drowsiness
• general feeling of discomfort or illness
• muscle weakness

• Abdominal or stomach cramps or discomfort
• abnormal hair growth
• acne-like rash
• blurred or double vision or any change in vision
• change in taste
• chills and fever
• disturbed color perception
• excessive tearing
• halos around lights
• headache
• itching skin
• loss of appetite
• night blindness
• overbright appearance of lights
• redness of skin
• seeing double
• skin rash, encrusted, scaly and oozing
• sleeplessness
• slurring of speech or other speech problems
• sudden decrease in amount of urine
• sweating
• trouble in sleeping
• tunnel vision
• unable to sleep
• unusual nervousness
• weight loss