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Vitamin K contains aluminum

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From another list I am on...........Vitamin K injection contains Aluminum

This injection given to every newborn unless parent refuses

it.................

<http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=1448>http://dailymed.nlm.n\

ih.gov/dailymed/drugInfo.cfm?id=1448

I pulled this link off of the FDA section which shows Vitamin K. Please

scroll down about half way to the WARNING section. Again, it says " this

product contains aluminum which may be at toxic levels. . . "

Nowhere else have I see that.

So strange that it would be in only one place. Its not listed in the

ingredients, if you look further down.

Maybe it is in the benzyl alcohol or one of the other ingredients.

See list of ingredients further down - it is NOT mentioned there. Only in

that one Warning paragraph.

Makes no sense. But I'll share with all on my lists. I'm glad you found

it - thanks

Sheri

" 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. "

<http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=1448>http://dailymed.nlm.n\

ih.gov/dailymed/drugInfo.cfm?id=1448

Aqueous Dispersion of Vitamin K1

Ampul

Rx only

Protect from light. Keep ampuls

in tray until time of use.

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.

DESCRIPTION

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 C31H46O2 and its structural formula is:

Image from Drug Label Content

Vitamin K1 Injection (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.

CLINICAL PHARMACOLOGY

Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) aqueous

dispersion of vitamin K1 for 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.

INDICATIONS AND USAGE

Vitamin K1 Injection (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 K1 Injection is indicated in:

*

anticoagulant-induced prothrombin deficiency caused by coumarin or

indanedione derivatives;

*

prophylaxis and therapy of hemorrhagic disease of the newborn;

*

hypoprothrombinemia due to antibacterial therapy;

*

hypoprothrombinemia secondary to factors limiting absorption or

synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue,

ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis

of the pancreas, and regional enteritis;

*

other drug-induced hypoprothrombinemia where it is definitely shown

that the result is due to interference with vitamin K metabolism, e.g.,

salicylates.

CONTRAINDICATION

Hypersensitivity to any component of this medication.

WARNINGS

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 K1 Injection (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 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 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.

PRECAUTIONS

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of carcinogenicity, mutagenesis or impairment of fertility have not

been conducted with Vitamin K1 Injection (Phytonadione Injectable Emulsion,

USP).

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted

with Vitamin K1 Injection. It is also not known whether Vitamin K1

Injection can cause fetal harm when administered to a pregnant woman or can

affect reproduction capacity. Vitamin K1 Injection should be given to a

pregnant woman only if clearly needed.

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

K1 Injection is administered to a nursing woman.

Pediatric Use

Hemolysis, jaundice, and hyperbilirubinemia in neonates, particularly those

that are premature, may be related to the dose of Vitamin K1 Injection.

Therefore, the recommended dose should not be exceeded (see ADVERSE

REACTIONS and DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

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.)

OVERDOSAGE

The intravenous LD50 of Vitamin K1 Injection (Phytonadione Injectable

Emulsion, USP) in the mouse is 41.5 and 52 mL/kg for the 0.2% and 1%

concentrations, respectively.

DOSAGE AND ADMINISTRATION

Whenever possible, Vitamin K1 Injection (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 K1 Injection 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 should not 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 K1 be given to

the newborn. A single intramuscular dose of Vitamin K1 Injection 0.5 to 1

mg within one hour of birth is recommended.

Treatment of Hemorrhagic Disease of the Newborn

Empiric administration of vitamin K1 should 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

K1 is usually diagnostic of hemorrhagic disease of the newborn, and failure

to respond indicates another diagnosis or coagulation disorder.

Vitamin K1 Injection 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

K1 Injection should be given concurrently.

Anticoagulant-Induced Prothrombin Deficiency in Adults

To correct excessively prolonged prothrombin time caused by oral

anticoagulant therapy­2.5 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.

Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP)

Summary of Dosage Guidelines (See circular text for details)

Newborns

Dosage

Hemorrhagic Disease

of the Newborn

Prophylaxis

0.5 to 1 mg IM within 1 hour of birth

Treatment

1 mg SC or IM

(Higher doses may be necessary if the

mother has been receiving oral

anticoagulants)

Adults

Initial Dosage

Anticoagulant-Induced

2.5 mg to 10 mg or

Prothrombin Deficiency

up to 25 mg

(caused by coumarin or

(rarely 50 mg)

indanedione derivatives)

Hypoprothrombinemia

2.5 mg to 25 mg or

Due to other causes

more (rarely up to

(Antibiotics;

50 mg)

Salicylates or other drugs;

Factors limiting absorption

or synthesis)

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 K1

Injection. The severity of the coagulation disorder should determine

whether the immediate administration of Vitamin K1 Injection is required in

addition to discontinuation or reduction of interfering drugs.

HOW SUPPLIED

Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is supplied in

a package of 25 as follows:

Amount of

Vitamin K1

List

No.

Container

Inj. In

Container

Volume

Concentration

9157

1 mL Ampul

1 mg

0.5 mL

2 mg/mL

9158

1 mL Ampul

10 mg

1 mL

10 mg/mL

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 2004

EN-0538

Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Vitamin K1 (Phytonadione)

PRODUCT INFO

Product Code 0409-9157 Dosage Form INJECTION, EMULSION

Route Of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule

INGREDIENTS

Name (Active Moiety) Type Strength

Phytonadione (Phytonadione) Active 2 MILLIGRAM In 1 MILLILITER

Polyoxyethylated Fatty Acid Derivative Inactive 70 MILLIGRAM In 1 MILLILITER

Dextrose Hydrous Inactive 37.5 MILLIGRAM In 1 MILLILITER

Water Inactive

Benzyl Alcohol Inactive 9 MILLIGRAM In 1 MILLILITER

Hydrochloric Acid Inactive

IMPRINT INFORMATION

Characteristic Appearance Characteristic Appearance

Color Score

Shape Symbol

Imprint Code Coating

Size

PACKAGING

# NDC Package Description Multilevel Packaging

1 0409-9157-01 16 CONTAINER In 1 CASE contains a CONTAINER

1 5 TRAY In 1 CONTAINER This package is contained within the CASE

(0409-9157-01) and contains a TRAY ()

1 5 AMPULE In 1 TRAY This package is contained within the CONTAINER () and

contains a AMPULE ()

1 0.5 MILLILITER In 1 AMPULE This package is contained within a TRAY and a

CONTAINER and a CASE (0409-9157-01)

Vitamin K1 (Phytonadione)

PRODUCT INFO

Product Code 0409-9158 Dosage Form INJECTION, EMULSION

Route Of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule

INGREDIENTS

Name (Active Moiety) Type Strength

Phytonadione (Phytonadione) Active 10 MILLIGRAM In 1 MILLILITER

Polyoxyethylated Fatty Acid Derivative Inactive 70 MILLIGRAM In 1 MILLILITER

Dextrose Hydrous Inactive 37.5 MILLIGRAM In 1 MILLILITER

Water Inactive

Benzyl Alcohol Inactive 9 MILLIGRAM In 1 MILLILITER

Hydrochloric Acid Inactive

IMPRINT INFORMATION

Characteristic Appearance Characteristic Appearance

Color Score

Shape Symbol

Imprint Code Coating

Size

PACKAGING

# NDC Package Description Multilevel Packaging

1 0409-9158-01 16 CONTAINER In 1 CASE contains a CONTAINER

1 5 TRAY In 1 CONTAINER This package is contained within the CASE

(0409-9158-01) and contains a TRAY ()

1 5 AMPULE In 1 TRAY This package is contained within the CONTAINER () and

contains a AMPULE ()

1 1 MILLILITER In 1 AMPULE This package is contained within a TRAY and a

CONTAINER and a CASE (0409-9158-01)

Revised: 08/2006

Visit The National Library of Medicine Copyright, Privacy, Accessibility

U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894

National Institutes of Health, Health & Human Services

--------------------------------------------------------

Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines -

http://www.nccn.net/~wwithin/vaccine.htm or

http://www.wellwithin1.com/vaccine.htm

Vaccine Dangers & Homeopathy Online/email courses

http://www.wellwithin1.com/vaccineclass.htm or

http://www.wellwithin1.com/homeo.htm

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