HYDROCODONE BITARTRATE AND IBUPROFEN- hydrocodone bitartrate and ibuprofen tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Доступна с:

Sun Pharmaceutical Industries, Inc.

ИНН (Международная Имя):

HYDROCODONE BITARTRATE

состав:

HYDROCODONE BITARTRATE 2.5 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term (generally less than 10 days) management of acute pain. Hydrocodone bitartrate and ibuprofen tablets are not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis. Hydrocodone bitartrate and ibuprofen tablets are contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. Hydrocodone bitartrate and ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rar

Обзор продуктов:

2.5 mg/200 mg: White to off-white, film-coated, round, biconvex, beveled edged tablets debossed with ‘281’ on one side and plain on the other side. Each tablet contains 2.5 mg of hydrocodone bitartrate, USP and 200 mg of ibuprofen, USP. They are supplied as follows: NDC 57664-281-83     Bottles of 30   CRC NDC 57664-281-88     Bottles of 100  CRC NDC 57664-281-08     Bottles of 100 NDC 57664-281-13     Bottles of 500 NDC 57664-281-18     Bottles of 1000 5 mg/200 mg: White to off-white, film-coated, round, biconvex, beveled edged tablets debossed with ‘203’ on one side and plain on the other side. Each tablet contains 5 mg of hydrocodone bitartrate, USP and 200 mg of ibuprofen, USP. They are supplied as follows: NDC 57664-203-83       Bottles of 30   CRC NDC 57664-203-88       Bottles of 100  CRC NDC 57664-203-08       Bottles of 100 NDC 57664-203-13       Bottles of 500 NDC 57664-203-18       Bottles of 1000 7.5 mg/200 mg: White to off-white, film-coated, round, biconvex, beveled edged tablets debossed with ‘102’ on one side and plain on the other side. Each tablet contains 7.5 mg of hydrocodone bitartrate, USP and 200 mg of ibuprofen, USP. They are supplied as follows: NDC 57664-102-83       Bottles of 30   CRC NDC 57664-102-88       Bottles of 100  CRC NDC 57664-102-08       Bottles of 100 NDC 57664-102-13       Bottles of 500 NDC 57664-102-18       Bottles of 1000 10 mg/200 mg: White to off-white, film-coated, round, biconvex, beveled edged tablets debossed with ‘280’ on one side and plain on the other side. Each tablet contains 10 mg of hydrocodone bitartrate, USP and 200 mg of ibuprofen, USP. They are supplied as follows: NDC 57664-280-83       Bottles of 30   CRC NDC 57664-280-88       Bottles of 100  CRC NDC 57664-280-08       Bottles of 100 NDC 57664-280-13       Bottles of 500 NDC 57664-280-18       Bottles of 1000 Store at 20° - 25°C (68° - 77°F). (See USP for Controlled Room Temperature). Dispense in a tight, light-resistant container with a child-resistant closure. PHARMACIST: Dispense with a Medication Guide. A Scheduled Controlled Drug Substance. DEA ORDER FORM REQUIRED Distributed by: Sun Pharmaceutical Industries, Inc.                           Cranbury, NJ 08512 6121T02 Rev. 09/2014         

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

COATED
Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE FOR NON-STEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS) HYDROCODONE
BITARTRATE AND IBUPROFEN TABLETS CII
Rx Only
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT
MEDICINES CALLED NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death.
This chance increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a “coronary artery
bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
WHAT ARE NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)?
NSAID medicines 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 A NON-STEROIDAL ANTI-INFLAMMATORY DRUG
(NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your hea

Характеристики продукта

HYDROCODONE BITARTRATE AND IBUPROFEN- HYDROCODONE BITARTRATE AND
IBUPROFEN TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS CII
RX ONLY
DESCRIPTION
Hydrocodone bitartrate and ibuprofen is supplied in a fixed
combination tablet form for oral
administration.
Hydrocodone bitartrate and ibuprofen combines the opioid analgesic
agent, hydrocodone bitartrate, with
the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.
Hydrocodone bitartrate is a semisynthetic and centrally acting opioid
analgesic. Its chemical name is:
4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate
(2:5). Its chemical formula is: C
H
NO
•C
H
O
•21/2H
O, and the molecular weight is 494.50. Its structural formula is:
Ibuprofen is a nonsteroidal anti-inflammatory agent [non-selective COX
inhibitor] with analgesic and
antipyretic properties. Its chemical name is:
(±)-2-(p-isobutylphenyl) propionic acid. Its chemical
formula is: C
H
O
, and the molecular weight is: 206.29. Its structural formula is:
Hydrocodone bitartrate and ibuprofen tablets for oral administration
are available in the following
strengths:
HYDROCODONE BITARTRATE, USP
IBUPROFEN, USP
18
21
3
4
6
6
2
13
18
2
2.5 mg/200 mg
2.5 mg
200 mg
5 mg/200 mg
5 mg
200 mg
7.5 mg/200 mg
7.5 mg
200 mg
10 mg/200 mg
10 mg
200 mg
Inactive ingredients in each hydrocodone bitartrate and ibuprofen
tablets include: butylated
hydroxyanisole, butylated hydroxytoluene, colloidal silicon dioxide,
corn starch, croscarmellose
sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
polyvinyl alcohol, stearic acid, talc, and titanium dioxide.
CLINICAL PHARMACOLOGY
HYDROCODONE COMPONENT
Hydrocodone is a semisynthetic opioid analgesic and antitussive with
multiple actions qualitatively
similar to those of codeine. Most of these involve the central nervous
system and smooth muscle. The
precise mechanism of action of hydrocodone and other opioids is not
known, although it is believed t