Ceftenmax 200mg USP medicine for respiratory infections (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Ceftibuten
Ingredient Tonsillitis, pharyngitis, otitis media, sinusitis, acute bronchitis, chronic bronchitis

Ingredient

Composition information	Content
Ceftibuten	200mg

Uses

indications

Ceftenmax drug is indicated for treatment of mild to medium infections, caused by sensitive bacteria in the following cases:

Middle otitis media: Acute otitis media caused by H. Influenzae (including beta-lactamase production strains), M.Catarrhalis (including beta-lactamase production strains), and S.Pyogenes (Beta-Hemolytic Streptococci group).

tonsillitis and sore throat caused by s.pyogenes (beta-hemolytic streptococci group A).

Exacection of chronic bronchitis caused by streptococcus pneumoniae (only penicillin sensitive strains), Haemophilus influenzae (including beta-lactamase production strains), and Moraxella Catarrhalis (including beta-lactamase production strains).

Pharmacology

The main substance is Ceftibuten. CEFTIBUTEN is the third -generation cephalosporin antibiotic, active on many types of gram -positive and gram -negative bacteria.The antibacterial mechanism of CEFTIBUTEN is a bactericidal by the mechanism associated with the essential protein of the cell into bacteria, leading to the inhibition of biosynthesis into bacterial cell walls.

Antibacterial spectrum: Ceftibuten also shows effects on many bacteria strains on vitro and clinically.

Aerobic grams: Streptococcus pneumoniae (only penicillin sensitive strains), Streptococcus pyogenes.

Aerobic Gram: Haemophilus Influenza (including beta-lactamase production strain), Moraxella Catatrhalis (including beta -lactamase production strain).

Cevtibuten is sustainable for most beta-lactamase, but is not sustainable with the presence of cephasporinase through intermediaries in bacteria such as bacteroides, citrobacter, enteracter, morganella, and seratia.

The bacterial resistance mechanism: Like other beta-lactam, Ceftibuten should not be used for resistance strains with beta-lactam due to the overall mechanism such as reducing permeability or changing point of penicillin bonding protein (PBP) such as S. PEMNUMONIAE resistant penicillin.

Anti -drug strains:

On In vitro, Cevtibuten has no effect on inhibiting bacterial strains such as Acinobacter, Bordetella, Campylobacter, Entobacter, Enterococcus, Flavobacterium, Hafnia, Listeria, Pseudomonas, Staphylococcus, and Streptococcus (except for Pneumonia and Pneumonia and Pneumonia Pyogenes). The drug shows very little effect on most anaerobic bacteria, including most bacteroides.

Pharmacokinetics

absorption

CEFTIBUTEN is quickly absorbed after oral, oral bioavailability reaches about 75-90%.

In adults, Ceftibuten dose 400 mg in the form of hard capsules of biochemistry is equivalent to oral fluid.

Food reduces the speed and absorption level of CEFTIBUTEN, but this impact mainly affects the bioavailability of Cevtibuten when used in the form of more fluid, less influential when used in the form of capsules.

After taking a dose of 400 mg/time/day CEFTIButen capsules for 7 days, the average peak concentration of 17.9 mcg/ml on the 7th day.

Distribution

After taking Ceftibuten distributed into the burning place, pulmonary fluid, nasal secretion, saliva, middle ear secretion, bronchial secretion, tonsils. It is unclear whether the drug through the placenta or is distributed to the milk. About 65% of drugs are linked to plasma proteins.

Elimination

CEFTIBUTEN is present in plasma and urine mainly cis -cebuten form, about 10% of the dose is converted into Trans -cebuten form on In Vivo. Division of transmission is lower, only about 12% compared to CIS isomers.

CIS-and trans-CEFTIBUTEN isomers are excreted mainly on urine. About 56% are eliminated in urine and 39% excreted in stool for 24 hours.

In adults with normal kidney function, the sale time of ceftibuten is about 2 - 2.6 hours.

In children from 6 months to 16 years old, the sale time of Cevtibuten is about 1.9 - 2.5 hours.

In patients with renal impairment, half -life of plasma averages 7.1 - 22.3 hours depends on the clearine clearance.

Before taking Ceftenmax 200mg USP medicine for respiratory infections (2 blisters x 10 tablets)

How to use

ceftenmax medicine for oral oral tablets, can be the same or not with meals.

Dosage and medication time for each specific case as directed by the doctor.

Dosage

Adults:

Acute otitis media: Oral dose 400 mg 1 time/day for 10 days.

Sore throat and tonsillitis: Oral dose 400 mg x 1 time/day for 10 days.

Exacentive batch of chronic bronchitis, oral dose 400 mg x 1 time/day for 10 days.

Children:

Acute otitis media: Children from 6 months to 11 years of age use 9 mg/kg x 1 time/day for 10 days.

Children ≥ 12 years of age 400 mg x 1 time/day for 10 days.

Middle ear infections: 7 -month -old children to 12 years of age 9 mg/kg x 1 time/day for 10 days, maximum 400 mg.

Sore throat and tonsillitis: Children 6 months old to 11 years old: 9 mg/kg x 1 time/day for 10 days.

Children ≥ 12 years: 400 mg x 1 time/day for 10 days.

Exacentive batch of chronic bronchitis, children ≥ 12 years: 400mg x 1 time/day for 10 days.

Patients with liver failure: No dose adjustment.

Patients with renal failure:

Creatinine clearance (ml/minute)

dose

9 mg/kg or 400 mg x 1 time/24 hours

30-49

4.5 mg/kg or 400 mg x 1 time/24 hours

5-29

2.25 mg/kg or 400 mg x 1 time/24 hours

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? CEFTIBUTEN can be removed from the dialysis system (65% of plasma concentrations).

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using Ceftenmax, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive system: Nausea, diarrhea, indigestion, vomiting, abdominal pain.

Central nervous system: headache, dizziness.

Uncommon, 1/1000

Digestive: Anorexia, constipation, dry mouth, indigestion, belching, flatulence.

Respiratory: Difficulty breathing, stuffy nose. Body: Fatigue, itching, rash.

Central nerve: drowsiness, paresthesia.

Vaginitis, candidiasis infection, difficulty urinating, sexual deviation.

Rare

Allergic reactions, anaphylaxis, Steven-Johnson syndrome, renal and liver dysfunction including cholecystitis, aids anemia, hemolytic anemia, hemorrhage, test for false impotent, leukopenia, all bloody reduction, loss of granulocytes, symptoms of fake colitis.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

CEFTENMAX drug is contraindicated in the following cases:

allergies to cephalosporin antibiotics, sensitive to penicillin or any ingredients of the drug.

Be cautious when using

as well as other broad -spectrum antibiotics, CEFTIBUTEN treatment can cause anti -drug 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.

diarrhea and colitis associated with Clostridium dificile, which can appear and develop excessively, are not sensitive bacteria (such as Entobacter, Pseudomonas, Enterococci, Candida) with prolonged use of antibiotics. Should be careful to monitor patients and appropriate treatment if superinfection.

Sensitive reaction:

Allergic reactions: may appear such as urticaria, itching, rash, fever and chills, white blood cells, pain or arthritis, edema, angioedema, hypertension, shock, steven-johnson syndrome, poisoned skin necrosis, flaking dermatitis, anaphylaxis. If the allergic reaction appears, stop using cevtibuten and use appropriate treatment (such as epinephrin, corticosteroids, maintain fully ventilated and oxygen).

Cross allergy: Some cross-allergic reactions occur between cephalosporin and other beta-lactam, including penicillin and cephamycin. Before starting treatment, careful consideration of previous allergic reactions with any cephalosporin or penicillin.

The effect of drugs on some tests: There is no record of interactions between chemical tests in the laboratory and ceftibuten. There have been reports on false positive reactions of Coombs tests during treatment with other cephalosporins. Therefore, it is necessary to determine the positive reaction of the Coombs test may be caused by the drug.

For people with renal failure, the development of the pathogens is not sensitive.

The ability to drive and operate machinery

In a few cases of drugs that can cause headaches and dizziness, so it should be noted when driving and operating machinery.

Pregnancy

ceftibuten does not cause teratogenic pregnancy at the oral dose of up to 400 mg/kg/day (about 8.6 times compared to the dose of human use, calculated on mg/m2/day). CEFTIBUTEN does not cause teratogenic rabbits at the dose of oral 40 mg/kg/day (about 1.5 times compared to the dosage used on humans, calculated on mg/m2/day and has shown no evidence of harmful effects on the fetus).

However, strict studies on pregnant women are incomplete. Because studies on animals are not always predicted to be responded to humans, they only use drugs when benefits are greater than the risk. Risk of pregnancy according to FDA: level b.

The period of breastfeeding

is still unclear whether ceftibuten will be distributed into breast milk or not. So be cautious when using medicine for nursing women.

Drug interaction

Theophyllin: There is no evidence of learning interaction with theophyllin intravenously, affecting the same use with theophylllin oral form.

Antacid (Antacid): The learning interaction is still unknown.

Antihistamine H2 (Ranitidine): Increases the concentration of ceftibuten.

Probenecid: Probenecid may increase the concentration of ceftibuten.

Birth control pills: Ceftibuten can reduce the effectiveness of birth control pills.

Storage

In a dry place, temperatures below 300C, avoid light.

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