IBUPROFEN AND FAMOTIDINE tablet, coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Lupin Pharmaceuticals, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 tablets are 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

Produkt oppsummering:

Ibuprofen and famotidine tablets, 800 mg/26.6 mg, are light blue, oval, biconvex, film-coated tablets debossed with "HZT" on one side and supplied as: NDC Number                                                                       Size 70748-312-09                                                                     Bottle of 90 tablets Storage Store at 25 C (77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature]

Autorisasjon status:

New Drug Application Authorized Generic

Informasjon til brukeren

Lupin Pharmaceuticals, Inc.
----------
SPL MEDGUIDE
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 8/2021
7074831209
Medication Guide
IBUPROFEN AND FAMOTIDINE TABLETS
(Iboo-pro-fen and fəˈmov tɪdin tablets)
What is the most important information I should know about ibuprofen
and famotidine tablets?
Ibuprofen and famotidine tablets 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
o Do not take ibuprofen and famotidine tablets right before or after a
heart surgery called a "coronary artery
bypass graft (CABG)." Avoid taking ibuprofen and famotidine tablets
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 tablets 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 taking medicines called
"corticosteroids", "anticoagulants",
"SSRIs", or "SNRIs"
o increasing doses of NSAIDs
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver
disease
o bleeding problems
You should take ibuprofen and famotidine tablets exactly as
prescribed, at the lowest dose possible and for
the shortest time needed. Ibuprofen and famotidine tablets contains a
non-steroidal anti-inflammatory drug
NSAID (ibuprofen). Do not use ibuprofen and famotidine tablets with
other medicines to lessen pain or
fever or with other medicines for colds or sleeping problems without
talking to your heal

Preparatomtale

IBUPROFEN AND FAMOTIDINE - IBUPROFEN AND FAMOTIDINE TABLET, COATED
LUPIN PHARMACEUTICALS, INC.
----------
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-INFLAMMATORYDRUGS(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 TABLETSARE CONTRAINDICATED IN THE SETTING OF
CORONARY
ARTERY BYPASS GRAFT (CABG) SURGERY (4, 5.1)
NSAIDSCAUSE 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 Eosinophilia and Systemic
Symptoms (DRESS)
(5.12) 4/2021
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 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