IBUPROFEN tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Доступно од:

DIRECTRX

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen tablets 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 . Ibuprofen tablets are contraindicated in the s

Резиме производа:

Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg (white, round shaped, film-coated tablets engraved "IBU" over "400" on one side). Bottles of 100 NDC 64380-809-06 Bottles of 500 NDC 64380-809-07 600 mg (white, oval shaped, biconvex film-coated tablets engraved "IBU" over "600" on one side) Bottles of 100 NDC 64380-808-06 Bottles of 500 NDC 64380-808-07 800 mg (white, capsule shaped, film-coated tablets engraved "IBU" over "800" on one side) Bottles of 100 NDC 64380-807-06 Bottles of 500 NDC 64380-807-07 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx only Manufactured by: Strides Shasun Limited Puducherry-605 014, India. Distributed by: Strides Pharma lnc. East Brunswick, NJ 08816 Revised: 04/2018

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
DIRECTRX
----------
Ibuprofen tablets are available in the following strengths, colors and
sizes:
400 mg (white, round shaped, film-coated tablets engraved "IBU" over
"400" on one side).
Bottles of 100 NDC 64380-809-06
Bottles of 500 NDC 64380-809-07
600 mg (white, oval shaped, biconvex film-coated tablets engraved
"IBU" over "600" on one side)
Bottles of 100 NDC 64380-808-06
Bottles of 500 NDC 64380-808-07
800 mg (white, capsule shaped, film-coated tablets engraved "IBU" over
"800" on one side)
Bottles of 100 NDC 64380-807-06
Bottles of 500 NDC 64380-807-07
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room
Temperature].
Rx only
Manufactured by:
Strides Shasun Limited
Puducherry-605 014, India.
Distributed by:
Strides Pharma lnc.
East Brunswick, NJ 08816
Revised: 04/2018
Revised: 10/2023
Document Id: 08653794-2b9e-eeab-e063-6394a90aef1f
34391-3
Set id: 82f8f9fd-7ae8-f0f4-e053-2a91aa0a7b8a
Version: 7
Effective Time: 20231023
DIRECTRX

Карактеристике производа

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
DIRECTRX
----------
IBUPROFEN 800 MG
Ibuprofen tablets contain the active ingredient ibuprofen, which is
(±) - 2 - (p -
isobutylphenyl) propionic acid. Ibuprofen is a white powder with a
melting point of 74° to
77° C and is very slightly soluble in water (<1 mg/mL) and readily
soluble in organic
solvents such as ethanol and acetone.
The structural formula is represented below:
[chem structure]
Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), is
available in 400 mg,
600 mg, and 800 mg tablets for oral administration. Inactive
ingredients: colloidal silicon
dioxide, microcrystalline cellulose, pregelatinized starch, sodium
starch glycolate, talc,
magnesium stearate, Opadry II contains hypromellose, polyethylene
glycol, sodium
citrate, lactose monohydrate and titanium dioxide.
Ibuprofen tablets contain ibuprofen which possesses analgesic and
antipyretic activities.
Its mode of action, like that of other NSAIDs, is not completely
understood, but may be
related to prostaglandin synthetase inhibition.
In clinical studies in patients with rheumatoid arthritis and
osteoarthritis, ibuprofen
tablets have been shown to be comparable to aspirin in controlling
pain and inflammation
and to be associated with a statistically significant reduction in the
milder gastrointestinal
side effects . Ibuprofen tablets may be well tolerated in some
patients who have had
gastrointestinal side effects with aspirin, but these patients when
treated with ibuprofen
tablets should be carefully followed for signs and symptoms of
gastrointestinal
ulceration and bleeding. Although it is not definitely known whether
ibuprofen tablets
causes less peptic ulceration than aspirin, in one study involving 885
patients with
rheumatoid arthritis treated for up to one year, there were no reports
of gastric
ulceration with ibuprofen tablets whereas frank ulceration was
reported in 13 patients in
the aspirin group (statistically significant p<.001).
Gastroscopic studies at varying doses show an incr