MECLOFENAMATE SODIUM capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

MECLOFENAMATE SODIUM (UNII: 94NJ818U2W) (MECLOFENAMIC ACID - UNII:48I5LU4ZWD)

Доступна с:

Mylan Pharmaceuticals Inc.

ИНН (Международная Имя):

MECLOFENAMATE SODIUM

состав:

MECLOFENAMIC ACID 50 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Carefully consider the potential benefits and risks of meclofenamate sodium capsules and other treatment options before deciding to use meclofenamate sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Meclofenamate sodium capsules are indicated: Meclofenamate sodium capsules are also indicated for the treatment of idiopathic heavy menstrual blood loss (see CLINICAL PHARMACOLOGY and PRECAUTIONS). As with all nonsteroidal anti-inflammatory drugs, selection of meclofenamate sodium capsules require a careful assessment of the benefit/risk ratio (see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS). Meclofenamate sodium capsules are not recommended in children because adequate studies to demonstrate safety and efficacy have not been carried out. Meclofenamate sodium capsules are contraindicated in patients with known hypersensitivity to meclofenamate sodium. Meclofenamate sodium capsules should not be given to patients who have ex

Обзор продуктов:

Meclofenamate Sodium Capsules, USP are available containing either 50 mg or 100 mg of meclofenamic acid as the sodium salt. The 50 mg capsules are hard-shell gelatin capsules with a coral opaque cap and a coral opaque body filled with an off-white powder blend. The capsules are axially printed with MYLAN over 2150 in black ink on both the cap and body. They are available as follows: NDC 0378-2150-01 bottles of 100 capsules The 100 mg capsules are hard-shell gelatin capsules with a coral opaque cap and a white opaque body filled with an off-white powder blend. The capsules are axially printed with MYLAN over 3000 in black ink on both the cap and body. They are available as follows: NDC 0378-3000-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

Mylan Pharmaceuticals Inc.
----------
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)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
o
with increasing doses of NSAIDs
o
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.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
o
anytime during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o
increasing doses of NSAIDs
o
longer use of NSAIDs
o
smoking
o
o
older age
o
poor health
o
advanced liver disease
o
drinking alcohol
bleeding problems
NSAIDs should only be used:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
for 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, including if you:
•

Характеристики продукта

MECLOFENAMATE SODIUM- MECLOFENAMATE SODIUM CAPSULE
MYLAN PHARMACEUTICALS INC.
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CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Meclofenamate sodium is N-(2,6-dichloro-m-tolyl) anthranilic acid,
sodium salt,
monohydrate. It is an anti-inflammatory drug for oral administration.
Meclofenamate
sodium capsules, USP contain 50 mg or 100 mg meclofenamic acid as the
sodium salt
and the following inactive ingredients: colloidal silicon dioxide, D&C
Yellow No. 10, FD&C
Blue No. 1, FD&C Red No. 3, gelatin, magnesium stearate,
microcrystalline cellulose,
pregelatinized starch (corn), sodium lauryl sulfate and titanium
dioxide.
In addition, the imprinting ink contains black iron oxide, D&C Yellow
No. 10 Aluminum
Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake,
FD&C Red No.
40 Aluminum Lake, propylene glycol and shellac glaze.
The structural formula of meclofenamate sodium is:
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 and PRECAUTIONS).
Meclofenamate sodium capsules are contraindicated in the setting of
coronary
artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and
WARNINGS).
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).
MOLECULAR FORMULA: C
H
CL
NNAO •H O
It is a white to creamy white, odorless to almost odorless,
crystalline powder with
melting point 287° to 291°C, molecular weight 336.15, and it is
freely soluble in water.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Meclofenamate sodium is a nonsteroidal agent which has demonstrated
anti-
inflammato