Oseltamivir Phosphate (Page 2 of 9)

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 to 90 mL/minute)

75 mg twice daily for 5 days

75 mg once daily

Moderate (> 30 to 60 mL/minute)

30 mg twice daily for 5 days

30 mg once daily

Severe (> 10 to 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 is not recommended

Oseltamivir phosphate is 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.

2.5 Preparation and Storage of Constituted Oseltamivir Phosphate for Oral Suspension

Prior to dispensing to the patient, constitute oseltamivir phosphate for oral suspension (supplied as powder):

a) Tap the closed bottle containing the supplied oseltamivir phosphate for oral suspension white to off-white colored powder several times to loosen the powder.

b) Measure 55 mL of water in a graduated cylinder.

c) Add the total amount of water for constitution to the bottle.

d) Close bottle with child-resistant cap tightly and shake the closed bottle well for 15 seconds.

e) Label the bottle with instructions to “Shake Well Before Use”.

f) The constituted oral suspension contains 360 mg of oseltamivir base per 60 mL of volume (6 mg per mL) and is white to off-white colored, tutti-frutti-flavored). Use the constituted oral suspension within 17 days of preparation when stored under refrigeration, 2º to 8ºC (36º to 46ºF), or within 10 days if stored at controlled room temperature, 25ºC (77ºF). Write the expiration date of the constituted oral suspension on the bottle label.

g) Ensure patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize the oral dosing dispenser and correctly measure the oral suspension as prescribed (see Tables 1 and 2).

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 oral suspension 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 oral suspension 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 for Oral Suspension Dose

Oseltamivir Phosphate for Oral Suspension 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 for oral suspension 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 75 mg Capsules 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 75 mg Capsules (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 75 mg capsules into the PET or glass bottle.

c. Gently swirl the suspension to ensure adequate wetting of the oseltamivir phosphate 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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