Smodir-dt treat mild and medium infections (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Cefdinir

Ingredient

Composition information	Content
Cefdinir	300mg

Uses

Indications

Smodir - DT is indicated in the following cases:

Treatment of mild and medium infections caused by sensitive bacteria in the following cases:

Community pneumonia.

Exacations in chronic bronchitis.

Sinusitis above.

Sore throat, tonsillitis.

Skin infections and soft tissue.

Pharmacy

cefdinir is an antibiotic with cephem nucleus, vinyl group in 3rd place and group 2 - Aminothiazolyl HDRYIMINO in the 7th position of 7 - AminoCephalosporanic Acid.

antibacterial spectrum

Based on antibacterial spectrum, CEFDinir of the 3rd generation.

CEFDinir is highly sustainable by the attack of β - lactamase caused by negative gram and gram -positive bacteria, but can be hydrolyzed by β - lactam through plasmid intermediaries. Like other 3rd generation cephalosporins such as (cefpodoxim prixetil, ceftibuten), cefdinir has wide antibacterial shows for aerobic Gram -negative bacteria, compared to the 1st generation Cephalosporin and 2nd generation but not active on most of the Enterobacter and Pseudomonas Aeruginosa.

On In vitro, Cefdinir has strong activity on Staphylococci and Streptococci than other 3rd generation cephalosporin such as (Cefpodoxim Proxetil, Ceftibuten). However, Cefdinir is not active on Enterrococci (Enterrococci Faecalis) and anti -methicillin streptococci streptococci.

Sensitivity test on in vitro: Staphylococci strains of penicillinase resistance (staphylococci resistant methicillin) also have resistance to cefdinir.

pharmacokinetic

CEFDINIR pharmacokinetics are studied on adults and children from 6 months to 12 months of age. There is no evidence of gender or race related to pharmacokinetics of the drug. In adults, with renal function impairment shows the pharmacokinetics of the drug related to changes in kidney function.

Cefdinir's

pharmacokinetics must not be studied in people with liver failure.

absorption

After taking Cefdinir, the peak plasma concentration is reached 2-4 hours after drinking. The bioavailability of Cefdinir for adults is 120%. When taking Cefdinir, bioavailability is estimated at 21% of the single dose of 300mg and 16% of the dose of 600mg. Estimated absorption of available is 25% after drinking.

In adults, these people are given 300mg or 600mg, the peak concentration in plasma reaches the dose of 1.6 or 2.87UG/ml.

Research results in adults aged 19 - 91 -dose 300mg are indicated that the peak concentration in plasma can be up to 44% and the area under the curve (AUC) is 86% higher.

For patients who are children from 6 months - 12 years old, they receive a single dose of 7mg/kg body weight. After taking Cefdinir, the peak concentration of plasma is achieved after 2.2 hours and the average is 2.3nug/ml. Single dose 14mg/kg body weight, the peak concentration of the average plasma is 3.86 Ug/ml after 1.8 hours.

During hunger, at high -fat meals, reducing the peak concentration in plasma and the area under the AUC curve of Cefdinir corresponding to 10% - 16%.

There is no evidence of cefdinir accumulated in plasma when using multiple doses. For people with normal kidney function, cefdinir 1-2 times/day.

Distribution

The average distribution of CEFDinir is about 0.35l/kg for adults and 0.67L/kg for children from 6 months - 12 years old. Cefdinir enters gastric juice, lymph nodes, epithelium, bronchial, mucosa with a rate of 15% - 48%.

In adults, when tonsillectomy after taking 300mg or 600mg Cefdinir, the average concentration of the drug is 0.25 or 0.36µg/g after drinking 4 hours. When sinus sinus surgery, the single -dose sinus surgery is 300mg or 600mg, less than 0.12 or 0.21µg/g of the corresponding dose. In adults, when undergoing bronchoscopy, 300mg or 600mg, the average concentration in the bronchial mucosa after 4 hours is 0.78 or 1.14µg/ml and the average at the epithelium is 0.29 or 0.49µg/ml.

In patients with acute otitis media due to bacteria when taking single dose 7 or 14mg/kg body weight, the average concentration of the drug after 3 hours is 0.21 or 0.72µg/ml.

CEFDINIR's maximum average concentration in oral solution after 4-5 hours with a dose of 300mg - 600mg is 0.65 or 1.1µg/ml.

cefdinir has no evidence of distribution into cerebrospinal fluid after drinking.

cefdinir does not eliminate breast milk at a dose of 600mg.

Cefdinir has about 60-70% of oral doses associated with plasma proteins in both adults and children, this cohesion does not depend on the concentration of the drug.

Elimination

Cefdinir metabolism is negligible and the drug is eliminated through the urinary tract mainly through the kidney with the sale time of 1.7 to 1.8 hours. Oral distribution is about 300mg or 600mg at about 11.6 or 15.5ml/min and 18.4 or 11.6 % of this dose.

In people with kidney failure, the clearance of Cefdinir decline. In patients with 30-60ml/minute clearance, the peak concentration of plasma and the semi -waste time of the drug increases by approximately 2 times and the area under the curve (AUC) increases to approximately 3 times. In patients with less than 30ml/minute clearance, the peak concentration in plasma increases nearly 2 times but the sale time and the area under the AUC curve increased by nearly 5 times or 6 times.

Cefdinir is absorbed in 4 hours of approximately 63% and the sale time for patients with renal impairment from 3.2 to 16 hours.

Before taking Smodir-dt treat mild and medium infections (1 blister x 10 tablets)

How to use

Take oral use.

Dissolve the pill with a glass of water.

Not used with meals.

Dosage

Adults and children over 13 years old

Take the dose of 300mg 12 hours/time used for 5 - 10 days or 600mg x 1 time/day for 10 days.

In the case of embryonic or skin infections

Take the dose of 300mg x 2 times/day for 10 days.

Patients with renal failure with creatinine

Take the dose of 300mg x1 times/day.

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?

Because there is no specific treatment, it is mainly symptomatic treatment. When symptoms of overdose, stop immediately and handle as follows: Gastric lavage, anti -convulsions may be used if clinical indications. Because the drug is not eliminated by the feces, no dialysis or peritoneal filter.

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. Note that it should not be used double the prescribed dose.

Side Effects

When using Smodir - DT, you may experience unwanted effects (ADR).

The unwanted effect of cefdinir is similar to other oral cephalosporins. Cefdinir is generally tolerated well. Diarrhea is the most unwanted effect that has been reported in adults and adolescents 16% and 8% in children using normal doses. Serious cases patients must stop taking the drug.

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

Smodir - DT contraindicated in the following cases:

Not for patients allergic to any ingredients of the drug or allergies to antibiotics of cephalosporin groups.

Precautions when used

Warning the risk of drug resistance, on patients with diarrhea related to Clostridium difficile, patients with renal impairment.

Be cautious about using drugs in patients allergic to cephalosporin, penicillin.

may need to reduce the dose for patients with renal failure. Must monitor kidney and blood function during treatment, especially when taking the drug for a long time with high doses

In the drug contains excipients with sodium Lauryl Sulfate: Use carefully with people with sensitive skin because it can cause local reactions such as stinging or burning sensation.

The ability to drive and operate machinery

The drug does not affect the ability to drive and operate machinery.

Pregnancy

The safety of drugs in pregnant women has not been determined. Therefore, it is necessary to be very careful when taking drugs in pregnant women or suspected pregnancy, once considering the benefits of treatment higher than possible risks.

Breastfeeding period

non -excreted drugs with a dose of 600mg oral. However, it must be very cautious when using medicine for breastfeeding women.

Drug interaction

Probenecid reduces the excretion of cefdinir through the renal tubules, thus increasing the concentration of cefdinir.

Used in combination with antacids reduces CEFDINIR absorption rate.

During treatment with CEFDinir, if you need to use iron supplements, you should use CEFDINIR before or after using iron supplements at least 2 hours.

affect subclinical

There may be a false positive reaction when a ketone test in urine with nitroprussid, but no this phenomenon occurs when tried with nitroferricyanid. Using Cefdinir can cause false positive results when testing in the urine with clinitiest, base solution or fehling solution. When using Cefdinir, glucose should be tested by enzyme reaction (such as Clinistix or TES - Tape). Cephalosporin antibiotics are known to sometimes cause positive results with direct tests.

Storage

In a dry place, temperatures below 30 ° C, avoid light.

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