HYDROCODONE BITARTRATE AND IBUPROFEN tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

STAT RX USA LLC

INN（国际名称）:

HYDROCODONE BITARTRATE

组成:

HYDROCODONE BITARTRATE 7.5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

Hydrocodone bitartrate and ibuprofen tablets 7.5 mg/200 mg are available as: White, film-coated, round, debossed "3585" on one side and debossed "V" on the reverse side in bottles of 10, 100, 500, and 1000. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance.

授权状态:

Abbreviated New Drug Application

资料单张

COATED
STAT RX USA 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 medicines should not be us

产品特点

HYDROCODONE BITARTRATE AND IBUPROFEN - HYDROCODONE BITARTRATE AND
IBUPROFEN TABLET, FILM COATED
STAT RX USA LLC
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HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS
7.5 MG/200 MG
CIII
RX ONLY
DESCRIPTION
Each hydrocodone bitartrate and ibuprofen tablet 7.5 mg/200 mg
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
4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate
(2:5). Its chemical formula is
C
H NO •C H O •2½H O, and the molecular weight is 494.50. Its
structural formula is:
Ibuprofen is a nonsteroidal anti-inflammatory agent [nonselective 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:
18
21
3
4
6
6
2
13
18
2
INACTIVE INGREDIENTS
Inactive ingredients include: colloidal silicon dioxide, hypromellose,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
povidone, pregelatinized starch,
sodium starch glycolate, 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 to
relate to the existence of opiate receptors in the central nervous
system. In addition to analgesia,
opioids may produce drowsiness, changes i