AquaMEPHYTON

Aquamephyton is part of the drug class:

• Vitamin K

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:

 AquaMEPHYTON injection is a yellow, sterile, aqueous colloidal solution of vitamin K1, with a pH of 5.0 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes.

Each milliliter contains:

Phytonadione 2 mg or 10 mg
Inactive ingredients:
Polyoxyethylated fatty acid derivative 70 mg
Dextrose 37.5 mg
Water for injection, q.s. 1 mL 
Added as preservative:
Benzyl alcohol 9 mg

1 mL Single-dose Ampul
NDC 52565-093-01

AquaMEPHYTON®
(Phytonadione Injectable Emulsion, USP)

10 mg/mL

Contains no more than 110 mcg/L of aluminum.
Protect from light.

Rx only

Teligent Pharma, Inc.
Buena, NJ 08310

0.5 mL Single-dose Ampul
NDC 52565-092-01

AquaMEPHYTON
(Phytonadione Injectable Emulsion, USP)

1 mg/0.5 mL
Neonatal Concentration

Contains no more than 110 mcg/L of aluminum.
Protect from light.

Rx only

Teligent Pharma, Inc.
Buena, NJ 08310

Applies to phytonadione: capsule, tablet

Along with its needed effects, phytonadione (the active ingredient contained in Aquamephyton) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking phytonadione:

• Decreased appetite
• decreased movement or activity
• difficulty in breathing
• enlarged liver
• general body swelling
• irritability
• muscle stiffness
• paleness
• yellow eyes or skin

• Difficulty in swallowing
• fast or irregular breathing
• lightheadedness or fainting
• shortness of breath
• skin rash, hives and/or itching
• swelling of eyelids, face, or lips
• tightness in chest
• troubled breathing and/or wheezing

• Blue color or flushing or redness of skin
• dizziness
• fast and/or weak heartbeat
• increased sweating
• low blood pressure (temporary)

Some side effects of phytonadione may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Flushing of face
• redness, pain, or swelling at place of injection
• skin lesions at place of injection (rare)
• unusual taste

Applies to phytonadione: compounding powder, injectable solution, oral tablet

Local

Rare (less than 0.1%): Injection site reactions (inflammation, atrophy, necrosis)
Very rare (less than 0.01%): Venous irritation or phlebitis (IV route)
Frequency not reported: Pain, swelling, and tenderness at the injection site[Ref]

Cardiovascular

Rare (less than 0.1%): Rapid and weak pulse, brief hypotension, cyanosis
Very rare (less than 0.01%): Facial flushing[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactoid reactions (IV route)
Frequency not reported: Allergic sensitivity, anaphylaxis[Ref]

Fatalities and other severe reactions have occurred during or immediately after the parenteral administration of phytonadione. The majority of these reactions have occurred with intravenous administration. These reactions resemble hypersensitivity or anaphylaxis and include shock and cardiac or respiratory arrest. Feelings of uneasiness, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea may precede the cardiopulmonary event. These severe reactions are more likely with, but are not limited to, rapid infusions of undiluted drug.[Ref]

Gastrointestinal

Gastrointestinal side effects have rarely included 'peculiar' sensations of taste.

Respiratory

Rare (less than 0.1%): Dyspnea[Ref]

Other

Frequency not reported: Death (IV and IM routes)[Ref]

Dermatologic

Uncommon (0.1% to 1%): Erythematous, indurated, pruritic plaques
Rare (less than 0.1%): Profuse sweating, scleroderma-like lesions,
Very rare (less than 0.01%): Sweating
Frequency not reported: Erythema perstans-like lesions[Ref]

Nervous system

Rare (less than 0.1%): Dizziness
Very rare (less than 0.01%): Unusual taste[Ref]

Hepatic

Hyperbilirubinemia occurred primarily with doses above those recommended.[Ref]

Rare (less than 0.1%): Hyperbilirubinemia in newborns
Frequency not reported: Jaundice in newborns[Ref]

Hematologic

Frequency not reported: Hemolysis in newborns[Ref]

General

The most common adverse events were dermatologic and injection site reactions.[Ref]

Some side effects of Aquamephyton may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Use is not recommended unless clearly needed AU TGA pregnancy category: Not formally assigned to a pregnancy category. US FDA pregnancy category: C

Animal studies have not been conducted. Vitamin K1 does not readily cross the placenta. There are no controlled data in human pregnancy. AU TGA pregnancy category: Not formally assigned to a pregnancy category. This class of drugs is generally exempt from pregnancy classification. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

The American Academy of Pediatrics classifies vitamin K1 as compatible with breastfeeding; they also caution that administration to the mother prenatally should not be substituted for newborn prophylaxis.

Caution is recommended; benefit to mother should outweigh risk to the infant Excreted into human milk: Yes Comments: Not recommended for nursing mothers as prophylaxis of newborn hemorrhagic disease.

Phytonadione injection is used to treat bleeding or blood clotting problems caused by vitamin K deficiency, certain medicines (eg, warfarin), or medical conditions (obstructive jaundice, ulcerative colitis). Phytonadione is a man-made form of vitamin K, which occurs naturally in the body. It treats and prevents low levels of blood clotting factors needed to help your blood to thicken and stop bleeding normally.

This medicine is available only with your doctor’s prescription.