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SANDOZ OSELTAMIVIR is a brand name for Oseltamivir, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of Influenza Sandoz Oseltamivir (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 clinical studies of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations PrSandoz Oseltamivir (oseltamivir phosphate) Page 6 of 45 • 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. Sandoz Oseltamivir 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.
Note:
Sandoz Oseltamivir is only available as capsules (30 mg, 45 mg and 75 mg). However, for pediatric patients over 1 year old as well as adults who have difficulties swallowing capsules, the capsule may be opened for appropriate dosing (see below and Emergency Compounding of an Oral Suspension from Sandoz Oseltamivir).
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.
Adults and Adolescents (≥ 13 years):
The recommended oral dose of Sandoz Oseltamivir for the treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily, for 5 days.
Pediatrics (1 to 12 years):
For children old enough to safely swallow Sandoz Oseltamivir, the doses can be taken as outlined in the table below. For children who cannot swallow capsules, the capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup.
Body Weight in kg Body Weight in lbs Recommended Dose for 5 Days ≤15 kg ≤ 33 lbs 30 mg twice daily > 15 kg to 23 kg > 33 lbs to 51 lbs 45 mg twice daily > 23 kg to 40 kg > 51 lbs to 88 lbs 60 mg twice daily > 40 kg > 88 lbs 75 mg twice daily 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 Sandoz Oseltamivir for prevention may continue for up to 14 days.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 4 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral Capsules / 30 mg, 45 mg and 75 mg oseltamivir (as oseltamivir phosphate) Black ink, croscarmellose sodium, gelatin, iron oxide black, iron oxide yellow (30 mg and 75 mg), iron oxide red (75 mg), isopropyl alcohol, povidone, pregelatinized maize starch, sodium lauryl sulfate (SLS)(75 mg), sodium stearyl fumarate, talc, and titanium dioxide.
For management of a suspected drug overdose, contact your regional poison control centre. PrSandoz Oseltamivir (oseltamivir phosphate) Page 14 of 45 Sandoz Oseltamivir is available as capsules containing 30 mg, 45 mg or 75 mg oseltamivir for oral use in the form of oseltamivir phosphate.
Sandoz Oseltamivir 30 mg capsules are available as hard gelatin capsules with light yellow opaque cap/body printed with “30” on cap and “OP” on the body in black ink. Sandoz Oseltamivir 45 mg capsules are available as hard gelatin capsules with grey opaque cap/body printed with “45” on cap and “OP” on body in black.
Sandoz Oseltamivir 75 mg capsules are available as hard gelatin capsules with cream cap and brown body printed with “OP” on cap and “75” printed on body. All three capsule strengths are available in blister packages of 10. 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.
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 • Sandoz Oseltamivir 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 PrSandoz Oseltamivir (oseltamivir phosphate) Page 6 of 45 • 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. Sandoz Oseltamivir 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.
Note:
Sandoz Oseltamivir is only available as capsules (30 mg, 45 mg and 75 mg). However, for pediatric patients over 1 year old as well as adults who have difficulties swallowing capsules, the capsule may be opened for appropriate dosing (see below and Emergency Compounding of an Oral Suspension from Sandoz Oseltamivir).
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.
• Sandoz Oseltamivir 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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PrSandoz Oseltamivir (oseltamivir phosphate) Page 7 of 45 Patients should be instructed to complete the entire course of therapy.
Adults and adolescents (≥ 13 years):
The recommended oral dose of Sandoz Oseltamivir for prevention of influenza following close contact with an infected individual (the index case) is 75 mg once daily. Safety has been demonstrated for up to 12 weeks in immunocompromised patients.
Pediatrics (1 to 12 years):
For children old enough to safely swallow Sandoz Oseltamivir, the doses can be taken as outlined in the table below. For children who cannot swallow capsules, the capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup.
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.
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 Sandoz Oseltamivir 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 Sandoz Oseltamivir once daily for 5 days.
Treatment of Influenza for patients undergoing routine hemodialysis:
In adult patients an initial dose of 30 mg of Sandoz Oseltamivir 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 Sandoz Oseltamivir 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 Sandoz Oseltamivir 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 Sandoz Oseltamivir 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 Sandoz Oseltamivir 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 […]
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. 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- PrSandoz Oseltamivir (oseltamivir phosphate) Page 15 of 45 existing liver disease.
2 Recommended Dose and 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, 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 patients). The patients cleared the virus normally and showed no clinical deterioration. PrSandoz Oseltamivir (oseltamivir phosphate) Page 16 of 45 There has been no evidence for emergence of drug resistance associated with the use of oseltamivir phosphate in clinical studies conducted to date in post-exposure (7 days), post- exposure within the household groups (10 days) and seasonal (42 days) prophylaxis of influenza in […]
Adults and Adolescents (≥ 13 years):
The recommended oral dose of Sandoz Oseltamivir for the treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily, for 5 days.
Pediatrics (1 to 12 years):
For children old enough to safely swallow Sandoz Oseltamivir, the doses can be taken as outlined in the table below. For children who cannot swallow capsules, the capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup.
Body Weight in kg Body Weight in lbs Recommended Dose for 5 Days ≤15 kg ≤ 33 lbs 30 mg twice daily > 15 kg to 23 kg > 33 lbs to 51 lbs 45 mg twice daily > 23 kg to 40 kg > 51 lbs to 88 lbs 60 mg twice daily > 40 kg > 88 lbs 75 mg twice daily 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 Sandoz Oseltamivir for prevention may continue for up to 14 days.
PrSandoz Oseltamivir (oseltamivir phosphate) Page 7 of 45 Patients should be instructed to complete the entire course of therapy.
Adults and adolescents (≥ 13 years):
The recommended oral dose of Sandoz Oseltamivir for prevention of influenza following close contact with an infected individual (the index case) is 75 mg once daily. Safety has been demonstrated for up to 12 weeks in immunocompromised patients.
Pediatrics (1 to 12 years):
For children old enough to safely swallow Sandoz Oseltamivir, the doses can be taken as outlined in the table below. For children who cannot swallow capsules, the capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup.
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.
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 Sandoz Oseltamivir 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 Sandoz Oseltamivir once daily for 5 days.
Treatment of Influenza for patients undergoing routine hemodialysis:
In adult patients an initial dose of 30 mg of Sandoz Oseltamivir can be […]