| Generic Name |
Cefixime for Oral Suspension |
| Strength |
100mg/5ml |
| Packing |
1 bottle/box |
| Origin |
China |
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Product name:
Cefixime for Oral Suspension 100mg/5ml
Character:
This product is white or white particles, aromatic, sweet taste.
Indications:
It is effective against the following infections caused by cefixime sensitive bacteria in Streptococcus (except Enterococcus), Pneumococcus, Gonococcus, Katabbranchia, Escherichia coli, Klebsiella, Serratia, Proteus, Influenzae:
* Acute attack of chronic bronchitis, acute bronchitis with bacterial infection, bronchiectasis with infection, pneumonia;
* Pyelonephritis, myositis, gonococcal urethritis;
* Acute bacterial infection of the biliary system (cholecystitis, cholangitis);
* Scarlet fever;
* Otitis media, sinusitis.
Adverse reactions:
Of the total 12,879 cases, 294 (2.58%) were found to have adverse reactions, including abnormal clinical values. These adverse reactions included diarrhea and other gastrointestinal symptoms in 112 cases (0.87%), skin symptoms such as skin rash in 29 cases (0.23%), in addition, clinical abnormalities included increased GPT in 78 cases (0.61%), increased GOT in 58 cases (0.45%), and increased eosinophilia in 26 cases (0.20%).
(1) Serious adverse reactions:
Shock: by causing shock (< 0.1%) possibility, should be closely observed, if there is discomfort, abnormal sensation in the mouth, asthma, dizziness, stool, tinnitus, sweating and other phenomena, should stop the administration of medicine, take appropriate treatment;
(2) Allergic symptoms: there is the possibility of allergic symptoms (including dyspnea, flushing, angioedema, urticaria, etc.) ([0.1%], should be closely observed, if there is abnormal occurrence of drug administration, take appropriate treatment;
(3)Skin lesions: There were cutaneous mucocutaneous syndrome (Stevens-Johnson syndrome, [0.1%]) and toxic epidermal necrosis (Lyell syndrome, < If fever, headache, joint pain, skin or mucous membrane erythema, blisters, skin tension, burning sensation, pain and other symptoms occur, drug administration should be stopped and appropriate treatment should be taken;
(4)Blood disorders: agranulocytosis (< 0.1%, early symptoms: fever, sore throat, headache, fatigue, etc.), hemolytic anemia (< 0.1%, early symptoms: fever, hemoglobinuria, anemia, etc.), the possibility of thrombocytopenia ([0.1%, early symptoms: spot-like bleeding, purple spots, etc.), and there have been reports of other cephalosporin antibiotics causing pancytopenia, so close observation, such as regular examination, should be stopped when abnormal occurrence, appropriate treatment should be taken;
(5)Renal dysfunction: due to acute renal insufficiency and other severe renal dysfunction (< Therefore, close observation should be conducted, such as regular examination, etc., if there is an abnormal occurrence, the administration should be stopped and appropriate disposal should be taken;
(6)Colitis: may cause severe colitis with bloody stool, such as pseudomembranous colitis, etc. (< 0.1%). In case of abdominal pain and recurrent diarrhea, the administration should be stopped immediately and appropriate treatment should be taken.
(7) Interstitial pneumonia, PIE syndrome: There are symptoms of interstitial pneumonia with fever, cough, dyspnea, chest X-ray abnormalities, eosinophilia, PIE syndrome (respectively < If the above symptoms occur, the administration 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%, and rare in less than 0.1%.
Allergy: common rash, urticaria, erythema, rare itching, fever, edema;
Blood: Common (0.1 ~ 5%) eosinophilia, rare granulocytopenia;
Liver: Common alanine aminotransferase (ALT/GPT) increased, AST/GOT increased, rarely jaundice;
Kidney: Rarely elevated BUN;
Digestive system: common diarrhea, stomach discomfort, rare nausea, vomiting, abdominal pain, burning sensation in the chest, loss of appetite, abdominal fullness, constipation;
Flora disorders: rare stomatitis, oral neulococcus disease;
Vitamin deficiency: rare vitamin K deficiency (hypoprothrombinemia, bleeding tendency, etc.), vitamin B deficiency (glossitis, stomatitis, loss of appetite, neuritis, etc.);
Other: headache, dizziness.
Pharmacology and toxicology:
Pharmacological action
This product is the third generation of oral cephalosporin, with a wide antibacterial spectrum, and has antibacterial activity against some Gram-positive and negative bacteria, especially against streptococcus (except enterococcus) and pneumococcus in Gram-positive bacteria, gonococcus, Branham's coccus, Coliform bacteria, Klebsiella, Scharella, Proteus, influenzae and other gram-negative bacteria. Its mechanism of action is to prevent the synthesis of bacterial cell walls, and its point of action varies according to the species of bacteria, and it has a high affinity with PBP1 (1a, 1b, 1c) and PBP3 in penicillin-binding proteins (PBP). This product has strong stability to the β-lactamase produced by various bacteria.
Toxicological study
Reproductive toxicity: Oral administration of 100 ~ 1000mg/kg before pregnancy and early pregnancy in SD rats, and oral administration of 320 ~ 3200mg/kg during organ formation, perinatal period and lactation period showed no effect on the fertility of rats, no teratogenic effect, and no abnormality in the growth, development and reproductive ability of newborn rats.
Storage:
Keep out of light, sealed and in a cool, dry place.
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