QuilliChew ER

Attention Deficit Hyperactivity Disorder (ADHD)

QuilliChew ER is primarily indicated for the treatment of ADHD. It is an extended-release medication designed to help increase attention and decrease impulsivity and hyperactivity. Because it is a chewable tablet, it is often prescribed for patients who have difficulty swallowing whole pills or capsules but require a long-acting medication that works throughout the day.

Comprehensive Treatment Programs

This medication is typically used as part of a total treatment program for ADHD that may include other components such as:

• Psychological counseling
• Educational support
• Social therapy
• Behavioral interventions

The goal of using QuilliChew ER within this program is to help stabilize symptoms so that other therapeutic and educational strategies can be more effective. It is intended for use in patients who have been diagnosed with ADHD according to standardized clinical criteria.

Mechanism of Action

QuilliChew ER contains methylphenidate, a medication that works by increasing the activity of two specific chemicals in the brain: dopamine and norepinephrine. These chemicals, known as neurotransmitters, play a key role in regulating attention, movement, and motivation.

While the exact way methylphenidate works to treat Attention Deficit Hyperactivity Disorder (ADHD) is not fully understood, it is believed to block the reabsorption of these neurotransmitters back into the brain's nerve cells. By keeping more dopamine and norepinephrine available in the spaces between nerve cells, the medication helps improve communication between different parts of the brain responsible for focus and behavior control.

Extended-Release Technology

QuilliChew ER is designed as an extended-release chewable tablet. This formulation allows the medication to be released into the body in two stages:

• Immediate release: A portion of the medication is released shortly after chewing and swallowing to provide early symptom relief.
• Extended release: The remaining medication is released gradually throughout the day to maintain consistent levels in the bloodstream.

This delivery system is intended to provide a steady effect, helping to manage ADHD symptoms for a longer duration compared to immediate-release versions of methylphenidate.

Common Side Effects

The most frequently reported side effects of QuilliChew ER include:

• Loss of appetite and weight loss
• Difficulty falling asleep or staying asleep
• Stomach pain, nausea, or vomiting
• Dry mouth
• Dizziness or headache
• Nervousness or irritability
• Increased heart rate or blood pressure

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Heart problems: Chest pain, shortness of breath, or fainting.
• Psychiatric symptoms: New or worsening behavior problems, aggression, hearing or seeing things that are not real, or believing things that are not true.
• Circulation issues: Numbness, pain, or skin color changes (pale, blue, or red) in the fingers or toes.
• Prolonged erections: Painful or long-lasting erections (priapism) that last four hours or more.
• Allergic reactions: Severe rash, hives, or swelling of the face, lips, or tongue.
• Seizures or blurred vision.

Abuse and Dependence

QuilliChew ER is a federally controlled substance because it can be abused or lead to dependence. Healthcare providers typically assess the risk of abuse before prescribing and monitor for signs of misuse or addiction during treatment. Misuse of stimulants can lead to serious heart problems or sudden death.

Cardiovascular Risks

Serious heart-related problems have been reported with methylphenidate use, including:

• Sudden death: This has occurred in children and adolescents with structural heart defects or other serious heart problems.
• Stroke and heart attack: These events have been reported in adults.
• Increased blood pressure and heart rate: Regular monitoring is usually required to check for significant changes in cardiovascular function.

Psychiatric Symptoms

Stimulant medications may cause or worsen certain mental health conditions. Patients should be monitored for:

• Psychotic or manic symptoms: This includes hearing voices, believing things that are not true, or becoming unusually suspicious.
• Aggression: New or worsening aggressive behavior or hostility may occur.
• Pre-existing conditions: Stimulants may worsen symptoms in patients with pre-existing psychosis or bipolar disorder.

Circulation and Growth

• Peripheral Vasculopathy: Problems with blood circulation, such as Raynaud’s phenomenon, may cause fingers or toes to feel numb, cool, or painful, or to change color.
• Growth Suppression: Long-term use of stimulants in pediatric patients may lead to slower growth in both height and weight. Healthcare providers typically monitor growth progress during treatment.

Other Important Precautions

• Seizures: There is some evidence that methylphenidate may lower the seizure threshold in patients with a history of seizures.
• Priapism: Prolonged and sometimes painful erections have been reported with methylphenidate products. This is a medical emergency requiring immediate attention.
• Phenylketonuria (PKU): QuilliChew ER chewable tablets contain phenylalanine, which can be harmful to individuals with PKU.
• Visual Disturbances: Some patients may experience blurred vision or difficulty focusing.

Contraindications

QuilliChew ER should not be used by individuals who:

• Are taking or have taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.
• Have glaucoma.
• Have a personal or family history of tics or a diagnosis of Tourette’s syndrome.
• Have a known hypersensitivity to methylphenidate or any other ingredients in the medication.

Pregnancy

There is limited information regarding the safety of using QuilliChew ER during pregnancy. Human data are insufficient to determine a clear risk of birth defects or miscarriage. This medication should only be used during pregnancy if a healthcare provider determines that the potential benefit justifies the potential risk to the fetus.

Healthcare providers may encourage patients who become pregnant while taking QuilliChew ER to enroll in a pregnancy registry. These registries monitor the health of the mother and the baby to collect more information about the safety of ADHD medications during pregnancy.

Breastfeeding

Methylphenidate, the active ingredient in QuilliChew ER, is known to pass into breast milk. The effects of this exposure on a nursing infant are not fully understood. If a mother uses this medication while breastfeeding, the infant should be monitored for potential side effects, such as:

• Increased agitation or irritability
• Difficulty sleeping
• Poor weight gain or feeding issues

Deciding whether to continue breastfeeding while taking QuilliChew ER involves weighing the benefits of breastfeeding against the potential risks of drug exposure to the infant. Patients should consult with their healthcare provider to determine the best course of action.

Dosage Form

QuilliChew ER is available as an extended-release chewable tablet. This formulation is designed to release the active medication gradually over time.

Physical Characteristics

• The tablets are scored, which allows them to be broken into pieces along the score lines.
• These tablets are specifically intended to be chewed and then swallowed.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved QuilliChew ER in December 2015. It is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older.

Boxed Warning

QuilliChew ER carries a boxed warning, the FDA’s most serious type of warning, regarding the risk of drug abuse and dependence. Healthcare providers are advised to assess the risk of abuse before prescribing and to monitor patients for signs of misuse and dependence during treatment.

Controlled Substance Status

Because it contains methylphenidate, QuilliChew ER is classified as a Schedule II (CII) controlled substance. This classification is used for drugs that have a currently accepted medical use but also a high potential for severe psychological or physical dependence.

Regulatory Requirements

As part of its regulatory status, the FDA requires that a Medication Guide be provided to patients each time the medication is dispensed. This guide outlines important safety information, including potential cardiovascular risks and psychiatric adverse events associated with stimulant medications. The FDA also conducts periodic pediatric safety reviews to monitor the drug's effects in children.

Insurance Coverage

The out-of-pocket cost for QuilliChew ER is primarily influenced by your health insurance plan. Most plans place medications into different cost tiers; brand-name drugs like QuilliChew ER often fall into higher tiers, which may require a higher co-pay or co-insurance payment than generic alternatives.

Pharmacy Pricing

Retail prices for QuilliChew ER can vary significantly between different pharmacies. Factors such as geographic location and whether you use a local retail pharmacy or a mail-order service can affect the final price. It is often helpful to compare prices at multiple locations.

Generic Availability

QuilliChew ER is a brand-name extended-release chewable tablet. While methylphenidate is available in many generic forms, this specific formulation may not have a direct generic equivalent that is interchangeable at the pharmacy level. Using a brand-name product typically results in higher costs than using generic versions of the same active ingredient.

Financial Assistance

Savings cards and patient assistance programs may be available through the manufacturer to help lower costs for eligible patients. Additionally, some pharmacies and third-party organizations offer discount coupons that can be used by individuals without insurance or those whose insurance does not cover the medication.