HYDROCODONE BITARTRATE AND IBUPROFEN tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Aidarex Pharmaceuticals LLC

INN (Isem Internazzjonali):

HYDROCODONE BITARTRATE

Kompożizzjoni:

HYDROCODONE BITARTRATE 7.5 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 is 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, rare

Sommarju tal-prodott:

Hydrocodone bitartrate and ibuprofen tablets are available as: White, film-coated round tablets debossed with " 524" on one side and plain on the other side. Store at 20° to 25°C (68° - 77°F) [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. A Schedule CS-II Controlled Substance.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

COATED
Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
(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 healthcare
provider and pharmacist.
•
if you are pregnant. NSAID m

Karatteristiċi tal-prodott

HYDROCODONE BITARTRATE AND IBUPROFEN- HYDROCODONE BITARTRATE AND
IBUPROFEN TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
----------
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS
7.5 MG/200 MG
CS-II
R ONLY
DESCRIPTION
Each hydrocodone bitartrate and ibuprofen tablet contains:
Hydrocodone Bitartrate, USP 7.5 mg
Ibuprofen, USP 200 mg
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:4,5
(a)_-_epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate
(2:5). Its chemical formula is:
C
H NO •C H O •2
H O, and the molecular weight is 494.50. Its structural formula is:
HYDROCODONE BITARTRATE STRUCTURAL FORMULA
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:
X
18
21
3
4
6
6
1/2
2
13
18
2
IBUPROFEN STRUCTURAL FORMULA
Inactive ingredients in hydrocodone bitartrate and ibuprofen tablets
include: colloidal silicon dioxide,
croscarmellose sodium, hypromellose 2910 3cP, hypromellose 2910 6cP,
lactose monohydrate,
magnesium stearate, microcrystalline cellulose, polyethylene glycol
400, polyethylene glycol 8000,
polydextrose, pregelatinized starch, titanium dioxide and triacetin.
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 to
relate to the existence of opiate receptors i