United States - English - NLM (National Library of Medicine)

eagle pharmaceuticals, inc. - dantrolene sodium (unii: 287m0347ev) (dantrolene - unii:f64qu97qcr) - dantrolene sodium 250 mg in 5 ml - ryanodex® is indicated for the: - treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see dosage and administration (2.1)] - prevention of malignant hyperthermia in patients at high risk. none risk summary available data from published case reports with ryanodex use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. dantrolene readily crosses the placenta; however, no serious adverse events have been reported in the neonate following maternal administration of dantrolene prior to delivery. there are risks to the pregnant woman and fetus associated with untreated malignant hyperthermia (see clinical considerations ). in animal reproduction studies, dantrolene sodium administered to rats and rabbits produced embryolethality (rabbits) and decreased pup survival (rats) at doses seven times the human oral dose (see data) . the estimated backgroun

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - dantrolene sodium (unii: 287m0347ev) (dantrolene - unii:f64qu97qcr) - dantrolene sodium 25 mg - dantrolene sodium capsules are 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 sodium capsules are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. if improvement occurs, it will ordinarily occur within the dosage titration (see dosage and administration ), 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 sodium capsules. occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium capsule 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 sodium capsules 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 sodium capsules 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. oral dantrolene sodium capsules are 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 sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for intravenous dantrolene sodium. oral dantrolene sodium capsules should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia. active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of dantrolene sodium capsules. dantrolene sodium capsules are contraindicated where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain or maintain increased function. drug abuse and dependency potential has not been evaluated in human or animal studies.

United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - dantrolene sodium (unii: 287m0347ev) (dantrolene - unii:f64qu97qcr) - dantrolene sodium 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 sodium 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 (see dosage and administration ), 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 sodium. occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium therapy. in such instances, information regarding improvement should be solicited from th

United States - English - NLM (National Library of Medicine)

carilion materials management - dantrolene sodium (unii: 287m0347ev) (dantrolene - unii:f64qu97qcr) - dantrolene sodium 25 mg - dantrolene sodium capsules are 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 sodium capsules are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. if improvement occurs, it will ordinarily occur within the dosage titration (see dosage and administration ), 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 sodium capsules. occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium capsule therapy. in such instances, information regarding impro

United States - English - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - dantrolene sodium (unii: 287m0347ev) (dantrolene - unii:f64qu97qcr) - dantrolene sodium 20 mg - 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. dantrolene sodium for injection 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). dantrolene sodium for injection 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. none.

United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - dantrolene sodium (unii: 287m0347ev) (dantrolene - unii:f64qu97qcr) - dantrolene sodium 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 sodium 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 (see dosage and administration ), 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 sodium. occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium therapy. in such instances, information regarding improvement should be solicited fro

United States - English - NLM (National Library of Medicine)

cardinal health 107, llc - dantrolene sodium (unii: 287m0347ev) (dantrolene - unii:f64qu97qcr) - dantrolene sodium capsules are 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 sodium capsules are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. if improvement occurs, it will ordinarily occur within the dosage titration (see dosage and administration ), 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 sodium capsules. occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium capsule therapy. in such instances, information regarding im

United States - English - NLM (National Library of Medicine)

american health packaging - dantrolene sodium (unii: 287m0347ev) (dantrolene - unii:f64qu97qcr) - dantrolene sodium capsules are 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 sodium capsules are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. if improvement occurs, it will ordinarily occur within the dosage titration (see dosage and administration ), 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 sodium capsules. occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium capsule therapy. in such instances, information regarding im

United States - English - NLM (National Library of Medicine)

lannett company, inc. - dantrolene sodium (unii: 287m0347ev) (dantrolene - unii:f64qu97qcr) - dantrolene sodium capsules are 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 sodium capsules 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 (see dosage and administration ), 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 sodium capsules. occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium capsules 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 sodium capsules 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 sodium capsules 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. oral dantrolene sodium capsules 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 sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for intravenous dantrolene sodium. oral dantrolene sodium capsules should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia. active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of dantrolene sodium capsules.  dantrolene sodium capsules is contraindicated where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain or maintain increased function. drug abuse and dependency potential has not been evaluated in human or animal studies.

United States - English - NLM (National Library of Medicine)

avpak - dantrolene sodium (unii: 287m0347ev) (dantrolene - unii:f64qu97qcr) - dantrolene sodium capsules are 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 sodium capsules are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. if improvement occurs, it will ordinarily occur within the dosage titration (see dosage and administration ), 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 sodium capsules. occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium capsule 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 sodium capsules 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 sodium capsules 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. oral dantrolene sodium capsules are 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 sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for intravenous dantrolene sodium. oral dantrolene sodium capsules should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia. active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of dantrolene sodium capsules. dantrolene sodium capsules are contraindicated where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain or maintain increased function. drug abuse and dependency potential has not been evaluated in human or animal studies.