Jornay PM

What is Jornay PM?

Jornay PM is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Jornay PM may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD.
It is not known if Jornay PM is safe and effective in children under 6 years of age.

Jornay PM is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep Jornay PM in a safe place to protect it from theft. Never give your Jornay PM to anyone else, because it may cause death or harm them. Selling or giving away Jornay PM may harm others, and is against the law.

Description

JORNAY PM contains methylphenidate hydrochloride, a central nervous system (CNS) stimulant.

Methylphenidate hydrochloride is a white, odorless crystalline powder. Its aqueous solutions are acidic. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. The chemical name of methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2•HCl and the molecular weight is 269.77. Its structural formula is

The molecular formula of the free base is C14H19NO2 and its molecular weight is 233.31.

JORNAY PM extended-release capsules contain beads with two functional film coatings (outer delayed-release and inner extended-release) surrounding a drug core coated with methylphenidate hydrochloride. The outer, delayed-release coating delays the initial release of methylphenidate while the inner extended-release coating controls the release throughout the day. JORNAY PM is available as extended-release capsules for oral use in five strengths. Each capsule contains 20 mg, 40 mg, 60 mg, 80 mg, or 100 mg of methylphenidate hydrochloride, which is equivalent to 17.4 mg, 34.8 mg, 52.2 mg, 69.6 mg, or 87.0 mg of methylphenidate free base, respectively.

JORNAY PM capsules also contain the following inactive ingredients: dibutyl sebacate, diglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer Type B, microcrystalline cellulose, monoglycerides, polysorbate 80, and talc. The capsule shell of 20 and 40 mg strength capsules is made of FD&C Blue #1, hypromellose, titanium dioxide, yellow iron oxide, and black ink for the imprint. The capsule shell of 60 and 80 mg strength capsules is made of FD&C Blue #1, hypromellose, titanium dioxide, and black i

Mechanism of Action

Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The exact mode of therapeutic action in ADHD is not known.

What is the most important information I should know about Jornay PM?

Jornay PM can cause serious side effects, including:

• Abuse and dependence. Jornay PM contains methylphenidate. Jornay PM, other methylphenidate containing products, and amphetamines, have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Jornay PM.
  • Tell your healthcare provider if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
• Heart-related problems, including:
  • sudden death, stroke, and heart attack in adults
  • sudden death in children who have heart problems or heart defects
  • increased blood pressure and heart rateYour healthcare provider should check you or your child carefully for heart problems before starting Jornay PM. Tell your healthcare provider if you or your child has any heart problems, heart defects, or high blood pressure.Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Jornay PM.

    Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Jornay PM.

• Mental (psychiatric) problems, including:
  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptomsTell your healthcare provider about any mental problems you or your child has, or about a family history of suicide, bipolar illness, or depression.Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with Jornay PM, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

Who should not take Jornay PM?

Do not take Jornay PM if you or your child is:

• allergic to methylphenidate hydrochloride, or any of the ingredients in Jornay PM. See the end of this Medication Guide for a complete list of ingredients in Jornay PM.
• taking or has taken within the last 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

What should I tell my healthcare provider before taking Jornay PM?

Before taking Jornay PM, tell your or your child’s healthcare provider about all medical conditions, including if you or your child:

• have heart problems, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• have circulation problems in fingers or toes
• are pregnant or plan to become pregnant. It is not known whether Jornay PM will harm your unborn baby.
  • There is a pregnancy registry for females who are exposed to Jornay PM during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Jornay PM and their baby. If you or your child becomes pregnant during treatment with Jornay PM, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants. You can register by calling 1-866-961-2388.
• are breastfeeding or plan to breastfeed. Jornay PM passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Jornay PM.

Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Jornay PM and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment with Jornay PM.
Your healthcare provider will decide whether Jornay PM can be taken with other medicines.

Especially tell your healthcare provider if you or your child takes medicine to treat depression, including MAOIs.
Know the medicines that you or your child takes. Keep a list of the medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

Do not start any new medicine during treatment with Jornay PM without talking to your or your child’s healthcare provider first.

How should I take Jornay PM?

• Take Jornay PM exactly as prescribed by your healthcare provider.
• Your healthcare provider may change the dose and timing of the Jornay PM dose if needed.
• Take Jornay PM by mouth 1 time each day in the evening between 6:30 p.m. and 9:30 p.m.
• Take Jornay PM at the same time each evening. Jornay PM should not be taken in the morning.
• Jornay PM can be taken with or without food, but take it the same way each time.
• Jornay PM capsules may be swallowed whole, or if Jornay PM capsules cannot be swallowed whole, the capsules may be opened and sprinkled onto applesauce. Make sure to sprinkle all the JORNAY PM onto the applesauce. The Jornay PM dose should not be divided.
  • swallow all the applesauce and medicine mixture right away
  • do not chew the applesauce and medicine mixture
  • do not store the applesauce and medicine mixture
• Your healthcare provider may sometimes stop Jornay PM treatment for a while to check for ADHD symptoms.
• If a dose of Jornay PM is missed, it should be taken as soon as you remember the same evening. If you do not remember until the next morning you should not take the dose. Wait until that evening to take the next scheduled dose. A missed dose should not be taken in the morning.
• If you or your child takes too much Jornay PM, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Jornay PM?

• Avoid drinking alcohol during treatment with Jornay PM. This may cause a faster release of the Jornay PM medicine.

What are the possible side effects of Jornay PM?

Jornay PM can cause serious side effects, including:

• See “What is the most important information I should know about Jornay PM?”
• Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If you or your child develops priapism, get medical help right away.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
  • fingers or toes may feel numb, cool, or painful
  • fingers or toes may change color from pale, to blue, to redTell your healthcare provider if you or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.Call your healthcare provider right away if you or your child has any signs of unexplained wounds appearing on fingers or toes during treatment with Jornay PM.
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Jornay PM. Jornay PM treatment may be stopped if your child is not gaining weight or height.

The most common side effects of methylphenidate products in children, adolescents, and adults with ADHD include:

• decreased appetite
• trouble sleeping
• nausea
• vomiting
• indigestion
• stomach pain
• weight loss
• anxiety
• dizziness
• irritability
• mood swings (affect liability)
• increased heart rate
• increased blood pressure

The most common side effects of Jornay PM, in children age 6 to 12 with ADHD include:

• trouble sleeping
• decreased appetite
• restlessness (psychomotor hyperactivity)
• headache
• nausea
• mood swings
• vomiting

These are not all the possible side effects of Jornay PM.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Jornay PM

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Jornay PM for a condition for which it was not prescribed. Do not give Jornay PM to other people, even if they have the same symptoms. It may harm them, and it is against the law.
You can ask your doctor or pharmacist for information about Jornay PM that is written for healthcare professionals.

How should I store Jornay PM?

• Store Jornay PM at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Jornay PM in a safe place, like a locked cabinet. Protect from humidity.
• Dispose of remaining, unused, or expired Jornay PM by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix JORNAY PM with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away Jornay PM in the household trash.

Keep Jornay PM and all medicines out of the reach of children.

What are the ingredients in Jornay PM?

Active Ingredient: methylphenidate hydrochloride

Inactive Ingredients: dibutyl sebacate, diglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer Type B, microcrystalline cellulose, monoglycerides, polysorbate 80, and talc.

The capsule shell of 20 and 40 mg strength capsules contains FD&C Blue #1, hypromellose, titanium dioxide, yellow iron oxide, and black ink for the imprint.
The capsule shell of 60 and 80 mg strength capsules contains FD&C Blue #1, hypromellose, titanium dioxide, and black ink for the imprint.
The capsules shell of 100 mg strength capsule contains black iron oxide, FD&C Blue#1, hypromellose, red iron oxide, titanium dioxide, black ink, and white ink for the imprint.

Label

Principal Display Panel – Jornay PM® 80 mg Bottle Label

• NDC 71376-204-03
• Take Only In The Evening
• Jornay PM® CII
• [methylphenidate hydrochloride]
• Extended-Release Capsules
• 80 mg
• Attention Pharmacist: Dispense the
  accompanying Medication Guide to
  each patient.
• Rx Only
• 100 Capsules

Principal Display Panel – Jornay PM® 100 mg Bottle Label

• NDC 71376-205-03
• Take Only In The Evening
• Jornay PM® CII
• [methylphenidate hydrochloride]
• Extended-Release Capsules
• 100 mg
• Attention Pharmacist: Dispense the
  accompanying Medication Guide to
  each patient.
• Rx Only
• 100 Capsules