Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - dantrolene sodium hemiheptahydrate, quantity: 50 mg - capsule - excipient ingredients: sodium lauryl sulfate; maize starch; lactose monohydrate; titanium dioxide; sunset yellow fcf; gelatin; iron oxide yellow; iron oxide red; magnesium stearate; purified talc; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - dantrium is indicated in controlling the manifestations of clinical spasticity resulting from serious chronic disorders such as 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. there is no evidence that patients with contractures will benefit. dantrium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders or electroconvulsive therapy. if improvement occurs, it will ordinarily occur within the dosage titration schedule (see dosage and administration), as manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrium. occasionally, subtle but meaningful improvements in spasticity may occur with dantrium therapy. in such instances informat

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - dantrolene sodium hemiheptahydrate 50mg (hemi-hepta hydrate); dantrolene sodium hemiheptahydrate 50mg (hemi-hepta hydrate) - capsule - 50 mg - active: dantrolene sodium hemiheptahydrate 50mg (hemi-hepta hydrate) excipient: gelatin ferric oxide e172 (containing ferric oxide, red and ferric oxide, yellow) ink lactose monohydrate magnesium stearate maize starch purified talc sunset yellow fcf titanium dioxide active: dantrolene sodium hemiheptahydrate 50mg (hemi-hepta hydrate) excipient: gelatin ink iron oxide red iron oxide yellow lactose monohydrate magnesium stearate maize starch purified talc sodium laurilsulfate sunset yellow fcf titanium dioxide - dantrium is indicated in controlling the manifestations of clinical spasticity resulting from serious chronic disorders such as 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. there is no evidence that patients with contractures will benefit. dantrium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders or electroconvulsive therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - dantrolene sodium hemiheptahydrate, quantity: 25 mg - capsule - excipient ingredients: titanium dioxide; sunset yellow fcf; purified talc; gelatin; iron oxide red; magnesium stearate; maize starch; sodium lauryl sulfate; lactose monohydrate; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; simethicone - dantrium is indicated in controlling the manifestations of clinical spasticity resulting from serious chronic disorders such as 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. there is no evidence that patients with contractures will benefit. dantrium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders or electroconvulsive therapy. if improvement occurs, it will ordinarily occur within the dosage titration schedule (see dosage and administration), as manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrium. occasionally, subtle but meaningful improvements in spasticity may occur with dantrium therapy. in such instances inf

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - dantrolene sodium hemiheptahydrate 50mg - capsule - 50 mg - active: dantrolene sodium hemiheptahydrate 50mg

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - dantrolene sodium hemiheptahydrate 25mg (hemi-hepta hydrate); dantrolene sodium hemiheptahydrate 25mg (hemi-hepta hydrate) - capsule - 25 mg - active: dantrolene sodium hemiheptahydrate 25mg (hemi-hepta hydrate) excipient: gelatin ferric oxide e172 (containing ferric oxide, red and ferric oxide, yellow) ink lactose monohydrate magnesium stearate maize starch purified talc sunset yellow fcf titanium dioxide active: dantrolene sodium hemiheptahydrate 25mg (hemi-hepta hydrate) excipient: gelatin ink iron oxide red iron oxide yellow lactose monohydrate magnesium stearate maize starch purified talc sodium laurilsulfate sunset yellow fcf titanium dioxide - dantrium is indicated in controlling the manifestations of clinical spasticity resulting from serious chronic disorders such as 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. there is no evidence that patients with contractures will benefit. dantrium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders or electroconvulsive therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - dantrolene sodium hemiheptahydrate 20mg - powder for injection - 20 mg - active: dantrolene sodium hemiheptahydrate 20mg excipient: mannitol - latest regulatory activity

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - dantrolene sodium hemiheptahydrate, quantity: 20 mg - injection, powder for - excipient ingredients: sodium hydroxide; mannitol - dantrium for injection is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crisis. it should be administered by intravenous injection as soon as the malignant hyperthermia reaction is recognised (i.e. tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilisation of anaesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - dantrolene sodium hemiheptahydrate 25mg - capsule - 25 mg - active: dantrolene sodium hemiheptahydrate 25mg

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)

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.