Oseltamivir Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Influenza

75 mg orally twice a day for 5 days

Approved indication: Treatment of acute, uncomplicated influenza infection in patients symptomatic no more than 48 hours

Usual Adult Dose for Influenza Prophylaxis

Following close contact with an infected individual: 75 mg orally once a day for at least 10 days
During a community outbreak of influenza: 75 mg orally once a day

Comments:
-Therapy should begin within 48 hours of exposure.
-Safety and efficacy have been established for up to 6 weeks in immunocompetent patients; duration of protection lasts as long as dosing is continued.
-Safety has been established for up to 12 weeks in immunocompromised patients.

Usual Pediatric Dose for Influenza

2 weeks to less than 1 year: 3 mg/kg orally twice a day

1 through 12 years:
15 kg or less: 30 mg orally twice a day
15.1 through 23 kg: 45 mg orally twice a day
23.1 through 40 kg: 60 mg orally twice a day
40.1 kg or greater: 75 mg orally twice a day

13 years or older: 75 mg orally twice a day

Duration of therapy: 5 days

Approved indication: Treatment of acute, uncomplicated influenza infection in patients (2 weeks or older) symptomatic no more than 48 hours

(Not approved by FDA)

American Academy of Pediatrics (AAP) recommendations:
Full-term infants less than 2 weeks: 3 mg/kg orally twice a day

Usual Pediatric Dose for Influenza Prophylaxis

1 through 12 years:
15 kg or less: 30 mg orally once a day
15.1 through 23 kg: 45 mg orally once a day
23.1 through 40 kg: 60 mg orally once a day
40.1 kg or greater: 75 mg orally once a day

13 years or older: 75 mg orally once a day

Duration of therapy:
-After close contact with an infected individual: 10 days
-During a community outbreak of influenza: May be continued for up to 6 weeks

Comments:
-Therapy should begin within 48 hours of exposure.
-The FDA has not approved dosing for patients less than 1 year of age.

(Not approved by FDA)

AAP recommendations for full-term infants:
Less than 3 months: Not recommended unless situation judged critical.
3 months to less than 1 year: 3 mg/kg orally once a day

Renal Dose Adjustments

Adults:
CrCl 10 to 30 mL/min:
Influenza treatment: 75 mg orally once a day for 5 days
Influenza prophylaxis: 75 mg orally every other day or 30 mg orally once a day

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh score 9 or less): No adjustment recommended.
Severe liver dysfunction: Data not available

Precautions

Consult WARNINGS section for dosing related precautions.

Safety and effectiveness for treatment of influenza have not been established in pediatric patients less than 2 weeks of age. Safety and effectiveness for prophylaxis of influenza have not been established in pediatric patients less than 1 year of age. In June 2010, the Emergency Use Authorization from the FDA (which allowed the use of oseltamivir in children less than 1 year of age) expired.

Dialysis

Patients with end-stage renal disease undergoing routine hemodialysis or continuous peritoneal dialysis: Data not available

Other Comments

Administration advice:
-Oseltamivir therapy should be initiated within 48 hours after the onset of influenza symptoms or within 48 hours of exposure.
-Oseltamivir may be taken without regard to food; administration with food may improve tolerability in some patients.
-Oseltamivir oral suspension is preferred for patients unable to swallow capsules.
-Oseltamivir oral suspension (commercial or emergency compounded) should be shaken well before each use; unused portions should be discarded after the completion of therapy.
-Missed doses should be taken as soon as the patient remembers except if it is within 2 hours of the next scheduled dose. The patient should then continue to take oseltamivir at the usual times.

Storage requirements:
-The constituted oseltamivir oral suspension should be used within 17 days of preparation when refrigerated (freezing should be avoided) or within 10 days when stored at controlled room temperature.
-The emergency compounded oral suspension (6 mg/mL) is stable for 35 days when refrigerated or 5 days when stored at room temperature.

Reconstitution/preparation techniques:
-The manufacturer's prescribing information should be consulted for preparation of oseltamivir for oral suspension. The oral suspension should be constituted by the pharmacist prior to dispensing to the patient.
-If oseltamivir oral suspension is unavailable: Oseltamivir capsules may be opened and mixed with sweetened liquids such as chocolate syrup (regular or sugar-free), corn syrup, caramel topping, or light brown sugar (dissolved in water).
-If the appropriate strengths of oseltamivir capsules are not available to mix with sweetened liquids and the oral suspension is unavailable: An emergency supply of oral suspension may be compounded from oseltamivir 75 mg capsules.

During emergency situations only:
-If commercial oseltamivir oral suspension is not available, emergency compounded oral suspension (6 mg/mL), enough for 1 patient's treatment for 5 days or prophylaxis for 10 days, may be prepared from oseltamivir 75 mg capsules as follows:
1. Determine the dose of oseltamivir for the patient then determine the total volume of an oral suspension necessary to be compounded; if the dose is between the listed doses, the total volume of oral suspension to compound should default to the next greater dose listed.
Dose of 15 mg or less: 37.5 mL total volume
Dose of 30 mg: 75 mL total volume
Dose of 45 mg: 100 mL total volume
Dose of 60 mg: 125 mL total volume
Dose of 75 mg: 150 mL total volume

2. Determine the number of oseltamivir 75 mg capsules, the amount of water, and the amount of vehicle (Cherry Syrup, Ora-Sweet(R) SF, or simple syrup) necessary to prepare the total volume of compounded oral suspension (6 mg/mL).
37.5 mL total volume: 3 capsules (225 mg oseltamivir) plus 2.5 mL water plus 34.5 mL vehicle
75 mL total volume: 6 capsules (450 mg oseltamivir) plus 5 mL water plus 69 mL vehicle
100 mL total volume: 8 capsules (600 mg oseltamivir) plus 7 mL water plus 91 mL vehicle
125 mL total volume: 10 capsules (750 mg oseltamivir) plus 8 mL water plus 115 mL vehicle
150 mL total volume: 12 capsules (900 mg oseltamivir) plus 10 mL water plus 137 mL vehicle

3. Use the following procedure to compound the oral suspension (6 mg/mL) from oseltamivir 75 mg capsules:
(a) Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle.
(b) Separate the capsule body from the cap and place the contents of the necessary number of oseltamivir 75 mg capsules into the PET or glass bottle.
(c) Gently swirl the suspension to ensure adequate wetting of the oseltamivir powder for at least 2 minutes.
(d) Slowly add the specified amount of vehicle to the bottle.
(e) Use a child-resistant cap to close the bottle 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, is soluble in the specified vehicles but some of the inert ingredients are insoluble, causing the suspension.

General:
-(July 2011) The concentration of oseltamivir oral suspension has been changed from 12 mg/mL to 6 mg/mL. FDA recommended that prescribers include the new concentration (6 mg/mL) and dose in mL on all prescriptions for oseltamivir oral suspension.
-The dosing device dispensed with the oseltamivir 12 mg/mL oral suspension should not be used with the emergency compounded oral suspension (6 mg/mL) due to the difference in concentration.
-For patients less than 1 year, the dosing device provided with the oseltamivir 6 mg/mL oral suspension should be removed; an appropriate dosing device that can accurately measure and administer small volumes should be provided.
-The sorbitol content in one 75 mg dose of the oral suspension is 2 g, which exceeds the daily maximum limit in patients with hereditary fructose intolerance.

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