Source: Health Sciences Authority (SG) Revision Year: 2020 Publisher: United Italian Trading Corporation (Pte) Ltd, 28 Tai Seng Street, #06-01 Singapore, 534106, Tel: +65 6284 8889 Name and adress of manufacturer: Pharma Vision San. Ve Tic. A.Ş., Davutpaşa Caddesi No: 145, ...
ROXIPIME is used in the treatment of the following infections mentioned, if the causative organism is susceptible.
Culture and susceptibility tests should be performed to determine susceptibility of infection factor organism against cefepime. Empirical treatment with ROXIPIME can be started without waiting results of susceptibility tests and it should be regulated according to antibiotic treatment result when results of these tests are determined.
In patient with aerobic-anaerobic mix infection risk, if there is especially bacteria which is insusceptible to cefepime, in initial of treatment, anaerobic drug addition to treatment is recommended until determining effective microorganism. When the results are appeared, it is decided whether ROXIPIME may be administered as in combination with other anti-infective agents according to sensitivity profile.
In adults with normal renal function and in children over 40 kg body weight, ROXIPIME dose administration scheme is shown in Table 1.
TABLE 1. Recommended Dosage Schedule for Adults with normal renal function and children over 40 kg (12 years and older)*:
| The severity of infection | Dose and route of administration | Dose range |
|---|---|---|
| Severe infections | 2 g IV | q12h |
| Very severe and life-threatening infections | 2 g IV | q8h |
* Normal treatment duration is 7-10 days. For more severe infections, longer duration treatment may be required. Empirical treatment duration of febrile neutropenia is 7 days or continue until neutropenia disappears.
It is used in children 12 years old and over.
For pediatric patients with body weight more than 40kg, adult recommendation doses in the table above may be administered (see; Table 1). Child doses should be administered in patients who are older than age of 12 and have less than 40 kg of body weight. Dose in child patients should not pass over recommended maximum dose of adults (2 g in 8 hourly). Limited experiences are available regarding intramuscular administration in child patient.
ROXIPIME is administered intravenously (See section 6.6). The dosage and route of administration vary according to the susceptibility degree of infection effective organisms, the severity of the injection, and the condition and renal function of the patient.
In patients with renal insufficiency, the dose of Cefepime should be adjusted to compensate the slower rate of renal elimination. The recommended initial dose of Cefepime in patients with mild to moderate renal insufficiency should be the same as in patients with normal renal function.
The recommended maintenance dose according to creatinine clearance in adult patients with renal insufficiency is presented in Table 2.
If only serum creatinine values are available Creatinine clearance can be determined by the following formula (Cockcroft and Gault equation).
In Males: Creatinine Clearance (mL /min) = Weight (kg) × (140-age) / 72 × serum creatinine (mg/dl)
Females: 0.85 × above value
TABLE 2. Maintenance dosing schedule in adult patients with renal insufficiency*:
| Creatinine Clearance (mL/min) | Recommended Maintenance Schedule | |
|---|---|---|
| Very serious or life-threatening infections | Severe infections | |
| >50 | 2 g every 8 hours | 2 g every 12 hours |
| 30-50 | 2 g every 12 hours | 2 g every 24 hours |
| 11-29 | 2 g every 24 hours | 1 g every 24 hours |
| ≤10 | 1 g every 24 hours | 500 mg every 24 hours |
| Hemodialysis* | 500 mg every 24 hours | 500 mg every 24 hours |
* Pharmacokinetic modeling shows that reduced dosage is necessary for these patients. Dosage on hemodialysis patients taken cefepime should be as follows: First day of cefepime treatment, 1g loading dose and following this 500 mg/day forall infections. On dialysis days, Cefepime should be administered following dialysis.
* Pharmacokinetic modeling shows that reduced dosage is necessary for these patients. Dosage on hemodialysis patients taken cefepime should be as follows: First day of cefepime treatment, 1g loading dose and following this 500 mg/day for all infections. On dialysis days, Cefepime should be administered following dialysis.
In patients undergoing hemodialysis, approximately 68% of the cefepime present in the body at the start of dialysis is removed during 3-hour dialysis period. In patients performed ambulatory peritoneal dialysis, cefepime may be administered at the same doses recommended for patients with normal renal function, (i.e., 250 mg, 500 mg, 1 g or 2 g depending on the severity of the infection at every 48 hours).
Since urinary excretion is the primary route of elimination of cefepime in pediatric patients (see; section 5.2), an adjustment of the dosage of ROXIPIME is necessary in this population. If only serum creatinine is available, creatinine clearance may be estimated using either of the following methods:
Creatinine clearance (mL/min./1.73 m²) = 0.55 × height (cm) / serum creatinine (mg/dl) or
Creatinine clearance (ml/min./1.73 m²) = 0.52 × height (cm) / serum creatinine (mg/dl) – 3.6
Dosage adjustments is not required in hepatic impairment.
For detailed information, please see section regarding children in “Posology/frequency of administration and duration” section.
In clinical studies, in case of not existing renal impairment, in elderly patients taken the usual recommended adult dose, it is recorded that clinical efficacy and safety of ROXIPIME are not different from adults (See, Section 4.4).
In cases of severe overdose, especially in patients with renal dysfunction, cefepime may be removed from the body by hemodialysis. The peritoneal dialysis is not helpful. Accidental overdosing has occurred when high doses were given to patients with impaired renal function. (See, Section 4.2, 4.2 and 4.8). Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.
24 months.
Store at room temperature below 30ºC as powder.
Store in the original package in order to protect from light.
It should be used in 24 hours below 30ºC at room temperature, in 7 days at 2-8ºC (refrigerator) after reconstituted.
25 ml type II transparent glass vial with gray coloured bromobutyl rubber stopper fixed with transparent aluminum/plastic flip-off cap and ampoule containing 10 ml water for injection.
In addition, 10 vials hospital packaging is also available.
ROXIPIME powder should be prepared by using diluent volumes indicated in Table 7.
TABLE 7. Preparation of Solutions of ROXIPIME:
| Amount to be added for reconstitution (ml) | Approximate volume to be obtained (ml) | Approximate Cefepime Concentration (mg/ml) | |
|---|---|---|---|
| Intravenous 500 mg vial 1 g vial 2 g vial | 5 10 10 | 5.6 11.3 12.5 | 100 100 160 |
| 1 g vial 1 g vial 2 g vial 2 g vial | 50 100 50 100 | 50 100 50 100 | 20 10 40 20 |
The I.V. administration is preferable for patients with severe or life- threatening infections, particularly if the possibility of shock is present.
In direct IV. Administration, ROXIPIME is applied by dissolving in the amounts shown in the table above with sterile water for injection, 5% dextrose injection or 0.9% sodium chloride. It is applied directly to the vein within 3-5 minutes or it is injected to the application set in patients undergoing an appropriate IV solution infusion.
For intravenous infusion, 500 mg, 1 g and 2 g ROXIPIME vial should be prepared as indicated above, as for direct IV administration. Then, add required quantity of the solution obtained to an intravenous administration set including suitable I.V. fluid. The obtained solution should be administered over a period of approximately 30 minutes.
Intravenous: ROXIPIME is compatible at concentrations between 1 mg per mL and 40 mg per mL with the following intravenous infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection. These solutions should be used in 24 hours below 30ºC at room temperature, in 7 days (in a refrigerator) at 2-8°C after reconstituted.
Note: Visual partıculate matter control should be performed in parenteral drugs before administration and if there is particulate matter, drug should not be used.
As with other cephalosporins, the color of ROXIPIME powder and solution can get darker; however, this does not affect the drugs potency.
Any unused product or waste material should be disposed of in accordance with local requirements.
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