Astellas Pharma


Cosma Medical
Full Prescribing Info
CEFSPAN Capsules 100 mg contain 100 mg (potency) of cefixime and powder for oral suspension contains 100 mg (potency) of cefixime per 5 mL (when reconstituted).
CEFSPAN is an oral cephem derivative developed by the Central Research Laboratories of Fujisawa Pharmaceutical Co., Ltd. Generically, it is called cefixime, which has a vinyl group at the 3 position and a carboxymethoxyimino group at the 7 position of 7-aminocephalosporanic acid.
This product is stable to various β-lactamases, differing from previous oral cephems and penicillins. It has broad-spectrum activity against gram-positive and -negative microorganisms; in particular, it has good activity against gram-negative bacilli. Its mode of action is bactericidal. It produces a maximum serum concentration 4 hours after oral administration, so with its prolonged serum concentration and urinary excretion, and its high biliary concentration, efficacy with twice daily dosing is possible.
Nonproprietary name: Cefixime (JAN, INN)
Abbreviation: CFIX
Chemical name: (-)-(6R,7R)-7-[(Z(-2-(2-Amino-4-thiazol-yl)-2-(carboxymethoxyimino) cetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.
Molecular formula: C16H15N5O7S2.
Molecular weight: 453.46.
Melting point: Approx. 240°C (decomposition).
Partition coefficient: 2.9x10-3 (1-octanol/water system).
Cefixime occurs as a white to light yellow crystalline powder with little or no characteristic odor. Cefixime is freely soluble in methanol, slightly soluble in ethanol, and practically insoluble in water or ether.
Pharmacology: Mechanism of Action: Its mode of action is inhibition of cell wall synthesis. It has high affinity for penicillin binding proteins (PBP) 1 (1a, 1b and 1c) and 3, with the site of activity varying according to organism.
Microbiology: Antibacterial Activity: Cefixime has broad-spectrum activity against gram positive and -negative microorganisms. In particular, in comparison with the other oral cephalosporins, it has potent activity against such gram-positive organisms as Streptococcus sp., Streptococcus pneumoniae, and such gram-negatives as Neisseria gonorrhoeae, Moraxella catarrhalis, Escherichia coli, Klebsiella sp., Serratia sp., Proteus sp., Haemophilus influenzae. Its mode of action is bactericidal.
It is extremely stable to β-lactamase produced by many organisms, and has good activity against β-lactamases producing organisms.
The following infections caused by cefixime-susceptible organisms, eg Streptococcus sp, Streptococcus pneumoniae, Moraxella (Branhamella) catarrhalis, Klebsiella and Proteus spp, Haemophilus influenzae, Salmonella typhi, Escherichia coli, Proteus mirabilis: Bronchitis, infected bronchiectasis, secondary infections of chronic respiratory tract diseases, pneumonia; acute exacerbation in COPD (chronic obstructions pulmonary diseases) otitis media, sinusitis, pyelonephritis, cystitis, gonococcal urethritis, typhoid.
Dosage/Direction for Use
Cap: For adults and children weighing ≥30 kg, the usual recommended daily dose is 100 mg (potency) of cefixime given orally twice daily. Dosage should be adjusted according to the age, body weight and condition of the patient. For more severe or intractable infections, the dosage may be increased up to 200 mg (potency) given twice daily.
DURATION OF TREATMENT: Bronchitis: 7-14 days; Infected bronchiectasis: 7-14 days; Secondary infections of chronic respiratory tract disease: 7-14 days; Pneumonia: 10-14 days; Acute exacerbation in COPD: 7-14 days; Pyelonephritis: 7-14 days; Cystitis: 5-7 days; Gonococcal urethritis: 7-10 days; Otitis media: 7-10 days; Sinusitis: 10-14 days; Typhoid: 14 days.
Oral susp: The usual daily dose is 1.5-3 mg (potency)/kg given orally twice daily. Dosage should be adjusted according the age, body weight and condition of the patient.
For more severe or intractable infections, the dosage may be increased up to 6 mg (potency)/kg given orally twice daily.
Patients with a history of shock caused by any ingredient of this product.
This product should not be administered to the following patients as a general rule. If necessary, however, it can be administered with care. Patients with a past history of hypersensitivity to any of ingredients in this product or any other cephem antibiotics.
Special Precautions
General Precautions: Careful inquiry about any form of hypersensitivity should be made, since reactions such as shock may occur.
Careful Administration: Patients with a history of hypersensitivity to penicillins; patients with a personal or familial history of some form of allergy such as bronchial asthma, rash, urticaria; patients with serious renal function disorder; patients with poor oral nutrition, patients receiving parenteral nutrition; elderly patients or patients in a debilitated state: Careful observation is essential in these patients as vitamin K deficiency symptoms may develop.
Influences on Laboratory Values: False-positive results may occur with urine-sugar tests using Benedict's solution, Fehling's solution and Clinitest. False-positives have not been reported with TesTape.
A positive direct Coombs' test may occur.
Impairment of Fertility: In studies where infant rats were given ≥1000 mg/kg/day orally, a reduced spermatogenesis was reported.
Use in Pregnancy: Safety during pregnancy has not been established. Cefspan should be administered to pregnant patients or women suspected of being pregnant, only if the expected therapeutic benefit is thought to outweigh any possible risk.
Use in Children: Safety in newborns or prematures has not been established.
Use in Elderly: This product should be administered with care and attention to the following points while closely monitoring the patient's condition such as paying special attention to the dose and dosing interval.
Adverse reactions are likely to occur in the elderly due to reduced physiological functions.
Bleeding tendency due to vitamin K deficiency may occur in the elderly.
Use In Pregnancy & Lactation
Safety during pregnancy has not been established. This product should be administered to pregnant patients or women suspected of being pregnant, only if the expected therapeutic benefit is thought to outweigh any possible risk.
Adverse Reactions
Shock: Adequate caution in administration should be used as shock symptoms may rarely occur. If any related signs or symptoms, eg feeling unwell, oral cavity discomfort, stridor, dizziness, abnormal urge to defecate, tinnitus or diaphoresis occur, Cefspan must be discontinued immediately.
Hypersensitivity: If signs of hypersensitivity reactions such as rash, urticaria, erythema, pruritus or fever occur, this product should be discontinued and appropriate measures should be taken.
Hematologic: Granulocytopenia or eosinophilia infrequently may occur. Rarely, thrombocytopenia may occur. Cefspan should be discontinued if any of these abnormalities is found. It has been reported that hemolytic anemia has occurred with other cephems.
Hepatic: Infrequently, an increase in SGOT, SGPT or alkaline phosphatase may occur.
Renal: Periodic monitoring of renal function is recommended as serious renal impairment, such as acute renal insufficiency may rarely occur. If any of these abnormalities is found, discontinuation of Cefspan and other appropriate measures should be taken.
Digestive: In rare instances, a serious colitis, eg pseudomembranous colitis, manifested by blood in stools, may occur. Abdominal pain or frequent diarrhea requires appropriate measures, including prompt withdrawal of Cefspan. Infrequently vomiting, diarrhea, abdominal pain, stomach discomfort, heartburn or anorexia and rarely nausea, feeling of enlarged abdomen or constipation 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, this product should be immediately discontinued and appropriate measures such as giving adrenocortical hormones should be taken.
Alteration in Bacterial Flora: Rarely, stomatitis or candidiasis may occur.
Vitamin Deficiencies: Rarely, vitamin K deficiencies (eg, hypoprothrombinemia or bleeding tendencies) or vitamin B group deficiencies (eg, glossitis, stomatitis, anorexia or neuritis) may occur.
Others: Rarely, headache or dizziness may occur.
Drug Interactions
Precautions for coadministration.
Cefspan should be administered with care when coadministered with Warfarin. Since this product may inhibit the production of vitamin K by enteric bacteria, the effects of warfarin may be enhanced.
Caution For Usage
Reconstituted solution: After reconstitution, the oral suspension could be stored in both room temperature below 25°C and in a refrigerator.
Shake well before using and keep tightly closed.
Discard any unused portion after 14 days.
Note: No refrigeration required before and after mixing.
Capsule: Store at temperature not exceeding 30°C.
Powder for oral suspension: Store at room temperature not exceeding 25°C.
MIMS Class
ATC Classification
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Cap 100 mg (light orange, opaque, hard gelatin) x 100's. Powd for oral susp 100 mg/5 mL x 30 mL.
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