Penicillin V Potassium

greater than or equal to 100 mg/mL at 72 °F (NTP, 1992)

Very sol in water; 1 g in about 150 ml alcohol

FDA approved drugs -> Active ingredient

FDA approved drugs -> Active ingredient

This chemical does not meet GHS hazard criteria for 1% (1 of 98) of reports.

Danger

H302 (96.9%): Harmful if swallowed [Warning Acute toxicity, oral]

P233, P260, P261, P264, P270, P271, P272, P280, P284, P301+P317, P302+P352, P304+P340, P321, P330, P333+P317, P342+P316, P362+P364, P403, and P501 (click each P-code to see the statement)

Aggregated GHS information provided per 98 reports by companies from 5 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

SYMPTOMS: Symptoms of exposure to this compound include hypersensitivity reactions such as anaphylactic shock with collapse and sometimes death. Other symptoms include cardiac arrhythmias, liver necrosis and hemolytic anemia. It can cause urticaria, fever, eosinophilia, joint pains, angioneurotic edema, erythema multiforme and exfoliative dermatitis. It can also cause allergies. Additional symptoms of exposure to this type of compound include rash, peripheral neuritis, wheezing, pruritus, flushing of the skin, neutropenia and drop in blood pressure. Other symptoms include maculopapular rash, bronchospasm, vasculitis, serum sickness and Stevens-Johnson syndrome. Exposure can cause pallor, cyanosis, collapse, frothy sputum, pulmonary edema, death, pharyngeal or laryngeal edema, nausea, vomiting, abdominal pain, cramping, convulsions and severe chest pain. It can also cause glossitis, angular and aphthous stomatitis, darkening of the tongue, transient diarrhea and heartburn.

Manufacturers, packers, and distributors of drug and drug products for human use are responsible for complying with the labeling, certification, and usage requirements as prescribed by the Federal Food, Drug, and Cosmetic Act, as amended (secs 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).

PENICILLIN VK+ is the potassium salt of penicillin v. This compound is incompatible with acids, oxidizing agents (especially in the presence of trace metals), heavy metal ions such as copper, lead, zinc and mercury; glycerol, sympathomimetic amines, thiomersal, wood alcohols, cetostearyl alcohol, hard paraffins, macrogols, cocoa butter and many ionic an nonionic surface-active agents. It is also incompatible with alkalis, compounds leached from vulcanized rubber, hydrochlorides of tetracyclines and organic peroxides. Other incompatibilities include reducing agents, alcohols, other hydroxy compounds, self-emulsifying stearyl alcohol, emulsifying wax, lanolin, crude cholinesterated bases, glycol, sugars, amines, aminacrine hydrochloride, ephedrine, procaine, rubber tubing, thiamine hydrochloride, zinc oxide, oxidized cellulose, iodine, iodides, thiols, chlorocresol and resorcinol. It may also be incompatible with naphthalene oils and vitamin B. (NTP, 1992)

EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop.

Commercially available ... penicillin V potassium tablets and powders for oral suspension or solution should be stored in tight containers at 15-30 °C. Following reconstitution, penicillin V potassium oral solutions should be refrigerated at 2-8 °C and any unused solution should be discarded after 14 days.

SMALL SPILLS AND LEAKAGE: If you spill this chemical, you should dampen the solid spill material with water, then transfer the dampened material to a suitable container. Use absorbent paper dampened with water to pick up any remaining material. Seal your contaminated clothing and the absorbent paper in a vapor-tight plastic bag for eventual disposal. Wash all contaminated surfaces with a soap and water solution. Do not reenter the contaminated area until the Safety Officer (or other responsible person) has verified that the area has been properly cleaned.

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.

RECOMMENDED RESPIRATOR: Where the neat test chemical is weighed and diluted, wear a NIOSH-approved half face respirator equipped with an organic vapor/acid gas cartridge (specific for organic vapors, HCl, acid gas and SO2) with a dust/mist filter. (NTP, 1992)

Mixing penicillins with aminoglycosides in vitro has resulted in substantial mutual inactivation; if these groups of antibacterials are to be administered concurrently, they should be administered at separate sites at least 1 hour apart. /Penicillins/

Concurrent of /methotrexate/ with penicillins has resulted in decreased clearance of methotrexate and in methotrexate toxicity; this is thought to be due to competition for renal tubular secretion; patients should be closely monitored; leucovorin doses may need to be increased and administered for longer periods of time. /Penicillins/

Since bacteriostatic drugs /Chloramphenicol, erythromycins, sulfonamides, or tetracyclines/ may interfere with the bactericidal effect of penicillins in the treatment of meningitis or in other situations in which a rapid bactericidal effect is necessary, it is best to avoid concurrent therapy; however, chloramphenicol and ampicillin are sometimes administered concurrently to pediatric patients. /Penicillins/

Probenecid decreases renal tubular secretion of penicillins when used concurrently; this effect results in increased and prolonged serum concentrations, prolonged elimination half-life, and increased risk of toxicity. Penicillins and probenecid are often used concurrently to treat sexually transmitted diseases or other infections in which high and/or prolonged antibiotic serum and tissue concentrations are required. /Penicillins/

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. [http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm?fuseaction=ntpsearch.searchresults&searchterm=132-98-9]

A double blind, randomized study was undertaken in 52 children to compare the bacteriological efficacy and safety of oral sultamicillin (iosylate (I) to those of oral penicillin V potassium (II) in the treatment of childhood streptococcal pharyngitis for a period of 10 days. The dosage was determined by age & weight: patients under 5 yr were given 125 mg/dose and patients over 20 kg, 375 mg/dose. Recolonization did not occur in the II group. Adverse effects were self-limited. One child receiving II developed an elevated serum transaminase level.

Two patients (aged 24 and 34 yr) with penicillin V potassium induced anaphylaxis experienced cardiac disorders immediately after 5 ml of 1:10,000 epinephrine chloride (I) admin by slow IV. Within sec after the injection, ventricular premature beats and apparent accelerated idioventricular rhythm occurred in one patient and possible ventricular tachycardia occurred in the other. It was concluded that patients during anaphylaxis should be monitored and the potential hazards of admin I by IV route in this clinical setting should be emphasized.

However, seizures, myoclonus, and problems with mentation and level of consciousness have been reported, particularly with penicillins. Most often this toxicity is seen in the setting of renal failure, which may allow drug accumulation. The precise mechanism responsible for these neurologic side effects is unclear, but it is known that direct application of penicillin to the brain is associated with seizures. /Penicillins/

In an epidemiologic study from Sweden, about half the cases of pseudomembranous colitis were associated with penicillins, about one third with cephalosporins, and about 14 percent with lincosamides (mostly clindamycin), reflecting the more frequent use of the penicillins and cephalosporins. The clustering of cases in some studies has suggested possible nosocomial transmission of C. difficile. /Penicillins and cephalosporins/

For more Human Toxicity Excerpts (Complete) data for PENICILLIN VK (29 total), please visit the HSDB record page.

Penicillin VK

TR-336: Toxicology and Carcinogenesis Studies of Penicillin VK (CASRN 132-98-9) in F344/N Rats and B6C3F1 Mice (Gavage Studies) (1988 )

07/14/87

No Evidence

No Evidence

No Evidence

Drug Induced Liver Injury Rank (DILIrank 2.0)

Penicillin v potassium

vNo-DILI-concern

0

No match

DOI:10.1016/j.drudis.2016.02.015

DHHS/NTP; Toxicology & Carcinogenesis Studies of Penicillin VK in F344/N Rats and B6C3F1 Mice (Gavage Studies) Technical Report Series No. 336 (1988) NIH Publication No. 88-2592 Acute neurotoxic effects of penicillin include visual, auditory hallucinations; encepalopathy; muscle hyperirritability; convulsions; and myoclonus. /Penicillins; from table/

... Conclusions: Under the conditions of these 2-year gavage studies, there was no evidence of carcinogenic activity of penicillin VK for F344/N rats or for B6C3F1 mice administered 500 or 1,000 mg/kg penicillin VK in corn oil gavage, 5 days per week for 2 years. ... Decreased survival of low and high dose male rats and of high dose female rats reduced the sensitivity of the studies for determining the presence or absence of a carcinogenic response in this species.

... Doses selected for F344/N rats and B6C3F1 mice in the 2 yr studies were 0, 500, or 1,000 mg/kg. Conclusions: Under the conditions of these 2-year gavage studies, there was no evidence of carcinogenic activity of penicillin VK for F344/N rats or for B6C3F1 mice administered 500 or 1,000 mg/kg penicillin VK in corn oil gavage, 5 days per week for 2 years. ... Decreased survival of low and high dose male rats and of high dose female rats reduced the sensitivity of the studies for determining the presence or absence of a carcinogenic response in this species.

Manufacturers, packers, and distributors of drug and drug products for human use are responsible for complying with the labeling, certification, and usage requirements as prescribed by the Federal Food, Drug, and Cosmetic Act, as amended (secs 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).

The penicillins and their metabolites are potent immunogens because of their ability to combine with proteins and act as haptens for acute antibody-mediated reactions. The most frequent (about 95 percent) or "major" determinant of penicillin allergy is the penicilloyl determinant produced by opening the beta-lactam ring of the penicillin. This allows linkage of the penicillin to protein at the amide group. "Minor" determinants (less frequent) are the other metabolites formed, including native penicillin and penicilloic acids. /Penicillins/

Bactericidal; inhibit bacterial cell wall synthesis. Action is dependent on the ability of penicillins to reach and bind penicillin-binding proteins (PBPs) located on the inner membrane of the bacterial cell wall. Penicillin-binding proteins (which include transpeptidases, carboxypeptidases, and endopeptidases) are enzymes that are involved in the terminal stages of assembling the bacterial cell wall and in reshaping the cell wall during growth and division. Penicillins bind to, and inactivate, penicillin-binding proteins, resulting in the weakening of the bacterial cell wall and lysis. /Penicillins/

PENICILLIN V POTASSIUM

Penicillins [CS]; Penicillin-class Antibacterial [EPC]

A dose of 1,000,000 units of the acid gives peak plasma levels of about 2 to 3 ug/ml, but the potassium salt will provide levels of 4.5 to 9 ug/ml.

Penicillin VK provides faster and higher blood levels of antibiotic than Penicillin V.

MEDICATION

MEDICATION (VET)

... tablets 250 and 500 mg

Penicillin V potassium powder for oral solution should be reconstituted at the time of dispensing by adding the amount of water specified on the bottle to provide a solution containing 125 or 250 mg of penicillin V per 5 ml. The water should be added to the powder for oral solution in 2 portions and the solution agitated vigorously immediately after each addition.

4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-[(2-phenoxyacetyl)amino]-, potassium salt (1:1), (2S,5R,6R)-: ACTIVE

... each mg of penicillin V potassium has a potency of 1380-1610 USP penicillin V units. Although potency of penicillin ... V potassium is generally expressed in terms of the weight of penicillin V, potency of the drugs may be expressed in terms of USP penicillin V units. For labeling purposes, each mg of penicillin V contained in ... penicillin V potassium preparations is considered equivalent to 1695 penicillin V units. However, the manufacturers state that potency of penicillin V potassium preparations containing 125, 250, or 500 mg of penicillin V is approximately equivalent to 200,000, 400,000, or 800,000 penicillin V units, respectively. Each 250 mg of penicillin V as the potassium salt contains 0.7 mEq of potassium.