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DANTROLENE SODIUM capsule


  1. No Title 1572546235
  2. No Title 1572546236
  3. No Title 1572547431
  4. No Title 1572548883
  5. No Title 1572551311
  6. No Title 1572551833
  7. No Title 1572553590
  8. No Title 1572554009
  9. Dantrolene Sodium Capsules
  10. No Title 1572451101
  11. Overdose
  12. Package/label Display Panel
  13. No Title 1572453272
  14. Packaging Information
  15. Package/label Display Panel Carton 25 Mg
  16. Package/label Display Panel Blister 25 Mg
  17. No Title 1572453628
  18. Principal Display Panel 100 Mg Capsules Bottle Label
  19. No Title 1572453785
  20. No Title 1572453786
  21. Principal Display Panel - 100 Mg-100 Ct Bottle Label
  22. No Title 1572455553
  23. Dantrolene Sodium
  24. No Title 1572457397
  25. Principal Display Panel - 25 Mg Bottle Label
  26. Principal Display Panel - 50 Mg Bottle Label
  27. Principal Display Panel - 100 Mg Bottle Label
  28. No Title 1572448581
  29. Description
  30. Clinical Pharmacology
  31. Indications And Usage
  32. Contraindications
  33. Warnings
  34. Precautions
  35. Adverse Reactions
  36. Drug Abuse And Dependence
  37. Overdosage
  38. Dosage And Administration
  39. How Supplied
  40. Principal Display Panel - 25 Mg Capsule Bottle Label
  41. Principal Display Panel - 50 Mg Capsule Bottle Label

No Title 1572546235 

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 dantrolene sodium 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. Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

No Title 1572546236 

Rx Only.

Dist. by:
Par Pharmaceutical
Chestnut Ridge, NY 10977 U.S.A.

Mfg. by:
Par Formulations Private Limited,
9/215, Pudupakkam, Kelambakkam 603 103.

Made in India

OS362-01-74-01
Revised: 07/2017

No Title 1572547431 

Dist. by:
Impax Generics
Hayward, CA 94544

Rx only

373-05
Rev. 09/2015

No Title 1572548883 

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 dantrolene sodium 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.

Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

No Title 1572551311 

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 dantrolene sodium 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. Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

No Title 1572551833 

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 dantrolene sodium 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.

Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

No Title 1572553590 

Rx only.

Prescribing Information as of July 2013.

Distributed by:
JHP Pharmaceuticals, LLC.
Rochester, MI, 48307

3003204A

No Title 1572554009 

Manufactured by:
Bora Pharmaceutical Laboratories Inc.

Jhunan, Taiwan

Distributed by:
Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

373-06

Rev. 11-2018-00

Dantrolene Sodium Capsules 

8230021/0414

Rx only

No Title 1572451101 

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 dantrolene sodium 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.

Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

Overdose 

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 along with immediate gastric lavage.

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. To date, no experience has been reported with dialysis and its value in dantrolene sodium overdose is not known.

Package/label Display Panel  

bag label
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7140(NDC:68084-300)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
Product Characteristics
Color yellow (yellow opaque) , green (light green opaque) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code G441
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55154-7140-0 10 in 1 BAG 09/25/2008
1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076856 09/25/2008
Labeler - Cardinal Health (603638201)

Revised: 7/2019 Cardinal Health

No Title 1572453272 

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 dantrolene sodium 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.

Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

Packaging Information 

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Impax Generics as follows:
(25 mg / 30 UD ) NDC 68084-300-21 packaged from NDC 0115-4411

Distributed by:
American Health Packaging
Columbus, OH 43217

8230021/0516OS

Package/label Display Panel Carton 25 Mg 

25 mg Dantrolene Capsules Carton

NDC 68084- 300-21

Dantrolene Sodium Capsules
PERIPHERAL SKELETAL MUSCLE RELAXANT

25 mg

30 Capsules (3 x 10) Rx Only

Each Capsule Contains:
Dantrolene sodium...................................................................25 mg
Dantrolene sodium contains about 15% water of hydration.

Usual Dosage: Dosage must be titrated and individualized for
maximum effect. See package insert for full prescribing
information.

Store at 20 C to 25 C (68 to 77 F); excursions permitted between
15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0115-4411, Impax Generics.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

430021
0230021/0419

Package/label Display Panel Blister 25 Mg 

25 mg Dantrolene Capsule Blister

Dantrolene Sodium
Capsule
PERIPHERAL SKELETAL
MUSCLE RELAXANT

25 mg

DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-300(NDC:0115-4411)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
Product Characteristics
Color yellow (yellow opaque) , green (light green opaque) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code G441
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68084-300-21 30 in 1 BOX, UNIT-DOSE 09/29/2008
1 NDC:68084-300-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076856 09/29/2008
Labeler - American Health Packaging (929561009)
Establishment
Name Address ID/FEI Business Operations
American Health Packaging 929561009 repack(68084-300)

Revised: 4/2019 American Health Packaging

No Title 1572453628 

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 dantrolene sodium 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. Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

Principal Display Panel 100 Mg Capsules Bottle Label 

NDC 49884-364-01

Dantrolene
Sodium Capsules

100 mg

For oral use only
PERIPHERAL SKELETAL MUSCLE RELAXANT
Rx only

100 Capsules

PAR PHARMACEUTICAL

Principal Display Panel - 100 mg Capsule Bottle Label
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-362
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Product Characteristics
Color ORANGE, BROWN (tan) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code Dantrium;25;mg;0149;0030
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49884-362-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/28/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA017443 03/28/2016
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-363
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Product Characteristics
Color ORANGE, BROWN (tan) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Dantrium;50;mg;0149;0031
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49884-363-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/28/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA017443 03/28/2016
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-364
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Product Characteristics
Color ORANGE, BROWN Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code Dantirum;100;mg;0149;0033
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49884-364-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/28/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA017443 03/28/2016
Labeler - Par Pharmaceutical, Inc. (092733690)
Establishment
Name Address ID/FEI Business Operations
Par Formulations Private Limited 676159161 ANALYSIS(49884-362, 49884-363, 49884-364) , MANUFACTURE(49884-362, 49884-363, 49884-364) , PACK(49884-362, 49884-363, 49884-364)

Revised: 12/2017 Par Pharmaceutical, Inc.

No Title 1572453785 

(25 mg, 50 mg and 100 mg)

Rx only

No Title 1572453786 

Manufactured by:
Bora Pharmaceutical Laboratories Inc.

Jhunan, Taiwan

Distributed by:
Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

373-06

Rev. 11-2018-00

Principal Display Panel - 100 Mg-100 Ct Bottle Label 

c
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-4411
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
Product Characteristics
Color YELLOW (yellow opaque) , GREEN (light green opaque) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code G441
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0115-4411-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2005
2 NDC:0115-4411-02 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2005
3 NDC:0115-4411-03 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076856 03/01/2005
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-4422
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Product Characteristics
Color YELLOW (yellow opaque) , BLUE (light blue opaque) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code G442
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0115-4422-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2005
2 NDC:0115-4422-02 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2005
3 NDC:0115-4422-03 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076856 03/01/2005
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-4433
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Product Characteristics
Color YELLOW (yellow opaque) , RED (reddish orange opaque) , ORANGE (reddish orange opaque) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code G443
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0115-4433-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2005
2 NDC:0115-4433-02 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2005
3 NDC:0115-4433-03 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076856 03/01/2005
Labeler - Amneal Pharmaceuticals of New York LLC (123797875)
Establishment
Name Address ID/FEI Business Operations
BORA PHARMACEUTICAL LABORATORIES INC. 656139511 ANALYSIS(0115-4411, 0115-4422, 0115-4433) , LABEL(0115-4411, 0115-4422, 0115-4433) , MANUFACTURE(0115-4411, 0115-4422, 0115-4433) , PACK(0115-4411, 0115-4422, 0115-4433)
Establishment
Name Address ID/FEI Business Operations
Reed-Lane 001819879 PACK(0115-4411, 0115-4422, 0115-4433)

Revised: 5/2019 Amneal Pharmaceuticals of New York LLC

No Title 1572455553 

Rx only

Dantrolene Sodium 

Label Image
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-1520(NDC:0115-4411)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
Product Characteristics
Color YELLOW (yellow opaque) , GREEN (light green opaque) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code G441
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68151-1520-0 1 in 1 PACKAGE; Type 0: Not a Combination Product 03/01/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076856 03/01/2005
Labeler - Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Business Operations
Carilion Materials Management 079239644 REPACK(68151-1520)

Revised: 7/2017 Carilion Materials Management

No Title 1572457397 

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 dantrolene sodium 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. Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

Principal Display Panel - 25 Mg Bottle Label 

Dantrolene Sodium Container Label-25mg

NDC 0527-3219-37

25 mg

Dantrolene Sodium Capsules

PERIPHERAL SKELETAL MUSCLE RELAXANT

100 Capsules
Rx Only

Lannett Company, Inc.

Principal Display Panel - 50 Mg Bottle Label 

Dantrolene Sodium Container Label-50mg

NDC 0527-3220-37

50 mg

Dantrolene Sodium Capsules

PERIPHERAL SKELETAL MUSCLE RELAXANT

100 Capsules
Rx Only

Lannett Company, Inc.

Principal Display Panel - 100 Mg Bottle Label 

Dantrolene Sodium Container Label-100mg

NDC 0527-3221-37

100 mg

Dantrolene Sodium Capsules

PERIPHERAL SKELETAL MUSCLE RELAXANT

100 Capsules
Rx Only

Lannett Company, Inc.


DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-3219
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
Starch, Corn (UNII: O8232NY3SJ)
Lactose Monohydrate (UNII: EWQ57Q8I5X)
Magnesium Stearate (UNII: 70097M6I30)
Talc (UNII: 7SEV7J4R1U)
D&C Yellow No. 10 (UNII: 35SW5USQ3G)
Fd&C Red No. 40 (UNII: WZB9127XOA)
Gelatin, Unspecified (UNII: 2G86QN327L)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)
Fd&C Blue No. 2 (UNII: L06K8R7DQK)
Butyl Alcohol (UNII: 8PJ61P6TS3)
Shellac (UNII: 46N107B71O)
Propylene Glycol (UNII: 6DC9Q167V3)
Ferrosoferric Oxide (UNII: XM0M87F357)
Product Characteristics
Color ORANGE, YELLOW Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code A;219
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0527-3219-37 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/26/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076686 10/26/2005
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-3220
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
Starch, Corn (UNII: O8232NY3SJ)
Lactose Monohydrate (UNII: EWQ57Q8I5X)
Magnesium Stearate (UNII: 70097M6I30)
Talc (UNII: 7SEV7J4R1U)
D&C Yellow No. 10 (UNII: 35SW5USQ3G)
Fd&C Red No. 40 (UNII: WZB9127XOA)
Gelatin, Unspecified (UNII: 2G86QN327L)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)
Fd&C Blue No. 2 (UNII: L06K8R7DQK)
Butyl Alcohol (UNII: 8PJ61P6TS3)
Shellac (UNII: 46N107B71O)
Propylene Glycol (UNII: 6DC9Q167V3)
Ferrosoferric Oxide (UNII: XM0M87F357)
Product Characteristics
Color ORANGE, YELLOW Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code A;220
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0527-3220-37 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/26/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076686 10/26/2005
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-3221
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
Starch, Corn (UNII: O8232NY3SJ)
Lactose Monohydrate (UNII: EWQ57Q8I5X)
Magnesium Stearate (UNII: 70097M6I30)
Talc (UNII: 7SEV7J4R1U)
D&C Yellow No. 10 (UNII: 35SW5USQ3G)
Fd&C Red No. 40 (UNII: WZB9127XOA)
Gelatin, Unspecified (UNII: 2G86QN327L)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)
Fd&C Blue No. 2 (UNII: L06K8R7DQK)
Butyl Alcohol (UNII: 8PJ61P6TS3)
Shellac (UNII: 46N107B71O)
Propylene Glycol (UNII: 6DC9Q167V3)
Ferrosoferric Oxide (UNII: XM0M87F357)
Product Characteristics
Color ORANGE, YELLOW Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code A;221
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0527-3221-37 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/26/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076686 10/26/2005
Labeler - Lannett Company, Inc. (002277481)
Establishment
Name Address ID/FEI Business Operations
Elite Laboratories, Inc. 785398728 manufacture(0527-3219, 0527-3220, 0527-3221)

Revised: 3/2018 Lannett Company, Inc.

No Title 1572448581 

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 dantrolene sodium 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. Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

Description 

The chemical formula of dantrolene sodium is hydrated 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene] amino]-2, 4-imidazolidinedione sodium salt. It is an orange powder, slightly soluble in water, but due to its slightly acidic nature the solubility increases somewhat in alkaline solution. The anhydrous salt has a molecular weight of 336. The hydrated salt contains approximately 15% water (3-1/2 moles) and has a molecular weight of 399. The structural formula for the hydrated salt is:

Chemical Structure

Dantrolene sodium is supplied in capsules of 25 mg, 50 mg, and 100 mg.

Inactive Ingredients: Each capsule contains croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, pharmaceutical ink, pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 25 mg capsule contains D&C Yellow #10 and FD&C Green #3, the 50 mg capsule contains FD&C Blue #1, and the 100 mg capsule contains FD&C Red #40 and FD&C Yellow #6.

Clinical Pharmacology 

In isolated nerve-muscle preparation, dantrolene sodium has been shown to produce relaxation by affecting the contractile response of the skeletal muscle at a site beyond the myoneural junction, directly on the muscle itself. In skeletal muscle, dantrolene sodium dissociates the excitation-contraction coupling, probably by interfering with the release of Ca++ from the sarcoplasmic reticulum. This effect appears to be more pronounced in fast muscle fibers as compared to slow ones, but generally affects both. A central nervous system effect occurs, with drowsiness, dizziness, and generalized weakness occasionally present. Although dantrolene sodium does not appear to directly affect the CNS, the extent of its indirect effect is unknown. The absorption of dantrolene sodium after oral administration in humans is incomplete and slow but consistent, and dose-related blood levels are obtained. The duration and intensity of skeletal muscle relaxation is related to the dosage and blood levels. The mean biologic half-life of dantrolene sodium in adults is 8.7 hours after a 100-mg dose. Specific metabolic pathways in the degradation and elimination of dantrolene sodium in human subjects have been established. Metabolic patterns are similar in adults and pediatric patients. In addition to the parent compound, dantrolene, which is found in measurable amounts in blood and urine, the major metabolites noted in body fluids are the 5-hydroxy analog and the acetamido analog. Since dantrolene sodium is probably metabolized by hepatic microsomal enzymes, enhancement of its metabolism by other drugs is possible. However, neither phenobarbital nor diazepam appears to affect dantrolene sodium metabolism.

Clinical experience in the management of fulminant human malignant hyperthermia, as well as experiments conducted in malignant hyperthermia susceptible swine, have revealed that the administration of intravenous dantrolene, combined with indicated supportive measures, is effective in reversing the hypermetabolic process of malignant hyperthermia. Known differences between human and swine malignant hyperthermia are minor. The prophylactic administration of oral or intravenous dantrolene to malignant hyperthermia susceptible swine will attenuate or prevent the development of signs of malignant hyperthermia in a manner dependent upon the dosage of dantrolene administered and the intensity of the malignant hyperthermia triggering stimulus. Limited clinical experience with the administration of oral dantrolene to patients judged malignant hyperthermia susceptible, when combined with clinical experience in the use of intravenous dantrolene for the treatment of malignant hyperthermia and data derived from the above cited animal model experiments, suggests that oral dantrolene will also attenuate or prevent the development of signs of human malignant hyperthermia, provided that currently accepted practices in the management of such patients are adhered to (see INDICATIONS AND USAGE); intravenous dantrolene should also be available for use should the signs of malignant hyperthermia appear.

Indications And Usage 

In Chronic Spasticity

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.

In Malignant Hyperthermia

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.

Contraindications 

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.

Warnings 

It is important to recognize that fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy.

At the start of dantrolene sodium therapy, it is desirable to do liver function studies (SGOT, SGPT, alkaline phosphatase, total bilirubin) for a baseline or to establish whether there is pre-existing liver disease. If baseline liver abnormalities exist and are confirmed, there is a clear possibility that the potential for dantrolene sodium hepatotoxicity could be enhanced, although such a possibility has not yet been established.

Liver function studies (e.g., SGOT or SGPT) should be performed at appropriate intervals during dantrolene sodium therapy. If such studies reveal abnormal values, therapy should generally be discontinued. Only where benefits of the drug have been of major importance to the patient, should reinitiation or continuation of therapy be considered. Some patients have revealed a return to normal laboratory values in the face of continued therapy while others have not.

If symptoms compatible with hepatitis, accompanied by abnormalities in liver function tests or jaundice appear, dantrolene sodium should be discontinued. If caused by dantrolene sodium and detected early, the abnormalities in liver function characteristically have reverted to normal when the drug was discontinued.

Dantrolene sodium therapy has been reinstituted in a few patients who have developed clinical and/or laboratory evidence of hepatocellular injury. If such reinstitution of therapy is done, it should be attempted only in patients who clearly need dantrolene sodium and only after previous symptoms and laboratory abnormalities have cleared. The patient should be hospitalized and the drug should be restarted in very small and gradually increasing doses. Laboratory monitoring should be frequent and the drug should be withdrawn immediately if there is any indication of recurrent liver involvement. Some patients have reacted with unmistakable signs of liver abnormality upon administration of a challenge dose, while others have not.

Dantrolene sodium should be used with particular caution in females and in patients over 35 years of age in view of apparent greater likelihood of drug-induced, potentially fatal, hepatocellular disease in these groups. Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term safety of dantrolene sodium in humans has not been established. Chronic studies in rats, dogs, and monkeys at dosages greater than 30 mg/kg/day showed growth or weight depression and signs of hepatopathy and possible occlusion nephropathy, all of which were reversible upon cessation of treatment. Sprague-Dawley female rats fed dantrolene sodium for 18 months at dosage levels of 15 mg/kg/day, 30 mg/kg/day, and 60 mg/kg/day showed an increased incidence of benign and malignant mammary tumors compared with concurrent controls. At the highest dose level, there was an increase in the incidence of benign lymphatic neoplasms. In a 30-month study at the same dose levels also in Sprague-Dawley rats, dantrolene sodium produced a decrease in the time of onset of mammary neoplasms. Female rats at the highest dose level showed an increased incidence of hepatic lymphangiomas and hepatic angiosarcomas.

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. Carcinogenicity in humans cannot be fully excluded, so that this possible risk of chronic administration must be weighed against the benefits of the drug (i.e. after a brief trial) for the individual patient.

Dantrolene sodium has produced positive results in the Ames S. Typhimurium bacterial mutagenesis assay in the presence and absence of a liver activating system.

Pregnancy

Pregnancy Category C

Adequate animal reproduction studies have not been conducted with dantrolene sodium. It is also not known whether dantrolene sodium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dantrolene sodium should be given to a pregnant woman only if clearly needed.

Labor and Delivery

In one non-randomized open-label study, 21 term pregnant patients received prophylactic oral dantrolene sodium 100 mg per day for 2 to 10 days prior to delivery. Dantrolene readily crossed the placenta with maternal and fetal whole blood levels approximately equal at delivery; neonatal levels then fell approximately 50% per day for 2 days before declining sharply. No neonatal respiratory and neuromuscular side effects were detected at low dose. More data, at higher doses, are needed before more definitive conclusions can be made.

Nursing Mothers

Dantrolene sodium should not be used in nursing mothers.

Usage in Pediatric Patients

The long-term safety of dantrolene sodium in pediatric patients under the age of 5 years has not been established. Because of the possibility that adverse effects of the drug could become apparent only after many years, a benefit-risk consideration of the long-term use of dantrolene sodium is particularly important in pediatric patients.

Geriatric Use

Clinical studies of dantrolene sodium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience in the literature has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. As with all patients receiving dantrolene sodium, it is recommended that elderly patients receive the lowest dose compatible with the optimal response. Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (for hepatotoxicity details and its management see Black Box and Warnings Sections).

Drug Interactions

Drowsiness may occur with dantrolene sodium therapy, and the concomitant administration of CNS depressants such as sedatives and tranquilizing agents may result in further drowsiness.

While a definite drug interaction with estrogen therapy has not yet been established, caution should be observed if the two drugs are to be given concomitantly. Hepatotoxicity has occurred more often in women over 35 years of age receiving concomitant estrogen therapy.

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/ -chloralose anesthetized swine has resulted in ventricular fibrillation and cardiovascular collapse in association with marked hyperkalemia. Until the relevance of these findings to humans is established, the combination of dantrolene sodium and calcium channel blockers is not recommended during the management of malignant hyperthermia.

Administration of dantrolene sodium may potentiate vecuronium-induced neuromuscular block.

Precautions 

Dantrolene sodium should be used with caution in patients with impaired pulmonary function, particularly those with obstructive pulmonary disease, and in patients with severely impaired cardiac function due to myocardial disease. Dantrolene sodium is associated with pleural effusion with associated eosinophilia. It should be used with caution in patients with a history of previous liver disease or dysfunction (see WARNINGS).

Information for Patients

Patients should be cautioned against driving a motor vehicle or participating in hazardous occupations while taking dantrolene sodium. Caution should be exercised in the concomitant administration of tranquilizing agents.

Dantrolene sodium might possibly evoke a photosensitivity reaction; patients should be cautioned about exposure to sunlight while taking it.

Adverse Reactions 

The most frequently occurring side effects of dantrolene sodium have been drowsiness, dizziness, weakness, general malaise, fatigue, and diarrhea. These are generally transient, occurring early in treatment, and can often be obviated by beginning with a low dose and increasing dosage gradually until an optimal regimen is established. Diarrhea may be severe and may necessitate temporary withdrawal of dantrolene sodium therapy. If diarrhea recurs upon re-administration of dantrolene sodium, therapy should probably be withdrawn permanently.

Other less frequent side effects, listed according to system, are:

Gastrointestinal: Constipation, rarely progressing to signs of intestinal obstruction, GI bleeding, anorexia, swallowing difficulty, gastric irritation, abdominal cramps, nausea and/or vomiting.

Hepatobiliary: Hepatitis (see WARNINGS).

Neurologic: Speech disturbance, seizure, headache, light-headedness, visual disturbance, diplopia, alteration of taste, insomnia, drooling.

Cardiovascular: Tachycardia, erratic blood pressure, phlebitis, heart failure.

Hematologic: Aplastic anemia, anemia, leukopenia, lymphocytic lymphoma, thrombocytopenia.

Psychiatric: Mental depression, mental confusion, increased nervousness.

Urogenital: Increased urinary frequency, crystalluria, hematuria, difficult erection, urinary incontinence and/or nocturia, difficult urination and/or urinary retention.

Integumentary: Abnormal hair growth, acne-like rash, pruritus, urticaria, eczematoid eruption, sweating.

Musculoskeletal: Myalgia, backache.

Respiratory: Feeling of suffocation, respiratory depression.

Special Senses: Excessive tearing.

Hypersensitivity: Pleural effusion with pericarditis, pleural effusion with associated eosinophilia, anaphylaxis.

Other: Chills and fever.

The published literature has included some reports of dantrolene sodium use in patients with Neuroleptic Malignant Syndrome (NMS). Dantrolene sodium capsules are not indicated for the treatment of NMS and patients may expire despite treatment with dantrolene sodium capsules.

For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Abuse And Dependence 

Drug abuse and dependency potential has not been evaluated in human or animal studies.

Overdosage 

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 overdose, general supportive measures should be employed along with immediate gastric lavage.

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. To date, no experience has been reported with dialysis and its value in dantrolene sodium overdose is not known.

Dosage And Administration 

For Use in Chronic Spasticity

Prior to the administration of dantrolene sodium capsules, consideration should be given to the potential response to treatment. A decrease in spasticity sufficient to allow a daily function not otherwise attainable should be the therapeutic goal of treatment with dantrolene sodium capsules. Refer to INDICATIONS AND USAGE section for description of response to be anticipated.

It is important to establish a therapeutic goal (regain and maintain a specific function such as therapeutic exercise program, utilization of braces, transfer maneuvers, etc.) before beginning dantrolene sodium capsule therapy. Dosage should be increased until the maximum performance compatible with the dysfunction due to underlying disease is achieved. No further increase in dosage is then indicated.

Usual Dosage

It is important that the dosage be titrated and individualized for maximum effect. The lowest dose compatible with optimal response is recommended.

In view of the potential for liver damage in long-term dantrolene sodium capsule use, therapy should be stopped if benefits are not evident within 45 days.

Adults

The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose.

25 mg once daily for seven days, then
25 mg t.i.d. for seven days
50 mg t.i.d. for seven days
100 mg t.i.d.

Therapy with a dose four times daily may be necessary for some individuals. Doses higher than 100 mg four times daily should not be used (see Box Warning).

Pediatric Patients

The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose.

0.5 mg/kg once daily for seven days, then
0.5 mg/kg t.i.d. for seven days
1 mg/kg t.i.d. for seven days
2 mg/kg t.i.d.

Therapy with a dose four times daily may be necessary for some individuals. Doses higher than 100 mg four times daily should not be used (see Box Warning).

For Malignant Hyperthermia

Preoperatively: Administer 4 mg/kg/day to 8 mg/kg/day of oral dantrolene sodium caspules in 3 or 4 divided doses for one or two days prior to surgery, with the last dose being given approximately 3 to 4 hours before scheduled surgery with a minimum of water.

This dosage will usually be associated with skeletal muscle weakness and sedation (sleepiness or drowsiness); adjustment can usually be made within the recommended dosage range to avoid incapacitation or excessive gastrointestinal irritation (including nausea and/or vomiting).

Post Crisis Follow-up: Oral dantrolene sodium capsules should also be administered following a malignant hyperthermia crisis, in doses of 4 mg/kg per day to 8 mg/kg per day in four divided doses, for a one to three day period to prevent recurrence of the manifestations of malignant hyperthermia.

How Supplied 

Dantrolene Sodium Capsules, 25 mg are rich yellow opaque bodies and light green opaque caps. Each cap and body imprinted in black with G441.
They are available as follows:

Bottles of 100: NDC 0115-4411-01
Bottles of 500: NDC 0115-4411-02
Bottles of 1000: NDC 0115-4411-03

Dantrolene Sodium Capsules, 50 mg are rich yellow opaque bodies and light blue opaque caps. Each cap and body imprinted in black with G442.
They are available as follows:

Bottles of 100: NDC 0115-4422-01
Bottles of 500: NDC 0115-4422-02
Bottles of 1000: NDC 0115-4422-03

Dantrolene Sodium Capsules, 100 mg are rich yellow opaque bodies and reddish orange opaque caps. Each cap and body imprinted in black with G443.
They are available as follows:

Bottles of 100: NDC 0115-4433-01
Bottles of 500: NDC 0115-4433-02
Bottles of 1000: NDC 0115-4433-03

Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.

Dispense in a tightly-closed, light-resistant container (USP).

Principal Display Panel - 25 Mg Capsule Bottle Label 

NDC 42023-144-01
Rx Only

Dantrolene Sodium
Capsules

25 mg

For oral use only
PERIPHERAL SKELETAL
MUSCLE RELAXANT

100 Capsules

JHP
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Label

Principal Display Panel - 50 Mg Capsule Bottle Label 

NDC 42023-145-01
Rx Only

Dantrolene Sodium
Capsules

50 mg

For oral use only
PERIPHERAL SKELETAL
MUSCLE RELAXANT

100 Capsules

JHP
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-144
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Product Characteristics
Color ORANGE, BROWN (tan) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 144
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42023-144-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2013 05/31/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA017443 04/08/2013 05/31/2020
DANTROLENE SODIUM
dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-145
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) DANTROLENE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Product Characteristics
Color ORANGE, BROWN (tan) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 145
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42023-145-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2013 10/31/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA017443 04/08/2013 10/31/2017
Labeler - Par Pharmaceutical, Inc. (092733690)

Revised: 5/2017 Par Pharmaceutical, Inc.



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