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Tenafet (Cefetamet)
Therapeutic Group: Anti Bacterial
Presentation

Tenafet 250: Each tablet contains Cefetamet Pivoxil Hydrochloride INN 250 mg.

Tenafet 500: Each tablet contains Cefetamet Pivoxil Hydrochloride INN 500 mg.

Tenafet powder for suspension: Each 5 ml reconstituted suspension contains Cefetamet Pivoxil Hydrochloride INN 250 mg.

Descriptions
Cefetamet Pivoxil is an oral third-generation cephalosporin antibiotic which is hydrolyzed to form the active agent, Cefetamet. It is a bactericidal antibiotic; kills bacteria by interfering with bacterial cell wall synthesis due to inhibition of Transpeptidase enzyme. Cefetamet has excellent in-vitro acitivity against the major respiratory pathogens- Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and group A b-haemolytic streptococci. It is also active against b-lactamase-producing strains of H. influenzae and M. catarrhalis. Cefetamet has marked activity against Neisseria gonorrhoeae and possesses a broad spectrum of activity against Enterobacteriaceae.
Indications
Cefetamet Pivoxil is indicated for the treatment of infections caused by sensitive microorganisms and in particular:

1) Otolaryngeal infections:

Otitis media

Sinusitis

Tonsillo-pharyngitis

2) Infections of the lower respiratory tract:

Tracheo-bronchitis

Bronchitis

Pneumonia

3) Infections of the complicated and uncomplicated urinary tract:

Acute pyelonephritis

Acute gonorrhea

Urethritis.
Dosage & Administration
For better absorption Cefetamet Pivoxil should be taken one hour before or after a meal.
Adults and children over 12 years:
500 mg twice daily.
Children under 12 years:
Usual dosage is 10 mg/kg twice daily.
<15 kg (approximately 6 months - 3 years) 125 mg twice daily
16 - 30 kg (approximately 3 - 9 years) 250 mg twice daily
31 - 40 kg (approximately 9 - 12 years) 375 mg twice daily
>40 kg (approximately over 12 years) 500 mg twice daily

Uncomplicated gonorrhea, acute urethritis, uncomplicated cystitis:
Single dose of 1500 - 2000 mg.
Elderly: In elderly patients, dosage adjustment is not necessary.
Renal insufficiency: In the patients with renal insufficiency, dosage modification is the following:
Hepatic insufficiency: In patients with hepatic insufficiency dosage adjustment is not necessary.
Side Effects
Most common gastrointestinal side effects may include diarrhea, nausea & vomiting. Like with other wider spectrum antibiotics, in the course of treatment with Cefetamet internal colonization from difficult Clostridium can be observed. In some cases, this microorganism or its toxin has been identified; in rare cases this reply has been accompanied from diarrhea. Very rarely Cefetamet may cause gastralgia, flatulence, pyrosis, increase in bilirubin level, transitory increase of the transaminases, pruritus, urticaria, localized edema, rash, weakness, fatigue, vertigo, transitory leukopenia, eosinophilia, gingivitis, proctitis, vaginitis, tendinitis, conjunctivitis, and fever.
Precautions
Cefetamet should be administered with caution to the patients who have previously manifested allergy phenomena or gastrointestinal problems. An anaphylactic reaction demands an emergency treatment. Like with other antibiotics, Cefetamet can cause the opportunistic development of non-sensitive germs (Candida, Enterococci, and difficult Clostridium); in such cases, a suitable therapy should be given. Discontinuation of the antibiotic helps to restore the normal microflora and the internal functions. In presence of difficult Clostridium cases, the treatment of choice is Vancomycin for oral use and the inhibiting drug of the peristalsis are contraindicated.
Contraindications
Cefetamet is contraindicated in patients with hypersensitivity to Cefetamet, any other cephalosporin or penicillins or any other ingredient of this formulation.
Use in Pregnancy & Lactation
The main preclinical studies carried out with Cefetamet have not evidenced teratogenic effects. There are no available data regarding safe use of Cefetamet during pregnancy & lactation. Therefore, it should be used during pregnancy & lactation only if the potential benefit justifies the potential risk to the fetus.
Drug Interaction
The antacids and/or the H2-blockers do not alter the pharmacokinetic profile of Cefetamet; therefore, it can be administered in combination with these drugs. Concomitant administration with diuretic (e.g. Furosemide) does not reduce renal function.
Overdose
In healthy volunteers, single doses of 4 gm have been administered without problems, except it causes transitory vertigo or dizziness. In case of prematurely diagnosed overdosage the gastric lavage can be useful. Then symptomatic treatment can be carried out.

Direction for Reconstitution of suspension
Add 35 ml (7 measuring spoonful) of boiled and cooled water to the dry mixture in the bottle. For ease of preparation add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.
Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 10 days.
Commercial Packaging
Tenafet 250: Each box contains 3 blister strips of 4 tablets.
Tenafet 500: Each box contains 3 blister strips of 4 tablets.
Tenafet powder for suspension: Each bottle contains dry powder to produce 50 ml suspension when reconstitute.
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