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Phytomenadione ampoule

Company name: Memphis Co. for Pharm. & Chem. Ind.

Trade name: Phytomenadione ampoule

Generic name: Phytomenadione

Composition:
Each ampoule contains:
Phytomenadione           10 mg

Excipients:
Polysorbate 80, propylene glycol, sodium acetate, glacial acetic acid.

Pharmaceutical form: ampoules

Pharmacological action:
Phytomenadione is necessary for synthesis of factor II (prothrombin), factor VII (proconvertin), factor IX (thromboplastin) and factor X in the liver.

Pharmacokinetics:
- Phytomenadione is absorbed from the GIT only in the presence of bile salts and pancreatic lipase.

- Once absorbed, vit. K accumulates in the liver, spleen and lungs, but significant amounts are not stored in the body for long periods.

- The action of phytomenadione when administered parentraly is generally detectable within 1 or 2 hours and hemorrhage is usually controlled within 3-8 hours.

Indications:
Phytomenadione is used in:
- Prevention and treatment of hypoprothrombinemia caused by vitamin K deficiency, oral anticoagulants or other factors which impair the absorption or synthesis of vitamin K.

- Prevention and treatment of hemorrhagic disease of the newborn.

- Restoring normal clotting time in patients with hypoprothrombinemia induced by salicylates, sulfonamides, quinidine or quinine or broad spectrum antibiotics, when interference with vitamin K activity is clearly the cause.

Dosage and administration:
- Phytomenadione ampoule can be used orally; it can be given undiluted or diluted in water or juice.
- Phytomenadione should be injected very slowly, at a rate not exceeding 1 mg/min.

Anticoagulant-induced hypoprothrombinemia:
- Patients with serious bleeding and elevated INR, hold warfarin and give vitamin K, 10 mg by slow IV infusion, administration of vitamin K can be repeated every 12 hours.

- Patients with life threatening bleeding and elevated INR, hold warfarin and give prothrombin complex concentrate, supplemented with vitamin K, 10 mg by slow IV infusion. Repeat if necessary depending on INR.

- Infants and children:
0.5-2 mg SC or IV for those who require further anticoagulant therapy.
2-5 mg SC or IV for patients who do not require further anticoagulant therapy.

- Infants and children with non life threatening significant bleeding:
0.5-2 mg SC or IV
- Infants and children with life threatening significant bleeding:
5 mg IV over 10-20 minutes.

Hemorrhagic disease of the newborn (HDNB):
Prophylaxis: Phytomenadione is given as a single IM injection to all newborn within 6 hours of birth, at a dose of 1 mg for infants with a birth weight of > 1500 g and 0.5 mg if birth weight is < 1500 g.
Treatment: 1 mg IM or SC

Hypoprothrombinemia from other causes:
When other drug therapy is the cause, discontinuation or reduction of the dosage of drug is suggested as an alternative to administration of vitamin K.
Adults: 2.5 - 25 mg (rarely up to 50 mg).
Infants: 2 mg and for older children 5-10 mg.

Total parenteral nutrition: for prevention of hypoprothrombinemia, the adult dosage is 5-10 mg IM weekly and for children 2-5 mg IM weekly.

Contraindications:

Hypersensitivity to vitamin K or any other components of the drug.

Side effects:
- Transient flushing sensations and peculiar sensations of taste is observed following phytomenadione injection as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis.

- Bronchospasm, shock, cardiac and/or respiratory arrest may also occur.

- Pain and swelling at the injection site may occur.

- Hypersensitivity reaction including rash, urticaria or anaphylaxis.

- Large doses of vitamin K or its analogues may further depress liver function in patients with severe hepatic disease.

- Neonates: in infants (particularly premature babies), excessive doses of vitamin K analogs during the first few days of life rarely cause: hyperbilirubinemia, sever hemolytic anemia, hemoglobinuria, kernicterus.

Drug interactions:
- Anticoagulant effects are antagonized by vitamin K therefore it may be necessary to use larger doses of the prothrombin depressing anticoagulant or to use one that acts on a different principle.

- Requirements for vitamin K may be increased with broad spectrum antibiotic, quinidine, quinine and high doses salicylates.

- Anticoagulant effects may be increased because of decreased vitamin K absorption when administered with cholestyramine or mineral oils. So, doses should be separated by several hours.

Pregnancy:
Phytomenadione is the drug of choice for maternal hypoprothrombinemia.

Lactation:
The maternal use of phytomenadione is compatible with breast feeding.

Warnings and precautions:
- Severe reactions, which may occur in patients receiving phytomenadione for the first time, resemble hypersensitivity or anaphylaxis, therefore, use of IV route should be restricted to those situations where other routes are not feasible.  

- Hypoprothrombinemia resulting from hepatocellular damage is not corrected by administration of 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.

- Newborn should be observed for vitamin K deficiency. The incidence of vitamin K deficiency is higher in breast fed infants.

- It is recommended that vitamin K prophylaxis be given to all newborns.

Therapeutic category: Vitamin.

Legal category: POM.

Package:

Storage:

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
  - The doctor and the pharmacist are the experts in medicines, their benefits and risks.
  - Do not by yourself interrupt the period of treatment prescribed.
  - Do not repeat the same prescription without consulting your doctor.
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Council of Arab Health Ministers, Union of Arab Pharmacists.