VICOPROFEN- hydrocodone bitartrate and ibuprofen tablet, coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Physicians Total Care, Inc.

DCI (Denominação Comum Internacional):

HYDROCODONE BITARTRATE

Composição:

HYDROCODONE BITARTRATE 7.5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Carefully consider the potential benefits and risks of VICOPROFEN and other treatment options before deciding to use VICOPROFEN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). VICOPROFEN tablets are indicated for the short-term (generally less than 10 days) management of acute pain. VICOPROFEN is not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis. VICOPROFEN 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. VICOPROFEN should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS – Anaphylactoid Reactions , and PRECAUTIONS - Preexisting Asthma ). VICOPROFEN is contraindicate

Resumo do produto:

VICOPROFEN tablets are available as: White film-coated round convex tablets, engraved with "VP" over Abbott "A" logo on one side and plain on the other side. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. © Abbott Manufactured by Halo Pharmaceutical Inc. Whippany, NJ 07981 U.S.A. for Abbott Laboratories North Chicago, IL 60064 U.S.A. Rev. 10/2009 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma   74146

Status de autorização:

New Drug Application

Folheto informativo - Bula

Physicians Total Care, Inc.
----------
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

Características técnicas

VICOPROFEN - HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, COATED
PHYSICIANS TOTAL CARE, INC.
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VICOPROFEN®
(HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS)
7.5 MG/200 MG
CS-III
DESCRIPTION
Each VICOPROFEN tablet contains:
Hydrocodone Bitartrate, USP 7.5 mg
Ibuprofen, USP 200 mg
VICOPROFEN is supplied in a fixed combination tablet form for oral
administration. VICOPROFEN
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 α-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 [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:
18
21
3
4
6
6
2
13
18
2
Inactive ingredients in VICOPROFEN tablets include: colloidal silicon
dioxide, corn starch,
croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, polysorbate 80, propylene glycol 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 in mood, and mental clouding.
IBUPROFEN COMPONENT
Ibuprofen is a non-steroidal anti-inflammatory agent that possesses
analgesic and antipyretic activities.
Its mode of action, like that of ot