Revonto

Name: Revonto

Indications

Revonto (dantrolene sodium for injection) is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Revonto should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).

Revonto is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.

How supplied

Revonto (NDC 27505-003-67) is available in vials containing a sterile lyophilized mixture of 20 mg dantrolene sodium, 3000 mg mannitol, and sufficient sodium hydroxide to yield a pH of approximately 9.5 when reconstituted with 60 mL sterile water for injection USP (without a bacteriostatic agent).

Store unreconstituted product at 20-25° C (68-77° F) [see USP Controlled Room Temperature] and avoid prolonged exposure to light.

Distributed by: US WorldMeds, Louisville, KY 40241. Revised: Oct 2016

Side effects

There have been occasional reports of death following malignant hyperthermia crisis even when treated with intravenous dantrolene; incidence figures are not available (the pre-dantrolene mortality of malignant hyperthermia crisis was approximately 50%). Most of these deaths can be accounted for by late recognition, delayed treatment, inadequate dosage, lack of supportive therapy, intercurrent disease and/or the development of delayed complications such as renal failure or disseminated intravascular coagulopathy. In some cases there are insufficient data to completely rule out therapeutic failure of dantrolene.

There are reports of fatality in malignant hyperthermia crisis, despite initial satisfactory response to i.v. dantrolene, which involve patients who could not be weaned from dantrolene after initial treatment.

The administration of Revonto to human volunteers is associated with loss of grip strength and weakness in the legs, as well as drowsiness and dizziness.

The following adverse reactions are in approximate order of severity:

  • There are rare reports of pulmonary edema developing during the treatment of malignant hyperthermia crisis in which the diluent volume and mannitol needed to deliver i.v. dantrolene possibly contributed.
  • There have been reports of thrombophlebitis following administration of intravenous dantrolene; actual incidence figures are not available. Tissue necrosis secondary to extravasation has been reported.
  • There have been rare reports of urticaria and erythema possibly associated with the administration of i.v. dantrolene sodium. There has been one case of anaphylaxis.
  • Injection site reactions (pain, erythema, swelling), commonly due to extravasation, have been reported.

None of the serious reactions occasionally reported with long-term oral dantrolene sodium use, such as hepatitis, seizures, and pleural effusion with pericarditis, have been reasonably associated with short-term Revonto therapy.

The following events have been reported in patients receiving oral dantrolene: aplastic anemia, leukopenia, lymphocytic lymphoma, and heart failure. (See package insert for dantrolene sodium capsules for a complete listing of adverse reactions.)

The published literature has included some reports of dantrolene sodium use in patients with Neuroleptic Malignant Syndrome (NMS). Revonto (dantrolene sodium for injection) is not indicated for the treatment of NMS and patients may expire despite treatment with Revonto.

For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS contact US WorldMeds at 1-888-900-8796 or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.FDA.gov/ medwatch/.

Read the entire FDA prescribing information for Revonto (Revonto Dantroene Sodium Injection)

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Revonto Overview

Dantrolene is a prescription medication used to relieve spasms and increased muscle tone caused by multiple sclerosis, stroke, or brain or spinal injury. Dantrolene belongs to a group of drugs called muscle relaxants. Dantrolene 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 dantrolene.

Uses of Revonto

Dantrolene is a prescription medication, which in capsule form, is used to relieve spasms and increased muscle tone caused by multiple sclerosis, stroke, or brain or spinal injury.

Dantrolene capsules and injection are both approved to treat or prevent malignant hyperthermia, an inherited, potentially fatal condition in which body temperature quickly rises and severe muscle contraction occurs when the affected person receives anesthesia during surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Revonto Drug Class

Revonto is part of the drug class:

  • Dantrolene and derivatives

Inform MD

Before taking dantrolene, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to any ingredient in dantrolene
  • have liver, heart, rheumatic, or lung disease
  • have had seizures or epilepsy
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

What are some things I need to know or do while I take Revonto?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • If you were given Revonto before or during surgery, signs of muscle weakness may last after surgery. This includes weak grip strength or weak leg muscles. Dizziness may also happen. These effects may last for up to 48 hours. Avoid driving and doing other tasks or actions that call for you to be alert during this time and until you see how this medicine affects you.
  • You may need help with standing and walking until your strength is back to normal.
  • Be careful eating meals on the day Revonto was given. Trouble swallowing and choking have happened. Talk with the doctor.
  • You will be watched closely by your doctor.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
  • Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Revonto while you are pregnant.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Revonto (dantrolene injection) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Revonto. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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