INTRODUCTION
RISPERDAL CONSTA 50MG (PFS) contains Risperidone which belongs to the group of medicines called anti-psychotic agents. It is used as a maintenance therapy for schizophrenia among patients who currently receive oral antipsychotics. Schizophrenia is a serious mental disorder in which the person may interpret things abnormally such as seeing, hearing or feeling things that are not there, believe things that are not true or feel unusually suspicious or confused. Symptoms include delusion, hallucination, confusion, disorganized speech or thinking and bizarre behavior.
RISPERDAL CONSTA 50MG (PFS) can also be used as a monotherapy or as adjunctive therapy to other medicines (such as lithium or valproate) for the maintenance of Bipolar Disorder. Bipolar Disorder is a mental illness characterized by alternate episodes of mania (excitement or hyperactivity) and depression. It helps to alleviate the symptoms of various mood disorders by affecting the levels of chemical messengers such as dopamine and serotonin. Avoid consumption of alcohol while taking this medicine.
The most common side effects of taking this medicine are injection site itching, pain or swelling, parkinsonism, anxiety, sleep disorders, headache, dizziness and blurred vision. Contact your doctor if any of these symptoms bothers you. Before taking this medicine, inform your doctor if you have heart, liver, kidney or any other neurological disorders. RISPERDAL CONSTA 50MG (PFS) may cause weight gain, dangerously low numbers of a certain type of white blood cell needed to fight infection and worsening of diabetes. This medicine is strictly not recommended for use in children and adolescents under 18 years of age and in elderly patients with dementia. Consult your doctor for advice.
USES OF RISPERDAL CONSTA 50MG (PFS)
- Treats schizophrenia and Bipolar disorder
HOW RISPERDAL CONSTA 50MG (PFS) WORKS
Risperidone is an anti-psychotic agent which helps to alleviate the symptoms of various mood disorders by affecting the levels of chemical messengers such as dopamine and serotonin. It also stops your symptoms from coming back. It works by inhibiting the activity of dopaminergic D2 and serotonergic 5-HT2A receptors, which leads to decrease in dopaminergic and serotonergic neurotransmission, and therefore decreasing positive symptoms of schizophrenia (such as delusions and hallucinations and improves your mood, thoughts or behavior.
DIRECTIONS FOR USE
RISPERDAL CONSTA 50MG (PFS) will be given to you only by a doctor or a nurse into the muscle (intramuscularly) either in the arm or buttock every 2 weeks. It can be alternated between the right and left sides but, should not be given intravenously. Your doctor will decide the correct dose and duration for you depending upon your age, weight and health condition. It is prescribed to you only after receiving first three weeks of oral therapy. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.
SIDE EFFECTS OF RISPERDAL CONSTA 50MG (PFS)
SERIOUS
- signs of stroke (such as dementia, sudden change in mental state, sudden weakness or numbness of your face, arms or legs, especially on one side and slurred speech)
- tardive dyskinesia (jerking movements with inability to control the movements of your face, tongue or other parts of your body)
- signs of blood clot (swelling, pain, and redness in the leg, chest pain and difficulty in breathing)
- severe allergic reaction (such as skin rash, itching, fever, swollen mouth, face, lip or tongue, shortness of breath or low blood pressure)
- Neuroleptic Malignant Syndrome (fever, muscle stiffness, sweating or low level of consciousness)
- priapism (prolonged or painful erection)
COMMON
- injection site reaction (such as itching, pain or swelling)
- common cold symptoms
- difficulty in sleeping, depression and anxiety
- symptoms of Parkinsonism (such as dyskinesia (slow or impaired movement), sensation of stiffness or tightness of the muscles, tremor or drooling)
- headache, dizziness, abnormal heart rate, low or high blood pressure, shortness of breath
- infection of respiratory tract (such as pneumonia, bronchitis, sinus infection)
- urinary tract infection, anemia
- symptoms of hyperprolactinemia (such as swelling of breast in men, erectile dysfunction, decreased sexual desire, breast discomfort and leakage of milk in females or missed menstrual periods)
- weight gain or loss, increased or decreased appetite
- dystonia (slow involuntary contraction of muscles of the body, abnormal movements of the eyes, mouth, tongue or jaw)
- blurred vision
- nausea or vomiting, diarrhea, constipation, stomach pain
- dry mouth, toothache
- skin rash or redness
- back pain, joint pain and muscle pain
- urinary incontinence
- swelling of the body, arms or legs, chest pain, fatigue and pain
RARE
- problems in blood vessels of the brain
- coma (due to uncontrolled diabetes)
- shaking of the head
- glaucoma, problems with eye movement
- thrombocytopenia (dangerously low levels of certain type of white blood cells)
- excessive intake of water
- walking in sleep
- sleep-related eating disorder
- low blood sugar
- catatonia (not moving or responding while awake)
- lack of emotion
- low level of consciousness
- lung congestion, crackly lung sounds, voice disorder breathing passage disorder
- inflammation of pancreas, a blockage in GI tract
- hard stools
- rhabdomyolysis (muscle pain)
- skin hardening, dandruff, skin lesion, hives
- blindness
- decreased body temperature,
- jaundice (yellowing of skin and eyes)
- swollen tongue
- chapped lips
HOW TO MANAGE SIDE EFFECTS
Nausea or vomiting:
Try taking this medicine with, or just after meals. Stick to simple meals. Do not eat rich or spicy food.
Constipation:
Eat fibre rich foods like fresh fruit, vegetables and cereals. Drink plenty of water. Exercise more regularly.
Diarrhea:
Drink lots of fluids, such as water or juice, to avoid dehydration. Do not take any medicines without speaking to a doctor.
Stomach pain:
Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid traveling, driving or operating any tools or machines while you are feeling dizzy. If the symptom still persists, contact your doctor for advice.
WARNING & PRECAUTIONS
PREGNANCY
RISPERDAL CONSTA 50MG (PFS) should be used with caution in pregnant women. Consult your doctor before taking this medicine.
BREASTFEEDING
RISPERDAL CONSTA 50MG (PFS) should be used with caution in breastfeeding women. Consult your doctor before taking this medicine.
DRIVING AND USING MACHINES
Do not drive or operate any machines, because this medicine may cause dizziness, tiredness and vision problems.
ALCOHOL
Avoid consumption of alcohol while taking this medicine.
KIDNEY
RISPERDAL CONSTA 50MG (PFS) should be taken with caution in patients with kidney disease. Consult your doctor for advice.
LIVER
RISPERDAL CONSTA 50MG (PFS) should be taken with caution in patients with liver disease. Consult your doctor for advice.
ALLERGY
Do not take this medicine if you are allergic to risperidone or any other ingredients in this medicine.
HEART DISEASE
RISPERDAL CONSTA 50MG (PFS) should be taken with caution in patients with heart problems such as irregular heartbeat, high or low blood pressure or other cardiovascular problems. Consult your doctor for advice.
OTHERS
Before taking RISPERDAL CONSTA 50MG (PFS), inform your doctor if you have following conditions:
- are at risk of having a stroke (such as circulation disorders of the brain)
- ever experienced involuntary movements of face, mouth and tongue
- Neuroleptic Malignant Syndrome (fever, muscle stiffness, sweating or low level of consciousness)
- Parkinson’s disease or dementia
- low levels of white blood cells in the past
- diabetes
- epilepsy
- prolonged or painful erection
- problems in controlling your body temperature
- hyperprolactinemia (abnormally high levels of prolactin blood)
- tumor dependent on prolactin levels
- family history of blood clots
- are going to have an eye operation
INTERACTIONS
Talk to your doctor, if you are taking,
- medicines that induce calmness and sedation (such as benzodiazepines (e.g. diazepam, clonazepam), opiates (e.g. morphine) and antihistamines (e.g. diphenhydramine))
- medicines used to treat heart problems (e.g., quinidine, propranolol, atenolol, verapamil, captopril, enalapril, diuretics (e.g., furosemide or chlorothiazide))
- medicines that decrease blood potassium levels (e.g. aldosterone, spironolactone)
- medicines used to treat epilepsy (e.g., phenytoin, carbamazepine or phenobarbital)
- medicines used to treat depression and other psychiatric disorders (e.g., paroxetine, fluoxetine, amitriptyline, sertraline and fluvoxamine)
- CNS stimulants (used to increase CNS activity) e.g., methylphenidate
- rifampicin (used to treat tuberculosis)
- Phenothiazines (used to treat psychosis) e.g., chlorpromazine
- cimetidine or ranitidine (used to reduce stomach acid)
- itraconazole and ketoconazole (used to treat fungal infections)
- ritonavir (used to treat HIV infection)
- levodopa (used to treat Parkinson’s disease)
SYNOPSIS
| Drug | : | Risperidone |
| Pharmacological Category | : | Antipsychotic agent |
| Therapeutic Indication | : | Schizophrenia |
| Dosage Forms | : | Tablet, Injection, Syrup |
MORE INFORMATION
Store the entire package in the refrigerator (2-8°C). If refrigeration is not available, it can be stored below 25°C for a maximum of 7 days. Use within 6 hours of reconstitution (if stored at or below 25°C). Keep out of reach of children.
FAQs ABOUT RISPERDAL CONSTA 50MG (PFS)
Can RISPERDAL CONSTA 50MG (PFS) cause depression?
Yes. It may cause depression in some patients. Contact your doctor if this symptom bothers you.
Can RISPERDAL CONSTA 50MG (PFS) cause fall?
Yes. It may cause fall (suddenly falling down on the floor) in some patients. Contact your doctor if this symptom bothers you.
Can RISPERDAL CONSTA 50MG (PFS) cause high blood pressure?
Yes. This medicine may cause high blood pressure in some patients. Contact your doctor if this symptom bothers you.
Is RISPERDAL CONSTA 50MG (PFS) habit-forming?
No. It is not habit-forming in nature. However, do not stop taking this medicine abruptly. Your doctor or healthcare provider will slowly reduce the dose and duration before stopping this medicine.
REFERENCES
1. KD. Tripathi. Drugs Used in Mental Illness: Antipsychotic and Antimanic Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 441-447.
2. Jonathan M. Meyer. Pharmacotherapy of psychosis and mania. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 417-428.
3. Gerald G. Briggs and Roger K. Freeman. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 3417-3423.
4. Janssen Pharmaceutica N.V., Belgium. Long-acting Injectable Risperidone in Patients with Schizophrenia After an Acute Episode. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on July 2013] [Accessed 16th December 2020] https://www.clinicaltrials.gov/ct2/show/NCT00216671
5. Pierre Chue. Long-acting risperidone injection: efficacy, safety, and cost-effectiveness of the first long-acting atypical antipsychotic. NCBI; PMC US National Library of Medicine, National Institute of Health. February 2007. [Accessed 16th December 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2654523/
6. Janssen Pharmaceuticals, Inc. Janssen labels. [Revised on September 2020] [Accessed 16th December 2020] http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RISPERDAL+CONSTA-pi.pdf
7. Janssen Pharmaceutica NV or McGregor Cory Ltd. Electronic Medicines Compendium (EMC); [Revised on October 2018] [Accessed 16th December 2020] https://www.medicines.org.uk/emc/files/pil.1690.pdf
8. Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Revised on August 2010] [Accessed 16th December 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf
PRODUCT DETAILS
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