Intuniv XR

Intuniv is widely used for the treatment of ADHD, a medical condition also known as Attention Deficit Hyperactivity Disorder, in patients older than 6 years. Unlike other ADHD drugs that use stimulants to make people feel more active, Intuniv is not a stimulant. Besides ADHD, Guanfacine Hydrochloride, an active ingredient in Intuniv, is also used to treat high blood pressure under the brand name Tenex. In simpler words, Guanfacine comes as an extended-release and immediate-release oral tablet. Intuniv, being the extended-release formulation, treats ADHD, and Tenex, an immediate-release formulation, helps in managing high blood pressure. People often get confused in these two forms. Both of the medication has different strengths. Therefore, it is essential to always consult a medical practitioner before starting your treatment with Intuniv.

Intuniv is an FDA-approved prescription medication primarily used for controlling symptoms of ADHD or attention deficit hyperactivity disorder in children and adolescents. The main ingredient, guanfacine, is a selective alpha-2A adrenergic receptor agonist that helps improve attention span and reduce impulsivity and hyperactivity in patients. Intuniv is distinct in its extended-release formulation, offering a once-daily dosing option that ensures a consistent release of the medication throughout the day.

Intuniv is available in extended-release tablet form, with 1, 2, 3, & 4 mg strengths. It should be taken orally, either in the morning or evening, at the same time each day, without crushing, chewing, or breaking the tablets. Intuniv is suitable for children aged six years and older, as well as adolescents. This medication works by targeting specific receptors in the brain to improve focus and control behavior.

However, there are specific common side effects of Intuniv, which may include drowsiness, fatigue, low blood pressure, and slow heart rate. Therefore, patients are advised to monitor for these side effects and consult their medical professional if they occur. Moreover, precautions should be taken when stopping Intuniv, as abrupt discontinuation can lead to increased blood pressure. That’s why it is recommended that the dose be altered gradually. A missed dose should be taken as soon as possible unless it is close to the next dose. In case of overdose, visit the nearest clinic. Store Intuniv at a specific room temperature, away from direct sunlight & moist places, and out of reach of children. By following these guidelines and consulting with a healthcare provider, patients can effectively manage their ADHD symptoms with Intuniv.

Intuniv ER is used to treat Attention Deficit Hyperactivity Disorder, abbreviated as ADHD, in children ages at least 6 years. This medication is also a part of an extensive treatment plan that includes psychological, educational, and social measures.

Strengths and Forms

Intuniv comes in the form of an extended-release oral tablet with the following strengths:

• 1 mg
• 2 mg
• 3 mg, and
• 4 mg

Recommended Dosage for Different Patients

Dose Selection

• Intuniv should be taken once a day, either in the morning or evening, but the medication should be taken at the same time each day.
• Doctors usually start Intuniv medication at 1 mg per day and adjust the dose by 1 mg per week. The daily dose is between 1 mg and 4 mg, based on clinical response and how well it is tolerated, for both standalone therapy and in combination with a psychostimulant. Doses above 4 mg/day have not been thoroughly studied in clinical trials.
• Clinical trials indicated that several significant side effects, such as low blood pressure, slow heart rate, and sedation, have dose-related and exposure-related risks. Therefore, it is essential to consider dosing Intuniv based on body weight (mg/kg) to balance the potential benefits and risks of treatment. Below is the dosing based on body weight:
  • 25 to 33.9 kg: 2-3 mg per day
  • 34 to 41.4 kg: 2-4 mg per day
  • 41.5 to 49.4 kg: 3-5 mg per day
  • 49.5 to 58.4 kg: 3-6 mg per day
  • 58.5 to 91 kg: 4-7 mg per day
  • More than 91 kg: 5-7 mg per day

Switching from Immediate-Release Guanfacine to INTUNIV

When switching from immediate-release Guanfacine, stop the IR treatment and follow the recommended schedule for Intuniv. Do not replace immediate-release tablets with Intuniv on a milligram-per-milligram basis due to different pharmacokinetic profiles. Guanfacine ER has a delayed peak concentration (Tmax), lower maximum concentration (Cmax), and reduced bioavailability compared to the same dose of Guanfacine IR.

Maintenance Treatment

Pharmacological treatment for ADHD may be required for the long term. Still, the effectiveness of the medication for a prolonged period, i.e., more than 9 weeks, has not been studied in controlled trials. Therefore, physicians using Guanfacine ER for extended periods should regularly re-evaluate its effectiveness for the individual patient.

Discontinuation

Temporary increases in blood pressure above the original baseline (rebound) have been reported after the sudden discontinuation of Guanfacine. To minimize these effects, your doctor may gradually reduce the dose by no more than 1 mg every 3 to 7 days.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

• Before jumping to the administration steps, make sure to read the medication guide or instruction sheets. Read all the instructions carefully and follow the dosing schedule as your doctor prescribes.
• Take your medication orally with a glass of water, milk, or any fluid once a day in the morning or evening unless directed otherwise.
• Try to take the medicine at bedtime to prevent drowsiness.
• Do not take the ER tablets with high-fat foods as it may increase the drug buildup in the body, thus leading to adverse side effects.
• Try to swallow the tablets as a whole.
• If you are having difficulty swallowing the tablets, talk to a medical professional. They will suggest alternate steps or treatment options.
• Do not break, split, chew, or crush the tablets, as it can release all of the drug at once, thus increasing the chances of side effects.
• Avoid switching between different forms of Guanfacine. Consult with your doctor beforehand when thinking of switching, as each form of the medication does not provide the same amount of the drug.
• Take your medicines exactly as prescribed by a medical professional. The doses are based on the patient’s medical condition, treatment response, weight, and other drugs patients are taking.
• Do not discontinue or alter the dosage without talking to your healthcare provider first. Doing so can lead to severe complications in the future.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

Intuniv is a once-daily, non-stimulant medication that the FDA approves to treat ADHD symptoms in children ages 6 to 12 and adolescents. It is a central alpha2A-adrenergic receptor agonist that affects specific brain receptors responsible for controlling attention, behavior, and impulse control. Unlike various stimulant medications used to treat ADHD, Intuniv works differently. Its mechanism of action involves targeting the prefrontal cortex of the brain (responsible for reasoning, decision-making, and other complex cognitive behaviors).

This medication has a distinctive quality as it addresses the significant areas of impairment and ADHD symptoms, which the rest of the stimulant medications lack. These areas include emotional sensitivity, hyperarousal, rejection sensitivity, and social aggression. Moreover, the alpha agonists in Intuniv lower the nervous system’s adrenaline side, bringing it to a level that is somewhat similar to a person without ADHD. This medication is used in combination with stimulant drugs to improve their effects. It can also be used as a monotherapy by people who do not benefit from stimulant medications or cannot tolerate them.

Common side effects of Intuniv may include:

• Dry mouth
• Headache
• Drowsiness
• Stomach pain
• Constipation
• Sedation
• Seizures
• Fatigue
• Not feeling sleepy
• Nausea
• Dizziness
• Blurred vision
• Confusion
• Sweating
• Weakness
• Irritability
• Decreased sexual ability
• Not feeling hungry
• Vomiting

Serious side effects of Intuniv may include:

• Low blood pressure (hypotension)
• High blood pressure (hypertension) if the medication is abruptly discontinued
• Sudden weight gain
• Fainting
• Slow heart rate
• Difficulty while breathing
• Feeling sleepy
• Chest pain
• Cough
• Lightheadedness
• Mental depression
• Frequent urination
• Chest tightness
• Noisy breathing
• Hives
• Allergies
• Swelling of the throat, tongue, face, or lips
• Anxiety
• Nervousness
• Hallucinations (specifically in children)
• Rashes

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Intuniv warnings highlight essential safety information to ensure proper use and avoid potential risks. Understanding these warnings can help manage side effects, prevent interactions, and ensure the medication’s effectiveness in treating ADHD symptoms. Always consult your healthcare provider.

• Hypotension, Bradycardia, & Syncope: Treatment with Intuniv can lead to dose-related drops in blood pressure and heart rate, although these effects may lessen over time. Some patients have also experienced low blood pressure when standing up (orthostatic hypotension) and fainting. Therefore, heart rate and blood pressure should be regularly checked before and during the course of treatment. It is recommended to use this medication cautiously in patients with a history of low blood pressure or conditions that may be worsened by low blood pressure and slow heart rate, such as heart block, cardiovascular diseases, or chronic kidney disease. Patients with a history of fainting or those prone to fainting should avoid dehydration and overheating. Monitor blood pressure and heart rate closely and adjust doses as needed, especially if the patient is also taking other blood pressure-lowering medications.
• Sedation and Somnolence: Sedation and drowsiness are common side effects reported in clinical trials of Intuniv. Be aware of increased sedative effects when using this medication with other central nervous system depressants, including barbiturates and phenothiazines. Due to this, patients are advised not to operate heavy machines or drive until they know how the medicine will affect them. Also, patients should avoid alcohol while taking this medication.
• Heart Conduction Problems: Intuniv can worsen conditions like sinus node dysfunction and AV block, especially in patients taking other medications with similar effects. Therefore, doctors may gradually increase the doses of these patients and monitor them for any signs of heart conduction problems.
• Rebound High Blood Pressure: Abruptly stopping Intuniv has been associated with significant increases in blood pressure and heart rate, sometimes leading to severe high blood pressure (hypertensive encephalopathy). This risk is higher in patients taking high doses or in children who may vomit and be unable to take their medication. To avoid these issues, avoid discontinuing the treatment suddenly and monitor for signs of increased blood pressure if discontinuation is necessary.

• Before starting your treatment with Intuniv, tell your practitioner about any allergies you may have. Doing so will prevent future complications.
• Before taking this medication, inform your medical provider about your medical history, especially of:
  • Heart diseases like slow heart rate
  • Kidney diseases
  • Liver problems
  • Fainting
  • Blood pressure problems
  • Family history of mental or mood disorders like depression, suicidal thoughts, and bipolar disorder
• Limit alcohol consumption when using this medication as it can make you dizzy, leading to life-threatening problems.
• Drink plenty of water or avoid becoming dehydrated to minimize the chances of dizziness and fainting. Do not perform overheated exercises during hot weather.
• If you are undergoing surgery or any medical procedure, inform your doctor about the products you use. This list includes all prescription drugs, nonprescription drugs, and herbal products.
• Children are at high risk of facing severe side effects of Intuniv, especially hallucinations and mood changes. Therefore, frequently visit the clinics and closely monitor your child for any unusual signs.
• Similar to children, older adults are also more sensitive to the side effects of Intuniv, especially dizziness when standing up, drowsiness, depression, and slow heart rate. Such side effects may increase the risk of falling, which can be fatal. Consult with a medical professional when taking this medication.
• If you are pregnant or planning to have a baby, make sure to consult with a professional before, as this medication may harm the fetus. While it is not clear, the usage of this medication during pregnancy should only be done when needed. Discuss every risk and benefit with your healthcare provider to avoid any complications.
• Similarly, if you are a lactating mother and taking Intuniv, talk to a medical practitioner before breastfeeding your child, as the drug may enter into the breast milk and cause serious harm to the infant. It is still unknown, but take expert opinion without taking any risk.
• It is important to note that Guanfacine tablets and Guanfacine extended-release tablets contain the same active ingredient. So, avoid taking these products simultaneously.
• Guanfacine is used as a part of a total treatment program for ADHD, including counseling and education. So, make sure that you follow every instruction from your doctor and therapist.
• Do not share your medicines with others, even if they have similar symptoms. Doing so can harm the other person, as the doses are prescribed based on each individual’s medical conditions and body needs.

It is contraindicated in patients who have a history of hypersensitivity to Intuniv or are allergic to any of the medication’s ingredients. The product contains certain inactive components that can cause allergic reactions, which can be life-threatening.

Patients are generally advised against missing or skipping any of their doses, but if someone has mistakenly forgotten to take a dose of Intuniv, they should:

• Take the missed as soon as possible or whenever you remember.
• If it is almost time for the next dose, you may omit the skipped dose and follow your regular dosing schedule as it is prescribed.
• Remember not to take double doses at the same time to make up for the missed one. Doing so can result in complications.
• Take the help of medication apps or set reminders on the phone to avoid skipping any doses.
• In case you have missed more than two doses of your medication in a row, talk to a medical professional for expert guidance. They will suggest some alternative options.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

While it is self-understandable not to overdose on any medication, there are certain conditions when things happen. If you have also exceeded the maximum daily dose of your medication, you should consult your medical practitioner and discuss every risk associated with it. However, if you are experiencing overdose symptoms, including slow heart rate, fainting, and severe drowsiness, immediately visit the nearest clinic or get medical assistance by calling 911.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

• Store your Intuniv ER tablets at a temperature of 25°C. You can also store it between 15° to 30°C for a brief period of time.
• Keep the medication in its original container with a locked cap.
• Store the container or medication somewhere safe and out of your children’s sight and reach, as many medications are not child-resistant and can be opened easily by young children.
• Keep them away from excess heat and moisture.
• Do not store the medicines in moist or damp areas like the bathroom or near the sink.
• Discard the product when it is not in use or reaches its expiration date.
• Ask your medical practitioner or pharmacist how to dispose of the medication/container properly to avoid any harm to the environment.
• Do not flush the medication down the toilet.
• Read the product’s label thoroughly for detailed storage instructions.
• Do not dispose of the medication or its container in household trash or wastewater. Follow local disposal regulations or consult a pharmacist for safe disposal methods.
• Avoid refrigerating the medication. Keep it in a dry place.
• Ask your doctor if you can take the medication while traveling. If it is allowed, store the medicines in a secure, temperature-controlled environment, such as a carry-on bag.
• Store Intuniv away from food and beverages to prevent contamination.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Drug interactions take place when two or more drugs interact with each other and cause adverse reactions. These interactions can occur in two ways. It may alter the medication’s functioning or increase the chances of developing serious side effects in patients. These drugs can be prescription drugs, nonprescription drugs, or herbal products. Therefore, patients need to know about the drugs and their interactions. Below is the list of medicines that you might be taking. It is important to note that this list does not contain all possible drug interactions of Guanfacine.

• There are certain drugs that reduce the effects of the Guanfacine. Avoid combining these drugs with Intuniv. Examples are:
  • Amitriptyline
  • Amoxapine
  • Clomipramine
  • Desipramine
  • Doxepin
  • Imipramine
  • Lofepramine
  • Maprotiline
  • Nortriptyline
  • Protriptyline
  • Trazodone
  • Trimipramine
• These drugs reduce the levels of Guanfacine by impacting intestinal enzymes CYP3A4 metabolism. Avoid using them with your medication. It includes:
  • Apalutamide
  • Ceritinib
  • Ivosidenib
  • Lorlatinib
• Some drugs increase the level of Guanfacine by affecting hepatic enzyme CYP3A4 metabolism. Therefore, it is advisable not to coadminister Intuniv with any of the following drugs:
  • Chloramphenicol
  • Cobicistat
  • Fexinidazole
  • Mifepristone
  • Tucatinib
  • Voxelotor
• There are other drugs that affect the working of Guanfacine. These drugs do not cause severe interactions but need to be monitored closely.
  • Thioridazine
  • Thiothixene
  • Timolol
  • Tipranavir
  • Trifluoperazine
  • Valproic acid
  • Verapamil
  • Voriconazole
  • Xipamide
  • Ziprasidone
  • Zotepine
  • Rucaparib
  • Saquinavir
  • Schisandra
  • Secobarbital
  • Sertraline
  • Sofosbuvir/velpatasvir
  • St John’s Wort
  • Stiripentol
  • Tadalafil
  • Tazemetostat
  • Tecovirimat
• There are some minor drug interactions that should not be overlooked. These are:
  • Chlorpropamide
  • Cornsilk
  • Cyclophosphamide
  • Danazol
  • Drospirenone
  • Esmolol
  • Forskolin
  • Glimepiride
  • Glipizide
  • Glyburide
  • Insulin aspart
  • Insulin detemir
  • Insulin glargine
  • Sitagliptin
  • Sotalol
  • Tizanidine
  • Tolazamide
  • Tolbutamide
  • Treprostinil
  • Vildagliptin

[Note: This isn’t a complete list, and there could be other drugs that interact with Intuniv. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

Here are some of the alternatives that patients can use in place of Intuniv:

• Adderall (amphetamine/dextroamphetamine)
• Vyvanse (lisdexamfetamine)
• Strattera
• Concerta
• Methylphenidate
• Azstarys
• Dexmethylphenidate / serdexmethylphenidate
• Atomoxetine Hcl
• Clonidine Hcl Er
• Viloxazine (qelbree)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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