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Mephyton

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Mephyton

Indications
Dosage
How Supplied

INDICATIONS

MEPHYTON (phytonadione) 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 (phytonadione) 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.

DOSAGE AND ADMINISTRATION

MEPHYTON (phytonadione) 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 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 (phytonadione) . The severity of the coagulation disorder should determine whether the immediate administration of MEPHYTON (phytonadione) 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.

HOW SUPPLIED

Tablets MEPHYTON (phytonadione) , 5 mg vitamin K1, are yellow, round, scored, compressed tablets, coded MSD 43 on one side and MEPHYTON (phytonadione) on the other. They are supplied as follows:

NDC 25010-405-15 bottles of 100.

Storage

Store in tightly closed original container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Always protect MEPHYTON (phytonadione) from light. Store in tightly closed original container and carton until contents have been used. (See PRECAUTIONS, General.)

Distributed by: Aton Pharma, Lawrenceville, NJ 08648, USA. Manufactured by: Merck and Co., Inc. West Point, PA 19486, USA. Issued May 2007. FDA Rev date: 2/9/2004

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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