Revonto

Mechanism of Action

Interferes with calcium release within skeletal muscle cells (from sarcoplasmic reticulum)

Pharmacokinetics

Peak plasma time: 5 hr

Concentration: 100 to >600 ng/mL

Half-life elimination: 4-8hr

Duration: 3 hr or longer

Protein Bound: substantial

Metabolism: Liver

Metabolites: 5-hydroxy derivative

Excretion: Urine (25%); feces (45-50%)

• US WorldMeds, LLC

Common side effects include:

• drowsiness
• dizziness
• weakness
• feeling of discomfort (malaise)
• fatigue
• diarrhea
• loss of grip strength and weakness in the legs (particularly when dantrolene is given by IV injection)

This is not a complete list of dantrolene side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported. See "Drug Precautions" section.

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

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.

Dantrolene falls into category C. Dantrolene should be given to a pregnant woman only if clearly needed.

In the U.S.

• Dantrium Intravenous
• Revonto
• Ryanodex

Available Dosage Forms:

• Powder for Suspension
• Powder for Solution

Therapeutic Class: Skeletal Muscle Relaxant, Direct Acting

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Blue lips and fingernails
• chest pain
• coughing that sometimes produces a pink frothy sputum
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty swallowing
• dizziness
• fast heartbeat
• hives
• increased sweating
• itching
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• swelling in legs and ankles
• tightness in chest
• tissue necrosis
• unusual tiredness or weakness
• wheezing

• Changes in skin color, pain, tenderness, or swelling of foot or leg

Some side effects 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:

• Flushing or redness of skin
• unusually warm skin

• Drowsiness
• muscle weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Choking.
• Trouble swallowing.
• Shortness of breath.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Flushing.
• Headache.
• Upset stomach.
• Change in voice.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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 Revonto) 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