Oseltamivir Phosphate: Package Insert and Label Information

OSELTAMIVIR PHOSPHATE- oseltamivir phosphate for suspension
AvKARE, Inc

1 INDICATIONS AND USAGE

1.1 Treatment of Influenza

Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.

1.2 Prophylaxis of Influenza

Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.

1.3 Limitations of Use

  • Oseltamivir phosphate for oral suspension is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
  • Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate for oral suspension [see Microbiology (12.4)] .
  • Oseltamivir phosphate for oral suspension is not recommended for patients with end-stage renal disease not undergoing dialysis [see Dosage and Administration (2.4) and Use in Specific Populations (8.6)] .

2 DOSAGE AND ADMINISTRATION

2.1 Dosage and Administration Overview

Administer oseltamivir phosphate for oral suspension for the treatment of influenza in patients 2 weeks of age or older [see Dosage and Administration (2.2)] or for prophylaxis of influenza in patients 1 year and older [see Dosage and Administration (2.3)] using:

  • Oseltamivir phosphate for oral suspension (supplied as a powder). This is the preferred formulation (6 mg per mL) for patients who cannot swallow capsules. Prior to use, the supplied oseltamivir phosphate for oral suspension powder must be constituted with water by the pharmacist to produce the oral suspension [see Dosage and Administration (2.5)] .

The oral suspension may be taken with or without food; however, tolerability may be enhanced if oseltamivir phosphate for oral suspension is taken with food.

Adjust the oseltamivir phosphate for oral suspension dosage in patients with moderate or severe renal impairment [see Dosage and Administration (2.4)] .

For patients who cannot swallow capsules, oseltamivir phosphate for oral suspension is the preferred formulation. When oseltamivir phosphate for oral suspension is not available from wholesaler or the manufacturer, oseltamivir phosphate capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup, corn syrup, caramel topping, or light brown sugar (dissolved in water). During emergency situations and when neither the oral suspension nor the age-appropriate strengths of oseltamivir phosphate capsules to mix with sweetened liquids are available, then a pharmacist may prepare an emergency supply of oral suspension from oseltamivir phosphate 75 mg capsules [see Dosage and Administration (2.6)] .

2.2 Recommended Dosage for Treatment of Influenza

Initiate treatment with oseltamivir phosphate for oral suspension within 48 hours of influenza symptom onset.

Adults and Adolescents (13 years of age and older)

The recommended oral dosage of oseltamivir phosphate for oral suspension for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily (12.5 mL of oral suspension twice daily) for 5 days.

Pediatric Patients (2 weeks of age through 12 years of age)

Table 1 displays the recommended oral dosage of oseltamivir phosphate for oral suspension for treatment of influenza in pediatric patients 2 weeks of age through 12 years of age and provides information about prescribing the capsule or the formulation for oral suspension.

2.3 Recommended Dosage for Prophylaxis of Influenza

Initiate post-exposure prophylaxis with oseltamivir phosphate for oral suspension within 48 hours following close contact with an infected individual. Initiate seasonal prophylaxis with oseltamivir phosphate for oral suspension during a community outbreak.

Adults and Adolescents (13 years of age and older)

The recommended dosage of oseltamivir phosphate for oral suspension for prophylaxis of influenza in adults and adolescents 13 years and older is 75 mg orally once daily (12.5 mL of oral suspension once daily) for at least 10 days following close contact with an infected individual and up to 6 weeks during a community outbreak. In immunocompromised patients, oseltamivir phosphate for oral suspension may be continued for up to 12 weeks [see Use in Specific Populations (8.9)] . The duration of protection lasts for as long as oseltamivir phosphate for oral suspension dosing is continued.

Pediatric Patients (1 year to 12 years of age)

Table 1 displays the recommended oral dosage of oseltamivir phosphate for oral suspension for prophylaxis of influenza in pediatric patients 1 year to 12 years of age based on body weight and provides information about prescribing the capsule or the formulation for oral suspension. Prophylaxis in pediatric patients is recommended for 10 days following close contact with an infected individual and up to 6 weeks during a community outbreak [see Use in Specific Populations (8.4) and Clinical Studies (14.2)] .

Table 1 Oseltamivir Phosphate Dosage Recommendations in Pediatric Patients for Treatment and Prophylaxis of Influenza

Weight

Treatment Dosage for 5 days

Prophylaxis Dosage for 10 days*

Volume of Oral Suspension (6 mg/mL) for each Dose

Number of Bottles of Oral Suspension to Dispense

Number of Capsules to Dispense (Strength)

Patients from 2 Weeks to less than 1 Year of Age

Any weight

3 mg/kg twice daily

Not applicable

0.5 mL/kg §

1 bottle

Not applicable

Patients 1 to 12 Years of Age Based on Body Weight

15 kg or less

30 mg twice daily

30 mg once daily

5 mL

1 bottle

10 capsules (30 mg)

15.1 kg to 23 kg

45 mg twice daily

45 mg once daily

7.5 mL

2 bottles

10 capsules (45 mg)

23.1 kg to 40 kg

60 mg twice daily

60 mg once daily

10 mL

2 bottles

20 capsules (30 mg)

40.1 kg or more

75 mg twice daily

75 mg once daily

12.5 mL

3 bottles

10 capsules (75 mg)

* The recommended duration for post-exposure prophylaxis is 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). The amount supplied (e.g., number of bottles or capsules) for seasonal prophylaxis may be greater than for post-exposure prophylaxis.

Use an oral dosing dispensing device that measures the appropriate volume in mL with the oral suspension.

Oseltamivir phosphate for oral suspension is the preferred formulation for patients who cannot swallow capsules.

§ For patients less than 1 year of age, provide an appropriate dosing device that can accurately measure and administer small volumes.

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).

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