Vitamin K1 10mg/ml For Inj, 1ml
WARNING: Very bad and sometimes deadly effects have happened during and after injection into a vein or a muscle. These effects looked like allergic reactions with very bad heart or breathing problems. Some people have had these effects after getting this drug for the first time. This drug must only be given into a vein or a muscle when it cannot be given other ways and the benefits are more than the risks. @ COMMON USES: It is used to replace low vitamin K.It is used to undo the effects of certain blood thinners like warfarin.It is used to treat or prevent bleeding.It is often given to newborn babies.
Drug Class
Anticoagulant Reversal Agent; Vitamin
Pharmacologic Class
Vitamin K Analog
Pregnancy Category
Category C
FDA Approved
Aug 1962
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vitamin K1 is a medicine that helps your blood clot. It's used when your blood is too thin, often because of certain medications like warfarin, or if you have a condition that prevents your body from making enough clotting factors. It helps your body produce the necessary proteins to stop bleeding.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the dosage instructions carefully. This medication is administered via injection into a muscle, vein, or under the skin (subcutaneously) in the fatty tissue.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the dosage instructions carefully. This medication is administered via injection into a muscle, vein, or under the skin (subcutaneously) in the fatty tissue.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- If you are taking warfarin, avoid large, sudden changes in your intake of vitamin K-rich foods (e.g., leafy green vegetables) as this can affect your INR. This is less critical when receiving injectable vitamin K for acute reversal.
- Report any signs of unusual bleeding or bruising to your doctor immediately.
- If you receive this injection, especially intravenously, report any discomfort, flushing, rash, or difficulty breathing immediately to your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication and route. For warfarin reversal (non-emergent, INR 4.5-10 without bleeding): 0.5-2 mg PO/SC/IV. For warfarin reversal (emergent, INR >10 or with bleeding): 5-10 mg IV. For vitamin K deficiency bleeding: 2.5-25 mg PO/SC/IM/IV.
Dose Range:
0.5 - 25 mg
Condition-Specific Dosing:
warfarin_reversal_non_emergent:
0.5-2 mg PO/SC/IV
warfarin_reversal_emergent:
5-10 mg IV (infused slowly)
vitamin_k_deficiency_bleeding:
2.5-25 mg PO/SC/IM/IV
Pediatric Dosing
Neonatal:
Vitamin K Deficiency Bleeding (VKDB) Prophylaxis: 0.5-1 mg IM/SC single dose. VKDB Treatment: 1-2 mg IV/SC.
Infant:
VKDB Treatment: 1-2 mg IV/SC. For warfarin reversal: 0.5-2 mg IV/SC/PO (dose adjusted by weight and INR).
Child:
For warfarin reversal: 0.5-2 mg IV/SC/PO (dose adjusted by weight and INR). For vitamin K deficiency: 2.5-10 mg IV/SC/IM/PO.
Adolescent:
Dosing similar to adult, adjusted by weight and indication.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
Not significantly dialyzable. No specific adjustment needed, but monitor coagulation parameters.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Use with caution. Response may be blunted due to impaired synthesis of clotting factors. Monitor INR closely.
Severe:
Use with caution. Response may be blunted. Consider lower initial doses and monitor INR closely. Impaired bile flow can affect absorption of oral vitamin K, but less relevant for parenteral forms.
Pharmacology
Mechanism of Action
Phytonadione (Vitamin K1) is a fat-soluble vitamin essential for the hepatic synthesis of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). It is also required for the synthesis of proteins C and S, which are natural anticoagulants. It acts as a cofactor for the enzyme gamma-glutamyl carboxylase, which catalyzes the post-translational carboxylation of specific glutamic acid residues on these clotting factors, enabling them to bind calcium and participate in the coagulation cascade.
Pharmacokinetics
Absorption:
Bioavailability:
IV: 100%; IM/SC: High but variable; Oral: Variable (20-80%) and dependent on bile salts.
Tmax:
IV: Immediate; IM: ~1-2 hours; SC: ~2-3 hours; Oral: ~4-12 hours.
FoodEffect:
Oral absorption is enhanced by dietary fat. Not applicable for parenteral forms.
Distribution:
Vd:
Not widely distributed; primarily concentrated in the liver. Approximately 0.1 L/kg.
ProteinBinding:
Highly protein bound (>90%), primarily to lipoproteins.
CnssPenetration:
Limited
Elimination:
HalfLife:
Plasma half-life: Approximately 1.5-3 hours. Biological effect (coagulation factor synthesis) lasts much longer (days).
Clearance:
Not readily available, but rapid hepatic clearance.
ExcretionRoute:
Primarily via bile into feces (40-50%), with some renal excretion (10-20%) as glucuronide conjugates.
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
IV: Coagulation factors begin to rise within 1-2 hours; significant effect within 3-6 hours. SC/IM: 6-12 hours. Oral: 6-12 hours.
PeakEffect:
IV: 12-24 hours. SC/IM/Oral: 24-48 hours.
DurationOfAction:
The effect on coagulation factors can last for several days (up to 1 week or more), depending on the dose and route.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Flushing
Feeling tired or weak
Chest pain or pressure
Fast heartbeat or abnormal heartbeat
Dizziness or fainting
Shortness of breath
Excessive sweating
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Pain, redness, or swelling at the injection site
* Change in taste
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Flushing
Feeling tired or weak
Chest pain or pressure
Fast heartbeat or abnormal heartbeat
Dizziness or fainting
Shortness of breath
Excessive sweating
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Pain, redness, or swelling at the injection site
* Change in taste
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe allergic reaction (difficulty breathing, swelling of face/throat, hives, rash, dizziness, rapid heartbeat)
- Signs of bleeding (unusual bruising, nosebleeds, blood in urine/stools, prolonged bleeding from cuts)
- Pain, swelling, or redness at the injection site
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergies, be sure to describe the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergies, be sure to describe the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Information About This Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
Potential Skin Reactions
Skin reactions can occur with this medication, sometimes up to 1 year after administration. If you experience a rash or any other skin reaction, promptly consult with your doctor.
Aluminum Toxicity Risk
This medication may contain aluminum, which can increase the risk of aluminum toxicity with long-term use. This risk is higher if you have kidney problems or are a premature infant. Discuss this risk with your doctor to understand the potential implications.
Benzyl Alcohol Precaution
Some formulations of this medication contain benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as serious side effects can occur with certain doses, especially when combined with other medications containing benzyl alcohol. Consult with your doctor to determine if this product contains benzyl alcohol.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is essential to discuss the benefits and risks of this medication to both you and your baby.
Reversing Blood Thinner Effects
This medication is used to reverse the effects of blood thinners, which are prescribed to prevent blood clots in individuals with certain health conditions. After using this medication, your risk of blood clots may increase. Follow your doctor's instructions carefully to minimize this risk and prevent blood clots.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
Potential Skin Reactions
Skin reactions can occur with this medication, sometimes up to 1 year after administration. If you experience a rash or any other skin reaction, promptly consult with your doctor.
Aluminum Toxicity Risk
This medication may contain aluminum, which can increase the risk of aluminum toxicity with long-term use. This risk is higher if you have kidney problems or are a premature infant. Discuss this risk with your doctor to understand the potential implications.
Benzyl Alcohol Precaution
Some formulations of this medication contain benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as serious side effects can occur with certain doses, especially when combined with other medications containing benzyl alcohol. Consult with your doctor to determine if this product contains benzyl alcohol.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is essential to discuss the benefits and risks of this medication to both you and your baby.
Reversing Blood Thinner Effects
This medication is used to reverse the effects of blood thinners, which are prescribed to prevent blood clots in individuals with certain health conditions. After using this medication, your risk of blood clots may increase. Follow your doctor's instructions carefully to minimize this risk and prevent blood clots.
Overdose Information
Overdose Symptoms:
- While rare with therapeutic doses, excessive doses could theoretically lead to overcorrection of coagulation, increasing risk of thrombosis, though this is less common than with other procoagulants.
- Hemolytic anemia, hyperbilirubinemia, and kernicterus have been reported in neonates, particularly with large doses of synthetic vitamin K analogs (menadione), but are rare with phytonadione.
What to Do:
Discontinue phytonadione. Monitor coagulation parameters (INR/PT). Supportive care. For severe overcorrection leading to thrombosis, anticoagulant therapy may be considered. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Warfarin (antagonistic effect, reverses anticoagulant action)
Moderate Interactions
- Mineral oil (may decrease absorption of oral vitamin K)
- Orlistat (may decrease absorption of oral vitamin K)
- Cholestyramine, Colestipol (may decrease absorption of oral vitamin K)
Monitoring
Baseline Monitoring
Prothrombin Time (PT) / International Normalized Ratio (INR)
Rationale: To assess baseline coagulation status and determine the need for vitamin K.
Timing: Prior to administration.
Liver Function Tests (LFTs)
Rationale: To assess hepatic function, as vitamin K is metabolized in the liver and clotting factors are synthesized there.
Timing: If hepatic impairment is suspected or known.
Routine Monitoring
Prothrombin Time (PT) / International Normalized Ratio (INR)
Frequency: 6-24 hours after administration, then daily or as clinically indicated until target INR is achieved.
Target: Dependent on clinical indication (e.g., INR 2-3 for most anticoagulated patients, or normal range for deficiency).
Action Threshold: If INR remains elevated or bleeding persists, consider repeat dosing or alternative therapies.
Vital Signs (especially during IV infusion)
Frequency: Continuously during IV infusion, then as per institutional protocol.
Target: Within normal limits.
Action Threshold: Hypotension, flushing, dyspnea, or chest pain may indicate an anaphylactoid reaction; stop infusion immediately.
Signs of Bleeding/Thrombosis
Frequency: Continuously.
Target: Absence of active bleeding or new thrombotic events.
Action Threshold: New or worsening bleeding requires immediate assessment and intervention. New thrombotic events require investigation.
Symptom Monitoring
- Signs of bleeding (e.g., bruising, petechiae, epistaxis, hematuria, melena, hematemesis)
- Signs of allergic/anaphylactoid reaction (e.g., flushing, rash, urticaria, dyspnea, chest tightness, hypotension, dizziness, swelling of face/lips/tongue)
- Pain or swelling at injection site (for IM/SC)
Special Patient Groups
Pregnancy
Phytonadione is classified as Pregnancy Category C. While animal studies have shown adverse effects at high doses, human data are limited. It is generally considered safe and indicated for use in pregnant women when clinically necessary, particularly for the treatment of vitamin K deficiency or reversal of anticoagulation, as the benefits often outweigh the potential risks. It does not readily cross the placenta.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk when indicated.
Second Trimester:
Limited data, but generally considered low risk when indicated.
Third Trimester:
Limited data, but generally considered low risk when indicated. Used for prophylaxis of VKDB in neonates, but maternal administration is not a reliable method for fetal prophylaxis.
Lactation
Phytonadione is excreted in breast milk in small amounts. However, the amount is generally considered too low to provide adequate prophylaxis against VKDB in breastfed infants. It is generally considered compatible with breastfeeding, and no adverse effects on breastfed infants have been reported. The benefits of breastfeeding typically outweigh the minimal risk.
Infant Risk:
Low
Pediatric Use
Widely used in pediatric populations, especially neonates, for the prophylaxis and treatment of Vitamin K Deficiency Bleeding (VKDB). Dosing is weight-based and specific to age group and indication. IV administration should be slow and cautious due to risk of severe reactions.
Geriatric Use
No specific dose adjustments are typically required for geriatric patients. However, older adults may be more susceptible to adverse reactions, particularly with IV administration. Monitor closely for signs of bleeding, thrombosis, and hypersensitivity reactions. Co-morbidities and polypharmacy should be considered.
Clinical Information
Clinical Pearls
- Intravenous (IV) administration of phytonadione carries a risk of severe, sometimes fatal, anaphylactoid reactions (flushing, dyspnea, chest pain, hypotension). This route should be reserved for urgent situations where rapid reversal is critical and other routes are not feasible. If IV is used, it must be diluted and infused very slowly (over at least 30 minutes).
- Subcutaneous (SC) or intramuscular (IM) routes are generally preferred for non-emergent situations due to lower risk of anaphylactoid reactions, though absorption can be variable.
- Oral administration is effective for non-urgent warfarin reversal or chronic vitamin K deficiency, especially for INR values <10 without bleeding.
- Phytonadione is light-sensitive and should be protected from light during storage and administration.
- The onset of action for phytonadione is slower than prothrombin complex concentrates (PCCs) or fresh frozen plasma (FFP) for rapid reversal of severe bleeding, but its effect is more sustained.
- Response to phytonadione can be blunted in patients with severe liver disease due to impaired synthesis of clotting factors, even with adequate vitamin K.
Alternative Therapies
- Fresh Frozen Plasma (FFP): Provides immediate replacement of all clotting factors, used for rapid reversal of severe bleeding.
- Prothrombin Complex Concentrates (PCCs): Provide concentrated factors II, VII, IX, X (and sometimes protein C and S), used for very rapid reversal of severe bleeding, especially in warfarin-associated hemorrhage.
- Recombinant Factor VIIa (rFVIIa): Used off-label for severe bleeding, but has a higher thrombotic risk and is generally not first-line for warfarin reversal.
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 1ml vial (10mg/ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly: do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Additionally, some medications may come with a separate patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.