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Generic name: IBUPROFEN
Alivio Medical Products, LLC
Dosage Form
N/A
Manufacturer
Alivio Medical Products, LLC
This medication contains important usage instructions, warnings, and side effect information that you should review before use.
Cardiovascular Risk
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options
before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration
consistent with individual patient treatment goals (see WARNINGS).
Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and
osteoarthritis.
Ibuprofen tablets are indicated for the relief of mild to moderate pain.
Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have
not been conducted.
DOSAGE AND USE: See package insert for complete product information
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest
effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk.
Rheumatoid arthritis and osteoarthritis, including flare - ups of chronic disease
Suggested Dosage: 1200 mg - 3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid). Individual patients may show a better response to 3200 mg
daily, as compared with 2400 mg, although in well - controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy.
Therefore, when treating patients with 3200 mg / day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.
The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at the time of initiating drug therapy or
as the patient responds or fails to respond.
In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis.
The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose - response relationship exists with single
doses up to 800 mg (See CLINICAL PHARMACOLOGY for effects of food on rate of absorption).
The availability of four tablet strengths facilitates dosage adjustment.
In chronic conditions, a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two
weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.
Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain.
In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no effective than the 400 mg dose.
Dysmenorrhea
For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as
necessary for the relief of pain.
CONTRAINDICATIONS
Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen.
Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic -
type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to
NSAIDs have been reported in such patients (see WARNINGS, ANAPHYLACTOID REACTIONS, and
PRECAUTIONS, PREEXISTING ASTHMA).
Ibuprofen tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery
bypass graft (CABG) surgery (see WARNINGS).
ADVERSE REACTIONS
The most frequent type of adverse reaction occurring with ibuprofen tablets is gastrointestinal. In controlled clinical trials the percentage of patients
reporting one or more gastrointestinal complaints were ranged form 4 % to 16 %.
In controlled studies when ibuprofen tablets were compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal
complaints was about half that seen in either the aspirin - or indomethacin - treated patients.
Adverse reactions observed during controlled clinical trials at an incidence greater than 1 % are listed in the table. These reactions listed in Column one
encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks.
Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and form marketing experience. These reactions have
been divided into two categories: Column two of the table lists reactions with therapy with ibuprofen tablets where the probability of a causal relationship
exists: for the reactions in Column three, a causal relationship with ibuprofen tablets has not been established.
Reported side effects were higher at doses of 3200 mg / day than at doses of 2400 mg or less per day in clinical trials of patients with rheumatoid arthritis.
The increases in incidence were slight were slight and still within the ranges reported in the table.
OVERDOSAGE
Approximately 1 1/2 hours after the reported ingestion of from 7 to 10 ibuprofen tablets (400 mg), a 19 - month old child weighing 12 kg was seen in the
hospital emergency room, apneic and cyanotic, responding only to painful stimuli. This type of stimulus, however, was sufficient to induce respiration.
Oxygen and parenteral fluids were given; a greenish - yellow fluid was aspirated from the stomach with no evidence to indicate the presence of ibuprofen.
Two hours after ingestion the child's condition seemed stable; she still responded only ro painful stimuli and continued to have periods of apnea lasting from
5 to 10 seconds. She was admitted to intensive care and sodium bicarbonate was administered as well as infusions of dextrose and normal saline. By four
hours post - ingestion she could be aroused easily, sit by herself and respond to spoken commands. Blood level of ibuprofen was 102.9 ug / mL approxiamtely
8 1/2 hours after accidental ingestion. As 12 hours she appeared to be completely recovered.
In two other reported cases where children (each weighing approximately 10 kg) accidentally, acutely ingested approximately 120 mg / kg, there were no
signs of acute intoxication or late sequelae. Blood level in one child 90 minutes after ingestion was 700 ug / mL - about 10 times the peak levels seen in
absorption - excretion studies.
A 19 - year old male who had taken 8,000 mg of ibuprofen over a period of a few hours complained of dizziness, and nystagmus was noted. After
hospitalization, parenteral hydration and three days bed rest, he recovered with no reported sequelae.
In cases of acute overdosage, the stomach should be emptied by vomiting or lavage, through little drug will likely be recovered if more than an hour has
elapsed since ingestion. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In
addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and reabsorption of ibuprofen tablets.
Medication Guide for Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of
prescription NSAID medicines)
What is the most important information I should know
about medicines called Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack
or stroke that can lead to death.This chance increases:
-with longer use of NSAID medicines
-in people who have heart disease
NSAID medicines should never be used right before or after
a heart surgery called a "coronary artery bypass
graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the
stomach and intestines at any time during treatment.
Ulcers and bleeding:
-can happen without warning symptoms
-may cause death.
The chance of a person getting an ulcer or bleeding
increases with:
-taking medicines called "corticosteroids" and "anticoagulants"
-longer use
-smoking
-drinking alcohol
-older age
-having poor health
NSAID medicines should only be used:
-exactly as prescribed
-at the lowest dose possible for your treatment
-for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling,
and heat (inflammation) form medical conditions such as:
-different types of arthritis
-menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory
Drug (NSAID)?
Do not take an NSAID medicine:
-if you had an asthma attack, hives, or other allergic
reaction with aspirin or any other NSAID medicine
-for pain right before or after heart bypass surgery
Tell your healthcare provider:
-about all of your medical conditions
-about all of the medicines you take. NSAIDs and some
other medicines can interact with each other and cause
serious side effects. Keep a list of your medicines to
show to your healthcare provider and pharmacist.
-if you are pregnant. NSAID medicines should not be
used by pregnant women late in their pregnancy.
-if you are breastfeeding. Talk to your doctor.
What are the possible side effects of Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
Serious side effects include: Other side effects include:
-heart attack -stomach pain
-stroke -constipation
-high blood pressure -diarrhea
-heart failure from body
swelling (fluid retention) -gas
-kidney problems including
kidney failure -heartburn
-bleeding and ulcers in the stomach
and intestines -nausea
-low red blood cells
(anemia) -vomiting
-life-threatening skin
reactions -dizziness
-life-threatening allergic reactions
-liver problems including liver failure
-asthma attacks in people who have asthma
Get emergency help right away if you have any of the
following symptoms:
-shortness of breath or trouble breathing
-chest pain
-weakness in one part or side of your body
-slurred speech
-swelling of the face or throat
Stop your NSAID medicine and call your healthcare provider
right away if you have any of the following symptoms:
-nausea
-more tired or weaker than usual
-itching
-your skin or eyes look yellow
-stomach pain
-flu-like symptoms
-vomit blood
-there is blood in your bowel movement or it is black and
sticky like tar
-unusual weight gain
-skin rash or blisters with fever
-swelling of the arms and legs, hands and feet
These are not all the side effects with NSAID medicines. Talk
to your healthcare provider or pharmacist for more information
about NSAID medicines.
Other information about Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs)
-Aspirin is an NSAID medicine but it does not increase the
chance of a heart attack. Aspirin can cause bleeding in the
brain, stomach and intestines. Aspirin can also cause
ulcers in the stomach and intestines.
-Some of these NSAID medicines are sold in lower doses
without a prescription (over - the - counter). Talk to your
healthcare provider before using over - the - counter NSAIDs
for more than 10 days.
NSAID medicines that need a prescription
Generic Name Tradename
Celecoxib Celebrex
Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfrom, Nalfrom 200
Flurbiprofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefanamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Neprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600
-Vicoprofen contains the same dose of ibuprofen as over - the - counter
(OTC) NSAIDs, and is usually used for less than 10 days to
treat pain. The OTC NSAID label warns that long term continuous
use may increase the risk of heart attack or stroke.
These are not all the side effects with NSAID medicines. Talk
to your healthcare provider or pharmacist for more information
and NSAID medicines. Call your doctor for medical advice
about side effects. You may report side effects to FDA
at 1-800-FDA-1088 and / or Able Wholesalers at
1-800-430-9814.
This Medication Guide has been approved by the U.S. Food
and Drug Administration
Revision: R306/09
Distributed by:
Able Wholesalers
1329A Baptist World Center Dr.
Nashville, TN 37207
1-800-430-9814
Each tablet contains: Ibuprofen, USP ......600 mg
Ibuprofen tablets contain the active ingredient ibuprofen, which is (+/-) - 2 - (p - isobutylphenyl)
propionic acid. Ibuprofen is a white powder with a melting point of 74 - 77 C and is very slightly soluble
in water (less than 1 mg / mL) and readily soluble in organic solvents such as ethanol and acetone.
Ibuprofen tablets, a nonsteroidal anti - inflammatory drug (NSAID), are available in 400 mg, 600 mg and
800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose
sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,
pregelatinized starch, talc and titanium dioxide.
[image: MM1]
HOW SUPPLIED
Ibuprofen tablets are available in the following strengths:
400 mg (White to off white, round, biconvex, film coated tablets debossed with '121' on one side and
plain on the other side)
Bottles of 90 (NDC 69512-400-90)
600 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain
on other side)
Bottles of 90 (NDC 69512-600-90)
800 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with '123' on
one side and plain on other side)
Bottles of 90 (NDC 69512-800-90)
Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]
Rx only
Distributed by:
Able Wholesalers
1329A Baptist World Center Dr.
Nashville, TN 37207
Photos of the product and/or packaging supplied by the manufacturer.
Ibuprofen tablets contain ibuprofen which possesses analgesic and antipyretic activities. Its mode of
action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin
synthetase inhibition.
In clinical studies in patients with rheumatoid arthritis and osteoarthritis, ibuprofen tablets have benn
shown to be comparable to aspirin in controlling pain and inflammation and to be associated with a
statistically significant reduction in the milder gastrointestinal side effects ( see ADVERSE REACTIONS).
Ibuprofen tablets may be well tolerated in some patients who have had gastrointestinal side effects
with aspirin, but these patients when treated with ibuprofen tablets should be carefully followed for
signs and symptoms of gastrointestinal ulceration and bleeding. Although it is not definitely known
whether ibuprofen tablets causes less peptic ulceration than aspirin, in one study involving 885
patients with rheumatoid arthritis treated for up to one year, there were no reports of gastric ulceration
with ibuprofen tablets whereas frank ulceration was reported in 13 patients in the aspirin group
(statistically significant p less than .001).
Gastropic studies at varying doses show an increased tendency toward gastric irritation at higher
doses. However, at comparable doses, gastric irritation is approximately half that seen with aspirin.
Studies using 51 Cr - taggedred cells indicate that fecal blood loss associated with ibuprofen tablets in
doses up to 2400 mg daily did not exceed the normal range, and was significantly less than that seen
in aspirin - treated patients.
In clinical studies in patients with rheumatoid arthritis, ibuprofen tablets have been shown to be
comparable to indomethacin in controlling the signs and symptoms of disease activity and to be
associated with a statistically signifcant reduction of the milder gastrointestinal (see ADVERSE
REACTIONS ) and CNS side effects.
Ibuprofen tablets may be used in combination with gold salts and / or corticosteroids.
Controlled studies have demonstrated that ibuprofen tablets are a more effective analgesic than
propoxyphene for the relief of episiotomy pain, pain following dental extraction procedures, and for
the relief of the symptoms of primary dysmenorrhea.
In patients with primary dysmenorrhea, ibuprofen tablets have been shown to reduce elevated levels
of prostaglandin activity in the menstrual fluid and to reduce resting and active intrauterine pressure,
as well as the frequency of uterine contractions. The probable mechanism of action is to inhibit
prostaglandin synthesis rather than simply to provide analgesia.
The ibuprofen in ibuprofen tablets is rapidly absorbed. Peak serum levels are generally
attained one to two hours after administration. With single doses up to 800 mg, a linear relationship
exists between amount of drug administered and the integrated area under the serum drug
concentration vs time curve. Above 800 mg, however, the area under the curve increases less than
proprotional to increases in dose. There is no evidence of drug accumulation or enzyme induction.
The adminstration of ibuprofen tablets either under fasting conditions or immediately before meals
yields quite similar serum ibuprofen concentration - time profiles. When ibuprofen tablets are
administered immediately after a meal, there is a reduction in the rate of absorption but no appreciable
decrease in the extent of absorption. The bioavailablity of the drug is minimally altered by
the presence of food.
A bioavailablity study has shown that there was no interference with the absorption of ibuprofen
when ibuprofen tablets were given in conjunction with an antacid containing both aluminum
hydroxide and magnesium hydroxide.
Ibuprofen is readily metabolized and eliminated in the urine. The excretion of ibuprofen is virtually
complete 24 hours after the last dose. The serum half - life is 1.8 to 2.0 hours.
Studies have shown that following ingestion of the drug, 45 % to 79 % of the dose was recovered in the
urine within 24 hours as metabolite A (25 %), (+) - 2 - [p - (2hydroxymethyl - propyl) phenyl] propionic acid
and metabolite B (37 %), (+) - [p - (2carboxypropyl) phenyl] propionic acid; the percentages of free acid and
conjugated ibuprofen were approximately 1 % and 14 %, respectively.
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