The following Structured Product Label (SPL) was submitted to the FDA by Apotex Corp for the product Multiple Vitamins (adult) Single Dose (NDC 60505-6172). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 1 indications and usage, 2 dosage and administration, 2.1 important dosage instructions, 2.2 preparation and administration instructions, 2.3 monitoring vitamin blood levels, 2.4 drug incompatibilities, 3 dosage forms and strengths, 4 contraindications, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Multiple vitamins injection (adult) is a combination of vitamins indicated for the prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition.
The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.
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 K1, folic acid, biotin, and vitamin B12.
Multiple vitamins injection (adult) is supplied as a single dose for intravenous use intended for administration by intravenous infusion after dilution.
Multiple vitamins injection (adult) Single Dose:
• Provides one daily dose of 10 mL (5 mL of Vial 1 plus 5 mL of Vial 2) which must be diluted prior to intravenous administration [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.
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) Single Dose:
• Use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
• Add 5 mL of Vial 1 and 5 mL of Vial 2 to at least 500 mL to 1,000 mL, of intravenous dextrose or saline solutions.
• Discard unused portion.
• Visually inspect for particulate matter and discoloration prior to administration.
• 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.
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.
• 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.
Multiple vitamins injection (adult) Single Dose: is an injection for intravenous administration consisting of two vials labeled Vial 1 (5 mL) and Vial 2 (5 mL). For the vitamin strengths [see Description (11)].
Vial 1 (Single Dose) is supplied as clear, yellow to orange colored solution in amber glass vial closed with a rubber stopper, aluminum flip-off seals of white color button.
Vial 2 (Single Dose) is supplied as clear, off-white to pale yellow colored solution in amber glass vial closed with a rubber stopper, aluminum flip-off seals of dark blue color button.
Multiple vitamins injection (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.
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.
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.
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)].
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.
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.
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. The administration of additional therapeutic doses of specific vitamins may be required [see Dosage and Administration (2.3)].
Multiple vitamins injection (adult) contains vitamin C which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose results.
The following adverse reactions are discussed in greater detail in other section of the 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
A number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions:
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.
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 B12 therapy may be inhibited by chloramphenicol.
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.
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.
Safety and effectiveness in children below the age of 11 years have not been established.
Safety and effectiveness for geriatric use have not been established.
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)].
Signs and symptoms of acute or chronic overdosage may be those of individual multiple vitamins injection (adult) component toxicity. In post-marketed surveillance, overdosage with multiple vitamins injection (adult) at two times the prescribed dose did not result in toxicity.
Multiple vitamins injection (adult) is a sterile product consisting of two vials provided as a single dose, intended for intravenous use for administration by intravenous infusion after dilution:
Multiple vitamins injection (adult) Single Dose- two 5 mL single-dose vials labeled Vial 1 and Vial 2.
Each 5 mL of Vial 1 contains:
| Ascorbic acid (Vitamin C) | 200 mg |
| Vitamin A* (as palmitate) | 3,300 IU |
| Vitamin D3* (cholecalciferol) | 200 IU |
| Thiamine (Vitamin B1) (as the hydrochloride) | 6 mg |
| Riboflavin (Vitamin B2) (as riboflavin 5-phosphate sodium) | 3.6 mg |
| Pyridoxine HCl (Vitamin B6) | 6 mg |
| Niacinamide | 40 mg |
| Dexpanthenol (as d-pantothenyl alcohol) | 15 mg |
| Vitamin E* (dl-α-tocopheryl acetate) | 10 IU |
| Vitamin K1* | 150 mcg |
*Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K.
Inactive ingredients: 1.4% polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection.
Each 5 mL of Vial 2 contains:
| Folic acid | 600 mcg |
| Biotin | 60 mcg |
| Vitamin B12 (cyanocobalamin) | 5 mcg |
Inactive ingredients: 30% propylene glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection.
Multiple vitamins injection (adult) makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.
Contains no more than 200 mcg/L of aluminum (combined Vials 1 and 2).
Carcinogenicity, mutagenicity, and fertility studies have not been performed with multiple vitamins injection (adult).
How Supplied
Multiple vitamins injection (adult) is supplied as follows:
Vial 1 (Single Dose) is supplied as clear, yellow to orange colored solution in amber glass vial closed with a rubber stopper, aluminum flip-off seals of white color button.
Vial 2 (Single Dose) is supplied as clear, off-white to pale yellow colored solution in amber glass vial closed with a rubber stopper, aluminum flip-off seals of dark blue color button.
Multiple vitamins injection (adult) Single Dose:
| Carton contains total ten single-dose vials | NDC 60505-6172-0 |
| Five of Vial 1 (5 mL) | NDC 60505-6299-1 |
| Five of Vial 2 (5 mL) | NDC 60505-6300-2 |
one Vial 1 plus one Vial 2 to be used for a single dose [see Dosage and Administration (2.1)].
Storage and Handling
Minimize exposure of multiple vitamins injection (adult) to light because vitamins A, D and riboflavin are light sensitive.
Store under refrigeration, 2°C to 8°C (36°F to 46°F).
Instruct patients (if age appropriate) and caregivers:
• To watch for signs of allergic reactions such as urticaria, shortness of breath, wheezing and angioedema since hypersensitivity reactions may occur to any of the vitamins or excipients contained in multiple vitamins injection (adult).
• To watch for and immediately report nausea, vomiting, headache, dizziness, blurred vision, especially if patients have renal impairment, as these may be signs of hypervitaminosis A.
• To report other adverse reactions such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia.
• That the patients on warfarin anticoagulant therapy will be monitored periodically with blood prothrombin/ INR levels to determine if their dose of warfarin needs to be adjusted.
• About the significance of periodic monitoring of blood vitamin concentrations to determine if vitamin deficiencies or excesses are developing and the need to monitor renal function, calcium, phosphorus, aluminum and vitamin A levels in patients with renal impairment.
• That multiple vitamins injection (adult) should be avoided in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.
• That vitamin C (ascorbic acid) contained in multiple vitamins injection (adult) may cause false negative urine glucose results.
APOTEX CORP.
MULTIPLE VITAMINS INJECTION (ADULT)
| Manufactured by: | Manufactured for: |
| Gland Pharma Limited | Apotex Corp. |
| Hyderabad, Telangana – 500 043,India | Weston, Florida |
| ML No. 103/AP/RR/97/F/R | 33326 |
Revised: July 2025
Rev: 02
5 mL NDC 60505-6172-0
Multiple Vitamins Injection
(Adult)
For intravenous infusion after dilution only.
STERILE
Contains 5 each of Vial 1 (5 mL) and Vial 2 (5mL).
One vial of each to be used for a single dose.
Store under refrigeration, 2°C to 8°C (36°F to 46°F).
APOTEX CORP. RX Only
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