Concerta is a central nervous system stimulant prescription medicine. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Concerta extended-release tablets are used to treat attention deficit hyperactivity disorder (ADHD) in children 6 years of age and older, adolescents, and in adults up to the age of 65.

Concerta should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Is Concerta a controlled substance?

Yes, Concerta (methylphenidate) is a Schedule 2 controlled substance and therefore has a high potential for abuse. It has a currently accepted medical use in the United States or a currently accepted medical use with severe restrictions. Abuse may lead to severe psychological or physical dependence. There may be variations in CSA schedules between individual states.

Warnings

You should not use Concerta if you have glaucoma, tics or Tourette’s syndrome, or severe anxiety, tension, or agitation.

Methylphenidate may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse. Keep the medication where others cannot get to it.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect. Call your doctor right away if you have chest pain or feel lightheaded or short of breath while taking Concerta.

Do not use Concerta if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine or have used a methylene blue injection.

Concerta may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder. Call your doctor right away if you have signs of psychosis such as paranoia, aggression, new behavior problems, or seeing or hearing things that are not real.

Before taking this medicine

You should not use Concerta if you are allergic to methylphenidate.

You should not take Concerta if you have:

• glaucoma;
• severe high blood pressure or a heart problem;
• overactive thyroid;
• a personal or family history of tics (muscle twitches) or Tourette’s syndrome; or
• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

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.

Do not use Concerta 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, and tranylcypromine.

Tell your doctor if you also use opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with methylphenidate could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• blood circulation problems in the hands or feet; or
• alcoholism or drug addiction.

To make sure Concerta is safe for you, tell your doctor if you have:

• problems with the esophagus, stomach, or intestines; or
• seizures, epilepsy, or an abnormal brain wave test (EEG).

Becoming dependent on this medicine during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of methylphenidate on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine. If you are breastfeeding, tell your doctor if you notice symptoms in the baby such as agitation, sleep problems, feeding problems, or reduced weight gain.

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

How should I take Concerta?

Take Concerta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away Concerta is against the law.

Take Concerta once each day in the morning. Concerta is an extended-release tablet. It releases medication into your or your child’s body throughout the day.

Concerta can be taken with or without food, but take it the same way each time.

Do not chew, crush, or break the Concerta tablets. Swallow the tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow the tablet whole. A different medicine may need to be prescribed.

The Concerta tablet does not dissolve completely in the body after all the medicine has been released. You or your child may sometimes notice the empty tablet in a bowel movement. This is normal.

Children should have their height and weight checked often while taking this medicine.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

Your doctor will need to check your progress on a regular basis. From time to time, your doctor may stop treatment for a while to check ADHD symptoms. Your heart and blood pressure may also need to be checked often.

Store Concerta tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of methylphenidate could be fatal.

Overdose symptoms may include nausea, dry mouth, vomiting, diarrhea, anxiety, agitation, restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking Concerta?

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how Concerta will affect you. Your reactions could be impaired.

Concerta side effects

Get emergency medical help if you have signs of an allergic reaction to Concerta: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of heart problems – chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis – hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems – numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Methylphenidate can affect growth in children. Your child’s height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common Concerta side effects may include:

• sweating, increased blood pressure;
• mood changes, anxiety, feeling nervous or irritable, trouble sleeping;
• fast heart rate, pounding heartbeats or fluttering in your chest;
• loss of appetite, weight loss;
• dry mouth, nausea, vomiting, stomach pain, indigestion; or
• headache, dizziness.

What is clonidine?

Clonidine lowers blood pressure by decreasing the levels of certain chemicals in your blood. This allows your blood vessels to relax and your heart to beat more slowly and easily.

Clonidine (Catapres tablet/patch, Javadin) is used to treat hypertension (high blood pressure).

The Kapvay brand is an extended-release tablet used to treat attention deficit hyperactivity disorder (ADHD).

Onyda XR is an extended-release oral suspension used to treat ADHD in children 6 years and older.

Clonidine is sometimes given with other medications. Clonidine is also available as a transdermal patch worn on the skin. Do not use two forms of this medicine at the same time.

Warnings

Before you take clonidine, tell your doctor if you have heart disease or severe coronary artery disease, a heart rhythm disorder, slow heartbeats, low blood pressure, a history of heart attack or stroke, kidney disease, or if you have ever had an allergic reaction to a Catapres TTS transdermal skin patch.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not take this medicine if you are allergic to clonidine.

To make sure clonidine is safe for you, tell your doctor if you have:

• heart disease or severe coronary artery disease;
• a heart rhythm disorder, slow heartbeats;
• high or low blood pressure, or a history of fainting spells;
• a heart attack or stroke;
• pheochromocytoma (tumor of the adrenal gland);
• kidney disease; or
• if you have ever had an allergic reaction to a Catapres TTS transdermal skin patch.

It is not known if clonidine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of clonidine on the baby.

Clonidine may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

If you are breastfeeding, tell your doctor if you notice somnolence, tiredness, rapid breathing, and poor feeding in the nursing baby.

Catapres is not approved for use by anyone younger than 18 years old. Do not give Kapvay to a child younger than 6 years old.

How should I take clonidine?

Take clonidine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Clonidine is usually taken in the morning and at bedtime. If you take different doses of this medicine at each dosing time, it may be best to take the larger dose at bedtime.

Clonidine may be taken with or without food.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

Javadin oral solution is for adults with hypertension and can be taken with or without food.

Tell your doctor if you have a planned surgery.

You may have withdrawal symptoms if you stop using this medicine suddenly. Ask your doctor before stopping the medicine.

Call your doctor if you are sick with vomiting. This is especially important for a child taking clonidine.

If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Clonidine Adult Dose for Hypertension

Oral Tablets:

• Initial dose: 0.1 mg orally 2 times a day (morning and bedtime)
• Titration: Increments of 0.1 mg orally per day may be made at weekly intervals to desired response
• Maintenance dose: 0.2 to 0.6 mg orally per day in divided doses
• Maximum dose: 2.4 mg orally per day in divided doses

Comments:
Taking the larger portion of the oral daily dose at bedtime may minimize the transient adjustment effects of dry mouth and drowsiness

Transdermal patches:

• Initial dose: 0.1 mg/24 hr patch applied every 7 days
• Maintenance dose: If, after 1 to 2 weeks, the desired reduction in blood pressure is not achieved, increase the dosage by adding another 0.1 mg/24 hr patch or changing to a larger system
• Maximum dose: Doses above two 0.3 mg/24 hr patches applied every 7 days is usually not associated with additional efficacy

Comments:
-The transdermal patch should be applied to a hairless area of intact skin on the upper outer arm or chest.
-Each new patch should be applied on a different skin site from the previous location.
-If the patch loosens during 7-day wearing, the adhesive cover should be applied directly over the system to ensure good adhesion.
-There have been rare reports of the need for patch changes prior to 7 days to maintain blood pressure control.
-When substituting patches for the oral formulation or for other antihypertensive drugs, physicians should be aware that the antihypertensive effect of the patches may not commence until 2 to 3 days after initial application; therefore, gradual reduction of prior drug dosage is advised. Some or all previous antihypertensive treatment may have to be continued, particularly in patients with more severe forms of hypertension.
Use: For hypertension, alone or in combination with other antihypertensive agents

Javadin Oral Solution:

• Initial dose: 0.1 mg orally twice daily with or without food (morning and bedtime).
• Titrate in increments of 0.1 mg per day at weekly intervals if necessary until the desired response is achieved.
• Usual maintenance dose: 0.2 mg-0.6 mg per day, given in divided doses.

Comments: Store at 20°C to 25°C (68°F to 77°F). Discard unused portion 60 days after first opening. 

Usual Pediatric Dose for Attention Deficit Disorder

Kapvay Extended-release tablets:
6 years and older:
-Initial dose: 0.1 mg orally at bedtime
-Titration: Increase in 0.1 mg/day increments every 7 days until desired response; doses should be administered twice daily (either split equally or with the higher split dosage given at bedtime)
-Maximum dose: 0.4 mg/day in 2 divided doses

Comments:
-May be taken with or without food.
-If a dose is missed, that dose should be skipped and take the next dose as scheduled.
-Tablets should be swallowed whole, and not crushed, chewed, or broken to avoid increasing the rate of drug release.
-When discontinuing therapy, taper daily dose by no more than 0.1 mg every 3 to 7 days.

Use: For the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

Onyda XR Extended-release oral suspension
–Children 6 years and older.
-Initial Onyda XR dose: 0.1 mg orally once daily at bedtime with or without food. Dosage may be increased in increments of 0.1 mg per day at weekly intervals.
-Maximum recommended dosage: 0.4 mg once daily at bedtime.
-Comments: Do not substitute Onyda XR for other clonidine products on a mg-per-mg basis because of differing pharmacokinetic profiles.
-When discontinuing: Taper the dose in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include feeling cold, irritable, weak, drowsy, or light-headed, or having weak reflexes, pinpoint pupils, slow heartbeats, shallow breathing, or a seizure.

What should I avoid while taking clonidine?

Avoid drinking alcohol. It may increase certain side effects of clonidine.

Avoid driving or hazardous activity until you know how clonidine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Clonidine side effects

Get emergency medical help if you have signs of an allergic reaction to clonidine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe chest pain, shortness of breath, irregular heartbeats;
• a very slow heart rate; or
• a light-headed feeling, like you might pass out.

Common clonidine side effects may include:

• drowsiness, dizziness;
• feeling tired or irritable;
• dry mouth;
• constipation, loss of appetite; or
• sleep problems (insomnia), nightmares.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect clonidine?

Using clonidine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• other heart or blood pressure medications;
• an antidepressant; or
• any other medicine that contains clonidine.

This list is not complete. Other drugs may interact with clonidine, including prescription and over-the-counter medicines, vitamins, and herbal products.