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:

Lupin Pharmaceuticals, Inc.

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 capsules and other treatment options before deciding to use mefenamic acid capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Mefenamic acid capsules are 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 capsules are 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 reported in such patients (seeWARNINGS; Anaphylactic Reaction, Exacerbation of Asthma Related to Aspirin Sensitivity). - In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS; Cardiovascular Thrombotic Events).

Product summary:

Mefenamic acid capsules USP, 250 mg are available as size '1' capsules having ivory cap and ivory body imprinted with "LU" on cap and "R31" on body in black ink, containing white to off white granular powder. They are supplied as follows: NDC 68180-185-06    Bottles of 30's NDC 68180-185-01    Bottles of 100's NDC 68180-185-13    24 (3 x 8) unit dose capsules Dispense in a tight container as defined in the USP. Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by:  Lupin Limited Goa 403 722 INDIA Revised: June 2021                                                                                                  ID#: 267984

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lupin Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Mefenamic (me-fe-NAM-ik) Acid Capsules USP
Rx only
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDS)
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
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
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 NSAIDs, tell our

Summary of Product characteristics

MEFENAMIC ACID- MEFENAMIC ACID CAPSULE
LUPIN PHARMACEUTICALS, INC.
----------
MEFENAMIC ACID CAPSULES USP
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 is a member of the fenamate group of nonsteroidal
anti-inflammatory
drugs (NSAIDs). Each ivory 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° 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 and magnesium stearate.
The capsule
shell contains gelatin, sodium lauryl sulfate, titanium dioxide, D&C
yellow No. 10, FD&C
yellow No. 6 and FD&C red No. 3.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Mefenamic acid has analgesic, anti-inflammatory, and antipyretic
properties.
The mechanism of action of mefenamic acid, like that of other NSAIDs,
is not completely
understood but involves inhibit