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To: RxLink®
From: Novogyne
Pharmaceuticals
Combipatch
(estradiol/norethindrone acetate transdermal system) Announcement
December 2004
Re: Combipatch
Combipatch
Packaging Change
Novogyne
Pharmaceuticals, a joint venture between Novartis Pharmaceuticals
Corporation and Noven Pharmaceuticals Inc. would like to inform you
about a change in packaging for Combipatch, effective immediately.
NEW PACKAGE
SIZE AND NEW NDC NUMBERS
COMBIPATCH
(ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
0.05/0.14
MG/DAY STRENGTH NDC #0078-0377-42
0.05/0.25
MG/DAY STRENGTH NDC #0078-0378-42
This package
size replaces old package size of 3x8's:
NDC
#0078-0377-45 Combipatch 0.05/0.14 mg/day
NDC
#0078-0378-45 Combipatch 0.05/0.25 mg/day
For a short
time, both package sizes, the new 1x8 and the original 3 boxes of 8
patches, will exist in the market. This is only a change in
packaging, and returns of the 3 boxes of 8 patches are NOT necessary.
Novartis Pharmaceuticals' normal return policy will still apply to
the original Combipatch 3 boxes of 8 patches inventory. Therefore,
please continue to dispense your current inventory of Combipatch
until your supply is exhausted. You will not be reimbursed for any
product returned outside of policy. Our policies are accessible on
our Novartis Customer Connection website's public page. The URL is www.ncc.novartis.com.
Please see
full Prescribing information enclosed.
If you have
any questions regarding Combipatch, please call our Customer Service
Department at 1-800-526-0175.
We appreciate
your understanding and your continued support.
Regards, Jorge Lorenzo
Director of Marketing
Novogyne Pharmaceuticals
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Estrogens and
progestins should not be used for the prevention of cardiovascular disease.
The Women's
Health Initiative (WHI) study reported increased risks of myocardial
infarction, stroke, invasive breast cancer, pulmonary emboli, and
deep vein thrombosis in postmenopausal women ( 50 to 79 years of age)
during 5 years of treatment with oral conjugated estrogens (CE 0.625
mg) combined with medroxyprogesterone acetate ( MPA 2.5 mg) relative
to placebo.
The Women's
Health Initiative Memory Study (WHIMS), a substudy of WHI, reported
increased rick of developing probable dementia in postmenopausal
women 65 years of age or older during 4 years of treatment with oral
conjugated estrogens plus MPA relative to placebo. It is unknown
whether this finding applies to younger postmenopausal womne.
Other doses of
oral conjugated estrogens with MPA, and other combinations and dosage
forms of estrogens and progestins were not studied in the WHI
clinical trials and, in the absence of comparable data, these risks
should be prescribed at the lowest effective doses and for the
shortest duration consistent with treatment goals and risks for the
individual women.
Estrogens and
estrogens/progestins combined should not be used in women with
undiagnosed abnormal genital bleeding; known, suspected, or history
of breast cancer; known or suspected estrogen-dependent neoplasia;
active deep vein thrombosis, pulmonary embolism, or history of these
conditions; active or recent arterial thromboembolic disease; liver
dysfunction or disease; or known or suspected pregnancy.
In clinical
trials, the most common side effects were breast pain, dysmenorrhea,
and headache.
Combipatch (
estradiol/norethindrone acetate transdermal system) is indicated for
women with an intact uterus for the treatment of moderate to severe
vasomotor symptoms associated with menopause, and moderate to severe
symptoms of vulvar and vaginal atrophy associated with menopause.
When prescribing solely for the treatment of
symptoms of
vulvar and vaginal atrophy, topical vaginal products should be considered. |
