Vitamin K1 1mg/0.5ml Inj, 0.5ml
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
Jun 1952
DEA Schedule
Not Controlled
Overview
What is this medicine?
Phytonadione is a man-made form of Vitamin K. It helps your blood clot properly and is used to treat or prevent bleeding problems, especially those caused by certain medications like warfarin (a blood thinner) or by a lack of Vitamin K in your body.
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 instructions carefully. This medication is administered via injection into a muscle, vein, or the fatty layer under the skin.
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 instructions carefully. This medication is administered via injection into a muscle, vein, or the fatty layer under the skin.
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 taking oral phytonadione, maintain a consistent intake of Vitamin K-rich foods (e.g., leafy green vegetables) if also on warfarin, as sudden changes can affect INR.
- Report any unusual bleeding or bruising to your doctor immediately.
- Avoid activities that could lead to injury or bleeding until your clotting is stable.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by indication and route. For warfarin reversal: 0.5-10 mg IV/SC/IM/oral, depending on INR and clinical urgency.
Dose Range:
0.5 - 10 mg
Condition-Specific Dosing:
warfarin_reversal_non_bleeding_high_INR:
1-2.5 mg oral/SC/IM
warfarin_reversal_bleeding_or_very_high_INR:
5-10 mg IV (slow infusion)
vitamin_k_deficiency_hypoprothrombinemia:
2.5-25 mg oral/SC/IM (rarely IV)
Pediatric Dosing
Neonatal:
Prophylaxis of VKDB: 0.5-1 mg IM/IV/oral once at birth. Treatment of VKDB: 1-2 mg IV/SC.
Infant:
Treatment of vitamin K deficiency: 1-2 mg IV/SC/IM/oral.
Child:
Treatment of vitamin K deficiency or warfarin reversal: 0.5-5 mg IV/SC/IM/oral, depending on severity and INR.
Adolescent:
Same as adult dosing for specific indications.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Dialysis:
No specific adjustment needed; not significantly dialyzable.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, but monitor response closely as hepatic synthesis of clotting factors may be impaired.
Severe:
No specific adjustment needed, but monitor response closely as hepatic synthesis of clotting factors may be impaired.
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 also participates in the synthesis of anticoagulant proteins C and S. It acts as a cofactor for the enzyme gamma-glutamyl carboxylase, which catalyzes the post-translational carboxylation of glutamic acid residues on these clotting factors, enabling them to bind calcium and participate in the coagulation cascade.
Pharmacokinetics
Absorption:
Bioavailability:
Variable orally (approx. 20-80%), good via IM/SC routes. IV is 100%.
Tmax:
IV: minutes; IM: 2-3 hours; SC: 2-3 hours; Oral: 6-10 hours.
FoodEffect:
Oral absorption is enhanced by bile salts and dietary fat.
Distribution:
Vd:
Not readily available, but concentrates in the liver.
ProteinBinding:
Highly protein bound, primarily to lipoproteins.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1.5-3 hours (terminal half-life).
Clearance:
Not readily available.
ExcretionRoute:
Primarily biliary/fecal excretion as glucuronide and sulfate conjugates; some renal excretion.
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
IV: 1-2 hours (effect on INR); Oral/SC/IM: 6-12 hours (effect on INR).
PeakEffect:
IV: 12-14 hours; Oral/SC/IM: 24-48 hours.
DurationOfAction:
24-72 hours (depending on dose and route).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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 persist, contact your doctor for guidance:
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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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 persist, contact your doctor for guidance:
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:
- Signs of allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Chest pain or discomfort
- Dizziness or fainting
- Sweating
- Blue lips or fingernails
- Unusual bleeding or bruising (e.g., nosebleeds, bleeding gums, blood in urine/stools, heavy menstrual bleeding)
- 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 the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. 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.
Skin Reactions and Other Potential Risks
Skin reactions, including rashes, may occur with this medication, even up to 1 year after treatment. If you experience any skin reaction, notify your doctor promptly. Additionally, this medication may contain aluminum, which can increase the risk of aluminum toxicity with long-term use, particularly in individuals with kidney problems or premature infants. Your doctor will discuss this risk with you.
Some formulations of this medication may contain benzyl alcohol. If possible, it is recommended to avoid products with benzyl alcohol in newborns and infants, as serious side effects can occur with certain doses, especially when combined with other medications containing benzyl alcohol. Consult 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. You will need to discuss the potential 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 in individuals with health conditions that increase the risk of blood clots. After using this medication, the risk of blood clots may increase. Follow your doctor's instructions carefully to minimize this risk and prevent blood clots.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. 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.
Skin Reactions and Other Potential Risks
Skin reactions, including rashes, may occur with this medication, even up to 1 year after treatment. If you experience any skin reaction, notify your doctor promptly. Additionally, this medication may contain aluminum, which can increase the risk of aluminum toxicity with long-term use, particularly in individuals with kidney problems or premature infants. Your doctor will discuss this risk with you.
Some formulations of this medication may contain benzyl alcohol. If possible, it is recommended to avoid products with benzyl alcohol in newborns and infants, as serious side effects can occur with certain doses, especially when combined with other medications containing benzyl alcohol. Consult 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. You will need to discuss the potential 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 in individuals with health conditions that increase the risk of blood clots. After using this medication, the 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, excessive doses may lead to transient flushing, dizziness, rapid pulse, sweating, and hypotension. In neonates, large doses have been associated with hyperbilirubinemia and kernicterus.
What to Do:
Discontinue the drug. Symptomatic and supportive care. For severe reactions, call 911 or poison control (1-800-222-1222).
Drug Interactions
Major Interactions
- Warfarin (antagonistic effect, reduces anticoagulant efficacy)
Moderate Interactions
- Mineral oil (decreased oral absorption of vitamin K)
- Cholestyramine (decreased oral absorption of vitamin K)
- Orlistat (decreased oral absorption of vitamin K)
- Fat-soluble vitamin malabsorption syndromes (may reduce efficacy of oral vitamin K)
Monitoring
Baseline Monitoring
Prothrombin Time (PT) / International Normalized Ratio (INR)
Rationale: To assess baseline coagulation status and guide dosing, especially for warfarin reversal.
Timing: Prior to administration
Clinical signs of bleeding
Rationale: To assess the severity of the bleeding event and guide urgency of treatment.
Timing: Prior to administration
Routine Monitoring
Prothrombin Time (PT) / International Normalized Ratio (INR)
Frequency: 6-12 hours after IV/SC/IM administration, or 12-24 hours after oral administration, then daily as needed.
Target: Depends on indication (e.g., INR < 1.5 for warfarin reversal, or target INR for specific conditions).
Action Threshold: If INR remains elevated or bleeding persists, consider repeat dose or alternative therapies.
Clinical signs of bleeding/thrombosis
Frequency: Continuously during acute phase, then daily.
Target: Resolution of bleeding, no new thrombotic events.
Action Threshold: Worsening bleeding or signs of thrombosis require immediate re-evaluation.
Symptom Monitoring
- Signs of bleeding (e.g., hematoma, petechiae, melena, hematuria, epistaxis)
- Signs of hypersensitivity reaction (e.g., flushing, rash, dyspnea, chest tightness, hypotension, anaphylaxis - especially with IV administration)
- Pain or swelling at injection site
Special Patient Groups
Pregnancy
Phytonadione is classified as Pregnancy Category C. While animal studies have shown adverse effects, human data are limited. It is generally considered safe and often used in pregnant women, particularly those on anticonvulsants, to prevent neonatal vitamin K deficiency bleeding. The benefits often outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk when indicated.
Second Trimester:
Low risk, often used for prophylaxis in at-risk pregnancies.
Third Trimester:
Low risk, commonly used for prophylaxis in at-risk pregnancies or prior to delivery in specific situations.
Lactation
Phytonadione is considered compatible with breastfeeding (Lactation Risk L2). Small amounts are excreted into breast milk, but these are not considered harmful to the infant. Breastfed infants may require supplemental vitamin K if the mother's intake is insufficient or if the infant is at risk for VKDB.
Infant Risk:
Low risk
Pediatric Use
Phytonadione is routinely administered to all newborns as prophylaxis against Vitamin K Deficiency Bleeding (VKDB). Dosing is weight-based for treatment of deficiency or warfarin reversal in older children. IV administration should be slow and cautious due to risk of hypersensitivity.
Geriatric Use
No specific dose adjustment is required for elderly patients. However, elderly patients may be more sensitive to the effects of warfarin and thus require careful monitoring of INR after phytonadione administration to avoid over-correction and subsequent thrombotic risk.
Clinical Information
Clinical Pearls
- IV administration of phytonadione should be reserved for urgent situations (e.g., active bleeding with high INR) due to the risk of severe hypersensitivity reactions, including anaphylaxis. Administer slowly over at least 30 minutes, diluted in appropriate solution (e.g., D5W, NS).
- For non-urgent warfarin reversal, oral or subcutaneous routes are preferred due to lower risk of adverse reactions.
- The effect of phytonadione on INR is not immediate; it takes several hours for new clotting factors to be synthesized. For immediate reversal of life-threatening bleeding, prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP) may be required in addition to vitamin K.
- Repeated large doses of vitamin K can make subsequent warfarin therapy difficult to manage due to prolonged resistance to warfarin's effects.
- Always verify the concentration and route of administration carefully, especially in neonates, to prevent dosing errors.
Alternative Therapies
- Prothrombin Complex Concentrate (PCC) - for rapid reversal of warfarin in life-threatening bleeding.
- Fresh Frozen Plasma (FFP) - for rapid reversal of warfarin in life-threatening bleeding (less concentrated than PCC).
- Recombinant Factor VIIa (rFVIIa) - for rapid reversal in specific situations, less commonly used for warfarin reversal.
- Oral Vitamin K supplements (for dietary deficiency or chronic management).
Cost & Coverage
Average Cost:
Varies, typically $10-$50 per 1mg/0.5ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 1 (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. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional 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 was taken to ensure prompt and effective treatment.