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Mineral Oil

Pronunciation

Pronunciation

(MIN er al oyl)

Index Terms

  • Heavy Mineral Oil
  • Liquid Paraffin
  • White Mineral Oil

Dosage Forms

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

Enema, Rectal:

Fleet Oil: (133 mL)

Generic: (133 mL [DSC], 135 mL)

Oil, Does not apply:

Generic: (1 mL, 473 mL [DSC], 480 mL, 500 mL, 3785 mL, 3800 mL, 3840 mL)

Oil, Oral:

GoodSense Mineral Oil: (473 mL) [odorless]

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

Brand Names: U.S.

  • Fleet Oil [OTC]
  • GoodSense Mineral Oil [OTC]

Pharmacologic Category

  • Laxative, Lubricant

Pharmacology

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

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.

Dosing: Adult

Constipation:

Oral:

Plain (nonemulsified) liquid: 15-45 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): 30-90 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

Refer to adult dosing.

Dosing: Pediatric

Constipation:

Oral:

Children 6 to <12 years:

Plain (nonemulsified) liquid: 5-15 mL in 24 hours (maximum: 15 mL in 24 hours). May be taken as a single dose (at bedtime) or in divided doses.

Suspension (emulsion) (Kondremul): 10-30 mL daily (maximum: 30 mL daily). May be taken as a single dose or divided in up to 3 equal divided doses.

Children ≥12 years and Adolescents: Refer to adult dosing.

Rectal (Fleet Mineral Oil):

Children 2 to <12 years: 59 mL as a single dose

Children ≥12 years: Refer to adult dosing.

Fecal impaction or following barium studies: Rectal (Fleet® Mineral Oil):

Children 2 to <12 years: 59 mL as a single dose

Children ≥12 years and Adolescents: Refer to adult dosing.

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.

Plain (nonemulsified): Administer on an empty stomach. Take 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. Do not take with meals.

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. Consider therapy modification

Adverse Reactions

Frequency not defined.

Gastrointestinal: Abdominal cramps, diarrhea, nausea, vomiting

Respiratory: Lipid pneumonitis with aspiration

Miscellaneous: Large doses may cause anal leakage causing anal itching, irritation, hemorrhoids, perianal discomfort, soiling of clothes

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: Healthcare 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). Avoid use in patients who may aspirate.

Pregnancy Considerations

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

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience abdominal cramps, bloating, or flatulence. Have patient report immediately to prescriber severe dizziness, passing out, severe abdominal pain, severe nausea, severe vomiting, severe diarrhea, rectal bleeding, or rectal pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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