MISOPROSTOL tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

MISOPROSTOL (UNII: 0E43V0BB57) (MISOPROSTOL - UNII:0E43V0BB57)

Fáanlegur frá:

Apotheca Inc.

INN (Alþjóðlegt nafn):

MISOPROSTOL

Samsetning:

MISOPROSTOL 200 ug

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use. See boxed WARNINGS. Misoprostol should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs). Misoprostol should not be taken by anyone with a history of allergy to prostaglandins.

Vörulýsing:

Misoprostol 200-mcg tablets are white, hexagonal, with G debossed above and 5008 debossed below the line on one side; supplied as follows: NDC 12634-502-00 Bottles of 10 NDC 12634-502-01 Bottles of 100 NDC 12634-502-09 Bottles of 35 NDC 12634-502-12 Bottles of 120 NDC 12634-502-18 Bottles of 180 NDC 12634-502-40 Bottles of 40 NDC 12634-502-42 Bottles of 42 NDC 12634-502-45 Bottles of 45 NDC 12634-502-50 Bottles of 50 NDC 12634-502-52 Blister Pack of 12 NDC 12634-502-54 Blister Pack of 14 NDC 12634-502-57 Blister Pack of 20 NDC 12634-502-59 Blister Pack of 30 NDC 12634-502-60 Bottles of 60 NDC 12634-502-61 Blister Pack of 10 NDC 12634-502-63 Blister Pack of 3 NDC 12634-502-66 Blister Pack of 6 NDC 12634-502-67 Blister Pack of 7 NDC 12634-502-69 Blister Pack of 9 NDC 12634-502-71 Bottles of 30 NDC 12634-502-74 Bottles of 24 NDC 12634-502-78 Bottles of 28 NDC 12634-502-79 Bottles of 25 NDC 12634-502-80 Bottles of 20 NDC 12634-502-81 Bottles of 21 NDC 12634-502-82 Bottles of 12 NDC 12634-502-84 Bottles of 14 NDC 12634-502-85 Bottles of 15 NDC 12634-502-90 Bottles of 90 NDC 12634-502-91 Blister Pack of 1 NDC 12634-502-92 Bottles of 2 NDC 12634-502-93 Bottles of 3 NDC 12634-502-94 Bottles of 4 NDC 12634-502-95 Bottles of 5 NDC 12634-502-96 Bottles of 6 NDC 12634-502-97 Bottles of 7 NDC 12634-502-98 Bottles of 8 NDC 12634-502-99 Bottles of 9 Store at or below 25°C (77°F), in a dry area.

Leyfisstaða:

New Drug Application Authorized Generic

Vara einkenni

MISOPROSTOL- MISOPROSTOL TABLET
APOTHECA INC.
----------
MISOPROSTOL
TABLETS
WARNINGS
MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE
BIRTH DEFECTS, ABORTION, OR PREMATURE BIRTH. UTERINE RUPTURE HAS
BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT
WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK
OF PREGNANCY (see also PRECAUTIONS and LABOR AND DELIVERY).
MISOPROSTOL SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE
RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDs) (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED
NOT TO GIVE THE DRUG TO OTHERS.
Misoprostol should not be used for reducing the risk of NSAID-induced
ulcers in women of
childbearing potential unless the patient is at high risk of
complications from gastric ulcers
associated with use of the NSAID, or is at high risk of developing
gastric ulceration. In such
patients, misoprostol may be prescribed if the patient
has had a negative serum pregnancy test within 2 weeks prior to
beginning therapy.
is capable of complying with effective contraceptive measures.
has received both oral and written warnings of the hazards of
misoprostol, the risk of possible
contraception failure, and the danger to other women of childbearing
potential should the drug
be taken by mistake.
will begin misoprostol only on the second or third day of the next
normal menstrual period.
DESCRIPTION
Misoprostol oral tablets contain either 100 mcg or 200 mcg of
misoprostol, a synthetic prostaglandin E
analog.
Misoprostol contains approximately equal amounts of the two
diastereomers presented below with their
enantiomers indicated by (±):
1
Misoprostol is a water-soluble, viscous liquid.
Inactive ingredients of tablets are hydrogenated castor oil,
hypromellose, microcrystalline cellulose,
and sodium starch glycolate.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Misoprostol is extensively absorbed, and undergoes rapid
de-esterification to its free acid, which is