Risperidone ODT 3mg Tablets

Risperidone is a selective monoaminergic antagonist with high affinity for serotonin 5-HT2A and dopamine D2 receptors. It also antagonizes alpha1-adrenergic and, to a lesser extent, H1-histaminergic and alpha2-adrenergic receptors. Antagonism at other receptors is less potent. The combined D2 and 5-HT2A antagonism is thought to contribute to its antipsychotic effects, with 5-HT2A antagonism potentially mitigating D2-mediated extrapyramidal symptoms (EPS).

Urgent Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Severe dizziness or passing out
Changes in behavior or mood
Shakiness, trouble moving around, or stiffness
Urination problems, such as inability to pass urine or changes in urine output
Trouble swallowing or speaking
Difficulty focusing
Seizures
Changes in eyesight
Shortness of breath
Drooling
Feeling extremely hot or cold
Hormonal changes, including:
+ Enlarged breasts
+ Nipple discharge
+ Erectile dysfunction or changes in menstrual cycle
Sexual problems, such as:
+ Decreased interest in sex
+ Ejaculation problems
Prolonged or painful erections (lasting more than 4 hours), which can lead to permanent sexual dysfunction if left untreated
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking or behavior
+ Fast or irregular heartbeat
+ Excessive sweating
Low white blood cell count, which can increase the risk of infection; if you have a history of low white blood cell count, inform your doctor and seek medical attention if you experience:
+ Fever
+ Chills
+ Sore throat
Tardive dyskinesia, a rare but potentially irreversible condition, characterized by:
+ Involuntary body movements
+ Problems with tongue, face, mouth, or jaw movements, such as tongue sticking out, puffing cheeks, mouth puckering, or chewing

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:

Weight gain
Restlessness
Dizziness, sleepiness, tiredness, or weakness
Anxiety
Gastrointestinal problems, such as:
+ Constipation
+ Diarrhea
+ Stomach pain
+ Upset stomach
+ Nausea or vomiting
Heartburn
Dry mouth
Changes in appetite
Common cold symptoms
Headache
Sleep disturbances
* Back, muscle, arm, or leg pain

If you experience any of these side effects or have concerns, contact your doctor or seek medical attention. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is vital to verify that this medication is compatible with all your medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.

Potential Side Effects and Risks
It may take several weeks to experience the full effects of this medication. Be aware that high blood sugar, diabetes, high cholesterol, and weight gain have been associated with similar medications, which may increase the risk of heart and brain blood vessel disease.

Monitoring and Follow-up
Regularly check your blood sugar levels as instructed by your doctor. Additionally, have your blood work checked as directed by your doctor and discuss the results with them.

Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription/over-the-counter medications that may cause drowsiness, consult with your doctor.

Precautions in Hot Weather and Physical Activity
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration.

Dizziness and Fall Risk
This medication may cause dizziness, drowsiness, and impaired balance, which can increase the risk of falls, broken bones, and other health problems.

Special Considerations

If you have phenylketonuria (PKU), consult with your doctor, as some products contain phenylalanine.
Older adults with dementia who take medications like this one have a higher risk of stroke, which can be fatal. This medication is not approved for treating dementia-related mental health issues.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect fertility, but this effect is reversible when the medication is stopped. If you have concerns, discuss them with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks to you and your baby.
Taking this medication during the third trimester of pregnancy may cause side effects or withdrawal symptoms in the newborn.

• CNS depressants (e.g., alcohol, opioids, benzodiazepines): Enhanced sedation and CNS depression.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): Increase plasma concentrations of risperidone and decrease 9-hydroxyrisperidone, leading to increased overall active moiety.
• CYP3A4 inducers (e.g., carbamazepine, rifampin, phenytoin): Decrease plasma concentrations of risperidone and 9-hydroxyrisperidone, potentially reducing efficacy.
• Dopamine agonists (e.g., levodopa, bromocriptine): Risperidone may antagonize their effects.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, moxifloxacin, thioridazine): Additive QT prolongation risk.
• Antihypertensives: Additive hypotensive effects.

• Cimetidine, ranitidine: May increase risperidone levels (minor effect).
• Verapamil: May increase risperidone and 9-hydroxyrisperidone levels.
• Furosemide: Increased mortality in elderly dementia patients when co-administered with risperidone (observational study, mechanism unclear).

• Extrapyramidal symptoms (EPS): Dystonia, akathisia, parkinsonism, tardive dyskinesia
• Orthostatic hypotension (dizziness, lightheadedness upon standing)
• Sedation/drowsiness
• Weight gain
• Hyperglycemia (increased thirst, urination, hunger)
• Dyslipidemia
• Hyperprolactinemia (galactorrhea, amenorrhea, gynecomastia, sexual dysfunction)
• Neuroleptic Malignant Syndrome (NMS): Fever, muscle rigidity, altered mental status, autonomic instability
• Seizures
• QT prolongation (palpitations, syncope)
• Dysphagia
• Priapism
• Body temperature dysregulation

Category C. Studies in animals have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Risperidone and its active metabolite are excreted in human breast milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for risperidone, and any potential adverse effects on the breastfed infant from risperidone or from the underlying maternal condition. Monitor breastfed infants for sedation, poor feeding, and developmental milestones.

Approved for specific indications: schizophrenia (13-17 years), bipolar mania (10-17 years), and irritability associated with autistic disorder (5-16 years). Children and adolescents may be more susceptible to weight gain, metabolic changes, and hyperprolactinemia. Close monitoring of growth, weight, metabolic parameters, and prolactin levels is essential.

Elderly patients with dementia-related psychosis treated with risperidone are at an increased risk of death (Black Box Warning). Increased risk of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) in elderly patients with dementia. Start with lower doses and titrate slowly due to potential for increased sensitivity to adverse effects (e.g., orthostatic hypotension, sedation, EPS).

• Risperidone ODT (Orally Disintegrating Tablet) is useful for patients who have difficulty swallowing pills or who may try to 'cheek' or hide their medication.
• The ODT formulation should be placed on the tongue and allowed to dissolve, then swallowed with or without water. Do not chew or crush.
• Monitor patients closely for metabolic side effects (weight gain, hyperglycemia, dyslipidemia), especially in children and adolescents.
• Hyperprolactinemia is a common side effect; monitor for symptoms like galactorrhea, amenorrhea, gynecomastia, and sexual dysfunction.
• Titrate dose slowly to minimize orthostatic hypotension and other dose-related side effects.
• Educate patients and caregivers about the Black Box Warning regarding increased mortality in elderly patients with dementia-related psychosis.
• Consider the long half-life of the active metabolite (9-hydroxyrisperidone) when adjusting doses or assessing steady-state effects.

• Other atypical antipsychotics (e.g., Olanzapine, Quetiapine, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine, Brexpiprazole)
• Typical antipsychotics (e.g., Haloperidol, Chlorpromazine) - generally less preferred due to higher EPS risk
• Mood stabilizers (e.g., Lithium, Valproate, Carbamazepine) for bipolar disorder
• SSRIs/SNRIs for mood/anxiety symptoms (if comorbid)
• Behavioral therapies and psychosocial interventions

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.