Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4023
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Tamiflu (Powder, For Suspension)
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TAMIFLU may be taken with or without food (see CLINICAL PHARMACOLOGY:
Pharmacokinetics). However, when taken with food,
tolerability may be enhanced in some patients.<br/>Standard Dosage���Treatment
of Influenza:<br/>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.<br/>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 5. TAMIFLU for Oral Suspension may also
be used by patients who cannot swallow a capsule. For pediatric patients
who cannot swallow capsules, TAMIFLU for Oral Suspension is the preferred
formulation. If the for Oral Suspension product is not available,
TAMIFLU Capsules may be opened and mixed with sweetened liquids such
as regular or sugar-free chocolate syrup. An oral dosing dispenser with 30 mg, 45 mg, and
60 mg graduations is provided with the oral suspension; the 75 mg
dose can be measured using a combination of 30 mg and 45 mg. It is
recommended that patients use this dispenser. In the event that the
dispenser provided is lost or damaged, another dosing syringe or otherdevice may be used to deliver the following volumes: 2.5 mL (1/2 tsp)
for children���15 kg, 3.8 mL (3/4 tsp) for>15 to 23 kg, 5.0
mL (1 tsp) for>23 to 40 kg, and 6.2 mL (1 1/4 tsp) for>40 kg.<br/>Standard Dosage���Prophylaxis
of Influenza:<br/>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. The duration of protection lasts for as long as
dosing is continued.<br/>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 6. TAMIFLU for
Oral Suspension may also be used by patients who cannot swallow a
capsule. For pediatric patients who cannot swallow capsules, TAMIFLU
for Oral Suspension is the preferred formulation. If the for Oral
Suspension product is not available, TAMIFLU Capsules may be opened
and mixed with sweetened liquids such as regular or sugar-free chocolate
syrup. An oral dosing dispenser with 30 mg, 45 mg, and
60 mg graduations is provided with the oral suspension; the 75 mg
dose can be measured using a combination of 30 mg and 45 mg. It is
recommended that patients use this dispenser. In the event that the
dispenser provided is lost or damaged, another dosing syringe or other
device may be used to deliver the following volumes: 2.5 mL (1/2 tsp)
for children���15 kg, 3.8 mL (3/4 tsp) for>15 to 23 kg, 5.0
mL (1 tsp) for>23 to 40 kg, and 6.2 mL (1 1/4 tsp) for>40 kg. Prophylaxis in pediatric patients following close contact
with an infected individual is recommended for 10 days. Prophylaxis
in patients 1 to 12 years of age has not been evaluated for longer
than 10 days duration. Therapy should begin within 2 days of exposure.<br/>Special Dosage Instructions:<br/>Hepatic Impairment: No dose adjustment is recommended for patients with
mild or moderate hepatic impairment (Child-Pugh score���9) .<br/>Renal Impairment: For plasma concentrations of oseltamivir carboxylate
predicted to occur following various dosing schedules in patients
with renal impairment, see CLINICAL PHARMACOLOGY: Pharmacokinetics:
Special Populations.<br/>Geriatric Patients: No dose adjustment is required for geriatric patients
.<br/>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: NOTE: SHAKE THE TAMIFLU FOR ORAL SUSPENSION WELL
BEFORE EACH USE. The constituted TAMIFLU for
Oral Suspension (12 mg/mL) should be used within 10 days of preparation;
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.<br/>Emergency Compounding of an Oral Suspension from TAMIFLU Capsules(Final Concentration 15 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 (12 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 (15 mg/mL) from TAMIFLU (oseltamivir phosphate) Capsules
75 mg using either of two vehicles: Cherry Syrup (Humco') or
Ora-Sweet' SF (sugar-free) (Paddock Laboratories). Other vehicles
have not been studied. This compounded suspension
should not be used for convenience or when the FDA-approved TAMIFLU
for OralSuspension 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 each patient. Refer
to Table 7. Second, determine the number of capsules and the
amount of vehicle (Cherry Syrup or Ora-Sweet SF) that are needed to
prepare the Total Volume (calculated from Table 7: 30 mL, 40 mL, 50 mL, or 60 mL) of compounded
oral suspension (15 mg/mL). Refer to Table 8. Third, follow the procedure below for compounding
the oral suspension (15 mg/mL) from TAMIFLU Capsules 75 mg<br/>STORAGE OF THE PHARMACY-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 amber glass and amber 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. Refer to Table 9 for the proper dosing instructions. Note: This compounding procedure results
in a 15 mg/mL suspension, which is different from the commercially
available TAMIFLU for Oral Suspension, which has a concentration of
12 mg/mL. Consider dispensing the suspension with a graduated oral syringe
for measuring small amounts of suspension. If possible, mark or highlight
the graduation corresponding to the appropriate dose (2 mL, 3 mL,
4 mL, or 5 mL) on the oral syringe for each patient. The dosing device
dispensed with the commercially available TAMIFLU for Oral Suspension
should NOT be used with the compounded suspension since they have
different concentrations.
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TAMIFLU (oseltamivir phosphate) is available as capsules
containing 30 mg, 45 mg, or 75 mg oseltamivir for oral use, in the
form of oseltamivir phosphate, and as a powder for oral suspension,
which when constituted with water as directed contains 12 mg/mL oseltamivir
base. In addition to the active ingredient, each capsule contains
pregelatinized starch, talc, povidone K 30, croscarmellose sodium,
and sodium stearyl fumarate. The 30 mg capsule shell contains gelatin,
titanium dioxide, yellow iron oxide, and red iron oxide. The 45 mg
capsule shell contains gelatin, titanium dioxide, and black iron oxide.
The 75 mg capsule shell contains gelatin, titanium dioxide, yellow
iron oxide, black iron oxide, and red iron oxide. Each capsule is
printed with blue ink, which includes FD&C Blue No. 2 as the colorant.
In addition to the active ingredient, the powder for oral suspension
contains sorbitol, monosodium citrate, xanthan gum, titanium dioxide,
tutti-frutti flavoring, sodium benzoate, and saccharin sodium. Oseltamivir phosphate is a white crystalline solid with
the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic
acid, ethyl ester, phosphate (1:1). The chemical formula is CHNO(free base). The
molecular weight is 312.4 for oseltamivir free base and 410.4 for
oseltamivir phosphate salt. The structural formula is as follows:
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Pharmacokinetics:<br/>Absorption and Bioavailability: Oseltamivir is readily absorbed from the gastrointestinal
tract after oral administration of oseltamivir phosphate and is extensively
converted predominantly by hepatic esterases to oseltamivir carboxylate.
At least 75% of an oral dose reaches the systemic circulation as oseltamivir
carboxylate. Exposure to oseltamivir is less than 5% of the total
exposure after oral dosing (see Table 1). Plasma concentrations of oseltamivir carboxylate
are proportional to doses up to 500 mg given twice daily . Coadministration with food has
no significant effect on the peak plasma concentration (551 ng/mL
under fasted conditions and 441 ng/mL under fed conditions) and the
area under the plasma concentration time curve (6218 ng���h/mL
under fasted conditions and 6069 ng���h/mL under fed conditions)
of oseltamivir carboxylate.<br/>Distribution: The volume of distribution (V) of oseltamivir
carboxylate, following intravenous administration in 24 subjects,
ranged between 23 and 26 liters. The binding
of oseltamivir carboxylate to human plasma protein is low (3%). The
binding of oseltamivir to human plasma protein is 42%, which is insufficient
to cause significant displacement-based drug interactions.<br/>Metabolism: Oseltamivir is extensively converted to oseltamivir
carboxylate by esterases located predominantly in the liver. Neither
oseltamivir nor oseltamivir carboxylate is a substrate for, or inhibitor
of, cytochrome P450 isoforms.<br/>Elimination: Absorbed oseltamivir is primarily (>90%) eliminated
by conversion to oseltamivir carboxylate. Plasma concentrations of
oseltamivir declined with a half-life of 1 to 3 hours in most subjects
after oral administration. Oseltamivir carboxylate is not further
metabolized and is eliminated in the urine. Plasma concentrations
of oseltamivir carboxylate declined with a half-life of 6 to 10 hours
in most subjects after oral administration. Oseltamivir carboxylate
is eliminated entirely (>99%) by renal excretion. Renal clearance
(18.8 L/h) exceeds glomerular filtration rate (7.5 L/h) indicating
that tubular secretion occurs, in addition to glomerular filtration.
Less than 20% of an oral radiolabeled dose is eliminated in feces.<br/>Special Populations:<br/>Renal Impairment: Administration of 100 mg of oseltamivir phosphate
twice daily for 5 days to patients with various degrees of renal impairment
showed that exposure to oseltamivir carboxylate is inversely proportional
to declining renal function. Oseltamivir carboxylate exposures in
patients with normal and abnormal renal function administered various
dose regimens of oseltamivir are described in Table 2.<br/>Hepatic Impairment: In clinical studies oseltamivir carboxylate exposure
was not altered in patients with mild or moderate hepatic impairment
.<br/>Pediatric Patients: The pharmacokinetics of oseltamivir and oseltamivir
carboxylate have been evaluated in a single dose pharmacokinetic study
in pediatric patients aged 5 to 16 years (n=18) and in a small number
of pediatric patients aged 3 to 12 years (n=5) enrolled in a clinical
trial. Younger pediatric patients cleared both the prodrug and the
active metabolite faster than adult patients resultingin a lower
exposure for a given mg/kg dose. For oseltamivir carboxylate, apparent
total clearance decreases linearly with increasing age (up to 12 years).
The pharmacokinetics of oseltamivir in pediatric patients over 12
years of age are similar to those in adult patients.<br/>Geriatric Patients: Exposure to oseltamivir carboxylate at steady-state
was 25% to 35% higher in geriatric patients (age range 65 to 78 years)
compared to young adults given comparable doses of oseltamivir. Half-lives
observed in the geriatric patients were similar to those seen in young
adults. Based on drug exposure and tolerability, dose adjustments
are not required for geriatric patients for either treatment or prophylaxis
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TAMIFLU is contraindicated in patients with known
hypersensitivity to any of the components of the product.
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TAMIFLU Capsules: 30-mg capsules (30 mg free base equivalent of the
phosphate salt): light yellow hard gelatin capsules. "ROCHE" is printed
in blue ink on the light yellow body and "30 mg" is printed in blue
ink on the light yellow cap. Available in blister packages of 10 (NDC
0004-0802-85). 45-mg capsules (45 mg free base
equivalent of the phosphate salt): grey hard gelatin capsules. "ROCHE"
is printed in blue ink on the grey body and "45 mg" is printed in
blue ink on the grey cap. Available in blister packages of 10 (NDC
0004-0801-85). 75-mg capsules (75 mg free base
equivalent of the phosphate salt): grey/light yellow hard gelatin
capsules. "ROCHE" is printed in blue ink on the grey body and "75
mg" is printed in blue ink on the light yellow cap. Available in blister
packages of 10 (NDC 0004-0800-85).<br/>Storage: Store the capsules at 25��C (77��F); excursions
permitted to 15��to 30��C (59��to 86��F). [See USP
Controlled Room Temperature]<br/>TAMIFLU for Oral Suspension: Supplied as a white powder blend for constitution
to a white tutti-frutti���flavored suspension. Available in glass
bottles containing approximately 33 mL of suspension after constitution.
Each bottle delivers 25 mL of suspension equivalent to 300 mg oseltamivir
base. Each bottle is supplied with a bottle adapter and 1 oral dispenser
(NDC 0004-0810-95).<br/>Storage: Store dry powder at 25��C (77��F); excursions
permitted to 15��to 30��C (59��to 86��F). [See USP
Controlled Room Temperature] Store constituted
suspension under refrigeration at 2��to 8��C (36��to
46��F). Do not freeze. Humco' is a
registered trademark of Humco Holding Group, Inc. Ora-Sweet' SF is a registered trademark of Paddock Laboratories
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At present, there has been no experience with overdose.
Single doses of up to 1000 mg of TAMIFLU have been associated with
nausea and/or vomiting.
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oseltamivir phosphate
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Tamiflu (Powder, For Suspension)
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Treatment Studies in Adult
Patients: A total of 1171 patients who participated in adult
phase III controlled clinical trials for the treatment of influenza
were treated with TAMIFLU. The most frequently reported adverse events
in these studies were nausea and vomiting. These events were generally
of mild to moderate degree and usually occurred on the first 2 days
of administration. Less than 1% of subjects discontinued prematurely
from clinical trials due to nausea and vomiting. Adverse events that occurred with an incidence of���1% in 1440
patients taking placebo or TAMIFLU 75 mg twice daily in adult phase
III treatment studies are shown in Table 3. This summary includes
945 healthy young adults and 495 "at risk" patients (elderly patients
and patients with chronic cardiac or respiratory disease). Those events
reported numerically more frequently in patients taking TAMIFLU compared
with placebo were nausea, vomiting, bronchitis, insomnia, and vertigo.<br/>Prophylaxis Studies in Adult
Patients: A total of 4187 subjects (adolescents, healthy adults
and elderly) participated in phase III prophylaxis studies, of whom
1790 received the recommended dose of 75 mg once daily for up to 6
weeks. Adverse events were qualitatively very similar to those seen
in the treatment studies, despite a longer duration of dosing (see Table 3). Events reported more frequently in subjects receiving TAMIFLU
compared to subjects receiving placebo in prophylaxis studies, and
more commonly than in treatment studies, were aches and pains, rhinorrhea,
dyspepsia and upper respiratory tract infections. However, the difference
in incidence between TAMIFLU and placebo for these events was less
than 1%. There were no clinically relevant differences in the safety
profile of the 942 elderly subjects who received TAMIFLU or placebo,
compared with the younger population. Adverse events included are: all events reported
in the treatment studies with frequency���1% in the oseltamivir
75 mg bid group. Additional adverse events occurring
in<1% of patients receiving TAMIFLU for treatment included unstable
angina, anemia, pseudomembranous colitis, humerus fracture, pneumonia,
pyrexia, and peritonsillar abscess.<br/>Treatment Studies in Pediatric
Patients: A total of 1032 pediatric patients aged 1 to 12 years
(including 698 otherwise healthy pediatric patients aged 1 to 12 years
and 334 asthmatic pediatric patients aged 6 to 12 years) participated
in phase III studies of TAMIFLU given for the treatment of influenza.
A total of 515 pediatric patients received treatment with TAMIFLU
for Oral Suspension. Adverse events occurring
in���1% of pediatric patients receiving TAMIFLU treatment are
listed in Table
4. The most frequently reported adverse event
was vomiting. Other events reported more frequently by pediatric patients
treated with TAMIFLU included abdominal pain, epistaxis, ear disorder,
and conjunctivitis. These events generally occurred once and resolved
despite continued dosing. They did not cause discontinuation of drug
in the vast majority of cases. The adverse event
profile in adolescents is similar to that described for adult patients
and pediatric patients aged 1 to 12 years.<br/>Prophylaxis in Pediatric Patients: Pediatric patients aged 1 to 12 years participated
in a postexposure prophylaxis study in households, both as index cases
(134) and as contacts (222). Gastrointestinal events were the most
frequent, particularly vomiting. The adverse events noted were consistent
with those previously observed in pediatric treatment studies (see Table 4). Adverse events included in Table 4 are: all events
reported in the treatment studies with frequency���1% in the
oseltamivir 75 mg bid group.<br/>Observed During Clinical Practice: The following adverse reactions have been identified
during postmarketing use of TAMIFLU. Because these reactions are reported
voluntarily from a population of uncertain size, it is not possible
to reliably estimate their frequency or establish a causal relationship
to TAMIFLU exposure. Body as a Whole: Swelling
of the face or tongue, allergy, anaphylactic/anaphylactoid reactions Dermatologic: Dermatitis, rash, eczema, urticaria, erythema
multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis Digestive: Hepatitis, liver function
tests abnormal Cardiac: Arrhythmia Gastrointestinal disorders: Gastrointestinal bleeding,
hemorrhagic colitis Neurologic: Seizure Metabolic: Aggravation of diabetes Psychiatric: Delirium, including symptoms such as altered level of
consciousness, confusion, abnormal behavior, delusions, hallucinations,
agitation, anxiety, nightmares
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Treatment of Influenza: TAMIFLU is indicated for the treatment of uncomplicated
acute illness due to influenza infection in patients 1 year and older
who have been symptomatic for no more than 2 days.<br/>Prophylaxis of Influenza: TAMIFLU is indicated for the prophylaxis of influenza
in patients 1 year and older. The following
points should be considered before initiating treatment or prophylaxis
with TAMIFLU:<br/>Description of Clinical Studies:
Studies in Naturally Occurring Influenza:<br/>Treatment of Influenza:<br/>Prophylaxis of Influenza:
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Tamiflu
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