Version May 2024
Dietary supplement: IV: Adult formulation: 10 mL/day added to ≥500 mL of parenteral nutrition or appropriate solution.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.
Refer to adult dosing.
Dietary supplement: IV:
Infants <1 kg: Pediatric formulation: 1.5 mL/day added to TPN or ≥100 mL of appropriate solution (maximum: 1.5 mL/day)
Infants 1 to 3 kg: Pediatric formulation: 3.25 mL/day added to TPN or ≥100 mL of appropriate solution. Multiples of this dose should not be given to infants weighing <3 kg.
Infants ≥3 kg and Children <11 years: Pediatric formulation: 5 mL/day added to TPN or ≥100 mL of appropriate solution
Children ≥11 years and Adolescents: Adult formulation: Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Cardiovascular: Edema
Central nervous system: Agitation, anxiety, dizziness, headache
Dermatologic: Erythema, pruritus, skin rash, urticaria
Endocrine & metabolic: Hypervitaminosis
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
Ophthalmic: Diplopia
Respiratory: Dyspnea, wheezing
Hypersensitivity to any component of the formulation; preexisting hypervitaminosis
Concerns related to adverse effects:
• Hypersensitivity reactions: Allergic reactions, including urticaria, shortness of breath, wheezing, and angioedema, have been reported following parenteral doses of thiamine; anaphylaxis has also been reported (rare).
• Hypervitaminosis A: Has been reported in patients with renal failure receiving 1.6 mg/day of retinol and in patients with liver disease; use with caution.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Megaloblastic anemia: Do not use prior to blood testing for megaloblastic anemia.
• Renal impairment: Use with caution in patients with renal impairment.
Concurrent drug therapy issues:
• Anticoagulants: Some formulations may contain vitamin K, which may reduce the effectiveness of vitamin K-dependent anticoagulants (eg, warfarin); periodically monitor PT/INR in these patients.
Dosage form specific issues:
• Aluminum: The parenteral product may contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal dysfunction. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses (Federal Register 2002). See manufacturer's labeling.
• Polysorbates: Some formulations may contain polysorbates which have been associated with the E-Ferol syndrome (thrombocytopenia, renal impairment, hepatomegaly, cholestasis, ascites, hypotension, metabolic acidosis) in low birth weight infants.
• Vitamin A: May adhere to plastic, resulting in inadequate vitamin A concentrations after administration. Additional vitamin A supplementation may be required, especially in low birth weight infants.
Other warnings/precautions:
• Laboratory test interference: Biotin in blood or other samples taken from patients who are ingesting high levels of biotin from dietary supplements (including multivitamins; prenatal multivitamins; biotin supplements; and dietary supplements for hair, skin, and nail growth) can cause clinically significant incorrect lab test results. Some testing methods use biotin technology (eg, troponin, hormone tests), using biotin to bind to specific proteins that are measured to detect health conditions. An increase in the number of reported adverse events, including one death, related to biotin interference with lab tests has been reported. If a lab test result does not correspond with a patient's clinical symptoms, biotin interference should be considered as a possible source of error (FDA Safety Communication 2017).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Content varies depending on product used. For more detailed information on ingredients in these and other multivitamins, please refer to specific product labeling.
No
IV: For IV use only (not for direct infusion); solution must be diluted prior to administration.
IV: Not for direct IV injection; must be diluted prior to administration; direct administration of solution may cause tissue irritation, dizziness, and fainting.
Dietary supplement: Nutritional supplement in patients receiving parenteral nutrition or requiring intravenous administration
Refer to individual vitamin monographs for requirements during pregnancy.
Refer to individual vitamin monographs for requirements while breastfeeding.
Blood vitamin concentrations periodically; renal function tests, calcium, phosphorus, and vitamin A levels in patients with renal impairment; vitamin A levels in patients with hepatic impairment or excessive alcohol consumption.
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