P : Caution in pregnancy
|| See TERMINOLOGY & ABBREVIATIONS ||
|Indication & Dosage||Oral Route
Vitamin K deficiency due to drugs or malabsorption
Adult: 10-40 mg daily.
Adult: Up to 5 mg may be used. Dose depends on INR and degree ofhaemorrhage.
Prophylaxis of vitamin K deficiency bleeding in neonates
Child: Neonate: 0.5-1 mg, given as a single dose via IM inj. Alternatively, 2 mg may be given orally, followed by a 2nd dose of 2 mg after 4-7 days.
Adult: 0.5-5 mg via slow IV inj. Dose depends on INR and degree of haemorrhage.
Vitamin K deficiency bleeding in neonates
Child: Infant: 1 mg by IV/IM/SC inj, further doses may be given if necessary
|Administration||May be taken with or without food.
|Special Precautions||Increased risk of severe haemolytic anaemia in neonates after large doses; severe hepatic impairment; pregnancy. Premature neonates weighing <2.5 kg.|
|Adverse Drug Reactions||Anaphylaxis, dyspnoea, cyanosis, pain, swelling, phloebitis at the Inj site, diaphoresis, dizziness, hypotension (rare), allergic reactions after SC and IM inj.|
|Drug Interactions||Decreased effect of oral anticoagulants. Please consult detailed drug interactions before prescribing.|
|Pregnancy Category (US FDA)||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.|
Store at 15-30°C.
|Pharmacology||Phytomenadione promotes hepatic synthesis of clotting factors. It is a naturally occurring compound that is used to prevent and treat haemorrhages related to vitamin K deficiency.
Absorption: Requires bile for absorption in GI tract.
Distribution: Mainly in the liver.
Metabolism: Rapidly metabolised to glucuronide and sulfate conjugates.
Excretion: In bile and urine as metabolites.
|ATC Classification||B02BA01 - phytomenadione; Belongs to the class of vitamin K. Used in the treatment of hemorrhage.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|BABYKION Oral/IM/IV||Chemist Laboratories Ltd.||Phytomenadione 2mg/0.2ml||Injection||2mg amp x5's: 100.00 MRP|
|DINAKION-10 Oral/IM/IV||Drug International Ltd||Phytomenadione 10mg/1ml||Injection||10mg amp x5's: 225.00 MRP|
|DINAKION-MM||Drug International Ltd||Phytomenadione 2mg/0.2ml||Injection||2mg amp x5's: 99.45 MRP|
|Injection K MM||Incepta Pharmaceuticals Limited||Phytomenadione 10mg/1ml bile acid/lecithin mixed-micelle solution||Injection Adult||1x5's:MRP 229.3 Tk|
|Injection K MM Paed.||Incepta Pharmaceuticals Limited||Phytomenadione 2mg/0.2ml bile acid/lecithin mixed-micelle solution||Injection Paediatric||1x5's:MRP 99.45 Tk|
|K-ONE MM||Square Pharmaceuticals Ltd.||Phytomenadione 2mg/0.2 ml||IM/IV/Oral Injection||1x3's: 59.82 MRP|
Why is this medication prescribed?
Several forms of Phytomenadione (Vitamin K) are used around the world as medicine. But in the U.S., the only form available is Vitamin K1 (phytonadione). Vitamin K1 is generally the preferred form of Vitamin K because it is less toxic, works faster, is stronger, and works better for certain conditions.
In the body, Phytomenadione (Vitamin K) plays a major role in blood clotting. So it is used to reverse the effects of 'blood thinning' medications when too much is given; to prevent clotting problems in newborns who don't have enough Phytomenadione (Vitamin K); and to treat bleeding caused by medications including salicylates, sulfonamides, quinine, quinidine, or antibiotics. Phytomenadione (Vitamin K) is also given to treat and prevent Phytomenadione (Vitamin K) deficiency, a condition in which the body doesn't have enough Phytomenadione (Vitamin K). It is also used to prevent and treat weak bones (osteoporosis) and relieve itching that often accompanies a liver disease called biliary cirrhosis.
People apply Phytomenadione (Vitamin K) to the skin to remove spider veins, bruises, scars, stretch marks, and burns. It is also used topically to treat rosacea, a skin condition that causes redness and pimples on the face. After surgery, Phytomenadione (Vitamin K) is used to speed up skin healing and reduce bruising and swelling.
Healthcare providers also give Phytomenadione (Vitamin K) by injection to treat clotting problems.
An increased understanding of the role of Phytomenadione (Vitamin K) in the body beyond blood clotting led some researchers to suggest that the recommended amounts for dietary intake of Phytomenadione (Vitamin K) be increased. In 2001, the National Institute of Medicine Food and Nutrition Board increased their recommended amounts of Phytomenadione (Vitamin K) slightly, but refused to make larger increases. They explained there wasn't enough scientific evidence to make larger increases in the recommended amount of Phytomenadione (Vitamin K).
The effectiveness ratings for Phytomenadione (Vitamin K) are as follows:
- Treating and preventing Vitamin K deficiency.
- Preventing certain bleeding or blood clotting problems.
- Reversing the effects of too much warfarin used to prevent blood clotting.
Insufficient evidence to rate effectiveness for...
- Weak bones (osteoporosis). So far, research results on the effects of Phytomenadione (Vitamin K) on bone strength and fracture risk in people with osteoporosis don't agree.
- Cystic fibrosis.
- Heart disease.
- High cholesterol.
- Spider veins.
- Stretch marks.
- Other conditions.
How does it work?
Phytomenadione (Vitamin K) is an essential vitamin that is needed by the body for blood clotting and other important processes.
Are there safety concerns?
Phytomenadione (Vitamin K) is safe for most people. Most people do not experience any side effects when taking in the recommended amount each day.
Special precautions & warnings:
Kidney disease: Too much Phytomenadione (Vitamin K) can be harmful if you are receiving dialysis treatments due to kidney disease.
Liver disease: Phytomenadione (Vitamin K) is not effective for treating clotting problems caused by severe liver disease. In fact, high doses of Phytomenadione (Vitamin K) can make clotting problems worse in these people.
Are there interactions with herbs and supplements?
Coenzyme Q-10 is chemically similar to Phytomenadione (Vitamin K) and, like Phytomenadione (Vitamin K), can promote blood clotting. Using these two products together can promote blood clotting more than using just one. This combination can be a problem for people who are taking warfarin to slow blood clotting. Coenzyme Q-10 plus Phytomenadione (Vitamin K) might overwhelm the effects of warfarin and could allow the blood to clot.
There is a concern that tiratricol might interfere with Vitamin K's role in blood clotting.
In animals, high doses of vitamin A interfere with Vitamin K's ability to clot blood. But it's not known if this also happens in people.
High doses of vitamin E (e.g. greater than 800 units/day) can make Phytomenadione (Vitamin K) less effective in clotting blood. In people who are taking warfarin to keep their blood from clotting, or in people who have low Phytomenadione (Vitamin K) intakes, high doses of vitamin E can increase the risk of bleeding.
Are there interactions with foods?
There are no known interactions with foods.
What dose is used?
- For bleeding disorders such as hypoprothrombinemia: 2.5-25 mg of Vitamin K1 (phytonadione).
- For counteracting bleeding that can occur when too much of the anticoagulant warfarin is given: 1-5 mg of Phytomenadione (Vitamin K) is typically used; however, the exact dose needed is determined by a lab test called the INR.
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