COMPOSITION :
Cefotiam HCl Powder for Injection 1 g, each vial contains : Cefotiam dihydrochloride equivalent to Cefotiam 1.g.
DESCRIPTIONS :
Cefotiam HCl is contains Cefotiam dihydrochloride (equivalent to Cefotiam) available as powder for injection 1 g.
INDICATIONS :
Severe infections due to Cefotiam sensitive strains of Staphylococcus, Streptococcus (excluding Enterococcus), Streptococcus pneumoniae, Neisseria gonorrhoeae, Branhamella catarrhalis, Haemophilus influenzae, Escherichia coli, Klebsiella, Enterobacter, Citrobacter, Proteus mirabilis and vulgaris, Proteus rettgeri and Proteus morganii.
Septicemia.
Postoperative wound, infection after burn, subcutaneous abscess, carbuncle, furuncle, furunculosis.
Osteomyelitis, suppurative arthritis.
Bronchitis, primary infection with bronchiectasis, pneumonia.
Suppurative disease of the lung, pyothorax.
Cholangitis, cholecystitis.
Peritonitis.
Pyelonephritis, cystitis, urethritis, prostatitis.
DOSAGE AND ADMINISTRATIONS :
Usually, in adults, 0.5 – 2 g daily IV or IM, in 2 – 4 equally divided doses. The dosage range should be adjusted according to age and severity infection. The daily dose may be increased up to 4 g for the treatment of septicemia.
In patients with impairment renal function, the following guidelines should be used (see table) :
| Creatinine clearance
(ml/minute) |
Dosage |
| 60 – 30
30 – 10 < 10 |
1 – 2 g daily
0.5 – 1 g daily 0.25 – 0.5 g daily |
Cefotiam for injection is under vacuum in the vial since carbon dioxide develop on dilution.
Cefotiam can be administered in the form of IV : 1 g of Cefotiam is dissolved in sterile water for injection. To dissolve, 5 ml of solvent is instilled into the vial. The diluent volume to be used is generally 20 ml.
CONTRAINDICATION :
Patients with a history of shock due to Cefotiam HCl.
ADVERSE REACTIONS :
Shock : Since shock symptoms may rarely occur, close observation should be made. If such symptoms as malaise, oral cavity discomfort, stridor, dizziness, feels stimulation on the movements of the large intestine, tinnitus, sweating occur, Cefotiam should be discontinued.
Hypersensitivity : If hypersensitivity reactions e.g., rash, urticaria, erythema, pruritus, fever, lymph node enlargement and arthralgia occur, treatment should be discontinued and appropriate measures taken.
Hematologic : Infrequently, erythropenia, leucopenia, thrombocytopenia, etc.
Hepatic : Infrequently, elevation of SGPT, SGOT, alkali P, may transient occur.
Gastrointestinal : Serious colitis with diarrhea accompanied by fever, abdominal pain, leukocytosis and mucous stool/bloody stool and in which endoscopy reveals formation of pseudomembranous plaques have been reported with other Cephem antibiotics eg, Cephalexin and Cephalothin sodium. If abdominal pain and frequent diarrhea occur, treatment should be discontinued and appropriate measures should be taken. Nausea, vomiting may rarely occur.
Alteration in bacterial flora : Rarely, stomatitis and candidiasis may occur.
Others : Rarely, fatigue, dizziness may occur.
WARNINGS AND PRECAUTIONS :
General : Careful examination must be conducted on the possibility of occurrence shock or other hypersensitivity reactions before the drug administration. Prior to the drug administration, a skin test is recommended.
Should not be used in patients who have a history of shock with Cefotiam.
Should be used with caution in patients who have a history of hypersensitivity to Cephalosporin or Penicillin.
Should be used with caution in patients who or whose parents or siblings have a predisposition to develop allergic reactions eg, bronchial asthma, rash, urticaria.
Should be used with caution in patients with severe renal disorder.
Used in pregnancy : As the safety of Cefotiam in pregnancy has not been establish. The drug should not be used in pregnant women or women suspected of being pregnant unless the potential benefits outweigh the possible hazards.
Caution for usage :
IV administration of Cefotiam in a large dose may cause vascular pain or thrombophlebitis on rare occasions. To prevent such reactions, due caution should be exercised in reconstituting the drug and also with regard to injection site and injection method. The injection speed should be as slow as possible.
IM administration of Cefotiam should be consider carefully the following points to prevent unwanted effects in tissues and nerves.
Should not be injected in the same place, repeatedly. Special precaution should be given to the administration of neonatus, premature and children.
Areas where there are nerves should be avoided.
Needle should be withdrawn immediately and site of injection replaced if perceived great pains or blood enter into a syringe.
After reconstitution, use the drug immediately. Even if the solution has to be stored, use it within 8 hours. The tone of the solution may deepen with time.
Others : During treatment with Cefotiam, it is recommended to perform hepatic and renal function tests and blood examinations at regular intervals.
PHARMACOLOGY :
Cefotiam is a broad spectrum antibiotic that is active against gram negative and gram positive bacteria and very real its activity against Escherichia coli, Klebsiella and Proteus mirabilis. Also active against Enterobacter, Citrobacter, Proteus positive indoles and Haemophilus influenzae.
It works is bactericide although in the minimum levels of growth inhibition (MIC).
Powerful antibacterial activity of Cefotiam against gram negative bacteria was probably caused by its high ability to penetrate outer membrane of bacteria cells and strong inhibitory activity to the formation of cross-linking peptidoglycan and because of its high affinity to Penicillin binding protein Ib and III which associated to bacteriolysis and cytodieresis inhibition.
DRUG INTERACTIONS :
The concomitant use of analogous compounds (other Cephem antibiotics) and such diuretics as Furosemide has been reported to increase the risk of renal disorder. Therefore, when Cefotiam is used in combination with such drugs, attention should be paid to the renal function.
PRESENTATIONS :
| Cefotiam HCl Powder for Injection 1 g | Box, 10 vials @ 1 g | Reg. No. GKL1640308544A1 |
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
After reconstitution, use the drug immediately. Even if the solution has to be stored, use it within 8 hours. The tone of the pale yellow solution may depend with time.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
