VIMOVO- naproxen and esomeprazole magnesium tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ), ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Available from:

STAT RX USA LLC

INN (International Name):

NAPROXEN

Composition:

NAPROXEN 375 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VIMOVO is a combination product that contains naproxen and esomeprazole. It is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months. VIMOVO is contraindicated in patients with known hypersensitivity to naproxen, esomeprazole magnesium, substituted benzimidazoles, or to any of the excipients. VIMOVO is contraindicated in 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 and Precautions (5.8, 5.13) ]. Hypersensitivity reactions, eg, angioedema a

Product summary:

VIMOVO 375 mg/20 mg tablets are oval, yellow film-coated tablets printed with 375/20 in black ink, supplied as: NDC 0186-0510-60 Bottles of 60 tablets VIMOVO 500 mg/20 mg tablets are oval, yellow film-coated tablets printed with 500/20 in black ink, supplied as: NDC 0186-0520-60 Bottles of 60 tablets NDC 0186-0520-39 Unit Dose Blisters, package of 100 tablets Storage: Store at 25°C (77°F); excursions permitted to 15- 30°C (59-86°F) [see USP Controlled Room Temperature]. Store in the original container and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.

Authorization status:

New Drug Application

Patient Information leaflet

VIMOVO - NAPROXEN AND ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE
STAT RX USA LLC
----------
MEDICATION GUIDE
VIMOVO (vi-moh´-voh)
(naproxen and esomeprazole magnesium)
Delayed Release Tablets
Read this Medication Guide before you start taking VIMOVO and each
time you get a refill. There may
be new information. This information does not take the place of
talking with your healthcare provider
about your medical condition or your treatment.
What is the most important information I should know about VIMOVO?
VIMOVO, which contains naproxen [a nonsteroidal anti-inflammatory drug
(NSAID)] and esomeprazole
magnesium, 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-containing medicines, such as VIMOVO, should never be used right
before or after a heart
surgery called a coronary artery bypass graft (CABG).
NSAID-containing medicines, such as VIMOVO, 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 steroid hormones (corticosteroids) and blood
thinners (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) from 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

Summary of Product characteristics

VIMOVO - NAPROXEN AND ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE
STAT RX USA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
_THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIMOVO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING_
_INFORMATION FOR VIMOVO._
VIMOVO
_(NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) DELAYED RELEASE TABLETS_
INITIAL U.S. APPROVAL: APRIL 2010
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CARDIOVASCULAR RISK
• NAPROXEN, A COMPONENT OF VIMOVO, MAY CAUSE AN INCREASED RISK OF
SERIOUS CARDIOVASCULAR THROMBOTIC
EVENTS, MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE FATAL. THIS
RISK MAY INCREASE WITH DURATION OF USE.
PATIENTS WITH CARDIOVASCULAR DISEASE OR RISK FACTORS FOR
CARDIOVASCULAR DISEASE MAY BE AT GREATER RISK. _(5.1)_
• VIMOVO IS CONTRAINDICATED FOR THE TREATMENT OF PERI-OPERATIVE PAIN
IN THE SETTING OF CORONARY ARTERY
BYPASS GRAFT (CABG) SURGERY. _(4, 5.1)_
GASTROINTESTINAL RISK
• NSAIDS, INCLUDING NAPROXEN, A COMPONENT OF VIMOVO, CAUSE AN
INCREASED RISK OF SERIOUS
GASTROINTESTINAL 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 ARE AT GREATER RISK FOR SERIOUS
GASTROINTESTINAL (GI) EVENTS. _(5.4)_
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS 05/2011
Hypomagnesemia (5.19)
Concomitant use of St John’s Wort or Rifampin with VIMOVO (5.20)
06/2011
INDICATIONS AND USAGE
Relief of signs and symptoms of osteoarthritis, rheumatoid arthritis,
and ankylosing spondylitis and to decrease the risk of
developing gastric ulcers in patients at risk of developing NSAID
associated gastric ulcers (1) (1)
DOSAGE AND ADMINISTRATION
One tablet twice daily. Use the lowest effective dose. Should be
avoided in moderate/severe renal insufficiency or in
severe hepatic insufficiency. Consider dose reduction in mild/moderate
hepatic insufficiency (2) (2)
DOSAGE FORMS AN