murray-kolb.qxp 29/5/07 10:33 am Page 26
DUET
®
DHA
ec
by StuartNatal
®
Q. Is it difficult, in terms of compliance issues,
Rx Only
to ensure that pregnant women understand the
DESCRIPTION: Duet
®
DHA
ec
is a prescription regimen of prenatal multi-vitamin, multi-mineral, and
benefits of increased vitamin intake, especially,
omega-3 fatty acid supplements, supplied as tablets and enteric coated softgel capsules.
as is the case with bone density, when the
effects are not evident immediately?
Each yellow oval Duet
®
Tablet* contains:
VITAMINS MINERALS
A (beta carotene) 3,000 IU Calcium (calcium carbonate) 200 mg
LMK: In my experience of talking to mothers, the majority
C (ascorbic acid) 120 mg Iron (ferrous bisglycinate
D (cholecalciferol) 400 IU and IronAid
®1
) 29 mg of them want to do what is best for their baby. If a
E (dl-alpha tocopheryl acetate) 30 mg Magnesium (magnesium oxide) 25 mg
B
physician recommends a supplement to them, most of
1
(thiamine mononitrate) 1.8 mg Zinc (zinc oxide) 25 mg
B
2
(riboflavin) 4 mg Copper (cupric oxide) 2 mg
them will take it. Fewer women seem to be concerned
Niacinamide 20 mg
B
6
(pyridoxine hydrochloride) 25 mg with the specifics—what is in the supplement and what
Folic acid 1 mg
B
12
(cyanocobalamin) 12 mcg
the benefit may be for the health of their baby—they just
Each frosted golden-colored oval enteric coated DHA softgel capsule* contains: want to do what is good for their baby. Some difficulties
300 mg purified omega-3 fatty acids including:
at least 200 mg DHA (docosahexaenoic acid)
can arise with some of the side effects of the supplements,
especially those with high iron, as these can lead to
OTHER INGREDIENTS (Duet
®
Tablet): Acacia, ascorbyl palmitate, butylated hydroxytoluene, casein,
cornstarch, croscarmellose sodium, dicalcium phosphate, dl-alpha tocopherol, gelatin, hypromellose,
gastrointestinal distress, constipation, and discomfort in
magnesium stearate, microcrystalline cellulose, mixed glycerides, polyethylene glycol, polysorbate
general, which can lead to compliance issues. It is
80, silicon dioxide, sodium aluminum silicate, sodium ascorbate, sodium benzoate, sorbic acid,
sucrose, titanium dioxide. important to educate the woman as to why it is important
OTHER INGREDIENTS (Enteric coated DHA softgel capsule): Ammonium hydroxide, ethylcellulose,
to keep taking the micronutrient supplements. In my
fractionated coconut oil, gelatin, glycerin, oleic acid, stearic acid, sodium alginate, and DHA concen-
trate derived from fish oil via a proprietary process. experience, some women think “well, I need it in the first
*USP Compliance: Duet
®
Tablet is formulated in conformance with official U.S. Pharmacopeia (USP)
2–3 months of pregnancy” and thereafter believe that is
standards of quality for potency, purity and dissolution. The enteric coated DHA softgel capsule com-
plies with the standards and methods outlined in the CRN Voluntary Monograph for potency and purity. sufficient. Compliance issues can often occur with
INDICATIONS: Duet
®
DHA
ec
is a prescription regimen of prenatal multi-vitamin, multi-mineral, and
morning sickness, and side effects. While most of the
omega-3 fatty acid supplements indicated for use in improving the nutritional status of women
throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. women that I have dealt with want to do what is best for
Duet
®
DHA
ec
is also useful in improving nutritional status prior to conception.
the developing fetus, they can usually benefit from further
CONTRAINDICATIONS: This product is contraindicated in patients with known hypersensitivity to
any of the ingredients including fish or fish oil. encouragement and perhaps further education.
WARNINGS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other
megaloblastic anemias where Vitamin B
12
is deficient.
Q. To whom does it fall, most commonly, to
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning advise would-be mothers on their
in children under 6. Keep this product out of reach of children. In case of accidental overdose,
call a doctor or poison control center immediately.
micronutrient supplementation?
Since daily ingestion of more than 3 grams per day of omega-3 fatty acids (including alpha-linolenic
LMK: Most commonly, the advice comes from the OBGYN,
acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA)) from fish oils may have
potential antithrombotic activities and may increase bleeding times, administration of DHA should be and sometimes from the primary care practitioner. It is
avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.
therefore important that the OBGYN is well informed about
PRECAUTIONS: Folic acid in doses above 0.1 mg daily may obscure the diagnosis of pernicious
anemia (hematologic remission may occur while neurological manifestations remain progressive). nutrition-related issues during pregnancy. Some studies exist
DRUG INTERACTIONS: Pyridoxine supplements should be avoided in patients receiving levodopa
that indicate there is a lack of nutrition understanding, but
alone, as the actions of levodopa may be antagonized.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral
this is not in general. I think this is something we could work
administration of folic acid.
on, educating the OBGYN further because they are the
DOSAGE AND ADMINISTRATION: Before, during and after pregnancy, one tablet and one enteric
coated softgel capsule taken by mouth daily, or as directed by a physician. The tablet and enteric
primary point of contact. The women do not generally seek
coated softgel capsule may be taken together or at different times of the day. Caution should be
out a nutritionist or a dietician because they will get their
exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.
HOW SUPPLIED: NDC 66479-850-30. Duet
®
DHA
ec
is supplied in child-resistant, unit-dose blister
advice from their physician. One of the things that’s difficult
cards containing 6 Duet
®
tablets and 6 enteric coated DHA softgel capsules per card. Each unit-of-
is that we actually know that vitamin deficiency can be
use dispensing carton contains 5 unit-dose cards which is a 30-day supply. Duet
®
is a yellow oval
tablet imprinted with the StuartNatal
®
logo (“heart-in-a-heart”) on one side and “848” on the other. suboptimal without there being any clinical signs of
The frosted golden-colored oval enteric coated DHA softgel capsule is imprinted with the
StuartNatal
®
logo (“heart-in-a-heart”).
deficiency. That makes it a little bit difficult, because if there
STORAGE: Store at controlled room temperature 20-25°C (68-77°F). Protect from moisture and are no clinical signs of deficiency then you do not really tend
excessive heat. Note that contact with moisture may produce surface discoloration of the tablet.
to think about their need for supplementation. ■
DISPENSING: Keep in a well-closed, light-resistant container as defined by the USP. Unit dose
blisters are child-resistant to opening, as a safeguard against ingestion by children. KEEP THIS
AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Suggested Further Reading
Questions or Comments: 1-877-926-6396
www.DuetDHA.com
1. Allen LH, Multiple micronutrients in pregnancy and lactation: an overview,
Am J Clin Nutr, 2005;81 (supplement):1206S–1212S.
Marketed by:
2. Picciano MF, Pregnancy and lactation: physiological adjustments, nutritional
requirements and the role of dietary supplements, J Nutr, 2003;133:
1997S–2002S.
3. Scholl TO, Iron status during pregnancy: setting the stage for mother and
Newport, KY 41071 USA
infant, Am J Clin Nutr, 2005;81 (supplement):1218S–1222S.
StuartNatal, Duet and the “heart-in-a-heart” logo are registered trademarks of Xanodyne
4. Haider BA, Bhutta ZA, Multiple-micronutrient supplementation for women
Pharmaceuticals, Inc. Patents pending. All rights reserved. during pregnancy, Cochrane Database Syst Rev, 2006;18:CD004905.
1
IronAid is a registered trademark of Chemi Nutra.
5. Fowles ER, Prenatal nutrition and birth outcomes, J Obstet Gynecol Neonatal
© 2006, Xanodyne
®
Pharmaceuticals, Inc. PI-850-A Rev 09/06
Nurs, 2004;33:809–22.
References:
6. Ladipo OA, Nutrition in pregnancy: mineral and vitaminamin supplements,
2. Dietary Reference Intakes Table—The Complete Set. Comp. The National Academy of Sciences.
Am J Clin Nutr, 2000;72(1 Suppl):280S–290S.
May, 2005. Food and Nutrition Board, Institute of Medicine, The National Academies. Available at
http://www.iom.edu/File.aspx?ID=21372. Accessed November 15, 2006.
US OBSTETRICS AND GYNECOLOGY 2007
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75