AquaMEPHYTON

AQUAMEPHYTON- phytonadione injection, emulsion
Teligent Pharma, Inc.

1 mg/0.5 mL PDP10 mg/mL PDP

WARNING — HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE

Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of AquaMEPHYTON. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see WARNINGS AND PRECAUTIONS (5.1)].

1 INDICATIONS AND USAGE

1.1 Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference

AquaMEPHYTON is indicated for the treatment of 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:

  • anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;
  • 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.

1.2 Prophylaxis and Treatment of Vitamin K Deficiency Bleeding in Neonates

AquaMEPHYTON is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Considerations

Whenever possible, administer AquaMEPHYTON by the subcutaneous route [see WARNING — HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE ]. When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute [see WARNINGS AND PRECAUTIONS (5.1)].

Monitor international normalized ratio (INR) regularly and as clinical conditions indicate. Use the lowest effective dose of AquaMEPHYTON.

The coagulant effects of AquaMEPHYTON are not immediate; improvement of INR may take 1-8 hours. Interim use of whole blood or component therapy may also be necessary if bleeding is severe.

Whenever possible, administer benzyl alcohol-free formulations in pediatric patients [see WARNINGS AND PRECAUTIONS(5.2) and USE IN SPECIFIC POPULATIONS (8.4)].

When AquaMEPHYTON is 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. AquaMEPHYTON is not a clotting agent, but overzealous therapy with AquaMEPHYTON may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and INR should be checked regularly as clinical conditions indicate.

2.2 Recommended Dosage for Coagulation Disorders from Vitamin K Deficiency or Interference

The recommended dosage of AquaMEPHYTON is based on whether the hypoprothrombinemia is anticoagulant-induced (e.g., due to coumarin or indanedione derivatives) or non-anticoagulant-induced (e.g., due to antibiotics; salicylates or other drugs; factors limiting absorption or synthesis) as follows:

  • Anticoagulant-Induced Hypoprothrombinemia: AquaMEPHYTON 2.5 mg to 10 mg or more subcutaneously, intramuscularly, or intravenously. Up to 25 mg to 50 mg may be administered as a single dose.

Repeated large doses of AquaMEPHYTON are not warranted in liver disease if the initial response is unsatisfactory. Failure to respond to AquaMEPHYTON may indicate that the condition being treated is inherently unresponsive to AquaMEPHYTON.

  • Hypoprothrombinemia Due to Other Causes(Non-Anticoagulation-Induced Hypoprothrombinemia): AquaMEPHYTON 2.5 mg to 25 mg or more intravenously, intramuscularly, or subcutaneously. Up to 50 mg may be administered as a single dose.

Evaluate INR after 6-8 hours, and repeat dose if INR remains prolonged. Modify subsequent dosage (amount and frequency) based on the INR or clinical condition.

2.3 Recommended Dosage for Prophylaxis and Therapy of Vitamin K Deficiency Bleeding in Neonates

Prophylaxis of Vitamin K-Deficiency Bleeding in Neonates
The recommended dosage of AquaMEPHYTON is 0.5 mg to 1 mg within one hour of birth for a single dose.
Treatment of Vitamin K Deficiency Bleeding in Neonates
The recommended dosage of AquaMEPHYTON is 1 mg given either subcutaneously or intramuscularly. Consider higher doses if the mother has been receiving oral anticoagulants.
A failure to respond (shortening of the INR in 2 to 4 hours) may indicated another diagnosis or coagulation disorder.

2.4 Directions for Dilution

Dilute AquaMEPHYTON with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Avoid use of other diluents that may contain benzyl alcohol, which can cause serious toxicity in newborns or low birth weight infants [see WARNINGS AND PRECAUTIONS (5.2) and USE IN SPECIFIC POPULATIONS (8.4).

When diluted, start administration of AquaMEPHYTON immediately after dilution. Discard unused portions of diluted solution as well as unused contents of the ampul.
Protect AquaMEPHYTON 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.

3 DOSAGE FORMS AND STRENGTHS

Injection: 2 mg/mL and 10 mg/mL single-dose ampuls

4 CONTRAINDICATIONS

Hypersensitivity to phytonadione or any other component of this medication. [see WARNINGS AND PRECAUTIONS (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of AquaMEPHYTON. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. These reactions have included shock, cardiorespiratory arrest, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea. Administer AquaMEPHYTON subcutaneously whenever feasible. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see DOSAGE AND ADMINISTRATION (2)].

5.2 Risk of Serious Adverse Reaction in Infants due to Benzyl Alcohol Preservative

Use benzyl alcohol-free formulations in neonates and infants, if available. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including AquaMEPHYTON. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations.

When prescribing AquaMEPHYTON in infants, consider the combined daily metabolic load of benzyl alcohol from all sources including AquaMEPHYTON (contains 9 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see USE IN SPECIFIC POPULATIONS (8.1, 8.2 and 8.4)].

5.3 Cutaneous Reactions

Parenteral administration of vitamin K replacements (including AquaMEPHYTON) may cause cutaneous reactions. Reactions have included eczematous reactions, scleroderma-like patches, urticaria, and delayed-type hypersensitivity reactions. Time of onset ranged from 1 day to a year after parenteral administration. Discontinue AquaMEPHYTON for skin reactions and institute medical management.

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