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Cefixime Dispersible Tablets

2022-10-21 Hits: 34 views

Composition
The main ingredient of this product is cefixime, and its chemical name is (6R, 7R)-7-[(Z)-2-(2- amino -4- thiazolyl) -2- (carboxymethyl imino) acetamido ]-3- ethylene -8- oxo -5- thio -1- azabicyclo [4
Molecular formula: C16H15N5O7S2· 3H2O
Molecular weight: 507.50

Character
This product is a film-coated tablet, which is white or yellowish after the coating is removed.

Indication
It is effective for the following infections caused by cefixime-sensitive bacteria in Streptococcus (except Enterococcus), Pneumococcus, Neisseria gonorrhoeae, Branham catarrhalis, Escherichia coli, Klebsiella, Serratia, Proteus and Influenza.
Acute attack of chronic bronchitis, acute bronchitis with bacterial infection, bronchiectasis with infection and pneumonia;
Nephritis, cystitis, gonococcal urethritis;
Acute bacterial infection of biliary system (cholecystitis, cholangitis);
Scarlet fever;
Otitis media, sinusitis.

As a generic drug supplier in China, Feiyue Pharmaceutical can provide finished drugs such as Cefixime Dispersible Tablets
Packaging: 10tablets/blister,10blisters/box
FEIYUE recruits agents worldwide, we can provide complete registration documents.

Dosage
Oral.
For adults and children weighing over 30kg:
Oral administration, 0.1g(1 tablet) once, twice a day; For severely infected adults, it can be increased to 0.2g(2 tablets) once, twice a day.
Children:
Oral administration, calculated as 1.5 ~ 3.0 mg per kilogram once, twice a day. Or follow the doctor’s advice.

Adverse effect
Of the total 12,879 cases, 249 cases (2.58%) were found to have adverse reactions including abnormal clinical examination values. These adverse reactions include gastrointestinal symptoms such as diarrhea in 112 cases (0.87%) and skin symptoms such as rash in 29 cases (0.23%). In addition, abnormal clinical examination values include GPT in 78 cases (0.61%), GOT in 58 cases (0.45%) and eosinophilia in 26 cases (0.20%).
(1) Serious adverse reactions:
① Shock: due to the possibility of causing shock (< 0.1%), close observation should be made. If there is discomfort, abnormal feeling in the mouth, asthma, dizziness, loose bowels, tinnitus, sweating and other phenomena, the medicine should be stopped and appropriate treatment should be taken;
② Allergic symptoms: There is the possibility of allergic symptoms (including dyspnea, general flushing, angioedema, urticaria, etc.) (< 0.1%), which should be closely observed. If there is any abnormality, stop the administration and take appropriate treatment;
③ Skin lesions: There is the possibility of skin mucosal eye syndrome (Stevens-Johnson syndrome, < 0.1%) and toxic epidermal necrosis (Lyell syndrome, < 0.1%), which should be closely observed. If there are symptoms such as fever, headache, joint pain, skin or mucosal erythema, blisters, skin tension, burning sensation and pain, the drug should be stopped.
④ Blood disorder: there is the possibility of agranulocytosis (< 0.1%, early symptoms: fever, sore throat, headache, tiredness, etc.), hemolytic anemia (< 0.1%, early symptoms: fever, hemoglobinuria, anemia, etc.) and thrombocytopenia (< 0.1%, early symptoms: spotting hemorrhage, purple spots, etc.), and
⑤ Renal dysfunction: Due to the possibility of causing severe renal dysfunction (< 0.1%) such as acute renal insufficiency, close observation should be made, for example, regular check-ups, etc. If any abnormality occurs, drug administration should be stopped and appropriate treatment should be taken;
⑥ Colitis: It may cause severe colitis with bloody stool, such as pseudomembranous colitis (< 0.1%). In case of abdominal pain and repeated diarrhea, the drug should be stopped immediately and appropriate treatment should be taken;
⑦ Interstitial pneumonia, PTE syndrome: there is the possibility of interstitial pneumonia, PTE syndrome ([0.1%] respectively) with symptoms such as fever, cough, dyspnea, abnormal chest X-ray, eosinophilia, etc. If the above symptoms occur, the drug should be stopped and appropriate treatment such as glucocorticoid should be taken;
(2) Other adverse reactions: The incidence of adverse reactions is common in 0.1 ~ 5%, but rare below 0.1%.
Allergy: common rash, urticaria, erythema, rare itching, fever and edema;
Blood: common (0.1% ~ 5%) eosinophilia and rare neutropenia;
Liver: The elevation of ALP/GPT and AST/GOT is common, and jaundice is rare;
Kidney: rare increase of BUN;
Digestive system: diarrhea, stomach upset, nausea, vomiting, abdominal pain, chest burning, loss of appetite, abdominal fullness and constipation are common;
Dysbacteriosis: rare stomatitis and oral monicoccosis;
Vitamin deficiency: rare vitamin K deficiency (low prothrombinemia, bleeding tendency, etc.), vitamin B deficiency (glossitis, stomatitis, loss of appetite, neuritis, etc.);
Others: headache, dizziness.

Taboo
People who are allergic to this product or other cephalosporin antibiotics.
drug interaction
Carbamazepine: When combined with this product, it can cause the level of carbamazepine to rise, and the concentration of carbamazepine in plasma should be monitored when it must be combined.
Warfarin and anticoagulant drugs: increase prothrombin time when combined with this product.

Store up
Keep in a cool, dark and dry place (no more than 20℃ away from light).

Pharmacological action
This product is the third-generation cephalosporin for oral administration, which has broad antibacterial spectrum and antibacterial activity against some Gram-positive bacteria and negative bacteria, especially Streptococcus in Gram-positive bacteria (except Enterococcus), Pneumococcus, Neisseria gonorrhoeae, Escherichia coli, Klebsiella, Serratia, Proteus, and Influenza. Its mechanism of action is to prevent the synthesis of bacterial cell walls, and its action is This product has strong stability to β -lactamases produced by various bacteria.
Toxicological research
Toxicity: SD rats were given 100 ~ 1000 mg/kg orally before pregnancy and early pregnancy, and 320 ~ 3200 mg/kg orally during organogenesis, perinatal and lactation. There was no effect on the fertility of rats, no teratogenic effect, and no abnormality in the growth, development and reproductive capacity of newborn rats.