Risperidone ER 25mg Inj Susp Kit

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. Its antipsychotic activity is believed to be mediated through a combination of D2 and 5-HT2A 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
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, such as:
+ Enlarged breasts
+ Nipple discharge
+ Erectile dysfunction or changes in menstrual cycle
Sexual problems, including:
+ 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 deadly condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking or 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 severe muscle problem, which may cause:
+ Uncontrollable body movements
+ Tongue, face, mouth, or jaw problems, 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
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Dry mouth
Changes in appetite
Common cold symptoms
Headache
Trouble sleeping
Back, muscle, arm, or leg pain
Irritation at the injection site

If you experience any of these side effects or have concerns, contact your doctor for medical advice. 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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never 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 understand how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, 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 drugs like this one have been associated with increased risks of high blood sugar or diabetes, high cholesterol, and weight gain, which may contribute to 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
In hot weather or during physical activity, be careful to avoid dehydration by drinking plenty of fluids.

Dizziness and Fall Risk
This medication may cause dizziness, drowsiness, and impaired balance, increasing the risk of falls and related injuries, such as fractures.

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. If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to weigh the benefits and risks to you and your baby. Taking this medication during the third trimester of pregnancy may lead to side effects or withdrawal symptoms in the newborn.

• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, moxifloxacin, thioridazine)
• Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) - may increase risperidone levels
• Strong CYP3A4 inducers (e.g., carbamazepine, rifampin, phenytoin) - may decrease risperidone levels
• CNS depressants (e.g., alcohol, opioids, benzodiazepines) - additive sedative effects

• Moderate CYP2D6 inhibitors (e.g., sertraline)
• Moderate CYP3A4 inducers (e.g., phenobarbital)
• Antihypertensives (additive hypotensive effects)
• Dopamine agonists (e.g., levodopa) - may antagonize effects

• Anticholinergic drugs (additive anticholinergic effects)

• Extrapyramidal symptoms (EPS) including parkinsonism, akathisia, dystonia
• Tardive dyskinesia (involuntary movements, especially of face and tongue)
• Neuroleptic Malignant Syndrome (NMS) - fever, muscle rigidity, altered mental status, autonomic instability
• Orthostatic hypotension (dizziness, lightheadedness upon standing)
• Hyperglycemia/Diabetes symptoms (increased thirst, urination, hunger)
• Hyperprolactinemia symptoms (galactorrhea, amenorrhea, gynecomastia, sexual dysfunction)
• Sedation/Drowsiness
• Cardiac symptoms (palpitations, dizziness, syncope)
• Signs of infection (due to rare leukopenia/neutropenia)

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 (9-hydroxyrisperidone) are excreted into breast milk. Decision to breastfeed should consider the benefit of breastfeeding to the infant, the mother's clinical need for the drug, and any potential adverse effects on the breastfed infant.

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

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death (Black Box Warning). Increased sensitivity to adverse effects (e.g., orthostatic hypotension, sedation, EPS). Use with caution, generally starting at lower doses and titrating slowly. Monitor closely for adverse effects.

• Risperidone ER injection requires a 3-week overlap with oral risperidone after the first injection to ensure therapeutic levels are achieved.
• Administer deep IM injection into the deltoid or gluteal muscle, alternating injection sites.
• Do not administer intravenously.
• Monitor for metabolic side effects (weight gain, hyperglycemia, dyslipidemia) regularly.
• Be vigilant for extrapyramidal symptoms (EPS) and tardive dyskinesia (TD); use AIMS scale for monitoring.
• Hyperprolactinemia is a common side effect; monitor for symptoms (e.g., galactorrhea, amenorrhea, sexual dysfunction).
• Orthostatic hypotension is a risk, especially during initial titration; advise patients to rise slowly.
• Patients should be stable on oral risperidone before transitioning to the ER injection.
• The 25mg dose is the lowest available strength for the ER injection.

• Other atypical antipsychotics (e.g., olanzapine, quetiapine, aripiprazole, ziprasidone, lurasidone, cariprazine, brexpiprazole)
• Other long-acting injectable antipsychotics (e.g., paliperidone palmitate, aripiprazole lauroxil, olanzapine pamoate)
• Typical antipsychotics (e.g., haloperidol, fluphenazine - generally less preferred due to higher EPS risk)

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, and do not take medication prescribed for someone else. 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. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.