MEFENAMIC ACID capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MEFENAMIC ACID (UNII: 367589PJ2C) (MEFENAMIC ACID - UNII:367589PJ2C)

Available from:

Belcher Pharmaceuticals,LLC

INN (International Name):

MEFENAMIC ACID

Composition:

MEFENAMIC ACID 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of mefenamic acid and  other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS). Mefenamic acid is indicated: - For relief of mild to moderate pain in patients ≥14 years of age, when therapy will not exceed one week (7 days). - For treatment of primary dysmenorrhea. Mefenamic acid is contraindicated in patients with known hypersensitivity to mefenamic acid. Mefenamic acid 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). Mefenamic acid is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (

Product summary:

Mefenamic acid is available as 250 mg green-banded, yellow capsules, imprinted with "BP" on the cap and "629" on the body in green ink. Bottles of 30, NDC# 62250-677-30. Dispense in a tight container as defined in the USP. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Belcher Pharmaceuticals,LLC
----------
MEDGUIDE
Mefenamic Acid Capsules USP, 250 mg
Rx Only
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) 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 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 all your medicines to
show to your healthcare provider and ph

Summary of Product characteristics

MEFENAMIC ACID- MEFENAMIC ACID CAPSULE
BELCHER PHARMACEUTICALS,LLC
----------
MEFENAMIC ACID CAPSULES USP, 250 MG
BOXED WARNING
CARDIOVASCULAR RISK
NSAIDs 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 ( See
WARNINGS).
Mefenamic acid is contraindicated for the treatment of peri-operative
pain in the
setting of coronary artery bypass graft (CABG) surgery ( See
WARNINGS).
GASTROINTESTINAL RISK
NSAIDs 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
events ( See
WARNINGS).
DESCRIPTION
Mefenamic acid is a member of the fenamate group of nonsteroidal
anti-inflammatory
drugs (NSAIDs). Each green-banded, yellow capsule contains 250 mg of
mefenamic acid
for oral administration. Mefenamic acid is a white to greyish-white,
odorless,
microcrystalline powder with a melting point of 230°-231°C and water
solubility of
0.004% at pH 7.1. The chemical name is N-2,3-xylylanthranilic acid.
The molecular weight
is 241.29. Its molecular formula is C
H
NO
and the structural formula of
mefenamic acid is:
15
15
2
Each capsule also contains lactose monohydrate. The capsule shell and
band contain
dimethicone, D&C yellow No. 10, FD&C blue No. 1 aluminum lake, FD&C
yellow No. 6,
gelatin, propylene glycol, shellac, titanium dioxide and yellow iron
oxide.
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS_
Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-
inflammatory, analgesic, and antipyretic activities in animal models.
The mechanism of
action of mefenamic acid, like that of other NSAIDs, is not completely
understood but
may be related