Cefspan

CEFSPAN^® 
Cefixime

Composition

Each capsule contains:
Cefixime	50 mg (potency) or 100 mg (potency).
Each teaspoon (5 ml) of suspension contains:
Cefixime	100 mg (potency).
Each film coated tablet contains:
Cefixime	200 mg (potency).

Pharmacology
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 Branhamella catarrhalis, Escherichia coli, Proteus sp., Haemophillus influenzae, Neisseria gonorrhoeae. Its mode of action is bactericidal. It is extremely stable to β-lactamase produced by many organisms, and has good activity against β-lactamase producing organism.

Mode 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.

Pharmacokinetics 
Serum concentration
Following a single oral dose of 50, 100 or 200 mg (potency) of Cefixime in healthy, fasted adults, maximum serum concentrations at 4 hours were, respectively, 0.69, 1.13 and 1.95 μg/ml. The serum half-life was 2.3 - 2.5 hours.
Following a single oral dose of 1.5, 3.0 or 6.0 mg (potency)/kg of Cefixime in pediatric patients with normal renal function, maximum serum concentrations at 3 - 4 hours were, respectively, 1.14, 2.01 and 3.97 μg/ml. The serum half-life was 3.2 - 3.7 hours.

Tissue penetration (distribution)
Penetration into sputum, tonsils, maxillary sinus mucosal tissue, otorrhea, biliary fluid and gall-bladder tissue is good.

Metabolism
No antibacterially active metabolites are found in the human serum or urine.

Excretion
Cefixime is excreted primarily renally. The extent of urinary excretion (up to 12 hours) after oral administration of 50, 100 or 200 mg (potency) in healthy, fasted adults was about 20-25%. Maximum urine concentrations were, respectively, 42.9, 62.2 and 82.7 μg/ml at 4-6 hours. The extent of urinary excretion (up to 12 hours) after oral administration of 1.5, 3.0 or 6.0 mg (potency)/kg in pediatric patients with normal renal function was about 13-20%.

Indications
Cefixime is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

• Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis.
• Otitis media caused by Haemophillus influenzae (Beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are betalactamase positive), and Streptococcus pyogenes.
• Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. 
• Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis, caused by Streptococcus pneumoniae and Haemophillus influenzae (beta-lactamase positive and negative strains).
• Treatment of typhoid fever in children. with multi-resistant to the standard drug regiments.
• Uncomplicated gonorrhoeae (cervical/urethral) which caused by Neisseria gonorrhoeae (penicilinase-and non penicilinase-producing strains).

Contraindications
Patients with a history of shock or hypersensitivity caused by any ingredient of this product.

Precautions

1. General Precautions: Careful inquiry about any form of hypersensitivity should be made, since reactions such as shock may occur.
2. 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.
3. Careful Administration:
   1. Patients with a history of hypersensitivity to penicillin.
   2. Patients with a personal or familial history of some form of allergy such as bronchial asthma, rash, urticaria.
   3. Patients with serious renal functions disorder.
   4. 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.
4. Use during Pregnancy: 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.
5. Use in Nursing Mother: It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.
6. Use in Newborns or Prematures: Efficacy and safety in children aged less than 6 months have not been established (including in newborn and prematures),

Adverse Reactions

1.	Shock Adequate caution in administration should be used as shock symptoms may rarely occur. If any related signs or symptoms such as feeling unwell, oral cavity discomfort, stridor, dizziness, abnormal urge to defecate, tinnitus or diaphoresis occur, this product must be discontinued immediately.
2.	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.
3.	Hematologic Granulocytopenia or eosinophilia infrequently may occur. Rarely thrombocytopenia may occur, This product should be discontinued if any of these abnormalities is found. It has been reported that hemolytic anemia has occurred with other cephems.
4.	Hepatic Infrequently an increase in GOT, GPT or alkaline phosphatase may occur.
5.	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 this product and other appropriate measures should be taken.
6.	Digestive In rare instances a serious colitis, such as pseudomembranous colitis, manifested by blood in stools, may occur. Abdominal pain or frequent diarrhoea requires appropriate measures, including prompt withdrawal of this product infrequently vomiting, diarrhoea, abdominal pain, stomach discomfort, heartburn or anorexia, and rarely nausea, feeling of enlarged abdomen or constipation may occur.
7.	Respiratory In rare instances, interstitial pneumoniae 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.
8.	Alteration in bacterial flora Rarely stomatitis or candidiasis may occur.
9.	Vitamin deficiencies Rarely vitamin K deficiencies (such as hypothrombinemia or bleeding tendencies) or vitamin B group deficiencies (such as glossitis, stomatitis, anorexia or neuritis) may occur.
10.	Others Rarely headache or dizziness may occur. In studies where infants rats were given 1.000 mg/kg/day orally, a reduced spermatogenesis was reported.
11.	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.

Dosage and Administration

• Cefspan^® capsules 50 mg/100 mg and tablet 200 mg: For adults and children weighing › 30 kg, the usual recommended daily dose is 50 - 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. 
• Cefspan^® suspension 100 mg: The usual pediatric daily dose is 1.5 - 3 mg (potency)/kg given orally twice daily. Dosage should be adjusted according to the 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.
• In children, otitis media should be treated with suspension, Clinical studies of otitis media were conducted with the suspension and the suspension results in high er peak blood levels than the tablet when administered at the same dose, Therefore, suspension should not be substituted in the treatment of otitis media. Typhoid lever in children: 10 - 15 mg/kg/day for 2 weeks.
• Patients with impaired renal function require modification of dosage depending on the degree of impairment. The recommended dosage is 75% of the standard dosage (i.e. 300 mg daily) when creatinine clearance is between 21 and 60 ml/min or for patients on renal hemodialysis. and 50% of the standard dosage (i.e. 200 mg daily) when creatinine clearance is less than 20 ml/min or for patients on continuous ambulatory peritoneal dialysis.
• In case of over dosage: Gastric lavage may be indicated; otherwise. no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis.
• For uncomplicated cervical/ urethral gonorrhoeae, a single dose of 400 mg is recommended.

Presentation

Capsule 50 mg	:	Box of 3 strips x 10 capsules	Reg. No. DKL 9211616501Al
Capsule 100 mg	:	Box of 3 strips x 10 capsules	Reg. No. DKL 9211616501Bl
Filcotab 200 mg	:	Box of 1 strip x 10 tablets	Reg. No. DKL 0311636517Al
Dry Syrup	:	Bottle of 30 ml	Reg. No. DKL 9211616738A1

After reconstitution, the suspension 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.
Add 20 ml of water, shake for 60 seconds.

Capsules : Store below 25°C,
Dry Syrup and Tablet: Store below 30°C.

HARUS DENGAN RESEP DOKTER
On medical prescription only

Manufactured by :
PT DANKOS FARMA, Jakarta-Indonesia
For: PT KALBE FARMA Tbk., Bekasi-Indonesia
Under licence of :
Astellas Pharma Inc., Osaka-Japan

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