Phyto K1
Phyto K1 Uses, Dosage, Side Effects, Food Interaction and all others data.
Vitamin K-1 (Phytomenadione) is a procoagulant factor. As a component of a hepatic carboxylase system, vitamin K- 1 is involved in the post translational carboxylation of clotting factors II (prothrombin), VII, IX and X and the clotting inhibitors protein C and protein S. Vitamin K-1 is ineffective in hereditary hypoprothrombinemia or hypoprothrombinemia induced by severe hepatic failure. Lack of vitamin K-1 leads to an increased tendency to haemorrhagic disease in the newborn. Vitamin K-1 administration, which promotes synthesis of the above-mentioned coagulation factors by the liver, can reverse an abnormal coagulation status and bleeding due to vitamin K-1 deficiency.
Phyto K1 is a vitamin K indicated in the treatment of coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by deficiency or interference in the activity of vitamin K. It has a long duration of action as vitamin K is cycled in the body, and a wide therapeutic index as large doses can be tolerated. Patients should have their prothrombin time monitored during therapy and healthcare professionals should be aware of the increased risk of hypersensitivity reactions with parenteral administration.
| Trade Name | Phyto K1 |
| Generic | Phylloquinone |
| Phylloquinone Other Names | 3-Phytylmenadione, alpha-Phylloquinone, Fitomenadiona, Phyllochinon, Phyllochinonum, Phylloquinone, Phythyl-menadion, Phytomenadione, Phytomenadionum, Phytonadione, Phytonadionum, Phytylmenadione, trans-Phylloquinone, Vitamin K, Vitamin K1 |
| Type | Injection, Tablet |
| Formula | C31H46O2 |
| Weight | Average: 450.6957 Monoisotopic: 450.349780716 |
| Groups | Approved, Investigational |
| Therapeutic Class | Vitamin-K Preparations |
| Manufacturer | Delvin Formulations Pvt Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Prophylaxis and treatment of haemorrhagic disease in the newborn.
Haemorrhage or risk of haemorrhage as a result of severe hypoprothrombinemia (i.e. deficiency of clotting factors II, VII, IX and X) of various etiologies, including overdosage of courmarin-type anticoagulants, their combination with phenylbutazone, and other forms of hypovitaminosis K (e.g. in obstructive jaundice as well as liver and intestinal disorders, and after prolonged treatment with antibiotics, sulphonamides or salicylates).
Prevention and treatment of bleeding due to vitamin K deficiency.
Phyto K1 is also used to associated treatment for these conditions: Coagulation Disorders, Hypoprothrombinemia, Hemorrhagic disease of the newborn, Vitamin supplementation
How Phyto K1 works
Vitamin K is a cofactor of gamma-carboxylase. Gamma carboxylase attaches carboxylic acid functional groups to glutamate, allowing precursors of factors II, VII, IX, and X to bind calcium ions. Binding of calcium ions converts these clotting factors to their active form, which are then secreted from hepatocytes into the blood, restoring normal clotting function.
Vitamin K may also carboxylate matrix proteins in chondrocytes, inhibiting calcification of joints, and may increase type II collagen. The role of vitamin K in osteroarthritis, bone density, and vascular calcification is currently under investigation.
Dosage
Phyto K1 dosage
Prophylaxis: Mild Hemorrhage or hemorrhagic tendency: The usual dose for Neonates is 2 mg orally at or just after birth. Then 2 mg on 4 th-5 th day and another 2 mg on 28 th - 30 th day orally. If the oral route is unsuitable then 2 mg of drug can be administered by IM or IV route. Children over 1 year of age are could be given 5-10 mg orally.
A single 1 mg (0.1 ml) dose IM is recommended in children who are not assured of receiving a second oral dose or, in the case of breast-fed children, who are not assured of receiving a third oral dose.
Therapy: Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical picture and coagulation status. Neonates with special risk factors[Pre-maturity, birth asphyxia (inadequate intake of oxygen by the baby during birth process), obstructive jaundice, inability to swallow, maternal use of anticoagulants or anti-epileptics]:
- 1 mg intramuscularly or intravenously at birth or shortly after birth if the oral route is unsuitable.
- Intramuscular and intravenous doses should not exceed 0.4 mg/kg in premature infants weighing less than 2.5 kg.
- The size and frequency of further doses should be based on coagulation status
To ensure a total protection of the newborns, 3 prophylactic doses of Vitamin K should be administered orally following the dosing schedule mentioned above.
Side Effects
There are isolated unconfirmed reports on the possible occurrence of anaphylactoid reactions and venous irritation or phlebitis after parenteral use of Phytomenadione injections.
Toxicity
High doses of vitamin K1 are not associated with toxicity. Intravenous administration has been associated with an increased risk of toxicity. These patients should be treated with symptomatic and supportive measures.
The intravenous LD50 in mice is 1170 mg/kg and the oral LD50 is >24180 mg/kg.
Precaution
Careful monitoring of the coagulation parameters is necessary for patients with severely impaired liver function after administration of Phytomenadione .
Interaction
Vitamin K-1 antagonises the effect of coumarin-type anticoagulants. Coadministration of anticonvulsants can impair the action of vitamin K-1.
Food Interaction
No interactions found.Volume of Distribution
The steady state volume of distribution of phylloquinone is 20 ± 6 L in subjects who are also taking phenprocoumon therapy.
Elimination Route
A 4 µg oral dose of phylloquinone is 13% ± 9% bioavailable, with a Tmax of 4.7 ± 0.8 hours. 1.5 ± 0.8 nmol is found in the plasma compartment, and 3.6 ± 3.4 nmol is found in the second compartment.
A 10 mg intramuscular phylloquinone dose is 89.2% ± 25.4% bioavailable. The same dose reaches a mean Cmax of 67 ± 30 ng/mL, with a mean Tmax of 9.2 ± 6.6 hours, and an AUC of 1700 ± 500 h*ng/mL.
A 10 mg intravenous phylloquinone dose has a mean AUC of 1950 ± 450 h*ng/mL.
Half Life
Intravenous phylloquinone has an initial half life of 22 minutes, followed by a half life of 125 minutes.
Clearance
Intravenous phylloquinone is 90% cleared in 2 hours, and 99% cleared in 8 hours. A 10 mg intravenous dose of phylloquinone has a mean clearance of 91 ± 24 mL/min.
Elimination Route
Intravenous phylloquinone is 36% eliminated in the feces in 5 days and 22% recovered in urine in 3 days.
Pregnancy & Breastfeeding use
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Contraindication
It is contraindicated in patients with known hypersensitivity to any of its constituents.
Storage Condition
Store at 15-30° C.
Innovators Monograph
You find simplified version here Phyto K1
Phyto K1 contains Phylloquinone see full prescribing information from innovator Phyto K1 Monograph, Phyto K1 MSDS, Phyto K1 FDA label
