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  • CLASSES

    Emollients and Protectants, Other
    Enemas for Constipation
    Other Agents for Constipation

    DEA CLASS

    OTC

    DESCRIPTION

    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.

    COMMON BRAND NAMES

    Fleet, Kondremul, Muri-Lube

    HOW SUPPLIED

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

    DOSAGE & INDICATIONS

    For the relief of occasional constipation or fecal impaction.
    Oral dosage (oral microemulsion or solution)
    Adults, Adolescents and Children >= 12 years

    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.

    Children 6—11 years

    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.

    Infants and Children < 6 years

    Safety and efficacy have not been established.

    Rectal dosage (rectal enema)
    Adults, Adolescents and Children >= 12 years

    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.

    Children 2 to 11 years

    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.

    MAXIMUM DOSAGE

    Adults

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

    Geriatric

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

    Adolescents

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

    Children

    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.

    Infants

    Do not use.

    Neonates

    Do not use.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustments are needed.

    Renal Impairment

    No dosage adjustments are needed.

    ADMINISTRATION

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

    Oral Administration
    Oral Liquid Formulations

    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 Administration
    Other Topical Formulations

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

    Rectal Administration

    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.
     

    STORAGE

    Generic:
    - Protect from direct sunlight
    Fleet:
    - Storage information not available
    Kondremul:
    - Store between 59 to 77 degrees F
    Muri-Lube:
    - Protect from light

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Do not use mineral oil in the presence of a known or suspected hypersensitivity to mineral oil or any ingredient in the products.

    Abdominal pain, acute abdomen, appendicitis, bleeding, GI obstruction, nausea/vomiting

    Do not use mineral oil products in patients with appendicitis, acute abdomen, undiagnosed abdominal pain, nausea/vomiting, GI obstruction, rectal bleeding or anal seepage.

    Dysphagia, geriatric

    Use oral mineral oil with caution in bedridden patients, such as the debilitated geriatric patient. Oral mineral oil products should be avoided in patients who have dysphagia or other conditions that may result in difficulty in swallowing, due to the risk for aspiration. It is recommended not to administer oral products at bedtime due to a potential risk of aspiration which may result in lipid pneumonitis. According to the Beers Criteria, orally administered mineral oil is considered a potentially inappropriate medication (PIM) for use in geriatric patients and should be avoided due to the potential for aspiration or other adverse effects and the availability of safer alternatives. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of medications in residents of long-term care facilities. The OBRA guidelines caution that laxatives may cause flatulence, bloating, and abdominal pain.

    Pregnancy

    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.

    Breast-feeding

    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.

    Children, infants, neonates

    Safety and efficacy of mineral oil products have not been established in infants and neonates. The oral formulation is not for use in children under 6 years. The rectal formulation is not indicated in children under 2 years.

    ADVERSE REACTIONS

    Moderate

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

    Mild

    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

    DRUG INTERACTIONS

    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.
    Atropine; Diphenoxylate: (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.
    Brompheniramine; 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.
    Brompheniramine; 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.
    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.
    Carbinoxamine; Hydrocodone; Phenylephrine: (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.
    Carbinoxamine; 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.
    Casanthranol; Docusate Sodium: (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.
    Chlorpheniramine; Guaifenesin; 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.
    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.
    Chlorpheniramine; Hydrocodone; Phenylephrine: (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.
    Chlorpheniramine; 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.
    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.
    Diphenhydramine; Hydrocodone; Phenylephrine: (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.
    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.
    Ergocalciferol, Vitamin D2: (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.
    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.
    Fish Oil, Omega-3 Fatty Acids (Dietary Supplements): (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.
    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.
    Guaifenesin; 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.
    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; Phenylephrine: (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; Potassium Guaiacolsulfonate: (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; Potassium Guaiacolsulfonate; 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.
    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 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.

    PREGNANCY AND LACTATION

    Pregnancy

    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.

    MECHANISM OF ACTION

    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.

    PHARMACOKINETICS

    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.

    Oral Route

    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.

    Other Route(s)

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