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זינט טבליות 125 מ"ג ZINNAT TABLETS 125 MG (CEFUROXIME AS AXETIL)

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צורת מתן:

פומי : PER OS

צורת מינון:

טבליה : TABLETS

Posology : מינונים

4.2        Posology and method of administration

Posology
The usual course of therapy is seven days (may range from five to ten days).
Table 1. Adults and children (40 kg)

Indication                                    Dosage
Acute tonsillitis and pharyngitis, acute bacterial   250 mg twice daily sinusitis
Acute otitis media                                   500 mg twice daily Acute exacerbations of chronic bronchitis            500 mg twice daily Cystitis                                             250 mg twice daily Pyelonephritis                                       250 mg twice daily Uncomplicated skin and soft tissue infections        250 mg twice daily Lyme disease                                         500 mg twice daily for 14 days (range of 10 to 21 days)

Table 2. Children (<40 kg)

Indication                                       Dosage
Acute tonsillitis and pharyngitis, acute         10 mg/kg twice daily to a maximum of 125 bacterial sinusitis                              mg twice daily
Children aged two years or older with otitis     15 mg/kg twice daily to a maximum of 250 media or, where appropriate, with more           mg twice daily severe infections
Cystitis                                         15 mg/kg twice daily to a maximum of 250 mg twice daily
Pyelonephritis                                   15 mg/kg twice daily to a maximum of 250 mg twice daily for 10 to 14 days
Uncomplicated skin and soft tissue               15 mg/kg twice daily to a maximum of 250 infections                                       mg twice daily
Lyme disease                                     15 mg/kg twice daily to a maximum of 250 mg twice daily for 14 days (10 to 21 days)

There is no experience of using Zinnat in children under the age of 3 months.

Cefuroxime axetil tablets and cefuroxime axetil granules for oral suspension are not bioequivalent and are not substitutable on a milligram-per-milligram basis (see section 5.2).

Renal impairment
The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established.

Cefuroxime is primarily excreted by the kidneys. In patients with markedly impaired renal function it is recommended that the dosage of cefuroxime should be reduced to compensate for its slower excretion. Cefuroxime is effectively removed by dialysis.
Table 5. Recommended doses for Zinnat in renal impairment

Creatinine clearance          T1/2 (hrs)                Recommended dosage ≥30 ml/min/1.73 m2             1.4–2.4       no dose adjustment necessary (standard dose of 125 mg to 500 mg given twice daily)

10-29 ml/min/1.73 m2           4.6           standard individual dose given every 24 hours 
<10 ml/min/1.73 m2             16.8          standard individual dose given every 48 hours 
During haemodialysis           2–4           a single additional standard individual dose should be given at the end of each dialysis


Hepatic impairment
There are no data available for patients with hepatic impairment. Since cefuroxime is primarily eliminated by the kidney, the presence of hepatic dysfunction is expected to have no effect on the pharmacokinetics of cefuroxime.

Method of administration

Oral use
Zinnat tablets should be taken after food for optimum absorption.
Zinnat tablets should not be crushed and are therefore unsuitable for treatment of patients who cannot swallow tablets. In children Zinnat oral suspension may be used.

Depending on the dosage, there are other presentations available.

שימוש לפי פנקס קופ''ח כללית 1994 Upper & lower respiratory tract infections (sinusitis, otitis, chronic bronchitis, pneumonia) genitourinary infections, pyelonephritis caused by: staphylococcus aureus & epidermidis (excluding methicillin resistant strains), streptococci (excluding enterococci), H. influenzae (including beta lactamase resistant strains) Branhamella catarrhalis, E. coli, klebsiella species, proteus mirabilis, proteus rettgeri, providencia, N. gonorrhea (including penicillinase producing strains)
תאריך הכללה מקורי בסל 01/01/1995
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