Oseltamavir Phosphate (Page 2 of 8)

2.4 Dosage in Patients with Renal Impairment

Table 2 displays the dosage recommendations for the treatment and prophylaxis of influenza in adults with various stages of renal impairment (estimated creatinine clearance of less than or equal to 90 mL per minute). Dosage modifications are recommended in adults with an estimated creatinine clearance less than or equal to 60 mL per minute [ see Use in Specific Population ( 8.6) and Clinical Pharmacology ( 12.3) ].
Table 2 Recommended Dosage Modifications for Treatment and Prophylaxis of Influenza in Adults with Renal Impairment or End Stage Renal Disease (ESRD) on Dialysis

Renal Impairment (Creatinine Clearance) Recommended Treatment Regimen * Recommended Prophylaxis Regimen*†
Mild (>60-90 mL/minute) 75 mg twice daily for 5 days 75 mg once daily
Moderate (>30-60 mL/minute) 30 mg twice daily for 5 days 30 mg once daily
Severe (>10-30 mL/minute) 30 mg once daily for 5 days 30 mg every other day
ESRD Patients on Hemodialysis (≤10 mL/minute) 30 mg immediately and then 30 mg after every hemodialysis cycle (treatment duration not to exceed 5 days) 30 mg immediately and then 30 mg after alternate hemodialysis cycles
ESRD Patients on Continuous Ambulatory Peritoneal Dialysis‡ (≤10 mL/minute) A single 30 mg dose administered immediately 30 mg immediately and then 30 mg once weekly
ESRD Patients not on Dialysis Oseltamivir phosphate capsules are not recommended Oseltamivir phosphate capsules are not recommended

* Capsules or oral suspension can be used for 30 mg dosing.
† The recommended duration for post-exposure prophylaxis is at least 10 days and the recommended duration for community outbreak (seasonal/pre-exposure) prophylaxis is up to 6 weeks (or up to 12 weeks in immunocompromised patients).
‡ Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients.

2.6 Emergency Preparation of Oral Suspension from 75 mg Oseltamivir Phosphate Capsules

The following directions are provided for use only during emergency situations and when FDA-approved, commercially manufactured oseltamivir phosphate for oral suspension is not available from wholesalers or the manufacturer.
The following emergency preparation instructions will provide one patient with enough oseltamivir phosphate for a 5-day course of treatment of influenza or a 10-day course of prophylaxis of influenza:
Step #1: Determine the dosage of oseltamivir phosphate for the patient [ see Dosage and Administration ( 2.2, 2.3, and 2.4) ] then determine the total volume of oral suspension needed to be prepared (see Table 3). Table 3 Emergency Preparation: Volume of Prepared Oral Suspension (6 mg per mL) Based Upon Oseltamivir Phosphate Dose

Oseltamivir Phosphate Dose* Total Volume to Prepare per Patient
15 mg or less 37.5 mL
30 mg 75 mL
45 mg 100 mL
60 mg 125 mL
75 mg 150 mL

* If the oseltamivir phosphate dose is between the doses listed, use the greater listed dose to determine the total volume of prepared oral suspension.
Step #2: Preparation must be performed with only one of the following vehicles (other vehicles have not been studied): Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Determine the number of capsules and the amount of water and vehicle needed to prepare the total volume (see Table 3) of prepared oral suspension (6 mg per mL) for a complete treatment or prophylaxis course (see Table 4). Table 4 Emergency Preparation: Number of Oseltamivir Phosphate Capsules 75 mg and Amount of Water and Vehicle Needed to Prepare the Total Volume of a Prepared Oral Suspension (6 mg per mL)

Total Volume of Prepared Oral Suspension 37.5 mL 75 mL 100 mL 125 mL 150 mL
Number of Oseltamivir Phosphate Capsules 75 mg (Total Strength)* 3 (225 mg) 6 (450 mg) 8 (600 mg) 10 (750 mg) 12 (900 mg)
Amount of Water 2.5 mL 5 mL 7 mL 8 mL 10 mL
Volume of Vehicle Cherry Syrup (Humco ®) OR Ora-Sweet ® SF (Paddock Laboratories) OR simple syrup 34.5 mL 69 mL 91 mL 115 mL 137 mL

*Includes overage to ensure all doses can be delivered
Step #3: Follow the instructions below for preparing the 75 mg oseltamivir phosphate capsules to produce the oral suspension (6 mg per mL):

a. Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle (see Table 4). Constitution in other bottle types is not recommended because there is no stability data with other bottle types.
b. Carefully separate the capsule body and cap and pour the contents of the required number of oseltamivir phosphate capsules 75 mg into the PET or glass bottle.
c. Gently swirl the suspension to ensure adequate wetting of the oseltamivir phosphate capsules powder for at least 2 minutes.
d. Slowly add the specified amount of vehicle to the bottle.
e. Close the bottle using a child-resistant cap and shake well for 30 seconds to completely dissolve the active drug and to ensure homogeneous distribution of the dissolved drug in the resulting suspension. The active drug, oseltamivir phosphate, readily dissolves in the specified vehicles. The suspension is caused by inert ingredients of oseltamivir phosphate capsules which are insoluble in these vehicles.
f. Put an ancillary label on the bottle indicating “Shake Well Before Use.”
g. Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions.
h. Place a pharmacy label on the bottle that includes the patient’s name, dosing instructions, drug name and any other required information to be in compliance with all State and Federal Pharmacy Regulations. Place an appropriate expiration date on the label according to storage conditions below.
i. Include the recommended dosage on the pharmacy label as per Tables 1 and 2 [ see Dosage and Administration ( 2.2, 2.3, and 2.4) ].
j. Store the prepared oral suspension in glass or PET bottles either:
• In a refrigerator [2° to 8°C (36° to 46°F)]: Stable for 5 weeks when stored in a refrigerator.
• At room temperature [25°C (77°F)]: Stable for 5 days when stored at room temperature.

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