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Mineral Oil

Generic name: mineral oil systemic

Brand names: Milkinol, Kondremul Plain, Muri-Lube, Liqui Doss, Kondremul, Fleet Mineral Oil Enema

Dosage Forms

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

Enema, Rectal:

Fleet Oil: (133 mL)

Generic: (135 mL)

Oil, Oral:

GoodSense Mineral Oil: (473 mL) [odorless]

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

Pharmacology

Mechanism of Action

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

Pharmacokinetics/Pharmacodynamics

Absorption

Minimal following oral or rectal administration

Distribution

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

Excretion

Feces

Onset of Action

Oral: 6 to 8 hours; Rectal: 2 to15 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

Contraindications

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

Dosage and Administration

Dosing: Adult

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

Dosing: Geriatric

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

Rectal: Refer to adult dosing.

Dosing: Pediatric

Constipation, occasional:

Oral:

Plain (nonemulsified) liquid:

Children 6 to 11 years: 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: 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 11 years: 10 to 30 mL/day in a single daily dose or in up to 3 divided doses

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

Rectal:

Children 2 to 11 years: Administer one half the contents of a 4.5 oz bottle as a single dose

Children ≥12 years and Adolescents: Administer the contents of one 4.5 oz bottle as a single dose

Constipation, chronic: Limited data available (Tabbers [NASPGHAN 2014]):

Oral: Children and Adolescents: 1 to 3 mL/kg/day divided in 1 to 2 doses; maximum daily dose: 90 mL/day

Rectal:

Children 2 to 11 years: 30 to 60 mL once daily

Children >11 years and Adolescents: 60 to 150 mL once daily

Fecal impaction:

Oral: Slow disimpaction: Children and Adolescents: 3 mL/kg twice daily for 7 days (Pashankar 2005; Wyllie 2011)

Rectal:

Children 2 to 11 years: Administer one half the contents of a 4.5 oz bottle as a single dose

Children ≥12 years and Adolescents: Administer the contents of one 4.5 oz bottle as a single dose

Removal of barium sulfate residues following barium administration: Rectal:

Children 2 to 11 years: Administer one half the contents of a 4.5 oz bottle as a single dose

Children ≥12 years and Adolescents: Administer the contents of one 4.5 oz bottle as a single dose

Administration

Oral: Mineral oil may be more palatable if refrigerated (NASGHAN 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.

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.

Storage

Oral plain (nonemulsified) liquid: Protect from sunlight.

Oral suspension (emulsion) (Kondremul®): Store at 15°C to 25°C (59°F to 77°F).

Rectal enema: Store at 20°C to 25°C (68°F to 77°F); protect from sunlight.

Drug Interactions

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. 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. 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. Consider therapy modification

Phytonadione: Mineral Oil may decrease the serum concentration of Phytonadione. Specifically, mineral oil may decrease the absorption of phytonadione. Monitor therapy

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. Exceptions: Calcipotriene; Calcitriol (Topical); Tacalcitol. Consider therapy modification

Adverse Reactions

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

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.

Monitoring Parameters

Monitor for response (stool frequency, consistency).

Pregnancy

Pregnancy Considerations

The use of mineral oil for the treatment of constipation in pregnancy is not recommended (Mahadevan 2006).

Patient Education

What is this drug used for?

  • It is used to treat constipation.
  • It is used to clean out the GI (gastrointestinal) tract.

Frequently reported side effects of this drug

  • Abdominal cramps
  • Bloating
  • Passing gas

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

  • Severe dizziness
  • Passing out
  • Severe abdominal pain
  • Severe nausea
  • Severe vomiting
  • Severe diarrhea
  • Rectal bleeding
  • Rectal pain
  • Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Source: Wolters Kluwer Health. Last updated January 22, 2020.