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RYANODEX
Overview
What is RYANODEX?
RYANODEX (dantrolene sodium) for injectable suspension is a sterile lyophilized powder. RYANODEX is supplied in 20 mL vials containing 250 mg dantrolene sodium and the following inactive ingredients: 125 mg mannitol, 25 mg polysorbate 80, 4 mg povidone K12 and sufficient sodium hydroxide or hydrochloric acid for pH adjustment. When reconstituted with 5 mL sterile water for injection USP (without a bacteriostatic agent), this yields a suspension with a pH of approximately 10.3.
RYANODEX is a skeletal muscle relaxant. Chemically, RYANODEX is a hydrate of 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-2,4-imidazolidinedione sodium salt. The structural formula for the hydrated salt is:
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 RYANODEX look like?
What are the available doses of RYANODEX?
For injectable suspension: 250 mg of lyophilized powder in a single-dose vial for reconstitution ()
What should I talk to my health care provider before I take RYANODEX?
How should I use RYANODEX?
RYANODEX is indicated for the:
In addition to RYANODEX treatment, institute the following supportive measures:
Administer RYANODEX by intravenous push at a minimum dose of 1 mg/kg. If the physiologic and metabolic abnormalities of MH continue, administer additional intravenous boluses up to the maximum cumulative dosage of 10 mg/kg.
If the physiologic and metabolic abnormalities reappear, repeat RYANODEX dosing by intravenous push starting with 1 mg/kg.
What interacts with RYANODEX?
Sorry No Records found
What are the warnings of RYANODEX?
Sorry No Records found
What are the precautions of RYANODEX?
Sorry No Records found
What are the side effects of RYANODEX?
Sorry No records found
What should I look out for while using RYANODEX?
None
What might happen if I take too much RYANODEX?
How should I store and handle RYANODEX?
Store at USP controlled room temperature 68°F to 77°F (20°C to 25°C) with excursions permitted between 15°C (59°F) and 30°C (86°F). Contents under pressure. Do not puncture or incinerate. Avoid contact with eyes or other mucous membranes. Keep out of reach of children. RYANODEX (NDC 42367-540-32) is available in 20 mL vials containing a sterile lyophilized mixture of 250 mg dantrolene sodium for reconstitution with 5 mL sterile water for injection USP (without a bacteriostatic agent) to yield an orange colored injectable suspension.Store unreconstituted product at 20 °C to 25 °C (68 ºF to 77 ºF) [see USP Controlled Room Temperature], with excursions permitted to 15 ºC to 30 ºC (59 ºF to 86 ºF) and avoid prolonged exposure to light.RYANODEX (NDC 42367-540-32) is available in 20 mL vials containing a sterile lyophilized mixture of 250 mg dantrolene sodium for reconstitution with 5 mL sterile water for injection USP (without a bacteriostatic agent) to yield an orange colored injectable suspension.Store unreconstituted product at 20 °C to 25 °C (68 ºF to 77 ºF) [see USP Controlled Room Temperature], with excursions permitted to 15 ºC to 30 ºC (59 ºF to 86 ºF) and avoid prolonged exposure to light.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
In isolated nerve-muscle preparation, dantrolene has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. In skeletal muscle, dantrolene dissociates the excitation-contraction coupling, probably by interfering with the release of Ca from the sarcoplasmic reticulum.
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.
The addition of dantrolene to the “triggered” malignant hyperthermic muscle cell may reestablish a normal level of ionized calcium in the myoplasm. Inhibition of calcium release from the sarcoplasmic reticulum by dantrolene 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.
Non-Clinical Toxicology
NoneDrug Interactions
A modest interaction has been reported for patients receiving 100 mg dapsone daily in combination with trimethoprim 5 mg/kg q6h. On Day 7, the serum dapsone levels averaged 2.1 ± 1.0 mcg/mL in comparison to 1.5 ± 0.5 mcg/mL for dapsone alone. On day 7, trimethoprim levels averaged 18.4 ± 5.2 mcg/mL in comparison to 12.4 ± 4.5 mcg/mL for patients not receiving dapsone. Thus, there is a mutual interaction between dapsone and trimethoprim in which each raises the level of the other about 1.5 times.
A crossover study designed to assess the potential of a drug interaction between dapsone, 100 mg/day and trimethoprim, 200 mg every 12 hours, in eight asymptomatic HIV positive volunteers (average CD4 count 524 cells/mm) demonstrated that there was not a significant drug interaction between dapsone and trimethoprim. However, an earlier report also by Lee et al, in 78 HIV infected patients with acute pneumonia, receiving dapsone, 100 mg/day and higher trimethoprim dose, 20 mg/kg/day, demonstrated that the serum levels of dapsone were increased by 40% and trimethoprim levels were increased by 48% when the drugs were administered concurrently.
RYANODEX is associated with skeletal muscle weakness. The administration of RYANODEX in human volunteers has been associated with loss of grip strength and weakness in the legs. Patients should not be permitted to ambulate without assistance until they have normal strength and balance.
RYANODEX has been associated with dyspnea, respiratory muscle weakness, and decreased inspiratory capacity. Monitor patients for the adequacy of ventilation.
RYANODEX has been associated with dysphagia. Assess patients for difficulty swallowing and choking.
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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