MEFENAMIC ACID capsule

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Advanced Rx Pharmacy of Tennessee, LLC

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 reported in such patients ( see WARNINGS; ANAPHYLACTIC REACTION, EXACERBATION

Produktu pārskats:

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 Capsules NDC: 80425-0306-01 Bottles of 60 Capsules NDC: 80425-0306-02 Bottles of 90 Capsules NDC: 80425-0306-03 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

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

MEFENAMIC ACID- MEFENAMIC ACID CAPSULE
Advanced Rx Pharmacy of Tennessee, LLC
----------
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 af

Produkta apraksts

MEFENAMIC ACID- MEFENAMIC ACID CAPSULE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
MEFENAMIC ACID 250MG CAPSULES
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).
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 15H 15NO 2 and the structural formula of
mefenamic acid is:
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.
Mechanism of Action
Mefenamic acid has analgesic, anti-inflammatory, and antipyretic
properties.
The mechanism of action of m