PITOCIN- oxytocin injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN)

Saatavilla:

Par Pharmaceutical, Inc.

INN (Kansainvälinen yleisnimi):

OXYTOCIN

Koostumus:

OXYTOCIN 10 [iU] in 1 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor. Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considere

Tuoteyhteenveto:

Pitocin (Oxytocin Injection, USP) Synthetic is available as follows: NDC 42023-116-25 Packages of twenty-five oversized 1-mL single-dose vials, each containing 10 units of oxytocin. NDC 42023-116-02 Packages of twenty-five 10 mL multiple-dose vial, each containing 10 units of oxytocin per mL (total = 100 units of oxytocin per vial). Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.)

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

PITOCIN- OXYTOCIN INJECTION
PAR PHARMACEUTICAL, INC.
----------
PITOCIN
(OXYTOCIN INJECTION, USP) SYNTHETIC
DESCRIPTION
Pitocin (oxytocin injection, USP) is a sterile, clear, colorless
aqueous solution of synthetic
oxytocin, for intravenous infusion or intramuscular injection. Pitocin
is a nonapeptide
found in pituitary extracts from mammals. It is standardized to
contain 10 units of
oxytocic hormone/mL and contains 0.5% Chlorobutanol, a chloroform
derivative as a
preservative, 1.65 mg acetic acid and 0.16 mg ammonium acetate as
buffers, and with
the pH adjusted with acetic acid to achieve a targeted pH of 3.5.
Pitocin may contain up
to 16% of total impurities. The hormone is prepared synthetically to
avoid possible
contamination with vasopressin (ADH) and other small polypeptides with
biologic activity.
Pitocin has the empirical formula C
H
N
O
S (molecular weight 1007.19). The
structural formula is as follows:
CLINICAL PHARMACOLOGY
Uterine motility depends on the formation of the contractile protein
actomyosin under
the influence of the Ca
-dependent phosphorylating enzyme myosin light-chain kinase.
Oxytocin promotes contractions by increasing the intracellular Ca
. Oxytocin has
specific receptors in the myometrium and the receptor concentration
increases greatly
during pregnancy, reaching a maximum in early labor at term. The
response to a given
dose of oxytocin is very individualized and depends on the sensitivity
of the uterus,
which is determined by the oxytocin receptor concentration. However,
the physician
should be aware of the fact that oxytocin even in its pure form has
inherent pressor and
antidiuretic properties which may become manifest when large doses are
administered.
These properties are thought to be due to the fact that oxytocin and
vasopressin differ
in regard to only two of the eight amino acids (see PRECAUTIONS
section).
Oxytocin is distributed throughout the extracellular fluid. Small
amounts of the drug
probably reach the fetal circulation. Oxytocin has a plasma half-life
of about 1 to 6