Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1242
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MEPHYTON (Tablet)
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Anticoagulant-Induced Prothrombin
Deficiency in Adults: To correct excessively prolonged prothrombin times
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. If, in 12 to 48 hours after
oral administration, the prothrombin time has not been shortened satisfactorily,
the dose should be repeated.<br/>Hypoprothrombinemia Due to Other Causes in Adults: 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
MEPHYTON. The severity of the coagulation disorder should determine
whether the immediate administration of MEPHYTON is required in addition
to discontinuation or reduction of interfering drugs. 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. The oral route should be avoided when the clinical disorder would
prevent proper absorption. Bile salts must be given with the tablets
when the endogenous supply of bile to the gastrointestinal tract is
deficient.
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| dailymed-instance:descripti... |
Phytonadione is a vitamin which is a clear, yellow
to amber, viscous, and nearly odorless liquid. It is insoluble in
water, soluble in chloroform and slightly soluble in ethanol. It has
a molecular weight of 450.70. Phytonadione is
2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is CHOand its structural formula is: MEPHYTON(Phytonadione) tablets
containing 5 mg of phytonadione are yellow, compressed tablets,
scored on one side. Inactive ingredients are acacia, calcium phosphate,
colloidal silicon dioxide, lactose, magnesium stearate, starch, and
talc.
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MEPHYTON tablets possess the same type and degree
of activity as does naturally-occurring vitamin K, which is necessary
for the production via the liver of active prothrombin (factor II),
proconvertin (factor VII), plasma thromboplastin component (factor IX),
and Stuart factor (factor X). The prothrombin test is sensitive
to the levels of three of these four factors���II, VII,
and X. Vitamin K is an essential cofactor for a microsomal enzyme
that catalyzes the post-translational carboxylation of multiple, specific,
peptide-bound glutamic acid residues in inactive hepatic precursors
of factors II, VII, IX, and X. The resulting gamma-carboxyglutamic
acid residues convert the precursors into active coagulation factors
that are subsequently secreted by liver cells into the blood. Oral phytonadione is adequately absorbed from the gastrointestinal
tract only if bile salts are present. After absorption, phytonadione
is initially concentrated in the liver, but the concentration declines
rapidly. Very little vitamin K accumulates in tissues. Little
is known about the metabolic fate of vitamin K. Almost no free
unmetabolized vitamin K appears in bile or urine. In normal animals and humans, phytonadione is virtually
devoid of pharmacodynamic activity. However, in animals and humans
deficient in vitamin K, the pharmacological action of vitamin K
is related to its normal physiological function; that is, to promote
the hepatic biosynthesis of vitamin K-dependent clotting factors. MEPHYTON tablets generally exert their effect within 6
to 10 hours.
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Hypersensitivity to any component of this medication.
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No. 7776���Tablets MEPHYTON, 5 mg
vitamin K, are yellow, round, scored, compressed
tablets, coded MSD 43 on one side and MEPHYTON on the other.
They are supplied as follows: NDC 0006-0043-68 bottles of 100.<br/>Storage: Store in tightly closed
original container at 25��C (77��F); excursions permitted
to 15-30��C (59-86��F) [see USP Controlled Room Temperature].
Always protect MEPHYTON from light. Store in tightly closed original
container and carton until contents have been used. Merck&Co.,
Inc. Whitehouse Station, NJ 08889, USA Issued April 2004 Printed in USA 7918719
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General: Vitamin Kis fairly rapidly degraded
by light; therefore, always protect MEPHYTON from light. Store MEPHYTON
in closed original carton until contents have been used.<br/>Drug Interactions: Temporary resistance to prothrombin-depressing anticoagulants
may result, especially when larger doses of phytonadione are used.
If relatively large doses have been employed, it may be necessary
when reinstituting anticoagulant therapy to use somewhat larger doses
of the prothrombin-depressing anticoagulant, or to use one which acts
on a different principle, such as heparin sodium.<br/>Laboratory Tests: Prothrombin time should be checked regularly as clinical
conditions indicate.<br/>Carcinogenesis, Mutagenesis,
Impairment of Fertility: Studies of carcinogenicity or impairment of fertility
have not been performed with MEPHYTON. MEPHYTON at concentrations
up to 2000 mcg/plate with or without metabolic activation, was
negative in the Ames microbial mutagen test.<br/>Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with MEPHYTON.
It is also not known whether MEPHYTON can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. MEPHYTON
should be given to a pregnant woman only if clearly needed.<br/>Pediatric Use: Safety and effectiveness in pediatric patients have
not been established with MEPHYTON. Hemolysis, jaundice, and hyperbilirubinemia
in newborns, particularly in premature infants, have been reported
with vitamin K.<br/>Nursing Mothers: It is not known whether this drug is excreted in
human milk. Because many drugs are excreted in human milk, caution
should be exercised when MEPHYTON is administered to a nursing woman.<br/>Geriatric Use: Clinical studies of MEPHYTON did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond
differently from younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and
younger patients. In general, dose selection for an elderly patient
should be cautious, usually starting at the low end of the dosing
range, reflecting the greater frequency of decreased hepatic, renal,
or cardiac function, and of concomitant disease or other drug therapy.
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The intravenous and oral LDs in the
mouse are approximately 1.17 g/kg and greater than 24.18 g/kg,
respectively.
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phytonadione
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MEPHYTON (Tablet)
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Severe hypersensitivity reactions, including anaphylactoid
reactions and deaths have been reported following parenteral administration.
The majority of these reported events occurred following intravenous
administration. Transient���flushing sensations���and���peculiar���sensations of taste have been observed
with parenteral phytonadione, as well as rare instances of dizziness,
rapid and weak pulse, profuse sweating, brief hypotension, dyspnea,
and cyanosis. Hyperbilirubinemia has been observed
in the newborn following administration of parenteral phytonadione.
This has occurred rarely and primarily with doses above those recommended.
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| dailymed-instance:indicatio... |
MEPHYTON 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. MEPHYTON tablets
are indicated in:
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MEPHYTON
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