Cefspan
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Indication
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 Haemophilia influenzae (Beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are beta-lactamase 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
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 Haemophilia influenzae (Beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are beta-lactamase 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
Contra Indication
Patients with a history of shock or hypersensitivity caused by any ingredient of this product.
Patients with a history of shock or hypersensitivity caused by any ingredient of this product.
Warning
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 : a.Patients with a history of hypersensitivity to penicillines. b.Patients with a personal or familial history of some form of allergy such as bronchial asthma, rash, urticaria. c. Patients with serious renal function disorder. d. 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).
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 : a.Patients with a history of hypersensitivity to penicillines. b.Patients with a personal or familial history of some form of allergy such as bronchial asthma, rash, urticaria. c. Patients with serious renal function disorder. d. 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).
Dosage
- Cefspan Capsules 50 mg / 100 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 (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 higher peak blood levels than the tablet when administered at the same dose. Therefore, suspension should not be substituted inn the treatment of otitis media. - Patients with impaired renal function require modification of dosage depending on the degree of impairment. The recommended dosage is 75% of the standard dosage (ie., 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 (ie, 200 mg daily) when creatinine clearance is less than 20 ml/min or for patients on continuous ambulatory peritoneal dialysis. - Incase 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.
- Cefspan Capsules 50 mg / 100 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 (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 higher peak blood levels than the tablet when administered at the same dose. Therefore, suspension should not be substituted inn the treatment of otitis media. - Patients with impaired renal function require modification of dosage depending on the degree of impairment. The recommended dosage is 75% of the standard dosage (ie., 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 (ie, 200 mg daily) when creatinine clearance is less than 20 ml/min or for patients on continuous ambulatory peritoneal dialysis. - Incase 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.
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