STARCEF Dry syrup

• Urinary infections without complication caused Escherichia coli and Proteus mirabilis

• Otitis media caused by Haemophilus influenzae (β-lactamase positive and negative strains)，

Moraxella (Branhamella) catarrhalis (most of which are β-lactamase positive) and Streptococcus pyogenes

• Pharyngitis and tonsillitis caused by Streptococcus pyogenes

• Acute bronchitis and acute exacerbation of chronic bronchitis, caused by Streptococcus pneumoniae and Haemophilus influenzae (β-lactamase positive and negative strains)

The usual daily dose for pediatric is 1.5-3 mg (0.075-0.15 ml of STARCEF dry syrup)/kg body weight given orally twice a day. Dosage should be adjusted according to the condition of the patients. For severe infections，the dosage may be increased up to 6 mg (0.3 ml of STARCEF dry syrup)/kg body weight given twice a day.

Reconstitution of dry syrup. Add 10 ml of water，shake for 30 second. Add 10 ml more of water and shake again for 30 second. After reconstitution，syrup may be kept for 7 days，either at room temperature or under refrigeration，without significant loss of potency. Keep tightly closed. Discard unused portion after 7 days.

Patients with history of shock or hypersensitivity due to any ingredients of STARCEF

Shock

Adequate caution should be exercised since shock symptoms may sometimes occur. If any related signs or symptoms，e.g. dysphoria，oral cavity discomfort，stridor，dizziness，abnormal urge to defecate，tinnitus or diaphoresis occur，STARCEF must be discontinued immediately.

Hypersensitivity

If signs of hypersensitivity reactions, e.g. rash，urticaria，erythema，pruritus or fever occur，the administration of STARCEF should be discontinued and appropriate measures should be taken.

Hematology

Granulocytopenia or eosinophilia may occur rarely. Sometimes, thrombocytopenia may also occur. The use of STARCEF should be discontinued if any of such disorders is found. It has been reported that hemolytic anemia has occurred in the use of other cephems

Hepatic

Infrequently, an increase in GOT，GPT or alkaline phosphatase may occur

Renal

Periodic monitoring of renal function is recommended since serious renal impairment，e.g. renal insufficiency may sometimes occur. If any of such abnormalities is found，STARCEF should be discontinued and appropriate measures should be taken

Digestive

In rare instances，a serious colitis，e.g. pseudomembranous colitis，manifested by blood in stools may occur

Respiratory

In rare instances，interstitial pneumonia or PIE syndrome，manifested by fever，cough，dyspnea，abnormal chest X-ray or eosinophilia may occur. If any such symptoms occur，STARCEF should be immediately discontinued and appropriate measures，e.g. administration of adrenocortical homones should be taken

Alteration in bacterial flora

Stomatitis or candidiasis may occur rarely

Vitamin deficiencies

Vitamin K deficiencies，e.g. hypoprothrombinemia or bleeding tendencies or vitamin B complex deficiencies (e.g. glossitis，stomatitis，anorexia or neuritis) may occur infrequently.

Others

Headache or dizziness may occur rarely. In studies where infant rats were given 1000 mg/kg body weight/day orally, a reduction in spermatogenesis was reported

Carbamazepine

Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Drug monitoring may be assistance in detecting alterations in carbamazepine plasma concentrations

General

Caution should be exercised since hypersensitivity reactions, e.g. shock may occur. STARCEF should not be administered in patients who may still be treated with other antibiotics. If necessary, it should be administered with caution. Patients with history or hypersensitivity to any ingredient of STARCEF or any other cephem antibiotics. Cefixime should be administered carefully to the following patients:

- Patients with a history of hypersensitivity to penicillin.

- Patients with a personal or familial history to various forms of allergy, e.g. bronchial asthma, rash and urticaria.

- Patients with serious renal dysfunction.

- Patients with poor oral nutrition, those receiving parenteral nutrition, the elderly or patients in debilitated state. These patients must be monitored as vitamin K deficiency symptoms may develop.

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