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Mecef 125mg/250mg 60ml

CLINICAL PHARMACOLOGY:
Cefadroxil is rapidly absorbed after oral administration. Following single doses of 500mg and 1g. average peak serum concentrations were approximately 16 and 28u/ml, respectively. Measurable serum levels were present 12 hours after administration. Absorption characteristics are not different between fasted and nonfasted subjects. Over 90% of the drug is excreted unchanged in the urine
within 24 hours. The elimination half-life is about 2 hours. Peak urine concentrations are approximately 1800u/ml during the period following a single 500mg oral dose. Increases in dosage generally produce a proportionate increase in cefadroxil urinary concentration. The urine antibiotic concentration, following a 1-g dose was maintained well above the MIC of susceptible urinary pathogens for 20 to 22 hours.

MICROBIOLOGY:
In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis. MECEF is active against the following organisms in vitro:
Beta-hemolytic streptococci
Streptococcus Pneumoniae        .
Staphylococci, including coagulase-positive, coagulase-negative, and penicillinase-producing strains
Escherichia coli
Proteus mirabilis
Klebsiella species
Moraxella (Branhamella) catarrhalis
Bacteroides species (excluding Bacterioides fragilis)
Other strains of sensitive gram-nagative organisms include some strains of Haemophilus influenzae, Salmonella species and shigella species.
Note; Most strains of Enterococci (Enterococcus faecalis and E. faecium)  are resistant to MECEF is not active against most strains of Enterobacter species, Morgenella morganii (formerly Proteus morganii) and Proteus vulgaris. It has no activity against Pseudomonas species and Acinetobacter, calcoaceticue (formerly Mima and Herellea species).

DISC SUSCEPTIBILITY TESTS:
Quantitative methods that require measurement of zone diameters give the most precise estimates of antibiotic susceptibility. One recommended laboratory procedure uses a cephalosporin class disc for testing susceptibility, interpretations correlate zone diameters of this disc test with MIC values for with this procedure a report of “susceptible” indicates that the infecting organism is likety to respond to therapy. A report of "resistant” indicates that the infecting organism is not likely to respond to therapy. A report of “intermediate susceptibility” suggests that the organism would be susceptible if the infection is confined to an area where adequate drug concentration can be achieved, for example, the urinary tract.

INDICATIONS:
MECEF is indicated in the treatment of the following infections When due to susceptible microorganisms Upper and lower respiratory tract infections, Skin and soft tissue infections, Genitourinary tract infections, Other infections: Osteomyelitis and septic arthritis.
Note: culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. Surgical procedures should be performed when indicated.
Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. MECEF is generally effective in the eradication of streptococci from the 3 oropharynx. However, data establishing the efficacy of cefadroxil for the prophylaxis of subsequent rheumatic fever are not available.

CONTRAINDICATIONS:
MECEF is contraindicated in patients with known allergy to the cephalosporin group of antibiotics or to any component of the formulation.

WARNINGS:
Before therapy with MECEF is instituted careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to MECEF, other cephalosporins, penicillins or other drugs. If this product is to be given to penicillin-sensitive patients, caution should be exercised because cross-sensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to MECEF occurs. discontinue the drug antibacterial agents, and may range from mild to life-threatening. Therefore it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. After the diagnosis of colitis has been established, therapeutic measures should be initiated.

PRECAUTIONS:
General MECEF should be used with caution in the presence of impaired renal function (See DOSAGE AND ADMINISTRATION for dosage guidelines). In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be made prior to and during therapy. Prolonged use of MECEF may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If super infection occurs during therapy appropriate measures should be taken. Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs’ testing of newbrons whose mothers have received cephalosporin antibiotics before parturition, It should be recognized that a positive Coomb's test may be due to the drug MECEF should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Carcinogenesis, Mutagenesis and impairment of Fertility. No long-term studies have been performed to determine carcinogenic potential. No genetic toxicity tests have been performed.

PREGNANCY:
Reproduction studies have been performed in mice and rats at doses up to 11 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefadroxil. There are however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predicitive of human response, this drug should be used during pregnancy only if clearly needed.

NURSING MOTHERS:
Cefadroxil is distributed into breast milk: therefore, this drug should be used with caution in nursing women.

ADVERSE EVENTS:
The adverse events observed with cafadroxii are similar to those observed with other cephalosporins. Gastrointestinal - Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment. Nausea, vomiting, and dyspepsia have been reported rarely. Administration with food deoreases nausea. Diarrhea also occurred. Hypersensitivity - In common with other cephalosporins, allergic reactions including pruritus, rash, urticaria, and angioedema has been observed. These reactions usually subsided upon discontinuation of the drug. Erythema multiform. Stevens-Johnson syndrome serum sickness, and anaphylaxis have been reported rarely. Other reactions have included genital pruritus, genital candidiasis, vagintis. moderate transient neutropenia, fever, and elevations in serum transaminase in common with other cephalosporins, agranulocytosis, thrombocytopenia and arthralgia have been rarely reported. During post marketing experience hepatic dysfunctions, including cholestasis has been reported, and rare reports of idiosyncratic hepatic failure have been received; because of the uncontrolled nature of those spontaneous reports, a causal relationship to MECEF has not been established.

OVERDOSAGE:
Data from a study children under six years of age who had ingested a maximum of 250 mg/kg of penicillin or a cephalosporin derivative suggested that ingestion less than 250 mg/kg of cephalosporins (i.e. 5 to 10 times of recommended dose) is not associated with significant outcomes. No treatment is required other than general support and observation. During the 72-hours evaluation period. most of the children remained asymptomatic. Gastrointestinal disturbances and rash were reported in some children. For amounts greater than 250 mg/kg, induce gastric emptying (emesis induction or gastric lavage) For information on removal of drug by hemodialysis. See Dosage and
Administration.

DOSAGE AND ADMINISTRATION:
MECEF is acid stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastronistestinal complaints occasionally associated with oral cephalosporin therapy.

ADULTS:
Urinary Tract Infections For uncomplicated lower urinary tract infections (i.e., cystitis) the usual
dosage is 1 or 2 g per day in a single dose or in two equally divided doses. For all other urinary tract infections the usual dosage is 2 g per day in two equally divided doses.   

SKIN AND SKIN STRUCTURE INFECTIONS:
For skin and skin structure infection the usual dosage is 1g per day in a single dose or two equally divided doses.

PHARYNGITIS AND TONSILLITIS:
Due to Group A beta-hemolytic streptococci Treatment of Group A beta-hemolytic streptococcal pharyngitis and tonsillitis 1g per day in a single dose or two equally divided doses for at least ten days.

UPPER AND LOWER RESPIRATORY TRACT INFECTIONS:
For mild infections the usual dosage is 1g per day in two equally divided doses. For moderate to severe infections the recommended dosage is 1g to 2g daily in two equally divided doses.

CHILDREN:
The recommended dosage for children is 25 to 50 mg/kg/day in two equally, divided doses (every 12 hours) as indicated. For pharyngitis, tonsillitis, and impetigo the recommended daily dosage may be administered as a single dose or in two equally divided dosage (every 12 hours)

In the treatment of beta-hemolytic streptococcal infections a therapeutic dosage of MECEF should be administered for at least 10 days. For the treatment of beta-hemolytic streptococcal pharyngitis or tonsillitis in both adults and children. MECEF may be administered in the usual daily dose either in two divided or a single dose.
In patients with renal impairment. The dosage of cefadroxil should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the intial dose Is 1g of MECEF and the maintenance dose (based on the creatinie clearance rate) is 500mg at the time intervals listed below.
Creatinine Clearance (ml/min/1.73 m2)             Dosage Interval
                                          0-10                                36 hours
                                         10-25                               24 hours
                                         25-50                               12 hours
Patients with creatinine clearance rates over 50 mI/min/1.73m2 may be treated as if they were patients having normal renal function. In five adult patients, it was demonstrated that an average of 63% of a 1-g oral dose is extracted from the body during a 6 to 8 hours hemodialysis session.

METHODS OF PREPARATIONS:
Oral Suspension Shake bottle to loosen the powder. To reconstitute, suspend with some water (Previously boiled and cooled) and shake well, Add More water upto the mark available on bottle and Shake well. Reconstituted suspension should be kept in refrigerator and consumed within a week.

STORAGE RECOMMENDATIONS:
Protect from light, store in a cool & dry place. Keep out of the reach of children. For oral use only. Shake well before use. MECEF unconstituted powder will remain stable until expiration date indicated on Package.