ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Manganese: Pediatric drug information

Manganese: Pediatric drug information
(For additional information see "Manganese: Drug information" and see "Manganese: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Mangimin [OTC] [DSC]
Brand Names: Canada
  • Micro-Mn
Therapeutic Category
  • Dietary Supplement;
  • Trace Element, Parenteral
Dosing: Neonatal

Note: Dosing presented as mcg/kg/day and mcg/day; use caution.

Adequate intake (AI): Note: Recommended intake from dietary sources (eg, breast milk, formula).

Neonates: Oral: 3 mcg/day (IOM 2001; NIH 2021).

Parenteral nutrition additive, maintenance requirement

Parenteral nutrition (PN) additive, maintenance requirement: Note: Manganese contamination is common with other PN products (eg, sodium phosphate, magnesium sulfate), which decreases or eliminates the need for routine supplementation; some experts suggest that additional supplementation is likely unnecessary (ASPEN [Corkins 2015]; ASPEN [Mirtallo 2004]; ESPGHAN/ESPEN/ESPR/CSPEN [Domellöf 2018]; Olson 2019; Srikrishnaraj 2021).

Term and Preterm Neonates: IV: 1 mcg/kg/day (ASPEN 2020; ASPEN [Corkins 2015]; ASPEN [Mirtallo 2004]).

Dosing: Pediatric

Note: Dosing presented as mcg/kg/day and mcg/day; use caution.

Parenteral nutrition additive, maintenance requirement

Parenteral nutrition (PN) additive, maintenance requirement: Note: Manganese contamination is common with other PN products (eg, sodium phosphate, magnesium sulfate), which decreases or eliminates the need for routine supplementation; some experts suggest that additional supplementation is likely unnecessary (ASPEN [Corkins 2015]; ASPEN [Mirtallo 2004]; ESPGHAN/ESPEN/ESPR/CSPEN [Domellöf 2018]; Olson 2019; Srikrishnaraj 2021).

ASPEN recommendations:

Infant and Children weighing ≤40 kg: IV: 1 mcg/kg/day; maximum daily dose: 55 mcg/day (ASPEN 2020; ASPEN [Corkins 2015]; ASPEN [Mirtallo 2004]).

Children and Adolescents weighing >40 kg: IV: 40 to 100 mcg/day (ASPEN 2020; ASPEN [Corkins 2015]; ASPEN [Mirtallo 2004]).

ESPGHAN/ESPEN/ESPR/CSPEN recommendations: Infants, Children, and Adolescents: IV: ≤1 mcg/kg/day; maximum daily dose: 50 mcg/day (Domellöf 2018).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Use caution; manganese chloride solution for injection contains aluminum.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Use caution; dose may need to be decreased or withheld in patients with hepatobiliary disease.

Dosing: Adult

(For additional information see "Manganese: Drug information")

Dietary supplement

Dietary supplement: Oral: 1 capsule/tablet daily.

Parenteral nutrition, maintenance requirement

Parenteral nutrition, maintenance requirement:

Note: Parenteral nutrition ordering requires advanced knowledge of nutrient and other metabolic requirements and should only be prescribed by clinicians trained in assessment and order writing for parenteral nutrition (ASPEN [Guenter 2015]).

Standard daily manganese requirement : IV: Elemental manganese 55 mcg daily as component of parenteral nutrition; adjust daily dose based on serum manganese and clinical considerations (ASPEN 2019).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. Use caution; manganese chloride solution for injection contains aluminum.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. Use caution; dose may need to be discontinued in patients who develop signs and symptoms of hepatobiliary disease (eg, cholestasis, cirrhosis).

Adverse Reactions

There are no adverse reactions listed in the manufacturer's labeling.

Contraindications

There are no contraindications listed within the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to manganese or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Neurotoxicity: Neuropsychiatric symptoms, including dysarthria, halting gait, mask-face, memory changes, mood changes, parkinsonian-like tremors, and seizures, have primarily been reported in patients on long-term therapy receiving higher than recommended doses and in association with cholestatic liver disease due to accumulation of manganese in the basal ganglia; has also been reported in patients on recommended doses with normal blood manganese concentrations. Symptoms usually resolved over weeks to months after discontinuation of therapy but may not completely resolve.

Disease-related concerns:

• Hepatobiliary disease: Use with caution in patients with hepatobiliary disorders (eg, cholecystitis, cirrhosis); may increase risk of manganese brain deposits and neurotoxicity, especially in patients on long-term therapy or higher than recommended dosages. Consider discontinuation of therapy in patients that develop signs or symptoms of hepatobiliary disease until clinical evaluation is complete.

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.

Other warnings/precautions:

• Appropriate use: Parenteral: Due to its highly acidic pH (pH 2.0), direct IV or IM injection is contraindicated; may result in severe tissue damage. Use only in conjunction with an admixture program.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous, as chloride:

Generic: Elemental manganese 0.1 mg/mL (10 mL)

Solution, Intravenous, as sulfate [preservative free]:

Generic: Elemental manganese 0.1 mg/mL (10 mL [DSC])

Tablet, Oral, as chelated:

Mangimin: Elemental manganese 10 mg [DSC] [corn free, rye free, wheat free]

Generic: Elemental manganese 50 mg

Tablet, Oral, as gluconate:

Generic: 50 mg [elemental manganese 5.7 mg]

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Manganese Chloride Intravenous)

0.1 mg/mL (per mL): $4.07

Tablets (Manganese Gluconate Oral)

50 mg (per each): $0.06

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as sulfate:

Micro-Mn: Elemental manganese 0.1 mg/mL (10 mL)

Administration: Pediatric

Parenteral: Not for direct IV or IM injection; must be diluted in parenteral nutrition solution prior to administration; acidic pH of the solution may cause tissue irritation and it is hypotonic.

Administration: Adult

Oral: May be administered with a meal.

IV: Do not administer IM or by direct IV injection; must be diluted in parenteral nutrition solution prior to administration (volume of fluid ≥100 mL). Acidic pH of the solution may cause tissue irritations and it is hypotonic.

Storage/Stability

Capsule/tablet (dietary supplement): Store at room temperature, away from heat and direct light. Do not freeze or refrigerate.

Injection: Store intact vial at 20°C to 25°C (68°F to 77°F). After admixture, discard unused portion immediately.

Use

Parenteral: Supplement to parenteral nutrition (PN) to maintain manganese serum concentrations and to prevent depletion of endogenous stores and subsequent deficiency (FDA approved in pediatric patients [age not specified] and adults).

Oral: Dietary supplement of manganese (Dietary supplement; consult product-specific labeling for manufacturer recommended ages).

Medication Safety Issues
Sound-alike/look-alike issues:

Manganese sulfate may be confused with magnesium sulfate

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Dietary Considerations

Dietary adequate intake (IOM 2001):

1 to 6 months: 0.003 mg/day.

7 to 12 months: 0.6 mg/day.

1 to 3 years: 1.2 mg/day.

4 to 8 years: 1.5 mg/day.

9 to 13 years:

Males: 1.9 mg/day.

Females: 1.6 mg/day.

14 to 18 years:

Males: 2.2 mg/day.

Females: 1.6 mg/day.

>18 years:

Males: 2.3 mg/day.

Females: 1.8 mg/day.

Pregnancy: 2 mg/day.

Lactation: 2.6 mg/day.

Pregnancy Considerations

Animal reproduction studies have not been conducted. Manganese crosses the placenta and can be detected in placental tissue and cord blood (Osada 2002).

Monitoring Parameters

Periodic manganese plasma level.

Reference Range

Whole blood: 6 to 12 mcg/L.

Mechanism of Action

Cofactor in many enzyme systems, stimulates synthesis of cholesterol and fatty acids in liver, and influences mucopolysaccharide synthesis

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Poor.

Distribution: Concentrated in mitochondria of brain, pituitary gland, pancreas, liver, kidney, and bone.

Excretion: Bile (primarily); urine (negligible).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BR) Brazil: Manganes mn;
  • (DE) Germany: Hypo 11a Mangan | Mangan | Mangan GPH;
  • (EE) Estonia: Kelasin mn;
  • (FR) France: Mangaplexe;
  • (KR) Korea, Republic of: Mangana;
  • (LT) Lithuania: Manganas homeoligo;
  • (NZ) New Zealand: Solgar chelated manganese;
  • (TH) Thailand: Chelated manganese
  1. American Society for Parenteral and Enteral Nutrition (ASPEN). Appropriate dosing for parenteral nutrition. http://www.nutritioncare.org/uploadedFiles/Documents/Guidelines_and_Clinical_Resources/PN%20Dosing%201-Sheet-FINAL.pdf. Published January 8, 2019.
  2. American Society for Parenteral and Enteral Nutrition (ASPEN). Appropriate dosing for parenteral nutrition: ASPEN recommendations. http://www.nutritioncare.org/PNDosing. Updated November 17, 2020. Accessed January 10, 2023.
  3. Aluminum in large and small volume parenterals used in total parenteral nutrition. Fed Regist. 2002;67(244):77792-77793. To be codified at 21 CFR §201.323.
  4. Berger MM, Shenkin A, Schweinlin A, et al. ESPEN micronutrient guideline. Clin Nutr. 2022;41(6):1357-1424. doi:10.1016/j.clnu.2022.02.015 [PubMed 35365361]
  5. Corkins MR, Balint J, Corkins KG, Bobo E, Plogsted S, Yaworski, JA, eds. A.S.P.E.N. Pediatric Nutrition Support Handbook. 2nd ed. American Society for Enteral and Parenteral Nutrition; 2015:chap. 35.
  6. Domellöf M, Szitanyi P, Simchowitz V, Franz A, Mimouni F; ESPGHAN/ESPEN/ESPR/CSPEN working group on pediatric parenteral nutrition. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Iron and trace minerals. Clin Nutr. 2018;37(6 Pt B):2354-2359. doi:10.1016/j.clnu.2018.06.949 [PubMed 30078716]
  7. Guenter P, Boullata JI, Ayers P, et al; Parenteral Nutrition Safety Task Force, American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Standardized competencies for parenteral nutrition prescribing: the American Society for Parenteral and Enteral Nutrition model. Nutr Clin Pract. 2015;30(4):570-576. doi:10.1177/0884533615591167 [PubMed 26078288]
  8. Institute of Medicine (IOM) (US) Panel on Micronutrients. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. National Academies Press; 2001. https://www.ncbi.nlm.nih.gov/books/NBK222310/
  9. Manganese 50 mg capsules [prescribing information]. Salt Lake City, UT: Solaray; received October 2022.
  10. Manganese 50 mg tablets [prescribing information]. Ronkonkoma, NY; PipingRock; received October 2022.
  11. Manganese chloride injection [prescribing information]. Lake Forest, IL: Hospira Inc; December 2023.
  12. MICRO MN (manganese) [product monograph]. Boucherville, Quebec, Canada: Sandoz Canada Inc; January 2022.
  13. Mirtallo J, Canada T, Johnson D, et al; Task Force for the Revision of Safe Practices for Parenteral Nutrition. Safe practices for parenteral nutrition. JPEN J Parenter Enteral Nutr. 2004;28(6):S39-S70. doi:10.1177/0148607104028006s39 [PubMed 15568296]
  14. National Institutes of Health (NIH). Manganese: fact sheet for health professionals. https://ods.od.nih.gov/factsheets/Manganese-HealthProfessional/. Updated March 29, 2021. Accessed December 4, 2023.
  15. Olson LM, Wieruszewski PM, Jannetto PJ, Abbott JC, McMahon MM, Nystrom EM. Quantitative assessment of trace-element contamination in parenteral nutrition components. JPEN J Parenter Enteral Nutr. 2019;43(8):970-976. doi:10.1002/jpen.1668 [PubMed 31197862]
  16. Osada H, Watanabe Y, Nishimura Y, et al, "Profile of Trace Element Concentrations in the Feto-Placental Unit in Relation to Fetal Growth," Acta Obstet Gynecol Scand, 2002, ;81(10):931-7. [PubMed 12366483]
  17. Srikrishnaraj A, Chambers K, South C, et al. Trace elements' contamination of pediatric parenteral nutrition solutions in Canada: a cause for concern. JPEN J Parenter Enteral Nutr. 2021;45(2):347-356. doi:10.1002/jpen.1836 [PubMed 32338772]
  18. Vanek VW, Borum P, Buchman A, et al. A.S.P.E.N. position paper: recommendations for changes in commercially available parenteral multivitamin and multi-trace element products. Nutr Clin Pract. 2012;27:440-491. [PubMed 22730042]
Topic 140499 Version 14.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟