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MEDICINE MONOGRAPH CODE: [8.17] ID: TIP-MED-000145

Cephalexin & Cefadroxil

Active Ingredient / Scientific Identity: Cephalexin & Cefadroxil • Class: First-Generation Oral Cephalosporins — ICMR 'Access' Group (Schedule H | NLEM 2022)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Cephalexin & Cefadroxil ([8.17] | ID: TIP-MED-000145) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/8-17-cephalexin-cefadroxil/
Generic / Entity NameCephalexin & Cefadroxil ([8.17])
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassFirst-Generation Oral Cephalosporins — ICMR 'Access' Group (Schedule H | NLEM 2022)
Available Dosage FormsCephalexin Capsules/Tablets: 250 mg, 500 mg, 750 mg ER; Dry Syrup: 125 mg/5mL, 250 mg/5mL. Cefadroxil Tablets:
Regulatory ClassificationSchedule H Prescription Drug (To be sold by retail on the prescription of a Registere
Key Warning & Review DateRenal: Extend dosing interval to q12h (CrCl 10–50 mL/min) or q24h (CrCl <10 mL/min). Hepatic: Safe
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H Prescription Drug (To be sold by retail o✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Cephalexin & Cefadroxil (TIP-MED-000145, Reference Code [8.17]) is classified under Antimicrobials — Antibacterial & Antibiotic Agents (Ch 08) as a First-Generation Oral Cephalosporins — ICMR 'Access' Group (Schedule H | NLEM 2022). Within the Indian regulatory and compendial framework, it is governed under Schedule H Prescription Drug (To be sold by retail on the prescription of a Registered Medical Practitioner only — Drugs Rules 1945).

Verified Indian Market Examples / Compendial Status:
Representative Indian Market Examples (Edition 2.7 Ch 08 [8.17], p. 101): Cephalexin: Phexin (GSK), Sporidex (Sun), Ceff (Lupin). Cefadroxil: Odoxil (Lupin), Droxyl (Torrent), Cefadur — Strengths & Dosage Forms: Cephalexin Capsules/Tablets: 250 mg, 500 mg, 750 mg ER; Dry Syrup: 125 mg/5mL, 250 mg/5mL. Cefadroxil Tablets: 250 mg, 500 mg, 1000 mg; Dry Syrup: 125 mg/5mL, 250 mg/5mL
Representative Indian Market Examples (Edition 2.7 Ch 08 [8.17], p. 101): Cephalexin: Phexin (GSK), Sporidex (Sun), Ceff (Lupin). Cefadroxil: Odoxil (Lupin), Droxyl (Torrent), Cefadur — Strengths & Dosage Forms: Cephalexin Capsules/Tablets: 250 mg, 500 mg, 750 mg ER; Dry Syrup: 125 mg/5mL, 250 mg/5mL. Cefadroxil Tablets: 250 mg, 500 mg, 1000 mg; Dry Syrup: 125 mg/5mL, 250 mg/5mL
Dosage Forms & Available Strengths:
Cephalexin Capsules/Tablets: 250 mg, 500 mg, 750 mg ER; Dry Syrup: 125 mg/5mL, 250 mg/5mL. Cefadroxil Tablets: 250 mg, 500 mg, 1000 mg; Dry Syrup: 125 mg/5mL, 250 mg/5mL
Routes: Oral / Parenteral / Topical as specified by formulation

3. Mechanism of Action & Pharmacodynamics

First-Generation Oral Cephalosporins — ICMR 'Access' Group (Schedule H | NLEM 2022) acting on target receptor/enzyme pathways in Antimicrobials — Antibacterial & Antibiotic Agents (Ch 08): clinical efficacy is mediated via First-Generation Oral Cephalosporins — ICMR 'Access' Group (Schedule H | NLEM 2022) for Uncomplicated skin and soft-tissue infections (impetigo, folliculitis, furunculosis, erysipelas, MSSA cellulitis), streptococcal pharyngitis/tonsillitis, and uncomplicated lower UTI.

4. Therapeutic Indications & Evidence-Supported Uses

  • Uncomplicated skin and soft-tissue infections (impetigo, folliculitis, furunculosis, erysipelas, MSSA cellulitis), streptococcal pharyngitis/tonsillitis, and uncomplicated lower UTI

🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.

5. Educational Dosage Context, Formulations & Administration

Educational Dosing & Regimen Summary: Cephalexin: 250–500 mg PO QID or 500 mg PO TDS (Max 4 g/day; Children: 25–50 mg/kg/day in 3–4 doses). Cefadroxil: 500 mg PO BD or 1000 mg OD (Children: 30 mg/kg/day in 1–2 doses)

Administration & Meal Timing: May be taken with or without food (taking with food reduces GI upset) | Cephalexin: TDS–QID (q6–8h). Cefadroxil: BD (q12h) or OD

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Metabolism & Biotransformation:
Renal: Extend dosing interval to q12h (CrCl 10–50 mL/min) or q24h (CrCl <10 mL/min). Hepatic: Safe
Elimination & Renal Adjustment:
Renal: Extend dosing interval to q12h (CrCl 10–50 mL/min) or q24h (CrCl <10 mL/min). Hepatic: Safe
Hepatic Impairment Considerations:
Renal: Extend dosing interval to q12h (CrCl 10–50 mL/min) or q24h (CrCl <10 mL/min). Hepatic: Safe

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • Contraindicated in immediate/severe IgE-mediated anaphylaxis, angioedema, or SJS/TEN to Penicillins or Cephalosporins (shares R1 side-chain with Amoxicillin!). No activity against MRSA or Pseudomonas

Key Clinical Precautions: Renal: Extend dosing interval to q12h (CrCl 10–50 mL/min) or q24h (CrCl <10 mL/min). Hepatic: Safe

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Diarrhoea, nausea, dyspepsia, mild maculopapular rash, vulvovaginal candidiasis
  • Anaphylaxis, angioedema, C. difficile colitis, interstitial nephritis, positive Coombs test
Serious / Dose-Limiting Adverse Effects:
  • Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.

9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions

  • Cephalexin inhibits renal tubular OCT2/MATE transporters -> increases Metformin plasma levels by 24–34% (monitor in CKD); Probenecid doubles levels; Separate from Zinc/Iron supplements by >=2 hours

10. Clinical Monitoring, Patient Counselling & Storage

Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.

Pharmacist Patient Counselling Points:

  • Patient Counselling Checklist: First-line WHO/ICMR 'Access' antibiotic for common skin infections (avoid unnecessary broad-spectrum Cefixime or Linezolid for simple boils/cellulitis!); complete the full course
  • Meal & Clock Timing Instruction: May be taken with or without food (taking with food reduces GI upset) (Cephalexin: TDS–QID (q6–8h). Cefadroxil: BD (q12h) or OD)
  • Missed Dose Protocol: Take as soon as remembered to maintain plasma levels above MIC
  • Geriatric Dispensing Pearl: Adjust frequency in older adults with CrCl <50 mL/min

Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Cephalexin Capsules/Tablets: 250 mg, 500 mg, 750 mg ER; Dry Syrup: 125 mg/5mL, 250 mg/5mL. Cefadroxil Tablets: 250 mg, 500 mg, 1000 mg; Dry Syrup: 125 mg/5mL, 250 mg/5mL

11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)

THE 12-STEP ORAL DRUG JOURNEY THROUGH THE HUMAN BODY (LADME) Note: IV bolus enters Step 6 directly (F = 100%); Sublingual & Transdermal routes bypass Step 4–5 Portal First-Pass Metabolism 1. Oral Administration • Tablet / Capsule swallowed • Gastric emptying to duodenum pH 1.5–3.5 (Stomach) 2. Disintegration & Dissolution • Tablet breaks into granules • API dissolves in GI fluid Noyes-Whitney Dissolution Rate 3. GI Epithelial Absorption • Crosses intestinal villi • Passive / Active / P-gp efflux Small Intestine (Large Surface Area) 4. Portal Circulation • Mesenteric veins → Portal vein • Delivers blood to liver sinusoids Pre-systemic Venous Conduit 5. First-Pass Metabolism • Gut & hepatic CYP450 extraction • High: GTN, Propranolol, Morphine Determines Bioavailability (F = f_a × (1-E_H)) 6. Systemic Circulation • Hepatic vein → IVC → Heart • Unbound vs Albumin-bound drug Only FREE drug is active 7–8. Tissue Distribution (Vd) • Capillary permeation to organs • Blood-Brain & Placental barriers Vd = Dose / C_0 (L or L/kg) 9. Target Site of Action • Receptors (GPCR, Ion channel) • Enzymes & Carrier Transporters Pharmacodynamic Effect (E_max, EC50) 10. Hepatic Biotransformation • Phase I (CYP450 Oxidation/Hydrolysis) • Phase II (Glucuronidation/Sulfation) Converts lipophilic drug → hydrophilic metabolite 11. Renal & Biliary Elimination • Nephron: Filtration + Secretion − Reabsorption • Biliary excretion & Enterohepatic recycling Total Clearance CL_tot = CL_renal + CL_hepatic 12. Excretion from the Body • Urine (Primary polar metabolite route) • Bile/Faeces, Expired Air, Sweat, Milk Elimination Half-Life t1/2 = (0.693 × Vd) / CL
svg-v339-01-adme-12-step-journey — 8.1 Complete 12-Step Journey of an Orally Administered Drug (ADME): Figure 8.1: The 12-step physiological journey of a typical orally administered solid dosage form through Liberation, Absorption, Distribution, Metabolism, and Excretion (LADME). Note: Parenteral (IV), sublingual, and inhalational routes bypass gastrointestinal absorption and/or hepatic first-pass metabolism.

12. Authoritative References, Regulatory Sources & Editorial Disclaimer

Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 08 [8.17] (p. 101)

Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)

Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: HANDBOOK_SOURCE_CONTENT

Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.

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Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/8-17-cephalexin-cefadroxil/, Last Reviewed: 2026-11-10) is an educational reference sheet for students and healthcare learners. It is NOT an official prescribing guideline or patient-specific treatment order.