| GHS-Einstufung | This chemical does not meet GHS hazard criteria for 0.6% (1 of 167) of reports.DangerH315 (26.3%): Causes skin irritation [Warning Skin corrosion/irritation]P233, P260, P261, P264, P264+P265, P271, P272, P273, P280, P284, P302+P352, P304+P340, P305+P351+P338, P319, P321, P332+P317, P333+P317, P337+P317, P342+P316, P362+P364, P391, P403, P403+P233, P405, and P501 (click each P-code to see the statement)Aggregated GHS information provided per 167 reports by companies from 12 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies. |
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| Regulatorische Informationen | Status: Active Update: 20-04-2020 https://echa.europa.eu/registration-dossier/-/registered-dossier/11498Ampicillin: Does not have an individual approval but may be used under an appropriate group standard |
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| Weitere Sicherheitsinformationen | IMAP assessments - 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-, [2S-[2.alpha.,5.alpha.,6.beta.(S*)]]-: Environment tier I assessment |
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| Gefahrenübersicht | Allergic contact dermatitis reported in a nurse[Kanerva, p. 1189] Asthma reported in pharmaceutical workers[Malo] |
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| FDA-Anforderungen | Oral Dosage Form New Animal Drugs. Specifications and conditions of use for dogs and cats. /Ampicillin capsules/Oral Dosage Form New Animal Drugs. Specifications and conditions of use for dogs. /Ampicillin trihydrate tablets/Oral Dosage Form New Animal Drugs. Specifications and conditions of use for dogs and cats. /Ampicillin trihydrate capsules/Oral Dosage Form New Animal Drugs. Specifications and conditions of use for dogs and cats. /Ampicillin trihydrate for oral suspension/For more FDA Requirements (Complete) data for AMPICILLIN (11 total), please visit the HSDB record page. |
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| Special Reports | DHHS/NTPToxicology & Carcinogenesis Studies of Ampicillin Trihydrate in F344/N Rats and B6C3F1 (Feed Studies) Mice Technical Report Series No. 318 (1987) NIH Publication No. 87-2574 /Ampicillin trihydrate/ |
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| Hazard Classes and Categories | Skin Irrit. 2 (26.3%) |
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| Lagerbedingungen | Ampicillin capsules and powder for oral suspension should be stored in tight containers @ 15-30 °C. Following reconstitution, oral suspensions of either anhydrous ampicillin or ampicillin trihydrate should preferable be refrigerated @ 2-8 °C but are stable for 7 days @ room temperature or 14 days @ 2-8 °C.Following reconstitution with sterile or bacteriostatic water for injection, ampicillin sodium solutions for IM or direct IV injection should be used within 1 hr after reconstitution and should not be frozen. |
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| Entsorgungsverfahren | SRP: At the time of review, criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices. |
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| Allowable Tolerances | A tolerance of 0.01 ppm is established for negligible residues of ampicillin in the uncooked edible tissues of swine and cattle and in milk. |
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| Wechselwirkungen | ...AMPICILLIN...MIXED IN VITRO WITH GENTAMICIN.../FOR PROLONGED PERIODS/ CAUSE LOSS OF GENTAMICIN ANTIMICROBIAL ACTIVITY.CONCURRENT ADMIN OF PENICILLIN & PROBENECID RESULTS IN HIGHER & MORE SUSTAINED SERUM ANTIBIOTIC LEVELS. /AMPICILLIN HAS BEEN SHOWN TO INTERACT IN SIMILAR MANNER/./GENTAMICIN/ RELATED DRUGS...KANAMYCIN, NEOMYCIN & TOBRAMYCIN MAY INTERACT...WITH CARBENICILLIN. /CARBENICILLIN/LIMITED...DATA INDICATE THAT ASPIRIN, IN LARGE DOSES, INCR SERUM LEVEL & HALF-LIFE OF PENICILLIN WHEN...GIVEN CONCURRENTLY. ALTHOUGH CONCURRENT USE OF HIGH DOSES OF ASPIRIN HAS BEEN SUGGESTED TO INCR CLINICAL BENEFITS OF PENICILLIN, POSSIBLE TOXICITIES DUE TO HIGH-DOSE ASPIRIN ADMIN DISCOURAGE SUCH THERAPY. /PENICILLIN/For more Interactions (Complete) data for AMPICILLIN (21 total), please visit the HSDB record page. |
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| Hepatotoxicity | The rate of serum aminotransferase and alkaline phosphatase elevations during ampicillin therapy is not well defined. High dose, intravenous ampicillin has been associated with ALT elevations in 9% to 11% of patients, but a similar rate is often found in comparator arms and the elevations are generally transient and asymptomatic. Rare instances of idiosyncratic liver injury have been reported in persons receiving the aminopenicillins, but they are rarely listed in large case series or prospective databases on drug-induced liver injury. The incidence of clinically apparent liver injury is far lower with ampicillin than occurs with amoxicillin, occurring probably in less than 1 in 200,000 exposed persons. Cases are characterized by a short latency period of a few days to as long as six weeks. The onset of liver injury can occur after the antibiotic is stopped. The serum enzyme pattern associated with aminopenicillin liver injury has included a hepatocellular pattern with marked elevations in ALT and AST, and minimal elevations in alkaline phosphatase and rapid recovery after withdrawal. In addition, cholestatic forms of hepatic injury with marked alkaline phosphatase elevations (as also seen with penicillin-induced liver injury) have also been described, some of which have been associated with prolonged cholestasis and, rarely, with vanishing bile duct syndrome. The onset of hepatic injury may be accompanied by skin rash, toxic epidermal necrolysis, or Stevens Johnson syndrome. Autoantibodies are uncommon. |
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| Unerwünschte Wirkungen | Skin Sensitizer - An agent that can induce an allergic reaction in the skin.Serious Adverse Drug Reactions |
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| Toxizitätsübersicht | * Neurological adverse reactions, including convulsions, may occur due to high CSF concentrations of ampicillin. |
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| Ongoing Test Status | The following link will take the user to the National Toxicology Program (NTP) Test Agent Search Results page, which tabulates all of the "Standard Toxicology & Carcinogenesis Studies", "Developmental Studies", and "Genetic Toxicity Studies" performed with this chemical. Clicking on the "Testing Status" link will take the user to the status (i.e., in review, in progress, in preparation, on test, completed, etc.) and results of all the studies that the NTP has done on this chemical. /Ampicillin trihydrate/ [http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm?fuseaction=ntpsearch.searchresults&searchterm=7177-48-2] |
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| Human Toxicity Excerpts | AGRANULOCYTOSIS WITH PERIPHERAL MONOCYTOSIS & BONE-MARROW HISTIOCYTOSIS HAS BEEN REPORTED FOLLOWING TREATMENT WITH AMPICILLIN.Ampicillin has comparatively few adverse properties, permitting it to be used preferentially over other agents such as chloramphenicol or tetracyclines when a broad-spectrum antibacterial drug is desired. It has been used as treatment for urinary, respiratory, and GI infections and bacterial otitis. Since ampicillin is excreted in bile, it can be used to treat biliary tract infections. Superinfections caused by Enterobacter, Pseudomonas, or Candida have occurred during oral ampicillin therapy, necessitating a reduced dose or substitution of another antibacterial drug.Ampicillin reportedly induces environmental or occupational asthma possibly by IgE mediation /from table/GI side effects of ampicillin include diarrhea, nausea/vomiting, epigastric/abdominal pain, and stomatitis/glossitis /from table/For more Human Toxicity Excerpts (Complete) data for AMPICILLIN (59 total), please visit the HSDB record page. |
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| Carcinogen Classification | AmpicillinGroup 3: Not classifiable as to its carcinogenicity to humansVolume 50: (1990) Pharmaceutical Drugs1989 |
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| Drug Induced Liver Injury | Drug-Induced Liver Injury Severity and Toxicity (DILIst)ampicillinDILI PositiveOralDOI:10.1016/j.drudis.2019.09.022 |
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| Non-Human Toxicity Excerpts | DEATH FROM RESP FAILURE WITH OR WITHOUT CONVULSIONS OCCURRED 6-18 HR AFTER SINGLE ORAL DOSES. ACUTE GASTROENTERITIS & CARDIOVASCULAR SHOCK WERE ASSOCIATED PHENOMENA. ...PATTERN...ALSO TRUE FOR GUINEA PIGS EXCEPT THAT LATE (1-2 WK) & GRADUALLY DEVELOPING TOXEMIA KILLED ALL SURVIVORS OF ACUTE RESPONSE. /PENICILLINS/IN HAMSTERS...SOMEWHAT MORE TOXIC BY ORAL THAN BY SC ROUTE WHEN OBSERVED FOR 14 DAYS AFTER SINGLE DOSES. TOLERANCE DEVELOPED TO MULTIPLE DOSING. PERHAPS SENSITIVITY OF GUINEA PIGS IS RELATED TO EFFECTS ON INTESTINAL MICROFLORA. SC LD50 IN NEWBORN (LESS THAN 72 HR) RATS WAS 7-FOLD LOWER THAN LD50 IN ADULTS. /PENICILLINS/Ampicillin may have an adverse effect on rabbits when administered orally. Rabbits that consumed 18.8 mg ampicillin/100 ml drinking water developed diarrhea and died within a month. Severe enteritis and renal tubular damage was thought to be related to an antibiotic-induced disturbance of intestinal bacterial equilibrium. The oral dose of ampicillin is approximately 12 mg/kg 4 times daily.Ampicillin has been used in a variety of domestic animals at doses ranging from 2 to 50 mg/kg. Blood concentrations are dose dependent and the maintenance dose must be administered at 4- to 6-hour intervals. Although ampicillin disappears from the blood quite rapidly, it appears that tissue concentrations may be greater than blood concentrations for a significant therapeutic effecteg, /it was/ reported that uterine tissue concentrations in the mare were 10-50% higher than serum. They recommended an IV dose of 11-16 mg ampicillin/kg at 4- to 8-hour intervals. Ampicillin has been used to treat bacterial infections in cattle. A dose of 4.5-11 mg/kg was administered parenterally once daily for 3 days. Clinical improvement was noted in 86% of the cases and adverse effect were noted in experimental tests.For more Non-Human Toxicity Excerpts (Complete) data for AMPICILLIN (17 total), please visit the HSDB record page. |
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| Evidence for Carcinogenicity | Evaluation: There is inadequate evidence for the carcinogenicity of ampicillin in humans. There is limited evidence for the carcinogenicity of ampicillin in experimental animals. Overall evaluation: Ampicillin is not classifiable as to its carcinogenicity to humans (Group 3). |
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| National Toxicology Program Studies | Toxicology and carcinogenesis studies of ampicillin trihydrate (97-99% pure) were conducted by administering the chemical in corn oil by gavage to groups of 50 F344/N rats and 50 B6C3F1 mice of each sex, 5 days/wk for 103 wk. Male and female rats received doses of 0, 750, or 1,500 mg/kg, and male and female mice received doses of 0, 1,500 or 3,000 mg/kg. ... Under the conditions of these 2 yr gavage studies, there was equivocal evidence of carcinogenicity of ampicillin trihydrate for male F344/N rats as shown by increased incidences of pheochromocytomas of the adrenal medulla and marginally increased incidences of mononuclear cell leukemia. There was no evidence of carcinogenicity for female F344/N rats receiving 750 or 1,500 mg/kg or for male or female B6C3F1 mice receiving 1,500 or 3,000 mg/kg per day. Noneoplastic lesions of the forestomach were seen in male rats and male and female mice. /Ampicillin trihydrate/ |
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| Effects During Pregnancy and Lactation | ◉ Summary of Use during Lactation |
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