CEFADROXIL Capsules, hard Ref.[6563] Active ingredients: Cefadroxil

• Cefadroxil does not penetrate in the CSF and is not indicated for the treatment of meningitis (see section 5.2).
• Penicillin is the first drug of choice for the treatment of the Streptococcus pyogenes and for the prevention of rheumatic fever. Data for cefadroxil are not sufficiently substantial for prophylaxis therapy.
• Special caution should be exercised in patients with history of severe allergies or asthma.
• In patients with a history of non severe hypersensitity to penicillins, or other non-cephalosporin beta–lactam drugs, cefadroxil should be used with special caution as cross allergies occur (incidence 5-10%).
• Renal impairment. Caution is necessary in patients with renal impairment; the dosage must be adjusted according to the grade of renal impairment (see section 4.2).
• History of gastro-intestinal disturbances. Cefadroxil should be used with caution in patients with a history of gastrointestinal disturbances, particularly colitis.
• The occurrence of diarrhoea may impair the resorption of other medicaments and therefore lead to an impairment of their efficacy.
• Allergic reactions. Treatment must be discontinued at once if allergic reactions occur (urticaria, exanthema, pruritus, fall of blood pressure and increased heart rate, respiratory disturbances, collapse, etc.) and suitable countermeasures should be taken (sympathomimetics, corticosteroids and/or antihistaminics).
• Prolonged use. Particularly on prolonged use frequent checks on the blood count and regular hepatic and renal function tests are advisable. Superinfections with fungi (e.g. candida) can occur on prolonged treatment with cefadroxil.
• In case of severe and persistent diarrhoea, an antibiotic-associated pseudomembranous colitis should be considered. In that case Cefadroxil must be discontinued immediately and a suitable therapy should be started (e.g. oral vancomycin, 250 mg q.i.d.). Antiperistaltics are contraindicated.
• Severe life-threatening infections or those which require higher posology or repetitive administrations per day may benefit of parenteral cephalosporins.
• The result of the Coombs' test can be transiently positive during or after treatment with cefadroxil. This also applies to Coombs' tests carried out in newborns whose mothers received treatment with cephalosporins before delivery.
• Forced diuresis leads to a decrease of cefadroxil blood levels.
• Urinary sugar should be determined enzymatically (e.g. with test strips) during treatment with cefadroxil since reduction tests can furnish falsely elevated values.

Contraindication of concomitant use

• Cefadroxil should not be combined with bacteriostatic antibiotics (e.g. tetracycline, erythromycin, sulfonamides, chloramphenicol) since an antagonistic effect is possible.
• Treatment with cefadroxil in combination with aminoglycoside antibiotics, polymyxin B, colistin or high-dose loop diuretics should be avoided since such combinations can potentiate nephrotoxic effects.

Concomitant use not recommended

• Frequent checks on coagulation parameters are necessary during concomitant longterm use of anticoagulants or thrombocyte aggregation inhibitors to avoid haemorrhagic complications.

Precautions

• Cefadroxil binds to cholestyramine which may lead to reduced bioavailability of cefadroxil.
• The concomitant administration of probenecid reduces the renal elimination of cefadroxil; therefore, plasma concentrations of cefadroxil may be increased when given in combination with probenecid.

Pregnancy

Although animal studies and clinical experience have not shown any evidence of teratogenicity, the safe use during pregnancy has not been established.

Breast-feeding

Cefadroxil is present in low concentrations in breast milk; sensitization, diarrhoea or colonization of the infants' mucosa with fungi are possible.

The use of cefadroxil during pregnancy and in lactating mothers should therefore be handled very strictly.

Cefadroxil may cause headache, dizziness, nervousness, sleeplessness and fatigue, therefore the ability to drive and use machines may be influenced (see section 4.8).

The adverse events are ranked under headings of frequency, using the following convention: 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), not known (cannot be estimated form the available data).

Adverse drug reactions occur in about 6% to 7%* of treated patients.

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

Infections and infestations

Uncommon: Clinical pictures due to a growth of opportunistic organisms (fungi), such as vaginal mycoses, thrush (see section 4.4).

Blood and lymphatic system disorders

Rare: Eosinophilia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis: rare cases during prolonged used, which subside upon discontinuation of therapy.

Very rare: Haemolytic anemia of immunologic origin.

Immune system disorders

Rare: Serum sickness-like reactions.

Very rare: Immediate allergic reaction (anaphylactic shock) (see section 4.4).

Nervous system disorders

Very rare: Headache, sleeplessness, dizziness, nervousness.

Gastrointestinal disorders

Common: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, glossitis (see section 4.4).

Very rare: Pseudomenbranous colitis has been reported (may range in severity from mild to life threatening) (see section 4.4).

Hepatobiliary disorders

Rare: Cholestase and idiosyncratic hepatic failure have been reported. Minor elevation of serum transaminases (ASAT, ALAT) and alcaline phosphatases.

Skin and subcutaneous tissue disorders

Common: Pruritus, rash, allergic exanthema, urticaria.

Rare: Angioneurotic edema.

Very rare: Stevens Johnson syndrom and erythema multiforma have been reported.

Musculoskeletal and connective tissue disorders

Rare: Arthralgia.

Renal and urinary disorders

Rare: Interstitial nephritis (see section 4.4).

General disorders and administration site conditions

Rare: Drug fever.

Very rare: Fatigue.

Investigations

Very rare: Direct and indirect positive Coombs tests (see section 4.4).

* incidence of suspected adverse reactions in an observational post-marketing study in 904 patients.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme: www.mhra.gov.uk/yellowcard.

Not applicable.