PRASTERA- prasterone and ibuprofen kit

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

Prasterone (UNII: 459AG36T1B) (Prasterone - UNII:459AG36T1B)

Disponible des:

Health Science Funding, LLC

Designació comuna internacional (DCI):

Prasterone

Composición:

Prasterone 200 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Oral prasterone (200mg per day) in female patients with active systemic lupus erythematosus (SLE) has in several blinded, placebo-controlled randomized clinical studies been associated with a reduced risk of auto-immune flare, §§6.2, 14.1.1, a reduced risk of breast cancer and a reduced risk of death from any cause, §§6.4, 14.2. Patients with SLE may have depressed serum levels of 5-dehydroepiandrosterone sulfate (5-DHEAS). Oral prasterone has been shown to restore SLE patients' serum 5-DHEAS levels. Prastera® oral softgels are intended for use in patients for whom medical evaluation shows a depressed serum level of DHEA and thus a distinctive need for exogenous DHEA. Prastera® oral prasterone softgels are intended to be used under medical supervision, for a patient receiving active and ongoing medical supervision, wherein the patient obtains medical care on a recurring basis for, among other things, instructions on the use of this product. Prastera® oral prasterone softgels are intended for the dietary m

Resumen del producto:

Prastera® softgels 200mg are oblong blue soft, liquid filled gelatin capsules. Store at not more than 25° C (77° F). Excursions are permitted to 15° C to 30° C (59° F to 86° F). See United States Pharmacopoeia , Controlled Room Temperature. Protect from excessive moisture or humidity. Dispense in a tight, light-resistant container as defined in USP/NF, using a child-resistant closure system, accompanied by a Patient Insert and in a convenience pack together with a blister strip of ibuprofen 400mg oral tablets. NDC 55607-400-10 Keep out of reach of children. Ibuprofen tablets are available in the following strengths: 400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121' on one side and plain on other side) Blister strips of 5       (NDC 55607-400-10) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only Manufactured for: Health Science Funding, LLC Morristown, NJ 07960 USA Manufactured by: Marksans Pharma Ltd. Verna, Goa-403 722, India Iss. 03/14

Estat d'Autorització:

unapproved drug other

Informació per a l'usuari

Health Science Funding, LLC
Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been
approved by FDA. For further information about unapproved drugs, click
here.
----------
Prasterone is a naturally-occurring pre-hormone secreted by the
adrenal cortex. SLE attacks the adrenal
cortex. Women with SLE thus often have depressed levels of this
pre-hormone.
Your doctor has prescribed PRASTERA® to supplement your body's level
of this pre-hormone. Use
PRASTERA® exactly as your doctor tells you.
You likely will not feel much different taking PRASTERA®. This does
not mean that it is not working,
so keep taking it unless your doctor tells you not to, or unless you
feel you are having an adverse reaction
to it.
In clinical studies, oral prasterone reduced lupus patients' risk of
auto-immune flare and death.
PRASTERA® does not, however, cure, mitigate, treat or prevent your
SLE. Thus, even while taking your
PRASTERA®, you will continue to have SLE. You therefore should
continue to see your doctor and
should continue other therapy they believe appropriate.
PRASTERA® may cause acne. If this happens, you can ask your doctor to
give you a prescription for a
PRASTERA® kit which includes a mild topical anti-acne treatment. If
that does not work, talk with your
health care provider because acne should go away simply by stopping
PRASTERA®.
PRASTERA® may cause hirsutism (unwanted body hair). This is
reversible by stopping taking
PRASTERA®.
PRASTERA® may cause abdominal pain, hypertension, and/or changes in
serum lipids or serum
hormone levels; your doctor may want to monitor these.
Tell your doctor what other drugs or dietary supplements you are
taking. If you are taking PRASTERA®,
you should not use any dietary supplement containing “DHEA” or
“dehydroepiandrosterone.”
If you are pregnant, intending to become pregnant, or are nursing, do
not use PRASTERA®.
Store PRASTERA® at not more than 25° C (77° F), and protect from
excessive moisture or humidity.
Keep out of

Fitxa tècnica

PRASTERA- PRASTERONE AND IBUPROFEN
HEALTH SCIENCE FUNDING, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRASTERA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PRASTERA .
PRASTERA PRASTERONE ORAL SOFTGELS 200MG ARE FOR ORAL USE ONLY.
INITIAL U.S. APPROVAL
INDICATIONS AND USAGE
PRASTERA® prasterone 200 mg oral softgels is indicated in female
patients with mild to moderate, active (SLEDAI ≥2)
systemic lupus erythematosus (SLE) to restore serum
5-dehydroandrosterone sulfate to levels typical of women without
SLE. In Phase III clinical trials in female patients with mild to
moderate active SLE, prasterone 200 mg was associated with
reduced risk of auto-immune flare, reduced risk of breast cancer and
reduced risk of death from any cause. (§§1, 6.2, 6.4,
6.5)
DOSAGE AND ADMINISTRATION
The recommended dose is one (1) softgel daily. (§2)
DOSAGE FORMS AND STRENGTHS
200mg oral softgel capsules supplied in a convenience package with
ibuprofen oral tablets 400mg. (§3)
CONTRAINDICATIONS
Known hypersensitivity to any of its ingredients. (§4)
Undiagnosed abnormal genital bleeding. (§4)
Known, suspected or history of breast cancer. (§4, §6.5)
History of, or known, deep vein thrombosis, pulmonary embolism,
arterial thromboembolic disease (e.g., stroke,
myocardial infarction). (§4)
Hypercholesterolemia or ischemic heart disease. (§4, §7.2.4)
Hepatic or renal impairment (pharmacokinetic data lacking). (§4,
§7.2)
Breast-feeding or known or suspected pregnancy. (§4)
History of psychiatric disorder. (§4, §8)
WARNINGS AND PRECAUTIONS
PRASTERA® is not intended for use in nursing or pregnant women,
children nor males (safety data is lacking). (§§4, 9)
PRASTERA® use may be prohibited by certain athletic anti-doping
regulations. (§9.5)
PRASTERA®