Demoxiclave 875 mg+125 mg is indicated for the short-term treatment of bacterial infections at the following sites:

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

Pharmacodynamics: This combination consists of Amoxicillin, a broad-spectrum bactericidal antibiotic, and Clavulanic Acid, a beta-lactamase inhibitor. Amoxicillin is active against many Gram-positive and Gram-negative bacteria but can be degraded by beta-lactamase enzymes. Clavulanic Acid inhibits these enzymes, protecting Amoxicillin and extending its antibacterial spectrum.

Pharmacokinetics: Both components have similar pharmacokinetic profiles. Peak blood concentrations are reached approximately one hour after oral administration. Absorption is improved when taken at the beginning of a meal. Both drugs have low protein binding, with about 70% remaining free in circulation. Increasing the dose leads to a proportional increase in blood levels.

Adults and children over 12 years:
Tablet:

• The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours.
• For more severe infections and infections of the respiratory tract, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.

Suspension:

• Children 6-12 years: 2 teaspoonful every 8 hours.
• Children 1-6years: 1 teaspoonful every 8 hours.
• Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.

Forte suspension:

• The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।
• For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).

Children of 2 to 12 years:
Mild to moderate infections:

• 25/3.6 mg/kg/day (Suspension)
• 2-6 years (13-21 kg) 2.5 ml suspension b.i.d
• 7-12years (22-40kg) 5 ml suspension b.i.d

Serious infections:

• 45/6.4 mg/kg/day (Forte Suspension)
• 2-6 years (13-21 kg) 5 ml suspension b.i.d
• 7-12 years (22-40 kg) 10 ml suspension b.i.d

IV Injection

Adults

• Usually, 1.2 gm every 8 hours
• Increased in more serious infections to 1.2 gm every 6 hours
• For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.

Children

• 0 to 3 months: 30 mg/kg every 8 hours. (every12 hours in the perinatal period and in premature infants.
• 3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.

Administration

Oral dosage form: This may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanic acid are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanic acid should be taken at the start of the meal.

IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.

This combination is contraindicated in patients with a history of hypersensitivity to penicillins. Cross-reactivity may occur with other beta-lactam antibiotics such as cephalosporins. It is also contraindicated in patients with a previous history of cholestatic jaundice or liver dysfunction associated with Co-amoxiclav or penicillin use.

Side effects are generally uncommon and mild. Reported effects include diarrhea, indigestion, nausea, vomiting, and candidiasis. Gastrointestinal discomfort may be reduced by taking the medication at the beginning of meals. Rarely, hepatitis and cholestatic jaundice may occur but are usually reversible. Skin reactions such as urticaria and erythematous rash may appear. Very rare but serious reactions include erythema multiforme, Stevens–Johnson syndrome, and exfoliative dermatitis. As with other beta-lactam antibiotics, angioedema and anaphylaxis may occur.

Animal studies have shown no harmful effects on the fetus. Limited human data suggest no significant risk; however, it should only be used during pregnancy if clearly necessary. Small amounts of amoxicillin are excreted in breast milk during lactation.

Use with caution in patients receiving anticoagulants or those with severe liver impairment. Dose adjustment is required in patients with moderate to severe renal dysfunction. Adequate hydration and urine output should be maintained, especially during high-dose therapy, to reduce the risk of crystalluria.

Renal impairment: Dose adjustment is required.

Adults:

• Mild impairment (Creatinine clearance >30 ml/min): No dose adjustment needed
• Moderate impairment (10–30 ml/min): 375 mg or 625 mg every 12 hours or IV dosing as appropriate
• Severe impairment (<10 ml/min): Maximum 375 mg every 12 hours or adjusted IV dosing; additional dose may be needed during dialysis

Children:
Dose should be reduced proportionately based on renal function.

Hepatic impairment:
Use with caution and monitor liver function regularly.

Overdose is uncommon, but if it occurs, gastrointestinal symptoms and disturbances in fluid and electrolyte balance may be seen. The drug can be removed by haemodialysis.

Broad-spectrum penicillin antibiotic.

Store below 25°C, protected from light and moisture. Reconstituted suspension should be kept refrigerated (not frozen) and used within 7 days. Reconstituted injection should be used within 20 minutes.