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Mephyton (Phytonadione) - Indications and Dosage

 



INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

MEPHYTON
Summary of Dosage Guidelines
(See circular text for details)
AdultsInitial 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.

HOW SUPPLIED

No. 7776 — Tablets MEPHYTON, 5 mg vitamin K1, are yellow, round, scored, compressed tablets, coded MSD 43 on one side and MEPHYTON on the other. They are supplied as follows:

NDC 0006-0043-68 bottles of 100.

Storage

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

Merck & Co., Inc.

Whitehouse Station, NJ 08889, USA

Issued April 2004

Printed in USA

7918719

Page last updated: 2007-01-20

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