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SALINOMYCIN

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Salinomycin is a carboxylic-polyether antibiotic used as an anticoccidial agent in veterinary practice.

Specific Substances

    1) Antibiotic 61477
    2) CAS 53003-10-4
    3) AHR-3096
    4) K-364
    5) K-748364A

Available Forms Sources

    A) FORMS
    1) Salinomycin is a polyether ionophoric antibiotic with a tricyclic spiroketal ring system and an unsaturated 6-membered ring in the molecule (Budavari, 1996; Vanderkop & MacNeil, 1990).
    B) SOURCES
    1) Salinomycin is produced by a strain of Streptomyces albus (Budavari, 1996) Folz et al, 1988).
    C) USES
    1) This agent is used as an anticoccidial in poultry (Wells et al, 1988), and growth promoter in cattle and swine (Vanderkop & MacNeil, 1990; Kavanagh & Sparrow, 1990).

Overview

Life Support

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

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) Salinomycin is not used in human medicine and human overdoses of the veterinary preparations were not found.
    B) Exposed individuals should have a careful, thorough medical history and physical examination performed, looking for any abnormalities. Exposure to chemicals with a strong odor often results in such nonspecific symptoms as headache, dizziness, weakness, and nausea.
    C) ANIMALS - Effects of overdose in animals have included hyperpnea, flaccid paralysis, hematuria, degenerative myopathy, dyspnea, abdominal pain, muscle weakness, and decreased urea nitrogen and serum potassium. Pathologic studies showed degeneration of myofibrils.
    0.2.20) REPRODUCTIVE
    A) At the time of this review, no data were available to assess the potential effects of exposure to this agent during pregnancy or lactation.
    0.2.21) CARCINOGENICITY
    A) At the time of this review, no data were available to assess the carcinogenic potential of this agent.

Laboratory Monitoring

    A) Animal Studies - Monitor electrolytes including BUN and serum potassium (hypokalemia).
    B) A number of chemicals produce abnormalities of the hematopoietic system, liver, and kidneys. Monitoring complete blood count, urinalysis, and liver and kidney function tests is suggested for patients with significant exposure.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) ACTIVATED CHARCOAL: Administer charcoal as a slurry (240 mL water/30 g charcoal). Usual dose: 25 to 100 g in adults/adolescents, 25 to 50 g in children (1 to 12 years), and 1 g/kg in infants less than 1 year old.

Range Of Toxicity

    A) Minimum lethal human exposure is unknown.

Clinical Effects

Summary Of Exposure

    A) Salinomycin is not used in human medicine and human overdoses of the veterinary preparations were not found.
    B) Exposed individuals should have a careful, thorough medical history and physical examination performed, looking for any abnormalities. Exposure to chemicals with a strong odor often results in such nonspecific symptoms as headache, dizziness, weakness, and nausea.
    C) ANIMALS - Effects of overdose in animals have included hyperpnea, flaccid paralysis, hematuria, degenerative myopathy, dyspnea, abdominal pain, muscle weakness, and decreased urea nitrogen and serum potassium. Pathologic studies showed degeneration of myofibrils.

Cardiovascular

    3.5.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) CARDIAC FAILURE
    a) HORSES - Horses have shown evidence of heart failure and various dysrhythmias following overdoses of salinomycin (Whitlock, 1990).
    b) CATTLE - Long-term ingestion (approximately 11 weeks) of feed contaminated with toxic levels of salinomycin resulted in cardiac failure in 39 of 380 cattle, with 8 fatalities. Clinical signs included: dyspnea, tachypnea, tachycardia, and exercise intolerance. Histopathology showed cardiomyopathy and pulmonary and hepatic lesions consistent with a diagnosis of congestive heart failure (Bastianello et al, 1996).

Respiratory

    3.6.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) DYSPNEA
    a) HORSES - Dyspnea and hyperpnea have been reported in horses poisoned by salinomycin (Whitlock, 1990).
    b) CATTLE - Dyspnea and tachypnea occurred in cattle, who developed congestive heart failure, following long-term ingestion (approximately 11 weeks) of feed containing toxic levels of salinomycin (Bastianello et al, 1996).

Neurologic

    3.7.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) PARALYSIS FLACCID
    a) Flaccid paralysis have been observed in both animals and birds with overdoses of salinomycin (Potter et al, 1986; Reece et al, 1985; Horrox, 1984).
    b) Guinea fowl given a diet of 12 to 23 ppm of salinomycin for 3 weeks developed flaccid paralysis and died (Reece et al, 1985).

Gastrointestinal

    3.8.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) ABDOMINAL PAIN
    a) HORSES - Abdominal pain has been noted in horses following salinomycin intoxication (Whitlock, 1990).

Genitourinary

    3.10.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) RENAL FUNCTION ABNORMAL
    a) Distended bladder, progressive hemoconcentration, a decreased BUN, polyuria, oliguria, azotemia, and hematuria has been reported in various animal species with overdose (Kavanagh & Sparrow, 1990) Whitlock, 1990; (Nagaraja et al, 1985).

Hematologic

    3.13.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) OTHER
    a) HEMOCONCENTRATION has occurred in cattle and horses following administration of salinomycin (Whitlock, 1990; (Nagaraja et al, 1985).

Musculoskeletal

    3.15.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) MYOPATHY
    a) Overdose of this antibiotic causes degenerative muscle changes in several animal and bird species. Flaccid paralysis, unsteady gait, and trembling of the muscles are often seen. Pathologic studies showed degeneration of myofibrils (Reece et al, 1985).

Reproductive

    3.20.1) SUMMARY
    A) At the time of this review, no data were available to assess the potential effects of exposure to this agent during pregnancy or lactation.
    3.20.2) TERATOGENICITY
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the teratogenic potential of this agent.
    3.20.3) EFFECTS IN PREGNANCY
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the potential effects of exposure to this agent during pregnancy or lactation.

Carcinogenicity

    3.21.2) SUMMARY/HUMAN
    A) At the time of this review, no data were available to assess the carcinogenic potential of this agent.
    3.21.3) HUMAN STUDIES
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the carcinogenic potential of this agent.

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Animal Studies - Monitor electrolytes including BUN and serum potassium (hypokalemia).
    B) A number of chemicals produce abnormalities of the hematopoietic system, liver, and kidneys. Monitoring complete blood count, urinalysis, and liver and kidney function tests is suggested for patients with significant exposure.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) Based on animal data, monitor electrolytes including BUN and potassium. Watch for hypokalemia, hypocalcemia, and azotemia.
    2) A number of chemicals produce abnormalities of the hematopoietic system, liver, and kidneys. Monitoring complete blood count, urinalysis, and liver and kidney function tests is suggested for patients with significant exposure.

Methods

    A) CHROMATOGRAPHY
    1) Salinomycin is an ionophore with a high molecular weight and functionality. This makes it difficult to analyze.
    a) High performance liquid chromatography methods have been developed to detect salinomycin in animal tissues (Vanderkop & MacNeil, 1990; Andreasen & Schleifer, 1995).
    2) FEED - A high speed liquid chromatographic method using post-column derivatization has been useful in determining content in feeds (Lapointe & Cohen, 1988).
    3) HUMANS - A High performance liquid chromatography method, with pre-column oxidation and heart cut column switching, was described for detection of salinomycin in the plasma of workers following occupational exposure from handling of animal feeds that may contain the antibiotic. Using this method, the limit of detection was 5 ng/mL (Karnes et al, 1993).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) Animal Studies - Monitor electrolytes including BUN and serum potassium (hypokalemia).
    B) A number of chemicals produce abnormalities of the hematopoietic system, liver, and kidneys. Monitoring complete blood count, urinalysis, and liver and kidney function tests is suggested for patients with significant exposure.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) ACTIVATED CHARCOAL
    1) PREHOSPITAL ACTIVATED CHARCOAL ADMINISTRATION
    a) Consider prehospital administration of activated charcoal as an aqueous slurry in patients with a potentially toxic ingestion who are awake and able to protect their airway. Activated charcoal is most effective when administered within one hour of ingestion. Administration in the prehospital setting has the potential to significantly decrease the time from toxin ingestion to activated charcoal administration, although it has not been shown to affect outcome (Alaspaa et al, 2005; Thakore & Murphy, 2002; Spiller & Rogers, 2002).
    1) In patients who are at risk for the abrupt onset of seizures or mental status depression, activated charcoal should not be administered in the prehospital setting, due to the risk of aspiration in the event of spontaneous emesis.
    2) The addition of flavoring agents (cola drinks, chocolate milk, cherry syrup) to activated charcoal improves the palatability for children and may facilitate successful administration (Guenther Skokan et al, 2001; Dagnone et al, 2002).
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.2) PREVENTION OF ABSORPTION
    A) ACTIVATED CHARCOAL
    1) CHARCOAL ADMINISTRATION
    a) Consider administration of activated charcoal after a potentially toxic ingestion (Chyka et al, 2005). Administer charcoal as an aqueous slurry; most effective when administered within one hour of ingestion.
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.3) TREATMENT
    A) SUPPORT
    1) No information was available about specific clinical effects of exposure to this agent; no specific treatment recommendations can be made.

Enhanced Elimination

    A) LACK OF INFORMATION
    1) No studies have addressed the utilization of extracorporeal elimination techniques in poisoning with this agent.

Range Of Toxicity

Summary

    A) Minimum lethal human exposure is unknown.

Minimum Lethal Exposure

    A) GENERAL/SUMMARY
    1) The minimum lethal human dose to this agent has not been delineated.

Maximum Tolerated Exposure

    A) GENERAL/SUMMARY
    1) The maximum tolerated human exposure to this agent has not been delineated.

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) ANIMAL DATA
    1) LD50- (INTRAPERITONEAL)MOUSE:
    a) 7 mg/kg (RTECS, 2001)
    2) LD50- (ORAL)MOUSE:
    a) 50 mg/kg (RTECS, 2001)

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Salinomycin is an effecient mediator of the transport of metal ions and hydrogen ions through cell membranes (Riddell & Tompsett, 1990).
    B) Salinomycin migrates metal ions, with a greater preference for potassium than other ions (Mitani et al, 1976; Mitani et al, 1975) Painter & Pressman, 1979).
    C) Salinomycin is effective against Gram positive bacteria, malaria, and as a coccidiostat (Miyazaki et al, 1974) Melhorn et al, 1984).
    D) Salinomycin has been investigated as a cardiac drug due to its potassium transport functions (Fahim et al, 1986).

Toxicologic Mechanism

    A) Experiments done on sheep and rats indicated that salinomycin transports calcium ions into the cytosol of parotid acinar cells from extracellular fluid, causing the release of amylase (Katoh & Tsuda, 1986).
    B) Ionophore antibiotics are used in cattle to intervene in rumen microbial metabolism to make fermentation more beneficial (Nagaraja et al, 1985).

Physicochemical

Molecular Weight

    A) 751.01 (Budavari, 1996)

Animal Toxicology

Clinical Effects

    11.1.1) AVIAN/BIRD
    A) TURKEYS are very susceptible to salinomycin. This agent depresses growth in young turkeys and causes dyspnea, flaccid paralysis, panting, unsteady gait, and death in older birds (Horrox, 1984; Reece et al, 1985; Potter et al, 1986; Andreasen & Schleifer, 1995).
    1) Forensic histology: Degeneration of myofibrils, proteinaceous exudation, and infiltration of heterophils and macrophages (Reece et al, 1985; Andreasen & Schleifer, 1995).
    B) GUINEA FOWL given a diet of 12 to 23 ppm for 3 weeks developed flaccid paralysis and died (Reece et al, 1985).
    11.1.2) BOVINE/CATTLE
    A) Cattle given salinomycin developed hemoconcentration, decreased serum urea nitrogen and decreased serum potassium concentrations (Nagaraja et al, 1985).
    B) Fatal cardiac failure was reported in 8 of 380 cattle following long-term ingestion (approximately 11 weeks) of feed containing toxic levels of salinomycin. Clinical signs included: dyspnea, tachypnea, tachycardia, and exercise intolerance. Histopathology of two of the 8 cattle showed cardiomyopathy and pulmonary and hepatic lesions consistent with a diagnosis of congestive heart failure (Bastianello et al, 1996).
    11.1.5) EQUINE/HORSE
    A) Horses poisoned by salinomycin develop hyperpnea, dyspnea, and distended bladder. There may be refusal to eat contaminated feed, abdominal pain, and muscle weakness. There may be evidence of heart failure with various arrhythmias (Whitlock, 1990; (Oehme & Pickrell, 1999).
    B) Horses may exhibit progressive hemoconcentration, polyuria or oliguria, azotemia, and mild hypocalcemia and hypokalemia may be present (Whitlock, 1990).
    11.1.10) PORCINE/SWINE
    A) Toxicity usually occurs when feed levels are too high; these data are based on one report of herd toxicity (Kavanagh & Sparrow, 1990).
    1) DOSE/ONSET - 400 adult swine were exposed to 166 milligrams/kilogram salinomycin (approximately 8 milligrams/kilogram body weight). Clinical signs of toxicity began 5 days after introduction of this feed.
    2) SIGNS - Lethargy, anorexia, dyspnea, trembling, weakness, hematuria
    3) LAB/POSTMORTEM FINDINGS - Severe degenerative myopathy (skeletal and cardiac) with high serum creatinine kinase levels
    4) OUTCOME - 9.6 per cent mortality. Survivors returned to normal feed intake and behavior 21 days after withdrawal of this feed. Some animals had also been receiving therapeutic tiamulin, known to delay salinomycin metabolism.

Treatment

    11.2.2) LIFE SUPPORT
    A) GENERAL
    1) MAINTAIN VITAL FUNCTIONS: Secure airway, supply oxygen, and begin supportive fluid therapy if necessary.
    11.2.5) TREATMENT
    A) HORSE
    1) There is no specific antidote. Exercise should be limited for 8 weeks or more. Feed a high potassium diet if possible, promote catharsis within the first 24 to 36 hours (mineral oil). Early treatment with vitamin E and selenium, before cardiac or muscular symptoms have occurred, may be of some benefit (Whitlock, 1990).
    B) SWINE
    1) One group of poisoned swine were treated with Vitamin E, but with inconsistent therapeutic effect (Kavanagh & Sparrow, 1990).
    2) Pigs which were anorexic and refused to drink benefited from hand watering 6 times daily (Kavanagh & Sparrow, 1990).

Range Of Toxicity

    11.3.1) THERAPEUTIC DOSE
    A) SWINE
    1) Salinomycin is licensed for use in swine diets at 60 milligrams per kilogram for pigs up to four months of age, and 20 to 30 milligrams per kilogram for pigs over 4 months old (Kavanagh & Sparrow, 1990).
    11.3.2) MINIMAL TOXIC DOSE
    A) SWINE
    1) A group of finishing pigs was inadvertently given salinomycin 166 milligrams per kilogram of feed. This was approximately a dose of 8 milligrams per kilogram of body weight (Kavanagh & Sparrow, 1990).
    2) Symptoms arose about 5 days after the start of the administration of the contaminated feed.
    B) HORSE
    1) The LD50 in horses is 0.6 mg/kg (Whitlock, 1990).
    C) POULTRY
    1) JUVENILE TURKEYS (age 7 to 34 weeks): 22 milligrams/kilogram or 7 to 15 parts per million in feed may cause toxicity and/or death (Potter et al, 1986; Reece et al, 1985).
    2) ADULT TURKEYS - 24 to 57 milligrams/kilogram or 15 to 30 parts per million caused toxicity and death (Stuart, 1983; Halvorson et al, 1982).
    D) BIRD
    1) GUINEA FOWL - Ten percent of a 500 member flock of guinea fowl keats developed flaccid paralysis after 3 weeks of ingesting feed with 12 to 23 ppm (Reece et al, 1985).

Kinetics

    11.5.1) ABSORPTION
    A) LACK OF INFORMATION
    1) There was no specific information on absorption at the time of this review.
    11.5.3) METABOLISM
    A) SWINE
    1) A tiamulin/salinomycin interaction may exist because tiamulin may interfere with the metabolism of salinomycin and result in higher tissue levels (Potts, 1990).
    a) This interaction is dose-dependent. Doses of 6 mg/kg or less (combined) do not seem to represent a significant problem (Miller, 1990; Miller et al, 1986).
    B) POULTRY
    1) CHICKENS - A tiamulin/salinomycin interaction has also been noted (Frigg et al, 1983).

Pharmacology Toxicology

    A) SPECIFIC TOXIN
    1) Experiments done on sheep and rats indicated that salinomycin transports calcium ions into the cytosol of parotid acinar cells from extracellular fluid, causing the release of amylase (Katoh & Tsuda, 1986).
    2) Ionophore antibiotics are used in cattle to intervene in rumen microbial metabolism to make fermentation more beneficial (Nagaraja et al, 1985).

Sources

    A) SPECIFIC TOXIN
    1) Salocin(R) (Hoechst).
    2) Bio-Cox(R) (Folz et al, 1988)
    3) Coxistac(R)

References

General Bibliography

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