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Aquamephyton (Phytonadione) - Indications and Dosage

 
 



INDICATIONS AND USAGE

AquaMEPHYTON 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.

AquaMEPHYTON injection is indicated in:

  • anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
  • prophylaxis and therapy of hemorrhagic disease of the newborn;
  • hypoprothrombinemia due to antibacterial therapy;
  • hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;
  • other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.

DOSAGE AND ADMINISTRATION

Whenever possible, AquaMEPHYTON should be given by the subcutaneous route (see Box Warning). When intravenous administration is considered unavoidable, the drug should be injected very slowly, not exceeding 1 mg per minute.

Protect from light at all times.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Directions for Dilution

AquaMEPHYTON may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Benzyl alcohol as a preservative has been associated with toxicity in newborns. Therefore, all of the above diluents should be preservative-free (see WARNINGS). Other diluents should not be used. When dilutions are indicated, administration should be started immediately after mixture with the diluent, and unused portions of the dilution should be discarded, as well as unused contents of the ampul.

Prophylaxis of Hemorrhagic Disease of the Newborn

The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of AquaMEPHYTON 0.5 to 1 mg within one hour of birth is recommended.

Treatment of Hemorrhagic Disease of the Newborn

Empiric administration of vitamin K1 should not replace proper laboratory evaluation of the coagulation mechanism. A prompt response (shortening of the prothrombin time in 2 to 4 hours) following administration of vitamin K1 is usually diagnostic of hemorrhagic disease of the newborn, and failure to respond indicates another diagnosis or coagulation disorder.

AquaMEPHYTON 1 mg should be given either subcutaneously or intramuscularly. Higher doses may be necessary if the mother has been receiving oral anticoagulants.

AquaMEPHYTON
Summary of Dosage Guidelines
(See circular text for details)
Newborns Dosage
Hemorrhagic Disease of the Newborn Prophylaxis
Treatment

0.5-1 mg IM
within 1 hour of birth
1 mg SC or IM
(Higher doses may be necessary if the mother has been receiving oral anticoagulants)
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)

Whole blood or component therapy may be indicated if bleeding is excessive. This therapy, however, does not correct the underlying disorder and AquaMEPHYTON should be given concurrently.

Anticoagulant-Induced Prothrombin Deficiency in Adults

To correct excessively prolonged prothrombin time 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 6 to 8 hours after parenteral administration the prothrombin time has not been shortened satisfactorily, the dose should be repeated.

In the event of shock or excessive blood loss, the use of whole blood or component therapy is indicated.

Hypoprothrombinemia Due to Other Causes in Adults

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.

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 AquaMEPHYTON. The severity of the coagulation disorder should determine whether the immediate administration of AquaMEPHYTON is required in addition to discontinuation or reduction of interfering drugs.

HOW SUPPLIED

Injection AquaMEPHYTON is a yellow, sterile, aqueous colloidal solution and is supplied in the following concentrations:

No. 7780--10 mg of vitamin K1 per mL

NDC 0006-7780-38 boxes of 5 × 1 mL ampuls

NDC 0006-7780-66 five boxes of 5 × 1 mL ampuls.

No. 7784--1 mg of vitamin K1 per 0.5 mL

NDC 0006-7784-33 five boxes of 5 × 0.5 mL ampuls.

STORAGE

Store container in original carton. Always protect AquaMEPHYTON from light. Store container in closed original carton until contents have been used. (See PRECAUTIONS, General.)

9073025 Issued February 2002

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