Combocef Tablet 100 mg+62.5 mg

Combocef Tablet 100 mg+62.5 mg Uses, Dosage, Side Effects, Food Interaction and all others data.

Clavulanic acid is a beta-lactamase inhibitor that is frequently combined with Amoxicillin or Ticarcillin to fight antibiotic resistance by preventing their degradation by beta-lactamase enzymes, broadening their spectrum of susceptible bacterial infections. Clavulanic acid is derived from the organism Streptomyces clavuligerus.When it is combined with amoxicillin, clavulanic acid is frequently known as Augmentin, Co-Amoxiclav, or Clavulin.

Clavulanic acid inactivates some beta-lactamase enzymes that are produced by bacteria, therefore preventing enzymatic destruction of amoxicillin. This helps to treat a variety of bacterial infections which would otherwise be resistant to antibiotics without the addition of clavulanic acid.

Trade Name Combocef Tablet 100 mg+62.5 mg
Generic Cefpodoxime Proxetil + Clavulanic Acid
Weight 100 mg+62.5 mg
Type Tablet
Therapeutic Class Third generation Cephalosporins
Manufacturer ACI Limited
Available Country Bangladesh
Last Updated: October 19, 2023 at 6:27 am
Combocef Tablet 100 mg+62.5 mg
Combocef Tablet 100 mg+62.5 mg

How Combocef Tablet 100 mg+62.5 mg works

Clavulanic acid contains a beta-lactam ring in its structure that binds in an irreversible fashion to beta-lactamases, preventing them from inactivating certain beta-lactam antibiotics, with efficacy in treating susceptible gram-positive and gram-negative infections.

Dosage

Combocef Tablet 100 mg+62.5 mg dosage

For adults (Age 12 years and older): Acute bacterial exacerbation of chronic bronchitis: 1 tablet 12 hourly for 10 days Acute community acquired pneumonia: 1 tablet 12 hourly for 14 days Pharyngitis or tonsillitis: ½ tablet 12 hourly for 5 to 10 days Skin and soft tissue infections: 2 tablet 12 hourly for 7 to 14 days Urinary tract infections: ½ tablet 12 hourly for 7 days Uncomplicated gonorrhea: Single dose Acute maxillary sinusitis: 1 tablet 12 hourly for 10 days For children: Children 2 months to 12 years- 10 mg/kg/day in divided dose, every 12 hours.

Side Effects

Cefpodoxime is well tolerated. Most common gastrointestinal adverse effects are diarrhea, vomiting and abdominal pain.

Toxicity

LD50 information

Clavulanic acid has demonstrated low oral acute toxicity in adult rodents, having an LD50 of more than 2000 mg/kg. The toxicity of clavulanic acid on pre-weaning rats was also studied. Gastrointestinal disturbance and mortality occurred, even at lower clavulanic acid doses of 125 mg/kg.

Overdose information

Overdose information has been obtained for the combination of amoxicillin and clavulanic acid, as these drugs are frequently administered together in a single product. Changes in fluid and electrolyte balances and gastrointestinal symptoms may occur in the case of an overdose. Offer symptomatic treatment or gastrointestinal disturbances, while considering the importance of fluid and electrolyte balance. This drug may be removed by a session of hemodialysis. When coadministered with amoxicillin, crystalluria causing renal failure has been observed. Seizures may also occur in a case of overdose, or in a patient with renal failure.

Precaution

Cefpodoxime should be administered with caution to patients receiving concurrent treatment with diuretics.

Interaction

Concomitant administration of Cefpodoxime at high doses with antacids or H2 blockers reduces peak plasma levels of Cefpodoxime.

Volume of Distribution

A study in 4 healthy volunteers administered a radiolabeled dose of clavulanic acid determined a volume of distribution of 12L.Clavulanic acid is distributed to various tissues and interstitial fluid. Clinically significant concentrations have been measured in the gallbladder, abdomen, skin, fat, and muscle tissues. Bile, pus, synovial and peritoneal fluids are also found to have therapeutic concentrations of clavulanic acid. Studies of animals have demonstrated that clavulanic crosses the placenta.

Elimination Route

Clavulanic acid, when taken orally, is well absorbed in the gastrointestinal tract. After administration of radiolabeled clavulanic acid to four human subjects, a minimum of 73% absorption and the average absolute bioavailability was calculated at 64%. The mean Cmax in a group of 8 healthy research volunteers was 2.098 ± 0.441 micrograms/ml in a pharmacokinetic study. The same study reported a mean Tmax of 1.042 ± 0.80 hours. Tmax is reported to be 40-120 minutes according to another pharmacokinetic study.

Half Life

The half-life of clavulanic acid is reported to be similar to amoxicillin, and last 45-90 minutes. A study of radiolabeled clavulanic acid administered to 4 healthy volunteers determined a half-life of 0.8 h.

Clearance

The clearance of clavulanic acid in a pharmacokinetic study of 4 healthy volunteers administered a radiolabeled dose of clavulanic acid was 0.21 l/min. Another resource indicates the average clearance of clavulanic acid is 12.20 liters/h/70 kg. Dose adjustments may be required in patients with renal failure.

Elimination Route

About 40 to 65% of the clavulanic acid is excreted as unchanged drug in urine during the first 6 hours following ingestion. The metabolites of clavulanic acid are found to be excreted in the urine and feces and as carbon dioxide in expired air. Clavulanate is cleared by both renal and non-renal processes. About 17% of radiolabeled dose of clavulanic acid was found to be exhaled in expired air and 8% of a dose was found to be excreted in the feces.

Pregnancy & Breastfeeding use

US FDA pregnancy category of Cefpodoxime & Clavulanic Acid is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.

Contraindication

Cefpodoxime is contraindicated in patients with known hypersensitivity to Cephalosporins.

Storage Condition

Keep in a dry place away from light and heat. Keep out of the reach of children.

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