Negara: Armenia
Bahasa: Inggris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cefixime (cefixime trihydrate)
SRS Pharmaceuticals Pvt. Ltd.
J01DD08
cefixime (cefixime trihydrate)
200mg
tablets chewable
(10/1x10/) blister
Prescription
Registered
2015-02-20
100 x 220 mm INSERT SIZE Black Cefichew 200/400 Cefixime Chewable Tablets Carefully read the instruction before use COMPOSITION: CEFICHEW 200 Each chewable tablet contains: Cefixime as trihydrate eq. to Anhydrous Cefixime………200 mg CEFICHEW 400 Each chewable tablet contains: Cefixime as trihydrate eq. to Anhydrous Cefixime…………400 mg TRADE NAME: 1)Cefichew 200 (Cefixime Chewable tablets 200mg) 2)Cefichew 400 (Cefixime Chewable tablets 400mg) ATC CODE : J01DD08 INTERNATIONAL NONPROPRIETARY NAME: 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7- [[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, trihydrate, [6R -[6, α 7 β (Z)]]-.(6R, 7R )-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-vinyl-5-thia-1- 2 azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7 -(Z)-[O-(carboxymethyl)oxime]trihydrate. PHARMACOTHERAPEUTICAL GROUPS : Third-generation cephalosporins ROUTE OF ADMINISTRATION: Oral PHARMACOLOGICAL ACTION: Cefixime, like other Cephalosporins has a bactericidal action resulting from the inhibition of cell wall synthesis. Cefixime is highly stable in the presence of beta-lactamase enzymes. Cefixime binds with high affinity to penicillin – binding proteins in the bacterial cell wall , thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with mechanical stability. The final stage in the synethesis of peptidoglycan involves the completion of the cross-linking. The terminal glycine residue of the petaglycine bridge is linked to the forth residue of the pentapeptide , the transpeptidase enzyme that performs this step in inhibited by cephalosporins and penicillins. As a result the bacterial cell wall is weakened , and the cell swells and then ruptures. Cefixime is bactericidal against a broad spectrum of bacteria at easily achievable plasma concentrations. PHARMACOKINETICS : Only 40 to 50% of an oral dose of cefixime is absorbed from the gastrointestinal tract, whether taken before or after meals, although t Baca dokumen lengkapnya
1. NAME OF THE MEDICINAL PRODUCT : CEFICHEW 200 THE SUMMARY OF THE PRODUCT CHARACTERISTICS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION with indication of active substances (International nonproprietary name or chemical name), indication of other excipients knowledge of which is essential for safe and proper administration of the medicinal product. BATCH SIZE : 100000 Tablets. SR. NO. INGREDIENTS LABEL CLAIM/ TABLET (IN MG) OVERAGES QTY./TABLET (IN MG) QTY./BATCH (IN KG) REASON FOR INCLUSION ACTIVE 1. Cefixime Trihydrate Eq. to Cefixime # 224.0 ≈ 200.0 5% *235.2 23.52 Antibiotic EXCIPIENTS 2. Aspartame - - 10.0 1.0 Sweetening Agent 3. Flavour Orange - - 10.0 1.0 Flavour 4. Flavour Strawberry - - 5.00 0.50 Flavour 5. Flavour Mixed Fruit - - 5.00 0.50 Flavour 6. Mannitol - - 134.50 13.45 For pleasant taste and mouth feel 7. Supersol M - - 286.30 28.63 Diluent 8. Magnesium Stearate - - 9.00 0.90 Diluent 9. Talc - - 5.00 0.50 Lubricant # 224 mg of Cefixime Trihydrate equivalent to 200mg of Cefixime. * Quantity may vary as per assay & water content. 5% overages added to compensate loss during production. 3. PHARMACEUTICAL FORM: Chewable Tablet 4. CLINICAL CHARACTERISTICS : 4.1 INDICATIONS : THERAPEUTIC INDICATIONS: Cefixime is used for the treatment of acute otitis media, pharyngitis and tonsillitis, respiratory tract infections (acute bronchitis, acute exacerbations of chronic bronchitis) , or urinary tract infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION (WHERE APPROPRIATE DOSAGE ADJUSTMENTS IN SPECIFIC PATIENT GROUP SHOULD BE STATED) : Tablet for oral use Cefixime chewable tablets should be chewed before swallowing. The prescribed dose may be administered without regard to meals. ADULT DOSAGE : The recommended adult dosage is 200mg-400mg daily accordance to the severity of infection given either as a single dose or in two divided doses. PEDIATRIC DOSAGE : Children older than 12 years of age or those weighing more than 50 kg may receive the usual adult dosage of cefixime. 4.3 CONTRAINDICATIONS: Cefixime is con Baca dokumen lengkapnya