Tamiflu

Tamiflu Manufacturers

• Dispensing Solutions, Inc.
  

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  Tamiflu | Dispensing Solutions, Inc.

  

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  2.1 Dosing for Treatment and Prophylaxis of Influenza

  TAMIFLU may be taken with or without food [see Clinical Pharmacology (12.3)]. However, when taken with food, tolerability may be enhanced in some patients.

  The recommended oral treatment and prophylaxis dose of TAMIFLU for patients 1 year of age and older is shown in Table 1.

  Table 1 Treatment and Prophylaxis Dosing of Oral TAMIFLU for Influenza For Patients 1 Year of Age and Older Based on Body Weight Weight (kg) Weight (lbs) Treatment Dosing
  for 5 days Prophylaxis Dosing for 10 days Volume of
  Oral Suspension
  (6 mg/mL)
  for each Dose Number of Bottles of Oral Suspension to Dispense Number of Capsules and Strength to Dispense 15 kg or less 33 lbs or less 30 mg twice daily 30 mg once daily 5 mL 1 bottle 10 Capsules
  30 mg 16 kg thru 23 kg 34 lbs thru 51 lbs 45 mg twice daily 45 mg once daily 7.5 mL 2 bottles 10 Capsules
  45 mg 24 kg thru 40 kg 52 lbs thru 88 lbs 60 mg twice daily 60 mg once daily 10 mL 2 bottles 20 Capsules
  30 mg 41 kg or more 89 lbs or more 75 mg twice daily 75 mg once daily 12.5 mL 3 bottles 10 Capsules
  75 mg 2.2 Standard Dosage – Treatment of Influenza

  Adults and Adolescents

  The recommended oral dose of TAMIFLU for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. Treatment should begin within 2 days of onset of symptoms of influenza. TAMIFLU for oral suspension may be used by patients who cannot swallow a capsule (see Table 1).

  Pediatric Patients

  TAMIFLU is not indicated for treatment of influenza in pediatric patients younger than 1 year.

  The recommended oral dose of TAMIFLU for pediatric patients 1 year and older is shown in Table 1. For pediatric patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU 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). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration (2.8)].

  2.3 Standard Dosage – Prophylaxis of Influenza

  Adults and Adolescents

  The recommended oral dose of TAMIFLU for prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual is 75 mg once daily for at least 10 days. Therapy should begin within 2 days of exposure. The recommended dose for prophylaxis during a community outbreak of influenza is 75 mg once daily. Safety and efficacy have been demonstrated for up to 6 weeks in immunocompetent patients. The duration of protection lasts for as long as dosing is continued. Safety has been demonstrated for up to 12 weeks in immunocompromised patients. TAMIFLU for oral suspension may also be used by patients who cannot swallow a capsule (see Table 1).

  Pediatric Patients

  The safety and efficacy of TAMIFLU for prophylaxis of influenza in pediatric patients younger than 1 year of age have not been established.

  The recommended oral dose of TAMIFLU for pediatric patients 1 year and older following close contact with an infected individual is shown in Table 1. For pediatric patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU 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). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration (2.8)].

  Prophylaxis in pediatric patients following close contact with an infected individual is recommended for 10 days. Therapy should begin within 2 days of exposure. For prophylaxis in pediatric patients during a community outbreak of influenza, dosing may be continued for up to 6 weeks.

  2.4 Renal Impairment

  Data are available on plasma concentrations of oseltamivir carboxylate following various dosing schedules in patients with renal impairment [see Clinical Pharmacology (12.3)].

  Treatment of Influenza

  Dose adjustment is recommended for adult patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU for the treatment of influenza. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU once daily for 5 days. No recommended dosing regimens are available for patients with end-stage renal disease undergoing routine hemodialysis or continuous peritoneal dialysis treatment.

  Prophylaxis of Influenza

  For the prophylaxis of influenza, dose adjustment is recommended for adult patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU every other day or 30 mg TAMIFLU every day. No recommended dosing regimens are available for patients undergoing routine hemodialysis and continuous peritoneal dialysis treatment with end-stage renal disease.

  2.5 Hepatic Impairment

  No dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh score ≤9) [see Clinical Pharmacology (12.3)].

  2.6 Geriatric Patients

  No dose adjustment is required for geriatric patients [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].

  2.7 Preparation of TAMIFLU for Oral Suspension

  It is recommended that TAMIFLU for oral suspension be constituted by the pharmacist prior to dispensing to the patient:

  a) Tap the closed bottle 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 and shake the closed bottle well for 15 seconds. d) Remove the child-resistant cap and push bottle adapter into the neck of the bottle. e) Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.

  Label the bottle with instructions to Shake Well before each use.

  The constituted TAMIFLU for oral suspension (6 mg/mL) should be used within 17 days of preparation when stored under refrigeration or within 10 days if stored at controlled room temperature; the pharmacist should write the date of expiration of the constituted suspension on a pharmacy label. The patient package insert and oral dispenser should be dispensed to the patient.

  2.8 Emergency Compounding of an Oral Suspension from 75 mg TAMIFLU Capsules (Final Concentration 6 mg/mL)

  The following directions are provided for use only during emergency situations. These directions are not intended to be used if the FDA-approved, commercially manufactured TAMIFLU for oral suspension is readily available from wholesalers or the manufacturer.

  Compounding an oral suspension with this procedure will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.

  Commercially manufactured TAMIFLU for oral suspension (6 mg/mL) is the preferred product for pediatric and adult patients who have difficulty swallowing capsules or where lower doses are needed. In the event that TAMIFLU for oral suspension is not available, the pharmacist may compound a suspension (6 mg/mL) from TAMIFLU capsules 75 mg using one of these vehicles: Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Other vehicles have not been studied. This compounded suspension should not be used for convenience or when the FDA-approved TAMIFLU for oral suspension is commercially available.

  First, calculate the total volume of an oral suspension needed to be compounded and dispensed for each patient. The total volume required is determined by the weight of the patient (see Table 2).

  Table 2 Volume of an Oral Suspension (6 mg/mL) Needed to be Compounded Based Upon the Patient's Body Weight Weight (kg) Weight (lbs) Total Volume to Compound
  per Patient (mL) 15 kg or less 33 lbs or less 75 mL 16 thru 23 kg 34 thru 51 lbs 100 mL 24 thru 40 kg 52 thru 88 lbs 125 mL 41 kg or more 89 lbs or more 150 mL

  Second, determine the number of capsules and the amount of water and vehicle (Cherry Syrup, Ora-Sweet® SF, or simple syrup) that are needed to prepare the total volume (determined from Table 2: 75 mL, 100 mL, 125 mL, or 150 mL) of compounded oral suspension (6 mg/mL) (see Table 3).

  Table 3 Number of TAMIFLU 75 mg Capsules and Amount of Vehicle (Cherry Syrup, Ora-Sweet® SF, or Simple Syrup) Needed to Prepare the Total Volume of a Compounded Oral Suspension (6 mg/mL) Total Volume of Compounded Oral Suspension to be Prepared 75 mL 100 mL 125 mL 150 mL Number of TAMIFLU 75 mg Capsules 6 capsules (450 mg oseltamivir) 8 capsules (600 mg oseltamivir) 10 capsules (750 mg oseltamivir) 12 capsules (900 mg oseltamivir) Amount of Water 5 mL 7 mL 8 mL 10 mL Volume of Vehicle Cherry Syrup (Humco®) OR
  Ora-Sweet® SF (Paddock Laboratories) OR simple syrup 69 mL 91 mL 115 mL 137 mL

  Third, follow the procedure below for compounding the oral suspension (6 mg/mL) from TAMIFLU capsules 75 mg:

  Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle (see Table 3). Carefully separate the capsule body and cap and pour the contents of the required number of TAMIFLU 75 mg capsules into the PET or glass bottle. Gently swirl the suspension to ensure adequate wetting of the TAMIFLU powder for at least 2 minutes. Slowly add the specified amount of vehicle to the bottle. Close the bottle using a child-resistant cap 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. (Note: The active drug, oseltamivir phosphate, readily dissolves in the specified vehicles. The suspension is caused by inert ingredients of TAMIFLU capsules which are insoluble in these vehicles.) Put an ancillary label on the bottle indicating "Shake Well Before Use." Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions. Place an appropriate expiration date on the label according to storage conditions below.

  Storage of the Emergency Compounded Suspension

  Refrigeration: Stable for 5 weeks (35 days) when stored in a refrigerator at 2° to 8°C (36° to 46°F). Room Temperature: Stable for five days (5 days) when stored at room temperature, 25°C (77°F).

  Note: The storage conditions are based on stability studies of compounded oral suspensions, using the above mentioned vehicles, which were placed in glass and polyethyleneterephthalate (PET) bottles. Stability studies have not been conducted with other vehicles or bottle types.

  Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, and drug name and any other required information to be in compliance with all State and Federal Pharmacy Regulations.

  Dosing of the Compounded Suspension (6 mg/mL)

  Refer to Table 1 for the proper dosing instructions for the pharmacy label.

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• Rebel Distributors Corp
  

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  Tamiflu | Rebel Distributors Corp

  

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  2.1 Dosing for Treatment and Prophylaxis of Influenza

  TAMIFLU may be taken with or without food [see Clinical Pharmacology (12.3)]. However, when taken with food, tolerability may be enhanced in some patients.

  The recommended oral treatment and prophylaxis dose of TAMIFLU for patients 1 year of age and older is shown in Table 1.

  Table 1 Treatment and Prophylaxis Dosing of Oral TAMIFLU for Influenza For Patients 1 Year of Age and Older Based on Body Weight Weight (kg) Weight (lbs) Treatment Dosing
  for 5 days Prophylaxis Dosing for 10 days Volume of
  Oral Suspension
  (6 mg/mL)
  for each Dose* Number of Bottles of Oral Suspension to Dispense Number of Capsules and Strength to Dispense * A 10 mL oral dosing dispenser is provided 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. † Delivery of this TAMIFLU for Oral Suspension dose requires administering 10 mL followed by another 2.5 mL. 15 kg or less 33 lbs or less 30 mg twice daily 30 mg once daily 5 mL 1 bottle 10 Capsules
  30 mg 16 kg thru 23 kg 34 lbs thru 51 lbs 45 mg twice daily 45 mg once daily 7.5 mL 2 bottles 10 Capsules
  45 mg 24 kg thru 40 kg 52 lbs thru 88 lbs 60 mg twice daily 60 mg once daily 10 mL 2 bottles 20 Capsules
  30 mg 41 kg or more 89 lbs or more 75 mg twice daily 75 mg once daily 12.5 mL† 3 bottles 10 Capsules
  75 mg 2.2 Standard Dosage – Treatment of Influenza

  Adults and Adolescents

  The recommended oral dose of TAMIFLU for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. Treatment should begin within 2 days of onset of symptoms of influenza. TAMIFLU for oral suspension may be used by patients who cannot swallow a capsule (see Table 1).

  Pediatric Patients

  TAMIFLU is not indicated for treatment of influenza in pediatric patients younger than 1 year.

  The recommended oral dose of TAMIFLU for pediatric patients 1 year and older is shown in Table 1. For pediatric patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU 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). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration (2.8)].

  2.3 Standard Dosage – Prophylaxis of Influenza

  Adults and Adolescents

  The recommended oral dose of TAMIFLU for prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual is 75 mg once daily for at least 10 days. Therapy should begin within 2 days of exposure. The recommended dose for prophylaxis during a community outbreak of influenza is 75 mg once daily. Safety and efficacy have been demonstrated for up to 6 weeks in immunocompetent patients. The duration of protection lasts for as long as dosing is continued. Safety has been demonstrated for up to 12 weeks in immunocompromised patients. TAMIFLU for oral suspension may also be used by patients who cannot swallow a capsule (see Table 1).

  Pediatric Patients

  The safety and efficacy of TAMIFLU for prophylaxis of influenza in pediatric patients younger than 1 year of age have not been established.

  The recommended oral dose of TAMIFLU for pediatric patients 1 year and older following close contact with an infected individual is shown in Table 1. For pediatric patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU 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). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration (2.8)].

  Prophylaxis in pediatric patients following close contact with an infected individual is recommended for 10 days. Therapy should begin within 2 days of exposure. For prophylaxis in pediatric patients during a community outbreak of influenza, dosing may be continued for up to 6 weeks.

  2.4 Renal Impairment

  Data are available on plasma concentrations of oseltamivir carboxylate following various dosing schedules in patients with renal impairment [see Clinical Pharmacology (12.3)].

  Treatment of Influenza

  Dose adjustment is recommended for adult patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU for the treatment of influenza. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU once daily for 5 days. No recommended dosing regimens are available for patients with end-stage renal disease undergoing routine hemodialysis or continuous peritoneal dialysis treatment.

  Prophylaxis of Influenza

  For the prophylaxis of influenza, dose adjustment is recommended for adult patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU every other day or 30 mg TAMIFLU every day. No recommended dosing regimens are available for patients undergoing routine hemodialysis and continuous peritoneal dialysis treatment with end-stage renal disease.

  2.5 Hepatic Impairment

  No dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh score ≤9) [see Clinical Pharmacology (12.3)].

  2.6 Geriatric Patients

  No dose adjustment is required for geriatric patients [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].

  2.7 Preparation of TAMIFLU for Oral Suspension

  It is recommended that TAMIFLU for oral suspension be constituted by the pharmacist prior to dispensing to the patient:

  a)Tap the closed bottle 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 and shake the closed bottle well for 15 seconds. d)Remove the child-resistant cap and push bottle adapter into the neck of the bottle. e)Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.

  Label the bottle with instructions to Shake Well before each use.

  The constituted TAMIFLU for oral suspension (6 mg/mL) should be used within 17 days of preparation when stored under refrigeration or within 10 days if stored at controlled room temperature; the pharmacist should write the date of expiration of the constituted suspension on a pharmacy label. The patient package insert and oral dispenser should be dispensed to the patient.

  2.8 Emergency Compounding of an Oral Suspension from 75 mg TAMIFLU Capsules (Final Concentration 6 mg/mL)

  The following directions are provided for use only during emergency situations. These directions are not intended to be used if the FDA-approved, commercially manufactured TAMIFLU for oral suspension is readily available from wholesalers or the manufacturer.

  Compounding an oral suspension with this procedure will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.

  Commercially manufactured TAMIFLU for oral suspension (6 mg/mL) is the preferred product for pediatric and adult patients who have difficulty swallowing capsules or where lower doses are needed. In the event that TAMIFLU for oral suspension is not available, the pharmacist may compound a suspension (6 mg/mL) from TAMIFLU capsules 75 mg using one of these vehicles: Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Other vehicles have not been studied. This compounded suspension should not be used for convenience or when the FDA-approved TAMIFLU for oral suspension is commercially available.

  First, calculate the total volume of an oral suspension needed to be compounded and dispensed for each patient. The total volume required is determined by the weight of the patient (see Table 2).

  Table 2 Volume of an Oral Suspension (6 mg/mL) Needed to be Compounded Based Upon the Patient's Body Weight Weight (kg) Weight (lbs) Total Volume to Compound
  per Patient (mL) 15 kg or less 33 lbs or less 75 mL 16 thru 23 kg 34 thru 51 lbs 100 mL 24 thru 40 kg 52 thru 88 lbs 125 mL 41 kg or more 89 lbs or more 150 mL

  Second, determine the number of capsules and the amount of water and vehicle (Cherry Syrup, Ora-Sweet® SF, or simple syrup) that are needed to prepare the total volume (determined from Table 2: 75 mL, 100 mL, 125 mL, or 150 mL) of compounded oral suspension (6 mg/mL) (see Table 3).

  Table 3 Number of TAMIFLU 75 mg Capsules and Amount of Vehicle (Cherry Syrup, Ora-Sweet® SF, or Simple Syrup) Needed to Prepare the Total Volume of a Compounded Oral Suspension (6 mg/mL) Total Volume of Compounded Oral Suspension to be Prepared 75 mL 100 mL 125 mL 150 mL * Includes overage to ensure all doses can be delivered Number of TAMIFLU 75 mg Capsules* 6 capsules (450 mg oseltamivir) 8 capsules (600 mg oseltamivir) 10 capsules (750 mg oseltamivir) 12 capsules (900 mg oseltamivir) Amount of Water 5 mL 7 mL 8 mL 10 mL Volume of Vehicle Cherry Syrup (Humco®) OR
  Ora-Sweet® SF (Paddock Laboratories) OR simple syrup 69 mL 91 mL 115 mL 137 mL

  Third, follow the procedure below for compounding the oral suspension (6 mg/mL) from TAMIFLU capsules 75 mg:

  Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle (see Table 3). Carefully separate the capsule body and cap and pour the contents of the required number of TAMIFLU 75 mg capsules into the PET or glass bottle. Gently swirl the suspension to ensure adequate wetting of the TAMIFLU powder for at least 2 minutes. Slowly add the specified amount of vehicle to the bottle. Close the bottle using a child-resistant cap 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. (Note: The active drug, oseltamivir phosphate, readily dissolves in the specified vehicles. The suspension is caused by inert ingredients of TAMIFLU capsules which are insoluble in these vehicles.) Put an ancillary label on the bottle indicating "Shake Well Before Use." Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions. Place an appropriate expiration date on the label according to storage conditions below.

  Storage of the Emergency Compounded Suspension

  Refrigeration: Stable for 5 weeks (35 days) when stored in a refrigerator at 2° to 8°C (36° to 46°F). Room Temperature: Stable for five days (5 days) when stored at room temperature, 25°C (77°F).

  Note: The storage conditions are based on stability studies of compounded oral suspensions, using the above mentioned vehicles, which were placed in glass and polyethyleneterephthalate (PET) bottles. Stability studies have not been conducted with other vehicles or bottle types.

  Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, and drug name and any other required information to be in compliance with all State and Federal Pharmacy Regulations.

  Dosing of the Compounded Suspension (6 mg/mL)

  Refer to Table 1 for the proper dosing instructions for the pharmacy label.

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  More Info
• Physicians Total Care, Inc.
  

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  Tamiflu | Physicians Total Care, Inc.

  

  ---

  2.1 Dosing for Treatment and Prophylaxis of Influenza

  TAMIFLU may be taken with or without food [see Clinical Pharmacology (12.3)]. However, when taken with food, tolerability may be enhanced in some patients.

  The recommended oral treatment and prophylaxis dose of TAMIFLU for patients 1 year of age and older is shown in Table 1.

  Table 1 Treatment and Prophylaxis Dosing of Oral TAMIFLU for Influenza For Patients 1 Year of Age and Older Based on Body Weight Weight (kg) Weight (lbs) Treatment Dosing
  for 5 days Prophylaxis Dosing for 10 days Volume of
  Oral Suspension
  (6 mg/mL)
  for each Dose Number of Bottles of Oral Suspension to Dispense Number of Capsules and Strength to Dispense 15 kg or less 33 lbs or less 30 mg twice daily 30 mg once daily 5 mL 1 bottle 10 Capsules
  30 mg 16 kg thru 23 kg 34 lbs thru 51 lbs 45 mg twice daily 45 mg once daily 7.5 mL 2 bottles 10 Capsules
  45 mg 24 kg thru 40 kg 52 lbs thru 88 lbs 60 mg twice daily 60 mg once daily 10 mL 2 bottles 20 Capsules
  30 mg 41 kg or more 89 lbs or more 75 mg twice daily 75 mg once daily 12.5 mL 3 bottles 10 Capsules
  75 mg 2.2 Standard Dosage – Treatment of Influenza

  Adults and Adolescents

  The recommended oral dose of TAMIFLU for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. Treatment should begin within 2 days of onset of symptoms of influenza. TAMIFLU for oral suspension may be used by patients who cannot swallow a capsule (see Table 1).

  Pediatric Patients

  TAMIFLU is not indicated for treatment of influenza in pediatric patients younger than 1 year.

  The recommended oral dose of TAMIFLU for pediatric patients 1 year and older is shown in Table 1. For pediatric patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU 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). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration (2.8)].

  2.3 Standard Dosage – Prophylaxis of Influenza

  Adults and Adolescents

  The recommended oral dose of TAMIFLU for prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual is 75 mg once daily for at least 10 days. Therapy should begin within 2 days of exposure. The recommended dose for prophylaxis during a community outbreak of influenza is 75 mg once daily. Safety and efficacy have been demonstrated for up to 6 weeks in immunocompetent patients. The duration of protection lasts for as long as dosing is continued. Safety has been demonstrated for up to 12 weeks in immunocompromised patients. TAMIFLU for oral suspension may also be used by patients who cannot swallow a capsule (see Table 1).

  Pediatric Patients

  The safety and efficacy of TAMIFLU for prophylaxis of influenza in pediatric patients younger than 1 year of age have not been established.

  The recommended oral dose of TAMIFLU for pediatric patients 1 year and older following close contact with an infected individual is shown in Table 1. For pediatric patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU 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). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration (2.8)].

  Prophylaxis in pediatric patients following close contact with an infected individual is recommended for 10 days. Therapy should begin within 2 days of exposure. For prophylaxis in pediatric patients during a community outbreak of influenza, dosing may be continued for up to 6 weeks.

  2.4 Renal Impairment

  Data are available on plasma concentrations of oseltamivir carboxylate following various dosing schedules in patients with renal impairment [see Clinical Pharmacology (12.3)].

  Treatment of Influenza

  Dose adjustment is recommended for adult patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU for the treatment of influenza. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU once daily for 5 days. No recommended dosing regimens are available for patients with end-stage renal disease undergoing routine hemodialysis or continuous peritoneal dialysis treatment.

  Prophylaxis of Influenza

  For the prophylaxis of influenza, dose adjustment is recommended for adult patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU every other day or 30 mg TAMIFLU every day. No recommended dosing regimens are available for patients undergoing routine hemodialysis and continuous peritoneal dialysis treatment with end-stage renal disease.

  2.5 Hepatic Impairment

  No dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh score ≤9) [see Clinical Pharmacology (12.3)].

  2.6 Geriatric Patients

  No dose adjustment is required for geriatric patients [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].

  2.7 Preparation of TAMIFLU for Oral Suspension

  It is recommended that TAMIFLU for oral suspension be constituted by the pharmacist prior to dispensing to the patient:

  a) Tap the closed bottle 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 and shake the closed bottle well for 15 seconds. d) Remove the child-resistant cap and push bottle adapter into the neck of the bottle. e) Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.

  Label the bottle with instructions to Shake Well before each use.

  The constituted TAMIFLU for oral suspension (6 mg/mL) should be used within 17 days of preparation when stored under refrigeration or within 10 days if stored at controlled room temperature; the pharmacist should write the date of expiration of the constituted suspension on a pharmacy label. The patient package insert and oral dispenser should be dispensed to the patient.

  2.8 Emergency Compounding of an Oral Suspension from 75 mg TAMIFLU Capsules (Final Concentration 6 mg/mL)

  The following directions are provided for use only during emergency situations. These directions are not intended to be used if the FDA-approved, commercially manufactured TAMIFLU for oral suspension is readily available from wholesalers or the manufacturer.

  Compounding an oral suspension with this procedure will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.

  Commercially manufactured TAMIFLU for oral suspension (6 mg/mL) is the preferred product for pediatric and adult patients who have difficulty swallowing capsules or where lower doses are needed. In the event that TAMIFLU for oral suspension is not available, the pharmacist may compound a suspension (6 mg/mL) from TAMIFLU capsules 75 mg using one of these vehicles: Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Other vehicles have not been studied. This compounded suspension should not be used for convenience or when the FDA-approved TAMIFLU for oral suspension is commercially available.

  First, calculate the total volume of an oral suspension needed to be compounded and dispensed for each patient. The total volume required is determined by the weight of the patient (see Table 2).

  Table 2 Volume of an Oral Suspension (6 mg/mL) Needed to be Compounded Based Upon the Patient's Body Weight Weight (kg) Weight (lbs) Total Volume to Compound
  per Patient (mL) 15 kg or less 33 lbs or less 75 mL 16 thru 23 kg 34 thru 51 lbs 100 mL 24 thru 40 kg 52 thru 88 lbs 125 mL 41 kg or more 89 lbs or more 150 mL

  Second, determine the number of capsules and the amount of water and vehicle (Cherry Syrup, Ora-Sweet® SF, or simple syrup) that are needed to prepare the total volume (determined from Table 2: 75 mL, 100 mL, 125 mL, or 150 mL) of compounded oral suspension (6 mg/mL) (see Table 3).

  Table 3 Number of TAMIFLU 75 mg Capsules and Amount of Vehicle (Cherry Syrup, Ora-Sweet® SF, or Simple Syrup) Needed to Prepare the Total Volume of a Compounded Oral Suspension (6 mg/mL) Total Volume of Compounded Oral Suspension to be Prepared 75 mL 100 mL 125 mL 150 mL Number of TAMIFLU 75 mg Capsules 6 capsules (450 mg oseltamivir) 8 capsules (600 mg oseltamivir) 10 capsules (750 mg oseltamivir) 12 capsules (900 mg oseltamivir) Amount of Water 5 mL 7 mL 8 mL 10 mL Volume of Vehicle Cherry Syrup (Humco®) OR
  Ora-Sweet® SF (Paddock Laboratories) OR simple syrup 69 mL 91 mL 115 mL 137 mL

  Third, follow the procedure below for compounding the oral suspension (6 mg/mL) from TAMIFLU capsules 75 mg:

  Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle (see Table 3). Carefully separate the capsule body and cap and pour the contents of the required number of TAMIFLU 75 mg capsules into the PET or glass bottle. Gently swirl the suspension to ensure adequate wetting of the TAMIFLU powder for at least 2 minutes. Slowly add the specified amount of vehicle to the bottle. Close the bottle using a child-resistant cap 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. (Note: The active drug, oseltamivir phosphate, readily dissolves in the specified vehicles. The suspension is caused by inert ingredients of TAMIFLU capsules which are insoluble in these vehicles.) Put an ancillary label on the bottle indicating "Shake Well Before Use." Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions. Place an appropriate expiration date on the label according to storage conditions below.

  Storage of the Emergency Compounded Suspension

  Refrigeration: Stable for 5 weeks (35 days) when stored in a refrigerator at 2° to 8°C (36° to 46°F). Room Temperature: Stable for five days (5 days) when stored at room temperature, 25°C (77°F).

  Note: The storage conditions are based on stability studies of compounded oral suspensions, using the above mentioned vehicles, which were placed in glass and polyethyleneterephthalate (PET) bottles. Stability studies have not been conducted with other vehicles or bottle types.

  Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, and drug name and any other required information to be in compliance with all State and Federal Pharmacy Regulations.

  Dosing of the Compounded Suspension (6 mg/mL)

  Refer to Table 1 for the proper dosing instructions for the pharmacy label.

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  2.1 Dosing for Treatment and Prophylaxis of Influenza

  TAMIFLU may be taken with or without food [see Clinical Pharmacology (12.3)]. However, when taken with food, tolerability may be enhanced in some patients.

  The recommended oral treatment and prophylaxis dose of TAMIFLU for patients 1 year of age and older is shown in Table 1.

  Table 1 Treatment and Prophylaxis Dosing of Oral TAMIFLU for Influenza For Patients 1 Year of Age and Older Based on Body Weight Weight (kg) Weight (lbs) Treatment Dosing
  for 5 days Prophylaxis Dosing for 10 days Volume of
  Oral Suspension
  (6 mg/mL)
  for each Dose* Number of Bottles of Oral Suspension to Dispense Number of Capsules and Strength to Dispense * A 10 mL oral dosing dispenser is provided 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. † Delivery of this TAMIFLU for Oral Suspension dose requires administering 10 mL followed by another 2.5 mL. 15 kg or less 33 lbs or less 30 mg twice daily 30 mg once daily 5 mL 1 bottle 10 Capsules
  30 mg 16 kg thru 23 kg 34 lbs thru 51 lbs 45 mg twice daily 45 mg once daily 7.5 mL 2 bottles 10 Capsules
  45 mg 24 kg thru 40 kg 52 lbs thru 88 lbs 60 mg twice daily 60 mg once daily 10 mL 2 bottles 20 Capsules
  30 mg 41 kg or more 89 lbs or more 75 mg twice daily 75 mg once daily 12.5 mL† 3 bottles 10 Capsules
  75 mg 2.2 Standard Dosage – Treatment of Influenza

  Adults and Adolescents

  The recommended oral dose of TAMIFLU for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. Treatment should begin within 2 days of onset of symptoms of influenza. TAMIFLU for oral suspension may be used by patients who cannot swallow a capsule (see Table 1).

  Pediatric Patients

  TAMIFLU is not indicated for treatment of influenza in pediatric patients younger than 1 year.

  The recommended oral dose of TAMIFLU for pediatric patients 1 year and older is shown in Table 1. For pediatric patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU 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). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration (2.8)].

  2.3 Standard Dosage – Prophylaxis of Influenza

  Adults and Adolescents

  The recommended oral dose of TAMIFLU for prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual is 75 mg once daily for at least 10 days. Therapy should begin within 2 days of exposure. The recommended dose for prophylaxis during a community outbreak of influenza is 75 mg once daily. Safety and efficacy have been demonstrated for up to 6 weeks in immunocompetent patients. The duration of protection lasts for as long as dosing is continued. Safety has been demonstrated for up to 12 weeks in immunocompromised patients. TAMIFLU for oral suspension may also be used by patients who cannot swallow a capsule (see Table 1).

  Pediatric Patients

  The safety and efficacy of TAMIFLU for prophylaxis of influenza in pediatric patients younger than 1 year of age have not been established.

  The recommended oral dose of TAMIFLU for pediatric patients 1 year and older following close contact with an infected individual is shown in Table 1. For pediatric patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU 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). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration (2.8)].

  Prophylaxis in pediatric patients following close contact with an infected individual is recommended for 10 days. Therapy should begin within 2 days of exposure. For prophylaxis in pediatric patients during a community outbreak of influenza, dosing may be continued for up to 6 weeks.

  2.4 Renal Impairment

  Data are available on plasma concentrations of oseltamivir carboxylate following various dosing schedules in patients with renal impairment [see Clinical Pharmacology (12.3)].

  Treatment of Influenza

  Dose adjustment is recommended for adult patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU for the treatment of influenza. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU once daily for 5 days. No recommended dosing regimens are available for patients with end-stage renal disease undergoing routine hemodialysis or continuous peritoneal dialysis treatment.

  Prophylaxis of Influenza

  For the prophylaxis of influenza, dose adjustment is recommended for adult patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU every other day or 30 mg TAMIFLU every day. No recommended dosing regimens are available for patients undergoing routine hemodialysis and continuous peritoneal dialysis treatment with end-stage renal disease.

  2.5 Hepatic Impairment

  No dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh score ≤9) [see Clinical Pharmacology (12.3)].

  2.6 Geriatric Patients

  No dose adjustment is required for geriatric patients [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].

  2.7 Preparation of TAMIFLU for Oral Suspension

  It is recommended that TAMIFLU for oral suspension be constituted by the pharmacist prior to dispensing to the patient:

  a)Tap the closed bottle 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 and shake the closed bottle well for 15 seconds. d)Remove the child-resistant cap and push bottle adapter into the neck of the bottle. e)Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.

  Label the bottle with instructions to Shake Well before each use.

  The constituted TAMIFLU for oral suspension (6 mg/mL) should be used within 17 days of preparation when stored under refrigeration or within 10 days if stored at controlled room temperature; the pharmacist should write the date of expiration of the constituted suspension on a pharmacy label. The patient package insert and oral dispenser should be dispensed to the patient.

  2.8 Emergency Compounding of an Oral Suspension from 75 mg TAMIFLU Capsules (Final Concentration 6 mg/mL)

  The following directions are provided for use only during emergency situations. These directions are not intended to be used if the FDA-approved, commercially manufactured TAMIFLU for oral suspension is readily available from wholesalers or the manufacturer.

  Compounding an oral suspension with this procedure will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.

  Commercially manufactured TAMIFLU for oral suspension (6 mg/mL) is the preferred product for pediatric and adult patients who have difficulty swallowing capsules or where lower doses are needed. In the event that TAMIFLU for oral suspension is not available, the pharmacist may compound a suspension (6 mg/mL) from TAMIFLU capsules 75 mg using one of these vehicles: Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Other vehicles have not been studied. This compounded suspension should not be used for convenience or when the FDA-approved TAMIFLU for oral suspension is commercially available.

  First, calculate the total volume of an oral suspension needed to be compounded and dispensed for each patient. The total volume required is determined by the weight of the patient (see Table 2).

  Table 2 Volume of an Oral Suspension (6 mg/mL) Needed to be Compounded Based Upon the Patient's Body Weight Weight (kg) Weight (lbs) Total Volume to Compound
  per Patient (mL) 15 kg or less 33 lbs or less 75 mL 16 thru 23 kg 34 thru 51 lbs 100 mL 24 thru 40 kg 52 thru 88 lbs 125 mL 41 kg or more 89 lbs or more 150 mL

  Second, determine the number of capsules and the amount of water and vehicle (Cherry Syrup, Ora-Sweet® SF, or simple syrup) that are needed to prepare the total volume (determined from Table 2: 75 mL, 100 mL, 125 mL, or 150 mL) of compounded oral suspension (6 mg/mL) (see Table 3).

  Table 3 Number of TAMIFLU 75 mg Capsules and Amount of Vehicle (Cherry Syrup, Ora-Sweet® SF, or Simple Syrup) Needed to Prepare the Total Volume of a Compounded Oral Suspension (6 mg/mL) Total Volume of Compounded Oral Suspension to be Prepared 75 mL 100 mL 125 mL 150 mL * Includes overage to ensure all doses can be delivered Number of TAMIFLU 75 mg Capsules* 6 capsules (450 mg oseltamivir) 8 capsules (600 mg oseltamivir) 10 capsules (750 mg oseltamivir) 12 capsules (900 mg oseltamivir) Amount of Water 5 mL 7 mL 8 mL 10 mL Volume of Vehicle Cherry Syrup (Humco®) OR
  Ora-Sweet® SF (Paddock Laboratories) OR simple syrup 69 mL 91 mL 115 mL 137 mL

  Third, follow the procedure below for compounding the oral suspension (6 mg/mL) from TAMIFLU capsules 75 mg:

  Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle (see Table 3). Carefully separate the capsule body and cap and pour the contents of the required number of TAMIFLU 75 mg capsules into the PET or glass bottle. Gently swirl the suspension to ensure adequate wetting of the TAMIFLU powder for at least 2 minutes. Slowly add the specified amount of vehicle to the bottle. Close the bottle using a child-resistant cap 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. (Note: The active drug, oseltamivir phosphate, readily dissolves in the specified vehicles. The suspension is caused by inert ingredients of TAMIFLU capsules which are insoluble in these vehicles.) Put an ancillary label on the bottle indicating "Shake Well Before Use." Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions. Place an appropriate expiration date on the label according to storage conditions below.

  Storage of the Emergency Compounded Suspension

  Refrigeration: Stable for 5 weeks (35 days) when stored in a refrigerator at 2° to 8°C (36° to 46°F). Room Temperature: Stable for five days (5 days) when stored at room temperature, 25°C (77°F).

  Note: The storage conditions are based on stability studies of compounded oral suspensions, using the above mentioned vehicles, which were placed in glass and polyethyleneterephthalate (PET) bottles. Stability studies have not been conducted with other vehicles or bottle types.

  Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, and drug name and any other required information to be in compliance with all State and Federal Pharmacy Regulations.

  Dosing of the Compounded Suspension (6 mg/mL)

  Refer to Table 1 for the proper dosing instructions for the pharmacy label.

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  Treatment of influenza (2.2)

  Adults and adolescents (13 years and older): 75 mg twice daily for 5 days Pediatric patients 1 to 12 years of age: Based on weight twice daily for 5 days Pediatric patients 2 weeks to less than 1 year of age: 3mg/kg twice daily for 5 days. Renally impaired adult patients (creatinine clearance 10-30 mL/min): Reduce to 75 mg once daily for 5 days (2.4)

  Prophylaxis of influenza (2.3)

  Adults and adolescents (13 years and older): 75 mg once daily for at least 10 days-Community outbreak: 75 mg once daily for up to 6 weeks Pediatric patients 1 to 12 years of age: Based on weight once daily for 10 days-Community outbreak: Based on weight once daily for up to 6 weeks Renally impaired adult patients (creatinine clearance 10-30 mL/min): Reduce to 75 mg once every other day or 30 mg once daily (2.4)

   

  Treatment with TAMIFLU should begin within 2 days of onset of symptoms of influenza or following close contact with an infected individual.

  TAMIFLU may be taken with or without food [see Clinical Pharmacology (12.3)]. However, when taken with food, tolerability may be enhanced in some patients.

  For patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU 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). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration (2.8)].

   

  Adults and Adolescents (13 years of age and older)

  The recommended oral dose of TAMIFLU for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. TAMIFLU for oral suspension may be used by patients who cannot swallow a capsule (12.5 mL of TAMIFLU for oral suspension [6 mg/mL] delivers 75 mg) [see Dosage and Administration (2.1)].

   

  Pediatric Patients (2 weeks to 12 years of age)

  The recommended oral dose of TAMIFLU for treatment of influenza in pediatric patients 1 year to 12 years of age is shown in Table 1.

  The recommended oral dose of TAMIFLU for treatment of influenza in pediatric patients 2 weeks to less than 1 year of age is 3 mg/kg twice daily for 5 days (shown in Table 1).

   

  Adults and Adolescents (13 years of age and older)

  The recommended oral dose of TAMIFLU for prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual is 75 mg once daily for at least 10 days. The recommended dose for prophylaxis during a community outbreak of influenza is 75 mg once daily. Safety and efficacy have been demonstrated for up to 6 weeks in immunocompetent patients. The duration of protection lasts for as long as dosing is continued. Safety has been demonstrated for up to 12 weeks in immunocompromised patients. TAMIFLU for oral suspension may also be used by patients who cannot swallow a capsule (12.5 mL of TAMIFLU for oral suspension [6 mg/mL] delivers 75 mg).

   

  Pediatric Patients (2 weeks to 12 years of age)

  The recommended oral dose of TAMIFLU for prophylaxis of influenza in pediatric patients 1 to 12 years of age based on body weight is shown in Table 1. Prophylaxis in pediatric patients following close contact with an infected individual is recommended for 10 days. For prophylaxis in pediatric patients during a community outbreak of influenza, dosing may be continued for up to 6 weeks.

  The safety and efficacy of TAMIFLU for prophylaxis of influenza have not been established in infants less than 1 year of age.

  Table 1 Treatment (twice daily dosing for 5 days) and Prophylaxis (once daily dosing for 10 days) Dosing of Oral TAMIFLU for Influenza in Pediatric Patients Weight
  (kg) Treatment Dosing for 5 days Prophylaxis Dosing for 10 days Volume of Oral Suspension (6 mg/mL) for each Dose* Number of Bottles of Oral Suspension to Dispense Number of Capsules and Strength to Dispense† 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 thru 23 kg 45 mg twice daily 45 mg once daily 7.5 mL 2 bottles 10 Capsules
  45 mg 23.1 kg thru 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

  1

  2

  3

  4

  5

   

  Data are available on plasma concentrations of oseltamivir carboxylate following various dosing schedules in patients with renal impairment [see Clinical Pharmacology (12.3)].

   

  Treatment of Influenza

  Dose adjustment is recommended for adult patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU for the treatment of influenza. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU once daily for 5 days. No recommended dosing regimens are available for patients with end-stage renal disease undergoing routine hemodialysis or continuous peritoneal dialysis treatment.

   

  Prophylaxis of Influenza

  For the prophylaxis of influenza, dose adjustment is recommended for adult patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU every other day or 30 mg TAMIFLU every day. No recommended dosing regimens are available for patients undergoing routine hemodialysis and continuous peritoneal dialysis treatment with end-stage renal disease.

   

  No dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh score ≤9) [see Clinical Pharmacology (12.3)].

   

  No dose adjustment is required for geriatric patients [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].

   

  It is recommended that TAMIFLU for oral suspension be constituted by the pharmacist prior to dispensing to the patient:

  a)Tap the closed bottle 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 and shake the closed bottle well for 15 seconds.d)Remove the child-resistant cap and push bottle adapter into the neck of the bottle.e)Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.

  Label the bottle with instructions to Shake Well before each use.

  The constituted TAMIFLU for oral suspension (6 mg/mL) should be used within 17 days of preparation when stored under refrigeration or within 10 days if stored at controlled room temperature; the pharmacist should write the date of expiration of the constituted suspension on a pharmacy label. The patient package insert and oral dispenser should be dispensed to the patient.

   

  The following directions are provided for use only during emergency situations. These directions are not intended to be used if the FDA-approved, commercially manufactured TAMIFLU for oral suspension is readily available from wholesalers or the manufacturer.

  Compounding an oral suspension with this procedure will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.

  Commercially manufactured TAMIFLU for oral suspension (6 mg/mL) is the preferred product for pediatric and adult patients who have difficulty swallowing capsules or where lower doses are needed. In the event that TAMIFLU for oral suspension is not available, the pharmacist may compound a suspension (6 mg/mL) from TAMIFLU capsules 75 mg using one of these vehicles: Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Other vehicles have not been studied. This compounded suspension should not be used for convenience or when the FDA-approved TAMIFLU for oral suspension is commercially available.

  First, determine the dose of TAMIFLU for the patients [see Dosage and Administration (2)] then determine total volume of an oral suspension needed to be compounded based on Table 2.

  Table 2 Volume of an Oral Suspension (6 mg/mL) Needed to be Compounded Based Upon the Patient's TAMIFLU Dose TAMIFLU Dose* Total Volume to Compound per Patient (mL) 15 mg or less 37.5 mL 30 mg 75 mL 45 mg 100 mL 60 mg 125 mL 75 mg 150 mL

  6

  Second, determine the number of capsules and the amount of water and vehicle (Cherry Syrup, Ora-Sweet® SF, or simple syrup) that are needed to prepare the total volume (determined from Table 2: 37.5 mL, 75 mL, 100 mL, 125 mL, or 150 mL) of compounded oral suspension (6 mg/mL) (see Table 3).

  Table 3 Number of TAMIFLU 75 mg Capsules and Amount of Vehicle (Cherry Syrup, Ora-Sweet® SF, or Simple Syrup) Needed to Prepare the Total Volume of a Compounded Oral Suspension (6 mg/mL) Total Volume of Compounded Oral Suspension to be Prepared 37.5 mL 75 mL 100 mL 125 mL 150 mL Number of TAMIFLU 75 mg Capsules* 3 capsules (225mg oseltamivir) 6 capsules (450 mg oseltamivir) 8 capsules (600 mg oseltamivir) 10 capsules (750 mg oseltamivir) 12 capsules (900 mg oseltamivir) Amount of Water 2.5 mL 5 mL 7 mL 8 mL 10 mL Volume of Vehicle
  Cherry Syrup (Humco®) OR
  Ora-Sweet® SF (Paddock Laboratories) OR simple syrup 34.5 mL 69 mL 91 mL 115 mL 137 mL

  7

  Third, follow the procedure below for compounding the oral suspension (6 mg/mL) from TAMIFLU capsules 75 mg:

  Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle (see Table 3). Carefully separate the capsule body and cap and pour the contents of the required number of TAMIFLU 75 mg capsules into the PET or glass bottle. Gently swirl the suspension to ensure adequate wetting of the TAMIFLU powder for at least 2 minutes. Slowly add the specified amount of vehicle to the bottle. Close the bottle using a child-resistant cap 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. (Note: The active drug, oseltamivir phosphate, readily dissolves in the specified vehicles. The suspension is caused by inert ingredients of TAMIFLU capsules which are insoluble in these vehicles.) Put an ancillary label on the bottle indicating "Shake Well Before Use." Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions. Place an appropriate expiration date on the label according to storage conditions below.

   

  Storage of the Emergency Compounded Suspension

  Refrigeration: Stable for 5 weeks (35 days) when stored in a refrigerator at 2° to 8°C (36° to 46°F). Room Temperature: Stable for five days (5 days) when stored at room temperature, 25°C (77°F).

  Note: The storage conditions are based on stability studies of compounded oral suspensions, using the above mentioned vehicles, which were placed in glass and polyethyleneterephthalate (PET) bottles. Stability studies have not been conducted with other vehicles or bottle types.

  Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, and drug name and any other required information to be in compliance with all State and Federal Pharmacy Regulations.

   

  Dosing of the Compounded Suspension (6 mg/mL)

  Refer to Dosage and Administration sections 2.2, 2.3, 2.4 and Table 1 for the proper dosing instructions for the pharmacy label.

   

  1 A 10 mL oral dosing dispenser is provided 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. 2 Oral Suspension is the preferred formulation for patients who cannot swallow capsules. 3 TAMIFLU is not approved for prophylaxis of patients less than 1 year of age 4 For patients less than 1 year of age, remove the provided 10 mL oral dosing dispenser from the packaging, and provide an appropriate dosing device that can accurately measure and administer small volumes. 5 Delivery of this TAMIFLU for Oral Suspension dose requires administering 10 mL followed by another 2.5 mL. 6 If the TAMIFLU dose is between the doses listed, the total volume of oral suspension to compound should default to the next greater dose listed. 7 Includes overage to ensure all doses can be delivered

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  2.1 Dosing for Treatment and Prophylaxis of Influenza

  Treatment with TAMIFLU should begin within 2 days of onset of symptoms of influenza or following close contact with an infected individual.

  TAMIFLU may be taken with or without food [see Clinical Pharmacology (12.3)]. However, when taken with food, tolerability may be enhanced in some patients.

  For patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU 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). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration (2.8)].

  2.2 Treatment of Influenza

  Adults and Adolescents (13 years of age and older)

  The recommended oral dose of TAMIFLU for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. TAMIFLU for oral suspension may be used by patients who cannot swallow a capsule (12.5 mL of TAMIFLU for oral suspension [6 mg/mL] delivers 75 mg) [see Dosage and Administration (2.1)].

  Pediatric Patients (2 weeks to 12 years of age)

  The recommended oral dose of TAMIFLU for treatment of influenza in pediatric patients 1 year to 12 years of age is shown in Table 1.

  The recommended oral dose of TAMIFLU for treatment of influenza in pediatric patients 2 weeks to less than 1 year of age is 3 mg/kg twice daily for 5 days (shown in Table 1).

  2.3 Prophylaxis of Influenza

  Adults and Adolescents (13 years of age and older)

  The recommended oral dose of TAMIFLU for prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual is 75 mg once daily for at least 10 days. The recommended dose for prophylaxis during a community outbreak of influenza is 75 mg once daily. Safety and efficacy have been demonstrated for up to 6 weeks in immunocompetent patients. The duration of protection lasts for as long as dosing is continued. Safety has been demonstrated for up to 12 weeks in immunocompromised patients. TAMIFLU for oral suspension may also be used by patients who cannot swallow a capsule (12.5 mL of TAMIFLU for oral suspension [6 mg/mL] delivers 75 mg).

  Pediatric Patients (2 weeks to 12 years of age)

  The recommended oral dose of TAMIFLU for prophylaxis of influenza in pediatric patients 1 to 12 years of age based on body weight is shown in Table 1. Prophylaxis in pediatric patients following close contact with an infected individual is recommended for 10 days. For prophylaxis in pediatric patients during a community outbreak of influenza, dosing may be continued for up to 6 weeks.

  The safety and efficacy of TAMIFLU for prophylaxis of influenza have not been established in infants less than 1 year of age.

  Table 1 Treatment (twice daily dosing for 5 days) and Prophylaxis (once daily dosing for 10 days) Dosing of Oral TAMIFLU for Influenza in Pediatric Patients Weight
  (kg) Treatment Dosing for 5 days Prophylaxis Dosing for 10 days Volume of Oral Suspension (6 mg/mL) for each Dose* Number of Bottles of Oral Suspension to Dispense Number of Capsules and Strength to Dispense† * An oral dosing dispensing device that measures the appropriate volume in mL should be utilized with the oral suspension. † Oral Suspension is the preferred formulation for patients who cannot swallow capsules. ‡ TAMIFLU is not approved for prophylaxis of patients less than 1 year of age § For patients less than 1 year of age, provide an appropriate dosing device that can accurately measure and administer small volumes. 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 thru 23 kg 45 mg twice daily 45 mg once daily 7.5 mL 2 bottles 10 Capsules
  45 mg 23.1 kg thru 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 2.4 Renal Impairment

  Data are available on plasma concentrations of oseltamivir carboxylate following various dosing schedules in patients with renal impairment [see Clinical Pharmacology (12.3)].

  Treatment of Influenza

  Dose adjustment is recommended for adult patients with creatinine clearance between 10 and 60 mL/min and patients with end-stage renal disease (ESRD) undergoing hemodialysis or continuous peritoneal dialysis receiving TAMIFLU for the treatment of influenza [see Clinical Pharmacology (12.3)]. TAMIFLU is not recommended for patients with ESRD not undergoing dialysis. The recommended doses are detailed in Table 2 below.

  Table 2 Recommended Dose Adjustments for Treatment of Influenza in Adult Patients with Renal Impairment or End Stage Renal Disease (ESRD) on Dialysis Renal Impairment/Creatinine Clearance Recommended Treatment Regimen* * Capsules or suspension can be used for 30 mg dosing. † Assuming three hemodialysis sessions are performed in the 5-day period. Treatment can be initiated immediately if influenza symptoms develop during the 48 hours between hemodialysis sessions; however, the post-hemodialysis dose should still be administered independently of time of administration of the initial dose. ‡ Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients. Mild
  Creatinine Clearance >60-90 mL/min 75 mg twice daily for 5 days Moderate
  Creatinine Clearance >30-60 mL/min 30 mg twice daily for 5 days Severe
  Creatinine Clearance >10-30 mL/min 30 mg once daily for 5 days ESRD Patients on Hemodialysis
  Creatinine Clearance ≤10 mL/min 30 mg after every hemodialysis cycle. Treatment duration not to exceed 5 days† ESRD Patients on Continuous Ambulatory Peritoneal Dialysis‡
  Creatinine Clearance ≤10 mL/min A single 30 mg dose administered immediately after a dialysis exchange

  Prophylaxis of Influenza

  For the prophylaxis of influenza, dose adjustment is recommended for adult patients with creatinine clearance between 10 and 60 mL/min and patients with end-stage renal disease (ESRD) undergoing hemodialysis or continuous peritoneal dialysis receiving TAMIFLU [see Clinical Pharmacology (12.3)]. The duration of prophylaxis is the same as recommended for patients with normal renal function. TAMIFLU is not recommended for patients with ESRD not undergoing dialysis. The recommended doses are detailed in Table 3 below.

  Table 3 Recommended Dose Adjustments for Prophylaxis of Influenza in Adult Patients with Renal Impairment or End Stage Renal Disease (ESRD) on Dialysis Renal Impairment/Creatinine Clearance Recommended Prophylaxis Regimen* * Capsules or suspension can be used for 30 mg dosing. † An initial dose can be administered prior to the start of dialysis. ‡ Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients. Mild
  Creatinine Clearance >60-90 mL/min 75 mg once daily Moderate
  Creatinine Clearance >30-60 mL/min 30 mg once daily Severe
  Creatinine Clearance >10-30 mL/min 30 mg every other day ESRD Patients on Hemodialysis
  Creatinine Clearance ≤10 mL/min 30 mg after alternate hemodialysis cycles† ESRD Patients on Continuous Ambulatory Peritoneal Dialysis‡
  Creatinine Clearance ≤10 mL/min 30 mg once weekly immediately after dialysis exchange 2.5 Hepatic Impairment

  No dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh score ≤9) [see Clinical Pharmacology (12.3)].

  2.6 Geriatric Patients

  No dose adjustment is required for geriatric patients [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].

  2.7 Preparation of TAMIFLU for Oral Suspension

  It is recommended that TAMIFLU for oral suspension be constituted by the pharmacist prior to dispensing to the patient:

  a) Tap the closed bottle 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.

  Label the bottle with instructions to Shake Well before each use.

  The constituted TAMIFLU for oral suspension (6 mg/mL) should be used within 17 days of preparation when stored under refrigeration or within 10 days if stored at controlled room temperature; the pharmacist should write the date of expiration of the constituted suspension on a pharmacy label. The patient package insert should be dispensed to the patient. Pharmacists should ensure patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Pharmacists should counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed (see Table 1).

  2.8 Emergency Compounding of an Oral Suspension from 75 mg TAMIFLU Capsules (Final Concentration 6 mg/mL)

  The following directions are provided for use only during emergency situations. These directions are not intended to be used if the FDA-approved, commercially manufactured TAMIFLU for oral suspension is readily available from wholesalers or the manufacturer.

  Compounding an oral suspension with this procedure will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.

  Commercially manufactured TAMIFLU for oral suspension (6 mg/mL) is the preferred product for pediatric and adult patients who have difficulty swallowing capsules or where lower doses are needed. In the event that TAMIFLU for oral suspension is not available, the pharmacist may compound a suspension (6 mg/mL) from TAMIFLU capsules 75 mg using one of these vehicles: Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Other vehicles have not been studied. This compounded suspension should not be used for convenience or when the FDA-approved TAMIFLU for oral suspension is commercially available.

  First, determine the dose of TAMIFLU for the patients [see Dosage and Administration (2)] then determine total volume of an oral suspension needed to be compounded based on Table 4.

  Table 4 Volume of an Oral Suspension (6 mg/mL) Needed to be Compounded Based Upon the Patient's TAMIFLU Dose TAMIFLU Dose* Total Volume to Compound per Patient (mL) * If the TAMIFLU dose is between the doses listed, the total volume of oral suspension to compound should default to the next greater dose listed. 15 mg or less 37.5 mL 30 mg 75 mL 45 mg 100 mL 60 mg 125 mL 75 mg 150 mL

  Second, determine the number of capsules and the amount of water and vehicle (Cherry Syrup, Ora-Sweet® SF, or simple syrup) that are needed to prepare the total volume (determined from Table 4: 37.5 mL, 75 mL, 100 mL, 125 mL, or 150 mL) of compounded oral suspension (6 mg/mL) (see Table 5).

  Table 5 Number of TAMIFLU 75 mg Capsules and Amount of Vehicle (Cherry Syrup, Ora-Sweet® SF, or Simple Syrup) Needed to Prepare the Total Volume of a Compounded Oral Suspension (6 mg/mL) Total Volume of Compounded Oral Suspension to be Prepared 37.5 mL 75 mL 100 mL 125 mL 150 mL * Includes overage to ensure all doses can be delivered Number of TAMIFLU 75 mg Capsules* 3 capsules (225 mg oseltamivir) 6 capsules (450 mg oseltamivir) 8 capsules (600 mg oseltamivir) 10 capsules (750 mg oseltamivir) 12 capsules (900 mg oseltamivir) Amount of Water 2.5 mL 5 mL 7 mL 8 mL 10 mL Volume of Vehicle
  Cherry Syrup (Humco®) OR
  Ora-Sweet® SF (Paddock Laboratories) OR simple syrup 34.5 mL 69 mL 91 mL 115 mL 137 mL

  Third, follow the procedure below for compounding the oral suspension (6 mg/mL) from TAMIFLU capsules 75 mg:

  Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle (see Table 5). Carefully separate the capsule body and cap and pour the contents of the required number of TAMIFLU 75 mg capsules into the PET or glass bottle. Gently swirl the suspension to ensure adequate wetting of the TAMIFLU powder for at least 2 minutes. Slowly add the specified amount of vehicle to the bottle. Close the bottle using a child-resistant cap 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. (Note: The active drug, oseltamivir phosphate, readily dissolves in the specified vehicles. The suspension is caused by inert ingredients of TAMIFLU capsules which are insoluble in these vehicles.) Put an ancillary label on the bottle indicating "Shake Well Before Use." Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions. Place an appropriate expiration date on the label according to storage conditions below.

  Storage of the Emergency Compounded Suspension

  Refrigeration: Stable for 5 weeks (35 days) when stored in a refrigerator at 2° to 8°C (36° to 46°F). Room Temperature: Stable for five days (5 days) when stored at room temperature, 25°C (77°F).

  Note: The storage conditions are based on stability studies of compounded oral suspensions, using the above mentioned vehicles, which were placed in glass and polyethyleneterephthalate (PET) bottles. Stability studies have not been conducted with other vehicles or bottle types.

  Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, and drug name and any other required information to be in compliance with all State and Federal Pharmacy Regulations.

  Dosing of the Compounded Suspension (6 mg/mL)

  Refer to Dosage and Administration sections 2.2, 2.3, 2.4 and Table 1 for the proper dosing instructions for the pharmacy label.

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