Mineral Oil

Pronunciation

Class: Cathartics and Laxatives
ATC Class: A06AD10
VA Class: GA203
CAS Number: 8012-95-1
Brands: Fleet, Kondremul, Milkinol, Phillips’ M-O

Introduction

Lubricant laxative; complex mixture of hydrocarbons derived from crude petroleum.a

Uses for Mineral Oil

Constipation

Relief of occasional constipation.a e f

Relief of constipation associated with stricture of the colon and for softening fecal impactions.d

Bulk-forming laxatives, stool softeners, or mineral oil are preferred to other laxatives when a soft stool is desired, especially in patients with conditions in which straining during defecation should be avoided (e.g., MI, hypertension, vascular diseases, diseases of the anus or rectum, hernias, recent rectal or abdominal surgery).c d

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Mineral oil may be preferred to bulk-forming laxatives to ease evacuation of feces in patients with constipation associated with hard, dry stools.c

Has been used in fixed combination with a saline laxative (magnesium hydroxide).f

Colonic Evacuation

Used as an enema to empty the colon prior to surgery or radiologic or colonoscopic procedures.c

Used as an enema to remove barium sulfate residues from the colon after barium administration.e

Mineral Oil Dosage and Administration

Administration

Administer orally or rectally.a b c e f

Mineral oil preparations should be used only occasionally and should not be used for longer than 1 week unless directed by a clinician.a b e f

Oral Administration

Mineral oil (plain, nonemulsified), mineral oil emulsion (suspension), or mineral oil in fixed combination with magnesium hydroxide is administered orally.b f

Plain (nonemulsified) mineral oil or fixed-combination mineral oil/magnesium hydroxide should be given only at bedtime on an empty stomach.a f

Each dose of fixed-combination mineral oil/magnesium hydroxide should be given with a full glass (250 mL) of liquid.f

Mineral oil emulsions may be more palatable than plain mineral oil.b Shake containers of mineral oil emulsion or fixed-combination mineral oil/magnesium hydroxide before use.b f h

Rectal Administration

Mineral oil is administered rectally as an enema.b

Administer carefully according to manufacturer’s instructions; gently insert squeeze bottle into rectum with tip pointing at navel.e

Dosage

Dosage of mineral oil emulsion is expressed in terms of mineral oil content.b

Pediatric Patients

Constipation
Oral

Children 6–11 years of age: 10–25 mL daily of mineral oil suspension given as a single dose or in divided doses.h Alternatively, 20–30 mL of fixed-combination mineral oil/magnesium hydroxide daily as a single dose or in divided doses.f

Children ≥12 years of age: 15–45 mL of plain mineral oil daily given as a single dose (minimum of 15 mL) or in divided doses.a b Alternatively, 30–75 mL of mineral oil suspension daily or 44–59 mL of fixed-combination mineral oil/magnesium hydroxide daily given as a single dose or in divided doses.f h

Rectal

Children 2–11 years of age: 30–60 mL of plain mineral oil given as an enema in a single dose.b

Children ≥12 years of age: 120 mL (range: 60–150 mL) of plain mineral oil given as an enema in a single dose.b

Adults

Constipation
Oral

15–45 mL daily of plain mineral oil given as a single dose (minimum of 15 mL) or in divided doses.a b Alternatively, 30–75 mL of mineral oil suspension daily or 44–59 mL of fixed-combination mineral oil/magnesium hydroxide daily given as a single dose or in divided doses.f h

Rectal

120 mL (range: 60–150 mL) of plain mineral oil given as an enema in a single dose.b

Prescribing Limits

Pediatric Patients

Constipation
Oral

Children 6–11 years of age: Maximum 20–30 mL of fixed-combination mineral oil/magnesium hydroxide daily.f

Children ≥12 years of age: Maximum 44–59 mL of fixed-combination mineral oil/magnesium hydroxide daily.f

Adults

Constipation
Oral

Maximum 44–59 mL of fixed-combination mineral oil/magnesium hydroxide daily.f

Cautions for Mineral Oil

Contraindications

  • Bedridden, geriatric, debilitated, or pregnant patients.a c f

  • Oral mineral oil in patients with dysphagia (e.g., esophageal or gastric retention, dysphagia, or hiatal hernia).a c d f

  • Appendicitis or undiagnosed rectal bleeding.d f

  • Concurrent treatment with stool softeners.a f

  • Known hypersensitivity to mineral oil or any ingredient in the fomulation.

Warnings/Precautions

General Precautions

Rectal Administration

When given rectally as an enema, possible perforation/abrasion of rectum.e Administer carefully according to manufacturer’s instructions.e

Aspiration

When given orally, possible aspiration and lipid pneumonitis.c Increased risk of aspiration in young children, geriatric or debilitated patients.c

Use of Fixed Combinations

When mineral oil is used in fixed combination with magnesium hydroxide, consider the cautions, precautions, and contraindications associated with magnesium hydroxide.f

Specific Populations

Pregnancy

Category C.g

Hypoprothrombinemia and hemorrhagic disease of the newborn reported after chronic oral administration during pregnancy.c

Pediatric Use

Plain mineral oil should not be used orally in children <12 years of age;a mineral oil suspension should not be used orally in children <6 years of age.h

Should not be used rectally in children <2 years of age.e

Fixed-combination mineral oil/magnesium hydroxide should not be used orally in infants.f

Geriatric Use

Increased risk of aspiration and lipid pneumonia.d Use with caution in debilitated geriatric patients.d

Common Adverse Effects

Rectal seepage, anal irritation, pruritus ani, rectal reflex impairment, infection/impaired healing of anorectal lesions.c

Interactions for Mineral Oil

Specific Drugs

Drugs

Interaction

Comments

Anticoagulants, oral (warfarin)

Possible decreased vitamin K absorption; increased anticoagulant effectd

Possible decreased warfarin absorptiond

Use mineral oil with caution; monitor INRd

Avoid concomitant administration with mineral oilc

Fat-soluble vitamins (i.e., vitamins A, D, E, and K)

Possible impaired absorption of fat-soluble vitamins with chronic use of oral mineral oilc

Avoid concomitant administration with mineral oil; administer lowest effective dose of mineral oilc

Administer mineral oil on an empty stomach; limit use to <1 weekc

Carotene

Impaired absorptionc

Avoid concomitant administration with mineral oil; administer lowest effective dose of mineral oilc

Digoxin

Impaired absorptionc

Avoid concomitant administration with mineral oil; administer lowest effective dose of mineral oilc

Oral contraceptives

Impaired absorptionc

Avoid concomitant administration with mineral oil; administer lowest effective dose of mineral oilc

Stool softeners (i.e., docusate sodium)

Possible increased mineral oil absorptionc

Do not use stool softeners concomitantly with mineral oilc

Mineral Oil Pharmacokinetics

Absorption

Bioavailability

Mineral oil emulsion 30–60% absorbed from the intestine after oral administration.b

Minimal absorption of plain mineral oil following oral or rectal administration.b

Onset

Laxative effect occurs 6–8 hours after oral administration and 5–15 minutes after rectal administration.b d

Distribution

Extent

Following oral administration, absorbed mineral oil distributed into the mesenteric lymph nodes, intestinal mucosa, liver, and spleen.b

Stability

Storage

Oral

Oil or Suspension

Plain mineral oil or mineral oil emulsion: Tight, light-resistant container at 20–25°C (may be exposed to 15–30°C).a

In fixed combination with magnesium hydroxide: Tight container at room temperature; avoid freezing.f

Rectal

Oil

Tight, light-resistant container at 20–25°C (may be exposed to 15–30°C).

Actions

  • After oral administration, appears to retard reabsorption of water from the intestinal tract and lubricate fecal material and the intestinal mucosa.a

  • Increased water retention may also increase bulk of the stool and hasten evacuation.a

  • Preparations emulsified with acacia may have increased wetting properties and enhanced fecal penetration.a

  • Rectal enemas exert laxative action via a lubricant effect and/or simple physical distention of the rectum.c

Advice to Patients

  • Importance of informing clinicians before use if abdominal pain, nausea, or vomiting is present or if a sudden change in bowel habits that persists over a period of 2 weeks has been noticed.a c f

  • Importance of discontinuing use and informing clinician if a bowel movement does not occur or rectal bleeding occurs after use.a f

  • Importance of not using laxative products for longer than 1 week unless directed by a clinician.e f

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c e f

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Mineral Oil

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Oil*

Fleet Mineral Oil

Fleet

Suspension*

2.5 mL/5 mL

Kondremul (sugar-free)

Insight

4.75 mL/5 mL

Milkinol (sugar-free)

Schwarz

Rectal

Oil*

 

Fleet Mineral Oil Enema

Fleet

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Mineral Oil Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

1.25 mL/5 mL with Magnesium Hydroxide 300 mg/5 mL*

Phillips’ M-O (regular or mint flavor)

Bayer

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

a. Purdue Products. Mineral oil prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004. Updated 2003.

b. AHFS drug information 2004. McEvoy GK, ed. Mineral Oil. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2777-8.

c. AHFS Drug Information 2004. McEvoy, GK, ed. Cathartics and laxatives general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2769-73

d. American Pharmaceutical Association. Handbook of nonprescriptin drugs. 14th ed. Washington, DC: American Pharmaceutical Association; 2004:380,384-6,1338.

e. C.B. Fleet Company, Inc. Mineral oil enema prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004.

f. Bayer Healthcare. Phillips MO lubricant laxative (magnesium hydroxide/mineral oil) prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004.

g. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Baltimore, MD: Williams & Wilkins; 2002:737.

h. Kondremul prescribing information. Insight Pharmaceuticals website . Accessed July 19, 2004.

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