Xtabac100 mg+62.5 mg

Cefpodoxime proxetil and clavulanic acid combination tablets are used to treat bacterial infections caused by susceptible, including beta-lactamase-producing, organisms, including:

• Acute maxillary sinusitis
• Community-acquired pneumonia and other lower respiratory tract infections
• Acute exacerbations of chronic bronchitis
• Upper respiratory tract infections, including pharyngitis and tonsillitis
• Urinary tract infections
• Skin and soft tissue infections

Contains cefpodoxime proxetil (a third-generation cephalosporin antibiotic) and clavulanic acid (a beta-lactamase inhibitor) as active ingredients, formulated as oral tablets or an oral suspension. Marketed strengths vary; confirm the exact cefpodoxime and clavulanic acid content on the specific product's own label.

Cefpodoxime proxetil and clavulanic acid is a combination antibiotic that pairs a broad-spectrum cephalosporin with clavulanic acid, a substance that blocks certain bacterial enzymes (beta-lactamases) that would otherwise break down and inactivate cefpodoxime. This combination allows the antibiotic to remain effective against some bacteria that have developed resistance mechanisms that would defeat cefpodoxime on its own, extending its usefulness against certain resistant respiratory and urinary tract infections.

Therapeutic Class: Antibiotic Combination (Cephalosporin + Beta-lactamase Inhibitor)

Cefpodoxime proxetil is an ester prodrug that is hydrolyzed during absorption to release active cefpodoxime; absorption is enhanced when taken with food. Peak plasma levels of cefpodoxime are reduced when taken concurrently with antacids or H2-receptor blockers, since these reduce stomach acidity needed for optimal absorption. Clavulanic acid, produced naturally by Streptomyces clavuligerus, binds to and inactivates beta-lactamase enzymes that certain bacteria produce specifically to destroy cefpodoxime and similar antibiotics, protecting the cefpodoxime component from this resistance mechanism.

• Take with food, to enhance absorption of the cefpodoxime component
• Swallow tablets whole with water, or measure the oral suspension with the device provided
• Avoid taking with antacids or acid-reducing medicines (H2 blockers) at the same time, since these can reduce cefpodoxime absorption; space these apart if both are needed
• Complete the full prescribed course, even if symptoms improve before the course is finished

The following should be assessed by a healthcare professional before combining with this medicine:

• Antacids and H2-receptor blockers: reduce peak plasma levels of cefpodoxime when taken at high doses concurrently, given the reduced stomach acidity needed for optimal absorption; space dosing apart where possible.
• Oral hormonal contraceptives: this antibiotic combination may reduce their effectiveness; an additional contraceptive method is generally advised during treatment.
• Probenecid: can increase and prolong cefpodoxime blood levels by reducing its renal clearance.
• Warfarin and other anticoagulants: cephalosporins may enhance anticoagulant effect in some patients; monitoring is advisable.
• Aminoglycosides and loop diuretics: combining with cephalosporins may theoretically increase the risk of kidney effects; use with caution if combined.

Common side effects

• Diarrhoea
• Abdominal pain, nausea, vomiting
• Headache, dizziness
• Vaginal itching or discharge (vaginitis)

Serious side effects (seek urgent medical attention)

• Severe or persistent diarrhoea, particularly if bloody, which may indicate Clostridioides difficile-associated colitis
• Signs of liver problems: yellowing of the skin or eyes, dark urine, unusual fatigue
• Signs of a severe allergic reaction, including anaphylaxis: rash, hives, swelling of the face or throat, difficulty breathing - can occur even without prior known allergy and requires immediate emergency treatment
• Severe skin reactions: widespread rash, blistering, or peeling skin
• Unusual bruising or bleeding, which may indicate a blood disorder

Pregnancy

Cefpodoxime has been used in pregnancy for bacterial infections when clinically indicated; consult your doctor before use during pregnancy, particularly regarding the clavulanic acid component, for which data are more limited.

Breastfeeding

Cefpodoxime is excreted in human milk; the combination should generally be avoided during breastfeeding, or used only if a doctor determines it is necessary, given potential effects on the nursing infant's gut flora.

• Penicillin allergy: caution is required, since cross-reactivity between penicillins and cephalosporins has been documented and may occur in up to 10% of patients with a history of penicillin allergy; a careful allergy history should be taken before starting.
• Complete the full course of treatment, even if symptoms improve early, to fully clear the infection and reduce the risk of antibiotic resistance.
• Use with caution in patients with a history of gastrointestinal disease, particularly colitis, given the risk of Clostridioides difficile-associated diarrhoea with any antibiotic.
• Use with caution in patients with hepatic or renal impairment; dose adjustment may be needed in significant renal impairment.
• Avoid alcohol during treatment, as it may worsen certain side effects.

Overdose may cause exaggerated gastrointestinal effects (nausea, vomiting, diarrhoea) and, in significant overdose, neuromuscular excitability or convulsions, particularly in patients with renal impairment where drug clearance is reduced; anticonvulsant therapy can be given if clinically indicated. Suspected significant overdose should be evaluated by a healthcare professional; treatment is generally supportive.

Store tablets at room temperature, protected from moisture. Oral suspension, once reconstituted, should generally be refrigerated and used within the manufacturer's specified period (commonly 14 days); check the specific product's instructions.

• Children 2 months to 12 years: Weight-based dosing (10 mg/kg/day based on the cefpodoxime component) in divided doses every 12 hours.
• Elderly: No specific dose adjustment is generally required based on age alone, though renal function should be considered.
• Renal impairment: Dose adjustment may be required, since cefpodoxime is eliminated by the kidneys.
• Hepatic impairment: Contraindicated in patients with a previous history of liver damage associated with this specific drug combination; use with caution in other hepatic conditions.

Treatment duration depends on the specific infection - commonly 10 days for acute maxillary sinusitis, and a course determined by the treating physician (typically 5-14 days) for other indications. The full prescribed course should be completed, even if symptoms resolve earlier.

The oral suspension requires reconstitution with water as directed on the specific product's label immediately before dispensing; shake well before each use, and store as directed (commonly refrigerated) for the specified in-use period.

Drug Class: Third-generation cephalosporin (cefpodoxime proxetil) combined with a beta-lactamase inhibitor (clavulanic acid)

Cefpodoxime works by binding to penicillin-binding proteins involved in bacterial cell wall synthesis, disrupting the bacteria's ability to build and maintain their cell walls, which kills susceptible bacteria. Clavulanic acid itself has minimal direct antibacterial activity, but it binds to and inactivates beta-lactamase enzymes that some bacteria produce to destroy cefpodoxime before it can act - by neutralizing this defense, clavulanic acid restores cefpodoxime's effectiveness against bacteria that would otherwise be resistant.

This combination is used in children 2 months to 12 years of age, with weight-based dosing (10 mg/kg/day based on the cefpodoxime component) given in divided doses every 12 hours, using an appropriate oral suspension formulation.