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Description
Synocef
(Cefixime) is a semisynthetic 3rd. generation Cephalosporin
antibiotic being structurally similar to Cefdinir, Cefpodoxime
proxetil,Ceftibuten. Like Cefdinir, Cefixime contains a vinyl
moiety which is partially responsible for the G.I. absorption
characteristics and may contribute to Cefixime's potent bacterial
activity.
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Composition
| Synocef
100 |
| Each
hard gelatine capsule contains: |
| Cefixime
USP (As Trihydrate) equivalent to |
| Anhydrous
Cefixime |
100
mg |
| Synocef
200 |
| Each
hard gelatine capsule contains: |
| Cefixime
USP (As Trihydrate) equivalent to |
| Anhydrous
Cefixime |
200
mg |
| Synocef
Dry Syrup |
| After
re-constitution each 5ml of susoension contains:
|
| Cefixime
USP (As Trihydrate) equivalent to |
| Anhydrous
Cefixime |
50
mg |
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Actions
Synocef
(Cefixime) is used orally in adult and pediatric
patients for the treatment infections caused by susceptible
microbes. Synocef ( Cefixime), like other 3rd.
generation Cephalosporins, has an expanded spectrum
of activity against gram negative bacteria compared
with first and 2nd. generation Cephalosporins. Synocef
(Cefixime) is usually bactericidal in action. Like other
Cephalosporins, the antibacterial activity of the drug
results from inhibition of mucipeptide synthesis in
the bacterial cell wall. Betalactum antibiotics bind
to several enzymes in the bacterial cytoplasmic membrane
(eg. carboxypeptidases, endopeptidase, transpeptidases)
that are involved in cell wall synthesis and cell division.
Cell death following exposure to beta-lactum antibiotics
usually results from lysis, which appears to be mediated
by bacterial autolysin such as peptidoglycan hydrolases.
The target enzymes of beta-lactum antibiotics have been
classified as penicillin binding proteins (PBPA)
which appear to vary substantially among bacterial species
and this explains the differences in the spectrum of
activity of beta-lactum antibiotics.
Approximately
30-50% of a single dose is absorbed following oral administration;
presence of food generally do not interfere with the
extent of absorption, though, rate of absorption of
the drug may be affected. Following oral administration
of a single 200 or 400 mg dose of Cefixime the time
to peek serum concentrations average 3.1 to 4.4 hours
and peek serum concentration average 2mcg/ml or 3.7mcg/ml
respectively.Cefixime is approximately 65-70% bound
to plasma protein, principally albumin, and the elimination
half-life, in patients
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with
normal renal function, average 2.4 to 4 hours and may range
upto 9 hours in some healthy adults, which is independent
of dosage from and is not dose dependent.
Indications
Uncomplicated
u.t.i. in men, women & children, pyelonephritis and other
complicated u.t. is in adults;Ac. otisis media, pharyngitis
& tonsilitis, acute and chronic bronchitis, mild to moderate
pneumonia in adults or children; typhoid fever and other salmonella
infections, shigellosis, uncomplicated gonorrhoea.
Precautions
& Contraindictions
Previous
hypersensitivity reactions to Cephalosporins, penicillins
or other drugs; should be used with caution in individuals
with a history of allergy to drugs.
Prolonged
use along with other antiinfective agents may result in overgrowth
of nonsusceptible organisms.
Safety
and eficacy of Cefuxime in pediatric patients younger than
6 months of age have not been established.
Adjustment
of dosage may be necessary geriatric patients because of decreased
renal function with age.
Adverse
Reactions
Similar
to those reported with the Cephalosporins; Cefixime is well
tolerated; most frequent adverse effects involve g.i. tract
- mild in 20%, moderate in 5-9% and severe in 2-3% of patients;
diarrhoea, frequent loose stool, abdominal pain, nausea, vomiting
dyspepsia, flatulence may occur in 1-11% of patients.
Hypersensitivity
reactions have been reported in upto 7% of patients and include
rash, urticaria, drug fever, pruritus, arthralgia, erythema-multiforme,
facial edema, etc.
Thrombocytosis,
thrombocytopenia, leukopenia, leukocytosis, eosinophilia have
been reported in less than 2% of patients. Transient rise
in AST (SGOT) and ALT(SGPT), alkaline phosphates, biliruin
have been reported in less than 2% of patients. Transient
increase in serum creatinine and BUN may occur in less than
2% of patients.
Drug
Interactions
No clinically
important effect is observed when taken with antacids either
simultaneously or 2 hours before. Increased prothrombin time
with or without bleeding has been reported following concomitant
use of anticoagulants (eg. warfarin). Concomitant use of Cefixime
& nifedipine increases oral bioavailability of Cefixime;
with carbamazepine there may be rise in carbamazepine plasma
concentrations.
Dosage
& Administration
Adults
: Recommended daily dose is 400 mg; may be given in
two divided doses of 200mg 12 hourly.
For
uncomplicated gonococcal urethritis/ceravicitis single dose
of 400mg is suggested.
Children : For children > 6 of age: recommended
dose is 8mg/kg/day given as a single dose or in two divided
doses every 12 hourly.
Packing
Synocef
100 - Strips of 10 capsules.
Synocef
200 - Strips of 4 capsules.
Synocef
Dry Syrup - Phials 30 ml.
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