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
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).
ActionsActions
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
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
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 |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 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.
More Mineral Oil resources
- Mineral Oil Side Effects (in more detail)
- Mineral Oil Use in Pregnancy & Breastfeeding
- Mineral Oil Drug Interactions
- Mineral Oil Support Group
- 0 Reviews · Be the first to review/rate this drug
- Mineral Oil Prescribing Information (FDA)
- Mineral Oil Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)
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