Fleet

Emollients and Protectants, Other
Enemas for Constipation
Lubricant Laxatives

For storage information, see the specific product information within the How Supplied Section.

Do not administer mineral oil with meals.
Mineral oil is an emulsion. Shake well before each use.
Use a calibrated medication spoon or other device to measure oral dosage.
Do not administer at bedtime due to a potential risk of mineral oil aspiration which may result in lipid pneumonitis.
With larger doses, rectal leakage of the oil may be a problem and require more attention to personal hygiene; protective garments for incontinence may be helpful.
Mineral oil should not be used orally for longer than one week without seeking advice of the health care provider.

Topical oil
Wash hands before and after application.
Avoid contact with eyes.

For rectal use only.
Hold bottle upright and grasp bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.
Position patient using one of the following options:
Left-side position: Lie on left side with knee bent and arms at rest.
Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.
With steady pressure, gently insert enema tip into rectum with tip pointing toward navel.
Squeeze bottle until recommended dose is expelled. It is not necessary to empty unit; a small amount of liquid will remain after use.
Remove tip gently from rectum.
Maintain position until urge to evacuate is strong (usually 1—5 minutes).
Discontinue use if resistance is encountered; forcing enema can result in injury.
If no urge to defecate is felt after 5 minutes of using, try to empty bowel with regular enema.
Instruct patient to contact physician if enema tip causes rectal pain or bleeding and/or if no liquid comes out of the rectum after 30 minutes as these signs may indicate a more serious condition.
Do not use mineral oil for longer than one week.
 

fecal incontinence / Early / 1.0-10.0
pneumonitis / Delayed / 0-0.1

diarrhea / Early / 1.0-10.0
skin irritation / Early / 1.0-10.0
nausea / Early / 1.0-10.0
syncope / Early / 0-1.0
weakness / Early / 0-1.0
dizziness / Early / 0-1.0
vomiting / Early / 0-1.0
hypovitaminosis / Delayed / 0-1.0
abdominal pain / Early / 10.0
fecal urgency / Early / 10.0

Fleet, Kondremul, Muri-Lube

OTC

Oral and rectal lubricant laxative, and topically as a skin protectant
Only laxative recommended for fecal impaction
Marketed prior to 1962, has not been evaluated formally by FDA for safety and efficacy.

30—90 mL per day PO as needed to relieve constipation. The maximum daily dose may be taken as a single dose or divided in up to 3 equal parts. Should not be used for longer than 1 week unless directed by a physician.

10—30 mL per day PO as needed to relieve constipation. The maximum daily dose may be taken as a single dose or divided in up to 3 equal parts. Should not be used for longer than 1 week unless directed by a physician.

Safety and efficacy have not been established.

120 mL rectally as a single dose. Do not use more than one enema per day. Should not be used longer than one week unless directed by physician.

60 mL rectally as a single dose. Do not use more than one enema per day. Should not be used longer than one week unless directed by physician.

No dosage adjustments are needed.

No dosage adjustments are needed.

Acetaminophen; Hydrocodone: (Moderate) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as mineral oil, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Alendronate; Cholecalciferol: (Moderate) Absorption of fat-soluble vitamins is reported to be decreased with prolonged oral administration of mineral oil. However, despite warnings in various texts, there is little direct evidence that the interaction is of practical/clinical importance with limited use as directed. It may be prudent for those taking dietary supplements of Vitamin A, D, E, or K to separate administration by 1 hour before or 4 hours after a mineral oil oral dosage to help limit absorption interactions. Theoretically, the effect on fat-soluble vitamin absorption may more likely occur with prolonged or chronic administration of mineral oil.
Atropine; Difenoxin: (Moderate) Diphenoxylate can decrease GI motility. Drugs used to treat constipation, such as laxatives, would counteract the effect of antidiarrheals. In general, it would be illogical to concurrently administer these drugs at the same time. If an antidiarrheal medication is needed, it would be wise to temporarily discontinue use of agents with laxative effects.
Bumetanide: (Moderate) Loop diuretics may increase the risk of hypokalemia especially in patients receiving prolonged therapy with laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy.
Calcium Phosphate, Supersaturated: (Moderate) Patients should be instructed not to administer additional laxatives or purgative agents during treatment with sodium phosphate monobasic monohydrate; sodium phosphate dibasic anhydrous.
Calcium; Vitamin D: (Moderate) Absorption of fat-soluble vitamins is reported to be decreased with prolonged oral administration of mineral oil. However, despite warnings in various texts, there is little direct evidence that the interaction is of practical/clinical importance with limited use as directed. It may be prudent for those taking dietary supplements of Vitamin A, D, E, or K to separate administration by 1 hour before or 4 hours after a mineral oil oral dosage to help limit absorption interactions. Theoretically, the effect on fat-soluble vitamin absorption may more likely occur with prolonged or chronic administration of mineral oil.
Chlorpheniramine; Hydrocodone: (Moderate) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as mineral oil, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Dichlorphenamide: (Moderate) Use dichlorphenamide and mineral oil together with caution. Dichlorphenamide increases potassium excretion and can cause hypokalemia and should be used cautiously with other drugs that may cause hypokalemia including laxatives. Measure potassium concentrations at baseline and periodically during dichlorphenamide treatment. If hypokalemia occurs or persists, consider reducing the dichlorphenamide dose or discontinuing dichlorphenamide therapy.
Diphenoxylate; Atropine: (Moderate) Diphenoxylate can decrease GI motility. Drugs used to treat constipation, such as laxatives, would counteract the effect of antidiarrheals. In general, it would be illogical to concurrently administer these drugs at the same time. If an antidiarrheal medication is needed, it would be wise to temporarily discontinue use of agents with laxative effects.
Docusate Sodium; Senna: (Major) The concurrent use of docusate salts with mineral oil to relieve constipation is not recommended because docusate can increase the systemic absorption of mineral oil. Inflammation of the intestinal mucosa, liver, spleen and lymph nodes may occur due to a foreign body reaction. Mineral oil deposition has been detected at these sites.
Docusate: (Major) The concurrent use of docusate salts with mineral oil to relieve constipation is not recommended because docusate can increase the systemic absorption of mineral oil. Inflammation of the intestinal mucosa, liver, spleen and lymph nodes may occur due to a foreign body reaction. Mineral oil deposition has been detected at these sites.
Estrogens: (Minor) While information regarding this interaction is limited, it appears that the simultaneous oral administration of estrogens and mineral oil may decrease the oral absorption of the estrogens, resulting in lower estrogen plasma concentrations. This interaction may be more likely with the chronic administration of mineral oil, as opposed to a single dose of mineral oil used for occasional constipation. In order to avoid an interaction, it would be prudent to separate administration times, giving estrogens 1 hour before or 2 hours after the oral administration of mineral oil.
Ethacrynic Acid: (Moderate) Loop diuretics may increase the risk of hypokalemia especially in patients receiving prolonged therapy with laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy.
Furosemide: (Moderate) Loop diuretics may increase the risk of hypokalemia especially in patients receiving prolonged therapy with laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy.
Guaifenesin; Hydrocodone: (Moderate) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as mineral oil, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Homatropine; Hydrocodone: (Moderate) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as mineral oil, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Hydrocodone: (Moderate) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as mineral oil, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Hydrocodone; Ibuprofen: (Moderate) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as mineral oil, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Hydrocodone; Pseudoephedrine: (Moderate) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as mineral oil, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Lactulose: (Major) In general, other laxatives, such as mineral oil, should not be used concurrently with lactulose, especially during the initial phase of therapy for portal-systemic encephalopathy, because the loose stools resulting from their use may falsely suggest that adequate lactulose dosage has been achieved.
Loop diuretics: (Moderate) Loop diuretics may increase the risk of hypokalemia especially in patients receiving prolonged therapy with laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy.
Phytonadione, Vitamin K1: (Moderate) Absorption of fat-soluble vitamins is reported to be decreased with prolonged oral administration of mineral oil. However, despite warnings in various texts, there is little direct evidence that the interaction is of practical/clinical importance with limited use as directed. It may be prudent for those taking dietary supplements of Vitamin A, D, E, or K to separate administration by 1 hour before or 4 hours after a mineral oil oral dosage to help limit absorption interactions. Theoretically, the effect on fat-soluble vitamin absorption may more likely occur with prolonged or chronic administration of mineral oil.
Sodium Phosphate Monobasic Monohydrate; Sodium Phosphate Dibasic Anhydrous: (Moderate) Patients should be instructed not to administer additional laxatives or purgative agents during treatment with sodium phosphate monobasic monohydrate; sodium phosphate dibasic anhydrous.
Torsemide: (Moderate) Loop diuretics may increase the risk of hypokalemia especially in patients receiving prolonged therapy with laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy.
Vitamin A: (Moderate) Absorption of fat-soluble vitamins is reported to be decreased with prolonged oral administration of mineral oil. However, despite warnings in various texts, there is little direct evidence that the interaction is of practical/clinical importance with limited use as directed. It may be prudent for those taking dietary supplements of Vitamin A, D, E, or K to separate administration by 1 hour before or 4 hours after a mineral oil oral dosage to help limit absorption interactions. Theoretically, the effect on fat-soluble vitamin absorption may more likely occur with prolonged or chronic administration of mineral oil.
Vitamin D analogs: (Moderate) Separate administration of oral vitamin D analogs by 1 hour before or 4 to 6 hours after mineral oil to limit effects on absorption and availability of the vitamin D analog. Absorption of fat-soluble vitamins may be decreased with concomitant administration of mineral oil. The bioavailability of orally administered vitamin D analogs may also be decreased.
Vitamin D: (Moderate) Absorption of fat-soluble vitamins is reported to be decreased with prolonged oral administration of mineral oil. However, despite warnings in various texts, there is little direct evidence that the interaction is of practical/clinical importance with limited use as directed. It may be prudent for those taking dietary supplements of Vitamin A, D, E, or K to separate administration by 1 hour before or 4 hours after a mineral oil oral dosage to help limit absorption interactions. Theoretically, the effect on fat-soluble vitamin absorption may more likely occur with prolonged or chronic administration of mineral oil.
Vitamin D: (Moderate) Absorption of fat-soluble vitamins is reported to be decreased with prolonged oral administration of mineral oil. However, despite warnings in various texts, there is little direct evidence that the interaction is of practical/clinical importance with limited use as directed. It may be prudent for those taking dietary supplements of Vitamin A, D, E, or K to separate administration by 1 hour before or 4 hours after a mineral oil oral dosage to help limit absorption interactions. Theoretically, the effect on fat-soluble vitamin absorption may more likely occur with prolonged or chronic administration of mineral oil.
Vitamin E: (Moderate) Absorption of fat-soluble vitamins is reported to be decreased with prolonged oral administration of mineral oil. However, despite warnings in various texts, there is little direct evidence that the interaction is of practical/clinical importance with limited use as directed. It may be prudent for those taking dietary supplements of Vitamin A, D, E, or K to separate administration by 1 hour before or 4 hours after a mineral oil oral dosage to help limit absorption interactions. Theoretically, the effect on fat-soluble vitamin absorption may more likely occur with prolonged or chronic administration of mineral oil.
Warfarin: (Moderate) Since vitamin K absorption may be theoretically decreased by the use of mineral oil, patients on chronic stable doses of warfarin should be monitored closely for changes in coagulation parameters when mineral oil is prescribed for regular use. This interaction is more theoretical than of practical concern, as evidence of this interaction is lacking, particularly since administration of mineral oil is likely to be on an 'as needed' intermittent basis. It would be prudent to monitor the response to warfarin (e.g., INR) regularly in patients who report concurrent use of mineral oil.

Fleet/Mineral Oil Rectal Enema: 100%
Kondremul Oral Emulsion: 2.5mL, 5mL
Mineral Oil/Muri-Lube Oral Sol

90 mL/day PO or 1 rectal enema/day PR for no longer than 1 week.

90 mL/day PO or 1 rectal enema/day PR for no longer than 1 week.

90 mL/day PO or 1 rectal enema/day PR for no longer than 1 week.

12 years: 90 mL/day PO or 1 rectal enema/day PR for no longer than 1 week.
6—11 years: 30 mL/day PO or 1/2 rectal enema/day PR for no longer than 1 week.
2—5 years: Oral safety and efficacy have not been established; 1/2 enema/day PR for no longer than 1 week.
< 2 years: Do not use.

Do not use.

Do not use.

Mineral oil is an oral and rectal lubricant laxative. Orally, its onset of action is usually 6—8 hours, and it works in the colon. Mineral oil retards colonic absorption of fecal water and softens the stool. Rectally, mineral oral works locally to lubricate and soften the stool. A bowel movement is usually produced in 2—15 minutes after rectal enema of mineral oil.

Mineral oil is administered orally, rectally as an enema, and topically. Very little systemic absorption occurs, although absorption is apparently enhanced in the presence of docusate. Specific information on the metabolism and excretion of mineral oil is unknown.

Mineral oil retards colonic absorption of fecal water and softens the stool. Its onset of action is usually 6—8 hours, and it works in the colon. Specific information on absorption and distribution is unknown; there appears to be minimal absorption of mineral oil from the gut.

Rectal Route
When mineral oil is administered rectally it generally produces a bowel movement in 2—15 minutes. Negligible systemic absorption occurs.

There are no adequate and well-controlled studies of mineral oil in pregnant women; mineral oil has not been formally evaluated by the FDA in regard to safety and efficacy and there are no animal studies (FDA pregnancy risk category C). Thus, it is not known whether this drug will cause fetal harm when administered to a pregnant woman or affect reproduction capacity. The safest first-line treatments to use for constipation during pregnancy are those that are not absorbed systemically (e.g., fiber, bulk-forming laxatives) in order to minimize drug exposure to the fetus. Expert opinions generally regard the use of mineral oil in pregnancy as potentially unsafe; use only when benefit to the mother outweighs potential fetal risk. Mineral oil should generally be avoided during pregnancy because it can impair maternal fat-soluble vitamin absorption (e.g., vitamin K), potentially leading to neonatal coagulopathy and hemorrhage.

It is not known whether mineral oil, USP, which is a purified petroleum byproduct, is excreted in human milk when used as a laxative. Because mineral oil is poorly absorbed orally in the mother, it should not reach the bloodstream of the infant or present major concerns during breast-feeding during short-term, limited use. Use of mineral oil has been reported in nursing mothers, with one small, observational study showing a lack of effect of the drug on infant bowel patterns. It is recommended that use be limited to only when necessary. One review recommends avoidance and use of alternatives such as increased fluid intake, docusate and fiber supplements first, due to lack of adequate safety data for mineral oil use during lactation. Repeated and chronic use of mineral oil should be avoided because in theory, repeated chronic use may cause a deficiency of fat-soluble vitamins (A, D, E, K) which may affect maternal nutrition and thus breast milk production or nutritional quality. The general exposure of humans to mineral oils (e.g., from food products, drugs, and cosmetics) and the toxicologic effects may be of concern; the long-term effects are still uncertain. Many cosmetic skin care products contain mineral oils and paraffins, and these are recommended not be applied to the breast or nipples prior to nursing as the infant may ingest the components, which may cause unintended chemical exposure or changes in bowel habits. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.