Risperidone ER 37.5mg Inj Susp Kit

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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination or flushing
+ Rapid breathing or breath that smells like fruit
Severe dizziness or fainting
Changes in behavior or mood
Shakiness, difficulty moving, or stiffness
Urination problems (difficulty starting or stopping urination, or changes in urine output)
Swallowing or speech difficulties
Difficulty focusing
Seizures
Changes in vision
Shortness of breath
Drooling
Feeling extremely hot or cold
Breast changes (enlargement, nipple discharge), erectile dysfunction, or menstrual changes
Sexual problems, such as decreased libido or ejaculation difficulties
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 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 or changes in thinking
Rapid or irregular heartbeat
Excessive sweating

Low White Blood Cell Count: Increased Risk of Infection

Drugs like this one can cause a decrease in white blood cell count, which may increase the risk of infection. 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, which can be permanent. If you experience any of the following symptoms, contact your doctor right away:

Uncontrolled body movements
Tongue sticking out, puffing cheeks, mouth puckering, or chewing problems

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, some individuals may encounter the following:

Weight gain
Restlessness
Dizziness, drowsiness, tiredness, or weakness
Anxiety
Constipation, diarrhea, stomach pain, nausea, or vomiting
Heartburn
Dry mouth
Changes in appetite
Common cold symptoms
Headache
Sleep disturbances
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 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 identify potential interactions between this medication and other substances.
Any health problems you have, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is crucial to:

Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This precaution will help prevent potential interactions and adverse effects.

Important Information to Share with Your Healthcare Team

Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

Precautions to Take While Using This Medication

To minimize the risk of accidents, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to reduce the likelihood of dizziness or fainting. 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 or diabetes, high cholesterol, and weight gain have been associated with medications like this one, which may increase 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.

Substance Interactions and Precautions

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

Heat and Hydration Precautions

In hot weather or during physical activity, be mindful of your fluid intake to prevent dehydration. 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 fractures.

Special Considerations for Older Adults

Older adults with dementia who take medications like this one have a higher risk of experiencing strokes, 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, Fertility, and Breastfeeding

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 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.

• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, moxifloxacin, thioridazine)
• CNS depressants (e.g., opioids, benzodiazepines, alcohol) - increased sedation
• Dopamine agonists (e.g., levodopa, bromocriptine) - antagonism of effects
• Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) - increased risperidone levels
• Strong CYP3A4 inducers (e.g., carbamazepine, rifampin, phenytoin) - decreased risperidone levels
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) - increased risperidone levels

• Antihypertensives - increased risk of orthostatic hypotension
• Drugs causing electrolyte imbalance (e.g., diuretics) - increased risk of arrhythmias
• Drugs that cause hyperprolactinemia (e.g., metoclopramide)
• Valproate - increased risperidone levels (mechanism unclear)
• Cimetidine, ranitidine - minor increase in risperidone levels

• Lithium - no significant pharmacokinetic interaction, but monitor for additive CNS effects.

• Sedation/Drowsiness
• Dizziness/Lightheadedness (especially upon standing)
• Tremor
• Muscle stiffness/Rigidity
• Restlessness/Akathisia
• Involuntary movements (e.g., lip smacking, tongue protrusion, grimacing)
• Changes in vision
• Difficulty swallowing
• Fever, muscle rigidity, altered mental status (Neuroleptic Malignant Syndrome)
• Sore throat, fever, signs of infection (agranulocytosis - rare)
• Excessive thirst, frequent urination, increased hunger (hyperglycemia)
• Breast enlargement, galactorrhea, menstrual irregularities, sexual dysfunction (hyperprolactinemia)
• Seizures
• Priapism

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 milk. Weigh the benefits of breastfeeding against the potential risks to the infant. Monitor breastfed infants for sedation, poor feeding, and developmental milestones.

Safety and efficacy of Risperdal Consta have not been established in pediatric patients (<18 years of age). Oral risperidone is approved for schizophrenia and bipolar disorder in adolescents.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone is not approved for the treatment of patients with dementia-related psychosis. Elderly patients may be more susceptible to orthostatic hypotension and tardive dyskinesia. Consider lower starting doses and slower titration.

• Risperidone ER injection requires a 3-week oral risperidone (or other oral antipsychotic) overlap after the first injection to ensure therapeutic levels are reached.
• The injection must be administered deep intramuscularly into the deltoid or gluteal muscle, alternating sites.
• It is crucial to reconstitute the microsphere vial with the provided diluent immediately before injection and shake vigorously.
• Monitor for metabolic side effects (weight gain, dyslipidemia, hyperglycemia) and extrapyramidal symptoms (EPS) including tardive dyskinesia.
• Hyperprolactinemia is a common side effect; monitor for symptoms like galactorrhea, amenorrhea, gynecomastia, and sexual dysfunction.
• Orthostatic hypotension is a risk, especially during initial dosing and titration; advise patients to rise slowly.
• Patients should be screened for cardiac risk factors and QT prolongation, especially if co-prescribed with other QT-prolonging agents.
• This long-acting injectable formulation can improve medication adherence and reduce relapse rates compared to oral formulations.

• Other atypical antipsychotic long-acting injectables (e.g., Paliperidone Palmitate (Invega Sustenna, Invega Trinza), Aripiprazole Lauroxil (Aristada), Olanzapine Pamoate (Zyprexa Relprevv))
• Oral atypical antipsychotics (e.g., oral risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, lurasidone, cariprazine, brexpiprazole)
• 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 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 your pharmacist or healthcare provider. If you are unsure about the correct disposal method, consult your pharmacist, as they can provide guidance on available drug take-back programs in your area. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist. 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 call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.