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Mineral oil: Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Fleet Oil [OTC];
  • GoodSense Mineral Oil [OTC]
Pharmacologic Category
  • Laxative, Lubricant
Dosing: Adult
Constipation

Constipation:

Oral: Note: Do not use for more than 1 week.

Plain (nonemulsified) liquid: 15 to 45 mL in 24 hours (maximum: 45 mL in 24 hours). May be taken as a single dose (at bedtime) or in divided doses.

Suspension (emulsion) (Kondremul): 30 to 90 mL daily (maximum: 90 mL daily). May be taken as a single dose or in up to 3 equal divided doses.

Rectal (Fleet Mineral Oil): 118 mL as a single dose.

Fecal impaction or following barium studies

Fecal impaction or following barium studies: Rectal (Fleet Mineral Oil): 118 mL as a single dose.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Mineral oil: Pediatric drug information")

Constipation, occasional:

Note: Other oral agents (eg, polyethylene glycol 3350) are preferred for pharmacologic constipation therapy. Mineral oil may be used as additional or second-line therapy (NASPGHAN [Tabbers 2014]). Due to risk of lipoid pneumonia, do not use oral mineral oil in patients at risk for aspiration, including infants and patients with neurological impairment, or in patients with significant gastroesophageal reflux, nausea, or vomiting (Colombo 2020; Kurlandsky 1992; Sharif 2001; Spickard 1994; Weinstein 2001).

Oral: OTC labeling:

Plain (nonemulsified) liquid:

Children 6 to <12 years: Oral: 5 to 15 mL/day in a single daily dose at bedtime or in divided doses; maximum daily dose: 15 mL/day.

Children ≥12 years and Adolescents: Oral: 15 to 45 mL/day in a single daily dose at bedtime or in divided doses; maximum daily dose: 45 mL/day.

Suspension (emulsion) (Kondremul):

Children 6 to <12 years: Oral: 10 to 30 mL/day in a single daily dose or in up to 3 divided doses.

Children ≥12 years and Adolescents: Oral: 30 to 90 mL/day in a single daily dose or in up to 3 divided doses.

Rectal: OTC labeling: Note: 118 mL mineral oil is delivered per 133 mL bottle.

Children 2 to <12 years: Rectal: 59 mL (½ bottle) as a single dose.

Children ≥12 years and Adolescents: Rectal: 118 mL (full bottle) as a single dose.

Constipation, chronic: Limited data available:

Note: Other oral agents (eg, polyethylene glycol 3350) are preferred for pharmacologic constipation therapy. Mineral oil may be used as additional or second-line therapy (NASPGHAN [Tabbers 2014]). Due to risk of lipoid pneumonia, do not use oral mineral oil in patients at risk for aspiration, including infants, patients with neurological impairment, or in patients with significant gastroesophageal reflux, nausea, or vomiting (Colombo 2020; Kurlandsky 1992; Sharif 2001; Spickard 1994; Weinstein 2001).

Oral:

Children and Adolescents: Oral: 1 to 2 mL/kg/day once daily or in divided doses; higher doses of 3 mL/kg/day may be necessary in some patients. Usual maximum daily dose is 45 mL/day; however, some patients may require up to 90 mL/day (NASPGHAN [Tabbers 2014]; manufacturer's labeling).

Rectal:

Children 2 to <12 years: Rectal: 30 to 60 mL once daily (NASPGHAN [Tabbers 2014]).

Children ≥12 years and Adolescents: Rectal: 60 to 150 mL once daily (NASPGHAN [Tabbers 2014]).

Fecal impaction: OTC labeling:

Note: Other oral agents (eg, polyethylene glycol 3350) are preferred for pharmacologic constipation therapy. Mineral oil may be used as additional or second-line therapy (NASPGHAN [Tabbers 2014]). 118 mL mineral oil is delivered per 133 mL bottle.

Children 2 to <12 years: Rectal: 59 mL (½ bottle) as a single dose.

Children ≥12 years and Adolescents: Rectal: 118 mL (full bottle) as a single dose.

Removal of residues following barium administration: OTC labeling: Note: 118 mL mineral oil is delivered per 133 mL bottle.

Children 2 to <12 years: Rectal: 59 mL (½ bottle) as a single dose.

Children ≥12 years and Adolescents: Rectal: 118 mL (full bottle) as a single dose.

Dosing: Older Adult

Oral: Avoid use (Beers Criteria [AGS 2019]).

Rectal: Refer to adult dosing.

Dosage Forms: US

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

Enema, Rectal:

Fleet Oil: (133 mL)

Generic: (135 mL [DSC])

Oil, Oral:

GoodSense Mineral Oil: (473 mL) [odorless]

Generic: (30 mL, 472 mL [DSC], 473 mL, 500 mL, 1000 mL, 4000 mL)

Generic Equivalent Available: US

Yes

Administration: Adult

Oral: Mineral oil may be more palatable if refrigerated (NASPGHAN 2006). Due to risk of aspiration, do not administer to patient in supine position. Do not take with meals.

Plain (nonemulsified): Administer at bedtime unless administered in divided doses. Administer at least 2 hours before or after other medications.

Suspension (emulsion) (Kondremul): Shake well before use. May administer plain or mixed with warm or cold water, milk, or cocoa.

Rectal (Fleet Mineral Oil): Gently insert enema rectally following the instructions on the package labeling.

Administration: Pediatric

Oral: Mineral oil may be more palatable if refrigerated (NASPGHAN 2006). Note: Due to risk of aspiration, do not administer to patient in supine position.

Plain (nonemulsified): Administer at least 2 hours before or after other medications. Do not administer with meals.

Suspension (emulsion) (Kondremul): Shake well before use. May be administered alone or mixed with warm or cold water, milk, or cocoa; do not administer with meals.

Rectal: Administer with patient lying on left side and knees bent or with patient kneeling and head and chest leaning forward until left side of face is resting comfortably. Remove protective shield and gently insert enema tip into rectum with a slight side-to-side movement with tip pointing toward the navel; have patient bear down. Do not force the enema tip into the rectum as this may cause injury. Squeeze the bottle until correct dose is administered. It is not necessary to empty the bottle completely for a one-bottle dose. Remove enema tip from rectum; patient should maintain position until urge to evacuate is strong (evacuate within 15 minutes).

Use: Labeled Indications

Oral: Temporary relief of occasional constipation

Rectal: Temporary relief of occasional constipation, relief of fecal impaction; removal of barium sulfate residues following barium administration

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.

Older Adult: High-Risk Medication:

Beers Criteria: Mineral oil (when administered orally) is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients 65 years and older (independent of diagnosis or condition) due to its potential for aspiration and adverse events; safer alternatives exist (Beers Criteria [AGS 2019]).

Pediatric patients: High-risk medication:

KIDs List: Mineral oil, when used in infants <1 year of age and administered orally, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of lipid pneumonitis (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Gastrointestinal: Abdominal cramps, diarrhea, nausea, oily rectal leakage (large doses; may cause anal irritation, hemorrhoids, perianal discomfort, pruritus ani, soiling of clothes), vomiting

Contraindications

Oral: Children <6 years, pregnancy, bedridden patients, elderly, use longer than 1 week, or difficulty swallowing.

Warnings/Precautions

Concerns related to adverse effects:

• Aspiration: Lipid pneumonitis results from aspiration of mineral oil; risk is increased in patients in prolonged supine position or conditions which interfere with swallowing or epiglottal function (eg, stroke, Parkinson's disease, Alzheimer's disease, esophageal dysmotility).

Other warnings/precautions:

• OTC labeling: Health care provider should be contacted in case of sudden changes in bowel habits which last over 2 weeks or if abdominal pain, nausea, vomiting, or rectal bleeding occur following use; do not use for >1 week, unless otherwise directed by healthcare provider. Do not use orally in children <6 years of age or rectally in children <2 years of age.

Warnings: Additional Pediatric Considerations

Due to risk of lipoid pneumonia, do not use oral mineral oil in patients at risk for aspiration, including infants and patients with neurological impairment, difficulty swallowing, significant gastroesophageal reflux, nausea, or vomiting (Colombo 2020; Kurlandsky 1992; Paul 2021; Sharif 2001; Spickard 1994; Weinstein 2001).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Multivitamins/Fluoride (with ADE): Mineral Oil may decrease the serum concentration of Multivitamins/Fluoride (with ADE). Management: Avoid concomitant oral administration of mineral oil and multivitamins when possible; consider separating the administration of these agents by several hours to minimize the risk of interaction. Risk D: Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): Mineral Oil may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, mineral oil may impair the absorption of fat-soluble vitamins. Management: Avoid concomitant oral administration of mineral oil and multivitamins when possible; consider separating the administration of these agents by several hours to minimize the risk of interaction. Risk D: Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): Mineral Oil may decrease the serum concentration of Multivitamins/Minerals (with AE, No Iron). Management: Avoid concomitant oral administration of mineral oil and multivitamins when possible; consider separating the administration of these agents by several hours to minimize the risk of interaction. Risk D: Consider therapy modification

Vitamin D Analogs: Mineral Oil may decrease the serum concentration of Vitamin D Analogs. More specifically, mineral oil may interfere with the absorption of Vitamin D Analogs. Management: Avoid concomitant, oral administration of mineral oil and vitamin D analogs. Consider separating the administration of these agents by several hours to minimize the risk of interaction. Monitor plasma calcium concentrations. Risk D: Consider therapy modification

Pregnancy Considerations

Mineral oil is not recommended for the treatment of constipation in pregnant women. Use may be associated with decreased maternal absorption of fat-soluble vitamins, which may cause adverse maternal and neonatal effects (Body 2016; Gomes 2018).

Dietary Considerations

Do not administer orally with food or meals because of the risk of aspiration; prolonged administration of mineral oil may decrease absorption of lipid-soluble vitamins A, D, E, and K. Light sterile mineral oils are not for injection.

Monitoring Parameters

Monitor for response (stool frequency, consistency).

Mechanism of Action

Eases passage of stool by decreasing water absorption and lubricating the intestine; retards colonic absorption of water

Pharmacokinetics

Onset of action: Oral: 6 to 8 hours; Rectal: 2 to15 minutes

Absorption: Minimal following oral or rectal administration

Distribution: Into intestinal mucosa, liver, spleen, and mesenteric lymph nodes

Excretion: Feces

Brand Names: International
  • Fleet enema para Adulto (MX)


For country abbreviations used in Lexicomp (show table)
  1. 2019 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2019 updated AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2019;67(4):674-694. doi: 10.1111/jgs.15767. [PubMed 30693946]
  2. Body C, Christie JA. Gastrointestinal diseases in pregnancy: nausea, vomiting, hyperemesis gravidarum, gastroesophageal reflux disease, constipation, and diarrhea. Gastroenterol Clin North Am. 2016;45(2):267‐283. doi:10.1016/j.gtc.2016.02.005 [PubMed 27261898]
  3. Colombo JL. Aspiration syndromes. In: Kliegman RM and St. Geme J, eds. Nelson Textbook of Pediatrics. 21st ed. Philadelphia, PA: Saunders Elsevier; 2020: chap 425.
  4. Constipation Guideline Committee of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). Evaluation and treatment of constipation in infants and children: Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2006;43(3):e1-e13.
  5. CVS Mineral Oil (mineral oil liquid) (prescribing information). Woonsocket, RI: CVS Pharmacy, Inc; 2018.
  6. Fleet (mineral oil) [prescribing information]. Lynchburg, VA: C.B. Fleet Co. Inc; 1997.
  7. Fleet (mineral oil enema) [prescribing information]. Lynchburg, VA: C.B. Fleet Company, Inc; 2018
  8. Gomes CF, Sousa M, Lourenço I, Martins D, Torres J. Gastrointestinal diseases during pregnancy: what does the gastroenterologist need to know? Ann Gastroenterol. 2018;31(4):385‐394. doi:10.20524/aog.2018.0264 [PubMed 29991883]
  9. GoodSense Mineral Oil [prescribing information]. Peachtree, GA: Geiss, Destin & Dunn Inc; received April 2019.
  10. Humco Mineral Oil Heavy (mineral oil liquid) [prescribing information]. Texarkana, TX: Humco; January 2018.
  11. Kondremul [package insert]. Lanhome, PA: Insight Pharmaceuticals; June 2013.
  12. Kondremul (mineral oil liquid) [prescribing information]. Tarrytown, NY: Insight Pharmaceuticals; 2015.
  13. Kurlandsky LE, Vaandrager V, Davy CL, Stockinger FS. Lipoid pneumonia in association with gastroesophageal reflux. Pediatr Pulmonol. 1992;13(3):184-188. doi:10.1002/ppul.1950130312 [PubMed 1437335]
  14. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
  15. Mineral oil [package insert]. Mount Vernon, NY: Geritrex Corporation; 2011.
  16. Mineral oil [prescribing information]. Mount Vernon, NY: Geritrex Corporation.
  17. Mineral oil [prescribing information]. Salisburg, NC: DZA Brands, LLC; received March 2022.
  18. Paul A, Punati J. What is the evidence for over the counter laxatives to treat childhood constipation? Curr Gastroenterol Rep. 2021;23(11):19. doi:10.1007/s11894-021-00818-1 [PubMed 34637057]
  19. Sharif F, Crushell E, O'Driscoll K, Bourke B. Liquid paraffin: a reappraisal of its role in the treatment of constipation. Arch Dis Child. 2001;85(2):121-124. doi:10.1136/adc.85.2.121 [PubMed 11466186]
  20. Spickard A 3rd, Hirschmann JV. Exogenous lipoid pneumonia. Arch Intern Med. 1994;154(6):686-692. [PubMed 8129503]
  21. Tabbers MM, DiLorenzo C, Berger MY, et al. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014;58(2):258-274. doi:10.1097/MPG.0000000000000266 [PubMed 24345831]
  22. Weinstein M. First do no harm: The dangers of mineral oil. Paediatr Child Health. 2001;6(3):129-131. doi:10.1093/pch/6.3.129 [PubMed 20084222]
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