Adzenys ER

Pregnancy Category: C; no adequate and well-controlled studies in pregnant women

Another stimulant (ie, dextroamphetamine sulfate) has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose

Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose

Lactation: Distributed in human breast milk; do not breastfeed

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Dry mouth.
• Not hungry.
• Not able to sleep.
• Hard stools (constipation).
• Headache.
• Weight loss.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Bad taste in your mouth.
• Feeling nervous and excitable.
• Restlessness.
• Belly pain.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

You should not use Adzenys ER if you are allergic to any stimulant medicine, or if you have:

• moderate to severe high blood pressure;

• overactive thyroid;

• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or

• a history of drug or alcohol addiction.

Do not use Adzenys ER if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Some medicines can interact with Adzenys ER and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

To make sure Adzenys ER is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• problems with drug or alcohol abuse;

• motor tics (muscle twitches) or Tourette's syndrome;

• kidney disease;

• a thyroid disorder;

• seizures or epilepsy;

• an abnormal brain wave test (EEG);

• coronary artery disease (clogged arteries); or

• blood circulation problems in the hands or feet.

Taking this medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Adzenys ER is not approved for use by anyone younger than 6 years old.

Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs Adzenys ER, and may increase side effects.

Many drugs can affect Adzenys ER. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.