A safe drug for treating nausea and vomiting of pregnancy

You have finally reached your goal. Your pregnancy test was positive and you are on top of the world! And then…, you wake up one day and you’re so nauseous you can’t even think about food without rushing to the bathroom.

You have NVP (nausea and vomiting of pregnancy), which is commonly known as morning sickness. Despite that name though, many women with NVP experience symptoms beyond just the morning hours. About 85 % of pregnant women have some symptoms of nausea, vomiting and/or dry heaves. It typically begins between the 4^th and 6^th week of pregnancy and ends between the 12^th and 16^th week. However, a small number of women experience NVP throughout their entire pregnancy.

Sometimes, just eating crackers before getting up in the morning or eating small, frequent meals throughout the day instead of three large ones can settle your stomach. But if your symptoms persist or interfere with your daily life, there is a new medication available that may help.

Many women will refuse to take any medicines for NVP, as they are worried about the baby. The good news is that the FDA has approved DICLEGIS to treat NVP. It is a delayed-release formulation that helps you control symptoms throughout the day, and it has a dosing schedule that allows you to determine the right amount for you. However, to be effective DICLEGIS should be taken daily, not just on an as-needed basis. DICLEGIS is the only Pregnancy Category A and FDA-approved prescription treatment for morning sickness. Pregnancy Category A means that results of controlled studies have not shown increased risk to an unborn baby during pregnancy.

What is DICLEGIS?

It is a fixed-dose combination drug product of doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (a Vitamin B6 analog).

What is the correct schedule for taking DICLEGIS?

The following schedule is the usual way you should start taking DICLEGIS

• Day 1- Take 2 tablets, by mouth at bedtime.

• Day 2- Take 2 tablets at bedtime. If your nausea and vomiting is better or controlled on Day 2, continue to take 2 tablets every night at bedtime. This will be your usual dose unless your healthcare provider tells you otherwise.

• Day 3- If you still had nausea and vomiting on Day 2, take 3 tablets on Day 3 (1 tablet in the morning and 2 tablets at bedtime).

• Day 4- If your nausea and vomiting was better or controlled on Day 3, continue to take 3 tablets each day (1 tablet in the morning and 2 tablets at bedtime). If you still had nausea and vomiting on Day 3, start taking 4 tablets each day (1 tablet in the morning, 1 tablet in the afternoon, and 2 tablets at bedtime).

Do not take more than 4 tablets (1 in the morning, 1 in the mid-afternoon, and 2 at bedtime) in 1 day.

Take DICLEGIS on an empty stomach with a glass of water.

Take DICLEGIS tablets whole. Do not crush, chew, or break DICLEGIS tablets before swallowing. If you cannot swallow DICLEGIS tablets whole, tell your healthcare provider.

What are the side effects?

It can cause sleepiness and therefore should not be used if a woman is engaging in activities requiring complete mental alertness (driving, or operating heavy machinery). DICLEGIS has anticholinergic properties and should be used with caution in women who have: (1) asthma, (2) increased intraocular pressure, (3) an eye problem called narrow angle glaucoma, (4) a stomach problem called stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) a bladder problem called bladder-neck obstruction. Women should not breast-feed while using DICLEGIS because the antihistamine component (doxylamine succinate) in DICLEGIS can pass into breast milk. Excitement, irritability, and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of DICLEGIS resulting in worsening of their apnea or respiratory conditions.

If you take too much DICLEGIS (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, and sudden and severe kidney problems. If you have these symptoms and they are severe, they may lead to death. Stop taking DICLEGIS, call your healthcare provider or go to the nearest hospital emergency room right away.

DICLEGIS is not approved for treating severe NVP (hyperemesis gravidarum). Please discuss with your physician as to whether it is a good choice for you.