SECURE is a semisynthetic, third - generation cephalosporin antibiotic for oral administration. The bactericidal action of SECURE results from inhibition of cell wall synthesis.
SECURE
is highly beta - lactamase stable and, as a result, many organisms resistant to penicillins and some cephalosporins, due to the presence of beta - lactamases, may be susceptible to SECURE.
SECURE
has been shown to be active against most strains of gram - negative and gram-positive organisms, both in vitro and in clinical studies. The serum half life of SECURE averages 3.0 to 4.0 hours, but may range up to 9 hours in some normal volunteers.
CAPSULES:
SECURE capsules 200mg.
Each capsule contains cefixime 200mg.
SECURE capsules 400mg.
Each capsule contains cefixime 400mg.
SUSPENSION:
Granules forpaediatric oral suspension:
SECURE fine granules contain 100mg ofCefixime (U.S.P.) in each 5mlvolumeof reconstituted pineapple-flavoured suspension.
SECURE DS fine granules contain 200mg of Cefixime (U.S.P.) in each 5ml volume of reconstituted apple - flavoured suspension.
INDICATIONS:
SECURE is an orally active cephalosporin antibiotic which has marked in - vitro bactericidal activity against a wide variety of Gram - positive & Gram - negative organisms. It is indicated for the treatment of the following acute infections when caused by susceptible micro- organisms.
Upper respiratory tract infections (URTI): e.g. Otitis media, sinusitis, pharyngitis & tonsillitis^ Lower respiratory tract infections (LRTI): e.g. bronchitis. :¦-
Urinary tract infections (UTI): e.g. cystitis, cystourethritis, uncomplicated pyelonephritis & uncomplicated gonorrhoea (cervical/urethral, rectal and pharyngeal).
IN VITRO ACTIVITY
Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae. Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive & negative) & Enterobacter species.
SECURE
is highly stable in the presence of beta-lactamase enzymes.
SECURE has been shown to be active in vitro against most strains of the following organisms: however, clinical efficacy has not been established. Streptococcus agalactiae, Haemophilus parainfluenzae (beta-lactamase positive & negative strains), Proteus vulgaris, Pasteurella multocida (P.septica), Providencia species, Salmonella species. Shigella species, Citrobacter diversus & Serratia marcescens.
Most strains of Enterococci (Streptococcus faecalis, group D streptococci) methicllin-resistant strains) are resistant to SECURE.
In addition most strains of Pseudomonas, Bacteroides fragilis. Listeria monocytogenes & Clostridia are resistant to SECURE.
DOSAGES ADMINISTRATION:
The usualcourse oftreatment is5-14 days.
Adults & children over 12 years:
The recommended dosage is 400mg daily administered as a single dose.
Children (Use Paediatric Oral Suspension):
The recommended dosage for children is 8mg/kg/day administered as a single dose. As a general guide for prescribing in children, the following daily doses in terms of volume of Paediatric Oral Suspension are suggested.
Children 1-4years :5 ml(secure suspension)or 2.5ml(Secure DS Susp.(daily.
Children 5-9 years :10 ml ;secure suspension) or 5ml (Secure DS Susp.) daily.
Children9-12years :1 5 ml (secure suspension)or 7.5ml (Secure DS Susp.)daily.
The dosage in children aged 6 months to one year should be calculated on mg/kg basis. Children weighing more than 30kg or nWar than io imarc chniiW ho troatoH with thp nsrnmmenrleri ariutt dose The safety & efficacv of SECURE has not been
CONTRA-INDICATIONS:
Patients with known hypersensitivity to cephalosporin antibiotics.
PRECAUTIONS* WARNINGS:
Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Patients have had severe reactions (including anaphylaxis) to both classes of drugs. SECURE should be administered with caution in patients with markedly impaired renal function.
USE IN PREGNACY/LACTATION:
There are no adequate and well controlled studies in pregnant woman. SECURE should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.
OVERDOSE:
Gastric lavage may be initiated in overdosage. No specific antidote exists. SECURE in not removed from the circulation in significant quantities by dialysis.
SIDE -EFFECTS
The most frequent side-effect seen with SECURE are diarrhoea and stool changes. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. SECURE should be discontinued if marked diarrhoea occurs. Other gastrointestinal side-effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembranous colitis has been reported.
Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy.
Thrombocytopenia, leukopenia and eosinophilli have been reported. These reactions were infrequent and reversible. Mild transient changes in liver and renal function tests have been observed.
Granules for Paediatric Oral Suspension:
To reconstitute 30ml suspension add 20 ml of cool, previously boiled water in two equal portions, shaking after each addition. After reconstitution, the suspension should be stored at room temperature for 7 days. For 60ml suspension add 40ml of cool, previously boiled water in four equal portions. Do not freeze.
Keep bottle tightly closed & shake well before use. Discard any unused portion after 7 days. Dilution of the suspension is not recommended.
PRESENTATION:
SECURE 200 mg Capsules: Blister Pack of 5 capsules. SECURE 400 mg Capsules: Blister Pack of 5 capsules.
SECURE 30ml Suspension: Granules for Paediatric Oral Suspension 30 ml (100mg/5ml on reconstitution). SECURE 60ml Suspension: Granules for Paediatric Oral Suspension 60 ml (100mg/5ml on reconstitution). SECURE DS Suspension:Granules for Paediatric Oral Suspension 30 ml (200mg/5ml on reconstitution).
SECURE
is highly beta - lactamase stable and, as a result, many organisms resistant to penicillins and some cephalosporins, due to the presence of beta - lactamases, may be susceptible to SECURE.
SECURE
has been shown to be active against most strains of gram - negative and gram-positive organisms, both in vitro and in clinical studies. The serum half life of SECURE averages 3.0 to 4.0 hours, but may range up to 9 hours in some normal volunteers.
CAPSULES:
SECURE capsules 200mg.
Each capsule contains cefixime 200mg.
SECURE capsules 400mg.
Each capsule contains cefixime 400mg.
SUSPENSION:
Granules forpaediatric oral suspension:
SECURE fine granules contain 100mg ofCefixime (U.S.P.) in each 5mlvolumeof reconstituted pineapple-flavoured suspension.
SECURE DS fine granules contain 200mg of Cefixime (U.S.P.) in each 5ml volume of reconstituted apple - flavoured suspension.
INDICATIONS:
SECURE is an orally active cephalosporin antibiotic which has marked in - vitro bactericidal activity against a wide variety of Gram - positive & Gram - negative organisms. It is indicated for the treatment of the following acute infections when caused by susceptible micro- organisms.
Upper respiratory tract infections (URTI): e.g. Otitis media, sinusitis, pharyngitis & tonsillitis^ Lower respiratory tract infections (LRTI): e.g. bronchitis. :¦-
Urinary tract infections (UTI): e.g. cystitis, cystourethritis, uncomplicated pyelonephritis & uncomplicated gonorrhoea (cervical/urethral, rectal and pharyngeal).
IN VITRO ACTIVITY
Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae. Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive & negative) & Enterobacter species.
SECURE
is highly stable in the presence of beta-lactamase enzymes.
SECURE has been shown to be active in vitro against most strains of the following organisms: however, clinical efficacy has not been established. Streptococcus agalactiae, Haemophilus parainfluenzae (beta-lactamase positive & negative strains), Proteus vulgaris, Pasteurella multocida (P.septica), Providencia species, Salmonella species. Shigella species, Citrobacter diversus & Serratia marcescens.
Most strains of Enterococci (Streptococcus faecalis, group D streptococci) methicllin-resistant strains) are resistant to SECURE.
In addition most strains of Pseudomonas, Bacteroides fragilis. Listeria monocytogenes & Clostridia are resistant to SECURE.
DOSAGES ADMINISTRATION:
The usualcourse oftreatment is5-14 days.
Adults & children over 12 years:
The recommended dosage is 400mg daily administered as a single dose.
Children (Use Paediatric Oral Suspension):
The recommended dosage for children is 8mg/kg/day administered as a single dose. As a general guide for prescribing in children, the following daily doses in terms of volume of Paediatric Oral Suspension are suggested.
Children 1-4years :5 ml(secure suspension)or 2.5ml(Secure DS Susp.(daily.
Children 5-9 years :10 ml ;secure suspension) or 5ml (Secure DS Susp.) daily.
Children9-12years :1 5 ml (secure suspension)or 7.5ml (Secure DS Susp.)daily.
The dosage in children aged 6 months to one year should be calculated on mg/kg basis. Children weighing more than 30kg or nWar than io imarc chniiW ho troatoH with thp nsrnmmenrleri ariutt dose The safety & efficacv of SECURE has not been
CONTRA-INDICATIONS:
Patients with known hypersensitivity to cephalosporin antibiotics.
PRECAUTIONS* WARNINGS:
Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Patients have had severe reactions (including anaphylaxis) to both classes of drugs. SECURE should be administered with caution in patients with markedly impaired renal function.
USE IN PREGNACY/LACTATION:
There are no adequate and well controlled studies in pregnant woman. SECURE should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.
OVERDOSE:
Gastric lavage may be initiated in overdosage. No specific antidote exists. SECURE in not removed from the circulation in significant quantities by dialysis.
SIDE -EFFECTS
The most frequent side-effect seen with SECURE are diarrhoea and stool changes. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. SECURE should be discontinued if marked diarrhoea occurs. Other gastrointestinal side-effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembranous colitis has been reported.
Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy.
Thrombocytopenia, leukopenia and eosinophilli have been reported. These reactions were infrequent and reversible. Mild transient changes in liver and renal function tests have been observed.
Granules for Paediatric Oral Suspension:
To reconstitute 30ml suspension add 20 ml of cool, previously boiled water in two equal portions, shaking after each addition. After reconstitution, the suspension should be stored at room temperature for 7 days. For 60ml suspension add 40ml of cool, previously boiled water in four equal portions. Do not freeze.
Keep bottle tightly closed & shake well before use. Discard any unused portion after 7 days. Dilution of the suspension is not recommended.
PRESENTATION:
SECURE 200 mg Capsules: Blister Pack of 5 capsules. SECURE 400 mg Capsules: Blister Pack of 5 capsules.
SECURE 30ml Suspension: Granules for Paediatric Oral Suspension 30 ml (100mg/5ml on reconstitution). SECURE 60ml Suspension: Granules for Paediatric Oral Suspension 60 ml (100mg/5ml on reconstitution). SECURE DS Suspension:Granules for Paediatric Oral Suspension 30 ml (200mg/5ml on reconstitution).
0 comments