Tamiflu (Page 8 of 9)
16 HOW SUPPLIED/STORAGE AND HANDLING
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).
Storage
Store the capsules at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].
TAMIFLU for Oral Suspension (Supplied as Powder)
Supplied as a white powder blend in a glass bottle. After constitution, the powder blend produces a white tutti-frutti–flavored oral suspension. After constitution with 55 mL of water, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL) [see Dosage and Administration (2.5)] (NDC 0004-0822-05).
Storage
Store dry powder at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].
Store constituted oral suspension under refrigeration for up to 17 days at 2º to 8ºC (36º to 46ºF). Do not freeze. Alternatively, store constituted oral suspension for up to 10 days at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Serious Skin/Hypersensitivity Reactions
Advise patients and/or caregivers of the risk of severe allergic reactions (including anaphylaxis) or serious skin reactions. Instruct patients and/or caregiver to stop TAMIFLU and seek immediate medical attention if an allergic-like reaction occurs or is suspected [see Warnings and Precautions (5.1)].
Neuropsychiatric Events
Advise patients and/or caregivers of the risk of neuropsychiatric events in TAMIFLU-treated patients with influenza and instruct patients to contact their physician if they experience signs of abnormal behavior while receiving TAMIFLU [see Warnings and Precautions (5.2)].
Important Dosing Information
Instruct patients to begin treatment with TAMIFLU as soon as possible from the first appearance of flu symptoms, within 48 hours of onset of symptoms. Similarly, instruct patients to start taking TAMIFLU for prevention as soon as possible after exposure [see Dosage and Administration (2)]. Instruct patients to take any missed doses as soon as they remember, except if it is near the next scheduled dose (within 2 hours), and then continue to take TAMIFLU at the usual times.
Influenza Vaccines
Instruct patients that TAMIFLU is not a substitute for receiving an annual flu vaccination. Patients should continue receiving an annual flu vaccination according to guidelines on immunization practices. Because of the potential for TAMIFLU to inhibit replication of live attenuated influenza vaccine (LAIV) and possibly reduce efficacy of LAIV, avoid administration of LAIV within 2 weeks or 48 hours after TAMIFLU administration, unless medically necessary [see Drug Interactions (7.1)].
Fructose Intolerance
Inform patients with hereditary fructose intolerance that one dose of 75 mg TAMIFLU oral suspension (supplied as powder) delivers 2 grams of sorbitol. Inform patients with hereditary fructose intolerance that this is above the daily maximum limit of sorbitol and may cause dyspepsia and diarrhea [see Warnings and Precautions (5.4)].
Distributed by:
Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
©2019 Genentech, Inc. All rights reserved
Licensor:
Gilead Sciences, Inc.Foster City, California 94404
This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised 08/2019 | ||
PATIENT INFORMATION | |||
TAMIFLU ® (TAM-ih-flew)(oseltamivir phosphate)capsules, for oral use | TAMIFLU ® (TAM-ih-flew)(oseltamivir phosphate)for oral suspension | ||
What is TAMIFLU? TAMIFLU is a prescription medicine used to:
It is not known if TAMIFLU is:
TAMIFLU does not treat or prevent illness that is caused by infections other than the influenza virus. TAMIFLU does not prevent bacterial infections that may happen with the flu. TAMIFLU is not recommended for people with end-stage renal disease (ESRD) who are not receiving dialysis. TAMIFLU does not take the place of receiving a flu vaccination. Talk to your healthcare provider about when you should receive an annual flu vaccination. | |||
Who should not take TAMIFLU? Do not take TAMIFLU if you are allergic to oseltamivir phosphate or any of the ingredients in TAMIFLU. See the end of this leaflet for a complete list of ingredients in TAMIFLU. | |||
What should I tell my healthcare provider before taking TAMIFLU? Before you take TAMIFLU, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. | |||
How should I take TAMIFLU?
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What are the possible side effects of TAMIFLU? TAMIFLU may cause serious side effects, including:
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The most common side effects of TAMIFLU when used for treatment of the flu include nausea, vomiting, and headache. The most common side effect of TAMIFLU when used for prevention of the flu include nausea, vomiting, headache, and pain. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of TAMIFLU. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||
How should I store TAMIFLU?
Keep TAMIFLU and all medicines out of the reach of children. | |||
General information about the safe and effective use of TAMIFLU. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TAMIFLU for a condition for which it was not prescribed. Do not give TAMIFLU to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about TAMIFLU that is written for health professionals. For more information, go to www.tamiflu.com. | |||
What are the ingredients in TAMIFLU? Active ingredient: oseltamivir phosphate Inactive ingredients: TAMIFLU capsules: croscarmellose sodium, povidone K30, pregelatinized starch, sodium stearyl fumarate, and talc 30mg capsule shell: gelatin, red iron oxide, titanium dioxide, and yellow iron oxide 45mg capsules shell: black iron oxide, gelatin, and titanium dioxide 75mg capsules shell: black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide TAMIFLU for oral suspension: monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti-frutti flavoring, and xanthan gum. Distributed by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990Licensor: Gilead Sciences, Inc., Foster City, California, 94404©2019 Genentech, Inc. All rights reserved |
This Instructions for Use has been approved by the U.S. Food and Drug Administration. | Revised 06/2016 | ||
INSTRUCTIONS FOR USE | |||
TAMIFLU ® (TAM-ih-flew)(oseltamivir phosphate)capsules, for oral use | TAMIFLU ® (TAM-ih-flew)(oseltamivir phosphate)for oral suspension | ||
How do I give a dose of TAMIFLU for oral suspension? | |||
Step 1. | Shake the TAMIFLU for oral suspension bottle well before each use. | ||
Step 2. | Open the bottle by pushing downward on the child resistant bottle cap and twisting it in the direction of the arrow. | ||
Step 3. | Measure the oral suspension with an appropriate oral dosing dispenser to be sure you get the correct dose.Contact your pharmacist if you do not have an appropriate oral dosing dispenser. | ||
Step 4. | Give the full contents of oral dosing dispenser directly into the mouth. | ||
Step 5. | Close the bottle with the child-resistant bottle cap after each use. | ||
Step 6. | Rinse oral dosing dispenser under running tap water and allow to air dry after each use. | ||
How do I mix the contents of TAMIFLU capsules with sweetened liquids, if directed by my healthcare provider or pharmacist? You will need: | |||
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Step 1. | Open the contents of the prescribed dose of TAMIFLU capsules into a small bowl. | ||
Step 2. | Add a small amount of the sweetened liquid to the capsule contents. | ||
Step 3. | Stir the mixture and give the entire dose of TAMIFLU. |
Representative sample of labeling (see the HOW SUPPLIED section for complete listing):
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