COMPOSITIONS :
Cefixime Trihydrate Dry Syrup 100 mg/5 ml, each 5 ml (a measuring spoon) contains : Cefixime trihydrate equivalent to Cefixime 100 mg.
DESCRIPTIONS :
Cefixime Trihydrate with Cefixime trihydrate (equivalent to Cefixime) as active ingredient is available in film coated tablet 100 mg, film coated caplet 200 mg and dry syrup 100 mg/5 ml.
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 mirabillis.
Otitis media caused by Haemophilus influenzae (β-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are β-lactamase positive strains) and Streptococcus pyogenes.
Pharyngitis and tonsilitis 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 the standard drug regiments.
Uncomplicated gonorrhea (cervical/urethral) which caused by Neisseria gonorrhoeae (penicillinase and non penicillinase producing strains).
DOSAGE AND ADMINISTRATIONS :
Cefixime Trihydrate Dry syrup : 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 infection, 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 result in higher 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 fever 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 (e.g., 300 mg daily) when creatinine clearance is between 21 and 60 ml/minute or for patients on renal hemodialysis and 50% of the standard dosage (e.g., 200 mg daily) when creatinine clearance is less than 20 ml/minute or for patients on continuous ambulatory peritoneal dialysis.
In case overdosage : Gastric lavage may be indicated otherwise no spesific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis.
For uncomplicated cervical/urethral gonorrhea, a single dose of 400 mg is recommended.
Preparation of Dry Syrup :
Add 10 ml of water, shake for 30 seconds. Add 10 ml of water again, shake for 30 seconds. 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.
CONTRAINDICATIONS :
Patients with a history of shock or hypersensitivity caused by any ingredients of this product.
WARNINGS AND PRECAUTIONS :
General precaution : Careful inquiry about any form of hypersensitivity should be made, since reactions such as shock may occur.
This product should not be administered to the following patients as a general rule. Patients with a past history of hypersensitivity to other cephem antibiotics. If necessary, however it can be administered with care.
Careful administration :
Patients with a history of hypersensitivity to Penicilins.
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 nutrion, patient 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.
Using during pregnancy : Safety during pregnancy has not been established. This product should be administered to pregnant patients or woman suspected of being pregnant, only if the expected therapeutic benefit is thought to outweigh any possible risk.
Use in nursing mother : It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporary during treatment with this drug.
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 :
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.
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. This product should be discontinued if any of these abnormalities is found. It has been reported that hemolytic anemia has occured with other cephems.
Hepatic : Infrequently an increase in GOT, GPT 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 this product and other appropriate measures should be taken.
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, diarrhea, abdominal pain, stomach discomfort, heartburn or anorexia and rarely nausea, feeling of enlarged abdomen or constipation may occur.
Respiratory : In rare instances, pulmonary infiltrates of eosinophilia (PIE), 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 (such as hypothrombinemia or bleeding tendencies) or vitamin B group deficiencies (such as glossitis, stomatitis, anorexia or neuritis) may occur.
Other : 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 positives have not been reported with Testape.
A positive direct Coombs test may occur.
PRESENTATIONS :
Cefixime Trihydrate Dry Syrup 100 mg/5 ml Bottle @ 30 ml
Reg. No. : GKL1002342538A1
STORAGE :
STORE BELOW 25ºC AND DRY PLACE
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.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
