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Cephalexin (Cephalexin)

Trade Name : Cephalexin

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 250 mg/1

CEPHALEXIN Cephalosporin Antibacterial [EPC],Cephalosporins [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 Cephalexin (Cephalexin) which is also known as Cephalexin and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 250 mg/1 per ml. Read more

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.     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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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
  • Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets and other antibacterial drugs, cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ()
  • Respiratory tract infection ()
  • Otitis media ()
  • Skin and skin structure infections ()
  • Bone infections ()
  • Genitourinary tract infections ()
  • No data
  • Duration of therapy ranges from 7 to 14 days depending on the infection type and severity. ()
  • Dosage adjustment is required in patients with severe and end stage renal disease (ESRD) defined as creatinine clearance below 30 mL/min. ()
  • Cephalexin Capsules USP
  • 250 mg: Swedish orange body and gray cap imprinted u201cTEVAu201d on the cap and u201c3145u201d on the body
  • 500 mg: Swedish orange body and Swedish orange cap imprinted u201cTEVAu201d on the cap and u201c3147u201d on the body
  • Cephalexin for Oral Suspension USP
  • A cherry mixed fruit flavored formula - 125 mg/5 mL and 250 mg/5 mL
  • Cephalexin Tablets USP
  • 250 mg: Tablet identification number and color: white, capsule-shaped tablet, debossed u201c2238u201d on one side with a score between the u201c2u201d and the u201c3u201d and u201cTEVAu201d on the reverse side.
  • 500 mg: Tablet identification number and color: white, capsule-shaped tablet, debossed u201c2240u201d on one side with a score between the u201c2u201d and the u201c4u201d and u201cTEVAu201d on the reverse side.
  • Capsules: 250 mg and 500 mg ()
  • For oral suspension: 125 mg/5 mL and 250 mg/5 mL
  • Tablets: 250 mg and 500 mg
  • Cephalexin is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.
  • Patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs. ()
  • No data
  • Serious hypersensitivity (anaphylactic) reactions
  • Arrayn- Clostridium difficile
  • Direct Coombsu2019 Test Seroconversion
  • Seizure Potential
  • The following serious events are described in greater detail in the Warning and Precautions section:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • In clinical trials, the most frequent adverse reaction was diarrhea. Nausea and vomiting, dyspepsia, gastritis, and abdominal pain have also occurred. As with penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported.
  • Other reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in aspartate transaminase (AST) and alanine transaminase (ALT) have been reported.
  • In addition to the adverse reactions listed above that have been observed in patients treated with cephalexin, the following adverse reactions and other altered laboratory tests have been reported for cephalosporin class antibacterial drugs:
  • Other Adverse Reactions
  • Altered Laboratory Tests:
  • The most common adverse reactions associated with cephalexin include diarrhea, nausea, vomiting, dyspepsia and abdominal pain. ()
  • No data
  • Metformin: increased metformin concentrations. Monitor for hypoglycemia. ()
  • Probenecid - The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin is not recommended. ()
  • Administration of cephalexin may result in a false-positive reaction for glucose in the urine. ()
  • No data
  • Renal Impairment: Monitor patients longer for toxicity and drug interactions due to delayed clearance. ()
  • Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures.
  • Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin.
  • 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, USP has the following structural formula:
  • CHNOSu2022HOu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0M.W. 365.41
  • The nucleus of cephalexin, USP 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. The isoelectric point of cephalexin, USP in water is approximately 4.5 to 5.
  • The crystalline form of cephalexin, USP which is available is a monohydrate. It is a white crystalline solid having a bitter taste. 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. Cephalexin, USP has a -phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.
  • Each capsule contains cephalexin monohydrate, USP equivalent to 250 mg (720 u03bcmol) or 500 mg (1,439 u03bcmol) of cephalexin.
  • Inactive Ingredients:
  • Capsule Shell and Print Constituents:
  • After mixing, each 5 mL of cephalexin for oral suspension USP will contain cephalexin monohydrate, USP equivalent to 125 mg (360 u03bcmol) or 250 mg (720 u03bcmol) of cephalexin.
  • Inactive Ingredients:
  • Each tablet contains cephalexin monohydrate, USP equivalent to 250 mg (720 u03bcmol) or 500 mg (1,439 u03bcmol) of cephalexin.
  • Inactive Ingredients:
  • No data
  • Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male and female rats, fertility and reproductive performance were not affected by cephalexin oral doses up to 1.5 times the highest recommended human dose based upon body surface area.
  • Cephalexin Capsules USPu2014
  • 250 mg: Swedish orange body and gray cap imprinted u201cTEVAu201d on the cap and u201c3145u201d on the body, in bottles of 100 (NDC 0093-3145-01) and 500 (NDC 0093-3145-05).
  • 500 mg: Swedish orange body and Swedish orange cap imprinted u201cTEVAu201d on the cap and u201c3147u201d on the body, in bottles of 100 (NDC 0093-3147-01) and 500 (NDC 0093-3147-05).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container.
  • Cephalexin for Oral Suspension USP
  • (a cherry mixed fruit flavored formula)u2014
  • 125 mg/5 mL: bottles of 100 mL (NDC 0093-4175-73) and 200 mL (NDC 0093-4175-74).
  • 250 mg/5 mL: bottles of 100 mL (NDC 0093-4177-73) and 200 mL (NDC 0093-4177-74).
  • Directions for mixing are included on the label.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Shake well before using. Keep tightly closed.
  • Cephalexin Tablets USPu2014
  • 250 mg: bottles of 100 (NDC 0093-2238-01). Tablet identification number and color: white, capsule-shaped tablet, debossed u201c2238u201d on one side with a score between the u201c2u201d and the u201c3u201d and u201cTEVAu201d on the reverse side.
  • 500 mg: bottles of 100 (NDC 0093-2240-01). Tablet identification number and color: white, capsule-shaped tablet, debossed u201c2240u201d on one side with a score between the u201c2u201d and the u201c4u201d and u201cTEVAu201d on the reverse side.
  • Store dry powder at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Allergic Reactions
  • Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to cephalexin, other beta-lactams (including cephalosporins) or other allergens (5.1)
  • Diarrhea
  • Advise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, advise patients to contact their healthcare provider.
  • Antibacterial Resistance
  • Counsel patients that antibacterial drugs including cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets are prescribed to treat a bacterial infection, tell patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets or other antibacterial drugs in the future.
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. U 1/2019
  • No data
  • No data
  • No data
  • No data
  • No data
  • No data

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