ROSEMONT, Pa., June 25, 2018 /PRNewswire/ -- Duchesnay
USA, a pharmaceutical company
specializing in women's health, has announced today its continued
partnership with actress, mom and singer Jana Kramer, to raise awareness about a newly
formulated FDA-approved prescription medication that is safe and
effective to treat morning sickness when diet and lifestyle changes
don't work, which the soon-to-be mother of two is currently taking
to manage her symptoms.
Jana Kramer and Duchesnay
USA previously partnered in 2017,
following Jana's first pregnancy when she experienced morning
sickness and served as an advocate to encourage expectant mothers
to speak to their healthcare providers about morning sickness
symptoms rather than suffering in silence. Jana is best known for
playing Alex Dupré on The WB/CW series One Tree Hill and for her
chart topping success on Country radio.
"Some women may not experience morning sickness symptoms or
remain quiet about it because they want to keep their pregnancy a
secret until they go to their first doctor's appointment. About
five weeks into my pregnancy I started feeling nauseous and knew I
couldn't keep my 'secret trimester' a secret for much longer. I
have a great relationship with my doctor and I spoke to him right
away about treatment options because diet and lifestyle changes
weren't working for me," said Kramer. "I had taken medication
during my prior pregnancies to help me manage my symptoms – but
this time I was told about Bonjesta®, a new formulation of the drug
combination I took before that is designed to be fast-acting and
long-lasting[1], which I found very easy to incorporate into my
daily routine because I can take fewer tablets per day."
"We are thrilled to be working with Jana again. As a member of
our Duchesnay family it is great to be able to help her manage her
morning sickness so she can keep up with her busy professional and
family life," stated Dean Hopkins,
Duchesnay USA's General Manager. "Our hope is to educate
expectant women and their families about morning sickness, and
empower and encourage them to speak with their doctors if they are
experiencing symptoms."
Morning sickness is extremely common, with up to 85% of pregnant
women experiencing it.[2] Symptoms can start as early as 4 to 6
weeks into a pregnancy which is usually prior the first prenatal
appointment.[3] Jana is among the approximately 3.4 of the
4 million pregnant women in the U.S. that are affected by
morning sickness symptoms each year.[4] Morning sickness is a real
medical condition that requires appropriate treatment, since
delaying treatment can make symptoms worse.[5]
For more information about morning sickness and
Bonjesta®, please visit www.bonjesta.com
ABOUT BONJESTA® EXTENDED-RELEASE
TABLETS
Bonjesta® is an FDA-approved
prescription medicine used to treat nausea and vomiting of
pregnancy in women who have not improved with change in diet or
other non-medicine treatments.
LIMITATIONS OF USE
It is not known if
Bonjesta® is safe and effective in women with
severe nausea and vomiting of pregnancy, a condition called
hyperemesis gravidarum. Women with this condition may need to be
hospitalized.
IMPORTANT SAFETY INFORMATION
Bonjesta® is intended for use in pregnant women.
Do not take Bonjesta® if you are allergic to doxylamine
succinate, other ethanolamine derivative antihistamines, pyridoxine
hydrochloride or any of the ingredients in Bonjesta®. Please refer
to the Patient Information leaflet for the complete list of
ingredients. You should also not take Bonjesta® in combination with
medicines called monoamine oxidase inhibitors (MAOIs), as these
medicines can intensify and prolong the adverse central nervous
system (CNS) effects of Bonjesta®. Please ask your healthcare
provider or pharmacist if you are not sure if you take an MAOI,
including Marplan, Nardil, Emsam, Eldepryl, Zelapar, and
Parnate.
Bonjesta® should be used with caution in women who have certain
medical conditions, such as asthma, or eye problems called
increased intraocular pressure or narrow angle glaucoma, stomach
problems called stenosing peptic ulcer or pyloroduodenal
obstruction, a bladder problem called urinary bladder-neck
obstruction, or who are breastfeeding or plan to breastfeed.
The absorption and action of Bonjesta® may be impacted when
tablets are taken with food. Therefore, you should take Bonjesta®
on an empty stomach with a glass of water.
The most common side effect of Bonjesta® is drowsiness. Do not
drive, operate heavy machinery, or do other activities that need
your full attention unless your healthcare provider says that you
may do so.
Do not drink alcohol, or take other CNS depressants such as
cough and cold medicines, certain pain medicines, and medicines
that help you sleep while you take Bonjesta®. Severe drowsiness can
happen or become worse causing falls or accidents.
Bonjesta® may cause an incorrect positive result for urine drug
screening tests for methadone, opiates and PCP.
These are not all the possible side effects of Bonjesta®. Call
your doctor for medical advice about side effects.
Tell your healthcare provider about all of your medical
conditions, including if you are breastfeeding or plan to
breastfeed, so he/she can assess if Bonjesta® is right for you.
Bonjesta® can pass into your breast milk and may harm your baby.
You should not breastfeed while using Bonjesta®.
It is not known if Bonjesta® is safe and effective in children
under 18 years of age.
Bonjesta® is an extended-release formulation, so signs of
overdose may not appear right away. If you take too much Bonjesta®
(overdose), you may have the following symptoms: restlessness, dry
mouth, the pupils of your eyes become larger (dilated), sleepiness,
dizziness, confusion, fast heart rate, seizures, muscle pain or
weakness, urination changes and build-up of fluid in the body. If
you have these symptoms and they are severe, they may lead to
death. Stop taking Bonjesta®, call your healthcare provider or go
to the nearest hospital emergency room right away. If you take too
much Bonjesta®, call your poison control center at
1-800-222-1222
Keep Bonjesta® and all medicines out of the reach of children.
Carefully read the storage instruction as detailed in the Bonjesta
Patient Information leaflet.
Duchesnay USA encourages you to
report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088
Please consult full Prescribing Information and Patient
Information.
About Nausea and Vomiting of Pregnancy (NVP)
Nausea
and vomiting of pregnancy (NVP), or "morning sickness", affects up
to 85 percent of pregnant women.2 NVP can present
differently for each woman. Symptoms may include nausea, gagging,
retching, dry heaving, vomiting, and odor and/or
food aversion.[6] For most pregnant women, symptoms
generally cease at approximately 16 to 20 weeks.[7] However,
about 10% of women can experience symptoms throughout their
pregnancy.3
About Duchesnay
Duchesnay USA is a specialty pharmaceutical company with
a long-standing commitment to women's health. The company focuses
on filling the void in terms of scientific research and education
and on developing pharmacological solutions that are safe and
effective for use during pregnancy and breastfeeding. Duchesnay
USA also commercializes a broad
portfolio of products to offer safe and effective therapeutic
options that meet the health and quality of life needs of women and
their family members at various stages of their lives. For more
information, visit www.duchesnayusa.com.
Media Contact
Amy Feldman
Lazar Partners Ltd.
212-867-1779
AFeldman@lazarpartners.com
[1] Bonjesta Prescribing Information. Duchesnay USA. 2018.
[2] Whitehead, SA, Andrews, LR, Chamberlain, VP.
Characterisation of Nausea and Vomiting in Early Pregnancy: A
Survey of 1000 Women. Journal of Obstetrics and Gynaecology. 1992;
12: 384-369.
[3] Vellacott, I. D., et al. (1988). "Nausea and vomiting in
early pregnancy." Int J Gynecol Obstet 27 (1): 57–62.
[4] Centers for Disease Control and Prevention (CDC). (2016).
"Births and Natality." Retrieved from:
https://www.cdc.gov/nchs/fastats/births.htm
[5] Nausea and Vomiting of Pregnancy, ACOG Practice Bulletin
#153: Clinical Management Guidelines for Obstetrician-Gynecologists
2015; 126, 3:e12-e24.
[6] Clark S, Costantine M, Hankins GDV. Review of NVP and HG and
early pharmacotherapeutic Intervention. Obstetrics and Gynecology
International Volume.2012.
[7] Gadsby, R, Barnie-Adshead, A, Jagger, C. A Prospective Study
of Nausea and Vomiting During Pregnancy. British Journal of General
Practice. 1993; 43:245–248.
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SOURCE Duchesnay USA