Ampicillin Sodium (Ampicillin)

Trade Name : Ampicillin

GC Hanford Manufacturing Company

INJECTION, POWDER, FOR SOLUTION

Strength 2 g/1

AMPICILLIN SODIUM Penicillin-class Antibacterial [EPC],Penicillins [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ampicillin Sodium (Ampicillin) which is also known as Ampicillin and Manufactured by GC Hanford Manufacturing Company. It is available in strength of 2 g/1 per ml. Read more

Ampicillin Sodium (Ampicillin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Ampicillin for Injection, USP, the monosodium salt of [2S-[2u03b1, 5 u03b1, 6u03b2(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. It has the following chemical structure:
  • The molecular formula is CHNNaOS, and the molecular weight is 371.39. Ampicillin for Injection, USP contains 2.9 milliequivalents of sodium per 1 gram of drug. Ampicillin for Injection, USP is supplied in vials equivalent to 125 mg, 250 mg, 500 mg, 1 gram or 2 grams of ampicillin. It is to be administered by intravenous or intramuscular routes.
  • Ampicillin for Injection, USP diffuses readily into most body tissues and fluids. However, penetration into the cerebrospinal fluid and brain occurs only when the meninges are inflamed. Ampicillin is excreted largely unchanged in the urine and its excretion can be delayed by concurrent administration of probenecid. The active form appears in the bile in higher concentrations than those found in serum. Ampicillin is the least serum-bound of all the penicillins, averaging about 20% compared to approximately 60 to 90% for other penicillins. Ampicillin for Injection, USP is well tolerated by most patients and has been given in doses of 2 grams daily for many weeks without adverse reactions.
  • Microbiology:n- in vitron- Array
  • The following bacteria have been shown in studies to be susceptible to Ampicillin for Injection, USP:
  • GRAM-POSITIVE ORGANISMS: Hemolytic and nonhemolytic streptococci, non penicillinase-producing staphylococci, spp., , and most strains of enterococci.
  • GRAM-NEGATIVE ORGANISMS:n , and many strains of Salmonella, Shigella, and .
  • Ampicillin does not resist destruction by penicillinase.
  • Susceptibility Tests: n- in vitro
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
  • Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:
  • Respiratory Tract Infectionsn- S. pneumoniaen- D. pneumoniae), Staphylococcus aureusn- H. influenzae
  • Bacterial Meningitisn- E. coli,n- Listeria monocytogenes, N. meningitidis
  • Septicemia and Endocarditisn- Streptococcusn- E. coli, Proteus mirabilisn- Salmonella
  • Urinary Tract Infections n- E. coli n- Proteus mirabilis
  • Gastrointestinal Infectionsn- Salmonella typhosan- Salmonellan- Shigella
  • Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing.
  • It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate.
  • Indicated surgical procedures should be performed.
  • A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.
  • Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.
  • There have been well-documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with a cephalosporin. Before initiating therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.
  • SERIOUS ANAPHYLACTOID REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE, OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.n
  • Clostridium difficilen- C. difficile.
  • C. difficilen- C. difficile
  • If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
  • General:
  • The possibility of superinfections with mycotic organisms or bacterial pathogens should be kept in mind during therapy. In such cases, discontinue the drug and substitute appropriate treatment.
  • A high percentage (43 to 100 percent) of patients with infectious mononucleosis who receive ampicillin develop a skin rash. Typically, the rash appears 7 to 10 days after the start of oral ampicillin therapy and remains for a few days to a week after the drug is discontinued. In most cases, the rash is maculopapular, pruritic and generalized. Therefore, the administration of ampicillin is not recommended in patients with mononucleosis. It is not known whether these patients are truly allergic to ampicillin.
  • Information for Patients:
  • Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
  • Laboratory Tests:
  • Transient elevation of serum transaminase has been observed following administration of ampicillin. The significance of this finding is not known.
  • Drug Interactions:
  • Drug/Laboratory Test Interactions:
  • Carcinogenesis, Mutagenesis and Impairment of Fertility:
  • Pregnancy category B:
  • Labor and Delivery:
  • Nursing Mothers:
  • Pediatric Use:n- Array
  • As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever or urticaria.
  • The following adverse reactions have been reported as associated with the use of ampicillin:
  • Gastrointestinal:
  • Hypersensitivity Reactions:
  • Note:
  • Liver:
  • Hemic and Lymphatic Systems:
  • To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or .
  • In cases of overdose, discontinue medication, treat symptomatically and institute supportive measures as required. In patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodialysis but not peritoneal dialysis.
  • No data
  • Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation, since the potency may decrease significantly after this period.
  • For Intramuscular Use:
  • While Ampicillin for Injection, USP 1 g and 2 g, are primarily for intravenous use, they may be administered intramuscularly when the 250 mg or 500 mg vials are unavailable. In such instances, dissolve in 3.5 or 6.8 mL Sterile Water for Injection, USP or Bacteriostatic Water for Injection, USP, respectively. The resulting solution will provide a concentration of 250 mg per mL.
  • Ampicillin for Injection, USP 125 mg, is intended primarily for pediatric use. It also serves as a convenient dosage form when small parenteral doses of the antibiotic are required.
  • Note:
  • For Direct Intravenous Use:
  • For Administration by Intravenous Drip: n- For Direct Intravenous Use)
  • Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Piggyback IV Package:
  • Ampicillin for Injection, USP equivalent to 125, 250, 500 mg, 1 or 2 grams ampicillin as the sodium salt per vial is supplied as follows:
  • NDC10515-143-00u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0
  • NDC10515-145-00u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0
  • NDC10515-146-00u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0
  • NDC10515-772-00u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • NDC10515-140-00u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • NDC10515-147-00u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • NDC10515-139-00u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • NDC10515-141-00u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Also available: Ampicillin for Injection, USP, Pharmacy Bulk Package bottle, contains ampicillin sodium equivalent to 10 grams ampicillin per bottle.
  • NDC10515-142-00u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Ampicillin for Injection, USP dry powder should be stored at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Rx only
  • CLINITESTu00ae is a registered trademark of Siemans Medical Solutions Diagnostics.CLINISTIXu00ae is a registered trademark of Bayer Healthcare LLC.
  • MANUFACTURED BY:G. C. Hanford Mfg. Co. Syracuse, New York 13201 USAn n
  • INS11080 12 u00a0u00a0 u00a0u00a0 u00a0u00a0 u00a0u00a0 u00a0u00a0 u00a0u00a0 06/2013
  • NDC 10515-145-00
  • Ampicillin for Injection, USP
  • FOR IM OR IV USE
  • EQUIVALENT TO 250 mg AMPICILLIN
  • Rx only
  • 10 vials
  • NDC 10515-146-00
  • Ampicillin for Injection, USP
  • FOR IM OR IV USE
  • EQUIVALENT TO 500 mg AMPICILLIN
  • Rx only
  • 10 vials
  • NDC 10515-772-00
  • Ampicillin for Injection, USP
  • FOR IM OR IV USE
  • EQUIVALENT TO 1 gram AMPICILLIN
  • Rx only
  • 10 vials
  • NDC 10515-140-00
  • Ampicillin for Injection, USP
  • FOR IM OR IV USE
  • EQUIVALENT TO 2 gram AMPICILLIN
  • Rx only
  • 10 vials

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