AMRI-K
Phytomenadione (Vitamin K1) 10 mg/mL
Solution for Intramuscular Injection
1. Disclaimer
This monograph is provided for educational and professional reference purposes. It is not a substitute for the current official product leaflet, prescribing information, or individualized assessment by a qualified physician or pharmacist. Injectable vitamin K1 requires particular care regarding indication, route, dose, coagulation status, and the underlying cause of bleeding.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
2. Summary
AMRI-K is an injectable preparation of phytomenadione (vitamin K1) used to correct coagulation abnormalities caused by vitamin K deficiency or interference with vitamin K activity. The product identified in Egyptian-market sources contains 10 mg of phytomenadione in each 1 mL ampoule, is intended for intramuscular administration, and is supplied in a pack of 5 ampoules. Current Egyptian product databases identify AMRI-K as a prescription product manufactured by Amriya Pharmaceutical Industries, Egypt, with ATC code B02BA01.
Vitamin K1 is required for hepatic formation of functional vitamin-K-dependent coagulation factors. Its administration therefore restores production of these factors when coagulation impairment is attributable to vitamin K deficiency or vitamin K antagonism.
3. Brand Name
AMRI-K
Current Egyptian-market listings identify the product as:
AMRI-K 10 mg/1 mL ampoules — 5 ampoules — IM use.
4. Category
Therapeutic category: Hemostatic / vitamin K preparation.
Pharmacological category: Vitamin K; antihemorrhagic.
ATC classification: B02BA01 — Phytomenadione.
5. Active Ingredient
Each 1 mL ampoule contains:
Phytomenadione (Vitamin K1) — 10 mg
Phytomenadione is also known as phytonadione or phylloquinone and is the naturally occurring vitamin K form used therapeutically. The current Egyptian product record confirms the 10 mg/mL strength.
6. Pharmaceutical Form & Strength
Dosage form: Sterile solution for injection.
Strength: 10 mg/mL
Container: 1 mL ampoule.
Route identified for AMRI-K: Intramuscular (IM) injection.
Pack size: 5 ampoules, each containing 1 mL.
7. Manufacturer & Marketing Authorization Holder
Manufacturer:
Amriya Pharmaceutical Industries, Alexandria, Egypt. Publicly available Egyptian-market records identify the manufacturing entity as Alamriah/Amriya for Pharmaceutical Industries.
Marketing Authorization Holder:
A current Egyptian public source separately distinguishing the MAH from the manufacturer was not independently verified. Available regulatory-market records outside Egypt list Amriya Pharmaceutical Industries as both manufacturer and market authorization holder for AMRI-K, but this should not be assumed to represent the current Egyptian legal MAH entry without confirmation from the current Egyptian registration record.
8. Mechanism of Action
Vitamin K1 acts as an essential cofactor for the hepatic γ-glutamyl carboxylation of specific glutamic-acid residues in precursor proteins for coagulation factors II, VII, IX, and X. This post-translational modification is necessary for these proteins to become functionally active coagulation factors. Vitamin K is also required for the vitamin-K-dependent natural anticoagulant proteins C and S.
In vitamin K deficiency, administration of phytomenadione restores the hepatic synthesis of functional vitamin-K-dependent clotting factors, allowing coagulation parameters to recover.
The effect is therefore not an immediate direct clot-forming action. New functional clotting factors must first be synthesized by the liver. Measurable improvement in prothrombin time generally requires time after administration.
Importantly, vitamin K1 does not reverse the anticoagulant effect of heparin.
9. Spectrum of Activity
AMRI-K is not an antimicrobial medicine and therefore has no antibacterial, antiviral, antifungal, or antiparasitic spectrum.
Its pharmacological activity is restricted to correction or prevention of vitamin-K-dependent coagulation abnormalities.
It is particularly relevant when hypoprothrombinemia is caused by:
- Vitamin K deficiency.
- Vitamin K antagonists such as coumarin derivatives.
- Certain conditions that impair vitamin K absorption or metabolism.
10. Pharmacokinetics
Following parenteral administration, phytomenadione is absorbed and is initially concentrated in the liver, its principal site of action. Only small amounts accumulate in other tissues. The metabolic fate of vitamin K1 is incompletely characterized, and little unchanged vitamin K appears in bile or urine.
The clinical effect depends on the restoration of hepatic synthesis of functional coagulation factors rather than on a direct pharmacological conversion of blood into a hypercoagulable state.
For injectable phytonadione, measurable improvement in prothrombin time generally begins after approximately 1–2 hours, while substantial correction of bleeding related to vitamin K deficiency may take several hours.
A precise, product-specific plasma half-life for AMRI-K could not be reliably established from publicly accessible current manufacturer information and is therefore not stated here.
11. Indications
Vitamin K1 injection is used for coagulation disorders caused by deficient formation of vitamin-K-dependent coagulation factors, including:
- Vitamin K deficiency associated with bleeding or hypoprothrombinemia.
- Coumarin- or other vitamin-K-antagonist-induced hypoprothrombinemia, according to the clinical situation and coagulation results.
- Hypoprothrombinemia associated with prolonged antibacterial therapy when vitamin K deficiency is established or strongly suspected.
- Hypoprothrombinemia caused by impaired intestinal absorption or impaired vitamin K availability, including conditions such as obstructive jaundice, biliary disorders, celiac disease, ulcerative colitis, intestinal resection, cystic fibrosis, and regional enteritis.
- Other drug-associated hypoprothrombinemia when interference with vitamin K metabolism has been demonstrated.
Vitamin K1 is also established for prevention and treatment of vitamin K deficiency bleeding (VKDB) in newborns, but neonatal prophylaxis requires age- and formulation-appropriate dosing and should not be extrapolated from the 10 mg/mL adult ampoule without specific clinical instructions.
12. Administration
AMRI-K is marketed as a solution for intramuscular injection. It should be administered by an appropriately trained healthcare professional and should not be self-injected.
Dose
The appropriate dose depends on:
- The cause and severity of vitamin K deficiency.
- The degree of hypoprothrombinemia or INR elevation.
- Presence and severity of bleeding.
- The anticoagulant involved, if applicable.
- Hepatic function and the patient's clinical status.
Published injectable phytonadione labeling provides adult doses in the approximate range of 2.5–10 mg for anticoagulant-induced hypoprothrombinemia, with higher doses sometimes used for other causes or severe deficiency. Exact dosing and route must be determined from the specific product information and clinical circumstances rather than treating one dose range as universal.
Important point concerning anticoagulant reversal
The choice of IM vitamin K in a patient receiving anticoagulants requires particular caution because an intramuscular injection can produce a hematoma in an anticoagulated patient. In major or life-threatening anticoagulant-associated bleeding, modern protocols may favor intravenous vitamin K together with a rapid replacement strategy such as PCC, depending on the anticoagulant and clinical circumstances. Therefore, AMRI-K should not be regarded as an automatic treatment for every anticoagulant-related bleeding episode.
Newborns
Vitamin K prophylaxis is routinely recommended for newborns in many current guidelines. The CDC describes 1 mg intramuscular vitamin K after birth as an effective prophylactic regimen for newborns. However, the 10 mg/mL AMRI-K ampoule is not a neonatal-specific presentation, and neonatal use should follow the applicable neonatal formulation and prescribing instructions.
13. Method of Preparation
AMRI-K is supplied as a ready-to-use injectable solution.
No reconstitution is required.
Because the formulation is an injectable vitamin K preparation, it should be inspected before administration and handled according to the manufacturer's current instructions for injectable products.
No mixing or dilution instructions specific to the current AMRI-K formulation were independently verified from a current public manufacturer leaflet and therefore are not provided here.
14. Contraindications
The principal contraindication is:
- Known hypersensitivity to phytomenadione or any component of the formulation.
Additional clinical situations may require avoidance or use only after careful risk-benefit assessment, particularly where the indication is uncertain or where administration by the IM route could create a significant bleeding risk.
Because AMRI-K is specifically an IM product, the risks of intramuscular administration must be considered in patients with significant coagulopathy or therapeutic anticoagulation.
15. Warnings & Precautions
Serious hypersensitivity and anaphylactoid reactions
Parenteral phytonadione has been associated with severe hypersensitivity/anaphylactoid reactions, including shock and, rarely, cardiovascular or respiratory arrest. Modern US labeling carries a boxed warning for serious reactions following both IV and IM administration and recommends restricting these routes to situations in which they are considered justified.
Accordingly, administration should occur in an appropriate medical setting with the ability to manage an acute hypersensitivity reaction.
Delayed therapeutic effect
Vitamin K1 does not immediately replace circulating clotting factors. In significant bleeding, vitamin K may need to be accompanied by blood or coagulation-factor replacement according to the clinical situation.
Liver disease
Patients with severe hepatic dysfunction may respond unpredictably because functional clotting-factor synthesis depends on the liver. Vitamin K cannot fully correct coagulopathy when the principal problem is severe loss of hepatic synthetic capacity rather than vitamin K deficiency.
Anticoagulated patients
IM administration should be used cautiously in patients with substantial anticoagulation because injection-site bleeding or hematoma may occur.
Coagulation monitoring
The response should be assessed with appropriate coagulation testing, particularly prothrombin time/INR, according to the indication.
Neonates
Neonates, especially premature infants, require special caution regarding formulation, dose, and excipients. The recommended neonatal dose should not be exceeded because excessive exposure has been associated with hemolysis, jaundice, and hyperbilirubinemia.
16. Drug Interactions
Coumarin anticoagulants
Vitamin K1 antagonizes the anticoagulant effect of warfarin and related coumarin derivatives. Administration can therefore reduce anticoagulation and may make re-establishment of therapeutic anticoagulation more difficult, particularly after larger doses. INR monitoring is essential.
Heparin
Vitamin K1 does not reverse heparin anticoagulation.
Antibiotics
Prolonged treatment with certain broad-spectrum antibacterial agents can contribute to vitamin K deficiency in susceptible patients, and correction of deficiency may be clinically indicated when hypoprothrombinemia is documented.
Other drugs affecting coagulation
The clinical effect of vitamin K1 may be influenced by other medicines that alter vitamin K metabolism, coagulation, or anticoagulant therapy. The complete medication profile should therefore be reviewed before administration.
17. Side Effects
Reported adverse effects of parenteral phytomenadione include:
Injection-site reactions
- Pain
- Swelling
- Tenderness
- Local inflammation
Systemic reactions
- Flushing
- Dizziness
- Transient hypotension
- Dyspnea
- Cyanosis
- Weak or rapid pulse
- Sweating
These reactions are uncommon but are clinically important because severe hypersensitivity-like reactions have also been reported.
Serious adverse reactions
Rare but potentially life-threatening reactions include:
- Anaphylactoid/anaphylactic-type reactions
- Shock
- Cardiovascular collapse
- Respiratory arrest
Severe reactions have been reported after both intravenous and intramuscular administration.
In neonates, excessive dosing can be associated with hemolysis, hyperbilirubinemia, and jaundice.
18. Use in Special Populations
Pregnancy
There are insufficient controlled data to define the fetal risk of injectable phytonadione conclusively. Available labeling recommends use during pregnancy only when clearly needed. The treatment decision should therefore be based on the clinical indication and expected benefit.
Breastfeeding
It is not firmly established from the cited current injectable product labeling whether clinically significant amounts of phytonadione are excreted into human milk. Caution is therefore appropriate when administering injectable phytonadione to a breastfeeding woman.
Pediatric patients
Pediatric use depends strongly on the indication and formulation. Vitamin K prophylaxis at birth is well established, but the neonatal regimen differs substantially from adult treatment of acquired hypoprothrombinemia. The 10 mg/mL AMRI-K ampoule should not be dose-selected for infants solely on the basis of the adult strength.
Elderly patients
No specific age-based contraindication is established, but treatment should account for comorbidities, anticoagulant therapy, hepatic function, renal function, and the risk of injection-related bleeding.
Renal impairment
No specific dose adjustment for AMRI-K based solely on renal impairment was independently verified. Clinical management should focus on the underlying cause of coagulopathy and the patient's coagulation profile.
Hepatic impairment
Particular caution is warranted in significant liver disease because the ability to synthesize functional clotting factors may remain impaired even after vitamin K administration.
19. Storage Conditions
Current product-market information identifies AMRI-K with a 36-month shelf life, and available product information identifies storage below 30°C. Protection from light is appropriate for injectable phytonadione preparations, which are light-sensitive. The product should be kept in its original packaging and out of the reach of children.
The current package leaflet should be followed for the exact storage conditions applicable to the specific batch and presentation.
20. Additional Sections
Current Egyptian-market presentation
The current Egyptian-market record identifies:
AMRI-K 10 mg/1 mL ampoules — 5 ampoules — intramuscular use
Active ingredient: Phytomenadione
Manufacturer: Amriya Pharmaceutical Industries
Dosage form: Solution for injection
ATC: B02BA01
Legal status: Prescription medicine
Shelf life: 36 months.
Current pharmacy-market listings also continue to identify the product as Amri-K 10 mg/mL, 5 ampoules, IM.
Important pharmacological distinction
Vitamin K1 is useful when coagulation impairment results from vitamin K deficiency or antagonism. It is not a universal antidote for every anticoagulant and does not reverse heparin.
Onset of action
The effect is delayed because vitamin K1 must support synthesis of new functional clotting factors. Consequently, it should not be regarded as an instantaneous hemostatic agent.
21. Frequently Asked Questions (FAQ)
What is AMRI-K used for?
AMRI-K contains vitamin K1 and is used to correct vitamin-K-related hypoprothrombinemia and bleeding or bleeding risk associated with vitamin K deficiency or vitamin K antagonists, depending on the clinical indication.
What is the active ingredient?
The active ingredient is phytomenadione (vitamin K1), 10 mg/mL.
What is the route of administration?
The Egyptian-market AMRI-K presentation is identified as a solution for intramuscular injection.
Is AMRI-K a blood thinner?
No. It is a vitamin K preparation with procoagulant activity in vitamin K deficiency or vitamin K antagonism.
Does vitamin K1 reverse warfarin?
Vitamin K1 can reverse or reduce the anticoagulant effect of warfarin and related vitamin-K antagonists, but the dose and route should be selected according to the INR, bleeding severity, and clinical circumstances.
Does vitamin K1 reverse heparin?
No. Vitamin K1 does not counteract heparin's anticoagulant mechanism.
Does AMRI-K work immediately?
No. Vitamin K1 must support hepatic synthesis of new clotting factors. Measurable improvement generally takes time, and severe bleeding may require additional immediate hemostatic therapy.
Can AMRI-K cause an allergic reaction?
Yes. Serious hypersensitivity/anaphylactoid reactions, although uncommon, have been reported with parenteral phytonadione, including after intramuscular administration.
Can AMRI-K be given to newborns?
Vitamin K prophylaxis is routinely recommended for newborns, but neonatal dosing and formulation are different from adult vitamin K treatment. A 10 mg/mL adult ampoule should not be used for a newborn without specific neonatal prescribing instructions.
Does AMRI-K contain an antibiotic?
No. It contains vitamin K1 (phytomenadione) and is classified as a hemostatic/vitamin K preparation.
What should be monitored during treatment?
The relevant coagulation parameters, particularly prothrombin time/INR, should be monitored according to the indication and clinical circumstances.
22. References
- DailyMed / U.S. National Library of Medicine. Phytonadione Injectable Emulsion, USP. Current labeling revised January 2025; mechanism, indications, contraindications, warnings, interactions, adverse reactions, dosing, and storage.
- electronic Medicines Compendium (emc). Konakion MM 10 mg/mL solution for injection — Summary of Product Characteristics; updated February 2024. Provides current professional information on phytomenadione, ATC B02BA01, indications, and clinical use.
- Centers for Disease Control and Prevention (CDC). Vitamin K deficiency bleeding and neonatal vitamin K prophylaxis; current recommendations for newborn vitamin K administration.
- Egyptian-market product database. AMRI-K 10 mg/1 mL ampoules; current product details including formulation, route, manufacturer, ATC classification, package size, shelf life, and registration data.
- Vezeeta Pharmacy Egypt. Current listing for AMRI-K 10 mg/mL, 5 ampoules, IM; confirms active ingredient, presentation, and manufacturer.
- Amriya Pharmaceutical Industries product material. AMRI-K identified as vitamin K1/phytomenadione, haemostatic, 5 × 1 mL ampoules for IM injection.
- Egyptian pharmaceutical pricing/registration documentation. AMRI-K 10 mg/mL ampoules, Amriya Pharmaceutical Industries, box of 5 ampoules.
- UAE Ministry of Health and Prevention registered medicines data. AMRI-K injection 10 mg/mL; manufacturer and MAH listed as Amriya Pharmaceutical Industries, Egypt.
Final verified clinical points
AMRI-K is a 10 mg/mL phytomenadione injection intended for IM use in the identified Egyptian presentation, manufactured by Amriya Pharmaceutical Industries and supplied as 5 × 1 mL ampoules.
The principal scientific corrections are that vitamin K1 is a cofactor for hepatic activation of factors II, VII, IX and X rather than a direct instant hemostatic agent; its effect is delayed because new clotting factors must be synthesized; it does not reverse heparin; and serious hypersensitivity/anaphylactoid reactions can occur with parenteral administration, including IM administration.
The neonatal indication is retained in the monograph because vitamin K prophylaxis is strongly established, but neonatal dosing is deliberately separated from the adult 10 mg/mL product presentation.