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.
