Prevent and stop the bleeding with

HEMATRON.

FORMULATION:

Each 1ml ampoule contains: Phytomenadione………………………….. 10mg

DESCRIPTION: USP Type I amber glass ampoule containing a clear and pale yellow solution

INDICATIONS:
  1. Phytomenadione (Hematron) Injection is used in the prevention and treatment of hemorrhagic disease of the
  2. Used for the following coagulation disorders caused by Vitamin K deficiency or interference with Vitamin K activity. ) Anticoagulant-induced hypoprothrombinemia caused by coumarin derivative. b.) Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K  metabolic ism. e.g., salicylates or antibiotics.
  3. Treatment of hypoprothrombinemia secondary to factors limiting absorption or synthesis of Vitamin
CONTRAINDICATIONS:
  1. Patients with a history of hypersensitivity to Phytomenadione (Hematron).
  2. Patients with hypoprothrombinemia caused by hepatocyte
  3. Patients with cholestasis

STORAGE CONDITION: Store at temperatures not exceeding 30 “C. Protect from light. Do not freeze.

DOSAGE FORMS AND PACKAGING AVAILABLE: USP Type I amber glass ampoule x lmL (Box of S0’s)

CAUTION: Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription. For suspected adverse drug reactions, report to the FDA: www.fda.gov.ph. Seek medical attention immediately at the first sign of any adverse drug reaction.

Phytomenadione is a synthetic preparation of  Vitamin  K. The presence of vitamin (i.e. Vitamin K or substances with vitamin  K activity) is essential for the formation within the body of prothrombin, factor VII, factor IX, and factor X and the clotting inhibitors protein C and protein S. Lack of vitamin K leads to an increased tendency to hemorrhagic disease in the newborn. When an antidote to an anticoagulant is necessary it is essential to use vitamin  Kl itself, as vitamin K analogs are much less effective. In the mixed micelles solution, vitamin Kl is solubilized by means of a physiological colloidal system, also found in the human body, consisting of lecithin and bile acid. Owing to the absence of organic solvents, the Phytomenadione mixed micelles solution is well tolerated on intravenous administration.

The fat-soluble vitamin K compounds phytomenadione require the presence of bile for their absorption from the gastrointestinal tract; the water-soluble derivatives can be absorbed in the absence of bile. Vitam in K accumulates mainly in the liver but is stored in the body only for short periods of time. Phytomenadione is rapidly metabolized to more polar metabolites and is excreted in bile and urine as glucuronide and sulfate conjugates.

  • Prevention of hemorrhagic disease of the newborn: For the prevention of hemorrhagic disease of the newborn, Phytomenadi­ one {Hematron) in doses of SOOmcg”‘1mg IM, IV or SC should be administered to the neonate within 1 hour of delivery.
  • Treatment of hemorrhagic disease of the newborn: For the treatment of hemorrhagic disease of the newborn, the usual dose of Phytomenadione (Hematron) is 1mg administered IM or subcutaneous l Larger doses may be required for neonates whose mothers have received anticoagulant therapy during pregnancy.
  • Anticoagulant-induced Hypoprothrombinemia: ADULTS: The usual initial dose of Phytomenadione (Hematron) is s~1omg administered by IM or subcutaneous injection, although initial doses of up to  25mg have been used in some patients. In rare instances, larger doses(e.g., 50mg)  may be required. The dose may be repeated  5~3  hours after the first parenteral dose if the initial response is not satisfactory. CHILDREN/BABIES: the usual initial dose of Phytomenadione (Hematron) is 2.S”‘l0mg(babies: 1~2mg) administered by IM  or subcutaneous injection. The dose may be repeated 5~3 hours after the first parenteral dose if the initial response is not satisfactory.
  • Hypoprothrombinemia from other causes: The dose of 2″’25mg may be administered to adults Up to 50mg may be given.

Should administer with great care to the following patients.

    1. A patient who has history and family history of asthma, rash, hives,
    2. A patient who has a history of drug hypersensitivity reaction.
    3. Patient with liver
    4. Newborn {especia ll y preterm infant).
    5. The end of
    6. Continuous administration of high dose (hyperbilirubinemia may occur).

Pediatric Precautions: Hemolysis, jaundice, and hyperbilirubinemia have been reported rarely in neonates, particularly premature neonates following large doses(10″’20mg) of Phytomenadione {Hematron). Consult hematologists before administering Phytomenadione (Hematron) to newborn babies. There are reports that the administration of Vitamin K  injection may cause a carcinogenic effect in newborn babies. Therefore, Hematron Injection should be indicated only when oral routes of administration are not possible.

Geriatric Precautions: Elderly patients are more sensitive to  Vitamin K injection. Therefore, the recommended dose should not be exceeded.

  • The safety of Phytomenadione (Hematron) for use in human pregnancy has not been    Phytomenadione (Hematron) should not be used in pregnancy and lactating women unless treatment benefit exceeds its risk.
  • The safety of Phytomenadione (Hematron) for nursing mothers has not been established whether this drug is being excreted in human breast mi l Carefully administer to nursing mothers

  • Vitamin Kl can reduce the anticoagulation effect of coumarin
  • Broad-spectrum antibiotics, quinidine,  quinine, and high dose of salicylates can reduce the effects of Phytomenadione (Hematron).

  • Temporary flushing of  the  face, alteration of taste, dizziness, tachycardia, sweating, brief hypotension, dyspnea, cyanosis, chest constriction, and peripheral vascular insufficiency may occur
  • Bronchospasm, shock, cardiac and/or respiratory arrest may
  • Rash, hives, or anaphylaxis is may occur
  • Pain, edema, tenderness, delayed induration, redness, swelling, and dermatitis-like rash at the injection site may occur. Erythema­tous and indurated plaques have occurred infrequently, usually after repeated injection; rarely, these have progressed to scleroderma-like lesions that have persisted for long periods of time.
  • Death from hyperbilirubinemia, severe hemolytic anemia, hemoglobinuria, kernicterus, and cerebral injury have been reported rarely in neonates, particular ly premature neonates following large doses of Phytomenadione.

  • Hypervitaminosis of vitamin K is unknown. Reintroduction of anti-coagulation may be affected.

  • Phytomenadione {Hematron) is relatively non-toxic, however, severe reactions have occurred rarely during or immediately following IV and IM  These severe reactions, which may occur in patients receiving Phytomenadione (Hematron) for the first time, resemble hypersensitivity, shock, anaphylaxis such as cardiac and/or respiratory arrest and death. Dilution and slow infusion may not prevent severe reactions; therefore, IV and IM  administration of the drug should be restricted to emergen­cy use.
  • When ampoules are cut, glass fragments may be mixed and may cause side effects. Carefully cut  ampoules,  particularly  when in use with the elderly and children