Cttoren 400 USP medicine for infection treatment (1 blister x 10 tablets)

cefditoren is sustainable with many types of beta-lactamase (including penicillinase and some cephalosporins) born by Gram-negative and gram-positive bacteria. Similar to the current 3rd generation cephalosporin (Cefdinir, Cefixim, Ceftibuten, Cefpodoxim) Cefditoren has a wider Gram -negative bacterium than the first and second -generation cephalosporin. Moreover, Cefditoren acts better with Gram -positive bacteria than other third -generation cephalosporins because of the cefditoren structure with methylthiazolyl group, while other third -generation cephalosporins are not available.

The mechanism of action of Cefditoren Pivoxil is similar to antibiotics of the 3rd generation cephalosporin group. Cefditoren Pivoxil is a drug (Prodrug) with very little antibacterial effects. Cefditoren Pivoxil is absorbed by the gastrointestinal tract and is hydrolyzed by esters to release the cefditoren that is active and pivalate into the bloodstream. Cefditoren has the effect of inhibiting the synthesis of bacterial cell walls by attaching one or more penicillin -mounted proteins (PBPS) to inhibit the final steps to transfer amino acids between peptidoglycan peptide chains in bacterial cell walls, thus inhibiting bacterial biosynthesis into bacterial cells. The bacteria are solved due to the activity of the emzymes Autolysin and Murein Hydrolase.

Dynamic pharmacokinetics

absorption: Cefditoren Pivoxil is absorbed by the gastrointestinal tract and hydrolyzed by esters into cefditoren that are active and pivalate into the bloodstream. When taken at hungry at the dose of 200 mg of Cefditoren, the highest concentration achieved in plasma is about 1.8 micrograms/ml after taking 1.5 - 3 hours. Born when drinking at hunger is about 14% and increases if taken with a fatty meal.

Distribution: The distribution volume is 9.3 ± 1.6 liters. The ratio attached to the plasma protein of cefditoren is 88%.

Metabolism and excretion: Cefditoren is not much metabolized and excreted in the urine in the form of unchanged in the glomerular filter and excreted in the renal tubules. The drug can be eliminated by dialysis outside the kidney. The disposal time of the drug is about 1.6 hours and lasts longer in patients with impaired renal function. Pivalat is formed by the hydrolysis of Cefditoren Pivoxil will combine with blood cartinin to form pigalolcartinin and excreted in urine.

Special subjects:

Elderly:

The effect of age -on -age age of Cefditoren has been evaluated on 48 men and women aged 25 to 75 years old to take 400 mg of Cefditoren Pivoxil (2 times a day) for 7 days. Physiological changes related to age show that there is an increase in cefditoren levels in plasma, namely CMAX higher than 26% and AUC higher than 33% in subjects aged 65 and over compared to younger subjects. The concentration of cefditoren clearance from plasma is lower than on 65 years of age, with a half-selling time of 16-26% longer than younger subjects.

CEFDITOREN clearance in the kidneys in patients aged 65 and above is 20-24% lower than young people.

No dose adjustment in elderly patients with normal renal function.

Sex:

The effect of gender on the pharmacokinetics of Cefditoren has been assessed in 24 men and 24 women using 400 mg of Cefditoren Pivoxil (2 times a day) for 7 days. Cefditoren concentration in women's plasma is higher than men, as evidenced by CMAX 14% higher and AUC is 16% higher. Cefditoren clearance in women in women is 13% lower than men.

However, there is no need to adjust the dose by gender.

Patients with renal failure:

Cefditoren pharmacokinetics are studied on 24 adults with other renal function level after using Cefditoren Pivoxil 400 mg (2 times a day) for 7 days.

The reduction of creatinine clearance (CLCR) is associated with an increase in non -linked cefditoren ratio in plasma and reducing the cefditoren elimination rate, leading to higher CEFDitoren plasma levels in patients with renal impairment.

No dose to be adjusted for patients with mild renal impairment (CLCR: 50 - 80 ml/min/1.73m2). Do not use more than 200 mg (2 times a day) for patients with average renal failure (Clcr: 30 - 49 ml/min/1.73m2) and 200 mg (once a day) for patients with severe renal impairment (CLCR:

Hemolysis:

CEFDITOREN pharmacokinetics research in 6 adults with end -stage renal disease (ESRD) is being given a hemorrhage with a single dose of 400 mg of Cefditoren Pivoxil is very different. The average selling time is 4.7 hours and ranges from 1.5 to 15 hours. Hematoparoology (4 hours) removes about 30% Cefditoren and does not change the final half -life. The appropriate dose for ESRD patients has not been determined.

Patients with liver failure:

CEFDITOREN pharmacokinetics research in 6 adults with mild liver function impairment (Child -Pugh A) and 6 cases of medium liver failure (Child - PUGH B), after using CEFDITOREN PIVOXIL 400 mg (2 times a day) for 7 days, the average CMAX and AUC value is a little higher than the normal liver function. No dose adjustment for patients with mild or medium liver failure (Child - PUGH A or B). The pharmacokinetics of Cefditoren on people with severe liver failure (Child - PUGH C) have not been studied.

Acute renal failure, allergies, joint pain, bronchial asthma, hypocalcemia, increased blood clotting time, hyperlem of blood glucose, interstitial pneumonia, leukemia, hyperkalemia, hypoglyc sodium, fungal infection, Stevens - Johnson syndrome, symptoms of fake colitis, platelet hemorrhage, toxic skin necrosis.

Instructions on how to handle ADR:

If hypersensitivity occurs, the drug should be stopped, in case of severe hypersensitivity, supportive treatment (using epinephrine, oxygen, antihistamine, corticosteroids).

Reducing the effect of prothrombin may occur with risky objects (kidney failure, liver failure, poor nutrition, prolonged antibiotic use, long -term anticoagulant treatment), need to monitor blood clotting time and supplement vitamin K.

If there is a convulsions, stop cefditor and take anti -convulsions.

Diarrhea caused by C. different and fake colitis, if mild just stop the drug. In medium and severe cases, electrolytes, protein supplements and metronidazol treatment.

Notify the doctor with unwanted effects when using the drug.

Be cautious when used

as well as other broad antibiotics, long -term treatment with cefditoren can cause resistance bacteria. Need to monitor patients closely, if there is a phenomenon of re -infection during treatment, it is necessary to change to other antibiotics appropriately.

Be careful when used for patients with a history of colitis due to Cefditoren can cause an imbalance in the microbiological system in the colon, making Clostridium difficile excessive.

There are cross-reactions between cephalosporins and other beta-lactam antibiotics. Therefore, before starting treatment with cefditoren, a thorough investigation of the patient's allergic history with cephalosporin, penicillin or other drugs.

People at risk of allergies and anaphylactic reactions.

When using Cefditoren can give a positive test of COOMB’s test, test ferricyanid is fake, test glucose positive impotent when using clinitest.

Be cautious when used for patients with a history of convulsions, if in the case of kidney failure, the risk of convulsions increases.

Use cautiously for patients with liver failure, kidney failure, adjusting dose if patients with severe renal failure.

For patients with carnitin deficiency, do not use prolonged cefditoren due to cefditoren causing carnitin elimination.

cefditoren can extend prothrombin time, so be cautious when used in patients with bleeding disorders.

Be cautious when used for children under 12 years old.

Because the product contains excipients with castor oil, it is important to note that unwanted effects have been reported to castor oil such as nausea, vomiting, abdominal pain and diarrhea. Products containing castor oil should not be used in cases of obstruction or stenosis, loss of force (normal exercise in the intestinal muscle), appendicitis, colitis, unexplained abdominal pain and serious dehydration.

Products containing Quinolein Yellow Lake color excipients can cause some allergic reactions in some patients. The doctor should be consulted before use if the history has an allergic reaction to the color of Quinolein Yellow Lake.

Use drugs for women during pregnancy and nursing mothers

using drugs for pregnant women:

Animal research does not see adverse reactions to the fetus. Cephalosporins pass the placenta and are considered safe for the fetus. Risk of pregnancy according to FDA: level b.

Use medicine for breastfeeding women:

The drug is distributed into breast milk so it is cautious with breastfeeding women.

The effect of the drug on driving and operating machinery

has not been studied on these subjects.

Drug interaction

Increased effects/toxicity: Probenecid increases the level of cefditoren in plasma thus increasing the effect/toxicity of cefditoren.

Reduce effects: Antacids, proton pump inhibitors and H2 receptor antagonists reduce CEFDITOREN absorption, thus reducing the effects of cefditoren.

Interaction with food: Food increases the absorption of cefditoren. Fatty meals can increase the maximum of the drug.

Testing interactions: Can cause direct positive coombs reaction, fake negative test ferricyanid, pseudo -positive test glucose when using clinitest.

contraceptive pills: Cefditoren Pivoxil does not affect the pharmacokinetics of ethinylelestradiol, component estrogen in most oral contraceptives.