LEUPROLIDE ACETATE kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

LEUPROLIDE ACETATE (UNII: 37JNS02E7V) (LEUPROLIDE - UNII:EFY6W0M8TG)

Disponível em:

Sun Pharmaceutical Industries, Inc.

DCI (Denominação Comum Internacional):

LEUPROLIDE ACETATE

Composição:

LEUPROLIDE ACETATE 5 mg in 1 mL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer. Leuprolide acetate injection is contraindicated in patients known to be hypersensitive to GnRH, GnRH agonist analogs or any of the excipients in leuprolide acetate injection: Reports of anaphylactic reactions to GnRH agonist analogs have been reported in the medical literature. Leuprolide (LOO proe lide) Acetate Injection Read the Instructions for Use before you start using leuprolide acetate injection and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Your doctor should show you how to draw up leuprolide acetate injection and give the injection the right way before you inject the first time. Do not share your syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.   Supplies you will need f

Resumo do produto:

Leuprolide acetate injection is a sterile solution supplied in a 2.8 mL multiple-dose vial. The vial is packaged as follows: 14 Day Patient Administration Kit with 14 disposable syringes with fixed needles and 28 alcohol swabs, NDC  47335-936-40 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light; store vial in carton until use.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

LEUPROLIDE ACETATE- LEUPROLIDE ACETATE
Sun Pharmaceutical Industries, Inc.
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INFORMATION FOR PATIENTS
Be sure to consult your physician with any questions you may have or
for information about leuprolide
acetate injection and its use.
WHAT IS LEUPROLIDE ACETATE INJECTION?
Leuprolide acetate injection is chemically similar to gonadotropin
releasing hormone (GnRH or LH-RH) a
hormone which occurs naturally in your body.
Normally, your body releases small amounts of LH-RH and this leads to
events which stimulate the
production of sex hormones.
However, when you inject leuprolide acetate injection, the normal
events that lead to sex hormone production
are interrupted and testosterone is no longer produced by the testes.
Leuprolide acetate injection must be injected because, like insulin
which is injected by diabetics, leuprolide
acetate injection is inactive when taken by mouth.
If you were to discontinue the drug for any reason, your body would
begin making testosterone again.
DIRECTIONS FOR USING LEUPROLIDE ACETATE INJECTION
1.
Wash hands thoroughly with soap and water.
2.
If using a new bottle for the first time, flip off the plastic cover
to expose the grey rubber stopper.
Wipe metal ring and rubber stopper with an alcohol wipe each time you
use leuprolide acetate
injection. Check the liquid in the container. If it is not clear or
has particles in it, DO NOT USE IT.
Exchange it at your pharmacy for another container.
3.
Remove outer wrapping from one syringe. Pull plunger back until the
tip of the plunger is at the 0.2
mL or 20 unit mark.
4.
Take cover off needle. Push the needle through the center of the
rubber stopper on the leuprolide
acetate injection bottle.
5.
Push the plunger all the way in to inject air into the bottle.
6.
Keep the needle in the bottle and turn the bottle upside down. Check
to make sure the tip of the needle
is in the liquid. Slowly pull back on the plunger, until the syringe
fills to the 0.2 mL or 20 unit mark.
7.
Toward the end of a two-week period, the amount of leuprolide acet

Características técnicas

LEUPROLIDE ACETATE- LEUPROLIDE ACETATE
SUN PHARMACEUTICAL INDUSTRIES, INC.
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LEUPROLIDE ACETATE INJECTION
RX ONLY
DESCRIPTION
Leuprolide acetate is a synthetic nonapeptide analog of naturally
occurring gonadotropin
releasing hormone (GnRH or LH-RH). The analog possesses greater
potency than the
natural hormone. The chemical name is
5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-
tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate
(salt) with the following
structural formula:
Leuprolide acetate injection is a sterile, aqueous solution intended
for subcutaneous
injection. It is available in a 2.8 mL multiple-dose vial containing
leuprolide acetate, USP (5
mg/mL), sodium chloride, USP (6.3 mg/mL) for tonicity adjustment,
benzyl alcohol, NF as
a preservative (9 mg/mL), and water for injection, USP. The pH may
have been adjusted
with sodium hydroxide, NF and/or glacial acetic acid, USP. The pH
range is 4.5 to 6.5.
CLINICAL PHARMACOLOGY
Leuprolide acetate, a GnRH agonist, acts as an inhibitor of
gonadotropin secretion.
Animal studies indicate that following an initial stimulation,
continuous administration of
leuprolide acetate results in suppression of ovarian and testicular
steroidogenesis. This
effect was reversible upon discontinuation of drug therapy.
Administration of leuprolide
acetate has resulted in inhibition of the growth of certain hormone
dependent tumors
(prostatic tumors in Noble and Dunning male rats and DMBA-induced
mammary tumors
in female rats) as well as atrophy of the reproductive organs.
In humans, subcutaneous administration of single daily doses of
leuprolide acetate
results in an initial increase in circulating levels of luteinizing
hormone (LH) and follicle
stimulating hormone (FSH), leading to a transient increase in levels
of the gonadal
steroids (testosterone and dihydrotestosterone in males, and estrone
and estradiol in
pre-menopausal females). However, continuous daily administration of
leuprolide acetate
results in decreased levels of LH and FSH. In males, testos