Starcef

Starcef

cefixime

Manufacturer:

Dexa Medica
Full Prescribing Info
Contents
Cefixime.
Action
Pharmacology: Antibacterial Activity: Cefixime has a bactericidal and broad-spectrum activity against gram-positive and gram-negative microorganisms. As with other oral cephalosporins, cefixime has potent activity against gram-positive microorganisms eg, Streptococcus sp, Streptococcus pneumoniae and gram-negative microorganisms eg, Branhamella catarrhalis, Escherichia coli, Proteus sp and Haemophilus influenzae. Its mechanism of action is by inhibition of cell wall synthesis. Cefixime has high affinity for penicillin-binding proteins (PBP) 1 (1a, 1b and 1c) and 3, with the site of activity varying according to the strains of organisms. Cefixime is stable to β-lactamase produced by many organisms and has a good activity against β-lactamase-producing organisms.
Pharmacokinetics: Serum Concentration: Following oral administration of a single dose of 50, 100 and 200 mg (potency) of cefixime in healthy, fasted adults, peak serum concentration within 4 hrs after administration were 0.69, 1.13 and 1.95 mcg/mL, respectively. The serum half-life is 2.3-2.5 hrs. Following oral administration of a single dose of 1.5, 3 or 6 mg (potency)/kg of cefixime in pediatrics with normal renal function, peak serum concentration within 3-4 hrs after administration were 1.14, 2.01 and 3.97 mcg/mL, respectively. The serum half-life is 3.2-3.7 hrs.
Distribution (Tissue Penetration): Penetration into sputum, tonsil, maxillary sinus mucosal tissue, otorrhea, biliary fluid and gallbladder tissue is good.
Metabolism: No antibacterially active metabolites are found in the serum and urine.
Elimination: Cefixime is primarily excreted via urine. The extent of urinary excretion (up to 12 hrs) after oral administration of 50, 100 or 200 mg (potency) in healthy, fasted adults was about 20-25% from administered dose. Peak urine concentration of 42.9, 62.2 and 82.7 mcg/mL, respectively, was reached within 4-6 hrs after administration. The extent of urinary excretion (up to 12 hrs) after oral administration of 1.5, 3 or 6 mg (potency)/kg body weight in pediatrics with normal renal function was about 13-20%.
Indications/Uses
Treatment of infections caused by susceptible microorganisms ie, urinary infections without complication 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 exacerbation of chronic bronchitis, caused by Streptococcus pneumoniae and Haemophilus influenzae (β-lactamase-positive and β-lactamase-negative strains).
Dosage/Direction for Use
Capsule: Adults and Children Weighing ≥30 kg: Recommended Daily Dose: 50-100 mg (potency) of cefixime given orally twice a day.
Dosage should be adjusted according to age, body weight and condition of the patients.
Severe Infections: The dosage may be increased up to 200 mg (potency), given twice a day.
Suspension: Children: Usual Daily Dose: 1.5-3 mg (potency)/kg body weight given orally twice a day. Dosage should be adjusted according to the condition of the patients.
Severe Infections: The dosage may be increased up to 6 mg (potency)/kg body weight given twice a day.
Otitis Media: Treat with Starcef suspension.
Clinical studies of otitis media treated with cefixime suspension resulted in higher peak plasma concentration than the tablet when administered at the same dose. Therefore, suspension should not be substituted with tablet in the treatment of otitis media.
Patients with impaired renal function need a dosage adjustment depending on the degree of impairment. Recommended Dosage: 75% of the standard dosage (ie, 300 mg a day) if creatinine clearance is between 21 and 60 mL/min or for patients on renal hemodialysis and 50% of the standard dosage (ie, 200 mg a day) if creatinine clearance is <20 mL/min or for patients on continuous ambulatory dialysis.
Reconstitution of Dry Syrup: Add 10 mL of water, shake for 30 sec. Add 10 mL more of water and shake again for 30 sec.
Overdosage
Gastric lavage may be performed if there is no specific antidote. Cefixime is not eliminated in significant quantities from the circulation by hemodialysis or peritoneal dialysis.
Contraindications
Patients with history of shock or hypersensitivity due to any ingredients of Starcef.
Special Precautions
General: Caution should be exercised since hypersensitivity reactions eg, 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 of 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 eg, 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.
Use in pregnancy: Safety during pregnancy has not been established.
Starcef should be administered to pregnant or those suspected of being pregnant only if the expected therapeutic benefits are thought to outweigh any possible risk.
Use in lactation: It is not known whether cefixime is excreted in human milk, therefore, nursing must be temporarily discontinued during treatment with Starcef.
Use in children: Safety and efficacy of cefixime administration in children <6 months has not been established (including newborns and prematures).
Adverse Reactions
Shock: Adequate caution should be exercised since shock symptoms may sometimes occur. If any related signs or symptoms eg, 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 eg, rash, urticaria, erythema, pruritus or fever occur, the administration of Starcef should be discontinued and appropriate measures should be taken.
Hematologic: 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 eg, 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 eg, pseudomembranous colitis, manifested by blood in stools may occur. Abdominal pain or continuous diarrhea requires appropriate measures; infrequently, vomiting, diarrhea, abdominal pain, stomach discomfort, heartburn or anorexia, nausea, feeling of fullness 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, Starcef should be immediately discontinued and appropriate measures eg, administration of adrenocortical hormones should be taken.
Alteration in Bacterial Flora: Stomatitis or candidiasis may occur rarely.
Vitamin Deficiencies: Vitamin K deficiencies eg, hypoprothrombinemia or bleeding tendencies or vitamin B group deficiencies (eg, 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.
Drug Interactions
Influences on Laboratory Test 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 Testape.
A positive direct Coombs' test may occur.
Storage
Store in a cool, dry place. Protect from light.
Dry Syrup: After reconstitution, 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.
MIMS Class
ATC Classification
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Cap 50 mg x 30's. 100 mg x 30's. 200 mg x 10's. Dry syrup 100 mg/5 mL x 30 mL.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in