DESCRIPTION
ORTHO TRI-CYCLEN ®Tablets ORTHO-CYCLEN ®Tablets
(norgestimate/ethinyl estradiol) Prescribing Information
Patients should be counseled that this product does not
protect against HIV infection (AIDS) and other sexually
transmitted diseases.
Each of the following products is a combination oral
contraceptive containing the progestational compound norgestimate
and the estrogenic compound ethinyl estradiol.
ORTHO TRI-CYCLEN ®21 Tablets and ORTHO TRI-CYCLEN
®28 Tablets. Each white tablet contains 0.180 mg of
the progestational compound, norgestimate (18,19-Dinor-17-pregn-4-
en-20-yn-3-one,17-( acetyloxy)-13-ethyl-, oxime,(17a)-(+)-)
and 0.035 mg of the estrogenic compound, ethinyl estradiol
(19-nor-17a-pregna, 1,3,5( 10)-trien-20-yne-3,17-diol).
Inactive ingredients include lactose, magnesium stearate,
and pregelatinized starch.
Each light blue tablet contains 0.215 mg of the progestational
compound norgestimate (18,19-Dinor-17-pregn-4- en-20-yn-3-one,
17-( acetyloxy)-13-ethyl-, oxime,( 17a)-(+)-)
and 0.035 mg of the estrogenic compound, ethinyl estradiol
(19-nor-17a-pregna, 1,3,5 (10)-trien-20-yne-3,17-diol).
Inactive ingredients include FD&C Blue No.2 Aluminum
Lake, lactose, magnesium stearate, and pregelatinized
starch.
Each blue tablet contains 0.250 mg of the progestational
compound norgestimate (18,19-Dinor-17-pregn-4- en-20-yn-3-one,
17-(acetyloxy)-13-ethyl-, oxime,( 17a)-(+)-)
and 0.035 mg of the estrogenic compound, ethinyl estradiol
(19-nor-17a-pregna, 1,3,5 (10)-trien-20-yne-3,17-diol).
Inactive ingredients include FD&C Blue No.2 Aluminum
Lake, lactose, magnesium stearate, and pregelatinized
starch.
Each green tablet in the ORTHO TRI-CYCLEN ®28 package
contains only inert ingredients, as follows: D&C Yellow
No.10 Aluminum Lake, FD&C Blue No.2 Aluminum Lake,
lactose, magnesium stearate, microcrystalline cellulose
and pregelatinized starch.
ORTHO-CYCLEN Ò 21 Tablets and ORTHO-CYCLEN®
28 Tablets. Each blue tablet contains 0.250 mg of the
progestational compound, norgestimate (18,19-Dinor-17-pregn-4-
en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17a)-(+)-)
and 0.035 mg of the estrogenic compound, ethinyl estradiol
(19-nor-17a-pregna,1,3,5(10)-trien-20-yne-3,17-diol).
Inactive ingredients include FD&C Blue No.2 Aluminum
Lake, lactose, magnesium stearate, and pregelatinized
starch.
Each green tablet in the ORTHO-CYCLEN ®28 package contains
only inert ingredients, as follows: D&C Yellow No.10
Aluminum Lake, FD&C Blue No.2 Aluminum Lake, lactose,
magnesium stearate, microcrystalline cellulose and pregelatinized
starch.
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