Zisuva 375mg/625mg/1G

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မြန်မာ

COMPOSITION

ZISUVA 375mg

Each uncoated tablet contains:

Amoxicillin Trihydrate BP equivalent to Amoxicillin …………………………… 200mg
Potassium Clavulanate BP equivalent to (as Diluted Potassium Clavulanate BP) Clavulanic acid…….. 125mg
Excipients ………………………………….. q.s.

ZISUVA 625mg

Each uncoated tablet contains:

Amoxicillin Trihydrate BP equivalent to Amoxicillin …………………………… 500mg
Potassium Clavulanate BP equivalent to (as Diluted Potassium Clavulanate BP) Clavulanic acid…….. 125mg
Excipients ………………………………….. q.s.

ZISUVA 1G

Each uncoated tablet contains:

Amoxicillin Trihydrate BP equivalent to Amoxicillin …………………………… 875mg
Potassium Clavulanate BP equivalent to (as Diluted Potassium Clavulanate BP) Clavulanic acid…….. 125mg
Excipients ………………………………….. q.s.

INDICATIONS

Treatment of otitis media, sinusitis, and infections caused by susceptible organisms involving the lower respiratory tract, skin and skin structure, and urinary tract; spectrum same as amoxicillin with additional coverage of beta-lactamase producing B. catarrhalis, H. influenzae, N. gonorrhoeae, and S. aureus (not MRSA). The expanded coverage of this combination makes it a useful alternative when amoxicillin resistance is present and patients cannot tolerate alternative treatments.

DOSAGE

Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.

The dose of ZISUVA 375 Tablets that is selected to treat an individual infection should take into account:

The expected pathogens and their likely susceptibility to antibacterial agents
The severity and the site of the infection
The age, weight and renal function of the patient as shown below.

The use of alternative presentations of ZISUVA

Tablets (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid should be considered as necessary. Treatment should not be extended beyond 14 days without review.

Adults and children ≥ 40 kg: One tablet taken three times a day.

Children < 40 kg: ZISUVA375 Tablets are not recommended in children <40 kg.

Elderly: No dose adjustment is considered necessary.

Renal impairment: Dose adjustments are based on the maximum recommended level of amoxicillin. No adjustment in dose is required in patients with creatinine clearance (CrCI)greater than 30ml/min.

Adults and children > 40 kg :

CrCI: 10-30 ml/min – 250 mg/125 mg twice daily CrCl < 10 ml/min – 250 mg/125 mg once daily Haemodialysis – Two doses of 250 mg/ 125 mg every 24 hours, plus two doses of

250mg/125mg during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amcxicillin and clavulanic acid are decreased)

Children < 40 kg:

In children < 40 kg with creatinine clearance less than 30 ml/min, the use of ZISUVA 375 Tablets presentations with an amoxicillin to clavulanic acid ratio of 2:1 is not recommended, as no dose adjustments are available. In such patients, ZISUVA formulations with an amoxicillin to clavulanic acid ratio of 4:1 are recommended.

Hepatic impairment: Dose with caution and monitor hepatic function at regular intervals.

ZISUVA 625 mg and 1 g

Usual dosages for the treatment of infection

Adults and children over 12 years:

Mild – Moderate infections: One ZISUVA

625 mg tablet twice daily

Severe infections: One ZISUVA 1g tablet twice daily or

One ZISUVA 625 mg tablet 3 times a day.

ZISUVA 625 mg and 1 g

Usual dosages for the treatment of infection
Adults and children over 12 years:
Mild – Moderate infections:

One ZISUVA 625 mg tablet twice daily
Severe infections:

One ZISUVA 1g tablet twice daily or
One ZISUVA 625 mg tablet 3 times a day

Therapy can be started parenterally and continued with an oral preparation.

ZISUVA 625mg / 1g tablets are not recommended in children of 12 years and under.

Dosage in renal impairment

Adults:

ZISUVA 1g tablet should only be used in patients with a glomerular filtration rate of >30 mi/min.

Mild impairment

(Creatinine clearance

> 30 ml/min)

Moderate impairment

(Creatinine clearance

10-30 ml/min)

Severe impairment

(Creatinine clearance

<10 ml/min)

No change in dosage (I.e. either one 625 mg tablet twice daily or one

1g tablet twice daily)

One 625 mg tablet twice daily.

The 1g tablet should not be administered.

Not more than one 625 mg tablet every 24 hours.

Dosage in hepatic impairment
Dose with caution; monitor hepatic function at regular intervals.

Method of Administration

Tablet to be consumed in whole, not to be broken.

To minimise potential gastrointestinal intolerance, administer at the start of a meal.

The absorption of ZISUVA is optimised when taken at the start of a meal.

Treatment should not be extended beyond 14 days without review

OVERDOSAGE:

Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients.

In the case of overdosage, discontinue amoxicillin and potassium clavulanate, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.

STORAGE

Store below 30°C. Protect from light and moisture.

KEEP MEDICINE OUT OF REACH OF CHILDREN.

PRESENTATION:

Zisuva 1g – Strip pack of 1 x 10’s in a carton with pack insert

Zisuva 625 – Strip pack of 2 X 7’s in a carton with pack insert

Zisuva 375- Strip pack of 1 x 10’s in a carton with pack insert

Updated on 6.2.2024

Manufactured by:

Zifam Pyrex Myanmar Co., Ltd.

Lot C6, Zone-A, Thilawa SEZ, Thanlyin and Kyaut Tan Township, Yangon, Myanmar.

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