Zocef/Zocef Kids/Zocef Hospi Adverse Reactions

Zocef: Tablet: The following adverse effects have been reported in the use of cefuroxime.
Gastrointestinal: Diarrhea, loose stools, abdominal pain, dyspepsia, flatulence, nausea and vomiting.
Hypersensitivity Reactions: Anaphylactic/anaphylactoid reactions, skin rashes, urticaria, drug fever, pruritus, angioedema and facial edema. There have been rare reports of erythema multiform, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Hepatic: Transient elevations in SGPT, SGOT, LDH.
Renal: Transient elevations in BUN or creatinine, acute renal failure.
Central Nervous System: Headache, Dizziness, Somnolence.
Other: Genital pruritus, vaginitis, candidiasis, muscle cramps, muscle stiffness, muscle spasm of neck, dysuria, chest pain, chills, shortness of breath, mouth ulcers, swollen tongue. Mild to moderate hearing loss has been reported in some children given cefuroxime for the treatment of meningitis.
Suspension: Gastrointestinal Disorders: diarrhea, nausea, vomiting.
Skin and subcutaneous tissue disorders: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Zocef Kids: Adverse drug reactions to Cefuroxime (as axetil) are generally mild and transient in nature.
Cefuroxime (as axetil) may vary according to the indication.
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).
Zocef Hospi: The most common adverse reactions are neutropenia, eosinophilia, transient rise in liver enzymes or bilirubin, particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver and injection site reactions.
The frequency categories assigned to the adverse reactions as follows are estimates, as for most reactions suitable data for calculating incidence are not available. In addition the incidence of adverse reactions associated with cefuroxime sodium may vary according to the indication.
Data from clinical trials were used to determine the frequency of very common to rare adverse reactions. The frequencies assigned to all other adverse reactions (i.e. those occurring at <1/10,000) were mainly determined using post-marketing data, and refer to a reporting rate rather than a true frequency.
Treatment related adverse reactions, all grades, are listed as follows by MedDRA body system organ class, frequency and grade of severity. The following convention has been utilised for the classification of frequency: very common ≥1/10; common ≥1/100 to <1/10, uncommon ≥1/1,000 to <1/100; rare ≥1/10,000 to <1/1,000; very rare <1/10,000 and not known (cannot be estimated from the available data). (See Table 11.)

Click on icon to see table/diagram/image

Paediatric population: The safety profile for cefuroxime sodium in children is consistent with the profile in adults.