suspension , tablets , forte tablets .
Active ingredients : Septazole tablets each tablet contains :
sulfamethoxazole 400 mg , trimethoprim 80 mg Septazole fort tab each tablets contains : sulfamethoxazole 800 mg , trimethoprim 160 mg Septazole suspension each 5 ml contains : sulfamethoxazole 200 mg , trimethoprim 40 mg Inactive Ingredients:
SeptazoIe Tablets : Maize ,starch, P.V P 25 & Magnesoum stearate
Septazole Forte Tablets : Maize Starch, P.VP 25, Explotab & Magnesium stearate
Septazole suecensen : Sucrose. Carboxymethyloenulose Sodium, Veegum HV. Sorbitol solution 70% , Saccharin Sodium, Methylparaben , Propylparaben, Geranine & Anethole.
Pharmaceutical form :
Suspeosion , Tablets
Pharmacological action :
sulfamethoxazole inhibits bacterial synthesis of dihydrofolic acid by competing with para aminobenzoic acid , trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the required enzyme , dihydrofolate reductase . thus septazole blocks two consecutive steps in the biosynthesis of nucleic acids and proteins essential to many bacteria in vitro studies have shown that bacterial resistance develops more slowly with septazole than with either trimethoprim or sulfamethoxazole alone .
Septazole is rapidly absorbed following oral administration. Both sulfamethoxazole and trimethoprim exist in the blood a, unbound, protein-bound, and metabolized forms
Peak blood levels for the individual components occur 1 to 4 hours after 0fltI administration. The mean serum half-lives of sulfamethoxazole and trimethoprim are 10 and 8to 10 hours. respectively Bofh tinethopnm and slfamelhoxazole distnbute to sputum. vaginal fluid, and middle ear fluid, trimethoprim also distributes to bronchial secretions and both pass the placental and are excreted in human milk excretion of septazole is primarily by the kinneys
– urinary Tract Infections :For the treatment of urinary tract , infections due 10 suspension strains of the following organisms Escherichia coli. klebsiella species Enterobacter species, morganella morganii, Proteus mirabills. and Proteus vulgans
– Acute otitis media :For the lreatment of acute otrtil media in pediatric patlenta due 10 susceptible strams of Streptococcus pneumoniae or haemophilus influenzae
– travelers diarrhea in adults : for the treatment of travelers diarrhea duo to susceptible strains of enterotoxigenic e coil – shigellosis : for the treatment of enteritis caused by susceptible strains of shigella flexneri and shigella sonnei when antibacterial therapy is indicated -pneumocystis carinii pneumonia : for the treatment of documented pneumocystis carinii pneumonia and for prophylaxis against pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing pneumocystis carinii pneumonia
Dosage & Administration:
1 – Urinary tract infectlona and ahlgellosis in adults and l)«liatrle patienta, and ilCute otitis media in pediatrk: patienta:
Adulta : One Septarole Forte tablet or two Septazole tablets, or four teaspoonfuls (20 ml) Sepgzole ,u’pe1lsiol”l ev8fY 12 hours fOf 1010 14 days. An idenllClll daily dosage is used for 5 days in the treatment of shigellosis Pediatric patients : use for children under 3 years under medical supervision only
Not recommended for Infanta less than two months except for treatment or prophylaxis of pneumocystis pneumonia
8 mg / kg trimethoprim and 40mg/kg sulfamethourole per 24 hours given in two divided doses every 12 hours for 10 days an identical daily dosage is used for 5 days in the treatment of shigellosis – pediatric patients : two months of age or older – for patients with impaired renal function : when renal function is impaired areduced dosage should be employed using the follwing tab – adults and pediatric patients : 15 to 20 mg/kg trimethoprim and 75 to 100 mg/kg sulfamethoxazole per 24 hours givin in equally doses every 6 hours for 14 to 21 days
– Prophylaxis: Adults:
The recommended dosage for prophylaxis in adults is one septatole fort tablet daily
1- patients with aknwn hypersensitivity to trimethoprim or sulfonamides
2- patients with documented megaloblastic anemia due to folate deficiency
3- Pregnant patients at term and in nursing mothers because sulfonamides pass the placenta and are excreted in the milk and may cause kernicterus
4 – Pediatric patients leas than 2 months of age
The most common adverse effects are gastrointestinal disturbances (nausea. vomiting, and anorexia) and allergic skin reactions (Such as rash and unlcafia) Hematologic: Agranulocytosis , aplastic anemia, thrombocytopenia, leukopenia ,neutropenia , hemolytic anemia, megaloblastic anemia
Gastrointestinal : stomatitis , glossitis , nausea , emesis , abdominal pain , diarrhea , anorexia Genitourinary : Renal failure , interstitial nephritis , bun and serum creatinine evevation , toxic nephrosis with oliguria , anuria , and crystalluria
Psyehlatric: Hallucmations, depression , apathy , nervousness
is elderly patients coneurrently receiving certain diuretics , ,primanly thiazides ,an increased incidenee of thrombocytopenia with purpura has been reported. ithas been reported that Seplazole may prolong the proIhlombin time 1(1 patients who are receIVIng the anticoagulant warfltfln this interaction should be kept in
mind when Septarole is given to patients alleady on anticoagulant therapy. and the coagulallOfl !me should be reassessed septazole may I(Ihibrt the hepatic metaboIiIm of phenytoin SeptuoIe gr.oen at a cornrnon clinical 00SItge. lI”ICfeased Itle phenyto.’l half-life by 39% and decreased \he phenytoin metabolic clearance rate by 27%. when adnwmstenng these drugs one should be alert for possible excessive phenytoin effect.
Pregnancy and Lactation:
septazole is contraindicated in pregnant patients at term and IrIIlUfSIIlg mothers, because ,ulfonamldes pass the placenta and are excreted in the milk and may cause kernicterus
Precautions & Warnings:
-It is not recommended for use in diabetic patients
-Sulfonamides Including sulfonamrde – contalrttng products suctl as trJnelhopnm , sutfarnethoxazoie should be discontinued at the first appearance of skin rash or any sign of adverse reaction.
-Cough. shortness of breath and pulmonary infiltrates are hypersensitivity reecuone of the respiratory tract that have been reported in assoeaton with sulfonamidetreatrnent,
The sulfooamides should not be used for the tfeatmenl of group A beta-hemoiytic streptococcal inlelmns In 8fl esdbtishad inlection. !hey will not wadicate the Treatment with antibaclunal agents alhml the normall are 0f the colon and may permit overgrowth of ciostndia.
Package & Storage:
Carton box contains 2 or 20 or 100 strips in 10 tablets of septazole
Carton box contain ,2 or 20 or 100 strips x 10 tablets of Septazole Forte
Carton box contains an ember glass bottle of 100 ml (for local market) & 120 or 125 ml (for export & tenders) of Septazole suspension
Seplazole suspension Store in temperature not ellceedang 30 C alrtight containers away from light
Produced by :
Alexandria co for Pharmacuticals and chemical industries alexandria – egypt.