Download Flexeril Leaflet - Global Pharmaceuticals Pakistan

PATIENT WITH RENAL IMPAIRMENT:
Normal dose may be given to patients with creatinine clearance of 60ml/min or greater. In patients whose creatinine clearance is less than
20 ml/min, it is recommended that a dose of 300 mg once daily should not be exceeded.
CONTRA-INDICATIONS:
Patients with known hypersensitivity to Cephalosporin.
PRECAUTION AND WARNING:
(Cefixime)
Capsule / Suspension / DS Suspension
Composition:
Flexeril Capsules: Each Capsule Contains Cefixime...............400mg
Flexeril Suspension (On reconstitution): Each 5ml Contains Cefixime..................100 mg
Flexeril DS Suspension (On reconstitution): Each 5ml Contains Cefixime..................200 mg
As other cephalosporin Flexeril should be given with caution to penicillin sensitive patients. As there is some evidence of partial cross
allergenicity between penicillin and cephalosporin patients have severe reaction (including anaphylaxis) to both classes of drugs. If an
allergic effect occurs with Flexeril drug should be discontinued and patient treated with appropriate agent if necessary. The use of broad
spectrum antibiotic alter the normal flora of the colon and may permit overgrowth. Clostridia, studies indicate that a toxin produced by
Clostridium difficile is a primary cause of antibiotic associated diarrhoea, Pseudomembranous colitis. So it is important to consider its
diagnosis in patients who developed diarrhoea in association with the use of antibiotic. The dose of Cefixime should be adjusted in patients
with severe renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD)
patients on dialysis should be monitored carefully. Special caution should be taken in patient with preexisting renal impairment when
Cefixime combines with aminoglycoside antibiotic, polymaxin b, colistin or high dose loop diuretics.
USE IN PREGNANCY AND BREAST FEEDING:
CLINICAL PHARMACOLOGY:
Studies have been performed in mice and rat at doses up to 400 times higher than human dose and resulted no evidence of impaired fertility
or harm to the fetus due to cefixime. There are no adequate and well-controlled studies in pregnant women and nursing mother available.
Flexeril should not be used in pregnancy or in nursing mother unless considered essential by the physician.
A single 400mg capsule produces an average peak concentration approximately 3.7 mcg/ml(range 1.3 to 7.7 mcg/ml). Peak serum
concentration occurs between 2 to 4 hours following oral administration of a single 400 mg capsule or 400mg of suspension of Flexeril
DRUG INTERACTION:
Description: Cefixime is a semisynthetic Third generation Cephalosporin antibiotic for oral administration.
INDICATIONS:
Flexeril (Cefixime) is an orally active Cephalosporin antibiotic, which has marked in-vitro bactericidal activity against wide range of
Gram positive and Gram negative organisms. It is indicated for the treatment of the acute infection caused by susceptible microorganisms.
Upper respiratory tract infection (URTI) Otitis media. Sinusitis, Pharyngitis, Tonsillitis, Lower respiratory Tract Infection (LRTI), Bronchitis,
Urinary Tract infection (UTI), Cystitis, Cystourethritis. Uncomplicated Pylonephritis and Uncomplicated gonorrhoea (Cervical/Urethral,
rectal and pharyngeal.
ANTIMICROBIAL ACTIVITY:
As with other cephalosporin, bactericidal action of Flexeril results from inhibition of cell-wall synthesis. Flexeril is highly stable in the
presence of beta-lactamase enzymes. As a result many organisms resistant to penicillins due to presence of beta-lactamase may be
susceptible to Flexeril. Flexeril has shown to be active against most strains of the following organisms.
Gram Positive Organisms:
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus agalactiae
Gram Negative Organisms:
Haemophilus influenzae (B_lactamase positive and negative strains)
Moraxella (Branhamella) catarrhalis (most of are beta-lactamase strains)
Escherichia coli.
Proteus mirabilis.
Neisseria gonorrhoeae
Haemophilus parainfluenzae (Beta-lactamase Positive and Negative strains)
Proteus vulgaris
Klebsiella pneumoniae
Klebsiella oxytoca
Pasteurella multocida
Providencia species
Salmonella species
Shigella Species
Citrobacter amalonaticus
Citrobacter diversus
Serratia marcescens
Note: Pseudomonas species. Strain for group “D” streptococci (including enterococci) Listeria monocytogenes, and most strains of
staphylococci (including methicillin resistant strains) and most strains of enterobacter are resistant to cefixime and most strains of
Bacteroides fagillis and clostridia are resistant to Cefixime.
No significant drug interaction has been reported. A false positive direct coomb’s test has been reported during treatment of cephalosporin
antibiotic, therefore it should be recognized that a positive coomb’s test may be due with the cephalosporin drugs.
OVERDOSE:
There is no experience with overdoses of Flexeril (Cefixime) Adverse reaction seen at the dose up to 2g which did not differ from the
profiles seen in patients treated with normal doses. Gastric lavage may be initiated in overdosage.
SIDE EFFECTS:
Flexeril is generally well tolerated. The undesirable effects observed in clinical trials were mild and self limiting in nature.
Gastrointestinal:
The most frequent side effect with Flexeril (Cefixime) is diarrhoea and stool change. In some cases severe diarrhoea have been
reported. Flexeril (Cefixime) should be discontinued if marked diarrhoea occurs, Other GI side effects seen frequently are nausea,
abdominal pain, dyspepsia, vomiting and flatulence.
Central nervous system: Headache and dizziness.
Hypersensitivity Reactions: Allergy in the form of rashes, pruritus, urticaria and drug fever have been observed, these reactions
usually subsided upon discontinuation of therapy.
Haematological and clinical changes: Thrombocytopenia, leukopenia and eosinophilia have been reported. These
reactions are in-frequent and reversible. Mild transient changes in liver and renal function test have been observed.
DIRECTIONS FOR RECONSTITUTION:
To prepare 30 ml oral suspension, use the provided water (20 ml). Shake bottle to loosen powder. Add half of the water in the
bottle and shake vigorously. Add remaining water to bottle and shake well. Reconstituted suspension should be used with in 7 days.
PRESENTATION:
Flexeril Capsules 400mg: Pack of 5 capsules
Flexeril Suspension: pack of 30 ml
Flexeril DS Suspension: pack of 30 ml
DOSAGE AND ADMINISTRATION:
The usual course of treatment is 5-14 days depending upon the severity of infection.
Adults and children over 12 years: the recommended dose is 400 mg daily administered as a single dose.
Children:
Oral Suspension
The recommended dosage for children is 8 mg/kg/day administered as a single dose. As a general for prescribing in children the following
daily dose in term of volume of oral suspension are suggested.
Children - 1 - 4 years, 5ml daily as single dose.
Children - 5 - 9 years, 10ml daily as single dose.
Children - 10 - 12 years, 15ml daily as single dose.
DS Oral Suspension
Children - 1 - 4 years, 2.5ml daily as single dose.
Children - 5 - 9 years, 5ml daily as single dose.
Children - 10 - 12 years, 7.5ml daily as single dose.
Adult & Children over 12 years, 10ml daily as single dose.
Children age between 6 months to 1 year dose should be calculated on mg/kg basis. Children aged more than 12 years should be given
adult dose. The safety and efficacy of cefixime has not been established in less than 6 months.
IN ELDERLY:
In elderly patients with normal renal function the same recommended dose may be given.
Manufactured by:
Global Pharmaceuticals
Plot No. 204-205, Industrial Triangle
Kahuta Road, Islamabad - Pakistan