ATC Class:A06AD10

VA Class:GA203

AHFS Class:

• Cathartics and Laxatives 56:12

Generic Name(s):

• Mineral Oil

Mineral oil (heavy or light), a complex mixture of hydrocarbons derived from crude petroleum, is a lubricant laxative.

Administration

Mineral oil or mineral oil emulsion is administered orally. Although mineral oil emulsions penetrate and soften fecal material more effectively and are more palatable than plain mineral oil, there appears to be little difference in laxative effectiveness between these two preparations. Mineral oil also may be administered rectally as an enema. Plain (nonemulsified) mineral oil should be administered only at bedtime on an empty stomach. Mineral oil emulsion may be administered with meals. Containers of mineral oil emulsion should be shaken before using.

Dosage

Dosage of mineral oil emulsion is expressed in terms of its mineral oil content. Oral mineral oil preparations should be used only occasionally and should not be administered for longer than 1 week.

The usual oral dosage of mineral oil for adults and children 12 years of age and older is 15-45 mL daily given as a single dose (minimum dose of 15 mL) or in divided doses. For children 6-11 years of age, the usual oral dosage of mineral oil is 5-15 mL daily given as a single dose (minimum of 5 mL) or in divided doses.

Mineral oil enemas are administered rectally in a usual dosage of 120 mL (range: 60-150 mL) daily given as a single dose in adults and children 12 years of age and older and 30-60 mL for children 2-11 years of age.

Pharmacokinetics

Absorption of mineral oil reportedly is minimal following oral or rectal administration. Although 30-60% of orally administered mineral oil emulsion reportedly is absorbed from the intestine, some clinicians believe that there is no evidence that the emulsion is absorbed to a greater extent than is nonemulsified mineral oil. The mineral oil that is absorbed following oral administration is distributed into the mesenteric lymph nodes, intestinal mucosa, liver, and spleen.

When administered orally, mineral oil and mineral oil emulsion produce laxation after 6-8 hours.

Chemistry

Mineral oil, heavy or light, is a complex mixture of hydrocarbons derived from crude petroleum and is used as a lubricant laxative. In refinement for human use, the aromatic amines and unsaturated hydrocarbons are removed from petroleum, leaving a variety of saturated hydrocarbons. Light mineral oil is similar to mineral oil but lower molecular weight hydrocarbons predominate, resulting in lower viscosity and specific gravity; it is not intended for use in internal liquid products. Mineral oil has a specific gravity of 0.845-0.905. Mineral oil occurs as a colorless, transparent, oily liquid that is free or practically free from fluorescence. Mineral oil is odorless and tasteless when cold, and develops not more than a faint odor of petroleum when heated. The oil is insoluble in water and in alcohol. Mineral oil may contain tocopherol or butylated hydroxytoluenes to inhibit oxidation. The palatability of mineral oil is improved when it is emulsified with acacia.

Additional Information

For further information on pharmacology, uses, cautions, drug interactions, and dosage and administration of mineral oil, see the Cathartics and Laxatives General Statement 56:12.