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Dantrium
Overview
What is Dantrium?
Dantrium Intravenous
Dantrium Intravenous
Dantrium
Dantrium
The hydrated salt contains approximately 15% water (3-1/2 moles) and has a molecular weight of 399. The anhydrous salt (dantrolene) has a molecular weight of 336.
What does Dantrium look like?
What are the available doses of Dantrium?
Sorry No records found.
What should I talk to my health care provider before I take Dantrium?
Sorry No records found
How should I use Dantrium?
Dantrium Intravenous
Dantrium Intravenous
Dantrium Intravenous
As soon as the malignant hyperthermia reaction is recognized, all anesthetic agents should be discontinued; the administration of 100% oxygen is recommended. 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 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.
What interacts with Dantrium?
None.
What are the warnings of Dantrium?
In patients with
diminished renal function, administration of PLASMA-LYTE R Injection
(Multiple Electrolytes Injection, Type 2, USP) may result in sodium or potassium retention. PLASMA-LYTE R Injection (Multiple Electrolytes
Injection, Type 2, USP) is not for use in the treatment of lactic
acidosis.
The use of
Since the effect of disease state and other drugs on related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive i.v. preoperatively should have vital signs monitored.
If patients judged malignant hyperthermia susceptible are administered intravenous or oral preoperatively, anesthetic preparation must still follow a standard malignant hyperthermia susceptible regimen, including the avoidance of known triggering agents. Monitoring for early clinical and metabolic signs of malignant hyperthermia is indicated because attenuation of malignant hyperthermia, rather than prevention, is possible. These signs usually call for the administration of additional i.v. dantrolene.
What are the precautions of Dantrium?
General:
Dantrium
When mannitol is used for prevention or treatment of late renal complications of malignant hyperthermia, the 3 g of mannitol needed to dissolve each 20 mg vial of i.v. should be taken into consideration.
Information for Patients:
Dantrium Intravenous
Hepatotoxicity seen (dantrolene sodium) has a potential for hepatotoxicity, and should not be used in conditions other than those recommended. Symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels of the drug. The incidence reported in patients taking up to 400 mg/day is much lower than in those taking doses of 800 mg or more per day. Even sporadic short courses of these higher dose levels within a treatment regimen markedly increased the risk of serious hepatic injury. Liver dysfunction as evidenced by blood chemical abnormalities alone (liver enzyme elevations) has been observed in patients exposed to for varying periods of time. Overt hepatitis has occurred at varying intervals after initiation of therapy, but has been most frequently observed between the third and twelfth month of therapy. The risk of hepatic injury appears to be greater in females, in patients over 35 years of age, and in patients taking other medication(s) in addition to (dantrolene sodium). should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT.
Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with therapy.
Drug Interactions: Dantrium
Dantrium
Cardiovascular collapse in patients treated simultaneously with verapamil and dantrolene sodium is rare. The combination of therapeutic doses of intravenous dantrolene sodium and verapamil in halothane/alpha-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 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 may potentiate vecuronium-induced neuromuscular block.
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
Dantrium
The only drug-related effect seen in a 30-month study in Fischer-344 rats was a dose-related reduction in the time of onset of mammary and testicular tumors. A 24-month study in HaM/ICR mice revealed no evidence of carcinogenic activity.
The significance of carcinogenicity data relative to use of in humans is unknown.
Dantrolene sodium has produced positive results in the Ames S. Typhimurium bacterial mutagenesis assay in the presence and absence of a liver activating system.
Dantrolene sodium administered to male and female rats at dose levels up to 45 mg/kg/day (approximately 1.4 times the maximum recommended daily dose on a mg/m basis) showed no adverse effects on fertility or general reproductive performance.
Pregnancy:
Dantrium
Dantrium Intravenous
Labor and Delivery:
Dantrium
Geriatric Use:
Dantrium Intravenous
What are the side effects of Dantrium?
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 rare 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 intravenous 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:
None of the serious reactions occasionally reported with long-term oral use, such as hepatitis, seizures, and pleural effusion with pericarditis, have been reasonably associated with short-term 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) for a complete listing of adverse reactions.)
The published literature has included some reports of use in patients with Neuroleptic Malignant Syndrome (NMS). is not indicated for the treatment of NMS and patients may expire despite treatment with .
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.
There have been rare reports of urticaria and erythema possibly associated with the administration of i.v. . There has been one case of anaphylaxis.
What should I look out for while using Dantrium?
None.
The use of
Since the effect of disease state and other drugs on related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive i.v. preoperatively should have vital signs monitored.
If patients judged malignant hyperthermia susceptible are administered intravenous or oral preoperatively, anesthetic preparation must still follow a standard malignant hyperthermia susceptible regimen, including the avoidance of known triggering agents. Monitoring for early clinical and metabolic signs of malignant hyperthermia is indicated because attenuation of malignant hyperthermia, rather than prevention, is possible. These signs usually call for the administration of additional i.v. dantrolene.
What might happen if I take too much Dantrium?
Because must be administered at a low concentration in a large volume of fluid, acute toxicity of could not be assessed in animals. In 14-day (subacute) studies, the intravenous formulation of was relatively non-toxic to rats at doses of 10 mg/kg/day and 20 mg/kg/day. While 10 mg/kg/day in dogs for 14 days evoked little toxicity, 20 mg/kg/day for 14 days caused hepatic changes of questionable biologic significance.
Symptoms which may occur in case of overdose include, but are not limited to, muscular weakness and alterations in the state of consciousness (e.g., lethargy, coma), vomiting, diarrhea, and crystalluria.
For acute overdosage, general supportive measures should be employed.
Intravenous fluids should be administered in fairly large quantities to avert the possibility of crystalluria. An adequate airway should be maintained and artificial resuscitation equipment should be at hand. Electrocardiographic monitoring should be instituted, and the patient carefully observed. The value of dialysis in overdose is not known.
How should I store and handle Dantrium?
Dantrium IntravenousNDCStore unreconstituted product at controlled room temperature (59°F to 86°F or 15°C to 30°C) and avoid prolonged exposure to light.Address medical inquiries to Procter & Gamble Pharmaceuticals, Medical Communications Department, PO Box 8006, Mason, Ohio 45040-8006.To place an order, call Procter & Gamble Pharmaceuticals Customer Service 800-448-4878.Mfg. by: Ben Venue LaboratoriesBedford, OH 44146Dist. By: TM Owner,Cincinnati, Ohio 45202Dantrium IntravenousNDCStore unreconstituted product at controlled room temperature (59°F to 86°F or 15°C to 30°C) and avoid prolonged exposure to light.Address medical inquiries to Procter & Gamble Pharmaceuticals, Medical Communications Department, PO Box 8006, Mason, Ohio 45040-8006.To place an order, call Procter & Gamble Pharmaceuticals Customer Service 800-448-4878.Mfg. by: Ben Venue LaboratoriesBedford, OH 44146Dist. By: TM Owner,Cincinnati, Ohio 45202Dantrium IntravenousNDCStore unreconstituted product at controlled room temperature (59°F to 86°F or 15°C to 30°C) and avoid prolonged exposure to light.Address medical inquiries to Procter & Gamble Pharmaceuticals, Medical Communications Department, PO Box 8006, Mason, Ohio 45040-8006.To place an order, call Procter & Gamble Pharmaceuticals Customer Service 800-448-4878.Mfg. by: Ben Venue LaboratoriesBedford, OH 44146Dist. By: TM Owner,Cincinnati, Ohio 45202Dantrium IntravenousNDCStore unreconstituted product at controlled room temperature (59°F to 86°F or 15°C to 30°C) and avoid prolonged exposure to light.Address medical inquiries to Procter & Gamble Pharmaceuticals, Medical Communications Department, PO Box 8006, Mason, Ohio 45040-8006.To place an order, call Procter & Gamble Pharmaceuticals Customer Service 800-448-4878.Mfg. by: Ben Venue LaboratoriesBedford, OH 44146Dist. By: TM Owner,Cincinnati, Ohio 45202Dantrium IntravenousNDCStore unreconstituted product at controlled room temperature (59°F to 86°F or 15°C to 30°C) and avoid prolonged exposure to light.Address medical inquiries to Procter & Gamble Pharmaceuticals, Medical Communications Department, PO Box 8006, Mason, Ohio 45040-8006.To place an order, call Procter & Gamble Pharmaceuticals Customer Service 800-448-4878.Mfg. by: Ben Venue LaboratoriesBedford, OH 44146Dist. By: TM Owner,Cincinnati, Ohio 45202Dantrium IntravenousNDCStore unreconstituted product at controlled room temperature (59°F to 86°F or 15°C to 30°C) and avoid prolonged exposure to light.Address medical inquiries to Procter & Gamble Pharmaceuticals, Medical Communications Department, PO Box 8006, Mason, Ohio 45040-8006.To place an order, call Procter & Gamble Pharmaceuticals Customer Service 800-448-4878.Mfg. by: Ben Venue LaboratoriesBedford, OH 44146Dist. By: TM Owner,Cincinnati, Ohio 45202Dantrium IntravenousNDCStore unreconstituted product at controlled room temperature (59°F to 86°F or 15°C to 30°C) and avoid prolonged exposure to light.Address medical inquiries to Procter & Gamble Pharmaceuticals, Medical Communications Department, PO Box 8006, Mason, Ohio 45040-8006.To place an order, call Procter & Gamble Pharmaceuticals Customer Service 800-448-4878.Mfg. by: Ben Venue LaboratoriesBedford, OH 44146Dist. By: TM Owner,Cincinnati, Ohio 45202Dantrium IntravenousNDCStore unreconstituted product at controlled room temperature (59°F to 86°F or 15°C to 30°C) and avoid prolonged exposure to light.Address medical inquiries to Procter & Gamble Pharmaceuticals, Medical Communications Department, PO Box 8006, Mason, Ohio 45040-8006.To place an order, call Procter & Gamble Pharmaceuticals Customer Service 800-448-4878.Mfg. by: Ben Venue LaboratoriesBedford, OH 44146Dist. By: TM Owner,Cincinnati, Ohio 45202Dantrium IntravenousNDCStore unreconstituted product at controlled room temperature (59°F to 86°F or 15°C to 30°C) and avoid prolonged exposure to light.Address medical inquiries to Procter & Gamble Pharmaceuticals, Medical Communications Department, PO Box 8006, Mason, Ohio 45040-8006.To place an order, call Procter & Gamble Pharmaceuticals Customer Service 800-448-4878.Mfg. by: Ben Venue LaboratoriesBedford, OH 44146Dist. By: TM Owner,Cincinnati, Ohio 45202
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
In isolated nerve-muscle preparation, has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. In skeletal muscle, dissociates the excitation-contraction coupling, probably by interfering with the release of Ca++ from the sarcoplasmic reticulum. The administration of intravenous to human volunteers is associated with loss of grip strength and weakness in the legs, as well as subjective CNS complaints (see also ). Information concerning the passage of across the blood-brain barrier is not available.
In the anesthetic-induced malignant hyperthermia syndrome, evidence points to an intrinsic abnormality of skeletal muscle tissue. In affected humans, it has been postulated that “triggering agents” (e.g., general anesthetics and depolarizing neuromuscular blocking agents) produce a change within the cell which results in an elevated myoplasmic calcium. This elevated myoplasmic calcium activates acute cellular catabolic processes that cascade to the malignant hyperthermia crisis.
It is hypothesized that addition of to the “triggered” malignant hyperthermic muscle cell reestablishes a normal level of ionized calcium in the myoplasm. Inhibition of calcium release from the sarcoplasmic reticulum by reestablishes the myoplasmic calcium equilibrium, increasing the percentage of bound calcium. In this way, physiologic, metabolic, and biochemical changes associated with the malignant hyperthermia crisis may be reversed or attenuated. Experimental results in malignant hyperthermia susceptible swine show that prophylactic administration of intravenous or oral dantrolene prevents or attenuates the development of vital sign and blood gas changes characteristic of malignant hyperthermia in a dose related manner. The efficacy of intravenous dantrolene in the treatment of human and porcine malignant hyperthermia crisis, when considered along with prophylactic experiments in malignant hyperthermia susceptible swine, lends support to prophylactic use of oral or intravenous dantrolene in malignant hyperthermia susceptible humans. When prophylactic intravenous dantrolene is administered as directed, whole blood concentrations remain at a near steady state level for 3 or more hours after the infusion is completed. Clinical experience has shown that early vital sign and/or blood gas changes characteristic of malignant hyperthermia may appear during or after anesthesia and surgery despite the prophylactic use of dantrolene and adherence to currently accepted patient management practices. These signs are compatible with attenuated malignant hyperthermia and respond to the administration of additional i.v. dantrolene (see ). The administration of the recommended prophylactic dose of intravenous dantrolene to healthy volunteers was not associated with clinically significant cardiorespiratory changes.
Specific metabolic pathways for the degradation and elimination of in humans have been established. Dantrolene is found in measurable amounts in blood and urine. Its major metabolites in body fluids are 5-hydroxy dantrolene and an acetylamino metabolite of dantrolene. Another metabolite with an unknown structure appears related to the latter. may also undergo hydrolysis and subsequent oxidation forming nitrophenylfuroic acid.
The mean biologic half-life of after intravenous administration is variable, between 4 to 8 hours under most experimental conditions. Based on assays of whole blood and plasma, slightly greater amounts of dantrolene are associated with red blood cells than with the plasma fraction of blood. Significant amounts of dantrolene are bound to plasma proteins, mostly albumin, and this binding is readily reversible.
Cardiopulmonary depression has not been observed in malignant hyperthermia susceptible swine following the administration of up to 7.5 mg/kg i.v. dantrolene. This is twice the amount needed to maximally diminish twitch response to single supramaximal peripheral nerve stimulation (95% inhibition). A transient, inconsistent, depressant effect on gastrointestinal smooth muscles has been observed at high doses.
Non-Clinical Toxicology
None.The use of
Since the effect of disease state and other drugs on related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive i.v. preoperatively should have vital signs monitored.
If patients judged malignant hyperthermia susceptible are administered intravenous or oral preoperatively, anesthetic preparation must still follow a standard malignant hyperthermia susceptible regimen, including the avoidance of known triggering agents. Monitoring for early clinical and metabolic signs of malignant hyperthermia is indicated because attenuation of malignant hyperthermia, rather than prevention, is possible. These signs usually call for the administration of additional i.v. dantrolene.
Cardiovascular collapse in patients treated simultaneously with verapamil and dantrolene sodium is rare. The combination of therapeutic doses of intravenous dantrolene sodium and verapamil in halothane/alpha-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 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 may potentiate vecuronium-induced neuromuscular block.
General:
Dantrium
When mannitol is used for prevention or treatment of late renal complications of malignant hyperthermia, the 3 g of mannitol needed to dissolve each 20 mg vial of i.v. should be taken into consideration.
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 rare 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 intravenous 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:
None of the serious reactions occasionally reported with long-term oral use, such as hepatitis, seizures, and pleural effusion with pericarditis, have been reasonably associated with short-term 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) for a complete listing of adverse reactions.)
The published literature has included some reports of use in patients with Neuroleptic Malignant Syndrome (NMS). is not indicated for the treatment of NMS and patients may expire despite treatment with .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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