INN monograph
Vitamin K
Vitamin / mineral / nutritional supplement · POM
Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Professional class pharmacology (Vitamin / mineral / nutritional supplement)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- (adult) is contraindicated in patients who have • An existing hypervitaminosis, or • A history of hypersensitivity due to any vitamins or excipients contained in this formulation.
- • Hypersensitivity to any of the vitamins or excipients ( 4 ) • Existing hypervitaminosis ( 4 )
Precautions
- 5 WARNINGS AND PRECAUTIONS • Risk of Aluminum Toxicity: For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels ( 5.1 ) • Allergic Reactions: To thiamine may occur ( 5.2 ) • Hypervitaminosis A : Patients with renal failure or liver disease may be at higher risk ( 5.3 ) • Decreased Anticoagulant Effect of Warfarin: Monitor INR ( 5.4 , 7.1 ) • Interferes with Megaloblastic Anemia Diagnosis: Avoid during testing for this disorder ( 5.5 ) • Risk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations ( 5.6 ) • False Negative Urine Glucose Tests: Due to vitamin C ( 5.7 ) 5.1 Aluminum Toxicity Multiple vitamins injection (adult) contains aluminum that may be toxic.
- Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
- Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum.
- Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.
- Tissue loading may occur at even lower rates of administration.
- To prevent aluminum toxicity periodically monitor aluminum levels with prolonged parenteral administration of multiple vitamins injection (adult) in patients with renal impairment. 5.2 Allergic Reactions to Thiamine Allergic reactions such as urticaria, shortness of breath, wheezing and angioedema have been reported following intravenous administration of thiamine, which is found in multiple vitamins injection (adult).
- There have been rare reports of anaphylactoid reactions following intravenous doses of thiamine.
- No fatal anaphylactoid reactions associated with multiple vitamins injection (adult) have been reported. 5.3.
- Hypervitaminosis A Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease, Therefore, supplementation of renal failure patients and patients with liver disease with vitamin A, an ingredient found in multiple vitamins injection (adult), should be undertaken with caution [ see Use in Specific Populations ( 8.6 and 8.7 ) ]. 5.4 Decreased Anticoagulant Effect of Warfarin Multiple vitamins injection (adult) contains Vitamin K, which may decrease the anticoagulant action of warfarin.
- In patients who are on warfarin anticoagulant therapy receiving multiple vitamins injection (adult) monitor blood levels of prothrombin/INR to determine if dose of warfarin needs to be adjusted. 5.5 Interference with Diagnosis of Megaloblastic Anemia Multiple vitamins injection (adult) contains folic acid and cyanocobalamin which can mask serum deficiencies of folic acid and cyanocobalamin in patients with megaloblastic anemia.
- Avoid the use of multiple vitamins injection (adult) in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies. 5.6 Potential to Develop Vitamin Deficiencies or Excesses In patients receiving parenteral multivitamins such as with multiple vitamins injection (adult), blood concentration should be periodically monitored to determine if deficiencies or excesses are developing.
- Multiple vitamins injection (adult) may not correct long-standing specific vitamin deficiencies.
Point of care
Dosing
Adult
• Multiple vitamins injection (adult) is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K 1 , folic acid, biotin, and vitamin B 12 ( 2.1 ) • Multiple vitamins injection (adult) is for administration by intravenous infusion after dilution ( 2.1 ) • Recommended daily dosage is 10 mL ( 2.1 ) • Multiple vitamins injection (adult) is supplied as a pharmacy bulk package. Pharmacy Bulk Package : Add the contents of Vial 1 to the contents of Vial 2. This provides ten 10 mL daily doses. Take 10 mL from Vial 2 and add to not less than 500 mL, and preferably 1,000 mL, of intravenous dextrose, saline or similar infusion solutions. ( 2.2 ) • After dilution in an intravenous infusion, refrigerate resulting solution unless used immediately. Use solution within 24 hours after dilution ( 2.2 ) • Monitor blood vitamin concentrations ( 2.3 ) • See Full Prescribing Information for drug incompatibilities ( 2.4 ) 2.1 Important Dosage Instructions Multiple vitamins injection (adult) is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K 1 , folic acid, biotin, and vitamin B 12 . Multiple vitamins injection (adult) is supplied as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution. Multiple vitamins injection (adult) Pharmacy Bulk Package: • Provides ten 10 mL daily doses when the content of vial 1 is transferred into the content of vial 2. One 10 mL dose is then added directly to intravenous fluid. Pharmacy bulk package of multiple vitamins injection (adult) is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion [ see Dosage and Administration ( 2.2 )]. Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated. Some patients do not maintain adequate levels of certain vitamins when this formulation in recommended amounts is the only source of vitamins. 2.2 Preparation and Administration Instructions Do not administer multiple vitamins injection (adult) as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and possible tissue irritation . Multiple vitamins injection (adult) Pharmacy Bulk Package : • Use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). • Transfer the contents of Vial 1 into the contents of Vial 2 to provide ten 10 mL single doses. • Each bulk vial closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. • Once the closure system has been penetrated, complete dispensing from the pharmacy bulk vial should be completed within 4 hours. The mixed solution may be refrigerated and stored for up to 4 hours. • Discard unused portion. • Visually inspect for particulate matter and discoloration prior to administration. • One daily 10 mL dose should be added directly to at least 500 mL to 1,000 mL, of intravenous dextrose, saline or similar infusion solutions. • After multiple vitamins injection (adult) is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution. • Minimize exposure to light because some of the vitamins in multiple vitamins injection (adult), particularly A, D and riboflavin, are light sensitive. 2.3 Monitoring Vitamin Blood Levels Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as the only source of vitamins for long periods of time. 2.4 Drug Incompatibilities • Multiple vitamins injection (adult) is not physically compatible with moderately alkaline solutions such as a sodium bicarbonate solution and other alkaline drugs such as acetazolamide sodium, aminophylline, ampicillin sodium, tetracycline HCl and chlorothiazide sodium. • Folic acid is unstable in the presence of calcium salts such as calcium gluconate. • Vitamin A and thiamine in multiple vitamins injection (adult) may react with bisulfite solutions such as sodium bisulfite or vitamin K bisulfate. • Do not add multiple vitamins injection (adult) directly to intravenous fat emulsions. • Consult appropriate references for additional listings of physical and chemical compatibility of solutions and drugs with the vitamin infusion when needed. If incompatibilities are identified, avoid admixture or Y-site administration with vitamin solutions.
Paediatric
8.4 Pediatric Use Safety and effectiveness in children below the age of 11 years have not been established.
Renal
Fat-soluble vitamins and potassium need care in advanced CKD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Vitamin A toxicity hepatic; niacin hepatotoxicity at high dose.
Safety
Drug interactions
- ||| All vitamin K compounds are 2-methyl-1,4- naphthoquinones.
- Two natural forms exist: vita- mins K1[phytonadione or phylloquinone] and K2[menaquinone].
- Vitamin K1 is found in food.
- Intestinal bacteria synthesize Vitamin K2 found in human tissues.
- Menadiol sodium diphosphate [vitamin K4] is a water-soluble derivative con- verted in the body to menadione [vitamin K3].
Safety
Adverse effects
- labeling. • Allergic reactions to thiamine [ see Warnings and Precautions ( 5.2 ) ]. • Hypervitaminosis A [ see Warnings and Precautions ( 5.3 ) ] The following adverse reactions have been identified during postapproval use of multiple vitamins injection (adult).
- Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis and anaphylactoid reactions including shortness of breath, wheezing and angioedema, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Use
Indications
- Prophylaxis and treatment haemorrhagic disease of the newborn (since vitamin K from the mother may possibly be insufficient due to its poor passage through the placenta and because intestinal bacteria responsible for its natural synthesis are not present for 1st 5-8 days after birth)
- in the management of overdose of anti-coagulants
- in patients with fat mal-absorption (Vitamin K is fat soluble hence it is not absorbed in fat mal-absorption disorders)
- treatment and prophylaxis of various coagulation disorders due to impaired synthesis of factors II, VII, IX, and X (this may result from vitamin K deficiency, impaired activity of vitamin K eg. hypoprothrombinemia due to coumarin or indanedione-derived oral anticoagulants and other drugs.
Pharmacology
Mode of action
It promotes the hepatic synthesis synthesis of clotting factors II, VII, IX, and X.
Full mechanism text
It promotes the hepatic synthesis synthesis of clotting factors II, VII, IX, and X. It promotes synthesis of proteins necessary for normal calcification of bones. It is normally formed by bacteria in the intestine as well as being present in the diet hence its deficiency can arise when there is no bacteria in the gut e.g. in the newborn and in-patients on antibiotics. As it needs bile salts to be absorbed, its absorption is reduced in obstructive jaundice.
ADME
Pharmacokinetics & PD
| Onset | Days–weeks for repletion |
|---|---|
| Duration | Depends on stores and ongoing intake |
| Route | INTRAVENOUS |
| Absorption | depends on GI integrity, food matrix and binders (e.g. calcium/iron interactions). Fat-soluble vitamins (A,D,E,K) accumulate; water-soluble generally renally cleared. |
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| Konakion | Distributed by Metro Pharmaceuticals Limited | Standard Commercial Pack | — |
| Mediphyto | Distributed by Medisel (K) Limited | Standard Commercial Pack | — |
| MKonakion | Roche | Standard Commercial Pack | — |
Special populations
Pregnancy & lactation
Pregnancy
8.1 Pregnancy Risk Summary Administration of the approved recommended dose of multiple vitamins injection (adult) in parental nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant patients should follow the U.S. Recommended Daily Allowances for pregnancy because their vitamin requirements may exceed those of nonpregnant patients. Deficiency of essential vitamins may result in adverse pregnancy outcomes (see Clinical Considerations). Animal reproduction studies have not been conducted with multiple vitamins injection (adult). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of essential vitamins has been associated with adverse pregnancy and fetal outcomes, such as maternal folic acid deficiency and an increased risk of neural tube defects. Therefore, parenteral nutrition with multiple vitamins injection should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake.
Lactation
• Pregnancy and Lactation: Pregnant and lactating patients should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant and nonlactating patients ( 8.1 , 8.2 ) • Renal Impairment: Monitor renal function, calcium, phosphorus and vitamin A levels in patients with renal impairment ( 8.6 ) • Hepatic Impairment: Monitor vitamin A level in patients with liver disease, high alcohol consumption ( 8.7 ) 8.1 Pregnancy Risk Summary Administration of the approved recommended dose of multiple vitamins injection (adult) in parental nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant patients should follow the U.S. Recommended Daily Allowances for pregnancy because their vitamin requirements may exceed those of nonpregnant patients. Deficiency of essential vitamins may result in adverse pregnancy outcomes (see Clinical Considerations). Animal reproduction studies have not been conducted with multiple vitamins injection (adult). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of essential vitamins has been associated with adverse pregnancy and fetal outcomes, such as maternal folic acid deficiency and an increased risk of neural tube defects. Therefore, parenteral nutrition with multiple vitamins injection should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. 8.2 Lactation Risk Summary Multiple vitamins present in multiple vitamins injection (adult) are also present in human milk. Administration of the approved recommended dose of multiple vitamins injection (adult) In parental nutrition is not expected to cause harm to a breastfed infant. There is no information on the effects of multiple vitamins injection (adult) on milk production. Lactating patients should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonlactating patients. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for multiple vitamins injection (adult) and any potential adverse effects on the breastfed child from multiple vitamins injection (adult) or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in children below the age of 11 years have not been established. 8.5 Geriatric Use Safety and effectiveness for geriatric use have not been established. 8.6 Renal Impairment Multiple vitamins injection (adult) has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin A levels in patients with renal impairment [ see Warnings and Precautions ( 5.1 and 5.3 ) ] . 8.7 Hepatic Impairment Multiple vitamins injection (adult) has not been studied in patients with liver impairments. Monitor vitamin A level in patients with liver disease, high alcohol consumption [ see Warnings and Precautions ( 5.3 ) ] .
Diet
Food & alcohol
- Drug & food interactions (label) 7 DRUG INTERACTIONS A number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions: Effect of multiple vitamins injection (adult) on other drugs: • Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin ( 7.1 ) • Bleomycin: Ascorbic acid and riboflavin may reduce the activity of bleomycin ( 7.1 ) • Levodopa: Pyridoxine may decrease blood levels of levodopa and levodopa efficacy may decrease ( 7.1 ) • Phenytoin: Folic acid may decrease phenytoin blood levels and increase risk of seizure activity ( 7.1 ) • Methotrexate: Folic acid may decrease response to methotrexate ( 7.1 ) Effects of other drugs on multiple vitamins injection (adult): • Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements ( 7.2 ). • Phenytoin: May decrease folic acid concentrations ( 7.2 ) • Chloramphenicol : In patients with pernicious anemia, the hematologic response to vitamin B 12 therapy may be inhibited ( 7.2 ) 7.1 Drug Interactions Affecting Co-Administered Drugs Warfarin : Vitamin K, a component of multiple vitamins injection (adult), antagonizes the anticoagulant action of warfarin. In patients who are co-administered warfarin and multiple vitamins injection (adult), blood levels of prothrombin/INR should be monitored to determine if dose of warfarin needs to be adjusted [see Warnings and Precautions ( 5.4 )]. Antibiotics : Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease antibiotic activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin : Ascorbic acid and riboflavin inactivate bleomycin in vitro , thus the activity of bleomycin may be reduced. Levodopa : Pyridoxine may increase the metabolism of levodopa (decrease blood levels of levodopa) and decrease its efficacy. Phenytoin: Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin resulting in increased seizure activity. Methotrexate: Folic acid may decrease a patient’s response to methotrexate therapy. 7.2 Drug Interactions Affecting Vitamin Levels Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements. Phenytoin : Phenytoin may decrease serum folic acid concentrations. Chloramphenicol: In patients with pernicious anemia, the hematologic response to vitamin B 12 therapy may be inhibited by chloramphenicol.
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Professional class pharmacology (Vitamin / mineral / nutritional supplement)
Last reviewed: 01 Aug 2026
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.