Tenafet（Cefetamet Pivoxil Hydrochloride )
Tenafet
Cefetamet Pivoxil Hydrochloride INN

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.

Description
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 and Uses
Cefetamet Pivoxil is indicated for the treatment of infections caused by sensitive microorganisms and in particular:

 Otolaryngeal infections:
 Otitis media
 Sinusitis
 Tonsillo-pharyngitis

Infections of the lower respiratory tract:
Tracheo-bronchitis
Bronchitis
Pneumonia

Infections of the complicated and uncomplicated urinary tract:
Acute pyelonephritis
Acute gonorrhea
Urethritis

Contraindications
Cefetamet is contraindicated in patients with hypersensitivity to Cefetamet, any other cephalosporin or penicillins or any other ingredient of this formulation.

Dosage And 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 daily16 - 30 kg (approximately 3 - 9 years) 250 mg twice daily31 - 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.

Hepatic insufficiency
In patients with hepatic insufficiency dosage adjustment is not necessary.

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.

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.

 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.

Overdosage
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 Pack
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