TOPRAK İLAÇ
Toprak İlaç, has participated in the CPHI Worldwide 2013 Exhibition in Frankfurt on October 22-24. Toprak İlaç, Toprak Pharmaceuticals has started marketing Cefixime and Thiocolchicoside in the Turkish market. Toprak İlaç, participated in the CPHI China Exhibition on 25-27 June, 2013. Toprak İlaç, has been awarded on February 28 2013 with TS EN ISO 13485:2012 by TÜRKAK.
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SULTASİD® FILM-COATED TABLETS
750 mg

FORMULATION:
Each film-coated tablet contains sultamicillin tosylate equivalent to 750 mg Sultamicillin.
Excipient: Titanium dioxide as an active substance

PHARMACOLOGICAL PROPERTIES:
Sultamicillin is a molecule formed as a result of linking of ampicilline and sulbactam, It is a beta-lactamase inhibitor to each other by a methylene bridge.
When taken orally, sultamicillin is hydrolyzed while being absorbed from gastrointestinal system and ampicillin and sulbactam pass to systemic circulation in equimolar amounts. The highest serum ampicillin concentration reached after oral administration of sultamicilin is approximately two fold of that reached by oral intake of ampicillin at the same dose. Bioavailability of ampicillin is not affected much when taken with food. Bioavailability of the dose taken orally is about 80% of the dose administered intravenously.
Serum half-lives of sulbactam and ampicillin are 45 minutes and 1 hour respectively 50-75% of both ampicillin and sulbactam are excreted unchanged in the urine. Elimination half life of the preparation is longer in patients with renal failure and elderly.
Bactericidal effect of sultamicillin is due to ampicillin it contains. Like all penicillin derivatives, ampicillin exerts it effect by inhibiting the synthesis of mucopeptide called mureine which is the main ingredient of bacterial cell wall. Sulbactam, since it is an irreversible beta-lactamase inhibitor, prevents breakdown of ampicillin by beta-lactamase enzymes, thus providing a synergic effect.

MICROBIOLOGICAL PROPERTIES:
Effect of ampicillin on susceptible microorganisms with respect to bactericidal action is similar to that of benzyl-penicillins. It acts by inhibiting the bacterial cell wall mucopeptide synthesis.
Ampicillin is an antibiotic with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative aerobic and anaerobic bacteria. However, ampicillin is not effective on these microorganisms which produce this enzyme since it is broken down by beta-lactamases.
Microorganisms which contain beta-lactamase and therefore resistant to penicillin, have been shown to be irreversibly inhibited by Sulbactam.
Although sulbactam alone has very little antibacterial activity, it maintains ampicillin activity against beta-lactamase producing strains. In particular, sulbactam has good inhibitory activity against the clinically important plasmid mediated beta-lactamases.
Plasma protein binding rates of sulbactam and ampicillin are 29.2% and 25.6% respectively.
After oral intake, sultamicillin is distributed to various tissues including tonsils, gall bladder, appendix and genital organs, as well as to sputum, bile, purulent acid discharge, wound excudates and middle ear effusion.
The presence of sulbactam in the SULTASİD FILM-COATED TABLET allows the action spectrum of action of ampicillin to extend to include microorganisms resistant to ampicillin.
The spectrum of action of the SULTASİD FILM-COATED TABLET is as follows:
Gram-Positive Bacteria:
Staphylococcus aureus (including those producing beta-lactamase), Staphylococcus epidermidis (including those producing beta-lactamase), Staphylococcus saprofiticus (including those producing beta-lactamase), Streptococcus faecalis (enterococcus), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans.
Gram-Negative Bacteria:
Haemophilus influenzae (including those producing beta-lactamase), Branhamella catarrhalis (including those producing beta-lactamase), Klebsiella (all of those known to produce beta-lactamase), Proteus mirabilis (including those producing beta-lactamase), Proteus vulgaris, Providencia rettgeri, Providencia stuarti, Morganella morganii ve Neisseria gonorrhoeae (including those producing beta-lactamase).
Anaerrobic Bacteria:
Clostridium species, Peptococcus species, Peptostreptococcus species, Bacteroides species (including Bacteroides fragilis).

INDICATIONS:
SULTASİD FILM-COATED TABLET is used in the following infections caused by susceptible microorganisms including those which produce beta-lactamase;
Upper respiratory tract infections such as sinusitis, pharyngitis, tonsillitis,laryngitis and otitis media
Lower respiratory tract infections such as bronchitis and bacterial pneumonia
Urinary system infections such as acute cystitis and its relapses and pyelonephritis
Skin and soft tissue infections such as impetigo, erysipelas, pyoderma, cellulitis, abscess and infected wounds
Peritonitis, cholecystitis, endometritis, pelvic and intra-abdominal infections
Gonococcal infections
Bacterial septicemia
SULTASİD FILM-COATED TABLET may be used as oral maintenance therapy in patients who previously received parenteral treatment with ampicillin/sulbactam.

CONTRAINDICATIONS:
SULTASİD FILM-COATED TABLET is contraindicated in individuals with known hypersensitivity reactions to penicillins.

WARNINGS/PRECAUTIONS:
Hypersensitivity reactions and severe anaphylactic reactions are generally seen as a result of parenteral administration and to a very lesser extent, following oral administration of penicillin. Such reactions more frequently and readily occur in individuals with a history of hypersensitivity reactions to penicillin and/or to various allergens. For example, severe reactions were reported during treatment with cephalosporins in individuals hypersensitive to penicillin. Therefore, before initiating a therapy with a penicillin derivative, a careful inquiry should be made to determine any previous hypersensitivity reaction against penicilllins, cephalosporins or other allergens. If any allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Severe anaphylactic reactions require immediate emergency treatment with adrenaline. In addition to this, respiration should be supported by precautions including oxygen, IV steroids and intubations when necessary.
Like other antibacterial drugs, sultamicilin has been reported to cause pseudomembranous colitis. Therefore, such diagnosis should be considered in patients who develop diarrhea following the administration of this drug. Antibacterial drug treatment may alter the normal flora of the colon and lead to proliferation of Clostridiums. Studies have shown that antibiotic related colitis is due primarily to the toxins produced by Clostridium difficile. Mild forms of pseudomambranous colitis generally respond to the discontinuation of drug. In moderate to severe cases, fluid electrolyte treatment, protein support and antibiotic treatment effective against Clostridium difficile may be needed.
As it is the case with other antibiotics, prolonged use of penicillins facilitates colonization of non-susceptible microorganisms including fungi; therefore appropriate therapeutic measures should be instituted against superinfection.
It is recommended that during long term treatment with SULTASİD FILM-COATED TABLET, hepatic and hematopoietic system functions should be monitored at regular intervals. There have been reports of high rate of skin rash as a result of the use of ampicillin in patients with infectious mononucleosis. Therefore, SULTASİD FILM-COATED TABLET should not be used in these group of patients.

Use in pregnant and lactating women:
Since there is not adequate evidence concerning the safety of the drug in pregnant women, it should be used in pregnancy only if clearly needed and under the physician?s supervision.
Since ampicillin and sulbactam pass into breast milk in low amounts, this drug should be administered with caution in nursing mothers.

SIDE EFFECTS/ADVERSE REACTIONS:
SULTASİD FILM-COATED TABLET is generally well tolerated. As in other beta-lactam antibiotics, following adverse reactions may occur during the administration of SULTASİD FILM-COATED TABLET.
Hypersensitivity Reactions: Macolopapular skin rashes, urticaria, fever and eosinophilia
Gastro-intestinal side effects: Nausea, vomiting, diarrhea. As in other antibiotics, pseudomembranous colitis may be seen during sultamicillin treatment (See Warnings/Precautions).
Hematologic side effects: Reversible anemia, thrombocytopenia, leukopenia and eosinophilia.
Hepatic functions: Transient elevations of transaminases (AST, ALT).
Skin related side effects: Skin rashes, itching and other skin reactions.
During treatment with the sulbactam/ampicillin combination, there may be side effects occurring in association only with ampicillin.
CONSULT YOUR DOCTOR IF AN UNEXPECTED REACTION OCCURS.

DRUG INTERACTIONS AND OTHER FORMS OF INTERACTION:
Probenecid reduces renal tubular secretion of ampicillin and sulbactam. During combined administration with probenecid, blood concentrations of ampicillin and sulbactam increase and stay longer in plasma.
Increase in skin rash is seen when used in combination with allopurinol.
During use of SULTASİD FILM-COATED TABLET, high concentrations of ampicillin are seen in the urine. Therefore false positive reactions occur in the urinary glucose tests. In such cases, urinary glucose determination through enzymatic glucose oxidase reactions is recommended.
Although its clinical relevance is not known, a transient reduction in plasma levels of total conjugated estriol, estriol-glucuronide, conjugated estron and estradiol may be seen in pregnant women following administration of ampicillin.

DOSAGE AND ADMINISTRATION:
Recommended dose for adults (including elderly) is 375-750 mg twice daily (every 12 hours). In children with body weight below 30 kg, the dose to be administered for most of the infections is 50 mg/kg/day (as divided into two, every 12 hours). Children with body weight over 30 g are administered adult dose.
Treatment is recommended to be continued until 48 hours after the fever has been reduced and other infection symptoms have disappeared. Duration of treatment is generally 5-14 days, however this duration may be prolonged when necessary. To prevent the occurrence of rheumatoid diseases or glomerulonephritis in infections associated with group A beta-hemolitic streptococci, it is recommended that treatment be continued for at least 10 days.
In uncomplicated gonorrhea cases, SULTASİD FILM-COATED TABLET may be administered as 2.25 g (3 tablets) at a single dose. For the purpose of prolonging the plasma half-life of sulbactam and ampicillin, the drug should be administered in combination with 1g probenecid.
In gonococcal infections and in cases of suspected syphilis, dark field examination and serological examination for at least four months should be performed before initiating the treatment with SULTASİD FILM-COATED TABLET.
In patients with severe renal failure (creatinine clearance < 30 mL/minute), elimination kinetics of sulbactam and ampicillin are similarly affected, hence the ratio of one to the other remains constant. The dose of sultamicillin in such patients should be administered at longer intervals similar to that in ampicillin treatment.

OVERDOSE:
In case of overdose; the increase in adverse reactions may be observed. The fact that beta-lactam antibiotics are present in high concentrations in cerebrospinal fluid,this may lead to some neurological adverse reactions such as seizures. Ampicillin and sulbactam may be removed from circulation by hemodialysis; However hemodialysis is not needed in patients with normal renal functions.

STORAGE CONDITIONS:
Should be kept below 30ºC (at room temperature) and in a moisture-free place.

SHOULD NOT BE USED WITHOUT FIRST CONSULTING A DOCTOR.

KEEP IT OUT OF THE SIGHT AND THE REACH OF CHILDREN, AND KEEP IT IN ITS ORIGINAL PACKAGE.

PRESENTATION:
In glass bottles of containing 10 film-coated tablets that each contains 750 mg sultamicillin as an active substance

OTHER COMMERCIALLY AVAILABLE PHARMACEUTICAL FORMS:
Sultasid 375 mg Film-Coated Tablets: In glass bottles containing 10 film-coated tablets that each contains 375 mg sultamicillin.
Sultasid 40 ml Dry Powder for Oral Suspension for Pediatric Use: In 40 ml bottles, which, after preparation, contains 250 mg sultamicillin in each 5 ml.
Sultasid 70 ml Dry Powder for Oral Suspension: In 70 ml bottles, which, after preparation, contains 250 mg sultamicillin in each 5 ml.
Sultasid 1 g Vials Containing Injectable Dry Powder IM/IV: In vials containing 1000 mg ampicillin and 500 mg sulbactam for parenteral use.

Authorization number: 05.03.1996 - 177/40

Authorization holder:
Toprak İlaç ve Kim. Mad. San. ve Tic. A.Ş. Toprak Center, Ihlamur Yıldız Cad. No:10 34353 Beşiktaş/İSTANBUL
Manufacturer:
Toprak İlaç ve Kim. Mad. San. ve Tic. A.Ş. Tem Otoyolu Adapazarı Çıkışı Kandaklar Mevkii ? Adapazarı / SAKARYA

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