Vitamin K1

Phytonadione comes as a tablet to take by mouth. It should be taken as directed by your doctor. Your doctor may sometimes prescribe another medication (bile salts) to take with phytonadione. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Do not stop taking phytonadione without talking to your doctor. Take phytonadione exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Before taking phytonadione,

• tell your doctor and pharmacist if you are allergic to phytonadione, any other medications, or any of the ingredients in phytonadione tablets. Ask your pharmacist for a list of the ingredients.
• Do not take anticoagulants ('blood thinners') such as warfarin (Coumadin) while you are taking phytonadione unless told to do so by your doctor.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antibiotics; salicylate pain relievers such as aspirin or aspirin-containing products, choline magnesium trisalicylate, choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking orlistat (Xenical), take it 2 hours before or 2 hours after phytonadione.

tell your doctor if you have or have ever had liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking phytonadione, call your doctor.

Phytonadione may cause side effects. If you experience the following symptom, call your doctor immediately:

• unusual bruising or bleeding

Phytonadione is a man-made form of vitamin K, which occurs naturally in the body.

Phytonadione is used to treat vitamin K deficiency and to treat certain bleeding or blood clotting problems.

Phytonadione may also be used for purposes not listed in this medication guide.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

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).

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.)

5/NDC 0409-9158-01

1 mL Single-dose Ampul
VITAMIN K1 Injection
Phytonadione Injectable Emulsion, USP
10 mg/mL
Rx only

Protect from light. Keep ampuls in tray until time of use.
For I.M., S.C., or I.V. (with caution).

Each mL contains phytonadione 10 mg; polyoxyethylated
fatty acid derivative 70 mg; dextrose, hydrous 37.5 mg;
benzyl alcohol 9 mg added as preservative. May contain
hydrochloric acid for pH adjustment. pH 6.3 (5.0 to 7.0).
Usual dosage: See insert. Store at 20 to 25°C (68 to 77°F).
[See USP Controlled Room Temperature.]

©Hospira 2004
Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Hospira

RL-0655 (10/04)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.