Risperidone ER 12.5mg Inj, 1 Vial

Risperidone is a selective monoaminergic antagonist with high affinity for serotonin 5-HT2 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 antipsychotic activity is believed to be mediated through a combination of D2 and 5-HT2 antagonism.

Urgent Side Effects: Seek Medical Help Right Away

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 immediately:

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
Difficulty urinating or changes in urine output
Trouble swallowing or speaking
Difficulty focusing
Seizures
Changes in vision
Shortness of breath
Drooling
Feeling extremely hot or cold
Enlarged breasts, nipple discharge, or changes in menstrual cycle
Erectile dysfunction, including painful erections or erections lasting longer than 4 hours (seek medical attention immediately to avoid long-term damage)
Sex problems, such as decreased interest in sex or ejaculation issues

Neuroleptic Malignant Syndrome (NMS): A Rare but Serious Condition

NMS is a potentially life-threatening condition that requires immediate medical attention. If you experience any of the following symptoms, contact your doctor right away:

Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Changes in thinking or behavior
Rapid heartbeat or irregular heartbeat
Excessive sweating

Low White Blood Cell Count: Increased Risk of Infection

Drugs like this one may increase the risk of infection due to low white blood cell counts. If you have a history of low white blood cell count, inform your doctor. Seek medical attention immediately if you experience signs of infection, such as:

Fever
Chills
Sore throat

Tardive Dyskinesia: A Rare but Serious Muscle Disorder

Tardive dyskinesia is a condition characterized by involuntary muscle movements. If you experience any of the following symptoms, contact your doctor right away:

Trouble controlling body movements
Problems with your tongue, face, mouth, or jaw, such as:
+ Tongue sticking out
+ Puffing cheeks
+ Mouth puckering
+ Chewing movements

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Weight gain
Restlessness
Dizziness, sleepiness, tiredness, or weakness
Anxiety
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Dry mouth
Changes in appetite
Signs of a common cold
Headache
Trouble sleeping
Back, muscle, arm, or leg pain
Irritation at the injection site

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. 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 any allergies you have, including:

Allergies to this medication or any of its components
Allergies to other medications, foods, or substances
The specific symptoms you experienced due to the allergy

Additionally, this medication may interact with other medications or health conditions. To ensure safe use, please disclose the following information to your doctor and pharmacist:

All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
Existing health problems or conditions

It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or adjust the dose 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, rise slowly from a sitting or lying down position. 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 drugs like this one have been associated with increased risks of high blood sugar or diabetes, high cholesterol, and weight gain, which may raise the risk of heart and brain blood vessel disease.

Monitoring and Follow-up
Follow your doctor's instructions for checking your blood sugar levels. 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, other forms of cannabis, or prescription or over-the-counter drugs that may cause drowsiness, consult with your doctor.

Precautions in Hot Weather and Physical Activity
Be cautious in hot weather or during physical activity, as this medication can increase the risk of fluid loss. Drink plenty of fluids to stay hydrated.

Dizziness and Fall Risk
This medication may cause dizziness, drowsiness, and impaired balance, which can increase the risk of falls and related injuries, such as broken bones. Take necessary precautions to ensure your safety.

Special Considerations for Older Adults
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.

Pregnancy and Fertility
This medication may affect fertility, but this effect is reversible when the medication is stopped. If you have concerns, discuss them with your doctor. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to weigh 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): Increased sedation and CNS depression.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, moxifloxacin): Increased risk of arrhythmias.
• Dopamine agonists (e.g., levodopa, bromocriptine): Antagonism of effects.
• Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine): Can increase plasma levels of risperidone and 9-hydroxyrisperidone.
• Strong CYP3A4 inducers (e.g., carbamazepine, rifampin, phenytoin): Can decrease plasma levels of risperidone and 9-hydroxyrisperidone.

• Antihypertensives: Enhanced hypotensive effects.
• Diuretics (especially in elderly with dementia-related psychosis): Increased risk of orthostatic hypotension.
• Cimetidine, ranitidine: May increase risperidone levels (minor effect).
• Clozapine: May increase risperidone levels.
• Valproate: May increase risperidone levels (minor effect).

• Lithium: No significant pharmacokinetic interaction, but monitor for additive CNS effects.

• Changes in mental status (e.g., confusion, agitation)
• Fever, muscle rigidity, sweating, irregular heart beat (signs of NMS)
• Uncontrolled movements (e.g., tardive dyskinesia, akathisia, dystonia)
• Excessive thirst or urination (signs of hyperglycemia)
• Dizziness or lightheadedness upon standing (orthostatic hypotension)
• Breast enlargement, milk production, menstrual irregularities, sexual dysfunction (hyperprolactinemia)
• Sore throat, fever, flu-like symptoms (agranulocytosis, though rare)
• Seizures
• Difficulty swallowing

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Risperidone and its active metabolite are excreted in human milk. The American Academy of Pediatrics considers risperidone to be a drug for which the effect on the nursing infant is unknown but may be of concern. Weigh the benefits of breastfeeding against the potential risks to the infant. Monitor the infant for sedation, poor feeding, and developmental milestones.

Safety and effectiveness of Risperidone ER injection have not been established in pediatric patients. Oral risperidone is approved for certain indications in children and adolescents (e.g., irritability associated with autistic disorder, schizophrenia, bipolar disorder).

Elderly patients with dementia-related psychosis treated with antipsychotic drugs 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. Use with caution due to increased sensitivity to adverse effects (e.g., orthostatic hypotension, sedation, EPS). Consider lower starting doses for oral risperidone before initiating ER injection.

• Risperidone ER injection requires 3 weeks of oral risperidone overlap after the first injection to ensure therapeutic levels are achieved, as the main release from the injection is delayed.
• The 12.5 mg dose is typically used for patients who require a lower maintenance dose or for dose titration, though 25 mg is the usual starting dose for most indications.
• Always administer IM into the deltoid or gluteal muscle using the appropriate needle size provided in the kit.
• Monitor for metabolic side effects (weight gain, dyslipidemia, hyperglycemia) and extrapyramidal symptoms (EPS) regularly.
• Hyperprolactinemia is a common side effect; monitor for symptoms like galactorrhea, amenorrhea, gynecomastia, and sexual dysfunction.
• Educate patients about the delayed onset and the need for oral overlap, as well as potential side effects and the importance of adherence to the every-2-week injection schedule.

• Other long-acting injectable atypical antipsychotics (e.g., paliperidone palmitate, aripiprazole lauroxil, olanzapine pamoate)
• Oral atypical antipsychotics (e.g., risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, lurasidone, cariprazine, brexpiprazole)
• Oral typical antipsychotics (e.g., haloperidol, fluphenazine)
• Other long-acting injectable typical antipsychotics (e.g., haloperidol decanoate, fluphenazine decanoate)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the proper disposal method, consult your pharmacist, as they can provide guidance on disposal procedures and potential drug take-back programs in your area. Additionally, some medications may have a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about this medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure timely and effective treatment.