Trade Name: Cephalexin

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals,Inc.

Presentation: POWDER, FOR SUSPENSION, HUMAN PRESCRIPTION DRUG

Strength: 250 mg/5mL

Storage and handling

CEPHALEXIN Cephalosporin Antibacterial [EPC],Cephalosporins [CS]

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • Cephalexin USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-u03b1-Amino-u03b1-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula Cn n n Hn n n Nn n n On n n Su2022Hn n n O and the molecular weight is 365.41.u00a0n nn
  • Cephalexin has the following structural formula:
  • The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group.u00a0 The isoelectric point of cephalexin in water is approximately 4.5 to 5.u00a0
  • The crystalline form of cephalexin which is available is a monohydrate.u00a0 It is a white crystalline solid having a bitter taste.u00a0 Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.
  • The cephalosporins differ from penicillins in the structure of the bicyclic ring system.u00a0 Cephalexin has a n n n phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.n nn
  • Cephalexin for Oral Suspension, USP is a white to off white granular powder with characteristic flavor, and gives orange colored viscous suspension after reconstitution with water.
  • After mixing, each 5 mL of Cephalexin for Oral Suspension, USP, will contain cephalexin monohydrate equivalent to 125 mg or 250 mg of anhydrous cephalexin. The suspensions also contains the following inactive ingredients: colloidal silicon dioxide, FD&C Yellow No.6, tutti-frutti flavor, orange flavor, sodium lauryl sulphate, sucrose and xanthan gum.
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  • Cephalexin for Oral Suspension, USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
  • Respiratory tract infections caused by n n n and n n n (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin for Oral Suspension, USP is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.)n nn
  • Otitis media due to n n n , n n n , and n n n n
  • Skin and skin structure infections caused by n n n and/or n n n n
  • Bone infections caused by n n n and/or n n n n
  • Genitourinary tract infections, including acute prostatitis, caused by n n n andn n n n
  • Note -
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin for Oral Suspension, USP and other antibacterial drugs, Cephalexin for Oral Suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.u00a0 When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.u00a0 In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
  • Cephalexin for Oral Suspension is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
  • BEFORE THERAPY WITH CEPHALEXIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALEXIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEPHALEXIN OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS. INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
  • There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.
  • Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. No exception should be made with regard to cephalexin.
  • Arrayn- C. difficile
  • C. difficilen- C. difficile
  • If CDAD is suspected or confirmed, ongoing antibiotic use not directed against n n n may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of n n n , and surgical evaluation should be instituted as clinically indicated. n nn
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  • Cephalexin for Oral Suspension is administered orally.
  • Cephalexin for Oral Suspension, USP is a white to off white granular powder with characteristic flavor, and gives orange colored viscous suspension after reconstitution with water.
  • The 250 mg/5 mL oral suspension is available as follows
  • NDC 66267-981-20
  • After mixing store in a refrigerator. May be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed.
  • Prior to mixing, store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • 1. National Committee for Clinical Laboratory Standards: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically-Fourth Edition. Approved Standard NCCLS Document M7-A4, Vol. 17, No. 2, NCCLS, Wayne, PA, January, 1997.
  • 2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests- Sixth Edition. Approved Standard NCCLS Document M2-A6, Vol. 17, No. 1, NCCLS, Wayne, PA, January, 1997.
  • 3. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing- Eighth Informational Supplement. Approved Standard NCCLS Document M100-S8, Vol. 18, No. 1, NCCLS, Wayne, PA, January, 1998.
  • Manufactured for : OrchidPharma, Inc.n n n Princeton, NJ 08540, USAn nn
  • Manufactured by : Hospira Healthcare India Pvt.Ltd.,n n n At Irungattukottai u2013 602 105, Indian nn
  • On behalf of : Orchid Healthcaren n n (A Division of Orchid Pharma Ltd.)n n n At Irungattukottai u2013 602 105, Indian nn
  • R01/16
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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Cephalexin (Cephalexin) which is also known as Cephalexin and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 250 mg/5mL.

Cephalexin (Cephalexin) 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.

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