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OSELTAMIVIR is a brand name for Oseltamivir, supplied as a powder for suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of Influenza Oseltamivir Powder for Oral Suspension (oseltamivir phosphate) is indicated for: • The treatment of uncomplicated acute illness due to influenza infection in adults and adolescents (≥ 13 years) who have been symptomatic for no more than 2 days. The treatment indication is based on two Phase III…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Hepatic Impairment: The safety, efficacy and pharmacokinetics in patients with severe hepatic impairment have not been studied. No studies have been carried out in pediatric patients with hepatic impairment.
• Infants: The efficacy of oseltamivir phosphate in infants younger than 1 year of age has not been established. Oseltamivir Powder for Oral Suspension should not be used in children under 1 year of age (see 16 NON- CLINICAL TOXICOLOGY, General Toxicology, Multiple Dose Toxicity).
2 Recommended Dose and Dosage Adjustment, Dosage Adjustment. 2 Recommended Dose and Dosage Adjustment Recommended Dose – Treatment of Influenza Treatment should begin no more than two days after the onset of symptoms of influenza. 5 mL oral suspension) twice daily, for 5 days.
Pediatrics (1 to 12 years):
The recommended oral dose of Oseltamivir Powder for Oral Suspension for pediatric patients 1 year and older is shown in the table below. 5 mL twice daily Use appropriate oral dosing dispenser for volume dispensed with the oral suspension.
In the event that the dispenser provided is lost or damaged, another dosing dispenser may be used to deliver the volumes. Recommended Dose – Prevention of Influenza Therapy should begin within 2 days of exposure after the onset of symptoms in the index case and continue for at least ten days.
Viral shedding may continue for up to 14 days in children and elderly after the onset of influenza illness. Therefore, if the index case is a child or an elderly person, therapy with Oseltamivir Powder for Oral Suspension for prevention may continue for up to 14 days.
Patients should be instructed to complete the entire course of therapy. 5 mL oral suspension) once daily. Safety has been demonstrated for up to 12 weeks in immunocompromised patients.
Pediatrics (1 to 12 years):
The recommended dose of Oseltamivir Powder for Oral Suspension for prevention in pediatric patients 1 year and older is shown in the table below. 5 mL once daily Use appropriate oral dosing dispenser for volume dispensed with the oral suspension.
In the event that the dispenser provided is lost or damaged, another dosing dispenser may be used to deliver the volumes. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency).
Renal Impairment:
No dose adjustment is necessary for patients with creatinine clearance above 60 mL/min. Dosage adjustments for adult patients with creatinine clearance ≤ 60 mL/min are as indicated below. Note that the dosage adjustments are based primarily on population pharmacokinetic modeling data.
Clinical safety and efficacy studies at these doses have not been performed. PrOseltamivir Powder for Oral Suspension (oseltamivir phosphate) Page 7 of 44 Treatment of Influenza: In adult patients with a creatinine clearance of > 30-60 mL/min, it is recommended that the dose be reduced to 30 mg of Oseltamivir Powder for Oral Suspension twice daily for 5 days.
In adult patients with a creatinine clearance of 10-30 mL/min, it is recommended that the dose be reduced to 30 mg of Oseltamivir Powder for Oral Suspension once daily for 5 days.
Treatment of Influenza for patients undergoing routine hemodialysis:
In adult patients, an initial dose of 30 mg of Oseltamivir Powder for Oral Suspension can be administered prior to the start of dialysis if influenza symptoms develop during the 48 hours between dialysis sessions. To maintain plasma concentrations at a therapeutic level, a dose of 30 mg of Oseltamivir Powder for Oral Suspension should be administered after every hemodialysis session, over a period of 5 days.
For adult patients on continuous ambulatory peritoneal dialysis (CAPD), a single 30 mg dose of Oseltamivir Powder for Oral Suspension administered prior to the start of dialysis is recommended for treatment.
Prevention of influenza:
In adult patients with a creatinine clearance of > 30-60 mL/min, it is recommended that the dose be reduced to 30 mg of Oseltamivir Powder for Oral Suspension once daily for 10-14 days. In adult patients with a creatinine clearance of 10-30 mL/min, it is recommended that the dose be reduced to 30 mg of Oseltamivir Powder for Oral Suspension every other day for a period of 10-14 days.
Prevention of Influenza for patients undergoing routine hemodialysis:
In adult patients, an initial dose of 30 mg of Oseltamivir Powder for Oral Suspension can be administered prior to the start of dialysis. To maintain plasma concentrations at a therapeutic level, a dose of 30 mg should be administered after […]
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging For management of a suspected drug overdose, contact your regional poison control centre. PrOseltamivir Powder for Oral Suspension (oseltamivir phosphate) Page 9 of 44 Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Powder for Oral Suspension / 6 mg/mL oseltamivir (as oseltamivir phosphate) when reconstituted Monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti-frutti flavouring and xanthan gum.
Oseltamivir Powder for Oral Suspension (6 mg/mL) Oseltamivir Powder for Oral Suspension contains 360 mg oseltamivir as oseltamivir phosphate per bottle, which when reconstituted contains 60 mL of suspension at a final concentration of 6 mg/mL oseltamivir.
345 g of sorbitol. 364 g of sorbitol which is unsuitable for subjects with hereditary fructose intolerance (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism). Oseltamivir Powder for Oral Suspension is available as a white powder blend for reconstitution to a white tutti-frutti-flavoured suspension.
Available in 100 mL glass bottles with a bottle adapter and 1 oral dispenser. Net contents after reconstitution: 60 mL containing oseltamivir phosphate equivalent to 360 mg oseltamivir base. 7 WARNINGS AND PRECAUTIONS General No increased efficacy was demonstrated in adult subjects receiving 150 mg oseltamivir phosphate twice daily for 5 days compared to those receiving 75 mg twice daily for the treatment of influenza.
There is no evidence for efficacy of oseltamivir phosphate in any illness caused by agents other than influenza viruses Types A and B. Data on treatment of influenza B are limited. Efficacy of oseltamivir phosphate in patients who begin treatment after 48 hours of symptoms has not been established.
Efficacy of oseltamivir phosphate in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population.
No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization. Safety and efficacy of repeated treatment or prevention courses have not been studied.
Efficacy of oseltamivir phosphate for treatment or prevention of influenza in immunocompromised patients has not been established. 345 g of sorbitol. 364 g of sorbitol, which is unsuitable for subjects with hereditary fructose intolerance.
PrOseltamivir Powder for Oral Suspension (oseltamivir phosphate) Page 10 of 44 Hepatic/Biliary/Pancreatic There have been post-marketing reports of elevated liver enzymes and hepatotoxicity including fulminant hepatitis/hepatic failure, in some cases with fatal outcome, where a causal relationship with oseltamivir could not be excluded, especially in patients with pre-existing liver disease.
2 Recommended Dose and Dosage Adjustment, Dosage Adjustment, Hepatic Impairment). Neuropsychiatric There have been post-marketing reports of delirium and self-injury, in some cases resulting in fatal outcomes, in patients with influenza who were receiving oseltamivir phosphate.
Because these events were reported voluntarily during clinical practice, estimate of frequency cannot be made but they appear to be uncommon based on oseltamivir phosphate usage data. These events were reported primarily among pediatric patients.
The contribution of oseltamivir phosphate to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behaviour. 5 Post-Market Adverse Drug Reactions, Neurologic, and Psychiatric).
Influenza can be associated with a variety of neurologic and behavioural symptoms, which can include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy, but can occur without obvious severe disease.
2 Recommended Dose and Dosage Adjustment, Dosage Adjustment, Renal Impairment. , creatinine clearance of < 10 mL/min) not undergoing dialysis. Hence, dosing recommendation cannot be provided for this group. 4% (5/1245) respectively in adult/adolescent patients.
In children with naturally acquired influenza virus infection, resistance was determined in 6 clinical studies WV15731 (0%; 0/5), WV15758 (8%; 15/183), WV15759/WV15871 (0%, 0/60), JV16284 (19%, 8/43), WV16193 (0%, 0/147), NV16871 (8%, 2/26).
4% (25/464) based on phenotyping and genotyping (full genotyping was not performed on all […]
3 Pediatrics and 14 CLINICAL TRIALS); therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥ 65 years of age): Efficacy of oseltamivir phosphate in the treatment of elderly patients has not been evaluated.
Safety data in 372 elderly patients ( 65 years old) showed no overall difference between these subjects and younger adults. 3 Pharmacokinetics, Special Populations and Conditions, Geriatrics). 2 CONTRAINDICATIONS • Oseltamivir Powder for Oral Suspension (oseltamivir phosphate) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations • Hepatic Impairment: The safety, efficacy and pharmacokinetics in patients with severe hepatic impairment have not been studied.
No studies have been carried out in pediatric patients with hepatic impairment. • Infants: The efficacy of oseltamivir phosphate in infants younger than 1 year of age has not been established. Oseltamivir Powder for Oral Suspension should not be used in children under 1 year of age (see 16 NON- CLINICAL TOXICOLOGY, General Toxicology, Multiple Dose Toxicity).
2 Recommended Dose and Dosage Adjustment, Dosage Adjustment. 2 Recommended Dose and Dosage Adjustment Recommended Dose – Treatment of Influenza Treatment should begin no more than two days after the onset of symptoms of influenza. 5 mL oral suspension) twice daily, for 5 days.
Pediatrics (1 to 12 years):
The recommended oral dose of Oseltamivir Powder for Oral Suspension for pediatric patients 1 year and older is shown in the table below. 5 mL twice daily Use appropriate oral dosing dispenser for volume dispensed with the oral suspension.
In the event that the dispenser provided is lost or damaged, another dosing dispenser may be used to deliver the volumes. Recommended Dose – Prevention of Influenza Therapy should begin within 2 days of exposure after the onset of symptoms in the index case and continue for at least ten days.
Viral shedding may continue for up to 14 days in children and elderly after the onset of influenza illness. Therefore, if the index case is a child or an elderly person, therapy with Oseltamivir Powder for Oral Suspension for prevention may continue for up to 14 days.
Patients should be instructed to complete the entire course of therapy. 5 mL oral suspension) once daily. Safety has been demonstrated for up to 12 weeks in immunocompromised patients.
Pediatrics (1 to 12 years):
The recommended dose of Oseltamivir Powder for Oral Suspension for prevention in pediatric patients 1 year and older is shown in the table below. 5 mL once daily Use appropriate oral dosing dispenser for volume dispensed with the oral suspension.
In the event that the dispenser provided is lost or damaged, another dosing dispenser may be used to deliver the volumes. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency).
Renal Impairment:
No dose adjustment is necessary for patients with creatinine clearance above 60 mL/min. Dosage adjustments for adult patients with creatinine clearance ≤ 60 mL/min are as indicated below. Note that the dosage adjustments are based primarily on population pharmacokinetic modeling data.
Clinical safety and efficacy studies at these doses have not been performed. PrOseltamivir Powder for Oral Suspension (oseltamivir phosphate) Page 7 of 44 Treatment of Influenza: In adult patients with a creatinine clearance of > 30-60 mL/min, it is recommended that the dose be reduced to 30 mg of Oseltamivir Powder for Oral Suspension twice daily for 5 days.
In adult patients with a creatinine clearance of 10-30 mL/min, it is recommended that the dose be reduced to 30 mg of Oseltamivir Powder for Oral Suspension once daily for 5 days.
Treatment of Influenza for patients undergoing routine hemodialysis:
In adult patients, an initial dose of 30 mg of Oseltamivir Powder for Oral Suspension can be administered prior to the start of dialysis if influenza symptoms develop during the 48 hours between dialysis sessions. To maintain plasma concentrations at a therapeutic level, a dose of 30 mg of Oseltamivir Powder for Oral Suspension […]
• Oseltamivir Powder for Oral Suspension (oseltamivir phosphate) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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