Doxylamine And Pyridoxine Side Effects
Get emergency medical help if you have signs of an allergic reaction:hives difficult breathing swelling of your face, lips, tongue, or throat.
Common side effects may include:
-
drowsiness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Data Supporting This Drug Combo Date Back To The 1950s When The Food And Drug Administration First Approved It As A Drug Known As Bendectin
However, several lawsuits and studies later claimed that the drug was linked with birth defects, and it was voluntarily taken off the market in the 1980s. It eventually emerged again under a new formulation in 2013 as Diclegis.
More recently, a 2010 randomized, placebo-controlled trial published in the American Journal of Obstetrics & Gynecology followed 256 women and found that the combination of doxylamine succinate and pyridoxine hydrochloride is “effective and well tolerated in treating nausea and vomiting of pregnancy.” After the study, nearly half of those who’d received the drug asked to keep using it while only 32.8 percent of those receiving the placebo asked the same.
Safe Allergy Remedies During Pregnancy
- Oral antihistamines, like cetirizine , chlorpheniramine , diphenhydramine , fexofenadine , and loratadine seem to be safe. So does cromolyn sodium nasal spray and the steroid nasal spray Rhinocort, according to Web MD.
- Allergy shots: If you took allergy shots before pregnancy, your doctor might recommend you continue taking them. But do not start them while pregnant.
- Sudafed 30-60 mg every 4-6 hours can be used in the second and third trimesters in women without gestational hypertension. Avoid use in the first trimester and with breastfeeding. Sudafed PE should be avoided because of its uncertain efficacy and safety in pregnancy.
Allergy Medications to Avoid During Pregnancy
- Decongestants: During your first trimester, dont take decongestants by mouth, according to Web MD. Decongestants may make some birth defects more likely. Watch out for antihistamines combined with a decongestant. Because theres not enough evidence for their safety, avoid antihistamine nasal sprays.
- Mucinex, Mucinex D, Mucinex DM, and the extra-strength versions of each, because the six forms of Mucinex contain guaifenesin. Avoid taking any of these during the first trimester of pregnancy. However, they may be safe to use during later trimesters. Ask your doctor.
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What Is Bonjesta Indicated For
Bonjesta® is specifically indicated to treat nausea and vomiting of pregnancy, commonly known as morning sickness, in women whose symptoms are not adequately controlled by diet and lifestyle changes.
It is important to note that Bonjesta® has not been studied for the treatment of hyperemesis gravidarum, the most severe form of nausea and vomiting of pregnancy. Also, the safety and effectiveness of Bonjesta® have not been studied in patients under 18 years of age.
Why Is This Medication Prescribed
Bonjesta is used to treat nausea and vomiting in pregnant women whose symptoms have not improved after changing their diet or using other non-medicine treatments. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of certain natural substances in the body that may contribute to nausea and vomiting. Pyridoxine is a vitamin. It is given because a lack of pyridoxine in the body may also be a factor in causing nausea and vomiting during pregnancy.
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Eat Small Meals Instead Of Big Meals
Break up the portions and timing of your meals. Hormones produced during pregnancy, especially in the first trimester, slow down your digestive system muscles making it harder to digest larger meals. Eat smaller portions and eat more frequently throughout the day. Having an empty stomach or low blood sugar can cause nausea or make nausea worse. Eating small meals every few hours can keep your blood sugar steady and your stomach feeling full, but not too full. If youre battling morning sickness, also stay away from spicy foods. Youll want to eat foods you know are easy to digest.
Signs And Symptoms Of Overdose
Bonjesta is an extended-release formulation, therefore, signs and symptoms of intoxication may not be apparent immediately.
Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia.
At toxic doses, doxylamine exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death.
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Lifestyle Changes And Natural Nausea Remedies To Try
Outside of pregnancy, nausea might have you running to the pharmacy for an over-the-counter solution. However, drug choice requires more thought when youre carrying a little one.
Often, pregnant women are able to manage their nausea on their own, according to Rebecca Berens, MD, assistant professor of family and community medicine at Baylor College of Medicine in Houston.
Home remedies with small, frequent, bland snacks, such as saltine crackers , says Dr. Berens. Hard candies such as peppermints, sour candies, and commercial products such as Preggie Pops can also be effective. Products containing ginger are known to be helpful, such as ginger candies and ginger teas.
Family nurse practitioner and owner of Staunton Primary Care in Cincinnati, Ciara Staunton agrees. She also says that avoiding nausea triggers is important.
Examples of some triggers include stuffy rooms, odors , heat, humidity, noise, and visual or physical motion, says Staunton. Quickly changing positions and not getting enough rest/sleep may also aggravate symptoms. Lying down soon after eating and lying on the left side are additional potentially aggravating factors. She explains that this could slow down digestion and keep food in your stomach for longer.
Heres a checklist of natural remedies to try if you experience nausea while pregnant:
You can also try homeopathic remedies like acupressure, but be sure to seek a practitioner who has experience treating pregnant patients.
Bonjesta Isnt Designed To Be Your First Line Of Defense Against Morning Sickness
For the record, ACOG defines mild morning sickness as feeling nauseated for a short time each day and maybe vomiting once or twice. In more severe cases, the nausea usually lasts longer and youll likely vomit more often. However, the organization recommends talking to your doctor about your morning sickness if its interfering with your life, regardless of how mild or severe you think it is.
If you have morning sickness, doctors will usually recommend that you first try to make diet and lifestyle modifications like eating crackers, sipping on ginger ale, and eating small, frequent meals instead of three meals a day, Dr. Shepherd says. While that may work for a mild case of morning sickness, it probably wont do the trick for more severe cases. If youre still struggling, your doctor will likely recommend that you take vitamin B6, Dr. Greves says.
If that doesnt help, ACOG recommends adding doxylamine to the mixor taking a drug that combines the two, like Bonjesta. Both drugstaken alone or togetherhave been found to be safe to be taken during pregnancy and have no harmful effects on the baby, ACOG says on its website. However, it’s not clear whether Bonjesta can ease the symptoms of hyperemesis gravidarum, which causes severe nausea and vomiting during pregnancy.
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Bonjesta May Cause Side Effects Tell Your Doctor If Any Of These Symptoms Are Severe Or Do Not Go Away:
- dry mouth, nose, and throat
- drowsiness
- confusion
- seizures
Bonjesta may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administrations MedWatch Adverse Event Reporting program online or by phone .
Nausea And Vomiting Of Pregnancy
HOWARD ERNEST HERRELL, MD, East Tennessee State University, Johnson City, Tennessee
Am Fam Physician. 2014 Jun 15 89:965-970.
Nausea and vomiting of pregnancy affects nearly 75% of pregnant women. The exact cause is unknown. In most cases, it is a mild, self-limited condition that can be controlled with conservative measures and has no adverse fetal sequelae. About 1% of women develop hyper-emesis gravidarum, which may result in adverse outcomes for the mother and fetus. Patients with nausea and vomiting of pregnancy should be evaluated for other causes, particularly if symptoms are unremitting or presentation is atypical. Initial treatment is conservative and includes dietary changes, emotional support, and vitamin B6 supplementation. Several safe and effective pharmacologic therapies are available for women who do not improve with initial treatment. Women with hyperemesis gravidarum may require more aggressive interventions, including hospitalization, rehydration therapy, and parenteral nutrition.
Nausea and vomiting occur in up to 74% of pregnant women, and 50% experience vomiting alone.1,2 Although the term morning sickness is commonly used to describe nausea and vomiting of pregnancy, the timing, severity, and duration of symptoms vary widely. Approximately 80% of women report that their symptoms last all day, whereas only 1.8% report symptoms that occur solely in the morning.2
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What Should I Know About Storage And Disposal Of This Medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture . If your medication came with a desiccant canister , leave the canister in the bottle.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDAs Safe Disposal of Medicines website for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach.
Tips To Help Survive Nausea During Pregnancy
Positive pink line on pregnancy test? Check. Small flutter on early ultrasound? Check. Nausea and vomiting? Double-check.
Often the constant feeling of nausea, which is accompanied by vomiting, soon overshadows the excitement of early pregnancy. Approximately 50-90 percent of women experience nausea and vomiting in their pregnancy, and 5 percent of women have the same symptoms throughout the entire pregnancy, per The American Congress of Obstetricians and Gynecologists.
âThe term âmorning sicknessâ is misleading nausea can occur any time of the day,â says Emily Linklater, D.O., Mayo Clinic Health System OB/GYN physician. âFor most women, the nausea ends sometime in the late stages of the first trimester. Nausea may also be worse or better in one pregnancy versus another.â
Unfortunately, science hasnt proven the exact cause of nausea and vomiting in pregnancy. The elevated pregnancy hormone, BHCG, and elevated estrogen have both been hypothesized as contributing to symptoms.
What can an expectant mother do? Here are some tips for surviving nausea and vomiting:
If over-the-counter options do not improve nausea and vomiting, then its wise to speak with your health care provider about anti-nausea prescription medications. Many prescription medications are safe in pregnancy and can relieve severe symptoms.
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Powerful Ways To Relieve Morning Sickness
If you are pregnant or thinking of becoming pregnant, theres no way to know for sure if you will suffer any morning sickness but your chances are pretty high. About 70 to 80 percent of women experience nausea in the first 12 weeks of pregnancy, and about 50 percent experience some vomiting. Some women never experience morning sickness, while others may feel sick throughout their entire pregnancy. You might have no morning sickness while pregnant with your first child and then not be as lucky with the next one. The key is to be prepared and know ahead of time how to best relieve morning sickness if it comes.
Drink Before Or After A Meal Not During
Staying hydrated is important, especially if youre vomiting. Drink small amounts of fluid throughout the day, but limit fluid intake during meals to avoid feeling too full. Drink 30 minutes before or after a meal instead. If you prefer drinking with your meal, have a small glass of water rather than a beverage containing sugar, as too much sugar can upset your stomach.
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What Is Morning Sickness
Morning sickness is one of the most common symptoms during early pregnancy. Although many women feel sick during a specific time of day, such as in the morning, others may experience this symptom at any time.
Doctors do not fully understand what causes morning sickness, but hormonal and blood glucose changes may play a role.
The symptoms of morning sickness are often relatively mild and will usually not harm the fetus. However, if a woman is unable to keep down food and fluids, this could put the fetus at risk. Any woman who is concerned about nausea and vomiting during pregnancy should see her doctor or obstetrician.
Up to 3 percent of pregnant women develop hyperemesis gravidarum, which is a more severe form of morning sickness. Doctors diagnose a woman with this condition when she loses more than 5 percent of her prepregnancy weight and has symptoms of dehydration.
Women with hyperemesis gravidarum may require medical treatment or hospitalization.
Some dietary and lifestyle interventions may help reduce or prevent morning sickness.
Strategies that a woman may wish to try include:
How Do Women Use This Treatment
The ACOG recommend that women first try dietary and lifestyle interventions to treat morning sickness. If these interventions do not work or the symptoms are severe, they suggest trying vitamin B-6.
If vitamin B-6 does not provide symptom relief, a woman may wish to try doxylamine too. The ACOG state that a person can take these drugs separately or as the combination drug Diclegis. However, Diclegis is a prescription drug, and the cost may be prohibitive for some people.
According to the American Academy of Family Physicians, for treating morning sickness, women should take:
- 10 to 25 milligrams of vitamin B-6 every 8 hours
- 25 mg of doxylamine at night
For Diclegis, the manufacturers recommend that women take two tablets daily at bedtime. If symptoms do not improve, they suggest increasing the dose to three or four tablets, taking the extra ones in the morning and mid-afternoon.
- vision problems
- sleep disturbances
People who experience severe or concerning side effects should stop taking vitamin B-6 and doxylamine and consult their doctor.
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Debate Over Drug Drives On
Duchesnay has complete confidence in the safety and efficacy of Diclegis, company spokeswoman Amy Feldman said in an emailed statement Tuesday.
Diclegis is a combination of the antihistamine doxylamine and pyridoxine, or vitamin B6. The two active ingredients are the most studied drug combination used in pregnancy, the statement said.
In July, Health Canada released a summary safety review confirming that the drugs benefits continue to outweigh its risks.
The drugs safety and efficacy have been proven in 16 cohort studies, two meta-analyses, an ecological study, a neurological development study and numerous others, the statement said. It is estimated that 35 million women around the world have used the combination of doxylamine succinate and pyridoxine hydrochloride to treat nausea and vomiting of pregnancy.
Indeed, the FDA required two studies the 1970s study and a 2010 study published in the American Journal of Obstetrics and Gynecology to approve Diclegis, Persaud said. Although the 2010 study showed the efficacy of the combination of doxylamine and pyridoxine in the drug, the 1970s study was referenced to show the efficacy of each ingredient individually.
In other words, if you were to subtract the 1970s study, the FDA could not have approved Diclegis, Persaud said.
According to the FDAs statement, the agency took into account the totality of the evidence submitted when deciding whether Diclegis could be approved.
What Nausea Medicine Is Safe While Pregnant
- Avoiding foods and smells that trigger your nausea.
- Keeping soda crackers by your bed and eating a couple before getting up. Allow some time for digestion, and rise slowly once you are ready.
- Eating smaller meals more frequently throughout the day instead of three big meals.
- Drinking less water/fluids with your meals, and instead, drink them between meals.
- Eating drier, plain foods such as white rice, dry toast, or a plain baked potato instead of richer, creamier foods.
- Sucking on hard candy.
- Keeping rooms well ventilated or having a fan close by for easier breathing. If neither of these is possible, take time to go outside to get some fresh air.
- Getting plenty of rest Listen to your body when you are feeling fatigued, and try lying down.
- Sniffing ginger or lemons, or drinking ginger ale or lemonade, which can help ease the feeling of nausea.
- Talking with your healthcare provider about the prenatal vitamins you are taking having too much iron may cause nausea, and switching to a different vitamin could help.
- Asking your healthcare provider about taking a vitamin B-6 supplement, which has proven to help reduce nausea and vomiting.
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