Dantrolene Cristalia is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by certain medical problems such as multiple sclerosis (MS), cerebral palsy, stroke, or injury to the spine. Dantrolene Cristalia does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition. Dantrolene Cristalia acts directly on the muscles to produce its relaxant effects.
Dantrolene Cristalia is also used to prevent or treat a medical problem called malignant hyperthermia that may occur in some patients during or following surgery or anesthesia. Malignant hyperthermia consists of a group of symptoms including very high fever, fast and irregular heartbeat, and breathing problems. It is believed that the tendency to develop malignant hyperthermia is inherited.
Dantrolene Cristalia is available only with your doctor's prescription.
Dantrolene Cristalia indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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In Chronic Spasticity
Dantrolene Cristalia is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene Cristalia is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
If improvement occurs, it will ordinarily occur within the dosage titration, and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without Dantrolene Cristalia.
Occasionally, subtle but meaningful improvement in spasticity may occur with Dantrolene Cristalia therapy. In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of Dantrolene Cristalia for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression.
A decision to continue the administration of Dantrolene Cristalia on a long-term basis is justified if introduction of the drug into the patient's regimen:
produces a significant reduction in painful and/or disabling spasticity such as clonus, or
permits a significant reduction in the intensity and/or degree of nursing care required, or
rids the patient of any annoying manifestation of spasticity considered important by the patient himself.
In Malignant Hyperthermia
Oral Dantrolene Cristalia is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous Dantrolene Cristalia sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for Dantrolene Cristalia® (Dantrolene Cristalia sodium)
Intravenous.
Oral Dantrolene Cristalia should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.
How should I use Dantrolene Cristalia?
Use Dantrolene Cristalia as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Dantrolene Cristalia is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Dantrolene Cristalia at home, carefully follow the injection procedures taught to you by your health care provider.
If Dantrolene Cristalia contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
If you miss a dose of Dantrolene Cristalia, contact your doctor or health care provider immediately.
Ask your health care provider any questions you may have about how to use Dantrolene Cristalia.
Uses of Dantrolene Cristalia in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Chronic spasticity:
Oral: Treatment of spasticity associated with upper motor neuron disorders (eg, spinal cord injury, stroke, cerebral palsy, or multiple sclerosis).
Malignant hyperthermia:
IV: Management of malignant hyperthermia (MH) crisis.
Oral, IV: Following a malignant hyperthermic crisis to prevent recurrence.
Note: Dantrolene Cristalia is not recommended for preoperative prophylaxis of MH, even in susceptible patients, provided non-triggering anesthetic agents are used.
Off Label Uses
Neuroleptic malignant syndrome
An analysis of 271 case reports of neuroleptic malignant syndrome (NMS) found that Dantrolene Cristalia monotherapy was associated with an increased rate of improvement in the first 24 hours, but a higher overall mortality rate compared to supportive therapy. Use of Dantrolene Cristalia in combination with other therapies (eg, bromocriptine) was associated with a lower mortality rate compared with Dantrolene Cristalia alone; therefore, combination therapy with Dantrolene Cristalia may be preferred over Dantrolene Cristalia monotherapy. Doses, duration of therapy, and responses have varied in case reports; the benefits of treatment are not established.
Dantrolene Cristalia description
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Chemically, Dantrolene Cristalia is a hydantoin derivative, but does not exhibit antiepileptic activity like other hydantoin derivates such as phenytoin.
Dantrolene Cristalia dosage
As soon as the malignant hyperthermia reaction is recognized, all anesthetic agents should be discontinued; the administration of 100% oxygen is recommended. Dantrolene Cristalia should be administered by continuous rapid intravenous push beginning at a minimum dose of 1 mg/kg, and continuing until symptoms subside or the maximum cumulative dose of 10 mg/kg has been reached.
If the physiologic and metabolic abnormalities reappear, the regimen may be repeated. It is important to note that administration of Dantrolene Cristalia should be continuous until symptoms subside. The effective dose to reverse the crisis is directly dependent upon the individual's degree of susceptibility to malignant hyperthermia, the amount and time of exposure to the triggering agent, and the time elapsed between onset of the crisis and initiation of treatment.
Pediatric Dose
Experience to date indicates that the dose of Dantrolene Cristalia for pediatric patients is the same as for adults.
Preoperatively
Dantrolene Cristalia and/or Dantrolene Cristalia sodium capsules may be administered preoperatively to patients judged malignant hyperthermia susceptible as part of the overall patient management to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia.
Dantrolene Cristalia
The recommended prophylactic dose of Dantrolene Cristalia is 2.5 mg/kg, starting approximately 1.25 hours before anticipated anesthesia and infused over approximately 1 hour. This dose should prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia provided that the usual precautions, such as avoidance of established malignant hyperthermia triggering agents, are followed.
Additional Dantrolene Cristalia may be indicated during anesthesia and surgery because of the appearance of early clinical and/or blood gas signs of malignant hyperthermia or because of prolonged surgery. Additional doses must be individualized.
Oral Administration of Dantrolene Cristalia Sodium Capsules
Administer 4 to 8 mg/kg/day of oral Dantrolene Cristalia sodium in three or four divided doses for 1 or 2 days prior to surgery, with the last dose being given with a minimum of water approximately 3 to 4 hours before scheduled surgery. Adjustment can usually be made within the recommended dosage range to avoid incapacitation (weakness, drowsiness, etc.) or excessive gastrointestinal irritation (nausea and/or vomiting). See also the package insert for Dantrolene Cristalia sodium capsules.
Post Crisis Follow-Up
Dantrolene Cristalia sodium capsules, 4 to 8 mg/kg/day, in four divided doses should be administered for 1 to 3 days following a malignant hyperthermia crisis to prevent recurrence of the manifestations of malignant hyperthermia.
Intravenous Dantrolene Cristalia sodium may be used postoperatively to prevent or attenuate the recurrence of signs of malignant hyperthermia when oral Dantrolene Cristalia sodium administration is not practical. The i.v. dose of Dantrolene Cristalia sodium in the postoperative period must be individualized, starting with 1 mg/kg or more as the clinical situation dictates.
PREPARATION
Each vial of Dantrolene Cristalia (Dantrolene Cristalia sodium for injection) should be reconstituted by adding 60 mL of sterile water for injection USP (without a bacteriostatic agent), and the vial shaken for approximately 20 seconds or until the solution is clear. 5% Dextrose Injection USP, 0.9% Sodium Chloride Injection USP, and other acidic solutions are not compatible with Dantrolene Cristalia and should not be used. The contents of the vial must be protected from direct light and used within 6 hours after reconstitution. Store reconstituted solution at 20-25° C (68-77° F) protected from direct light. Each vial of Dantrolene Cristalia sodium for injection should be reconstituted by adding 60 mL of sterile water for injection USP (without a bacteriostatic agent), and the vial shaken for approximately 20 seconds or until the solution is clear.
Reconstituted Dantrolene Cristalia should not be transferred to large glass bottles for prophylactic infusion due to precipitate formation observed with the use of some glass bottles as reservoirs.
For prophylactic infusion, the required number of individual vials of Dantrolene Cristalia should be reconstituted as outlined above. The contents of individual vials are then transferred to a larger volume sterile intravenous plastic bag. Stability data on file indicate commercially available sterile plastic bags are acceptable drug delivery devices. However, it is recommended that the prepared infusion be inspected carefully for cloudiness and/or precipitation prior to dispensing and administration. Such solutions should not be used. While stable for 6 hours, it is recommended that the infusion be prepared immediately prior to the anticipated dosage administration time.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Dantrolene Cristalia is metabolized by the liver, and it is theoretically possible that its metabolism may be enhanced by drugs known to induce hepatic microsomal enzymes. However, neither phenobarbital nor diazepam appears to affect Dantrolene Cristalia metabolism. Binding to plasma protein is not significantly altered by diazepam, diphenylhydantoin, or phenylbutazone. Binding to plasma proteins is reduced by warfarin and clotibrate and increased by tolbutamide.
Cardiovascular collapse in patients treated simultaneously with varapamil and Dantrolene Cristalia sodium is rare. The combination of therapeutic doses of intravenous Dantrolene Cristalia sodium and verapamil in halothane/a-chloralose anesthetized swine has resulted in ventricular fibrillation and cardiovascular collapse in association with marked hyperkalemia. It is recommended that the combination of intravenous Dantrolene Cristalia sodium and calcium channel blockers, such as verapamil, not be used together during the management of malignant hyperthermia crisis until the relevance of these findings to humans is established.
Administration of Dantrolene Cristalia may potentiate vecuronium-induced neuromuscular block.
There have been occasional reports of death following malignant hyperthermia crisis even when treated with intravenous Dantrolene Cristalia; incidence figures are not available (the pre-Dantrolene Cristalia 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 Cristalia.
There are reports of fatality in malignant hyperthermia crisis, despite initial satisfactory response to i.v. Dantrolene Cristalia, which involve patients who could not be weaned from Dantrolene Cristalia after initial treatment.
The administration of Dantrolene Cristalia 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 Cristalia possibly contributed.
There have been reports of thrombophlebitis following administration of intravenous Dantrolene Cristalia; 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 Cristalia 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 Cristalia sodium use, such as hepatitis, seizures, and pleural effusion with pericarditis, have been reasonably associated with short-term Dantrolene Cristalia therapy.
The following events have been reported in patients receiving oral Dantrolene Cristalia: aplastic anemia, leukopenia, lymphocytic lymphoma, and heart failure.
The published literature has included some reports of Dantrolene Cristalia sodium use in patients with Neuroleptic Malignant Syndrome (NMS). Dantrolene Cristalia (Dantrolene Cristalia sodium for injection) is not indicated for the treatment of NMS and patients may expire despite treatment with Dantrolene Cristalia.
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/.
You should not take this medication if you are allergic to Dantrolene Cristalia, or if you have liver disease such as hepatitis or cirrhosis.
You may be more likely to develop liver problems while taking Dantrolene Cristalia if you are a woman, or if you are older than 35. Talk with your doctor about your individual risk.
Do not use Dantrolene Cristalia at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone.
Before taking Dantrolene Cristalia, tell your doctor if you have a history of liver disease, a breathing disorder such as COPD, heart disease, or a history of heart attack.
Dantrolene Cristalia can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Dantrolene Cristalia can cause muscle weakness, which can affect your ability to swallow. Use caution to prevent choking while you are eating meals. Talk with your doctor if you are unable to eat because of this side effect.
Avoid drinking alcohol. It can increase some of the side effects of Dantrolene Cristalia.
Your doctor may occasionally change your dose to make sure you get the best results from this medication.
Active ingredient matches for Dantrolene Cristalia:
Dantrium (Australia, Belgium, Canada, Chile, France, Greece, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, South Africa, United Kingdom, United States)
DailyMed. "DANTROLENE SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Dantrolene Cristalia are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Dantrolene Cristalia. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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