FDA records indicate that there are no current recalls for this drug.
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Zee Ibutab Recall
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Questions & Answers
Side Effects & Adverse Reactions
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction,
especially in people allergic to aspirin. Symptoms may include:
■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
■ rash ■ skin reddening ■ blisters
If an allergic reaction occurs, stop use and seek medical help
right away.
Stomach bleeding warning: This product contains a
nonsteroidal anti-inflammatory drug (NSAID), which may cause
severe stomach bleeding. The chance is higher if you
■ are age 60 or older
■ have had stomach ulcers or bleeding problems
■ take a blood thinning (anticoagulant) or steroid drug
■ take other drugs containing prescription or nonprescription
NSAIDs (aspirin, ibuprofen, naproxen, or others)
■ have 3 or more alcoholic drinks every day while using this
product
■ take more or for a longer time than directed
Do not use
■ if you have ever had an allergic reaction to any other pain
reliever/fever reducer
■ right before or after heart surgery
Ask a doctor before use if
■ stomach bleeding warning applies to you
■ you have a history of stomach problems, such as heartburn
■ you have problems or serious side effects from taking pain
relievers or fever reducers
■ you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, or asthma
■ you are taking a diuretic
Ask a doctor or pharmacist before use if you are
■ under a doctor's care for any serious condition
■ taking aspirin to prevent heart attack or stroke, because
ibuprofen may decrease this benefit of aspirin
■ taking any other drug
When using this product
■ take with food or milk if stomach upset occurs
■ the risk of heart attack or stroke may increase if you use more
than directed or for longer than directed
Stop use and ask a doctor if
■ you experience any of the following signs of stomach bleeding:
■ feel faint ■ vomit blood ■ have bloody or black stools
■ have stomach pain that does not get better
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present in the painful area
■ any new symptoms appear
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Uses
■ temporarily relieves minor aches and pains due to:
■ headache ■ the common cold ■ muscular aches
■ backache ■ toothache ■ minor pain of arthritis
■ menstrual cramps
■ temporarily reduces fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Zee Ibutab Manufacturers
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Zee Medical Inc
Zee Ibutab | Taiho Pharmaceutical Co., Ltd.
2.1 Recommended DoseThe recommended starting dose of LONSURF is 35 mg/m2 up to a maximum of 80 mg per dose (based on the trifluridine component) orally twice daily within one hour of completion of morning and evening meals on Days 1 through 5 and Days 8 through 12 of each 28-day cycle until disease progression or unacceptable toxicity. Round dose to the nearest 5 mg increment.
Do not take additional doses to make up for missed or held doses.
LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
2.2 Dose ModificationsObtain complete blood cell counts prior to and on Day 15 of each cycle.
Do no initiate the cycle of LONSURF until:
Absolute neutrophil count (ANC) is greater than or equal to 1,500/mm3 or febrile neutropenia is resolved Platelets are greater than or equal to 75,000/mm3 Grade 3 or 4 non-hematological adverse reactions are resolved to Grade 0 or 1Within a treatment cycle, withhold LONSURF for any of the following:
Absolute neutrophil count (ANC) less than 500/mm3 or febrile neutropenia Platelets less than 50,000/mm3 Grade 3 or 4 non-hematological adverse reactionsAfter recovery, resume LONSURF after reducing the dose by 5 mg/m2/dose from the previous dose level, if the following occur:
Febrile neutropenia Uncomplicated Grade 4 neutropenia (which has recovered to greater than or equal to 1,500/mm3) or thrombocytopenia (which has recovered to greater than or equal to 75,000/mm3) that results in more than 1 week delay in start of next cycle Non-hematologic Grade 3 or Grade 4 adverse reaction except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or Grade 3 diarrhea responsive to antidiarrheal medicationA maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 twice daily. Do not escalate LONSURF dose after it has been reduced.
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