The following directions are provided for use only during emergency situations and when FDA-approved, commercially manufactured oseltamivir phosphate for oral suspension is not available from wholesalers or the manufacturer.
The following emergency preparation instructions will provide one patient with enough oseltamivir phosphate for a 5-day course of treatment of influenza or a 10-day course of prophylaxis of influenza:
Step #1: Determine the dosage of oseltamivir phosphate for the patient [see Dosage and Administration (2.2, 2.3, and 2.4)] then determine the total volume of oral suspension needed to be prepared (see Table 3).Table 3 Emergency Preparation: Volume of Prepared Oral Suspension (6 mg per mL) Based Upon Oseltamivir Phosphate Dose
|Oseltamivir Phosphate Dose*||Total Volume to Prepare per Patient|
|15 mg or less||37.5 mL|
|30 mg||75 mL|
|45 mg||100 mL|
|60 mg||125 mL|
|75 mg||150 mL|
* If the oseltamivir phosphate dose is between the doses listed, use the greater listed dose to determine the total volume of prepared oral suspension.
Step #2: Preparation must be performed with only one of the following vehicles (other vehicles have not been studied): Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Determine the number of capsules and the amount of water and vehicle needed to prepare the total volume (see Table 3) of prepared oral suspension (6 mg per mL) for a complete treatment or prophylaxis course (see Table 4).Table 4 Emergency Preparation: Number of Oseltamivir Phosphate Capsules 75 mg and Amount of Water and Vehicle Needed to Prepare the Total Volume of a Prepared Oral Suspension (6 mg per mL)
|Total Volume of Prepared Oral Suspension||37.5 mL||75 mL||100 mL||125 mL||150 mL|
|Number of Oseltamivir Phosphate Capsules 75 mg (Total Strength)*||3 (225 mg)||6 (450 mg)||8 (600 mg)||10 (750 mg)||12 (900 mg)|
|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|
*Includes overage to ensure all doses can be delivered
Step #3: Follow the instructions below for preparing the 75 mg oseltamivir phosphate capsules to produce the oral suspension (6 mg per mL):
a. Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle (see Table 4). Constitution in other bottle types is not recommended because there is no stability data with other bottle types.
b. Carefully separate the capsule body and cap and pour the contents of the required number of oseltamivir phosphate capsules 75 mg into the PET or glass bottle.
c. Gently swirl the suspension to ensure adequate wetting of the oseltamivir phosphate capsules powder for at least 2 minutes.
d. Slowly add the specified amount of vehicle to the bottle.
e. 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. The active drug, oseltamivir phosphate, readily dissolves in the specified vehicles. The suspension is caused by inert ingredients of oseltamivir phosphate capsules which are insoluble in these vehicles.
f. Put an ancillary label on the bottle indicating “Shake Well Before Use.”
g. 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.
h. Place a pharmacy label on the bottle that includes the patient’s name, dosing instructions, drug name and any other required information to be in compliance with all State and Federal Pharmacy Regulations. Place an appropriate expiration date on the label according to storage conditions below.
i. Include the recommended dosage on the pharmacy label as per Tables 1 and 2 [see Dosage and Administration (2.2, 2.3, and 2.4)].
j. Store the prepared oral suspension in glass or PET bottles either:
• In a refrigerator [2° to 8°C (36° to 46°F)]: Stable for 5 weeks when stored in a refrigerator.
• At room temperature [25°C (77°F)]: Stable for 5 days when stored at room temperature.
Oseltamivir Phosphate Capsules, USP:
• 30-mg capsules (30 mg free base equivalent of the phosphate salt): Light yellow cap and light yellow body size ‘4’ hard gelatin capsules containing white to off white granules with “30mg” on cap and “M53” on body imprinted with blue ink.
• 45-mg capsules (45 mg free base equivalent of the phosphate salt): Grey cap and grey body size ‘4’ hard gelatin capsules containing white to off white granules with “45mg” on cap and “M54” on body imprinted with blue ink.
• 75-mg capsules (75 mg free base equivalent of the phosphate salt): Light yellow cap and grey body size ‘2’ hard gelatin capsules containing white to off white granules with “75mg” on cap and “M55” on body imprinted with blue ink.
Oseltamivir phosphate capsules are contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme [see Warnings and Precautions (5.1)].
Cases of anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme have been reported in postmarketing experience with oseltamivir phosphate capsules. Stop oseltamivir phosphate capsules and institute appropriate treatment if an allergic-like reaction occurs or is suspected. The use of oseltamivir phosphate capsules is contraindicated in patients with known serious hypersensitivity to oseltamivir phosphate [see Contraindications (4) and Adverse Reactions (6.2)].
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