Zinnat 125mg 50ml Syp


UGX27,400

ZINNAT is an oral prodrug of the bactericidal cephalosporin antibiotic cefuroxime, which is resistant to most β (beta)-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms.
It is indicated for the treatment of infections caused by susceptible bacteria. Susceptibility to ZINNAT will vary with geography and time and local susceptibility data should be consulted where available (See Pharmacology: Pharmacodynamics under Actions).

Indications include Upper respiratory tract infections, for example, ear, nose and throat infections, such as otitis media, sinusitis, tonsillitis and pharyngitis; lower respiratory tract infections, for example, pneumonia, acute bronchitis, and acute exacerbations of chronic bronchitis; genito-urinary tract infections, for example, pyelonephritis, cystitis and urethritis; skin and soft tissue infections, for example, furunculosis, pyoderma and impetigo; gonorrhoea, acute uncomplicated gonococcal urethritis, and cervicitis.
Tablet: Cefuroxime is also available as the sodium salt (ZINACEF) for parenteral administration. This permits the use of sequential therapy with the same antibiotic when a change from parenteral to oral therapy is clinically indicated.
Where appropriate ZINNAT is effective when used following initial parenteral ZINACEF (cefuroxime sodium) in the treatment of pneumonia and acute exacerbations of chronic bronchitis.

Dosage / Direction for Use
The usual course of therapy is seven days (range 5 to 10 days).
Tablet: ZINNAT should be taken after food for optimum absorption.
Oral suspension: For optimal absorption, ZINNAT should be taken with food.
Adults: Tablet: Most infections: 250 mg twice daily.
Urinary tract infections: 250 mg twice daily.
Mild to moderate lower respiratory tract infections e.g. bronchitis: 250 mg twice daily.
More severe lower respiratory tract infections, or if pneumonia is suspected: 500 mg twice daily.
Pyelonephritis: 250 mg twice daily.
Uncomplicated gonorrhoea: Single dose of 1 g.
Sequential therapy: Pneumonia: 1.5 g ZINACEF twice daily (given I .v. or i.m.) for 48 to 72 hours, followed by 500 mg twice daily ZINNAT (cefuroxime axetil) oral therapy for 7 to 10 days.
Acute exacerbations of chronic bronchitis: 750 mg ZINACEF twice daily (given I .v. or i.m.) for 48 to 72 hours, followed by 500 mg twice daily ZINNAT (cefuroxime axetil) oral therapy for 5 to 10 days.
Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.
Oral suspension: Most infections: 250mg twice daily.
Urinary tract infections: 250mg twice daily.
Mild to moderate lower respiratory tract infections e.g. bronchitis: 250mg twice daily.
More severe lower respiratory tract infections, or if pneumonia is suspected: 500mg twice daily.
Pyelonephritis: 250mg twice daily.
Uncomplicated gonorrhoea: a single dose of 1g.
Children: Tablet: See Table 3.

ZINNAT tablets should not be crushed or split and are therefore unsuitable for the treatment of patients, such as younger children, who cannot swallow whole tablets.
There is no experience of using ZINNAT in children under the age of 3 months.
Oral suspension: There are no clinical trial data available on the use of ZINNAT in children under the age of 3 months. In infants and children, it may be preferable to adjust dosage according to weight or age. The dose in infants and children 3 months to 12 years is 10mg/kg twice daily for most infections, to a maximum of 250mg daily. In otitis media or more severe infections, the recommended dose is 15mg/kg twice daily to a maximum of 500mg daily.
The following two tables, divided by age group and weight, serve as a guideline for simplified administration from measuring spoons (5ml) for the 125mg/5ml or the 250mg/5ml multi-dose suspension, and 125 mg single-dose sachets. (See Table 4 and Table 5.)

To enhance compliance and improve the dosing accuracy in very young children, a dosing syringe can be supplied with a multidose bottle containing 50 ml of suspension. However, dosing in spoonfuls should be considered a more favourable option if the child is able to take the medication from the spoon.
If required, the dosing syringe may also be used in older children (refer to the dosing tables as follows).
The recommended doses for the paediatric dosing syringe are expressed in ml or mg and according to body weight in the following tables. (See Tables 6 and Table 7.)

ZINNAT is also available as the sodium salt (ZINACEF) for parenteral administration. This permits parenteral therapy with ZINNAT to be followed by oral therapy in situations where a change from parenteral to oral treatment is clinically indicated.
Renal impairment: Cefuroxime is primarily excreted by kidneys. In patients with the markedly impaired renal function, it is recommended that the dosage of cefuroxime be reduced to compensate for its slower excretion (see the table as follows).

Overdosage
Signs and symptoms: Overdosage of cephalosporins can cause cerebral irritation leading to convulsions.
Treatment: Serum levels of cefuroxime can be reduced by haemodialysis and peritoneal dialysis.
Contraindications
Patients with known hypersensitivity to cephalosporin antibiotics.
Special Precautions
Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.
As with other antibiotics, use of ZINNAT may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible organisms (e.g. enterococci and Clostridium difficile), which may require interruption of treatment.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Tablet: With a sequential therapy regime the timing of the change to oral therapy is determined by the severity of the infection, the clinical status of the patient and susceptibility of the pathogens involved. If there is no clinical improvement within 72 hours, then the parenteral course of treatment must be continued.
Please refer to the relevant prescribing information for cefuroxime sodium before initiating sequential therapy.
Oral suspension: The sucrose content of ZINNAT suspension and granules (see Excipients/Inactive Ingredients under Description) should be taken into account when treating diabetic patients, and appropriate advice provided.
ZINNAT suspension contains aspartame, which is a source of phenylalanine and so should be used with caution in patients with phenylketonuria.
Effects on Ability to Drive and Use Machines: As this medicine may cause dizziness, patients should be warned to be cautious when driving or operating machinery.

Use In Pregnancy & Lactation
There is no experimental evidence of embryopathy or teratogenic effects attributable to ZINNAT but, as with all drugs, it should be administered with caution during the early months of pregnancy. Cefuroxime is excreted in human milk, and consequently, caution should be exercised when ZINNAT is administered to a nursing mother.
Adverse Reactions
Adverse drug reactions to ZINNAT are generally mild and transient in nature.
The frequency categories assigned to the adverse reactions as follows are estimates, as for most reactions suitable data (for example from placebo-controlled studies) for calculating incidence were not available. In addition, the incidence of adverse reactions associated with ZINNAT may vary according to the indication.
Data from large clinical studies were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e. those occurring at <1/1000) were mainly determined using post-marketing data and refer to a reporting rate rather than true frequency. Placebo-controlled trial data were not available. Where incidences have been calculated from clinical trial data, these were based on drug-related (investigator-assessed) data.
The following convention has been used for the classification of frequency: very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1000 to <1/100; rare ≥1/10,000 to <1/1000; very rare <1/10,000.
Infections and infestations: Common: Overgrowth of Candida.
Blood and lymphatic system disorders: Common: Eosinophilia.
Uncommon: Positive Coombs’ test, thrombocytopenia, leukopenia (sometimes profound).
Very rare: Haemolytic anaemia.
Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed against the drug to produce a positive Coombs’ test (which can interfere with cross-matching of blood) and very rarely haemolytic anaemia.
Immune system disorders: Hypersensitivity reactions including Uncommon: Skin rashes.
Rare: Urticaria, pruritus.
Very rare: Drug fever, serum sickness, anaphylaxis.
Nervous system disorders: Common: Headache, dizziness.
Gastrointestinal disorders: Common: Gastrointestinal disturbances including diarrhoea, nausea, abdominal pain.
Uncommon: Vomiting.
Rare: Pseudomembranous colitis (See Precautions).
Hepatobiliary disorders: Common: Transient increases of hepatic enzyme levels, [ALT (SGPT), AST (SGOT), LDH].
Very rare: Jaundice (predominantly cholestatic), hepatitis.
Skin and subcutaneous tissue disorders: Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis).

Interactions

Drugs which reduce gastric acidity may result in a lower bioavailability of ZINNAT compared with that of the fasting state and tend to cancel the effect of enhanced post-prandial absorption.
In common with other antibiotics, Zinnat may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving ZINNAT. This antibiotic does not interfere in the alkaline picrate assay for creatinine.

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