COMPOSITIONS :
Cefixime Trihydrate Film Coated Caplet 200 mg, each film coated caplet contains : Cefixime trihydrate equivalent to Cefixime 200 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 Film coated caplet and Film coated tablet : 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 infection, the dosage may be increased up to 200 mg (potency) given twice daily.
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 Film Coated Caplet 200 mg Box, 3 blisters @ 10 film coated caplets
Reg. No. : GKL0802340009A1
STORAGE :
STORE BELOW 25ºC AND DRY PLACE
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
