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LAXATIVES-EMOLLIENT

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Docusate sodium is therapeutically classified as a stool softener. Mineral oil is categorized as a lubricant laxative.

Specific Substances

    A) DIOCTYL CALCIUM SULFOSUCCINATE (synonym)
    1) Calcium 1,4-bis(2-ethylhexyl) sulfosuccinate
    2) Docusate Calcium (synonym)
    3) CAS 128-49-4
    DICOTYL POTASSIUM SULFOSUCCINATE (synonym)
    1) Docusate Potassium (synonym)
    2) Potassium 1,4-bis(2-ethylhexyl) sulfosuccinate
    3) CAS 7491-09-0
    DIOCTYL SODIUM SULFOSUCCINATE (synonym)
    1) Docusate Sodium (synonym)
    2) Di(2-ethylhexyl) sodium sulfosuccinate
    3) Sodium dioctyl sulfosuccinate (synonym)
    4) CAS 577-11-7
    LINSEED OIL (synonym)
    1) Flaxseed oil (synonym)
    2) Groco
    3) CAS 80001-26-1
    MINERAL OIL (synonym)
    1) Petrolatum liquid (synonym)
    2) Oil mist (synonym)
    3) Paraffin oil (synonym)
    4) CAS 8012-95-1
    GENERAL TERMS
    1) Glycylalcohol (synonym)
    2) Laxative (Emollient)
    3) Emollient Laxatives

Available Forms Sources

    A) FORMS
    1) Emollient laxatives are available in a variety of forms, including tablets, capsules, liquid solution, syrup, and suppositories.
    B) USES
    1) Emollient laxatives may be grouped into classes that are relatively distinct:
    a) The surface active surfactants include dioctyl sodium sulfosuccinate (Docusate sodium), dioctyl calcium sulfosuccinate (Docusate calcium), and dioctyl potassium sulfosuccinate (Docusate potassium).
    b) Docusate sodium is an anionic surfactant which reduces the surface tension of the oil-water interface of the feces, allowing water and lipids to penetrate the stool and help in hydrating and softening fecal material (Prod Info COLACE(R) oral capsules, 2006). Docusate sodium is used to treat constipation or to reduce straining in patients with hemorrhoids or anal fissure. In addition, it is used to remove bowel content before abdominal radiological procedures (Sweetman, 2003).
    c) Mineral oil (a hydrocarbon from petroleum) is an emollient, used to soften and lubricate hard stools, allowing their passage without irritating the mucosa. It is used to treat occasional constipation and relieve fecal impaction. It is also indicated to prevent constipation in patients who should avoid straining (eg, in hypertension, coronary occlusion, proctologic procedures, or postoperative care). In addition, mineral oil is used for the removal of barium sulfate residues from the colon after barium administration (Prod Info Fleet(R) mineral oil, 2001).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Emollient laxatives are indicated for the prevention and treatment of constipation . Specific representatives of the class of emollient laxatives include mineral oil, dioctyl calcium sulfosuccinate (docusate calcium), dioctyl sodium sulfosuccinate (docusate sodium), and dioctyl potassium sulfosuccinate (docusate potassium).
    B) PHARMACOLOGY: Both types of emollient laxatives produce an effect by softening and hydrating the feces without either direct or indirect reflex stimulation of peristalsis. They produce a cathartic effect within 12 to 48 hours.
    C) TOXICOLOGY: Pulmonary aspiration of these products is unusual, but lipoid pneumonitis can develop if it occurs. Mineral oil suppresses the normal cough reflex. Inhibition of both respiratory epithelial ciliary movement and outward flow of mucus allows oil to reach the alveoli, where a small fraction enters the hilar and abdominal lymph nodes or the liver and spleen via the peribronchial lymphatics. Pulmonary lipases cannot hydrolyze mineral oil; it is taken up by macrophages, which disintegrate in time to release the oil. A cycle of uptake and release begins, leading to diffuse interstitial fibrosis, granulomatous reaction, or both occurs.
    D) EPIDEMIOLOGY: Exposure is common but severe toxicity is rare.
    E) WITH THERAPEUTIC USE
    1) Abdominal pain, nausea, diarrhea, and bitter taste have occurred following the use of docusate. Anal seepage of large doses of mineral oil may cause pruritus ani, irritation, and perianal discomfort.
    F) WITH POISONING/EXPOSURE
    1) Toxicity following acute ingestion of excessive amounts of these laxatives is generally minimal and limited to the gastrointestinal tract. Nausea, vomiting, diarrhea, foreign body reaction, intestinal obstruction, melanosis coli, cathartic colon, and fecal leakage may be noted. Onset of symptoms may be delayed for 1 to 3 days. Aspiration of mineral oil may result in lipoid pneumonia, which may cause permanent lung injury.
    0.2.20) REPRODUCTIVE
    A) Docusate calcium, docusate potassium, docusate sodium, glycerin, and mineral oil are classified as FDA pregnancy category C.
    B) Mineral oil has caused testicular tumors in the fetus, although the risk of teratogenic effects in humans appears to be very low.
    C) Docusate sodium is excreted in breast milk and may cause increased bowel activity in nursing infants.

Laboratory Monitoring

    A) Plasma levels of these agents are not available or clinically useful.
    B) Monitor fluid status and electrolyte concentrations in patients with significant diarrhea or vomiting.
    C) Aspiration lipoid pneumonia has been reported in patients using mineral oil. Monitor arterial blood gases, pulse oximetry, and pulmonary function tests, and obtain a chest x-ray in any patient with respiratory symptoms.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Treatment is symptomatic and supportive. Excessive diarrhea should be treated with oral or intravenous fluids and monitoring of fluid and electrolyte status.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Treatment is symptomatic and supportive. In patients with aspiration lipoid pneumonia, orotracheal intubation may be necessary. Corticosteroids have been used in a few anecdotal reports of chronic pneumonitis; efficacy is not established and they are not routinely recommended. Extracorporeal membrane oxygenation (ECMO) (a pulmonary bypass procedure used in cases of reversible acute pulmonary and cardiovascular failure) has been successful in the therapy of two cases of pediatric aspiration involving mineral oil or mineral seal oil found initially unresponsive to standard therapy for hydrocarbon aspiration.
    C) DECONTAMINATION
    1) PREHOSPITAL: Due to low toxicity and potential for aspiration of these compounds, gastric decontamination is not recommended unless a serious coingestant or other clinical concern exists.
    2) HOSPITAL: Due to low toxicity and potential for aspiration of these compounds, gastric decontamination is not recommended unless a serious coingestant or other clinical concern exists.
    D) AIRWAY MANAGEMENT
    1) Endotracheal intubation and mechanical ventilation may be required in patients with severe respiratory distress.
    E) ANTIDOTE
    1) None.
    F) PATIENT DISPOSITION
    1) HOME CRITERIA: Patients with a minor unintentional exposure who are asymptomatic or have mild symptoms can likely be managed at home.
    2) OBSERVATION CRITERIA: Moderate to severely symptomatic patients and those with self harm ingestions should be sent to a health care facility for evaluation and treated until symptoms resolve.
    3) ADMISSION CRITERIA: Patients who remain symptomatic despite adequate treatment should be admitted.
    4) CONSULT CRITERIA: Consult a Poison Center for assistance in managing patients with severe toxicity or in whom the diagnosis is unclear.
    G) PITFALLS
    1) Pitfalls in managing these patients include missing alternative diagnoses or not recognizing iatrogenic overdoses. When managing a suspected overdose, the possibility of multi-drug involvement should be considered.
    H) DIFFERENTIAL DIAGNOSIS
    1) Gastroenteritis, food poisoning, parasites, infectious disease or drugs or chemicals that cause nausea, vomiting or diarrhea.

Range Of Toxicity

    A) TOXICITY: No specific toxic dose has been established. Toxicity following acute ingestion of excessive amounts of these laxatives is generally minimal.
    B) A 17-year-old adolescent girl began taking mineral oil 400 mL daily (recommended 60 mL daily) for a 5-month period. Despite excessive use, no symptoms were reported and there was no laboratory evidence of fat-soluble vitamin malabsorption.
    C) THERAPEUTIC DOSE: DOCUSATE SODIUM: ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: 50 to 300 mg daily as a single daily dose or in divided doses. CHILDREN 2 TO UNDER 12 YEARS OF AGE: 50 to 150 mg daily as a single daily dose or in divided doses. MINERAL OIL: Fleet(R) mineral oil enema: ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: One 133-mL bottle (118-mL delivered dose) in a single daily dose. CHILDREN 2 TO UNDER 12 YEARS OF AGE: One-half bottle (59-mL delivered dose) in a single daily dose. Oral mineral oil: ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: 15 to 45 mL orally once daily. CHILDREN 5 TO 11 YEARS OF AGE: 5 to 15 mL orally once daily.

Clinical Effects

Summary Of Exposure

    A) USES: Emollient laxatives are indicated for the prevention and treatment of constipation . Specific representatives of the class of emollient laxatives include mineral oil, dioctyl calcium sulfosuccinate (docusate calcium), dioctyl sodium sulfosuccinate (docusate sodium), and dioctyl potassium sulfosuccinate (docusate potassium).
    B) PHARMACOLOGY: Both types of emollient laxatives produce an effect by softening and hydrating the feces without either direct or indirect reflex stimulation of peristalsis. They produce a cathartic effect within 12 to 48 hours.
    C) TOXICOLOGY: Pulmonary aspiration of these products is unusual, but lipoid pneumonitis can develop if it occurs. Mineral oil suppresses the normal cough reflex. Inhibition of both respiratory epithelial ciliary movement and outward flow of mucus allows oil to reach the alveoli, where a small fraction enters the hilar and abdominal lymph nodes or the liver and spleen via the peribronchial lymphatics. Pulmonary lipases cannot hydrolyze mineral oil; it is taken up by macrophages, which disintegrate in time to release the oil. A cycle of uptake and release begins, leading to diffuse interstitial fibrosis, granulomatous reaction, or both occurs.
    D) EPIDEMIOLOGY: Exposure is common but severe toxicity is rare.
    E) WITH THERAPEUTIC USE
    1) Abdominal pain, nausea, diarrhea, and bitter taste have occurred following the use of docusate. Anal seepage of large doses of mineral oil may cause pruritus ani, irritation, and perianal discomfort.
    F) WITH POISONING/EXPOSURE
    1) Toxicity following acute ingestion of excessive amounts of these laxatives is generally minimal and limited to the gastrointestinal tract. Nausea, vomiting, diarrhea, foreign body reaction, intestinal obstruction, melanosis coli, cathartic colon, and fecal leakage may be noted. Onset of symptoms may be delayed for 1 to 3 days. Aspiration of mineral oil may result in lipoid pneumonia, which may cause permanent lung injury.

Heent

    3.4.3) EYES
    A) DOCUSATE sodium in concentrations more than 0.1% may cause conjunctival irritation (Gosselin et al, 1984).
    3.4.6) THROAT
    A) WITH THERAPEUTIC USE
    1) DOCUSATE SODIUM: Throat irritation has occurred following the use of docusate (Gilman et al, 1990a; Reynolds, 1991; Prod Info Colace(R), 1991a).

Respiratory

    3.6.2) CLINICAL EFFECTS
    A) PULMONARY ASPIRATION
    1) MINERAL OIL INGESTIONS: Cases of aspiration lipoid pneumonia have been reported although commercial mineral oil for internal use has a viscosity of 34.5 to 64 centistokes, which ought to render it less at risk for aspiration compared with hydrocarbons with viscosities of less than 3 to 20 centistokes (Gerarde, 1963).
    a) CASE REPORT: Acute lipoid pneumonitis was reported in a 13-month-old girl found with an open bottle of baby oil (Reyes de la Rocha et al, 1985).
    b) CASE REPORT: A 36-year-old woman with a 2-year history of anorexia nervosa and bulimia associated with diuretic, laxative, and alcohol abuse plus depression with multiple suicide attempts developed occult mineral oil aspiration leading to respiratory failure (Ferguson & Miller, 1988).
    c) CASE REPORT: Exogenous lipoid pneumonia was diagnosed by lung biopsy in a patient who was ingesting Vaseline Intensive Care Lotion(R) (1% to 10% mineral oil) and baby oil (80% mineral oil) as laxatives (Cornacchia et al, 1989).
    d) CASE REPORT: A 16-month-old male presented with fever and respiratory distress after aspirating baby oil in the bath tub. He developed diffuse pneumonitis and progressive respiratory distress that was ultimately treated with extracorporeal membrane oxygenation (ECMO). There was no improvement after 20 days of ECMO, (29 days after presentation), ECMO was withdrawn, and the patient died (Enrione & Tucker, 1995).
    2) CHRONIC TOXICITY
    a) MINERAL OIL INHALATION: Chronic inhalation of mineral oil mists during occupational exposure has been reported to cause lipoid pneumonia (Skorodin & Chandrasekhar, 1983; Foe & Bigham, 1954; Pujol et al, 1990; Proudfit et al, 1950) Weissman, 1951), some of which has been gravity-dependent on x-ray (Van den Plas et al, 1990).
    b) MINERAL OIL INGESTION: Lipoid pneumonitis has been well described in patients who chronically use mineral oil orally or nasally.
    1) Most patients have predisposing factors such as neurologic disorders (coma, dysphagia), esophageal disorders (achalasia, hiatus hernia, reflux), hard palate defects, local or general anesthesia, chronic illness, or forced ingestion in neonates or infants (Bandla et al, 1999; Lipinski et al, 1981; Elston, 1966; Paraskevaides, 1990).
    2) Chronic aspiration in children generally carries a worse prognosis than in adults (de Oliveira et al, 1985).
    3) CASE REPORT: Becton et al (1984) reported a case of lipoid pneumonia in an 18-year-old cancer patient using large quantities of flavored lip gloss containing mineral oil (Becton et al, 1984).
    4) CASE REPORT: A 68-year-old woman who had been taking 10 to 15 mL of mineral oil at bedtime since childhood developed dyspnea and chronic lung disease, with bilateral alveolar infiltrates, volume loss, middle lobe consolidation, and restrictive and obstructive defects on pulmonary function testing (Berg & Saenger, 1998). Microscopic analysis of bronchioalveolar lavage fluid was consistent with lipoid pneumonia. There were no significant changes in symptoms or radiographs 4 years after stopping mineral oil.
    c) GRANULOMA/FIBROSIS: Granuloma of the lungs may develop with prolonged ingestion of mineral oil, especially at bedtime (Guest et al, 1967; Rosenow, 1978; Salm & Hughes, 1970).
    d) BRONCHOGENIC CARCINOMA: The diagnosis of chronic lipoid pneumonitis in adults is often concurrent with a diagnosis of bronchogenic carcinoma. Three cases have been reported where the malignant tumor was superimposed on a preexisting area of isolated lipoid pneumonia (Bryan & Boitnott, 1969; Felson & Ralaisomay, 1983).

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) NAUSEA, VOMITING AND DIARRHEA
    1) WITH THERAPEUTIC USE
    a) Abdominal pain, nausea, diarrhea, and bitter taste have occurred following the use of docusate (Gilman et al, 1990a; Reynolds, 1991; Prod Info Colace(R), 1991a).
    2) WITH POISONING/EXPOSURE
    a) Nausea, vomiting, and diarrhea may occur following ingestions of large amounts of emollient laxatives.
    b) FECAL LEAKAGE: 10 of 13 (77%) posthemorrhoidectomy patients randomized to receive sterculia, mineral oil, and magnesium hydroxide two times daily developed fecal leakage, compared with 5 of 17 (29%) similar patients randomized to receive concentrated wheat husk three times daily (Johnson et al, 1987).
    1) The increased leakage can be due to the increased fecal water content induced by magnesium hydroxide and the soft, oily consistency imparted by the paraffin-based aperients to the stool.
    B) INTESTINAL OBSTRUCTION
    1) FOREIGN BODY REACTION in the intestinal mucosa and other tissues may result from mineral oil ingestion (Gilman et al, 1990).
    2) CASE REPORT: A 13-month-old girl who swallowed about 50 grams of Vaseline presented with peritonitis and intestinal obstruction (Goh & Buick, 1987). Laparotomy yielded lumps of the white, soft paraffin obstructing the cecum and colon.
    C) GASTROENTERITIS
    1) MELANOSIS COLI: PeriColace(R) may cause brownish-black discoloration of the mucous membranes of the lower colon and rectum (Vanin & Saylor, 1989). This is an endoscopic diagnostic clue to chronic laxative abuse. It develops over 4 to 12 months without causing any functional problems, and it is reversible over a period of several months.
    2) CATHARTIC COLON: Inflammation of the mucosa, degeneration of Auerbach's plexi, superficial punctate ulcerations, submucosal cysts, dilation, and loss of colonic haustral markings, with abdominal pain, bloating, and constipation characterize a cathartic colon associated with chronic abuse of Correctol(R), which is a multi-ingredient preparation containing dioctyl sodium sulfosuccinate (Vanin & Saylor, 1989).
    3) DIARRHEA and intestinal bloating have been reported in animals given toxic doses of docusate sodium (Gosselin et al, 1984).

Hepatic

    3.9.2) CLINICAL EFFECTS
    A) LIVER ENZYMES ABNORMAL
    1) WITH POISONING/EXPOSURE
    a) DOCUSATE: Elevation of alkaline phosphatase and other liver enzymes may occur when dioctyl sodium sulfosuccinate, a hepatotoxic agent by itself, is combined with oxyphenisatin, danthron, and quinidine (Deisseroth et al, 1972; Dujovone & Shoeman, 1972; Gilman et al, 1990; Goldstein, 1973; Tolman et al, 1976).

Genitourinary

    3.10.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) LACK OF EFFECT
    a) REPRODUCTIVE EFFECTS: Dioctyl sodium sulfosuccinate (0.5% and 1%) administered in the diet of 3 successive generations of rats had no effects on the reproductive function of either sex in any generation and produced no treatment-related antemortem or macroscopic findings (MacKenzie et al, 1990).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) ERUPTION
    1) SURFACTANTS: Skin rash has been reported from use of surfactant laxatives (fecal softeners), especially with leakage of oil past the anal sphincter (Gilman et al, 1990).
    2) Anal seepage of large doses of mineral oil may cause pruritus ani, irritation, and perianal discomfort.

Reproductive

    3.20.1) SUMMARY
    A) Docusate calcium, docusate potassium, docusate sodium, glycerin, and mineral oil are classified as FDA pregnancy category C.
    B) Mineral oil has caused testicular tumors in the fetus, although the risk of teratogenic effects in humans appears to be very low.
    C) Docusate sodium is excreted in breast milk and may cause increased bowel activity in nursing infants.
    3.20.2) TERATOGENICITY
    A) TESTIS NEOPLASM MALIGNANT
    1) MINERAL OIL: A human teratogen by inhalation, mineral oil has caused testicular tumors in the fetus (Lewis, 1996).
    B) LACK OF EFFECT
    1) DOCUSATE SODIUM: The risk of teratogenic effects in humans appears to be very low (FDA, 1984).
    3.20.3) EFFECTS IN PREGNANCY
    A) HYPOMAGNESEMIA
    1) Neonatal hypomagnesemia, manifested by jitteriness, was considered secondary to maternal hypomagnesemia caused by the use of docusate sodium by the mother during pregnancy (Schindler, 1984).
    B) PREGNANCY CATEGORY
    1) Docusate calcium, docusate potassium, docusate sodium, glycerin, and mineral oil are classified as FDA pregnancy category C (Briggs et al, 1998).
    3.20.4) EFFECTS DURING BREAST-FEEDING
    A) BREAST MILK
    1) Docusate sodium is excreted in breast milk and may cause increased bowel activity in nursing infants (Forest, 1976).

Carcinogenicity

    3.21.3) HUMAN STUDIES
    A) GASTRIC CARCINOMA
    1) MINERAL OIL is a questionable human carcinogen by inhalation producing gastrointestinal tumors at a dose of 5 mg/m(3)/5 years (RTECS , 1990a; Lewis, 1996).
    B) SKIN CARCINOMA
    1) Exposure to mineral oils have been linked with cancers of the skin and scrotum, but these effects could be attributed to contaminants, additives, or both (Jarvholm et al, 1985; Proctor et al, 1988).
    2) ANIMALS: Fully solvent refined oils have not been shown to be carcinogenic to experimental animals who have been fed or painted with mineral oil (IARC, 1984).

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Plasma levels of these agents are not available or clinically useful.
    B) Monitor fluid status and electrolyte concentrations in patients with significant diarrhea or vomiting.
    C) Aspiration lipoid pneumonia has been reported in patients using mineral oil. Monitor arterial blood gases, pulse oximetry, and pulmonary function tests, and obtain a chest x-ray in any patient with respiratory symptoms.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) Fluid and electrolyte status should be monitored in patients demonstrating severe vomiting and diarrhea.

Radiographic Studies

    A) CHEST RADIOGRAPH
    1) Chest x-rays should be obtained in patients with respiratory signs or symptoms (eg, cough, tachypnea, fever, dyspnea).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.1) ADMISSION CRITERIA/ORAL
    A) Patients who remain symptomatic despite adequate treatment should be admitted.
    6.3.1.2) HOME CRITERIA/ORAL
    A) Patients with a minor unintentional exposure who are asymptomatic or have mild symptoms can likely be managed at home.
    6.3.1.3) CONSULT CRITERIA/ORAL
    A) Consult a Poison Center for assistance in managing patients with severe toxicity or in whom the diagnosis is unclear.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) Moderate to severely symptomatic patients and those with self harm ingestions should be sent to a health care facility for evaluation and treated until symptoms resolve.

Monitoring

    A) Plasma levels of these agents are not available or clinically useful.
    B) Monitor fluid status and electrolyte concentrations in patients with significant diarrhea or vomiting.
    C) Aspiration lipoid pneumonia has been reported in patients using mineral oil. Monitor arterial blood gases, pulse oximetry, and pulmonary function tests, and obtain a chest x-ray in any patient with respiratory symptoms.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) PREHOSPITAL: Due low toxicity and potential aspiration risk of these compounds, gastric decontamination is not recommended unless a serious coingestant or other clinical concern exists.
    6.5.2) PREVENTION OF ABSORPTION
    A) SUMMARY: Due to low toxicity and potential aspiration of these compounds, gastric decontamination is not recommended unless a serious coingestant or other clinical concern exists.
    6.5.3) TREATMENT
    A) MONITORING OF PATIENT
    1) Plasma levels of these agents are not available or clinically useful.
    2) Monitor fluid status and electrolyte concentrations in patients with significant diarrhea or vomiting.
    3) Aspiration lipoid pneumonia has been reported in patients using mineral oil. Monitor arterial blood gases, pulse oximetry, and pulmonary function tests, and obtain a chest x-ray in any patient with respiratory symptoms.
    B) DIARRHEA
    1) Maintain high fluid intake until diarrhea resolves. Oral fluid should consist of hypotonic solution containing appropriate electrolytes such as oral Pedialyte(R) or Gatorade(R).
    C) PULMONARY ASPIRATION
    1) Corticosteroids have been used in a few anecdotal reports of chronic pneumonitis; efficacy is not established (Ayvazian et al, 1967) and they are not routinely recommended.
    2) ECMO: Extracorporeal membrane oxygenation (ECMO) (a pulmonary bypass procedure used in cases of reversible acute pulmonary and cardiovascular failure) has been successful in the therapy of 2 cases of pediatric aspiration involving mineral oil or mineral seal oil found initially unresponsive to standard therapy for hydrocarbon aspiration (Jaeger et al, 1987).

Abstracts

Case Reports

    A) ACUTE EFFECTS
    1) IGNITION FLUID: A 29-year-old female clown developed lipoid pneumonia after inhaling a mouthful of ignition fluid (containing 20% isoparaffins, 80% n-paraffins) while training to be a fire eater (Beerman et al, 1984). Cough, dyspnea, and severe chest pain were reported. Chest x-ray showed a large homogenous infiltrate. Initial treatment included corticosteroids, benzylpenicillin, and intercostal blockade and high doses of dextropropoxyphene with acetaminophen for severe chest pain.
    2) Pulmonary function deteriorated over the next week (PO2 8.4, kPa 63 mmHg). A fever (39.4 degrees C), increased pulmonary infiltrates, and pleural effusion occurred. Treatment included doxycycline and corticosteroids. The patient's condition improved over the following 3 weeks. At follow-up 2 months after the accident, complete disappearance of the pulmonary abnormality was reported.
    B) INFANT
    1) BABY OIL: A 13-month-old girl found coughing with an open bottle of baby oil and with oil on the mouth developed fever, tachycardia, and tachypnea 5 hours later, despite a normal chest x-ray. Progressive respiratory distress occurred within 2 days and the patient's worsening pulmonary infiltrates cleared up only after intensive management for 163 days (Reyes de la Rocha et al, 1985).
    C) ADULT
    1) LIPGLOSS: Although acute toxicity is unlikely due to small amounts available, chronic excessive use of a mineral-oil based lipgloss resulted in lipoid pneumonia in an 18-year-old girl (Becton et al, 1984).

Range Of Toxicity

Summary

    A) TOXICITY: No specific toxic dose has been established. Toxicity following acute ingestion of excessive amounts of these laxatives is generally minimal.
    B) A 17-year-old adolescent girl began taking mineral oil 400 mL daily (recommended 60 mL daily) for a 5-month period. Despite excessive use, no symptoms were reported and there was no laboratory evidence of fat-soluble vitamin malabsorption.
    C) THERAPEUTIC DOSE: DOCUSATE SODIUM: ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: 50 to 300 mg daily as a single daily dose or in divided doses. CHILDREN 2 TO UNDER 12 YEARS OF AGE: 50 to 150 mg daily as a single daily dose or in divided doses. MINERAL OIL: Fleet(R) mineral oil enema: ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: One 133-mL bottle (118-mL delivered dose) in a single daily dose. CHILDREN 2 TO UNDER 12 YEARS OF AGE: One-half bottle (59-mL delivered dose) in a single daily dose. Oral mineral oil: ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: 15 to 45 mL orally once daily. CHILDREN 5 TO 11 YEARS OF AGE: 5 to 15 mL orally once daily.

Therapeutic Dose

    7.2.1) ADULT
    A) MINERAL OIL
    1) 15 to 45 mL ORALLY once daily at bedtime, MAX 45 mL (Burnham et al, 2002)
    2) enema: empty contents of 1 bottle (133 mL) into RECTUM once (Prod Info Fleet(R) mineral oil, 2001)
    B) DOCUSATE SODIUM
    1) The usual recommended adult oral dose of docusate sodium is 50 to 200 milligrams daily (Prod Info Colace(R), 1993).
    2) Docusate sodium is also given as an enema in doses of 50 to 100 milligrams (Prod Info Colace(R), 1991).
    C) SPECIFIC SUBSTANCE
    1) POLOXAMER 188: 240 to 480 mg orally at bedtime with a full glass of water as needed can soften the stools in 3 to 5 days (Gilman et al, 1990).
    7.2.2) PEDIATRIC
    A) MINERAL OIL
    1) (5 to 11 yr) 5 to 15 mL ORALLY once daily at bedtime (Burnham et al, 2002)
    2) (12 yr and older) enema: empty contents of 1 bottle (133 mL) into RECTUM once (Prod Info Fleet(R) mineral oil, 2001)
    3) (2 to 11 yr) enema: empty contents of 1-half bottle (66.5 mL) into RECTUM once (Prod Info Fleet(R) mineral oil, 2001)
    B) DOCUSATE SODIUM
    1) (less than 3 yrs) docusate sodium 10 to 40 mg/day ORALLY once daily or in divided doses, 2 to 4 times daily (Prod Info Colace(R), 1993)
    2) (3 to 6 yrs) docusate sodium 20 to 60 mg/day ORALLY once daily or in divided doses, 2 to 4 times daily (Prod Info Colace(R), 1993)
    3) (6 to 12 yrs) docusate sodium 40 to 120 mg/day ORALLY once daily or in divided doses, 2 to 4 times daily (Prod Info Colace(R), 1993)
    4) (over 12 yrs) docusate sodium 50 to 200 mg/day ORALLY once daily or in divided doses, 2 to 4 times daily (Prod Info Colace(R), 1993)

Maximum Tolerated Exposure

    A) SPECIFIC SUBSTANCE
    1) MINERAL OIL
    a) CASE REPORT: A 17-year-old healthy adolescent girl (50 kg and height 160 cm) with a history of chronic constipation and laxative use to have a normal bowel movement began taking mineral oil 400 mL daily (recommended dose 30 mL twice daily) for a 5-month period. Despite excessive use, no symptoms were reported. Physical exam was negative, and there was no laboratory evidence of fat-soluble (including vitamin A, D, E, and K) vitamin malabsorption. Vitamin A was 43 mg/dL (30 to 80 mg/dL) and Vitamin E was 5.4 mg/dL (5 to 20 mg/dL). Mineral oil was reduced, with alternative therapy started (Gal-Ezer & Shaoul, 2006).
    2) SURFACTANTS
    a) Ingestion of greater than 50 mg/kg may cause gastrointestinal effects leading to dehydration. These agents are generally well tolerated.

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) DOCUSATE SODIUM
    1) LD50- (ORAL)MOUSE:
    a) 2640 mg/kg (Sax & Lewis, 1989a)
    2) LD50- (INTRAPERITONEAL)RAT:
    a) 590 mg/kg (Sax & Lewis, 1989a)
    3) LD50- (ORAL)RAT:
    a) 1900 mg/kg (Sax & Lewis, 1989a)
    B) MINERAL OIL
    1) LD50- (ORAL)MOUSE:
    a) 22 g/kg (RTECS , 1990)

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Both types of emollient laxatives produce an effect by softening and hydrating the feces without either direct or indirect reflex stimulation of peristalsis. They produce a cathartic effect within 24 to 48 hours (Miller & Greenblatt, 1979).
    B) Lubricant laxatives increase water retention in the stool by coating stool surfaces and intestines with water-immiscible film (USP, 1990). Lubricant effects ease passage of contents through intestines.
    C) Stool softener laxatives reduce surface film tension by interfacing liquid contents of the bowel, promoting permeation of additional liquid in the stool to form a softer mass (USP, 1990).
    D) Dioctyl sodium sulfosuccinate causes water and salt accumulation in ligated colonic segments of rats, whereas net absorption of isotonic saline solution occurs in control rats (Gosselin et al, 1984). Rodent ileum, jejunum, and colon perfused with 0.5 mmol docusate sodium have flattened mucosal cells and absent brush borders.

Toxicologic Mechanism

    A) MINERAL OIL
    1) Mineral oil suppresses the normal cough reflex. Some of the oil ingested before bedtime trickles down the pharynx into the trachea.
    a) Inhibition of both respiratory epithelial ciliary movement and outward flow of mucus allows oil to reach the alveoli, where a small fraction enters the hilar and abdominal lymph nodes or the liver and spleen via the peribronchial lymphatics (Salm & Huges, 1970).
    2) Pulmonary lipases cannot hydrolyze mineral oil, which does not cause necrosis but is instead emulsified and taken up by macrophages, which disintegrate in time to release the oil.
    a) With inhibition of ciliary action, it is not expectorated, and a cycle of uptake and release begins. In a few months, diffuse interstitial fibrosis, granulomatous reaction, or both occurs (Rosenow, 1978; Salm & Hughes, 1970).
    3) Another pathogenesis for mineral oil granulomata of the lung is the sclerosing effect of an endogenous fatty acid to lipoid (Wagner et al, 1955).
    B) SURFACTANTS: Dioctyl sodium sulfosuccinate, a detergent, elevates alveolar surface tension by displacement of pulmonary surfactant from the alveolar hypophase (Nieman et al, 1990). There is then a marked fall in arterial oxygen tension, an increase in airway pressure, and an increased alveolar epithelial permeability.
    C) ASPIRATION HAZARD
    1) Aspiration toxicity of hydrocarbons is related to viscosity. Products with viscosities of 150 to 250 SUS, such as heavy greases and oils (eg, No. 10 SAE Motor Oil) have a very limited toxicity.
    2) Viscosity in the 30 to 35 SUS range or lower, such as mineral seal oil, has a high aspiration hazard. Small amounts of low-viscosity material aspirated can spread over large portions of the pulmonary bed, resulting in chemical pneumonitis.

Physicochemical

Physical Characteristics

    A) DOCUSATE CALCIUM: White precipitate (Budavari, 1996); white amorphous solid with characteristic odor of octyl alcohol (S Sweetman , 2000)
    B) DOCUSATE POTASSIUM: White amorphous solid with characteristic odor of octyl alcohol (S Sweetman , 2000)
    C) DOCUSATE SODIUM: White, wax-like solid with characteristic odor of octyl alcohol (S Sweetman , 2000; Lewis, 1996)
    D) MINERAL OIL: Colorless, oily liquid, practically tasteless, odorless (S Sweetman , 2000; Lewis, 1996)

Molecular Weight

    A) Docusate Calcium: 883.24 (Budavari, 1996)
    B) Docusate Potassium: 460.7 (S Sweetman , 2000)
    C) Docusate Sodium: 444.56 (Budavari, 1996)

References

General Bibliography

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