Augment (125 mg+31.25 mg)/5 ml

Description

Indications

Co-amoxiclav is prescribed for the short-term treatment of bacterial infections affecting various body systems, including:

• Upper respiratory tract infections (such as tonsillitis, sinusitis, and otitis media)
• Lower respiratory tract infections (including acute and chronic bronchitis, lobar pneumonia, and bronchopneumonia)
• Genito-urinary tract infections (such as cystitis, urethritis, and pyelonephritis)
• Skin and soft tissue infections
• Bone and joint infections (such as osteomyelitis)
• Other infections, including septic abortion, puerperal sepsis, and intra-abdominal infections.

Use this medication only as prescribed by a registered physician.

Composition

• Tablets:
  • 375 mg tablet: Amoxicillin 250 mg (as Amoxicillin Trihydrate BP) + Clavulanic Acid 125 mg (as Diluted Potassium Clavulanate BP)
  • 625 mg tablet: Amoxicillin 500 mg + Clavulanic Acid 125 mg
  • 1 gm tablet: Amoxicillin 875 mg + Clavulanic Acid 125 mg
• Powder for Suspension:
  • Standard suspension (5 ml): Amoxicillin 125 mg + Clavulanic Acid 31.25 mg
  • Forte suspension (5 ml): Amoxicillin 400 mg + Clavulanic Acid 57.5 mg
• Injection:
  • 1.2 gm vial: Amoxicillin Sodium BP (equivalent to 1 gm Amoxicillin) + Clavulanate Potassium USP (equivalent to 200 mg Clavulanic Acid)
  • 0.6 gm vial: Amoxicillin Sodium BP (equivalent to 500 mg Amoxicillin) + Clavulanate Potassium USP (equivalent to 100 mg Clavulanic Acid)

Pharmacology Co-amoxiclav is a combination of Amoxicillin (a broad-spectrum antibiotic) and Clavulanic Acid (a beta-lactamase inhibitor). Amoxicillin effectively eliminates various Gram-positive and Gram-negative bacteria, but its action is limited by beta-lactamase-producing organisms. Clavulanic Acid helps overcome this limitation by inhibiting beta-lactamase enzymes, thereby extending the antibacterial spectrum.

After oral administration, both Amoxicillin and Clavulanic Acid reach peak serum concentrations within approximately one hour. Absorption is optimal when taken at the beginning of a meal. Approximately 70% of both compounds remain unbound in the bloodstream. Increasing the dosage proportionally elevates serum levels.

Dosage and Administration Adults and Children over 12 years:

• Tablets:
  • Standard dose: 625 mg every 12 hours or 375 mg every 8 hours
  • Severe infections: 1 gm every 12 hours or 625 mg every 8 hours

Children (Suspension):

• 6-12 years: 2 teaspoonfuls every 8 hours
• 1-6 years: 1 teaspoonful every 8 hours
• Below 1 year: 25 mg/kg/day in divided doses every 8 hours

Forte Suspension (for serious infections):

• Mild to moderate infections: 25/3.6 mg/kg/day
• Severe infections: 45/6.4 mg/kg/day
  • 2-6 years (13-21 kg): 5 ml twice daily
  • 7-12 years (22-40 kg): 10 ml twice daily

IV Injection:

• Adults: 1.2 gm every 8 hours; severe cases may require 1.2 gm every 6 hours
• Surgical prophylaxis: 1.2 gm at induction, with high-risk procedures requiring 2-3 gm every 8 hours
• Children:
  • 0-3 months: 30 mg/kg every 8 hours (every 12 hours in neonates and preterm infants)
  • 3 months-12 years: 30 mg/kg every 8 hours; severe cases may need administration every 6 hours

Administration Guidelines

• Oral forms: Can be taken with or without food, but absorption is improved when taken at the start of a meal. Taking it with meals may also reduce gastrointestinal side effects.
• IV injection: Not for intramuscular or subcutaneous use. Administer via slow IV injection (over 2 minutes) or infusion (over 30 minutes). Reconstituted vials must be used within 20 minutes.

Drug Interactions

• May prolong bleeding time and prothrombin time.
• May reduce the efficacy of oral contraceptives.
• Concurrent use with allopurinol increases the risk of allergic skin reactions.

Contraindications

• Known hypersensitivity to Penicillins or other beta-lactam antibiotics (such as Cephalosporins)
• History of Co-amoxiclav or Penicillin-induced cholestatic jaundice

Side Effects Most side effects are mild and transient, including:

• Gastrointestinal issues: Diarrhea, nausea, vomiting, indigestion, and pseudomembranous colitis
• Hepatic effects: Rare cases of hepatitis and cholestatic jaundice
• Skin reactions: Urticaria, erythematous rashes, and, rarely, severe conditions like Stevens-Johnson Syndrome
• Allergic reactions: Anaphylaxis and angioedema (rare)

Use During Pregnancy and Lactation

• Animal studies have shown no teratogenic effects.
• Limited human data suggest no harmful effects, but use during pregnancy should only be considered if absolutely necessary.
• Small amounts of Amoxicillin may be excreted in breast milk.

Precautions and Warnings

• Use with caution in patients with severe liver dysfunction or those on anticoagulants.
• Dosage adjustment is necessary for patients with moderate to severe renal impairment.
• High doses require adequate fluid intake to reduce the risk of crystalluria.

Dosage Adjustments for Renal Impairment

• Mild impairment (Creatinine clearance > 30 ml/min): No adjustment needed
• Moderate impairment (Creatinine clearance 10-30 ml/min): One 375 mg or 625 mg tablet every 12 hours; IV: 1.2 gm followed by 0.6 gm IV every 12 hours
• Severe impairment (Creatinine clearance < 10 ml/min): Maximum dose of 375 mg tablet every 12 hours or 1.2 gm IV followed by 0.6 gm IV every 24 hours; an additional 0.6 gm IV may be required during and after dialysis

Overdose Effects

• Overdose is rare but may cause gastrointestinal disturbances and electrolyte imbalance.
• Hemodialysis can aid in drug removal if necessary.

Therapeutic Class

• Broad-spectrum Penicillins

Reconstitution Guidelines

• IV injection: Dissolve 1.2 gm powder in 20 ml of Water for Injection BP. Do not mix with dextrose solutions, sodium bicarbonate, protein-based fluids, blood, or plasma.
• The reconstituted solution can be injected into the drip tubing over 3-4 minutes.

Storage Instructions

• Store below 25°C, protected from light and moisture.
• Reconstituted suspension should be refrigerated and used within 7 days.
• Reconstituted IV vials must be used within 20 minutes.