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Phytonadione (Vitamin K1)
(Chewable tablets & Injection)

Composition:
Phytonadione(Vitamin K1) Each tablet contains:
Phytonadione (Vitamin K1)..................................10mg
Each 1 ml ampoule contains:
Phytonadione (Vitamin K1)..................................10mg

Properties:
Phytonadione tablets & injection possess the same type and degree of activity as does naturally-occurring Vitamin K , which is necessary for hepatic biosynthesis of active prothrombin ( factor II), proconvertin ( factor VII ), plasma thromboplastin component ( factor IX ), and Stuart factor( factor X ).
Phytonadione is a specific antagonist for coumarin and indanedione and similar anticoagulants. It is indicated in the prophylaxis and treatment of hemorrhagic diseases. Phytonadione is readily absorbed orally and after injection. After absorption, it accumulates mainly in the liver, very little accumulates in tissues, it is metabolized to more polar metabolites and is excreted in bile and urine as glucuronide and sulphate conjugates.

Indications:
Anticoagulant-induced prothrombin deficiency.
Hypo-prothrombinemia due to other causes as that due to salicylates or antibiotics.
Hypo-prothrombinemia secondary to factors limiting absorption or synthesis of vitamin K1.

Contraindications:
Phytonadione is contraindicated in patients with known hypersensitivity to the drug.

Use in pregnancy and nursing mothers:
Pregnancy:
It is not known whether Phytonadione has an effect on pregnant woman or not, so Phytonadione should be given to pregnant woman only if clearly needed.
Nursing mothers :
A study has shown that vitamin K1 is excreted in human milk. This should be considered if it is necessary to administer Phytonadione to a nursing mother.

Precautions:
General:
Temporary resistance to prothrombin-depressing anticoagulants may result especially when large doses of Phytonadione are used, so if relatively large doses of Phytonadione are used, it may be necessary when reinstituting anticoagulant therapy to use somewhat larger dose of the prothrombin-depressing anticoagulant or one which has a different mode of action such as heparin.
Laboratory tests :
The dose, frequency of administration and duration of treatment depend on the severity of the prothrombin deficiency and should be regulated by repeated determinations of prothrombin time.

Warning:
Phytonadione does not directly counteract the effects of oral anticoagulants or heparin, but it promotes the synthesis of prothrombin by the liver usually within 2 hours, so blood or plasma transfusions may be required for severe blood loss or lack of response to vitamin K1.

Dosage & route of administration & duration:
Hemorrhagic disease of newborn:
Prophylaxis.................. 0.5 - 1 mg IM within 1 hour of birth.
Treatment.....................1 mg SC or IM ( higher doses may be necessary if mother has been receiving oral anticoagulants ).
Anticoagulant-Induced Prothrombin Deficiency in Adults (caused by coumarin or indanedione derivatives) :
2.5 - 10 mg or up to 25 mg initially and rarely up to 50 mg ( orally or by injection ).
Frequency & amount of subsequent doses should be determined by prothrombin time response or clinical condition. If in 6 to 8 hours after injection or 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated.
Hypo-prothrombinemia due to other causes in Adults ( e.g. antibiotics, salicylates or other drugs ):
2.5 - 25 mg initially and rarely up to 50 mg ( orally or by injection ).
The severity of the coagulation disorder should determine whether to discontinue or reduce the dosage of drugs interfering with coagulation mechanisms ( antibiotics or salicylates ) only or to administer Phytonadione immediately in addition of discontinuation or reduction of these drugs.

N.B.:
Phytonadione injection should be injected IM or IV very slowly not exceeding 1 mg / minute .
Blood or blood component transfusion is required in addition of Phytonadione therapy in case of excessive bleeding in newborn or patients with anticoagulant - induced Prothrombin Deficiency .
Heparin should be used in case of Phytonadione over dosage.

Drug interaction:
Because Vitamin K1 is a pharmacologic antagonist to coumarin and indanedione derivatives, patients being treated with these anticoagulants should not receive Phytonadione except for the treatment of excessive hypo-prothrombinemia.

Side effects:
Allergic reactions are possible and pain or swelling rarely occur at site of injection.
Although Phytonadione has a greater margin of safety than the water soluble vitamin K1 ,analogues, hyper-bilirubinemia has been reported in the newborn, particularly in premature when used at 5 to 10 times the recommended dosage.
In patients with severe hepatic diseases, large doses of Phytonadione, may further depress liver function.

Storage: Protect from light & at temp. not exceeding 30°C.
Keep medicine out of the reach of children.

Presentation:
Box of 10 , 20 or 1000 tablets.
Box of 3 , 6 or 100 ampoules .

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