Drug Direntab 200-US Treatment of infection (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Cefditoren
Ingredient US Pharma USA Joint Stock Company

Ingredient

Composition information	Content
Cefditoren	200mg

Uses

Indications

Direntab drug indicated in the following cases:

Cefditoren is indicated for cases of gram -negative bacteria infections, sensitive grams, including respiratory infections, skin infections and subcutaneous organization.

Viêm phổi mắc phải cộng đồng do các tác nhân Haemophilus influenzae (gồm cả chủng sinh beta lactamase), Haemophilus parainfluenzae (gồm cả chủng sinh beta lactamase), Moraxella catarrhalis (gồm cả chủng sinh beta lactamase), Streptococcus pneumoniae (chủng nhạy cảm với penicillin).

Đợt cấp của viêm phế quản mạn cũng do các tác nhân Haemophilus influenzae (gồm cả chủng sinh beta lactamase), Haemophilus parainfluenzae (gồm cả chủng sinh beta lactamase), Moraxella catarrhalis (gồm cả chủng sinh beta lactamase), Streptococcus pneumoniae (chủng nhạy cảm với penicillin).

Sore throat and tonsillitis due to streptococcus pyogenes (blood -soluble beta streptococcal) sensitive.

Skin infections and subcutaneous organization caused by Staphylococcus aureus (including Beta Lactamase) and Streptococcus Pyogenes sensitive.

Pharmacokology

Cefditoren Pivoxil is a semi -synthetic antibiotic of the 3rd generation cephalosporin group used by oral treatment in the treatment of acute bacterial infections or acute batches of chronic bronchitis, infected pneumonia in the community caused by sensitive bacteria, including:

Haemophilus influenzae, Haemophilus parainfluenzae, streptococcus pneumoniae sensitive to penicillin, moraxella catatrhalis, sore throat (streptococcus pyogenes), skin infections and non -complication skin organization (staphylococcus aureus aureus pyogenes)

cefditoren is sustainable with many types of beta lactamase (including penicillinase and some cephalosporinase) caused by Gram -negative and gram -positive bacteria.

Similar to the current 3rd generation cephalosporin (Cefdinir, Cefixim, Certibuten, Cefpodoxim) Cefditoren has a wider Gram -negative bacteria 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 methylthiazoleyl group, while other third -generation cephalosporins do not exist. The mechanism of action of Cefditoren Pivoxil is similar to antibiotics of Cephalosporin group 3.

Cefditoren Pivoxil is a drug (Prodrug) with very little antibacterial effects.

Cefditoren Pivoxil is absorbed by the digestive tract and 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), which inhibits the final step of transferring amino acids between peptidic chains of peptidoglycan synthesis in bacterial cell walls, thus inhibiting bacterial biosynthesis. The bacteria are solved due to the activity of the emzymes Autolysin and Murein Hydrolase.

pharmacokinetic

absorption

Cefditoren Pivoxil is absorbed by the gastrointestinal tract and is hydrolyzed by esters into cefditoren that are active and pivalate into the bloodstream. When taken at hungry at the dose of 200 mg Cefditoren, the highest concentration achieved in plasma is about 1.8 micrograms/ml after taken 1.5 - 3 hours.

Birth 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 elimination

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 kidneys.

The sale 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 Special

Elderly

The effect of age -active age of Cefditoren has been assessed over 48 men and women from 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 the objects> 65 years old, with a selling time of 16–26% longer than the younger subjects.

CEFDitor's clearance in the kidneys in patients aged 65 and older is 20–24% lower than young people.

No dose adjustment in elderly patients with normal renal function.

Gender

The effects of gender on the dynamic of Cefditoren have been assessed in 24 men and 24 women using 400 mg of Cefditoren Pivoxil (2 times a day) for 7 days. Cefditoren concentration in the blood of women is higher than that of men, as evidenced by CMAX higher than 14% and AUC is 16% higher. Cefditoren clearance in women in women is 13% lower than men, but do not need to adjust the dose by gender.

Patients with kidney 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 (CLCR) clearance 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 insufficiency.

No dose to adjust 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 medium renal failure (Clcr: 30–49 ml/min/1.73 m2) and 200 mg (once a day) for patients with severe renal impairment (CLCR:

Hematopalyst

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.

Before taking Drug Direntab 200-US Treatment of infection (1 blister x 10 tablets)

How to use

oral drugs. Should take whole tablets with meals to increase the absorption of drugs into the blood.

Dosage

Dosage for adults and children over 12 years: 200 - 400 mg/time, 2 times/day.

Infections Dosage Treatment time Time/day 10 days ]

Mild kidney failure (Clcr 50 - 80 ml/minute): No dose adjustment.

Moderate kidney failure (CLCR 30 - 49 ml/minute): recommend only 200 mg/time, 2 times/day.

Severe renal failure (CLCR

End -stage renal failure: Not determined in accordance.

Dose for patients with liver failure:

Mild and medium liver failure: No dose correction.

Severe liver failure: There is no information about pharmacokinetics of cefditoren in these patients.

Dose for the elderly:

There is no recommendation if the patient has a normal renal function.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? However, like other beta -lactam antibiotics, unwanted effects after overdose include nausea, vomiting, epigastric pain, diarrhea, and convulsions. Hematoparosis can assist in removing cefditoren from the body, especially if the kidney function is damaged (30% decrease in plasma concentrations after 4 hours of blood separation).

If you have any overdose symptoms, stop taking the medication immediately and immediately notify your doctor.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Direntab often has unwanted effects (ADR) such as:

ADR> 10%: diarrhea.

Central nervous system: headache.

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

Instructions on how to handle ADR:

If hypersensitivity occurs, the drug should be stopped, cases of severe hypersensitivity, need to support support (use 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 physician the unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

DIRENTAB is contraindicated in the following cases:

Patients allergic to cefditoren, antibiotics of cephalosporin group, sensitivity to penicillin or any ingredients of the drug.

Precautions when used

as well as other broad antibiotics, long -term treatment with cefditoren can cause resistance bacteria. It is necessary 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, adjust the dose if patients with severe renal impairment. For patients with carnitin deficiency, non -use cefditoren is due to cefditoren causing increased 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 case of obstruction or stenosis, loss of force (normal loss of exercise in the intestinal muscle), appendicitis, colitis, unexplained abdominal pain and serious dehydration.

Products containing colorutoric color dozen, Tartrazin Yellow Lake can cause some allergic reactions in some patients. The doctor's consultation should be consulted before use if the history has an allergic reaction to Sunset Yellow Lake, Tartrazin Yellow Lake.

Using drugs for women during pregnancy and lactation

Pregnant women

Animal research does not see adverse reactions to the fetus. Cephalosporin passes through the placenta and is considered safe for the fetus.

Risk of pregnancy according to FDA: level b.

breastfeeding women

The allocated drug can be entered into breast milk, so use carefully with breastfeeding women.

The effect of the drug on driving and operating machinery

has not been studied on these subjects.

Interactive drug 2>

drug interactions may affect the activity of the drug or cause side effects.

Patients should notify the doctor or pharmacist a list of the drugs and functional foods you are using. Do not use or increase or decrease the dose of the drug without the guidance of a doctor.

Increases toxic effects: Probenecid increases plasma cefditoren levels thus increasing the effect/toxicity of cefditoren.

Reducing drug effects: Antacids, proton pump inhibitors and H2 receptor -resistant drugs reduce Cefditoren absorption, thus reducing the effect of Cefditoren.

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

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

Cefditoren Pivoxil birth control pills do not affect the pharmacokinetics of ethinylelestradiol, the ingredients in most oral contraceptives.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.