Date of approval.
Date of revision.
Cefdinir Dispersible Tablets Instructions
Please read the instructions carefully and use under the guidance of a physician
Drug Name]
Generic name: Cefdinir Dispersible Tablets
English name: Cefdinir Dispersible Tablets
Hanyu Pinyin: Toubaodini Fensanpian
Ingredients
The main ingredient of this product is cefdinir.
Chemical name: (6R,7R)-7-[[(2-amino-4-thiazolyl)-(oxime)acetyl]amino]-3-vinyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.
Chemical structure formula.
Molecular formula: C14H13N5O5S2
Molecular weight: 395.42
【Properties】.
This product is slightly yellow to yellow tablets.
Indications】
Cefdinir-sensitive Staphylococcus spp, Streptococcus spp, Streptococcus pneumoniae, Streptococcus digestiveis, Propionibacterium, Neisseria gonorrhoeae, Catamorax, Escherichia coli, Klebsiella spp, Proteus mirabilis, Proteus mirabilis, Haemophilus influenzae and other strains caused by the following infections.
Pharyngitis, tonsillitis, acute bronchitis, pneumonia.
Otitis media, sinusitis.
pyelonephritis, cystitis, gonococcal urethritis.
adnexitis, intrauterine infection, vestibular adenitis.
mastitis, perianal abscesses, secondary infections of traumatic or surgical wounds.
Folliculitis, boils, boils, carbuncles, infectious impetigo, dermatitis, cellulitis, lymphangitis, nail fungus, subcutaneous abscesses, powdery infection, chronic sepsis.
Blepharitis, mydriasis, blepharitis
Specification
0.1g
Dosage and Administration
Disperse with water and take orally or swallow directly. Note: Dispersion should be done with room temperature water.
The regular dose for adults is 1 tablet (100mg potency) once, 3 times a day.
The dose can be increased or decreased according to age and symptoms, or according to medical advice.
Adverse reactions
Among 13,715 patients treated with this product, 354 cases (2.58%) of adverse reactions (including abnormal laboratory data) have been reported. The major adverse reactions were gastrointestinal symptoms (110 cases, 0.80%), such as diarrhea or abdominal pain, and skin symptoms (31 cases, 0.23%), such as rash or pruritus. The major laboratory data abnormalities included elevated glutathione (126 cases, 0.92%) and glutathione (89 cases, 0.65%); and eosinophilia (41 cases, 0.30%).
1. Clinical adverse reactions
0.1%≤ incidence<5% incidence<0.1% incidence not available
Allergy rash urticaria, pruritus, fever, edema erythema Hematology eosinophilia granulocytopenia Renal Elevated blood urea nitrogen Gastrointestinal diarrhea, abdominal pain, stomach discomfort nausea, vomiting, heartburn, loss of appetite, constipation Microbiology Stomatitis candidiasis vitamin deficiency vitamin K deficiency symptoms (hypoprothrombinemia, bleeding tendency), B complex vitamin deficiency symptoms (tongue inflammation, stomatitis, appetite (deficiency, neuritis) Others Dizziness, headache, chest pressure numbness Note: If the above symptoms occur, the drug should be discontinued immediately and treated appropriately. 2. Other adverse reactions
Dermatology: Shi-Jo syndrome (<0.1%) or toxic epidermal necrolysis loosening (<0.1%) may occur. Patients should be closely monitored. If fever, headache, arthralgia, erythema/blistering on skin or mucous membranes, skin feeling tight/burning/painful, the drug should be discontinued immediately and treated appropriately.
Allergic reactions: Allergic reactions such as dyspnea, erythema, angioedema, urticaria may occur with an incidence of <0.1%. Patients should be closely observed and if abnormalities occur, the drug should be discontinued immediately and treated appropriately
Shock: Shock may occur, incidence<0.1%. Patients should be closely observed and if symptoms such as sensory discomfort, discomfort in the mouth, wheezing, dizziness, dysgeusia, tinnitus or sweating occur, the drug should be discontinued immediately and treated appropriately.
Hematology: Complete hematocrit (<0.1%), granulocyte deficiency (<0.1%, initial symptoms of fever, sore throat, headache, discomfort), thrombocytopenia (<0.1%, initial symptoms of petechiae, purpura) or hemolytic anemia (<0.1%, initial symptoms of fever, hemoglobinuria, anemia symptoms) may occur. Patients should be closely observed and if abnormalities occur, the drug should be discontinued immediately and treated appropriately.
Colitis: severe colitis (<0.1%) may occur, such as pseudomembranous colitis confirmed by blood and stool. Patients should be closely monitored and if symptoms such as abdominal pain or frequent diarrhea occur, the drug should be discontinued immediately and treated appropriately.
Interstitial pneumonia or PIE syndrome: Interstitial pneumonia or PIE syndrome confirmed by fever, cough, dyspnea, abnormal chest radiography or eosinophilia may occur (<0.1%). If such symptoms occur, the drug should be discontinued immediately and treated appropriately, such as with adrenocorticosteroid drugs.
Renal disease: Severe renal disease (<0.1%), such as acute renal failure, may occur. Patients should be closely observed and if abnormalities occur, the drug should be discontinued immediately and treated appropriately.
Fulminant hepatitis, abnormal liver function or jaundice: Serious hepatitis may occur (<0.1%), such as fulminant hepatitis with markedly elevated glutamic aminotransferase, glutamic oxalacetic aminotransferase or alkaline phosphatase, abnormal liver function (<0.1%) or jaundice (<0.1%). Patients should be closely observed and if abnormalities occur, the drug should be discontinued immediately and treated appropriately.
[Contraindications].
It is contraindicated for those who have a history of shock to this product. Use with caution in patients with a history of hypersensitivity to penicillin or cephalosporins.
Precautions】
By convention, the course of this product should be limited to the shortest cycle required to treat the patient after the susceptibility of the microorganism to this product has been determined to prevent the development of drug-resistant bacteria.
It is recommended to avoid co-administration with iron preparations. If combination cannot be avoided, iron should be administered after 3 hours of administration.
Because of the possibility of allergic reactions such as shock, a detailed allergy history should be obtained.
The following patients should be used with caution
Those with a history of allergy to penicillin antibiotics.
Those who have a body type prone to bronchial asthma, rash, urticaria and other allergic symptoms in themselves or their relatives.
Patients with severe renal dysfunction: Since cefdinir is present in the serum of patients with severe renal dysfunction for a longer period of time, the dose should be reduced and the dosing interval extended according to the severity of renal dysfunction. For patients undergoing hemodialysis, the recommended dose is 100 mg once a day.
Patients with severe underlying disease, those who cannot eat well or take nutrition non-orally, those of advanced age, and those with cachexia (as vitamin K deficiency can occur, close clinical observation is required).
Effect on clinical test values
In addition to the test paper urine glucose test, false positives may occur during urine glucose testing with Benedict’s reagent, Fehling’s reagent and Clinitest test, and should be noted.
A positive direct serum antiglobulin test may occur and should be noted.
Other precautions
Red feces may appear when combined with iron-added products (such as milk powder or enteral nutrition).
Red urine may appear.
Pregnant women and nursing mothers
The safety of the drug during pregnancy has not been established. For pregnant women or women suspected of having pregnancy, the advantages and disadvantages of using the drug should be weighed and should only be used if the advantages outweigh the disadvantages.
For women who are breastfeeding, the advantages and disadvantages should be weighed and used only when the advantages outweigh the disadvantages.
For children]
For the use in children, please refer to the instruction of Cefdinir Granules.
The safety of medication for premature infants and newborns with low body weight has not been established.
Use in elderly patients
Special attention should be paid to the following aspects when using this product in elderly patients, and the dose and dosing interval should be adjusted according to clinical observation of the patients.
Elderly patients may be prone to adverse reactions due to decreased physical function.
Due to vitamin K deficiency, elderly patients may have a tendency to bleed.
Drug Interactions]
Caution is required when combining this product with the following drugs.
Drug signs, symptoms and therapeutic mechanism and risk factors Iron preparation is recommended to be avoided in combination with cefdinir because it may cause a decrease in absorption of cefdinir by approximately 10%. If combination cannot be avoided, the dosing interval between the two should be greater than 3 hours. This product may bind to iron ions in the intestine, forming a complex that is difficult to absorb. The effect of warfarin potassium may be enhanced by warfarin potassium, but no interaction between the two has been reported. Antacids (containing aluminum or magnesium) should not be administered until 2 hours after administration of this product because their effects may be diminished by reduced absorption of cefdinir. The mechanism is not clear.
[Drug overdose].
The use of cefdinir in overdose has not been studied. In acute, toxic, erosive ulcer studies, a single oral dose of 5600 mg/kg did not produce adverse effects. In contrast, other β-lactam antagonists, the following adverse reactions can be demonstrated with overdose: nausea, vomiting, diarrhea and convulsions. Serum dialysis can remove cefdinir from the body. For patients with toxic reactions caused by overdose, serum dialysis is effective, especially for patients with renal insufficiency.
Pharmacology and Toxicology
Pharmacological effects
Antibacterial effect
It has a broad antibacterial spectrum against Gram-positive and Gram-negative bacteria, especially against Staphylococcus spp. and Streptococcus spp. among Gram-positive bacteria, and has stronger antibacterial activity than previous oral cephalosporins in a bactericidal manner.
It is stable to β-lactamase produced by many kinds of bacteria and also has excellent antibacterial activity against β-lactamase producing bacteria.
Mechanism of action
The mechanism of action is to block the synthesis of bacterial cell wall, with strong affinity for penicillin-binding protein (PBP) 1(1a,1bs), 2 and 3, but the active site varies for different bacteria.
Non-clinical toxicological studies
Acute and chronic toxicity studies with cefdinir in test animals such as rats and dogs have shown that cefdinir is well tolerated. Cefdinir has not been found to be teratogenic or mutagenic.
Pharmacokinetics
1. Blood concentration
In 6 healthy adults, oral doses of 50, 100 and 200 mg (potency) of cefdinir in a single dose on an empty stomach reached peak concentrations of 0.64, 1.11 and 1.74 μg/mL after about 4 hours, respectively, with a plasma half-life of 1.6 to 1.8 hours.
Plasma drug concentration profiles of male healthy adults after a single oral dose of cefdinir
Six healthy adults who received 100 mg (potency) of cefdinir orally in one dose on an empty stomach and after eating could reach the peak blood concentration of 1.25 and 0.79 μg/ml after about 4 hours, respectively, and its absorption was slightly reduced when administered after eating.
In patients with impaired renal function, the plasma half-life of 100mg (potency) cefdinir was prolonged with the decrease of renal function.
Creatinine clearance
(mL/min) No. Half-life T1/2
(hr) Area under the curve AUC
(μg-hr/ml) ≥10031.662.7651～7012.4110.7431～5032.927.48≤3024.0616.946The plasma half-life of this product was prolonged nearly 11 times after a single oral dose of 100 mg (potency) after meal in hemodialysis patients. A single oral dose of 100 mg (potency) of cefdinir after a meal in the same patients hemodialysed for 4 hours at peak blood levels. The shortened half-life in those undergoing hemodialysis was approximately 1/6 of that in those not undergoing hemodialysis, with a clearance rate of 61%.
Peak concentration Cmax (μg/mL) 2.362.03 time to peak T max (hr) 9.00-half-life T1/2 (hr) 16.952.76 area under the curve AUC 0→∞ (μg-hr/mL) 69.0530.18 clearance (%) -612. distribution
It was distributed in patients’ sputum, tonsils, mucosal tissue of maxillary sinus, middle ear secretion, skin tissue and oral tissue, and it is not known whether it has distribution in breast milk.
3. Metabolism
No metabolites with antibacterial activity were found in human blood, urine and feces.
4. Excretion
Cefdinir is mainly excreted through the kidneys
In healthy adults (fasting), the urinary excretion rate (0-24 hours) is about 26-33% when 50, 100 and 200 mg (potency) are taken orally, and the peak urinary concentrations are 44.3, 81.5 and 132 μg/ml in 4-6 hours, respectively.
In patients with impaired renal function, a single oral dose of 100mg (potency) of cefdinir is excreted slowly and in proportion to the degree of renal impairment.
Storage】Store under shade and seal.
Package】Polyamide/aluminum/polyvinyl chloride cold pressed solid pharmaceutical compound hard tablets with pharmaceutical packaging with aluminum foil blister package, 3 tablets/plate×1 plate/box, 5 tablets/plate×1 plate/box, 6 tablets/plate×1 plate/box, 6 tablets/plate×2 plate/box.
【Validity】18 months
【Execution standard
【Approval Number】State Drug Certification H20100147
【Manufacturing enterprise
Company Name: Sinopharm Group Zhijun (Shenzhen) Pharmaceutical Co.
Address: No. 16, Lanqing 1st Road, Guanlan Hi-Tech Park, Longhua New District, Shenzhen
Zip code: 518110
Telephone number: 400-880-2335
Fax number: (0755) 82263799 (0755) 82429265
Service mailbox: [email protected]
Website: www.szzhijun.com