Cotempla XR-ODT

Cotempla XR-ODT is a prescription medication used to treat ADHD in children and adolescents ages 6 to 17 years old. Cotempla XR-ODT belongs to a group of drugs called central nervous system stimulants. These work in the brain and change the amounts of different natural substances. 

Cotempla XR-ODT comes as a tablet that dissolves on your tongue. Cotempla XR-ODT is taken 1 time a day, in the morning, with or without food. Do not chew, divide, or break Cotempla XR-ODT tablets. Let the tablet completely dissolve before swallowing. 

Common side effects of Cotempla XR-ODT include decreased appetite, difficulty sleeping, and vomiting. 

Cotempla XR-ODT is a prescription medication used to treat ADHD in children and adolescents ages 6 to 17 years old. ADHD is associated with symptoms such as difficulty focusing or difficulty staying still or quiet. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Cotempla XR-ODT. See the "Cotempla XR-ODT Precautions" section. 

Common side effects of Cotempla XR-ODT include the following:

• decreased appetite
• weight loss
• nausea
• difficulty sleeping
• dry mouth
• stomach pain
• agitation

This is not a complete list of Cotempla XR-ODT side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Monoamine oxidase inhibitors such as
  • isocarboxazid (Marplan)
  • phenelzine (Nardil)
  • tranylcypromine (Parnate)
  • selegiline (Emsam, Eldepryl, Zelapar)
  • rasagiline (Azilect)

This is not a complete list of Cotempla XR-ODT drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Cotempla XR-ODT including the following:

Potential for Abuse and Dependence. Psychological and physical dependence. It is recommended that you talk with your doctor before either increasing the dose or abruptly stopping the use of this drug.

Heart toxicity. Toxicity from Cotempla XR-ODT may occur, which may result in disease of the heart muscle or heart failure. Tell your doctor if you experience any of the following symptoms:

• worsening shortness of breath
• increased swelling of your feet, legs, or abdomen
• a cough that does not go away
• new or increasing irregularities in your heart rate
• a pressure, squeezing, burning, or tightness in the chest
• fatigue

Increase in Blood Pressure and Heart Rate. Changes in the heart function. Monitor for large changes in blood pressure or heart rate. 

Psychiatric Changes. Cotempla XR-ODT can cause psychotic or manic symptoms to return if previously present. New psychotic or manic symptoms could also start in patients with no previous history. Tell your doctor if you experience any of the following symptoms:

• hallucinations
• delusional thinking
• hyperactivity
• decreased sleep

Long, painful erections. These have occurred at higher doses. Seek immediate medical attention if prolonged erections occur. 

Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Your doctor may decrease your dose or stop Cotempla XR-ODT if peripheral vasculopathy is confirmed.

Slowing of growth (height and weight) in children. Cotempla XR-ODT is associated with weight loss and decreased growth with long-term use. 

Do not take Cotempla XR-ODT if you:

• are allergic to Cotempla XR-ODT or any of its ingredients
• are using or have used a monoamine oxidase inhibitor (see drug interactions) within the last 14 days

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cotempla XR-ODT, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Cotempla XR-ODT tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Cotempla XR-ODT or to any of its ingredients
• have or have had Tourette's syndrome
• have or have had glaucoma
• have or have had an irregular heartbeat, high blood pressure, or other heart problems
• have or have had depression, bipolar disorder, or any other mental disorder
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given Cotempla XR-ODT, and the babies did not show any medical issues related to Cotempla XR-ODT. Additionally, there have been few human studies, but pregnant women were given Cotempla XR-ODT and their babies did not have any problems related to this medication.

A pregnancy exposure registry monitors the outcomes of pregnant women taking Cotempla XR-ODT. Register for the National Pregnancy for Psychostimulants at 1-866-961-2388.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Cotempla XR-ODT has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Cotempla XR-ODT, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered.

Take Cotempla XR-ODT exactly as prescribed. 

Cotempla XR-ODT comes as a tablet that dissolves on your tongue. Cotempla XR-ODT is taken 1 time a day, in the morning. Do not chew, divide, or break Cotempla XR-ODT tablets. Let the tablet completely dissolve before swallowing. 

You can take this medication with or without food but it is recommended to take Cotempla XR-ODT consistently either with our without food. 

Avoid drinking alcohol while taking Cotempla XR-ODT.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Cotempla XR-ODT at the same time. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended starting dose of Cotempla XR-ODT for the treatment of ADHD is 17.3 mg once in the morning. Your doctor may increase your dose weekly based on symptoms. The max dose of Cotempla XR-ODT is 51.8 mg. 

If you take too much Cotempla XR-ODT, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Do not push the Cotempla XR-ODT tablets through the blister pack. Peel the foil packaging and then remove the tablet to place immediately on the tongue.

Store Cotempla XR-ODT at room temperature. Keep blister packs in the reusable travel case after removed from the carton. 

Keep Cotempla XR-ODT and all medications out of the reach of children. 

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, like Cotempla XR-ODT, and amphetamines, have an increased risk for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.