CYTOTEC- misoprostol tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Physicians Total Care, Inc.

INN (Medzinárodný Name):

MISOPROSTOL

Zloženie:

MISOPROSTOL 100 ug

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Cytotec (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. Cytotec has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Cytotec should be taken for the duration of NSAID therapy. Cytotec 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. Cytotec should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs). Cytotec should not be taken by anyone with a history of allergy to prostaglandins.

Prehľad produktov:

Cytotec 100-mcg tablets are white, round, with SEARLE debossed on one side and 1451 on the other side; supplied as: NDC Number             Size 54868-2176-4            bottle of 20 54868-2176-0            bottle of 30 54868-2176-3            bottle of 40 Store at or below 25°C (77°F), in a dry area.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

CYTOTEC - MISOPROSTOL TABLET
PHYSICIANS TOTAL CARE, INC.
----------
WARNINGS
CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT
CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE
RUPTURE HAS BEEN REPORTED WHEN CYTOTEC 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). CYTOTEC 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.
Cytotec 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, Cytotec 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 Cytotec only on the second or third day of the next normal
menstrual period.
DESCRIPTION
Cytotec 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
responsible for its c