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NAT-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 NAT-OSELTAMIVIR (oseltamivir phosphate, capsules and powder for oral suspension) 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…
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. NAT-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. 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 NAT-OSELTAMIVIR capsules 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):
The recommended oral dose of NAT-OSELTAMIVIR oral suspension for pediatric patients 1 year and older is shown in the table below. NAT-OSELTAMIVIR oral suspension may also be used by adult patients who cannot swallow a capsule. If oseltamivir phosphate oral suspension is not available, NAT-OSELTAMIVIR capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup.
For children old enough to safely swallow capsules, the 30 and 45 mg capsules can also be taken as outlined in the table below. 5 mL twice daily Use appropriate oral dosing dispenser for volume dispensed with the oral suspension; the 75 mg dose can be measured using a combination of 30 mg and 45 mg.
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 NAT-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 For management of a suspected drug overdose, contact your regional poison control centre. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Capsule / 30 mg, 45 mg and 75 mg oseltamivir (as oseltamivir phosphate) Croscarmellose sodium, povidone K30, pregelatinized starch, sodium stearyl fumarate and talc.
The 30 mg capsule shell contains gelatin, red iron oxide, titanium dioxide and yellow iron oxide. The 45 mg capsule shell contains black iron oxide, gelatin and titanium dioxide. The 75 mg capsule shell contains black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide.
Each capsule is printed with blue ink, which includes FD&C Blue No. 2 aluminum lake, propylene glycol and shellac. Oral Powder for Oral Suspension / 6 mg/mL oseltamivir (as oseltamivir phosphate) when reconstituted Colloidal silicon dioxide.
monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti-frutti flavouring and xanthan gum. PrNAT-OSELTAMIVIR (Oseltamivir phosphate) Page 13 of 48 NAT-OSELTAMIVIR (oseltamivir phosphate) 30 mg, 45 mg and 75 mg Capsules NAT-OSELTAMIVIR 30 mg capsules are available as white to off white powder filled in size ‘4’ capsules with yellow colour cap imprinted with ‘30 mg’ with blue colour ink and yellow colour body imprinted with ‘NAT’ with blue colour ink.
NAT-OSELTAMIVIR 45 mg capsules are available as white to off white powder filled in size ‘4’ capsules with grey colour cap imprinted with ‘45 mg’ with blue colour ink and grey colour body imprinted with ‘NAT’ with blue colour ink. NAT-OSELTAMIVIR 75 mg capsules are available as white to off white powder filled in size ‘2’ capsules with yellow colour cap imprinted with “75 mg” with blue colour ink and grey colour body imprinted with “NAT” with blue colour ink.
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 • NAT-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 • 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. NAT-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. 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 NAT-OSELTAMIVIR capsules 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):
The recommended oral dose of NAT-OSELTAMIVIR oral suspension for pediatric patients 1 year and older is shown in the table below. NAT-OSELTAMIVIR oral suspension may also be used by adult patients who cannot swallow a capsule. If oseltamivir phosphate oral suspension is not available, NAT-OSELTAMIVIR capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup.
• NAT-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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Patients should be instructed to complete the entire course of therapy.
Adults and adolescents (≥ 13 years):
The recommended oral dose of NAT-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):
The recommended dose of NAT-OSELTAMIVIR oral suspension for prevention in pediatric patients 1 year and older is shown in the table below. NAT-OSELTAMIVIR oral suspension may also be used by adult patients who cannot swallow a capsule.
If Oseltamivir phosphate oral suspension is not available, NAT-OSELTAMIVIR capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup. For children old enough to safely swallow capsules, the 30 and 45 mg capsules can also be taken as outlined in the table below.
5 mL once daily Use appropriate oral dosing dispenser for volume dispensed with the oral suspension; the 75 mg dose can be measured using a combination of 30 mg and 45 mg. In the event that the dispenser provided is PrNAT-OSELTAMIVIR (Oseltamivir phosphate) Page 7 of 48 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.
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 NAT-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 NAT-OSELTAMIVIR once daily for 5 days.
Treatment of Influenza for patients undergoing routine hemodialysis:
In adult patients, an initial dose of 30 mg of NAT-OSELTAMIVIR can be administered prior to the start of […]
All three capsules strengths are available in blister packages of 10. NAT-OSELTAMIVIR Powder for Oral Suspension (6 mg/mL) NAT-OSELTAMIVIR powder for oral suspension contains 390 mg oseltamivir as oseltamivir phosphate per bottle, which when reconstituted contains 65 mL of suspension at a final concentration of 6 mg/mL oseltamivir.
142 g of sorbitol. 6 g of sorbitol which is unsuitable for subjects with hereditary fructose intolerance (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism). NAT-OSELTAMIVIR powder for oral suspension is available as a white to off-white granular powder blend for reconstitution to a white to off-white tutti-frutti-flavoured suspension.
Available in 100 mL glass bottles with a 10 mL oral syringe and a universal or 28 mm press-in bottle adapter, provided by a dispensing pharmacist. Net contents after reconstitution: 65 mL containing oseltamivir phosphate equivalent to 390 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 PrNAT-OSELTAMIVIR (Oseltamivir phosphate) Page 14 of 48 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. 142 g of sorbitol. 6 g of sorbitol, which is unsuitable for subjects with hereditary fructose intolerance.
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 […]
For children old enough to safely swallow capsules, the 30 and 45 mg capsules can also be taken as outlined in the table below. 5 mL twice daily Use appropriate oral dosing dispenser for volume dispensed with the oral suspension; the 75 mg dose can be measured using a combination of 30 mg and 45 mg.
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 NAT-OSELTAMIVIR for prevention may continue for up to 14 days.
Patients should be instructed to complete the entire course of therapy.
Adults and adolescents (≥ 13 years):
The recommended oral dose of NAT-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):
The recommended dose of NAT-OSELTAMIVIR oral suspension for prevention in pediatric patients 1 year and older is shown in the table below. NAT-OSELTAMIVIR oral suspension may also be used by adult patients who cannot swallow a capsule.
If Oseltamivir phosphate oral suspension is not available, NAT-OSELTAMIVIR capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup. For children old enough to safely swallow capsules, the 30 and 45 mg capsules can also be taken as outlined in the table below.
5 mL once daily Use appropriate oral dosing dispenser for volume dispensed with the oral suspension; the 75 mg dose can be measured using a combination of 30 mg and 45 mg. In the event that the dispenser provided is PrNAT-OSELTAMIVIR (Oseltamivir phosphate) Page 7 of 48 lost or damaged, another dosing dispenser may be used to deliver the volumes.
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