Cephalosporin Antibiotic
ROKSICAP
ROKSICAP® Capsule
Box of 10 strips @ 10 capsules
Reg. No. : DKL0532400701A1
ROKSICAP® Dry Syrup
Bottle ...
ROKSICAP
Category
Cephalosporin Antibiotic
Type
General Anaesthetic
Package
ROKSICAP® Capsule
Box of 10 strips @ 10 capsules
Reg. No. : DKL0532400701A1
ROKSICAP® Dry Syrup
Bottle containing dry syrup to be dispersed with drinking water up to 60 ml
Reg. No.: DKL 0932403038A1
ROKSICAP® Forte Dry Syrup
Bottle containing dry syrup to be dispersed with drinking water up to 60 ml
Reg. No.: DKL 0932403038B1
Composition
ROKSICAP® Capsule
Each capsule contains :
Cefadroxil Monohydrate equivalent to 500 mg of Cefadroxil.
ROKSICAP® Dry Syrup
After reconstitution, each 5 mL contains :
Cefadroxil Monohydrate equivalent to 125 mg of Cefadroxil.
ROKSICAP® Forte Dry Syrup
After reconstitution, each 5 mL contains :
Cefadroxil Monohydrate equivalent to 250 mg of Cefadroxil.
Indication
ROKSICAP® is indicated for the treatment of infections caused by susceptible microorganisms, especially for infection caused by Gram-positive bacteria, anaerobic bacteria, and many Gram-negative bacteria such as E. coli, P. mirabilis and Klebsiella.
- Respiratory-tract infections :
Tonsilitis, pharyngitis, pneumonia, bronchitis, bronchiectasis, pulmonary abscess, empyema, pleuritis, sinusitis, otitis media.
Skin and soft tissue infections :
Lymphadenitis, abscesses, cellulitis, decubitus ulcer, mastitis, furunculosis, erysipelas.
- Genito-urinary tract infections :
Pyelonephritis, cystitis, adnexitis, endometritis.
- Other infections :
Osteomyelitis, arthritis, septicemia, peritonitis, puerperal sepsis.
It is not recommended for upper respiratory-tract infections and otitis media caused by H. influenzae.
Dossage
Treatment should be continued to 2 - 3 days after infection symptoms disappeared.
ROKSICAP® Capsule
Adults : Usual doses are 1 - 2 g daily, given in two divided doses every 12 hours or once every 24 hours.
Urinary-tract infections
Uncomplicated lower urinary-tract infections (cystitis) : 1 - 2 g daily as a single dose or in two divided doses.
Other urinary-tract infections : 2 g daily in two divided doses.
Skin and soft tissue infection
1 g daily as a single dose or in two divided doses.
Upper and lower respiratory-tract infections
Mild infections : 1 g daily in two divided doses.
Moderate to severe infections : 1 - 2 g daily in two divided doses (500 mg - 1 g every 12 hours).
Pharyngitis and tonsillitis caused by gruop A beta-haemolytic streptococci, 1 g daily in two divided doses for 10 days.
In patients with renal function impairment, dose should be appropriated (with decrease the daily dose/prolong interval between 2 doses) according to creatinine clearance rate to prevent drug accumulation. The recommended dose are 500 mg in this follow condition :
Creatinine Clearance Interval
0 - 10 ml/minutes 36 hours
10 - 25 ml/minutes 24 hours
25 - 50 ml/minutes 12 hours
Children :
Age ? 6 years : 500 mg in divided dose, every 12 hours.
Age 1 - 6 years : 250 mg in divided dose, every 12 houts.
Infants < 1 year of age : 25 mg/kg body weight/day in divided dose, every 12 hours.
ROKSICAP® Dry Syrup
Children :
25 - 50 mg/kg bodyweight/day in divided dose, every 12 hours.
treatment.
Dizziness, headache, fever, arthralgia, thrombocytopenia, agranulocytosis, and Stevens-Johnson syndrome.
Other reactions have included hepatic dysfunction including cholestasis and elevations in serum transaminase, genital pruritus, genital moniliasis, vaginitis, moderate transient neutropenia.
Special Precaution :
It should be used with caution in patients with known histories of penicillin allergy due to the possibility of cross reaction occurs.
Patients with impaired renal function.
Colitis patients.
False positive reactions to Coomb's test and for glucose in the urine using Benedict's of Fehling's solutions, may occur.
Prolonged use of Cefadroxil may cause the non-susceptible microorganisms over growth.
Safety usage in pregnant women and premature infants have not been established.
Dosage :
Treatment should be continued to 2 - 3 days after infection symptoms disappeared.
ROKSICAP® Capsule
Adults : Usual doses are 1 - 2 g daily, given in two divided doses every 12 hours or once every 24 hours.
Urinary-tract infections
Uncomplicated lower urinary-tract infections (cystitis) : 1 - 2 g daily as a single dose or in two divided doses.
Other urinary-tract infections : 2 g daily in two divided doses.
Skin and soft tissue infection
1 g daily as a single dose or in two divided doses.
Upper and lower respiratory-tract infections
Mild infections : 1 g daily in two divided doses.
Moderate to severe infections : 1 - 2 g daily in two divided doses (500 mg - 1 g every 12 hours).
Pharyngitis and tonsillitis caused by gruop A beta-haemolytic streptococci, 1 g daily in two divided doses for 10 days.
In patients with renal function impairment, dose should be appropriated (with decrease the daily dose/prolong interval between 2 doses) according to creatinine clearance rate to prevent drug accumulation. The recommended dose are 500 mg in this follow condition :
Creatinine Clearance Interval
0 - 10 ml/minutes 36 hours
10 - 25 ml/minutes 24 hours
25 - 50 ml/minutes 12 hours
Children :
Age ? 6 years : 500 mg in divided dose, every 12 hours.
Age 1 - 6 years : 250 mg in divided dose, every 12 houts.
Infants < 1 year of age : 25 mg/kg body weight/day in divided dose, every 12 hours.
ROKSICAP® Dry Syrup
Children :
25 - 50 mg/kg bodyweight/day in divided dose, every 12 hours.
CHILDREN SUSPENSION DOSE TABLE
Daily Dose (every 12 hours, in ml)
Body Weigth (Kg) ROKSICAP®
Dry Syrup
125 mg / 5 ml ROKSICAP®
Forte Dry Syrup
250 mg / 5 ml
4.5 - 9.1 2.5 -
9.1 - 13.6 5 2.5
13.6 - 18.2 7.5 5
18.2 - 22.7 10 7.5
22.7 - 27.3 12.5 10
How to make suspension :
Pour drinking water until slightly below mark. Close bottle tightly. Hold bottle upside-down and shake until all granules dispersed. Add sufficient drinking water up to mark (60 ml) and shake well. After reconstitution, the suspension is stable for 7 days at room temperature (25° - 30°) or 14 days when stored under refrigeration.
Precaution
- It should be used with caution in patients with known histories of penicillin allergy due to the possibility of cross reaction occurs.
- Patients with impaired renal function.
- Colitis patients.
- False positive reactions to Coomb's test and for glucose in the urine using Benedict's of Fehling's solutions, may occur.
- Prolonged use of Cefadroxil may cause the non-susceptible microorganisms over growth.
- Safety usage in pregnant women and premature infants have not been established.
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FORIFEK
FORIFEK® 500 mg Capsule
Box of 2 strips @ 10 capsules.
Reg. No. : DKL9722221501A1
FORIFEK® Dry Syrup ...
FORIFEK
Category
Cephalosporin Antibiotic
Type
General Anaesthetic
Package
FORIFEK® 500 mg Capsule
Box of 2 strips @ 10 capsules.
Reg. No. : DKL9722221501A1
FORIFEK® Dry Syrup
Bottle 60 ml.
Reg. No. : DKL9722221438A1
Composition
FORIFEK® Capsule
Each capsule contains :
Cefaclor Monohydrate equivalent to 500 mg of Cefaclor.
FORIFEK® Dry Syrup
After reconstitution, each 5 mL contains :
Cefaclor Monohydrate equivalent to 125 mg of Cefaclor.
Indication
FORIFEK® is indicated in the treatment of the following infections when caused by susceptible stains of the designated microorganisms :
- Otitis media caused by S. pneumoniae, H. influenzae, Staphylococci, and S. pyogenes (group A ?-hemolytic streptococci).
- Lower respiratory infections, including pneumonia, caused by S. pneumoniae, H. influenzae, and S. pyogenes (group A ?-hemolytic streptococci).
- Upper respiratory infections, including pharyngitis and tonsillitis, caused by S. pyogenes (group A ?-hemolytic streptococci).
- Urinary tract infections, including pyelonephritis and cystitis, caused by E. coli, P. mirabilis, Klebsiella sp. and coagulase negative staphylococci.
- Skin and skin structure infections caused by Staphylococcus aureus and S. pyogenes (group A ?-hemolytic streptococci).
Dossage
- Adults :
The usual dosage is 250 mg every 8 hours. For bronchitis and pneumonia : 250 mg, 3 times daily. For more severe infections or those caused by less susceptible organisms, doses may be doubled, or as directed by the physician.
- Children :
The usual recommended daily dosage for children is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.
- In treatment of ?-hemolytic streptococcal infections, a therapeutic dosage of Cefaclor should be administered for at least 10 days.
- Doses of 4 g per day have been administered safely to normal subjects for 28 days, but the total daily dosage should not exceed this amount.
Precaution
- Cefaclor should be given cautiously to penicillin - sensitive patients, because cross - hypersensitivity, including anaphylaxis has been clearly documented.
- If an allergic reaction, occurs, the drug discontinued, and the patient should be treated with appropriate agents.
- Prolonged use of Cefaclor may result in the overgrowth of nonsusceptible organisms.
- It should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
- A false-positive reaction for Coombs' tests and glucose in the urine may occur. This has been observed with Benedict's and Fehling's solutions.
- Caution should be exercised when Cefaclor is administered to pregnant women and nursing mother because the effectiveness of Cefaclor have not been established.
- Caution should be exercised when Cefaclor is administered to patients with renal function impairment.
Safety and effectiveness of this product for use in infants less than 1 month of age have not been established.
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CEFACEF
CEFACEF® 100 Capsule
Box of 3 strips @ 10 capsules.
Reg. No. : DKL1032404201A1
CEFACEF® Dry Syrup
Box of ...
CEFACEF
Category
Cephalosporin Antibiotic
Type
Antacids & Antiulcerants
Package
CEFACEF® 100 Capsule
Box of 3 strips @ 10 capsules.
Reg. No. : DKL1032404201A1
CEFACEF® Dry Syrup
Box of bottle containing dry syrup to be dispersed with drinking water up to 30 mL.
Reg. No. DKL1032404338A1
Composition
CEFACEF® 100 Capsule
Each capsule contains:
Cefixime Trihydrate equivalent to 100 mg of Cefixime.
CEFACEF® Dry Syrup
After reconstitution, each 5 mL contains:
Cefixime Trihydrate equivalent to 100 mg of Cefixime.
Indication
CEFACEF® is indicated for the treatment of following infections which caused by susceptible microorganisms :
- Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
- Upper respiratory tract infections, e.g. otitis media,pharyngitis and tonsillitis.
- Lower respiratory-tract infections, e.g. acute bronchitis and acute exacerbations of chronic bronchitis.
- Uncomplicated gonorrhoeae.
Dossage
1. Adults
- Usual dose: 50 - 100 mg, twice daily.
- Patients with impaired renal function require dosage modification depending on the degree of impairment.
- Patients with creatinine clearance > 60 mL/minute: Standard dosage.
- Patients with creatinine clearance between 21-60 mL/minute: 75% of the standard dosage.
- Patients with creatinine clearance < 20 mL/minute: 50% of standard dosage.
- For uncomplicated gonorrhoeae, a single dose of 400 mg Cefixime may be given.
2. Children
- Body weight > 30 kg, its recommended to use the daily dose: 50 - 100 mg of Cefixime, twice daily.
- Body weight < 30 kg: 1.5 - 3 mg/kg body weight daily, administered in divided doses, twice daily.
- For more severe or intractable infections, the dosage may be increased up to 6 mg/kg body weight daily, administered in divided doses, twice daily.
In the children, otitis media should be treated with suspension, suspension should not be substituted.
- Dosage may be appropriated according to the age, body weight and condition of the patients.
- In case of overdosage, gastric lavage may be indicated, because there is no specific antidote exists. Cefixime is not removed in significant quantities from circulation by hemodialysis or peritoneal dialysis.
3. Direction for reconstitution
Pour 10 mL of drinking water, shake for 30 seconds, pours futher 10 mL of drinking water, shake again to make homogenous suspension. After reconstitution, the suspension is stable fo 7 days at room temperature (25 - 30C). Shake well before use.
Precaution
- The dose should be adjusted in patients with impaired renal function.
It should be used in pregnant and nursing women only if clearly necessary.
- Safety and effectiveness of the drug in children under 6 months have not been established.
- It should be given with caution to penicillin sensitive patients.
- It should be carefully administered to the patients who have such personal or family allergic history as bronchial asthma, rash or urticaria.
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INTRICEF
Box of 1 vial @ 1 g and aqua pro injection @ 10 ml.
Reg. No. : DKL0832401944A1
Reg. ...
INTRICEF
Category
Cephalosporin Antibiotic
Type
General Anaesthetic
Package
Box of 1 vial @ 1 g and aqua pro injection @ 10 ml.
Reg. No. : DKL0832401944A1
Reg. No. W.f.i : GKL022223243A1
Composition
Ceftriaxone Sodium Anhydrous equivalent to 1 g of Ceftriaxone
Indication
Infection caused by pathogens sensitive to INTRICEF® :
- Septicemia.
- Meningitis.
- Abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts).
- Infections of the bone, joints and soft tissue.
- Renal and urinary tract infections.
- Lower and upper respiratory tract injections, particularly pneumonia.
- Genital infections including gonorrhoeae.
- Peri and post-operative prophylaxis.
Dossage
Standard dosages
Adults and children > 12 years of age :
The usual dose is 1 - 2 g once daily (every 24 hours). In severe infections and in cases in which organism are only moderately sensitive, the daily dosage may be increased to a maximum dose of 4 g daily.
Neonates, infants, and children up to 12 years :
Recommended once daily administration.
- Neonates (up to 2 weeks) :
A daily dose of 20 - 50 mg/kg body weight not more than 50 mg/kg body weight/day on the account of the immaturity of the infant's enzyme systems. It is not necessary to differentiate between premature and mature infants.
- Infants and children (3 weeks to 12 years) :
Daily dose of 20 - 80 mg/kg body weight. For children weighing ? 50 kg, the normal adult dose can be used. For intravenous administration the doses of 50 mg/kg body weight should be given by infusion for a minimum of 30 minutes.
Elderly :
The recommended dosages as for adults.
No dosages adjustment is necessary for elderly patients.
Duration of treatment :
Depends on the cause of the disease.
As with antibiotic therapy in general, administration of Ceftriaxone should be continued for a minimum of 48 to 72 hours after the fever subsides or the bacteria eradication has been obtained.
Combination treatment
Experimental studies of Ceftriaxone administered in combination aminoglycosides showed that a synergetic effect occurs. This is of particular importance in severe, life-threatening infection due to Pseudomonas aeruginosa. Both drugs must be administrated separately.
Special Dosages Instruction :
Meningitis
With bacterial meningitis in infants and children, treatment should start with doses of 100 mg/kg body weight/day (not more than 4 g) once a day. As soon as the microorganism has been identified and its sensitivity determined, the dosages can be reduce accordingly. The best result has been achieved with the following treatment times :
- Neisseria meningitidis 7 days
- Haemophilus influenzae 7 days
- Streptococcus pneumoniae 10 - 14 days
Gonorrhoea
For the treatment of gonorrhoea (penicillinase and non-penicillinase producting strans), a single intramoscular dose of 250 mg is recommended.
Peri-operative prophylaxis :
To avoid post-operative infections in contaminated or potentially contaminated operations, a single dose of 1 - 2 g/day depending on infection risk, 30 - 90 minutes before the operation is recommended.
For colorectal surgery, concurrent (but separate) administration of INTRICEF® and a 5-nitro-imidazole as ordinazole derivative might be considered.
Renal and hepatic impairment :
In patients with impaired renal function, there is no need to reduce the dosage of INTRICEF® provided liver function is intact. Only in case of pre-terminal renal failure (creatinine clearance < 10 ml per minutes) should the daily dosage be limited to 2 g or less.
In patients with liver damage there is no need for the dosage to be reduce provided renal function's intact.
In severe renal impairment accompanied by hepatic insufficiency, the plasma concentration of INTRICEF® should be determined at regular intervals and dosage should be adjusted.
In patients under going dialysis, no additional supplementary dosing is required following the dialysis.
Instruction for use :
- The used of freshly prepared solution is recommended.
These maintain stability at 6 hours at room temperature (25° - 30°C) or 24 hours at temperature 5°C.
- Do not use if the color of solution ranges from light yellow to amber.
- 1 g of INTRICEF® should be dissolved in 10 ml of aqua pro injection. The solution should be administrated by intravenous injection over 2 - 4 minutes.
Drug Interaction :
- In vitro study, antagonistic effects have been observed with the combination of Chloramphenicol and Ceftriaxone.
- Coomb's test and galactosaemia test may give false-positive results.
- Non-enzymatic methods for glucose determination in urine may give false-positive results. For this reason, urine glucose determination during therapy should be done enzymatically.
- Incompatibilities : INTRICEF® should not be mix with calcium - containing solution (such as Hartmann's solution and Ringer's solution), amsacrine, vancomycin, fluconazole and aminoglycoside.
Precaution
- It should be used with caution in patients with anaphylactic shock.
- It should be used with caution in neonates with hyperbilirubinemia, especially in premature infants.
- Pseudomembranous colitis has resulted in patients who present with diarrhea subsequent to the administration of antibacterial agents.
- Superinfections with nonsusceptible microorganism may occur.
- The blood count should be regularly monitored during prolonged treatment.
- Read the instruction and dosages carefully.
- Safety usage in pregnant woman has not been established.
- It should be used with caution in nursing mothers.
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TAXECAP
Box of 1 vial @ 1 g and 1 ampoule water for injection @ 4 ml.
Reg. No. : DKL ...
TAXECAP
Category
Cephalosporin Antibiotic
Type
General Anaesthetic
Package
Box of 1 vial @ 1 g and 1 ampoule water for injection @ 4 ml.
Reg. No. : DKL 0832402344A1
Composition
Each vial contains :
Cefotaxime Sodium equivalent to 1 g of Cefotaxime
Indication
TAXECAP® is indicated for serious infections caused by microorganism that are sensitive in conditions below :
Lower respiratory tract infections; urinary tract infections, including uncomplicated gonorrhoea that caused by Neisseria gonorrhoeae including penicillinase producing strains; skin and soft tissue infections, intra-abdominal infections including peritonitis; bone and joints infections; central nerve system infections such as meningitis; septicemia; thypoid fever; gynecologist infections, including : pelvic inflammatory disease, endometritis, pelvic cellulitis; perioperative prophylaxis.
Dossage
Dose, usage and frequency of administration depend on infection, bacterial sensitivity, and patient's conditions (see dosage table). Therapy may be started before the result of sensitivity test is known.
Adult and children with age up to 12 years
- May be given TAXECAP® 1 g every 12 hours.
- In severe infection, dose may be raised until maximum 12 g per day.
- If daily dose is 4 g, the injection may be given twice every 12 hours.
- If higher dose is necessary, the injection may be given with 6 - 8 hours interval.
Patient with renal dysfunctions
In patient with creatinine clearance <20 ml/minutes, maintaining doses should be reduced until half of normal doses. Doses should be depend on the sensitivity of the causative bacteria and infection level.
Perioperative prophylaxis
1 - 2 g of TAXECAP® should be given about 30 - 90 minutes prior to surgery.
Neonates
- 0 - 1 weeks age : 50 mg/kg bodyweight every 12 hours i.v.
- 1 - 4 weeks age : 50 mg/kg bodyweight every 8 hours i.v.
- For the treatment of uncomplicated gonorrhoea, 1 g of TAXECAP® i.m may be given.
- For infections that are caused by less sensitive bacteria, dose may be increased.
- The presence oh syphillis infection in patients must be checked before the treatment initiated.
- Depends on the risk of infection, the same dose may be repeatable.
Children and infants (with age 1 month until 10 years old)
- Body weight < 50 kg : 50 - 180 mg/kg body weight divided into 4 - 6 equal doses.
- Body weight > 50 kg : adult doses should be taken.
Duration of treatment
- Depend on the patient's response.
- Treatment should be continued at least 48 - 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained.
- Infections caused by group A beta-hemolytic streptococci need minimum 10 days of treatment.
Usages :
TAXECAP® may administered intravenously or intramuscularly.
- Intravenous Injection
1 g of TAXECAP® dry injection dissolved in 4 ml water for injection, shake carefully during dissolving, inject over 3 - 5 minutes straight to vein or distal part from the clamped infusion hose.
- Intramuscular Injection
1 g of TAXECAP® dry injection dissolved in 4 ml water for injection, inject deeply at gluteus muscle. To prevent pain because of the intramuscular injection, dissolve 1 g of TAXECAP® in 4 ml lidocaine 1 %.
- Only fresh reconstituted of TAXECAP® should be used.
- Keep the solution in temperature below 25°C not more than 24 hours or for 10 days at 5°C.
- Do not use if the solution is cloudy or contains precipitate.
Precaution
- It should be used with caution in patients with gastrointestinal disturbances history, especially colitis.
- In patients with hypersensitivity to penicillin, cross hypersensitivity may occur.
- Cefotaxime Sodium should not be used in pregnancy, especially at first three semester, except there is any urgent indication.
- It should be used with caution in nursing mothers, since Cefotaxime Sodium is excreted in breast milk.
- In patient where amoniglycoside therapy is concomitant with Cefotaxime, renal function test should be taken.
- Blood cells count should be taken in patient that is already treated for more than 10 days and the treatment should be discontinued when neutropenia occurs.
- Long term treatment with antibiotic may cause a resistant microorganism growth, therefore the patient's condition should be checked in several interval times.
- Prolonged used Cefotaxime may cause non-susceptible microorganism overgrowth.
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CAPROCEF
Box of 1 vial @ 1 g and 1 ampoule of water for injection @ 10 ml.
Reg. No.: DKL1032404544A1
CAPROCEF
Category
Cephalosporin Antibiotic
Type
General Anaesthetic
Package
Box of 1 vial @ 1 g and 1 ampoule of water for injection @ 10 ml.
Reg. No.: DKL1032404544A1
Reg. No. W.f.i : GKL0222236243A1
Composition
Each vial contains:
Cefpirome Sulphate equivalent to 1 g Cefpirome.
Inactive ingredient:
Sodium Carbonate as buffer.
Indication
CAPROCEF® is indicated for the treatment of infections caused by bacteria of established sensitivity, as follows:
- Lower respiratory tract infections (bronchopneumonia & lobar pneumonia).
- Complicated upper (pyelonephritis) and lower urinary tract infections.
- Skin and soft tissue infections (cellulitis, skin abscess and wound - infections).
- Septicemia.
- Infections in neutropenic (except those caused by Pseudomonas aeruginosa) and immunocompromised patients.
- Severe infections in intensive care patients.
Dossage
CAPROCEF® is to be used by the parenteral route, the dosage, mode of administration and duration of treatment depend upon the severity of the infection, sensitivity of the pathogens, condition of the patient and renal function.
For urinary tract,skin and soft tissue infections, the unit dose may be increased to 2 g in very severe cases.
Elderly :
No dose adjustment is required unless renal impairment is present.
Children :
There is insufficient evidence on which to base an appropriate dosage regimen in children under 12 years of age. Therefore, CAPROCEF® is not recommended for this age group.
Reconstitution Procedure :
The dry powder in vial is to be dissolved in 10 mL of water for injection. After dissolves, carbondioxide is released and positive pressure develops. For easy use, it is recommended to follow the recommendation of reconstitution procedure below:
- Hold the vial in an upright position. Remove approximately 10 mL air from the vial.
- Add recommended volume of solvent slowly, hold the syringe plunger tightly. After completion, remove the needle. Shake to obtain a clear solution. As the antibiotic dissolves carbon dioxide is released causing frothing which clear quickly.
- A high pressure inside the vial will be developed. Depress the syringe plunger fully and hold the plunger tightly. Insert the needle to the upright vial to the neck and withdrawal approximately 10 mL of gas.
- Invert the vial. With a syringe plunger fully depressed, insert the needle keeping it within solution. The pressure aids withdrawal of the solution.
- Bubble of carbondioxide in syringe clear quickly on tapping. As there are carbondioxide, smaller bubbles can be injected without ill effect.
Directions for use :
CAPROCEF® is given by intravenous injection over 3 to 5 minutes or infusion over 20 to 30 minutes.
Precaution
- Should be used with caution in patient with penicillin sensitive history, because cross-sensitivity may occurs.
- Monitoring the renal function if Cefpirome administered concomitant with aminoglycosides or loop diuretic drugs.
- Should not be used during pregnancy and breast feeding because in vitro studies have shown that Cefpirome crosses the human placenta. Cefpirome is also excreted in breast milk, either Cefpirome treatment should be discontinued or breast feeding stopped.
- Safety using for children not known yet.
- For the treatment exceed 10 days, the blood count should be taken and if neutropenia occur, the therapy should be discontinued.
- In several cases, severe and persistent diarrhea has been observed during and after treatment with antibiotics of several different classes. This may be the symptom of pseudomembranous colitis (in most cases due to Clostridium difficile) which may be fatal. This is rare complication with cephalosporins. Once pseudomembranous colitis is suspected as the diagnosis, confirmed by sigmoidoscopy, Cefpirome therapy must be discontinued immediately and specific antibiotic therapy must be started. Products which may cause faecal stasis arecontra-indicated.
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CAPRIFIM
Box of 1 vial @ 1 g.
Reg. No. : DKL1032404444A1
CAPRIFIM
Category
Cephalosporin Antibiotic
Type
General Anaesthetic
Package
Box of 1 vial @ 1 g.
Reg. No. : DKL1032404444A1
Composition
Each vial contains :
Cefepime Hydrochloride Monohydrate equivalent to 1 g of Cefepime.
Inactive Ingredient : L-Arginine as a buffer.
Indication
Adult >= 16 years :
CAPRIFIM® is indicated in the treatment of infections listed below when caused by susceptible bacteria.
- Lower respiratory tract infections, including pneumonia and bronchopneumonia.
- Complicated upper (pyelonephritis) and lower urinary tract infections.
- Skin and skin structure infections.
- Intra-abdominal infections, including peritonitis and biliary tract infections.
- Severe or complicated gynecological infections.
- Septicemia.
- Empiric treatment in febrile neutropenia.
Culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organisms to CAPRIFIM®. Empiric therapy with CAPRIFIM® may be instituted before result of susceptible studies are known; however, once these result become available, antibiotic treatment should be adjusted accordingly.
Dossage
Adult Patients
The recommended adults and pediatric dosage and routes of administration are outlined in the following table. CAPRIFIM® should be administered intravenaously over approximately 30 minutes.
Pediatric patients (2 months - < 16 years) with body weight up to 40 kg.
Urinary tract infections, skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenia patients: 50 mg/kg body weight/dose, 12 hourly for 7 to 10 days.
Febrile neutropenia patients: 50 mg/kg body weight/dose, 8 hourly for 7 to 10 days.
Maximum dose: should not exceed the recommended adult dose.
Administration :
For intravenous infusion, constitute the 1 g vial and add 10 ml of compatible IV diluents. The resulting solution should be administered over approximately 30 minutes. During infusion of a solution containing Cefepime, it is desirable to discontinue the other solution.
For intramuscular administration, constitute the 1 g vial and add 2.4 mL of compatible IM diluents, with one of the following diluents: Sterile water for injection, 0.9% Sodium chloride, 5% Dextrose, 0.5% or 1.0% Lidocaine hydrochloride, or sterile bacteriostatic water for injection with parabens or benzyl alcohol (See Table 2).
IM use of CAPRIFIM® should be limited for patients with mild to moderate uncomplicated or complicated urinary tract infections caused by E. coli.
To reconstitute, add compatible diluents and then shake until a clear solution obtained.
Reconstituted solution of CAPRIFIM® is stable for 24 hours at temperature (15 - 25 C) or for 7 days under refrigeration (2 - 8 C). Discard any unused solutions after these periods.
Precaution
- In patients with impaired renal function, such as reduction of urinary output because of renal insufficiency (creatinine clearance =50 ml/min) or other conditions that may compromise renal function, the dosage of CAPRIFIM® should be adjusted to compensate for the slower rate of renal elimination because high and prolonged serum antibiotic concentrations can occur from usual dosage in patients with renal insufficiency.
- Antibiotics should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. If an allergic reaction occurs, discontinue the drug and treat the patient appropriately. Serious hypersensitivity reactions may require epinephrine and other supportive therapy.
- Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics, including Cefepime. Therefore, it is important to consider this diagnosis in patients who develop diarrhea in association with the use of antibiotics. Mild cases of colitis may respond to drug discontinuation alone; moderate to severe cases may require more elaborate management.
- Renal function should be carefully monitored if drugs with nephrotoxi potential e.g. aminoglycosides and potent diuretics, are administered with CAPRIFIM®.
- As with other antibiotics, use of CAPRIFIM® may result in overgrowth of nonsusceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.
- Caution should be made when Cefepime is administered to pregnant women or nursing mothers.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and renal function should be monitored.
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