Sulcilate Tablet 375mg Atabay treats respiratory infections (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Sultamicillin

Ingredient

Composition information	Content
Sultamicillin	375mg

Uses

indications

Sulcilat Tablet 375mg is indicated in the following cases:

Treatment of the following infections caused by sensitive microorganisms:

Upper respiratory tract infections include: sinusitis , otitis media, and tonsillitis. Indications for patients need therapy with sultamicillin/ampicillin after initial treatment with sulbactam/ampicillin intramuscular/intravenously. Penicillin resistance. While the antibacterial activity of sulbactam is mainly limited to Neisseriaceae bacteria, microbiological studies on anti -drug bacteria have shown that sodium sulbactam has the ability to protect penicillin and cephalosporin not destroyed by anti -drug bacteria, in which sodium sulbactam reproduces the resonance effect on penicillin and cephalosperin. Because sulbactam also binds to some penicillin bonding proteins (PBP), for some sensitive bacteria strains, using Sulbactam-Ampicillin combination will be more effective than using only one beta-lactam.

The bactericidal ingredient of ampicillin, as well as benzyl penicillin, prevents sensitive bacteria in the strong cell division by inhibiting mucopeptide biosynthesis in cell walls.

Sultamicillin has an effective antibacterial effect with many Gram (+) and Gram (-) bacteria, including Staphylococcus aureus and Staphylococcus Epidermidis (both penicillin-resistant strains and some methicillin antacids); Streptococcus Pneumoniae, Streptococcus Faecalis and other strains of Streptococcus strains; Haemophilus Influenzae and Haemophilus parainfluenzae (both seminarians beta-lactamase and not producing beta-lactamase); Moraxella catrhalis; Anaerobic bacteria include bacteroides fragilis and bacteria of the same; Escherichia coli; Klebsiella; Proteus (including two types of Indole+ and Indole-); Entobacter, Morganella Morganii; Citrobacter; Neisseria meningitidis and neisseria gonorrhoeae.

pharmacokinetics

absorption - distribution

In humans, after oral use, sultamicillin is hydrolyzed while absorption forms sulbactam and ampicillin at a ratio of 1: 1 in the circulatory system. The bioavailability of an oral dose is 80% of the dose of sulbactam and ampicillin equivalent to intravenously. Using the drug after eating does not affect the bioavailability of sultamicillin. The highest concentration of ampicillin in serum after using sultamicillin is approximately twice the ampicillin concentration when taken orally. Simultaneous use of probenecid and sultamicillin increases and prolongs the concentration of ampicillin and sulbactam in the blood.

Metabolism

Sultamicillin is hydrolyzed while absorption formed sulbactam and ampicillin.

Elimination

Sell waste time in healthy volunteers using sulbactam and ampicillin is 0.75 hours and 1 hour with 50% - 75% each substance is excreted intact through urine.

Increasing waste time in the elderly and patients with renal function. Probenecid reduces the excretion of both ampicillin and sulbactam in the renal tubules.

Before taking Sulcilate Tablet 375mg Atabay treats respiratory infections (1 blister x 10 tablets)

How to use

Take oral use.

Dosage

Adults

Sultamicillin dose is recommended in adults (including elderly patients) of 375-750 mg, taken twice daily. In both adults and children, treatment usually continues up to 48 hours after the fever and other abnormal signs disappear. Usually, it is necessary to treat for 5-14 days but the treatment time may last if necessary.

In the treatment of unprecedented gonorrhea, sultamicillin can be used for a dose of 2.25 g (6 tablets 375 mg or 3 tablets 750 mg). Should be used simultaneously with 1.0 g probenecid to maintain sulbactam and ampicillin levels in plasma. Cases of gonorrhea with suspected syphilis should check with black background microscopes before using sultamicillin and do serum test monthly for at least four months.

Recommended treatment for at least 10 days for any bacterial infections due to hemoly streptococci (hemolytic streptococci) to prevent acute rheumatoid fever or glomerulonephritis.

Children and children:

Sultamicillin dose for most infections in children weighing less than 30 kg is 25-50 mg/kg/day, oral, divided into twice, depending on the severity of the infection and consideration of the doctor. Children weighing 30 kg or more can use the usual dosage of adults.

Patients with renal failure:

In patients with severe renal impairment (creatinine clearance

Instructions for sulcilate use dose for patients with renal failure:

Creatinine clearance (ml/min/1.73 m2)

Slashing time Sultamicillin Tosilat (hourly)

Sulcilat dose is recommended

1.5 g every 6 hours - 8 hours

15-29

1.5 g every 12 hours

5-14

1.5 g every 24 hours

Creatinine concentration in serum should show the stable state of the kidney function.

weight for male patients (kg) x (140 - age)/(72 x The content of creatinine in serum)

For female patients: 0.85 x above.

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?

Overdose:

There is little information on sodium ampicillin and sodium sulbactam. Overdose of the drug causes the main manifestations of the extended reaction of unwanted effects that have been reported. It is necessary to consider the high level of beta-lactam antibiotic concentration in cerebrospinal fluid (CSF) that can cause nervous effects, including epilepsy. Because both ampicillin and sulbactam are removed from the circulatory system by hemorrhage, these procedures can increase the elimination of the drug from the body if used overdose in patients with renal insufficiency.

Overdose treatment:

There is no data on overdose, no overdose of the drug.

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 Sulcilat Tablet 375 mg , you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive: diarrhea, nausea, abdominal pain.

Uncommon, 1/1000

Blood disorders and lymphatic systems: thrombocytopenia.

Nervous system disorders: headache, drowsiness. 1/1000

infection and parasitic infection: fake colitis,

nervous system disorders: convulsions, dizziness. Peeling skin.

Infection and parasitic infection: Anti -drug candidiasis infection

Blood disorders and lymphatic systems: reducing 3 lines of peripheral blood cells (panctopenia), increased blood clotting time, leukemia, neutropenemia, hemolytic anemia, anemia, hyperthyroidemia, platelet hemorrhage. circuit.

Metabolic and nutrient disorders: Anorexia. Aminotransferase, increased alanin aminotransferase, black stool, bowelitis, hemorrhage, stomatitis, dry mouth, epigastric pain, taste disorders, flatulence, lazy, black hair growth, indigestion. Ban, itching, skin reaction, urticaria, dermatitis

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

Sulcilat Tablet 375mg contraindicated in the following cases:

Contraindicated use of sultamicillin for patients with a history of hypersensitivity to any penicillin antibiotic.

Be cautious when using

serious hypersensitivity reactions (anaphylactic reaction), sometimes deadly, reported in patients being treated with penicillin, including sultamicillin. These reactions often occur in people with a history of hypersensitivity to penicillin and/or hypersensitivity to many allergens. There have been reports on people with a history of hypersensitivity to penicillin with serious reaction when treated with cephalosporin.

Before penicillin treatment, it is necessary to carefully ask the previous allergic history with penicillin, cephalosporin, and other allergens. If allergic reactions occur, the medication should be stopped and applied appropriate treatment.

If you encounter serious anaphylaxis, emergency should be immediately rescued by adrenalin. It is possible for patients to breathe oxygen, intravenous intravenous and airway ventilation, including intubation as directed.

Serious skin reaction, such as poisoned epidemn (toxic epidertnal necrolysis), Stevens -Johnson syndrome (Stevens -ihnson Syndrome -SIS), flaking dermatitis and diverse roses have been reported in ampicillin/sulbactam treatment patients. If a serious skin reaction occurs, it is necessary to stop taking this medication and start using appropriate therapy.

Like other antibiotics, it is necessary to continuously monitor the signs of superinfection due to non -sensitive bacterial proliferation, including fungi. If there are signs of superinfection, immediately stop taking the drug and/or apply appropriate treatment.

diarrhea caused by Clostridium Difficile (CDAD) has been reported when used for most antibiotics, including sultamicillin, and the severity of mild diarrhea to death. Treatment with antibacterial agents changes the natural microbiological system of the intestine, resulting in excessive development of C. Difficile.

c. Difficile produces toxins A and B, contributing to the development of CDAD. C. Difficile strains produce many toxins that increase the incidence of disease and death, because these infections may be difficult to treat with antibiotic therapies and may need to remove the colon. It is necessary to think about CDAD disease in all patients who appear diarrhea after antibiotics, should be carefully recorded because the CDAD report occurs more than 2 months after antibiotic treatment.

There has been a correlation between liver damage due to cholestatic hepatitis and jaundice and ampicillin/sulbactam. Patients must be recommended to contact the doctor if there are signs and symptoms of liver disease.

Due to single -lifted leukemia derived from viruses, ampicillin should not be used. High proportion of patients with mononoculatocalt hyperpses using ampicillin has been rash.

should be checked periodically to detect systemic dysfunction during prolonged therapy; This includes kidney, liver and hematuria function.

The main elimination sugar of sulbactam and ampicillin after drinking is through urine. Because the kidney function is not fully developed in newborns, when using sultamicillin in infants should consider this.

Patients with rare genetic problems such as galactose intolerance, lactase enamel deficiency or malcose - galactose should not be used.

The ability to drive and operate machinery

There is no evidence of the effect of the drug on the ability to drive and operate machinery.

Pregnancy

Studies on reproductive animals does not show that sultamicillin reduces the fetal fertility or harmful to the fetus. Sulbactam passes through the placenta. However, safety when used during pregnancy in humans has not been determined. Therefore, sultamicillin should only be used during pregnancy if the benefits are greater than the potential risk.

The period of breastfeeding

should not use sultamicillin during breastfeeding. Ampicillin and sulbactam concentrations are excreted in milk, which should be considered because babies can be exposed, especially when the kidney function has not been fully developed in infants.

Drug interaction

allopurinol:

Simultaneous use of allopurinol and ampicillin significantly increases the rate of skin rash in patients taking both drugs compared to the patient group only taking ampicillin only.

anticoagulants:

penicillin may cause changes in platelet adhesive and coagulation tests. These effects may increase the effects of anticoagulants.

Alkaline drugs (chloramphenicol, erythromycin, sulfonamid and tetracycline):

Alkaline drugs can affect penicillin's bactericidal ability, it is best to avoid simultaneous use.

Estrogen -containing birth control pills:

There has been a report on decreased contraceptive effectiveness in women using ampicillin, leading to unwanted pregnancy. Although the possibility is low, patients should be provided with an option to use an alternative or additional method of contraception while using ampicillin.

methotrexate:

Simultaneous use with penicillin reduces the clearance and increases the toxicity of methotrexate. Patients should be closely monitored. Leucovorin dose may be increased and extended the use time.

Probenecid:

Probenecid reduces ampicillin and sulbactam excretion through the renal tubules when used simultaneously, this effect increases and prolongs the concentration of antibiotics in serum. Extend the sale time and increase the risk of poisoning.

Interaction in labo:

Positive positive urinary glucose can occur in urine analysis tests with Benedict reagent, fehling and clinitest reagent. After giving pregnant women ampicillin, noticing the concentration of conjugated estriol, estriol glucuronid, conjugated ester and estradiol in plasma are temporarily reduced. This effect can also occur with sodium sulbactam/sodium ampicillin intravenously/intravenously.

Storage

at temperatures below 30 ° C. Avoid light.

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