CYCOMIN Phytomenadione 10mg / mL Solution for IM/IV Injection 10's
RXDRUG-DR-XY15470
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Phytomenadione Injection is indicated in the treatment of hemorrhage or threatened hemorrhage associated with a low blood level of prothrombin or factor VII. The main indications are: An antidote to anticoagulant drugs of the coumarin type. Treatment of neonatal hemorrhage and prevention of vitamin K deficiency states in newborn infants, if oral prevention with phytomenadione is not possible.
Dosage/Direction for Use
Adults: As an antidote to anticoagulant drugs.
For potentially fatal and severe hemorrhage: Phytomenadione therapy should be accompanied by a more immediate effective treatment such as transfusions of whole blood or blood clotting factors. The anticoagulant should be withdrawn and an intravenous injection of Phytomenadione Injection given slowly in a dose of 10-20 mg. The prothrombin level should be estimated three hours later, and if the response has been inadequate, the dose should be repeated. Not more than 40 mg of phytomenadione should be given intravenously in 24 hours.
Less severe hemorrhage: Phytomenadione Injection is given by IM injection in doses of 10-20 mg. The prothrombin level is estimated 8 to 12 hours later and if the response has been inadequate, the dose should be repeated.
Adults: Other indications: Doses of 10-20 mg as required.
Use in the elderly: Elderly patients tend to be more sensitive to reversal of anticoagulation with phytomenadione; dosage in this group should be at the lower end of the ranges recommended for adults.
Children: If, on the recommendation of a physician, a children's dosage is required, then it is suggested that 5-10 mg be given.
Treatment of newborn infants: Prophylactic; If oral prophylaxis is not possible, 1 mg by intramuscular Injection.
Therapeutic: 1 mg by intramuscular injection, repeated at eight hourly intervals if necessary.
Phytomenadione Injection ampoules are for intramuscular or intravenous injection. Phytomenadione Injection should not be diluted.
For potentially fatal and severe hemorrhage: Phytomenadione therapy should be accompanied by a more immediate effective treatment such as transfusions of whole blood or blood clotting factors. The anticoagulant should be withdrawn and an intravenous injection of Phytomenadione Injection given slowly in a dose of 10-20 mg. The prothrombin level should be estimated three hours later, and if the response has been inadequate, the dose should be repeated. Not more than 40 mg of phytomenadione should be given intravenously in 24 hours.
Less severe hemorrhage: Phytomenadione Injection is given by IM injection in doses of 10-20 mg. The prothrombin level is estimated 8 to 12 hours later and if the response has been inadequate, the dose should be repeated.
Adults: Other indications: Doses of 10-20 mg as required.
Use in the elderly: Elderly patients tend to be more sensitive to reversal of anticoagulation with phytomenadione; dosage in this group should be at the lower end of the ranges recommended for adults.
Children: If, on the recommendation of a physician, a children's dosage is required, then it is suggested that 5-10 mg be given.
Treatment of newborn infants: Prophylactic; If oral prophylaxis is not possible, 1 mg by intramuscular Injection.
Therapeutic: 1 mg by intramuscular injection, repeated at eight hourly intervals if necessary.
Phytomenadione Injection ampoules are for intramuscular or intravenous injection. Phytomenadione Injection should not be diluted.
Overdosage
Hypervitaminosis of vitamin K1 is unknown.
Reintroduction of anti-coagulation may be affected.
Reintroduction of anti-coagulation may be affected.
Contraindications
Use in patients with a known hypersensitivity to any of the constituents (see Precautions).
Phytomenadione Injection containing Benzyl alcohol is contraindicated in newborn infants, especially in immature neonates.
Use in Pregnancy: There is no specific evidence regarding the safety of Phytomenadione Injection in pregnancy, but as with most drugs, the administration during pregnancy should only occur if the benefits outweigh the risks.
Phytomenadione Injection containing Benzyl alcohol is contraindicated in newborn infants, especially in immature neonates.
Use in Pregnancy: There is no specific evidence regarding the safety of Phytomenadione Injection in pregnancy, but as with most drugs, the administration during pregnancy should only occur if the benefits outweigh the risks.
Special Precautions
Phytomenadione Injection contains a polyethoxylated castor oil as a non-ionic surfactant. In animal studies, polyethoxylated castor oil can produce severe anaphylactoid reactions associated with histamine release. There is a strong circumstantial evidence that similar reactions occurring in patients may have been caused by polyethoxylated castor oil. Polyethoxylated castor oil, when given to patients over a period of several days, can also produce abnormal lipoprotein electrophoretic patterns, alterations in blood viscosity and erythrocyte aggregation.
In potentially fatal and severe hemorrhage due to overdosage of coumarin anticoagulants, intravenous injection of Phytomenadione Injection must be administered slowly and not more than 40 mg should be given during a period of 24 hours. Phytomenadione therapy should be accompanied by a more immediate effective treatment such as transfusions of whole blood clotting factors. When patients with prosthetic heart valves are given transfusions for the treatment of severe or potentially fatal hemorrhages, fresh frozen plasma should be used.
Large doses of phytomenadione should be avoided if it is intended to continue with anticoagulant therapy. Vitamin K1, is not an antidote to heparin.
In potentially fatal and severe hemorrhage due to overdosage of coumarin anticoagulants, intravenous injection of Phytomenadione Injection must be administered slowly and not more than 40 mg should be given during a period of 24 hours. Phytomenadione therapy should be accompanied by a more immediate effective treatment such as transfusions of whole blood clotting factors. When patients with prosthetic heart valves are given transfusions for the treatment of severe or potentially fatal hemorrhages, fresh frozen plasma should be used.
Large doses of phytomenadione should be avoided if it is intended to continue with anticoagulant therapy. Vitamin K1, is not an antidote to heparin.
Use In Pregnancy & Lactation
Use in Pregnancy: There is no specific evidence regarding the safety of Phytomenadione in pregnancy but, as with most drugs, the administration during pregnancy should only occur if the benefits outweigh the risks.
Phytomenadione is not recommended for pregnant women as prophylaxis of vitamin K deficiency bleeding in the newborn.
Phytomenadione is not recommended for pregnant women as prophylaxis of vitamin K deficiency bleeding in the newborn.
Adverse Reactions
IV inj: Flushing of the face, sweating, chest constriction, cyanosis & peripheral vascular collapse. IM inj: Local cutaneous & SC changes.
Storage
Store below 25°C; Protect from light.
Action
Pharmacology: Pharmacodynamics: Phytomenadione is a synthetic preparation of vitamin K. The presence of vitamin K (i.e. vitamin K or substances with vitamin K activity) is essential for the formation within the body of prothrombin, factor VII, factor IX and factor X. Lack of vitamin K leads to an increased tendency to haemorrhage. When an antidote to an anticoagulant is necessary it is essential to use vitamin K1 itself, as vitamin K analogues are much less effective.
Pharmacokinetics: In blood plasma, 90% of vitamin K1 is bound to lipoproteins. Following an intramuscular dose of 10 mg vitamin K, plasma concentrations of 10-20 mcg/l are produced (normal range 0.4-1.2 mcg/l). Systemic availability following intramuscular administration is about 50% and elimination half-life in plasma is approximately 1.5-3 hours.
Pharmacokinetics: In blood plasma, 90% of vitamin K1 is bound to lipoproteins. Following an intramuscular dose of 10 mg vitamin K, plasma concentrations of 10-20 mcg/l are produced (normal range 0.4-1.2 mcg/l). Systemic availability following intramuscular administration is about 50% and elimination half-life in plasma is approximately 1.5-3 hours.
MedsGo Class
Haemostatics
Features
Brand
Cycomin
Full Details
Dosage Strength
10 mg / ml
Drug Ingredients
- Phytomenadione
Drug Packaging
Solution for IM/IV Injection 10's
Generic Name
Phytomenadione
Dosage Form
Solution for IM/IV Injection
Registration Number
DR-XY15470
Drug Classification
Prescription Drug (RX)
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