Viloxazine Hydrochloride - Uses, Side Effects, Dosage, and More

Overview:

Viloxazine is a drug developed by a United States-based company, Supernus pharmaceuticals. The FDA (Food and Drug Administration) approved the drug for treating ADHD (attention deficit hyperactivity disorder) patients on April 2nd, 2021. Viloxazine was first recognized in the United Kingdom before being endorsed worldwide. Viloxazine is a serotonin-norepinephrine modulating agent (SNMA). The drug is supplied as an extended-release capsule for children and adults with ADHD.

ADHD is a childhood disorder characterized by neurodevelopmental disturbances in children. It is a chronic condition that causes difficulty concentrating, impulsive behavior, and hyperactivity in children.

Three subtypes of ADHD have been identified:

• Predominantly inattentive presentation.

• Predominantly hyperactive-impulsive presentation.

• Combined presentation.

ADHD commonly occurs in childhood and can continue to persist in adulthood. Treatment of ADHD includes medication (use of stimulants and non-stimulants) and behavioral therapy. Viloxazine hydrochloride belongs to the non-stimulant group, and the capsules should be taken once daily. Within the first few months of treatment, Viloxazine is known to increase suicidal thoughts in children. Therefore, parents should carefully monitor their children. However, the FDA has approved Quelbree for the treatment of ADHD, considering its benefits.

How Does Viloxazine Work?

The action of Viloxazine is related to the reuptake inhibition of norepinephrine (noradrenaline) without affecting its release. Viloxazine inhibits the transportation of norepinephrine and increases its level in the nucleus accumbens, amygdala, and prefrontal cortex. Additionally, dopamine levels increase significantly in the prefrontal cortex, amygdala, and considerably in the nucleus accumbens. The increase in dopamine reuptake occurs due to the norepinephrine transporter. Therefore, the potential for drug abuse is very little compared to other drugs used in treating ADHD, as Viloxzine has a more negligible effect on dopamine transmission.

Dopamine addiction has been linked to increased dopamine activity in the D1 pathway of the nucleus accumbens. However, studies have shown no drug dependency in animal models upon Viloxazine administration. Researchers have also discovered that Viloxazine is a weak inhibitor of alpha and beta-adrenergic receptors. According to early studies, Viloxazine appears not to inhibit the uptake of serotonin in the brain and platelet. However, a study using rat neuronal slices exposed to Viloxazine showed an increase in serotonin release.

In contrast, Viloxazine increases the brain's susceptibility to serotonin, causing it to synthesize 5-hydroxytryptophan, which causes the hind limb extensor reflex and behavioral symptoms. These may be the results of increased serotonin receptor activation. The amygdala, nucleus accumbens, and prefrontal cortex also showed increases in serotonin following Viloxazine administration in vivo studies. Viloxazine has also been suggested to antagonize the 5HT7 receptor, the 5HT2C receptor, and the 5HT2B receptor. As a result, antagonism of the 5HT2B GABA interneurons in the prefrontal cortex leads to an increase in serotonin levels. The final characteristic of Viloxazine is that compared to other antidepressants, it has a weak inhibition of H1 and H2 histamine receptors, M1 to M4 muscarinic receptors, deficient cholinergic activity, and weak inhibition of both MAO-A (monoamine oxidase A) and MAO-B (monoamine oxidase B). Viloxazine may also have antidepressive effects due to its ability to increase serotonin in the brain.

Uses:

Viloxazineis approved for treating ADHD (attention deficit hyperactivity disorder) in patients between 6 years to 17 years. ADHD is a chronic neurodevelopmental condition that affects children and adults. Viloxzine hydrochloride was approved in 2021 for relieving the symptoms of ADHD.

Dosage:

The Recommended Starting Dose for Patients Aged 6 to 11 Years:

• 100 mg orally once daily.

• Depending on the patient’s response and tolerability, dosage may be given in increments of 100 mg at weekly intervals.

• 400 mg is the maximum dose recommended for pediatric patients of age 9 to 11 years.

The Recommended Starting Dose for Patients 12 to 17 Years:

• 200 mg orally once daily.

• Depending on response and tolerability, the dosage may be titrated by an increment of 200 mg to the maximum recommended dosage of 400 mg once daily after one week.

• The treatment may be extended periodically to evaluate the response, and the dosage is adjusted according to the needs.

Warning:

Suicidal Thoughts and Behaviors

Viloxazine treatment is known to induce suicidal thoughts and behavior in patients with ADHD. However, no suicides occurred during the clinical trials. Patients also experience higher rates of suicide and irritability. As of now, there is no certainty as to if there is a link between the emergence of such symptoms and the development of suicidal impulses. Still, it is believed that depressed mood, anxiety, agitation, mania, hypomania, panic attacks, impulsive behavior, and aggression may signal a predisposition to suicidality. In patients experiencing the emergence of suicidal thoughts or behaviors or symptoms that could indicate emerging suicidal ideation or behavior, the family or caregiver of the patient should be advised to monitor the patient for suicidal ideation or behavior.

Blood Pressure and Heart Rate

Viloxazaine is known to cause an elevation in the heart rate and blood pressure. In patients receiving Viloxazine, the heart rate increased by 20 beats per minute. In addition, patients who were treated with a 400 mg daily dose of Viloxzaine had more than a 15 mm Hg increase in diastolic blood pressure. Therefore, it is important to ask your child’s physician to regularly monitor the blood pressure and heart rate before and after Viloxazine treatment.

Activation of Mania or Hypomania

Patients with bipolar disorder may experience manic or mixed episodes when taking noradrenergic drugs, such as Viloxazine. It is appropriate to get screened for such neurological conditions before starting Viloxazine. Assessing your child’s medical history and a personal or family history of suicide, depression, and bipolar disorder is crucial.

Somnolence and Fatigue - Viloxazine can cause somnolence and fatigue in children. Patients on Viloxazine also reported lethargy and sedation. Therefore, your child must not perform activities that require mental alertness, such as operating a motor vehicle or operating hazardous machinery during Viloxazine therapy.

Allergic and Adverse Reactions - Clinical trials reported adverse reactions in 3 % of patients receiving Viloxazine treatment. The commonly reported adverse effects were headaches (migraine, migraine with aura, tension headache), fatigue, and decreased appetite. Also widely encountered are upper respiratory tract infections such as nasopharyngitis, pharyngitis, sinusitis, and viral sinusitis. In addition, some patients can experience abdominal pain and discomfort. Therefore, it is essential to discontinue Viloxazine treatment after seeking a physician’s advice if your child experiences adverse reactions.

For Patients:

Learn About ADHD:

ADHD or attention deficit hyperactivity disorder is a common condition associated with neurodevelopmental disturbances in children. The condition is characterized by an imbalance in neurotransmitters such as norepinephrine and dopamine in the brain. As a result, children become hyperactive and lack attention. Norepinephrine and dopamine are mainly involved in attention, planning, and organizing thoughts. Therefore, disturbances in these neurotransmitters cause ADHD in children.

Learn More About Viloxazine:

Why and When to Switch to Viloxazine?

Viloxazine is a drug approved by the FDA to treat ADHD in children. Viloxazine treatment gives a positive clinical response and improves the quality of life. The overall treatment outcomes of Viloxazine are associated with enhancing the patient's cognitive function with limited side effects compared to other medications used for ADHD.

What Differentiates Viloxazine From Other Conventional Medicines?

Viloxazine Versus Other Medications:

The recommended treatment for ADHD involves two groups of drugs - stimulants and non-stimulants. Stimulants have a response rate of 70 %, and these medications are used on mood, anxiety, growth, blood pressure, sleep pattern, and pulse rate. Additionally, these medications are known to induce aggressive behavior and hallucinations. For patients who are intolerant to the stimulant group of drugs, non-stimulants can be a good alternative. Viloxazaine belongs to the non-stimulant group of drugs and has shown promising results in clinical trials.

How Does Viloxazine Work?

However, it is believed that the action of Viloxazine is related to the reuptake inhibition of noradrenaline (a hormone and a neurotransmitter in the brain) without affecting its release. The transportation of norepinephrine across the brain tissues is inhibited by Viloxazine, thereby increasing its concentration in other areas of the brain. As a result, dopamine (another crucial neurotransmitter) levels are significantly increased in the prefrontal cortex, amygdala, and the nucleus accumbens without affecting dopamine transmission.

Note:

1. Norepinephrine: It acts as a hormone and neurotransmitter in the brain. Noradrenaline or norepinephrine increases alertness, restlessness, and anxiety. It plays an important role in memory formation and retrieval.

2. Dopamine: It is a key neurotransmitter in the brain that plays a key role in behavior, memory, attention, mood, sleep pattern, learning, etc.

3. Prefrontal Cortex: Front region of the brain or part of the brain that plays an essential role in cognitive development.

4. Amygdala: Part of the brain responsible for emotional behavior and motivation.

5. Nucleus Accumbens: A major structure involved in emotional and motivational processing.

What Are the Effects of Viloxazine?

The effects of Viloxazine are unique compared to other medications used for ADHD. Viloxazine blocks the reuptake of noradrenaline and works on hormones such as oxytocin, vasopressin, cortisol, and substance P. It also affects the 5HT receptors of the brain that are responsible for the modulation of dopamine and epinephrine. Additionally, Viloxazaine has cardiac effects which are not clinically significant.

Note:

1. Oxytocin: Also known as the love hormone, released by the hypothalamus gland.

2. Vasopressin: Hormone secreted by the hypothalamus gland responsible for regulating blood pressure and water retention.

3. Cortisol: A steroid hormone produced by the adrenal glands.

4. Substance P: A neurotransmitter responsible for pain perception, memory processing, cell growth, etc.

5. 5HT Receptors: A group of protein-sensitive receptors found in the brain.

Things to Tell Physicians Before They Prescribe Viloxazine:

1. It is important to inform the physician regarding your child’s medical history before starting the medication or the history of signs and symptoms of ADHD if diagnosed priorly.

2. If your child is under other medications or suffering from other medical conditions, it should be notified.

3. Inform regarding any family history of suicide, bipolar disorder, and depression if present.

4. If your child is allergic to any medication, inform your doctor to avoid future complications.

5. Discuss your child’s hospitalization and immunization records before Viloxazine treatment.

6. Discuss all the medications taken in the past or currently consumed. This is crucial as certain medications can cause harmful effects when taken along with Viloxazaine.

7. Intimate about significant past or planned future surgeries for your child.

8. If you are a female patient planning for pregnancy, currently pregnant, or breastfeeding, inform your physician.

9. Get your child’s vitals (heart rate and blood pressure) monitored before starting Viloxazine.

10. Get your child’s liver and renal function tests to rule out other conditions.

Starting Viloxazine:

How to Take Viloxazine?

• Take Viloxazine as prescribed by your doctor.

• Viloxazaine should be taken orally with or without food.

• Do not crush, cut, or chew the capsules.

• Swallow the entire pill or open the contents and consume it along with applesauce.

• Consume the whole teaspoon of applesauce and the sprinkled medication without chewing.

• The capsules should be consumed within two hours, and storing the open contents should not be promoted in the future.

• The capsule should be stored at 20 to 25 degrees Celsius. However, storage between 15 to 30 degrees Celsius is permitted.

Common Side Effects to Look Out For:

Viloxazine causes several side effects; therefore, monitor your child periodically to avoid complications. Inform your physician if you notice any unusual symptoms. Common side effects of Viloxazian include:

1. Tiredness, fatigue, and lethargy.

2. Suicidal thoughts, irritability, behavioral changes, and insomnia.

3. Panic attacks, impulsive behavior, aggressive behavior, depression, etc.

4. Increased heart rate and blood pressure.

5. Runny nose, headache, cough, and cold (symptoms of upper respiratory tract infection).

6. Migraine-like symptoms.

7. Nausea, abdominal pain, and discomfort.

Get Regular Blood Tests:

Although Viloxazine is not known to cause kidney and liver impairment, it is advised to get regular blood tests to monitor the kidney and liver functions.

Avoid Self-Medication If:

• If your child’s physician has not instructed on the dosage of the drug.

• If your child is currently on other medications for ADHD or other conditions.

• If your child experiences suicidal thoughts and behavioral changes.

• If your child’s physician has not evaluated your child's vitals and other medical conditions.

The Recommended Diet for Patients on Viloxazine:

Unless the doctor advises, most patients are advised to continue with their regular diet. However, ensure your child consumes a nutritious and balanced diet. For example, nuts, grains, fruits, vegetables, and foods rich in iron and folic acid should be consumed. In addition, Omega fatty acids are beneficial and can be added to a regular meal.

Staying On Viloxazine:

Tips to Stay on Track

The intensity of the symptoms can take several weeks to reduce after the treatment. If the condition has not improved, contact your child’s physician, and they may advise discontinuing the treatment. Report the symptoms of side effects after Viloxazine treatment as they can cause complications. Follow the dosing schedule as instructed by the physician.

Things to Keep In Mind

1. In case of overdosage, monitor yourself for any symptoms of adverse reactions and contact your physician so that appropriate symptomatic treatment can be given immediately.

2. Contact your doctor to schedule the subsequent dosing if your child missed or forgot to take the scheduled dose, as it may interfere with the recovery.

3. Regularly follow up with your child’s physician and be aware of any adverse behavioral changes in your child.

For Doctors:

Indications

Viloxazine hydrochloride is currently approved for treating ADHD (attention deficit hyperactivity disorder) in children and young adult patients between 6 to 17 years. Viloxzine hydrochloride was approved in April 2021 for relieving the symptoms of ADHD. It belongs to the group of SNMA (serotonin-norepinephrine modulating agent) and is a non-stimulant.

Pharmacology:

Mechanism of Action

The exact mechanism of action of Viloxazine has not been understood yet. However, it is believed that the action of Viloxazine is related to the reuptake inhibition of norepinephrine (noradrenaline) without affecting its release. The transportation of norepinephrine is inhibited by Viloxazine, thereby increasing its concentration in different brain areas. As a result, dopamine levels are significantly increased in the prefrontal cortex, amygdala, and the nucleus accumbens without affecting dopamine transmission.

Pharmacokinetics

Viloxazine maximum concentration (Cmax) and area under the curve (AUC) proportionally increase over 100 mg to 400 mg of dosage range given once daily. The curve reaches a steady state after two days of one dose daily administration of Viloxazine, and the drug does not accumulate.

Pharmacodynamics

Viloxazine acts by binding to the norepinephrine transporter (NET) with an inhibitor constant of Ki= 0.63 µM. It inhibits the reuptake of norepinephrine at a concentration required for 50 % inhibition (IC50) at 0.2 µM. Even if the given dose is 4.5 times higher than the maximum recommended dose, Viloxazine did not have any clinically relevant prolonging effect on the QT interval. In addition, Viloxazine did not affect the PR interval or QRS duration in healthy volunteers. However, according to nonclinical studies, Viloxzaine is known to inhibit cardiac sodium channels.

Absorption

Compared to immediate-release formulas, the bioavailability of Viloxazine extended-release capsules was 88 %. In addition, 200 mg of Viloxazine achieves maximum plasma concentration (Tmax) after five hours of administration, although Tmax ranges from three to nine hours.

If Viloxazine extended-release is administered with a high-fat meal, both Cmax and AUC (area under the curve) decreased by 9 % and 8 %, respectively. Tmax of Viloxazine increases by about 2 hours when given with a high-fat meal. When Viloxazine is sprinkled on applesauce, the Cmax and AUC decreased by 10 % and 5 %, respectively. Viloxazine binds to 75 % to 82 % of human plasma proteins when the blood concentration reaches as low as 0.5 mcg/mL and as high as 10 mcg/mL.

Metabolism

Viloxazine is mainly metabolized by CYP2D6, UGT2B15, and UGT1A9 (enzymes). Therefore, the primary metabolite of Viloxazine detected in plasma is 5-hydroxy-viloxazine glucuronide.

Elimination

The half-life of viloxazine is 7.02 ± 4.74 hours (mean + standard deviation). Virloxazine is excreted primarily by the kidneys. Viloxazine administered intravenously in radiolabeled form was recovered in urine 90 % of the time within 24 hours following administration. There is less than 1 % excretion in the bowel movements of the drug.

Warnings and Precautions:

Suicidal Thoughts and Behaviors

Viloxazine treatment is known to induce suicidal thoughts and behavior in patients with ADHD.

However, no suicides occurred during the clinical trials. Patients also experience higher rates of suicide and irritability. As of now, there is no certainty as to if there is a link between the emergence of such symptoms and the development of suicidal impulses. Still, it is believed that depressed mood, anxiety, agitation, akathisia, mania, hypomania, panic attacks, impulsive behavior, and aggression may signal a predisposition to suicidality. In patients experiencing the emergence of suicidal thoughts or behaviors or symptoms that could indicate emerging suicidal ideation or behavior, consider modifying the therapeutic regimen, including possibly discontinuing Viloxazine, mainly if these symptoms were severe or abrupt in onset or did not describe the patient's presenting complaint. In addition, the family or caregiver of the patient should be advised to monitor the patient for suicidal ideation or behavior.

Blood Pressure and Heart Rate

Viloxazaine causes elevation in the heart rate and blood pressure. The heart rate of the patients also increased by 20 beats per minute in patients receiving Viloxazine. In addition, patients who were treated with a 400 mg daily dose of Viloxzaine had more than a 15 mmHg increase in diastolic blood pressure at any time during the clinical trial. Therefore, it is important to periodically assess the blood pressure and heart rate before initiating Viloxazine treatment.

Activation of Mania or Hypomania

Patients with bipolar disorder may experience manic or mixed episodes when taking noradrenergic drugs, such as Viloxazine. Therefore, it is appropriate to screen patients before treating them with Viloxazine for bipolar disorder, including assessing their medical history and a personal or family history of suicide, depression, and bipolar disorder.

Somnolence and Fatigue

The use of Viloxazine can cause somnolence and fatigue. In addition, patients receiving Viloxazine reported lethargy and sedation. Therefore, it is important to advise patients not to perform activities that require mental alertness, such as operating a motor vehicle or operating hazardous machinery during Viloxazine therapy.

Allergic and Adverse Reactions

Clinical trials reported adverse reactions in 3 % of patients receiving Viloxazine treatment. The commonly reported adverse effects were headaches (migraine, migraine with aura, tension headache), fatigue, and decreased appetite. Some patients also reported upper respiratory tract infections such as nasopharyngitis, pharyngitis, sinusitis, and viral sinusitis. Additionally, some patients reported abdominal pain and discomfort. Therefore, it is essential to discontinue Viloxazine treatment if patients experience adverse reactions.

Carcinogenesis and Mutagenesis

Viloxazine treatment did not increase the occurrence of tumors in animal models. In addition, genotoxic effects, carcinogenicity, and chromosomal aberrations after Viloxazine administration were not seen.

Fertility Impairment

According to animal models, Viloxazine did not affect fertility in both genders after the oral administration of the medication.

Indications and Uses

Viloxazine hydrochloride is currently approved for treating ADHD (attention deficit hyperactivity disorder) in children and young adult patients between 6 to 17 years of age. It belongs to the group of SNMA (serotonin-norepinephrine modulating agent) and is a non-stimulant.

Dosage and Administration

Before administering Viloxazine, the patient's blood pressure and heart rate should be assessed. In addition, patients should be screened for a family history of bipolar disorder, suicide, and depression.

Recommended Dosage

• Pediatric patients 6 to 11 years of age: As a starting dosage, pediatric patients between the ages of 6 and 11 years should take 100 mg twice daily. Then, depending on response and tolerability, the dosage can be titrated in 100 mg increments at weekly intervals up to 400 mg once daily.

• Pediatric patients 12 to 17 years of age: A dosage of 200 mg once a day is recommended for pediatric patients 12 to 17 years of age. After one week, the dosage may be gradually increased by 200 mg increments up to 400 mg once daily, as determined by response and tolerability. ADHD may require long-term treatment with medications. Viloxazine dosage can be adjusted as needed based on periodic reevaluations.

Dosage Recommendations in Patients with Renal Impairment -

The recommended dosage of Viloxazine for patients with renal impairment is 100 mg once daily. Dosage may be adjusted in weekly increments of 50 mg to 100 mg, and a maximum dosage of 200 mg is recommended once daily. In patients with mild to moderate renal impairment dosage adjustment is not required.

Administration Information

Viloxazaine should be administered orally with or without food. The capsules should not be cut, crushed, or chewed. Advise the patients to swallow the entire pill or to open the contents and consume it along with applesauce. Consuming the whole teaspoon of applesauce and the sprinkled medication without chewing is recommended. The capsules should be consumed within two hours, and storing the open contents should not be promoted in the future.

Usage, Storage, and Training Instructions

Viloxazine capsules are available as the following:

• 100 mg: Yellow opaque body and capsule.

• 150 mg: Lavender opaque body and capsule.

• 200 mg: Light green opaque body and capsule.

The capsule should be stored at 20 to 25 degrees Celsius. However, storage between 15 to 30 degrees Celsius is permitted.

Contraindications

• In patients receiving monoamine oxidase inhibitors (MAOI), the prescription of Viloxazine is contraindicated. Even within 14 days following discontinuing an MAOI, Viloxazine is not recommended due to the associated risk of severe hypertensive crisis.

• Administering the sensitive CYP1A2 substrates or CYP1A2 substrates along with a narrow therapeutic range is another contraindication.

Drug interactions

1. Monoamine Oxidase Inhibitors (MAOI):

If Viloxazine is used with monoamine oxidase inhibitors, it may lead to a life-threatening hypertension crisis. Therefore, Viloxazine should not be used along with or within two weeks after using MAOIs. Examples of contraindicated MAOIs include Selegiline, Isocarboxazid, Phenelzine, Tranylcypromine, Safinamide, and Rasagiline.

2. Sensitive CYP1A2 Substrates or CYP1A2 Substrates With a Narrow Therapeutic Range:

The therapeutic impact of Viloxazine inhibits CYP1A2 strongly. Viloxazaine increases total exposure, but not peak exposure of CYP1A2 substrates that are sensitive when used together.

As a result, it may increase the risk of adverse reactions associated with CYP1A2 substrates. Examples of CYP1A2 substrates include Alosetron, Duloxetine, Ramelteon, Tasimelteon, Tizanidine, and Theophylline.

3. Moderate Sensitive CYP1A2:

Viloxazine strongly inhibits the action of CYP1A2 substrates. As a result, the use of Viloxazine and CYP1A2 increases the exposure sensitivity of CYP1A2, which increases the associated adverse reactions. Therefore, the use of CYP1A2 substrate is not recommended with Viloxazine, and dosage modifications might be advised in such cases. Examples of CYP1A2 substrates are - Clozapine and Pirfenidone.

4. CYP2D6 Substrates:

Viloxazaine weakly inhibits the action of the CYP2D6 substrate. When administered along with CYP2D6, Viloxazaine increases the exposure of CYP2D6 substrates and adversely affects the patients. Dosage adjustment is recommended in such cases. Examples of CYP2D6 are - Atomoxetine, Desipramine, Tolterodine, Venlafaxine, Dextromethorphan, Nortriptyline, Nebivolol, Perphenazine, Metoprolol, and Risperidone.

5. CYP3A4 Substrates:

Viloxazaine is a weak inhibitor of CYP3A4 substrate, and it increases the exposure of CYP3A4 substrates when administered together. Therefore, patients should be intervened and monitored for adverse reactions, and the dosage should be adjusted accordingly. Examples of CYP3A4 substrates include Alfentanil, Tacrolimus, Tipranavir, Avanafil, Buspirone, Ibrutinib, Conivaptan, Darifenacin, Darunavir, Ebastine, Triazolam, Everolimus, Lovastatin, Midazolam, Saquinavir, Simvastatin, lomitapide, Sirolimus, Vardenafil, Naloxegol, Lurasidone, and Nisoldipine.

Use in Specific Populations

1. Pregnancy:

Viloxazaine is known to cause maternal harm when administered during pregnancy. If the harmful effects of the drug outweigh the benefits, the drug should be discontinued. However, the data available about the detrimental impact of Viloxazaine on pregnant women is insufficient to determine the risk of congenital disabilities, miscarriage, and adverse maternal outcomes. Animal models did not reveal any significant maternal toxicity on organogenesis after the oral administration of Viloxazaine, even up to 2 times the maximum recommended dose. Generally, all pregnancies risk birth loss, defects, and other adverse effects. The estimated pregnancy risk of Viloxazine is not known. According to animal trials, Viloxazine is thought to cause maternal toxicity and not fetal defects. The effects on animal models included decreased maternal body weight, weight gain, lower birth weight, delayed growth, sexual maturation, etc.

2. Lactating Mothers:

There is absolutely no documented detail on the presence of Viloxazine in human milk and its effects on breastfed infants. However, in animal models, Viloxzaine was likely to be present in the milk, and hence it is expected to be present in the human milk. Therefore, it is essential to consider the risks and benefits of prescribing Viloxazine to breastfeeding women.

3. Pediatric Population:

Viloxazine effectively treats the symptoms of ADHD in children between 6 to 17 years of age. However, the drug's safety in children less than six years old has not been established. Patients receiving Viloxazine should be monitored for suicidal behavior and weight changes. In juvenile animal models, Viloxzaine decreased bodyweight, weight gain, food consumption, sexual maturation, and reproductive capacity at doses several times higher than the recommended dose. However, learning and memory were not affected.

4. Geriatric Use:

There are very scarce details available on the effects of Viloxazineon on geriatric patients.

5. Patients With Renal Impairment:

A reduction in the dosage is recommended in patients with severe kidney impairment as it is known to worsen the condition. However, dosage adjustment is not required for patients with mild to moderate renal impairment.

6. Patients With Hepatic Impairment:

The toxic effects of Viloxazine in patients with hepatic impairment are yet to be determined. However, Viloxazine is not recommended in patients with hepatic impairment.