1. Disclaimer
The information provided in this report is intended for educational and professional reference purposes only and does not replace professional medical judgment, diagnosis, or treatment.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. By using this blog, you agree to assume personal responsibility for relying on the information provided.
2. Summary
DELTACLAV is a fixed-dose combination antibacterial product containing amoxicillin, a broad-spectrum aminopenicillin, and clavulanic acid, a β-lactamase inhibitor. The addition of clavulanic acid protects amoxicillin from enzymatic degradation by many β-lactamase–producing bacteria, thereby extending its antibacterial spectrum. DELTACLAV is widely used in the treatment of respiratory tract, urinary tract, skin and soft tissue, dental, and mixed aerobic–anaerobic infections caused by susceptible organisms.
3. Brand Name
DELTACLAV®
4. Category
- Antibacterial agent
- Penicillins combined with β-lactamase inhibitors
- ATC code: J01CR02
5. Active Ingredient
- Amoxicillin (as amoxicillin trihydrate)
- Clavulanic acid (as potassium clavulanate)
6. Pharmaceutical Form & Strength
Film-Coated Tablets
- 625 mg: Amoxicillin 500 mg + Clavulanic acid 125 mg
- 1 g: Amoxicillin 875 mg + Clavulanic acid 125 mg
Powder for Oral Suspension
- 228.5 mg/5 mL: Amoxicillin 200 mg + Clavulanic acid 28.5 mg
- 457 mg/5 mL: Amoxicillin 400 mg + Clavulanic acid 57 mg
- 642.9 mg/5 mL: Amoxicillin 600 mg + Clavulanic acid 42.9 mg (high-dose pediatric formulation)
7. Manufacturer & Marketing Authorization Holder
Manufactured in Egypt under license from Delta Pharma, with production by one or more of the following (depending on dosage form and batch):
- Misr Pharmaceutical Company
- Sigma Tec
- Sedico
Manufacturing details may vary and should always be confirmed from the current product packaging.
8. Mechanism of Action
Amoxicillin exerts bactericidal activity by inhibiting bacterial cell wall synthesis through binding to penicillin-binding proteins (PBPs), resulting in cell lysis.
Clavulanic acid is a β-lactamase inhibitor that irreversibly inactivates many plasmid-mediated β-lactamases, thereby preventing amoxicillin degradation and restoring activity against resistant organisms.
9. Spectrum of Activity
DELTACLAV is active against many β-lactamase–producing and non-producing organisms.
Gram-Positive Aerobes
- Streptococcus pneumoniae
- Streptococcus pyogenes
- Streptococcus viridans
- Staphylococcus aureus (non-MRSA)
- Enterococcus faecalis
- Listeria monocytogenes
Gram-Negative Aerobes
- Haemophilus influenzae
- Moraxella catarrhalis
- Escherichia coli
- Klebsiella species
- Proteus mirabilis
- Neisseria gonorrhoeae
- Neisseria meningitidis
- Pasteurella multocida
Anaerobes
- Bacteroides species (including B. fragilis)
- Clostridium species
- Peptostreptococcus species
Note: Antimicrobial susceptibility varies geographically; local antibiograms should guide therapy.
10. Pharmacokinetics
- Absorption: Well absorbed orally; administration with food improves gastrointestinal tolerance
- Distribution: Widely distributed in body tissues and fluids; limited CSF penetration unless meninges are inflamed
- Protein Binding: Amoxicillin ~17–20%; clavulanic acid ~25%
- Metabolism: Minimal (clavulanate partially metabolized)
- Elimination: Primarily renal (glomerular filtration and tubular secretion)
- Half-life: Approximately 1–1.5 hours (prolonged in renal impairment)
11. Indications
- Upper respiratory tract infections (sinusitis, otitis media, tonsillitis)
- Lower respiratory tract infections (acute/chronic bronchitis, pneumonia)
- Skin and soft tissue infections
- Urinary tract infections
- Dental infections
- Bone and joint infections
- Intra-abdominal and mixed aerobic–anaerobic infections
- Post-operative infections
12. Administration
- Oral use
- Administer at the start of a meal to reduce gastrointestinal adverse effects
- Dosing is based on the amoxicillin component
- Dose adjustment required in renal impairment
13. Method of Preparation
(For oral suspension only)
- Shake bottle to loosen powder
- Add water up to the mark indicated on the label
- Shake vigorously
- Allow to stand for 5 minutes
- Shake well before each dose
14. Contraindications
- Hypersensitivity to penicillins, clavulanic acid, or other β-lactam antibiotics
- History of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanate
- Suspected infectious mononucleosis
15. Warnings & Precautions
- Risk of serious hypersensitivity reactions, including anaphylaxis
- Monitor hepatic function during prolonged therapy
- Dose adjustment required in renal impairment
- Risk of Clostridioides difficile–associated diarrhea
- Prolonged use may result in superinfection
- Maintain adequate hydration during high-dose therapy
16. Drug Interactions
- Probenecid: Increases amoxicillin levels (avoid)
- Allopurinol: Increased risk of rash
- Oral anticoagulants: Possible INR elevation
- Methotrexate: Reduced clearance and increased toxicity
- Oral contraceptives: Possible reduction in efficacy
17. Side Effects
Common
- Diarrhea
- Nausea, vomiting
- Abdominal discomfort
Uncommon/Rare
- Skin rash, urticaria
- Cholestatic hepatitis
- Pseudomembranous colitis
- Interstitial nephritis
- Hematologic abnormalities (rare)
18. Use in Special Populations
- Pregnancy: Category B; use if clearly needed
- Lactation: Excreted in breast milk; generally considered safe
- Pediatrics: Widely used; high-dose formulations for resistant S. pneumoniae
- Elderly: Monitor hepatic and renal function
- Renal impairment: Dose adjustment mandatory
19. Storage Conditions
- Store tablets and dry powder at room temperature, protected from moisture
- Reconstituted suspension: refrigerate (2–8°C) and use within 7 days
- Keep out of reach of children
20. Additional Sections
Overdose
Primarily gastrointestinal symptoms. Management is supportive. Maintain hydration; hemodialysis may remove amoxicillin and clavulanate in severe cases.
21. Frequently Asked Questions (FAQ)
Q: Can DELTACLAV be taken with food?
A: Yes. Food improves tolerability.
Q: Is DELTACLAV effective against MRSA?
A: No.
Q: Can treatment be stopped once symptoms improve?
A: No. The full prescribed course must be completed.
22. References
- British National Formulary (BNF)
- FDA Prescribing Information – Amoxicillin/Clavulanate
- European Medicines Agency (EMA)
- WHO Model Formulary
- Sanford Guide to Antimicrobial Therapy
- Goodman & Gilman’s The Pharmacological Basis of Therapeutics
