IBUPROFEN AND FAMOTIDINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM), FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)

Available from:

Ascend Laboratories, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies (14), Use in Specific Populations (8.5)] . Ibuprofen and famotidine tablet is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ibuprofen or famotidine or any components of the drug product [see Warnings and Precautions (5.8, 5.11)] . - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or ot

Product summary:

Ibuprofen and famotidine tablets 800 mg/26.6 mg, are light blue to blue oval shaped, film coated tablets imprinted with ''IF826'' in black on one side and plain on other side and supplied as: NDC Number                                                                        Size 67877-626-90                                                                      Bottle of 90 tablets 67877-626-01                                                                      Bottle of 100 tablets 67877-626-05                                                                      Bottle of 500 tablets 67877-626-06                                                                      Carton of 6 (1 x 6) Unit-dose Tablets Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IBUPROFEN AND FAMOTIDINE - IBUPROFEN AND FAMOTIDINE TABLET, FILM
COATED
Ascend Laboratories, LLC
----------
MEDICATION GUIDE
IBUPROFEN and FAMOTIDINE
(EYE bue PROE fen and fa moe' ti deen)
tablets, for oral use
What is the most important information I should know about ibuprofen
and famotidine tablet?
Ibuprofen and famotidine tablet can cause serious side effects
including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
o with increasing doses of medicine containing NSAIDs
o with longer use of medicine containing NSAIDs
Do not take ibuprofen and famotidine tablet right before or after a
heart surgery called a “coronary artery
bypass graft (CABG).” Avoid taking ibuprofen and famotidine tablet
after a recent heart attack, unless your
healthcare provider tells you to. You may have an increased risk of
another heart attack if you take ibuprofen
and famotidine tablet after a recent heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with
the use of NSAIDs
o smoking
o drinking alcohol
o taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”,
or “SNRIs”
o older age
o poor health
o increasing doses of NSAIDs
o advanced liver disease
o longer use of NSAIDs
o bleeding problems
You should take ibuprofen and famotidine tablet exactly as prescribed,
at the lowest dose possible and for the
shortest time needed.
Ibuprofen and famotidine tablet contains a non-steroidal
anti-inflammatory drug NSAID (ibuprofen). Do not
use ibuprofen and famotidine tablet with other medicines to lessen
pain or fever or with other medicines for
colds or sleeping problems without talking to your healthcare provider
first, because the

Summary of Product characteristics

IBUPROFEN AND FAMOTIDINE - IBUPROFEN AND FAMOTIDINE TABLET, FILM
COATED
ASCEND LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IBUPROFEN AND
FAMOTIDINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR IBUPROFEN
AND FAMOTIDINE TABLETS.
IBUPROFEN AND FAMOTIDINE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL:
2011
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE_
_FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK
OF SERIOUS
CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND
STROKE, WHICH
CAN BE FATAL. THIS RISK MAY OCCUR EARLY IN TREATMENT AND MAY INCREASE
WITH DURATION
OF USE (5.1)
IBUPROFEN AND FAMOTIDINE TABLET IS CONTRAINDICATED IN THE SETTING OF
CORONARY ARTERY
BYPASS GRAFT (CABG) SURGERY (4, 5.1) NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
ADVERSE EVENTS
INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF THE STOMACH OR
INTESTINES, WHICH
CAN BE FATAL. THESE EVENTS CAN OCCUR AT ANY TIME DURING USE AND
WITHOUT WARNING
SYMPTOMS. ELDERLY PATIENTS AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC
ULCER DISEASE
AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS (5.2)
RECENT MAJOR CHANGES
• Warnings and Precautions, Drug Reaction with 4/2021
Eosinophilia and Systemic Symptoms (DRESS) (5.12)
• Warnings and Precautions, Fetal Toxicity (5.13) 4/2021
INDICATIONS AND USAGE
Ibuprofen and famotidine tablet, a combination of a nonsteroidal
anti-inflammatory drug (NSAID) ibuprofen
and the histamine H -receptor antagonist famotidine, is indicated for
the relief of signs and symptoms of
rheumatoid arthritis and osteoarthritis and to decrease the risk of
developing upper gastrointestinal
ulcers, which in the clinical trials was defined as a gastric and/or
duodenal ulcer, in patients who are taking
ibuprofen for those indications. The clinical trials primarily
enrolled patients less t