Composition: |
 |
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 .
|
