LEVONEST levonorgestrel and ethinyl estradiol

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Inapatikana kutoka:

Novast Laboratories, Ltd.

INN (Jina la Kimataifa):

LEVONORGESTREL

Tungo:

LEVONORGESTREL 0.05 mg

Dawa ya aina:

PRESCRIPTION DRUG

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

LEVONEST - LEVONORGESTREL AND ETHINYL ESTRADIOL
NOVAST LABORATORIES, LTD.
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LEVONEST™ (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP,
TRIPHASIC REGIMEN)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Each LEVONEST™ (levonorgestrel and ethinyl estradiol
tablets—triphasic regimen) cycle of 28
tablets consists of three different drug phases as follows:
Phase 1 comprised of 6 yellow tablets, each containing 0.050 mg of
levonorgestrel (d(-)-13 beta-ethyl-
17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic
progestogen, and 0.030 mg of
ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,
17-diol); phase 2 comprised of 5 green
tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl
estradiol; and phase 3 comprised
of 10 light brown tablets, each containing 0.125 mg levonorgestrel and
0.030 mg ethinyl estradiol; then
followed by 7 white inert tablets. The inactive ingredients present in
the yellow, green and light brown
tablets are lactose, magnesium stearate and pregelatinized corn
starch.
Each yellow tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C
Yellow #6 Aluminum Lake,
FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene
glycol 3350 NF, lecithin
(soya), talc, and polyvinyl alcohol. Each green tablet also contains
FD&C Yellow #5 Aluminum Lake,
FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium
dioxide, macrogol/
polyethylene glycol 3000 NF, lecithin (soya), talc, and polyvinyl
alcohol. Each light brown tablet also
contains iron oxide yellow, iron oxide red, iron oxide black, titanium
dioxide, macrogol/ polyethylene
glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each
inactive, white tablet (7) contains the
following inactive ingredients: Titanium dioxide, polydextrose,
hypromellose, triacetin,
macrogol/polyethylene glycol 8000, lactose, magnesium stearate and
pregelatinized corn starch.
CLINICAL PHARMACOLOGY
C