MEFENAMIC ACID- mefenamic acid capsule

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Prasco Laboratories

INN (International Nazwa):

MEFENAMIC ACID

Skład:

MEFENAMIC ACID 250 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 ;   G astrointestinal  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, urticarial, 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,

Podsumowanie produktu:

Mefenamic acid is available as 250 mg blue-banded, ivory capsules, imprinted with “  FHPC 400" and "PONSTEL® ". Bottles of 30       NDC 66993-070-30 Dispense in a tight container as defined in the USP.  Store at  room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Distributed by: Prasco Laboratories Mason, OH 45040 USA Manufactured by: Halo Pharmaceutical Inc Whippany, NJ 07981 Revised 06/2016 For inquiries call 1-800-849-9707

Status autoryzacji:

New Drug Application Authorized Generic

Ulotka dla pacjenta

Prasco Laboratories
----------
MEDICATION GUIDE
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 your healthcare provider about all of your
medical conditions,

Charakterystyka produktu

MEFENAMIC ACID- MEFENAMIC ACID CAPSULE
PRASCO LABORATORIES
----------
MEFENAMIC ACID
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, USP are a member of the fenamate group of
nonsteroidal anti-inflammatory
drugs (NSAIDs). Each blue-banded, 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°-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:
Each capsule also contains lactose, NF. The capsule shell and/or band
contains citric acid, USP; D&C
yellow No. 10; FD&C blue No. 1; FD&C red No. 3; FD&C yellow No. 6;
gelatin, NF; glycerol
monooleate; silicon dioxide, NF; sodium benzoate, NF; sodium lauryl
sulfate, NF; titanium dioxide,
USP.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Mefenamic acid has analgesic, anti-inflammatory, and antipyretic
properti