Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3945
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Vitamin K1 (Injection, Emulsion)
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Whenever possible, Vitamin KInjection (Phytonadione
Injectable Emulsion, USP) should be given by the subcutaneous route. (See
Box Warning.) When intravenous administration is considered unavoidable, the
drug should be injected very slowly, not exceeding 1 mg per minute. Protect
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. Directions
for Dilution Vitamin KInjection
may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection,
or 5% Dextrose and Sodium Chloride Injection. Benzyl alcohol as a preservative
has been associated with toxicity in newborns. Therefore,all of the above diluents should be preservative-free (see WARNINGS). Other diluents shouldnot be used. When dilutions
are indicated, administration should be started immediately after mixture
with the diluent, and unused portions of the dilution should be discarded,
as well as unused contents of the ampul. Prophylaxis
of Hemorrhagic Disease of the Newborn The
American Academy of Pediatrics recommends that vitamin Kbe given
to the newborn. A single intramuscular dose of Vitamin KInjection
0.5 to 1 mg within one hour of birth is recommended. Treatment of Hemorrhagic Disease of the Newborn Empiric
administration of vitamin Kshould not replace proper laboratory
evaluation of the coagulation mechanism. A prompt response (shortening of
the prothrombin time in 2 to 4 hours) following administration of vitamin
Kis usually diagnostic of hemorrhagic disease of the newborn,
and failure to respond indicates another diagnosis or coagulation disorder. Vitamin
KInjection 1 mg should be given either subcutaneously or intramuscularly.
Higher doses may be necessary if the mother has been receiving oral anticoagulants. Whole
blood or component therapy may be indicated if bleeding is excessive. This
therapy, however, does not correct the underlying disorder and Vitamin KInjection
should be given concurrently. Anticoagulant-Induced
Prothrombin Deficiency in Adults To correct
excessively prolonged prothrombin time 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 (see WARNINGS). If in 6
to 8 hours after parenteral administration the prothrombin time has not been
shortened satisfactorily, the dose should be repeated. In the event of shock or excessive blood loss, the use
of whole blood or component therapy is indicated. Hypoprothrombinemia Due to Other Causes in Adults 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. 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 Vitamin
KInjection. The severity of the coagulation disorder should determine
whether the immediate administration of Vitamin KInjection is
required in addition to discontinuation or reduction of interfering drugs.
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Phytonadione is a vitamin, which is a clear, yellow to amber,
viscous, odorless or 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: Vitamin KInjection
(Phytonadione Injectable Emulsion, USP) is a yellow, sterile, nonpyrogenic
aqueous dispersion available for injection by the intravenous, intramuscular
and subcutaneous routes. Each milliliter contains phytonadione 2 or 10 mg,
polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in
water for injection; benzyl alcohol 9 mg added as preservative. May contain
hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione
is oxygen sensitive.
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Vitamin KInjection (Phytonadione Injectable
Emulsion, USP) aqueous dispersion of vitamin Kfor parenteral
injection, possesses 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-carboxy-glutamic acid residues convert the precursors into active coagulation
factors that are subsequently secreted by liver cells into the blood. Phytonadione
is readily absorbed following intramuscular administration. 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. The
action of the aqueous dispersion, when administered intravenously, is generally
detectable within an hour or two and hemorrhage is usually controlled within
3 to 6 hours. A normal prothrombin level may often be obtained in 12 to 14
hours. In the prophylaxis and treatment of hemorrhagic
disease of the newborn, phytonadione has demonstrated a greater margin of
safety than that of the water-soluble vitamin K analogues.
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Vitamin KInjection (Phytonadione Injectable
Emulsion, USP) is supplied in a package of 25 as follows: Store at 20 to 25��C (68 to 77��F). [See USP Controlled
Room Temperature.] Protect
from light. Keep ampuls in tray until time of use. HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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WARNING���INTRAVENOUS AND
INTRAMUSCULAR USE Severe reactions, including
fatalities, have occurred during and immediately after INTRAVENOUS injection
of phytonadione, even when precautions have been taken to dilute the phytonadione
and to avoid rapid infusion. Severe reactions, including fatalities, have
also been reported following INTRAMUSCULAR administration. Typically these
severe reactions have resembled hypersensitivity or anaphylaxis, including
shock and cardiac and/or respiratory arrest. Some patients have exhibited
these severe reactions on receiving phytonadione for the first time. Therefore
the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations
where the subcutaneous route is not feasible and the serious risk involved
is considered justified.
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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. Laboratory
Tests Prothrombin time should be checked regularly as
clinical conditions indicate.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies of carcinogenicity, mutagenesis or impairment of
fertility have not been conducted with Vitamin KInjection (Phytonadione
Injectable Emulsion, USP).<br/>Pregnancy: Pregnancy Category C: Animal reproduction studies have not
been conducted with Vitamin KInjection. It is also not known
whether Vitamin KInjection can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. Vitamin KInjection
should be given to a pregnant woman only if clearly needed.<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 Vitamin KInjection is administered to a nursing woman.<br/>Pediatric Use: Hemolysis, jaundice, and hyperbilirubinemia in neonates,
particularly those that are premature, may be related to the dose of Vitamin
KInjection. Therefore, the recommended dose should not be exceeded
(see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).
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The intravenous LDof Vitamin KInjection
(Phytonadione Injectable Emulsion, USP) in the mouse is 41.5 and 52 mL/kg
for the 0.2% and 1% concentrations, respectively.
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Phytonadione
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Vitamin K1 (Injection, Emulsion)
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Deaths have occurred after intravenous and intramuscular
administration. (See Box Warning.) Transient���flushing
sensations���and���peculiar���sensations of taste have been
observed, as well as rare instances of dizziness, rapid and weak pulse, profuse
sweating, brief hypotension, dyspnea, and cyanosis. Pain,
swelling, and tenderness at the injection site may occur. The
possibility of allergic sensitivity including an anaphylactoid reaction, should
be kept in mind. Infrequently, usually after repeated
injection, erythematous, indurated, pruritic plaques have occurred; rarely,
these have progressed to scleroderma-like lesions that have persisted for
long periods. In other cases, these lesions have resembled erythema perstans. Hyperbilirubinemia
has been observed in the newborn following administration of phytonadione.
This has occurred rarely and primarily with doses above those recommended.
(See PRECAUTIONS, Pediatric Use.)
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Benzyl alcohol as a preservative in Bacteriostatic Sodium
Chloride Injection has been associated with toxicity in newborns. Data are
unavailable on the toxicity of other preservatives in this age group. There
is no evidence to suggest that the small amount of benzyl alcohol contained
in Vitamin KInjection (Phytonadione Injectable Emulsion, USP),
when used as recommended, is associated with toxicity. An
immediate coagulant effect should not be expected after administration of
phytonadione. It takes a minimum of 1 to 2 hours for measurable improvement
in the prothrombin time. Whole blood or component therapy may also be necessary
if bleeding is severe. Phytonadione will not counteract
the anticoagulant action of heparin. When vitamin Kis
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. Phytonadione
is not a clotting agent, but overzealous therapy with vitamin Kmay
restore conditions which originally permitted thromboembolic phenomena. Dosage
should be kept as low as possible, and prothrombin time should be checked
regularly as clinical conditions indicate. Repeated
large doses of vitamin K are not warranted in liver disease if the response
to initial use of the vitamin is unsatisfactory. Failure to respond to vitamin
K may indicate that the condition being treated is inherently unresponsive
to vitamin K. Benzyl alcohol has been reported to be
associated with a fatal���Gasping Syndrome���in premature infants. WARNING:
This product contains aluminum that may be toxic. Aluminum may reach toxic
levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature,
and they required large amounts of calcium and phosphate solutions, which
contain aluminum. Research indicates that patients with
impaired kidney function, including premature neonates, who receive parenteral
levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at
levels associated with central nervous system and bone toxicity. Tissue loading
may occur at even lower rates of administration.
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Vitamin KInjection (Phytonadione Injectable
Emulsion, USP) 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. Vitamin
KInjection is indicated in:
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Vitamin K1
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