Mephyton

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Side Effects & Adverse Reactions

An immediate coagulant effect should not be expected after administration of phytonadione.

Phytonadione will not counteract the anticoagulant action of heparin.

When vitamin K1is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy. Phytonadione is not a clotting agent, but overzealous therapy with vitamin K1 may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and prothrombin time should be checked regularly as clinical conditions indicate.

Repeated large doses of vitamin K are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. Failure to respond to vitamin K may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

MEPHYTON is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.

MEPHYTON tablets are indicated in:

anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
hypoprothrombinemia secondary to antibacterial therapy;
hypoprothrombinemia secondary to administration of salicylates;
hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed.

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History

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Other Information

Phytonadione is a vitamin which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.

Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H46O2 and its structural formula is:

MEPHYTON1 (Phytonadione) tablets containing 5 mg of phytonadione are yellow, compressed tablets, scored on one side. Inactive ingredients are acacia, calcium phosphate, colloidal silicon dioxide, lactose, magnesium stearate, starch, and talc.

Sources

Mephyton Manufacturers

Rebel Distributors Corp

Mephyton | Rebel Distributors Corp

MEPHYTON
Summary of Dosage Guidelines
(See circular text for details) Adults Initial Dosage Anticoagulant-Induced
Prothrombin Deficiency
(caused by coumarin or indanedione derivatives) 2.5 mg-10 mg or up to
25 mg (rarely 50 mg) Hypoprothrombinemia due
to other causes
(Antibiotics; Salicylates or other drugs;
Factors limiting absorption or synthesis) 2.5 mg-25 mg or more
(rarely up to 50 mg) Anticoagulant-Induced Prothrombin Deficiency in Adults
To correct excessively prolonged prothrombin times caused by oral anticoagulant therapy— 2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required. Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition. (See WARNINGS.) If, in 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated.
Hypoprothrombinemia Due to Other Causes in Adults
If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent MEPHYTON. The severity of the coagulation disorder should determine whether the immediate administration of MEPHYTON is required in addition to discontinuation or reduction of interfering drugs.

A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.

The oral route should be avoided when the clinical disorder would prevent proper absorption. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.

No Recall
Pd-rx Pharmaceuticals, Inc.

Mephyton | Pd-rx Pharmaceuticals, Inc.

MEPHYTON Summary of Dosage Guidelines (See circular text for details) Adults Initial Dosage Anticoagulant-Induced Prothrombin Deficiency
(caused by coumarin or indanedione derivatives) 2.5 mg-10 mg or up to 25 mg
(rarely 50 mg) Hypoprothrombinemia due to other causes
(Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis) 2.5 mg-25 mg or more (rarely up to 50 mg) Anticoagulant-Induced Prothrombin Deficiency in Adults
To correct excessively prolonged prothrombin times caused by oral anticoagulant therapy – 2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required, Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition. (See WARNINGS.) If, in 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated.
Hypoprothrombinemia Due to Other Causes in Adults
If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent MEPHYTON. The severity of the coagulation disorder should determine whether the immediate administration of MEPHYTON is required in addition to discontinuation or reduction of interfering drugs.

A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.

The oral route should be avoided when the clinical disorder would prevent proper absorption. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.

No Recall
Physicians Total Care, Inc.

Mephyton | Physicians Total Care, Inc.

MEPHYTON Summary of Dosage Guidelines (See circular text for details) Adults Initial Dosage Anticoagulant-Induced Prothrombin Deficiency
(caused by coumarin or indanedione derivatives) 2.5 mg-10 mg or up to 25 mg
(rarely 50 mg) Hypoprothrombinemia due to other causes
(Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis) 2.5 mg-25 mg or more (rarely up to 50 mg) Anticoagulant-Induced Prothrombin Deficiency in Adults
To correct excessively prolonged prothrombin times caused by oral anticoagulant therapy – 2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required, Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition. (See WARNINGS.) If, in 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated.
Hypoprothrombinemia Due to Other Causes in Adults
If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent MEPHYTON. The severity of the coagulation disorder should determine whether the immediate administration of MEPHYTON is required in addition to discontinuation or reduction of interfering drugs.

A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.

The oral route should be avoided when the clinical disorder would prevent proper absorption. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.

No Recall
Valeant Pharmaceuticals North America Llc

Mephyton | Valeant Pharmaceuticals North America Llc

MEPHYTON Summary of Dosage Guidelines (See circular text for details) Adults Initial Dosage Anticoagulant-Induced Prothrombin Deficiency
(caused by coumarin or indanedione derivatives) 2.5 mg-10 mg or up to 25 mg
(rarely 50 mg) Hypoprothrombinemia due to other causes
(Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis) 2.5 mg-25 mg or more (rarely up to 50 mg) Anticoagulant-Induced Prothrombin Deficiency in Adults
To correct excessively prolonged prothrombin times caused by oral anticoagulant therapy – 2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required, Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition. (See WARNINGS.) If, in 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated.
Hypoprothrombinemia Due to Other Causes in Adults
If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent MEPHYTON. The severity of the coagulation disorder should determine whether the immediate administration of MEPHYTON is required in addition to discontinuation or reduction of interfering drugs.

A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.

The oral route should be avoided when the clinical disorder would prevent proper absorption. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.

No Recall
Kaiser Foundation Hospitals

Mephyton | Kaiser Foundation Hospitals

MEPHYTON Summary of Dosage Guidelines (See circular text for details) Adults Initial Dosage Anticoagulant-Induced Prothrombin Deficiency
(caused by coumarin or indanedione derivatives) 2.5 mg-10 mg or up to 25 mg
(rarely 50 mg) Hypoprothrombinemia due to other causes
(Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis) 2.5 mg-25 mg or more (rarely up to 50 mg) Anticoagulant-Induced Prothrombin Deficiency in Adults
To correct excessively prolonged prothrombin times caused by oral anticoagulant therapy – 2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required, Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition. (See WARNINGS.) If, in 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated.
Hypoprothrombinemia Due to Other Causes in Adults
If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent MEPHYTON. The severity of the coagulation disorder should determine whether the immediate administration of MEPHYTON is required in addition to discontinuation or reduction of interfering drugs.

A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.

The oral route should be avoided when the clinical disorder would prevent proper absorption. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.

No Recall
Cardinal Health

Mephyton | Cardinal Health

MEPHYTON Summary of Dosage Guidelines (See circular text for details) Adults Initial Dosage Anticoagulant-Induced Prothrombin Deficiency
(caused by coumarin or indanedione derivatives) 2.5 mg-10 mg or up to 25 mg
(rarely 50 mg) Hypoprothrombinemia due to other causes
(Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis) 2.5 mg-25 mg or more (rarely up to 50 mg) Anticoagulant-Induced Prothrombin Deficiency in Adults
To correct excessively prolonged prothrombin times caused by oral anticoagulant therapy – 2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required, Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition. (See WARNINGS.) If, in 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated.
Hypoprothrombinemia Due to Other Causes in Adults
If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent MEPHYTON. The severity of the coagulation disorder should determine whether the immediate administration of MEPHYTON is required in addition to discontinuation or reduction of interfering drugs.

A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.

The oral route should be avoided when the clinical disorder would prevent proper absorption. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.

No Recall
Carilion Materials Management

Mephyton | Carilion Materials Management

MEPHYTON Summary of Dosage Guidelines (See circular text for details) Adults Initial Dosage (caused by coumarin or indanedione derivatives) Anticoagulant-Induced Prothrombin Deficiency
2.5 mg-10 mg or up to 25 mg (rarely 50 mg)
(Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis) Hypoprothrombinemia due to other causes
2.5 mg-25 mg or more (rarely up to 50 mg) Anticoagulant-Induced Prothrombin Deficiency in Adults
To correct excessively prolonged prothrombin times caused by oral anticoagulant therapy – 2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required, Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition. (See .) If, in 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated. WARNINGS
Hypoprothrombinemia Due to Other Causes in Adults
If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent MEPHYTON. The severity of the coagulation disorder should determine whether the immediate administration of MEPHYTON is required in addition to discontinuation or reduction of interfering drugs.

A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.

The oral route should be avoided when the clinical disorder would prevent proper absorption. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.

No Recall