Cefacef

Cefixime trihydrate.

Capsule: Each capsule contains cefixime trihydrate equivalent to 100 mg of cefixime.
Dry Syrup: Each 5 mL of dry syrup contains cefixime 100 mg, after reconstitution.
Film-coated caplet: Each film-coated caplet contains: cefixime trihydrate equivalent to 200 mg of cefixime.

Pharmacology: Cefixime has a broad spectrum activity against Gram-positive and Gram-negative microorganisms. In particular, in comparison with 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, Haemophilus influenzae, Neisseria gonorrhoeae. Its mode of action is bactericidal. Cefixime is extremely stable to β-lactamase producing organisms.
Cefixime mode of action is inhibition of cell wall synthesis. It has high affinity for penicillin-binding protein (PBP) 1 (1a, 1b, and 1c) and 3, with the site of activity varying according to organism.

Cefacef 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 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 exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae (β-lactamase-positive and -negative strains).
Treatment of typhoid fever in children with multi-resistant to standard treatment.
Uncomplicated gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase and nonpenicillinase-producing strains).

Adults and children weighing ≥30 kg: Usual recommended daily dose is 50-100 mg given orally, twice daily.
Children weighing ≤30 kg: 1.5-3 mg/kg body weight twice daily in divided doses. For more severe or intractable infections, the dosage may be increased up to 200 mg, given twice daily. Dosage should be adjusted according to the age, body weight, and condition of patient. More Severe or Intractable Infections: Up to 6 mg/kg body weight twice daily in divided doses as twice daily.
Typhoid fever in children: 10-15 mg/kg BB/day for 2 weeks.
Patients with impaired renal function require dosage modification 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 21-60 mL/min or for patients on renal hemodialysis.
The recommended dosage is 50% of the standard dosage (i.e. 200 mg daily) when creatinine clearance is <20 mL/min or for patient on continuous ambulatory peritoneal dialysis (CAPD).
For uncomplicated cervical/urethral gonorrhea, a single dose of 400 mg is recommended.

Cefacef 200: In case of overdosage, gastric lavage may be indicated, otherwise no specific antidote exists. CEFACEF 200 is not removed in significant quantities from the circulation by haemodialysis or peritoneal dialysis.

Patients with a history of shock or hypersensitive to cephalosporins and other components contained in the drug.

General precautions: Careful inquiry about any form of hypersensitivity should be made since reactions e.g. shock may occur.
Carefully administration to: Patients with a history of hypersensitivity to penicillin, patient with history of some forms of allergy e.g. bronchial asthma, rash, urticaria, patient with serious renal function disorder, and patients with poor oral nutrition, patients receiving parenteral nutrition, elderly patients or patients in a debilitated state since vitamin K.
Use in Children: Cefacef: Children with otitis media should be treated with suspension only. Safety and effectiveness of use in children <6 months have not been established.
Cefacef 200: Efficacy and safety in children aged less than 6 months have not been established (including new born and prematures).

Use in Pregnancy: Safety during pregnancy has not been established. This product should be administered to pregnant patients only if the expected therapeutic benefit is thought to outweigh any possible risk.
Use in Lactation: It is not known whether CEFACEF 200 is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this product.

Cefacef is generally well tolerated. The majority of adverse reactions were transient and self-eliminating naturally.
Shock: Adequate caution in administration should be used as shock symptoms may rarely occur. If any related signs or symptoms e.g. feeling unwell, oral cavity discomfort, stridor, dizziness, abnormal urge to defecate, tinnitus or diaphoresis occur, CEFACEF 200 must be discontinued immediately.
Hypersensitivity: If signs of hypersensitivity reactions e.g. rash, urticaria, erythema, pruritus or fever occur, CEFACEF 200 should be discontinued and appropriate measures should be taken.
Haematologic: Granulocytopenia, or eosinophilia, and thrombocytopenia may occur. CEFACEF 200 should be discontinued if any of these abnormalities is found. It has been reported that haemolytic anemia has occurred with other cephems.
Hepatic: Infrequently, an increase in ALT, AST, or alkaline phosphatase may occur.
Renal: Periodic monitoring of renal function is recommended as serious renal impairment e.g. acute renal insufficiency, may occur. If any of these abnormalities are found, discontinuation of CEFACEF 200 and other appropriate measures should be taken.
Digestive: In rare instances, a serious colitis e.g. pseudomembranous colitis, manifested by blood in stool may occur. Abdominal pain or frequent diarrhea requires appropriate measures, including prompt withdrawal of CEFACEF 200. 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, CEFACEF 200 should be immediately discontinued and appropriate treatment e.g. giving adrenocorticoid hormones should be taken.
Alteration in bacterial flora: Rarely, stomatitis or candidiasis may occur.
Vitamin deficiencies: Rarely, vitamin K deficiencies (e.g. hypoprothrombinemia or bleeding tendencies) or vitamin B group deficiencies (e.g. glositis, stomatitis, anorexia or neuritis) may occur.
Others: Rarely, headache or dizziness may occur.
Influences on laboratory values: False-positive results may occur with urine sugar tests using Benedict's solution, Fehling's solution, and Clinitest. False-positive results have not been reported with test-tape. A positive direct Coombs test may occur.

Cefacef 200: Antacids: There is no significant effect on the pharmacokinetics properties in concomitant administration of cefixime with antacids.
Anticoagulants: Concomitant administration of cefixime with anticoagulants (eg, warfarin) may prolong prothrombin time, with or without bleeding.
Carbamazepine: Concomitant administration of cefixime with Carbamazepine may increase the concentration of carbamazepine in the plasma hence the concentration of carbamazepine should be monitored.
Nifedipine: Concomitant administration of cefixime with Nifedipine may increase the bioavailability of cefixime (increase concentration of peak plasma and AUC concentration).
Probenecid: Concomitant administration of cefixime with Probenecid may increase peak concentration and AUC of cefixime, also decrease renal clearance and distribution volume of the drug.
Salicylate: Concomitant administration of cefixime with Salicylate may increase concentration of cefixime in the blood.

Store below 30°C.

Cephalosporins

J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

G