IBUPROFEN AND FAMOTIDINE tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Teva Pharmaceuticals USA, Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Ibuprofen and famotidine tablets, a combination of the NSAID ibuprofen and the histamine H2 -receptor antagonist famotidine, are 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 o

Огляд продуктів:

Ibuprofen and famotidine tablets, 800 mg/26.6 mg, are light blue to blue, oval, biconvex, film-coated tablet imprinted with TEVA 8107 on one side and plain on the other side and supplied as: NDC Number 0093-8107-98 Size Bottle of 90 tablets Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Ibuprofen (eye" bue proe' fen) and Famotidine (fa moe' ti deen)
Tablets, for oral use
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:
•
with increasing doses of medicine containing NSAIDs
•
with longer use of medicine containing NSAIDs
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:
•
anytime during use ○ without warning symptoms ○ that may cause
death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or
intestinal bleeding with the use of NSAIDs
•
smoking
•
drinking alcohol
•
taking medicines called “corticosteroids”,
anticoagulants”,
“SSRIs”, or “SNRIs”
•
older age
•
poor health
•
increasing doses of NSAIDs
•
advanced liver disease
•
longer use of NSAIDs
•
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 contain 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

Характеристики продукта

IBUPROFEN AND FAMOTIDINE- IBUPROFEN AND FAMOTIDINE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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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 TABLETS ARE 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 Eosinophilia and Systemic
Symptoms (DRESS)
(5.12)
4/2021
Warnings and Precautions, Fetal Toxicity (5.13)
4/2021
INDICATIONS AND USAGE
Ibuprofen and famotidine tablets, a combination of a nonsteroidal
anti-inflammatory drug (NSAID)
ibuprofen and the histamine H -receptor antagonist famotidine, are
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 th