Cefpotek^® (Tablets) Instructions for Use

Marketing Authorization Holder

Nobel Ilac Sanayii Ve Ticaret, A.S. (Turkey)

Manufactured By

Nobel Ilac Sanayii Ve Ticaret, A.S. (Turkey)

Or

Nobel Almaty Pharmaceutical Factory, JSC (Kazakhstan)

ATC Code

J01DD13 (Cefpodoxime)

Active Substance

Cefpodoxime (Rec.INN registered by WHO)

Dosage Form

Cefpotek®

Film-coated tablets, 200 mg: 10, 14, or 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, oblong, with a score on one side; the core on the cross-section is light yellow.

Excipients: Avicel RC591 (microcrystalline cellulose, sodium carboxymethylcellulose) – 152.52 mg, sodium lauryl sulfate – 14 mg, hypromellose – 7.22 mg, colloidal silicon dioxide (Aerosil 200) – 1.76 mg, magnesium stearate – 3.6 mg.

Film coating composition: Sepifilm Blanc LP761 – 15 mg, including hypromellose (E464) – 45-55%, microcrystalline cellulose (E460) – 5-15%, stearic acid (E570) – 18-22%, titanium dioxide (E171) – 15-25%.

5 pcs. – blisters (2) – cardboard packs.
5 pcs. – blisters (4) – cardboard packs.
7 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Third generation cephalosporin

Pharmacotherapeutic Group

Systemic antibacterial agents; other beta-lactam antibacterial agents; third-generation cephalosporins

Pharmacological Action

An antibiotic from the group of third-generation cephalosporins, it acts bactericidally, disrupting the synthesis of the bacterial cell wall. It is resistant to beta-lactamases.

It is active against gram-positive bacteria: Streptococcus pyogenes, Streptococcus pneumoniae (except for penicillin-resistant strains), Staphylococcus aureus (including strains producing penicillinase); gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae (beta-lactamase-positive and negative strains), Moraxella (Branhamella) catarrhalis, Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae and Klebsiella oxytoca), Neisseria gonorrhoeae, indole-positive Proteus, other Proteus species, including Proteus vulgaris; Providencia, Enterobacter (including Enterobacter cloacae and Enterobacter aerogenes). Salmonella spp., Shigella spp; active in vitro against most strains: Brucella, Neisseria, Aeromonas hydrophila, Yersinia enterocolitica, Providencia rettgeri, Providencia stuartii and strains of Citrobacter, Morganella and Serratia.

It is not active against Streptococcus spp. (group D), methicillin-resistant strains of Staphylococcus spp., Corynebacterium spp. (groups J and K), Pseudomonas spp. (including Pseudomonas aeruginosa), Listeria monocytogenes, Acinetobacter baumannii, Clostridium difficile, Bacteroides spp. It has weak activity against anaerobes, including most Bacteroides species, Campylobacter, Yersinia. It is destroyed by chromosomally derived cephalosporinases of Citrobacter, Enterobacter, Bacteroides.

Pharmacokinetics

Cefpodoxime proxetil is a prodrug that is de-esterified in the body (in the small intestine), converting into the active metabolite Cefpodoxime.

After single and multiple doses from 100 to 400 mg of the drug, a therapeutic concentration of 1.0-4.5 mg/l is reached within 1.9-3.1 hours. Absolute bioavailability is 50%.

It binds to blood proteins (20-30%).

About 30-35% of the dose is excreted unchanged in the urine within 12 hours. T_1/2 ranges from 2.1 to 2.8 hours.

In case of impaired renal function, excretion decreases: with a CrCl of 50-80 ml/min, T_1/2 is 3.5 hours, 30-49 ml/min – 5.9 hours, 5-29 ml/min – 9.8 hours.

In elderly individuals, including those with bronchopulmonary infection, a slight prolongation of T_1/2 and blood concentrations is noted, but this does not require dose adjustment.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to cefpodoxime

• Infections of the upper and lower respiratory tract: tonsillitis, pharyngitis, acute sinusitis, acute bronchitis, pneumonia; exacerbation of chronic bronchitis (in individuals who abuse alcohol, smokers, and persons over 65 years of age);
• Uncomplicated urinary tract infections (cystitis);
• Uncomplicated gonorrhea;
• Uncomplicated anorectal infections in women caused by Neisseria gonorrhoeae;
• Skin and soft tissue infections;
• Other infections caused by microorganisms sensitive to the drug (gastrointestinal infections, oral infections).

ICD codes

Dosage Regimen

Orally, with meals

Adults and children over 12 years

For patients with severe renal impairment (CrCl below 30 ml/min), the single dose is halved.

Adverse Reactions

Allergic reactions skin rash, itching, eosinophilia, urticaria, angioedema, fever, anaphylactic shock.

From the nervous system dizziness, headaches, irritability, increased fatigue, insomnia, “nightmare” dreams.

From the genitourinary system menstrual cycle disorder.

From the digestive system nausea, persistent diarrhea, constipation, gastritis, vomiting, abdominal pain, dysbacteriosis (overgrowth of Clostridium difficile), pseudomembranous colitis, salivation, flatulence, decreased appetite.

From the respiratory system cough.

From the cardiovascular system decreased BP.

From the hematopoietic organs thrombocytosis, thrombocytopenia, leukocytosis, leukopenia, lymphocytosis, granulocytosis, basophilia, monocytosis, neutropenia, lymphocytopenia, nosebleed.

Laboratory parameters increased activity of “hepatic” transaminases and alkaline phosphatase, hyperbilirubinemia, LDH, GGT, urea, creatinine, hyper- or hypoglycemia, hypoproteinemia and hypoalbuminemia, decreased Hb, positive Coombs test, increased prothrombin time. Chest pain, increased sweating, weakness.

Contraindications

• Childhood (under 12 years);
• Hypersensitivity to cefpodoxime, components of the drug, other cephalosporins.

With caution hypersensitivity to penicillins, pregnancy, lactation period, chronic colitis, renal failure, combination with “loop” diuretics and other nephrotoxic drugs.

Use in Pregnancy and Lactation

Use with caution during pregnancy, comparing the potential benefit for the mother and the possible risk to the fetus.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Use in Renal Impairment

Use with caution in renal failure. For patients with severe renal impairment (CrCl below 30 ml/min), the single dose is halved.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

A positive Coombs test may occur.

Overdose

Symptoms nausea, vomiting, epigastric discomfort, diarrhea.

Treatment hemodialysis or peritoneal dialysis, especially in case of impaired renal function.

Drug Interactions

Diuretics, aminoglycosides, polymyxin B, ethacrynic acid block the secretion of cephalosporins, increase their concentration in the blood serum, prolong T_1/2, and enhance nephrotoxicity.

NSAIDs slow down the excretion of cephalosporins by the kidneys, increasing the risk of bleeding.

H₂-histamine receptor blockers reduce bioavailability due to changes in gastric pH.

It enhances the effect of indirect anticoagulants (by suppressing intestinal microflora, it reduces the prothrombin index).

Antacids in high doses (sodium bicarbonate, aluminum hydroxide) reduce absorption.

When administered simultaneously with bactericidal antibiotics, synergy is manifested; with bacteriostatic antibiotics (macrolides, chloramphenicol, tetracyclines) – antagonism; it enhances the nephrotoxicity of aminoglycosides.

Storage Conditions

At a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.