البلد: أرمينيا
اللغة: الإنجليزية
المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cefixime (cefixime trihydrate)
Maxim Pharmaceuticals Pvt. Ltd.
J01DD08
cefixime (cefixime trihydrate)
400mg
tablets chewable
(10/1x10/) in blister
Prescription
Registered
2020-02-21
PACK INSERT CEFICHEW 200/400 (Cefixime Chewable Tablets) COMPOSITION: CEFICHEW 200 Each chewable tablet contains: Cefixime USP as trihydrate eq. to Anhydrous Cefixime…………200 mg CEFICHEW 400 Each chewable tablet contains: Cefixime USP as trihydrate eq. to Anhydrous Cefixime…………400 mg ATC CODE: J01DD08 INTERNATIONAL NONPROPRIETARY NAME: 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thi azolyl)[(carbo- xymethoxy)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-azabicyclo[4.2.0]oct-2-ene- 2-carboxylic acid, 7-(Z)-[O-(carboxy methyl)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 the rate of absorption may be decreased in the presence of food. Absorption is fairly slow; peak plasma concentrations of 2 to 3 micrograms/mL and 3.7 to 4.6 microgr اقرأ الوثيقة كاملة
THE SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT : CEFICHEW 400 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 # 448.0 ≈ 400.0 5% *470.40 47.04 Antibiotic EXCIPIENTS 2. Aspartame - - 20.0 2.0 Sweetening Agent 3. Flavour Orange - - 10.0 1.0 Flavour 4. Flavour Strawberry - - 7.0 0.700 Flavour 5. Flavour Mixed Fruit - - 5.0 0.500 Flavour 6. Mannitol - - 177.0 17.700 For pleasant taste and mouth feel 7. Supersol M - - 292.60 29.260 Diluent 8. Magnesium Stearate - - 12.0 1.200 Diluent 9. Talc - - 6.0 0.600 Lubricant # 448mg of Cefixime Trihydrate equivalent to 400mg 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 اقرأ الوثيقة كاملة