Ampicillin Sodium (Ampicillin)

Trade Name : Ampicillin

Athenex Pharmaceutical Division, LLC.

INJECTION, POWDER, FOR SOLUTION

Strength 10 g/100mL

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 Athenex Pharmaceutical Division, LLC.. It is available in strength of 10 g/100mL 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

Packaging and Delivery

Validated Cold Chain Shipment

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
  • AthenexRx only
  • 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.n
  • Ampicillin for Injection, USP the monosodium salt of [2S-[2u03b1,5u03b1,6u03b2(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin for intravenous use. The pharmacy bulk package contains sterile ampicillin sodium equivalent to 10 grams ampicillin. 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.n
  • Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates.n
  • A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see ).n
  • It has the following molecular structure:n
  • The molecular formula is CHNNaOS, and the molecular weight is 371.39.n
  • The pH range of the reconstituted solution is 8 to 10. Ampicillin for Injection, USP contains 65.83 mg (2.86 milliequivalents) of sodium per 1 gram of drug. Ampicillin for Injection, USP is white to off-white crystalline powder. The solution after constitution is clear and colorless. Each Ampicillin for Injection Pharmacy Bulk Package bottle contains ampicillin sodium equivalent to 10 grams of ampicillin.n
  • 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. Due to maturational changes in renal function, ampicillin half-life decreases as postmenstrual age (a sum of gestational age and postnatal age) increases for infants with postnatal age of less than 28 days. 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.n
  • While studies have demonstrated the susceptibility of most strains of the following organisms, clinical efficacy for infections other than those included in the section has not been demonstrated.n
  • Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:n
  • Respiratory Tract Infectionsn- Streptococcus pneumoniae, Staphylococcus aureusn- H. influenzae,
  • Bacterial Meningitisn- E. Colin- Listeria monocytogenes, N. meningitidis
  • Septicemia and Endocarditisn- Streptococcus sppn- E. Coli, Proteus mirabilisn- Salmonella spp.
  • Urinary Tract Infectionsn- E. Colin- Proteus mirabilis.
  • Gastrointestinal Infectionsn- Salmonella typhin- Salmonella spp.,n- Shigella spp.
  • 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.n
  • 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.n
  • Indicated surgical procedures should be performed.n
  • A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.n
  • 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.n
  • 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.n
  • No data
  • 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.n
  • The following adverse reactions have been reported as associated with the use of ampicillin:n
  • 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.n
  • This insert is for a Pharmacy Bulk Package and is intended for preparing IV admixtures only. Dosage recommendations for intravenous injection are for informational purposes only.n
  • Infections of the respiratory tract and soft tissues.
  • Patients weighing 40 kg (88 lbs) or more:
  • Patients weighing less than 40 kg (88 lbs):
  • Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).
  • Patients weighing 40 kg (88 lbs) or more:
  • Patients weighing less than 40 kg (88 lbs):
  • In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.n
  • No data
  • Ampicillin for Injection, USP is supplied as follows:n
  • Each Ampicillin for Injection, USP Pharmacy Bulk Package bottle contains ampicillin sodium equivalent to 10 grams of ampicillin.n
  • Store dry powder at 20u00ba to 25u00baC (68u00ba to 77u00baF). [See USP Controlled Room Temperature.]n
  • Sterile, Nonpyrogenic, Preservative-free.
  • The container closure is not made with natural rubber latex.
  • Athenexn
  • Revised: September 2018n
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 BOTTLE LABELn
  • NDC 70860-118-99n
  • Ampicillin for Injection, USPn
  • 10 grams per Pharmacy Bulk Packagen
  • PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSIONn
  • NOT TO BE DISPENSED AS A UNITn
  • Rx onlyn
  • For Intravenous Usen

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