[[anticoagulant]]-induced [[prothrombin]] deficiency caused by [[coumarin]] or indanedione derivatives, [[hypoprothrombinemia]] secondary to [[antibacterial therapy]], [[hypoprothrombinemia]] secondary to administration of [[salicylates]], [[hypoprothrombinemia]] secondary to [[obstructive jaundice]] or biliary fistulas
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Skin reaction, IM
skin reaction, IM
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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.
anticoagulant-induced [[prothrombin]] deficiency caused by [[coumarin]] or indanedione derivatives;
[[hypoprothrombinemia]] secondary to [[antibacterial therapy]];
[[hypoprothrombinemia]] secondary to administration of [[salicylates]];
[[hypoprothrombinemia]] secondary to [[obstructive jaundice]] or biliary fistulas but only if [[bile salts]] are administered concurrently, since otherwise the oral [[vitamin K]] will not be absorbed.
T1
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.
[[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.
=====Condition1=====
* Dosing Information
* Dosing Information
:*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.
:* Dosage
=====Hypoprothrombinemia=====
=====Condition2=====
* Dosing Information
* Dosing Information
:*[[hypoprothrombinemia]] secondary to [[antibacterial therapy]]; [[hypoprothrombinemia]] secondary to administration of [[salicylates]];[[hypoprothrombinemia]] secondary to [[obstructive jaundice]] or biliary fistulas but only if [[bile salts]] are administered concurrently, since otherwise the oral [[vitamin K]] will not be absorbed.
:*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.
:* Dosage
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
=====Condition3=====
* Dosing Information
:* Dosage
=====Condition4=====
* Dosing Information
:* Dosage
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=====Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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|fdaLIADPed=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
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|offLabelPedGuideSupport=
=====Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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|offLabelPedNoGuideSupport=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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|warnings=
|warnings=
*An immediate coagulant effect should not be expected after administration of phytonadione.
*An immediate [[coagulant]] effect should not be expected after administration of phytonadione.
*Phytonadione will not counteract the [[anticoagulant]] action of [[heparin]].
*Phytonadione will not counteract the [[anticoagulant]] action of [[heparin]].
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*Phytonadione is not a [[clotting]] agent, but overzealous therapy with vitamin K1 may 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.
*Phytonadione is not a [[clotting]] agent, but overzealous therapy with vitamin K1 may 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 a [[congenital]] coagulation defect or that the condition being treated is unresponsive to [[vitamin K]].
*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 a [[congenital]] coagulation defect or that the condition being treated is unresponsive to [[vitamin K]].
====Precautions====
====Precautions====
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|clinicalTrials=
*Severe [[hypersensitivity]] reactions, including [[anaphylactoid]] reactions and deaths have been reported following parenteral administration. The majority of these reported events occurred following [[intravenous]] administration.
*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]].
*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.
*[[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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|drugInteractions=
*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.
*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.
<!--Use in Specific Populations-->
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* '''Pregnancy Category C'''
* '''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.
*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.
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*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.
*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]].
*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 posttranslational carboxylation of multiple, specific, peptidebound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X. The resulting gammacarboxyglutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood.
*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 posttranslational carboxylation of multiple, specific, peptidebound glutamic acid residues in inactive [[hepatic]] precursors of factors II, VII, IX, and X. The resulting gammacarboxyglutamic acid residues convert the precursors into active [[coagulation]] factors that are subsequently secreted by liver cells into the blood.
<!--Structure-->
<!--Structure-->
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*Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H46O2 and its structural formula is:
*Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H46O2 and its structural formula is:
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
: [[File:{{PAGENAME}}04.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
*MEPHYTON1 (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.
*MEPHYTON1 (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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|PK=
|PK=
*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.
*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.
*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
*MEPHYTON tablets generally exert their effect within 6 to 10 hours
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*Storage
*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. (See PRECAUTIONS, General.)
:*Store in tightly closed original container at 25°C (77°F); excursions permitted to 15-30°C(59-86°F). Always protect MEPHYTON from light. Store in tightly closed original container and carton until contents have been used.
<!--Patient Counseling Information-->
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|lookAlike=
|lookAlike=
* Mephyton® — methadone®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
* Mephyton® — methadone®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
<!--Drug Shortage Status-->
<!--Drug Shortage Status-->
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{{LabelImage
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
|fileName={{PAGENAME}}02.png|This image is provided by the National Library of Medicine.
}}
}}
{{LabelImage
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
|fileName={{PAGENAME}}03.png|This image is provided by the National Library of Medicine.
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
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.
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.
When vitamin K1 is 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 K1 may 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 a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K.
Precautions
General
Vitamin K1 is fairly rapidly degraded by light; therefore, always protect MEPHYTON from light. Store MEPHYTON in closed original carton until contents have been used.
Adverse Reactions
Clinical Trials Experience
Severe hypersensitivity reactions, including anaphylactoid reactions and deaths have been reported following parenteral administration. The majority of these reported events occurred following intravenous administration.
Hyperbilirubinemia has been observed in the newborn following administration of parenteral phytonadione. This has occurred rarely and primarily with doses above those recommended.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Phytonadione (tablet) in the drug label.
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.
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.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Phytonadione (tablet) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Phytonadione (tablet) during labor and delivery.
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.
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.
Gender
There is no FDA guidance on the use of Phytonadione (tablet) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Phytonadione (tablet) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Phytonadione (tablet) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Phytonadione (tablet) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Phytonadione (tablet) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Phytonadione (tablet) in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Monitoring
There is limited information regarding Monitoring of Phytonadione (tablet) in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Phytonadione (tablet) in the drug label.
Overdosage
Acute Overdose
The intravenous and oral LD50s in the mouse are approximately 1.17 g/kg and greater than 24.18 g/kg, respectively.
Chronic Overdose
There is limited information regarding Chronic Overdose of Phytonadione (tablet) in the drug label.
Pharmacology
There is limited information regarding Phytonadione (tablet) Pharmacology in the drug label.
Mechanism of Action
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 posttranslational carboxylation of multiple, specific, peptidebound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X. The resulting gammacarboxyglutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood.
Structure
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 C31H46O2 and its structural formula is:
MEPHYTON1 (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.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Phytonadione (tablet) in the drug label.
Pharmacokinetics
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
Nonclinical Toxicology
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.
Clinical Studies
There is limited information regarding Clinical Studies of Phytonadione (tablet) in the drug label.
How Supplied
Tablets MEPHYTON, 5 mg vitamin K1, are yellow, round, scored, compressed tablets, coded ATON 405 on one side and MEPHYTON on the other. They are supplied as follows:
NDC 25010-405-15 bottles of 100.
Storage
Store in tightly closed original container at 25°C (77°F); excursions permitted to 15-30°C(59-86°F). Always protect MEPHYTON from light. Store in tightly closed original container and carton until contents have been used.
Storage
There is limited information regarding Phytonadione (tablet) Storage in the drug label.
Images
Drug Images
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