MEFENAMIC ACID- 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:

Micro Labs Limited

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; Gastrointestinal Bleeding, Ulceration, and Perforation ). 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 the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to mefenamic acid or any components of the drug product ( see   WARNINGS; Anaphylactic Reactions, Serious Skin Reactions) . - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been

Product summary:

Mefenamic Acid Capsules USP 250 mg are Size ‘1’ yellow-yellow capsules with ‘ML’ imprinted on the cap & ‘250’ imprinted on the body. They are supplied as follows: Bottles of 30                                                   NDC 42571-258-30 Bottles of 100                                                 NDC 42571-258-01 Dispense in a tight container as defined in the USP. Storage Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. For inquiries call 1-855-839-8195 Manufactured by: Micro Labs Limited Goa- 403 722, INDIA. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev.11/2021

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Micro Labs Limited
----------
MEDICATION GUIDE
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDS)
Mefenamic Acid (mef-e-NAM-ik AS-id) Capsules, USP 250 mg
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAID can cause serious side effects, including:
•
Increase 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 NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft (CABG)".
Avoid taking NSAIDs 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 NSAIDs
after a recent heart attack.
•
Increase 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
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
older age
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
bleeding problems
NSAID should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
or the shortest time needed
What are NSAIDs?
NSAIDs 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 NSAIDs? Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart bypass surgery.
Before taking NS

Summary of Product characteristics

MEFENAMIC ACID - MEFENAMIC ACID CAPSULE
MICRO LABS LIMITED
----------
MEFENAMIC ACID CAPSULES, USP
250 MG
RX ONLY
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
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 ( _SEE WARNINGS_).
MEFENAMIC ACID IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY
BYPASS GRAFT (CABG) SURGERY (SEE _CONTRAINDICATIONS, WARNINGS_).
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
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 (SEE _WARNINGS_).
DESCRIPTION
Mefenamic Acid Capsules are a member of the fenamate group of
nonsteroidal anti-
inflammatory drugs (NSAIDs). Each Size '1' Yellow-Yellow capsule, with
'ML' imprinted on
the cap & '250' imprinted on the body, 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° to 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
contains D&C yellow
No. 10; FD&C blue No. 1; FD&C red No. 3; FD&C yellow No. 6; gelatin,
sodium lauryl
sulfate, titanium dioxide, black iron oxide, propylene glycol &
shellac.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Mefenamic acid has analgesic, anti-inflammatory, and antipyretic
pro