INTRODUCTION
RISPERDAL CONSTA 50MG INJECTION(PFS) contains Risperidone which belongs to a group of medicines called Anti-psychotics. It is used in the maintenance of treatment of schizophrenia. It is used for the patients who are undergoing treatment with the oral (tablets or syrups) form of RISPERDAL CONSTA 50MG INJECTION(PFS).
Schizophrenia is a psychiatric disorder characterized by symptoms like seeing, hearing or feeling things that are not there, disorganized thinking and speech, abnormal movements and negative symptoms (social isolation, lack of emotion, etc).
While treating you with RISPERDAL CONSTA 50MG INJECTION(PFS), your doctor might want you to take certain diagnostic tests such as blood sugar level, prolactin levels, or keeping a check on your body weight.
Avoid consumption of alcohol while receiving RISPERDAL CONSTA 50MG INJECTION(PFS). Before receiving RISPERDAL CONSTA 50MG INJECTION(PFS), inform your doctor if you have liver, kidney or heart problems, or about to have any eye surgery, diabetes, Parkinson’s disease, epilepsy, painful or prolonged erection.
RISPERDAL CONSTA 50MG INJECTION(PFS) is not recommended in pregnant women and should be used with caution in breastfeeding women. RISPERDAL CONSTA 50MG INJECTION(PFS) is not recommended for use in elderly patients having dementia and should be used with caution in other elder patients, therefore consult your doctor before receiving. RISPERDAL CONSTA 50MG INJECTION(PFS) is not recommended for children and adolescents under 18 years age.
The most common side effects of receiving RISPERDAL CONSTA 50MG INJECTION(PFS) are sleep problems, irritability, depression, weight gain, dizziness, tremor, and headache. Contact your doctor if any of the symptoms worsen or doesn’t improve while receiving RISPERDAL CONSTA 50MG INJECTION(PFS).
USES OF RISPERDAL CONSTA 50MG INJECTION(PFS)
- it is used in the maintenance of treatment of schizophrenia
HOW RISPERDAL CONSTA 50MG INJECTION(PFS) WORKS
RISPERDAL CONSTA 50MG INJECTION(PFS) shows antipsychotic activity by blocking certain receptors (D2 and 5-HT2) in the brain, thus decreasing symptoms of schizophrenia.
DIRECTIONS FOR USE
RISPERDAL CONSTA 50MG INJECTION(PFS) must be given by a doctor or nurse into the muscle (intramuscularly) of either your arm or buttocks. Your doctor will decide the correct dose and duration of RISPERDAL CONSTA 50MG INJECTION(PFS) for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF RISPERDAL CONSTA 50MG INJECTION(PFS)
COMMON
- difficulty falling or staying asleep, feeling sleepy, impaired alertness
- anxiety, depression
- parkinsonism (slow or impaired movement, sensation of stiffness or tightness of the muscles, sensation of freezing up and then restarting, slow shuffling walk, increased saliva or drooling, a loss of expression on the face, a tremor while at rest)
- headache
- dizziness
- tremor
- raised levels of a hormone called "prolactin" (symptoms in men include breast swelling, difficulty in getting or maintaining erections, decreased sexual desire or other sexual dysfunction. In women they may include leakage of milk from the breasts, breast discomfort, missed menstrual periods, or other problems with your cycle or fertility problems)
- pneumonia (infection of the lungs), common cold and flu symptoms, sinus infection
- urinary tract infection
- anaemia
- high blood sugar
- weight gain, raised appetite, weight loss, decreased appetite
- irritability, depression, anxiety (worry, uneasiness), restlessness, sleep disturbances
- dystonia (slow or sustained involuntary contraction of facial and other muscles including abnormal movements of the eyes, mouth, tongue or jaw)
- dyskinesia (involuntary muscle movements like repetitive, spasm-like movements, or twitching), tremor (shaking)
- blurred vision
- fast heart rate, raised / reduced blood pressure, chest pain
- shortness of breath, throat pain, cough, nose bleeds, stuffy nose
- stomach pain and discomfort, vomiting, nausea, constipation, diarrhoea, indigestion, dry mouth
- toothache
- rash, skin redness
- muscle spasms, or bone, muscle, back and joint pain
- incontinence (lack of control) of urine
- swelling of the body, arms or legs
- chest pain, weakness, fatigue (tiredness), pain
- fall
- injection site reaction, including itching, pain or swelling
UNCOMMON
- infection of the eye, tonsils, nails, skin, an infection confined to a single area of skin or part of the body, viral infection, skin inflammation due to mites
- diabetes (high blood sugar), too much drinking of water
- increased blood cholesterol
- mania (excited mood), confusion, reduced sexual drive, nervousness, nightmares
- unresponsive to stimuli, loss or low level of consciousness
- a restless urge to move parts of your body, balance disorder, abnormal coordination, dizziness upon standing, disturbance in attention, speech problems, loss or abnormal sense of taste, reduced sensation of skin to pain and touch, a tingling, pricking sensation or numbness of skin
- increased sensitivity of the eyes to light, dry and red eyes, increased tears
- vertigo (spinning sensation), ringing in the ears, ear pain
- palpitations (fluttering or pounding feeling in your chest)
- low blood pressure (especially while standing up), flushing
- stomach or intestinal infection, lack of voluntary control over defecation, very hard stool, difficulty swallowing, excessive passing of gas or wind
- itching, hair loss, thickening of skin, eczema (an inflammatory skin condition), dry and discolored skin, acne, flaky, itchy scalp, skin disorder, skin lesion
- abnormal posture, joint stiffness and swelling, weak muscles, neck pain
- frequent urination, inability to pass urine, pain when passing urine
- erectile dysfunction, ejaculation disorder
- loss of, or missed menstrual periods, or other problems with your cycle (females)
- development of breasts in men
- leakage of milk from the breasts, sexual dysfunction, breast pain and discomfort, vaginal discharge
- swelling of the face, eyes, lips or mouth
- chills, increase in body temperature
- change in the way you walk
- convulsions
- feeling unwell, chest discomfort
- pain related to diagnostic or treatment procedures
RARE
- infection
- sleep walking, sleep-related eating disorder
- inappropriate secretion of antidiuretic hormone (hormone controlling urine)
- sugar in the urine, raised blood triglycerides (type of fat)
- low blood sugar
- absence of emotion, inability to reach orgasm
- catatonia (unable to move or respond while awake)
- blood vessel problems in the brain
- coma due to uncontrolled diabetes
- shaking of the head
- glaucoma (increased pressure within the eyeball), eye rolling, problems with movement of your eyes, eyelid margin crusting
- eye problems during cataract surgery
- dangerously excessive intake of water
- chapped lips, swollen tongue, skin rash related to drug
- dandruff
- pain in muscles and breakdown of muscle fibres (rhabdomyolysis)
- irregular heartbeat
- trouble breathing during sleep, fast, shallow breathing
- inflammation of the pancreas
- raised blood insulin levels (a hormone that controls blood sugar levels)
- low body temperature, coldness in arms and legs
- symptoms of drug withdrawal
- jaundice (skin and the eyes appears yellowish)
Stop receiving RISPERDAL CONSTA 50MG INJECTION(PFS) and consult your doctor immediately if you experience any of the following side effects:
- have dementia and feel a sudden change in your mental state or sudden numbness or weakness involving your face, arms or legs, especially on one side, or slurred speech (even for a short period of time)
- experience tardive dyskinesia (uncontrollable twitching or jerking movements in your face, tongue, or other parts of your body)
- experience blood clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness), which can travel through blood vessels to the lungs leading to chest pain and breathlessness
- experience severe allergic reaction indicated by fever, swelling of mouth, face, lip or tongue, breathlessness, itching, skin rash or low blood pressure
- glaucoma (increased pressure within the eyeball)
- rhabdomyolysis (breakdown of muscle fibres making the muscles weak and sores)
- extremely low numbers of the white blood cells needed to fight infection in your blood
- high temperature, muscle stiffness, sweating or a lowered level of consciousness (Neuroleptic Malignant Syndrome)
- if you are a man and experience prolonged or painful erection (priapism)
HOW TO MANAGE SIDE EFFECTS
Diarrhea:
Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor. Ask for your doctor’s advice if diarrhea doesn’t improve.
Nausea:
Stick to simple meals and avoid eating rich or spicy food while receiving RISPERDAL CONSTA 50MG INJECTION(PFS). Do not take any medication on your own. Ask for your doctor’s advice if nausea doesn’t improve.
Headache:
Try to take rest and don’t involve yourself in exertive activities. Rest in a quiet and dark room. Apply a pain-relieving balm on your forehead. Ask for your doctor’s advice if headache doesn’t improve
Vomiting:
Drink clear or ice-cold drinks. Eat light, bland foods and avoid fried, oily, or sweet foods while receiving RISPERDAL CONSTA 50MG INJECTION(PFS). Avoid carbonated drinks. Ask for your doctor’s advice if vomiting doesn’t improve.
Dizziness:
Lie, or sit down immediately when you feel dizzy. If you're feeling severe episode of spinning(vertigo), lie in a dark and quite place with eyes closed. Try to avoid vehicle driving. Discuss with your doctor if the symptom worsens.
Stomach pain:
Try to rest and relax. Try to have smaller and frequent meals. Keep a heat pad on your stomach. Take your physicians advice.
Constipation:
Eat plenty of fiber rich foods such as vegetables, fresh fruits, and cereals and drink plenty of water while receiving RISPERDAL CONSTA 50MG INJECTION(PFS). Exercise more regularly. Ask for your doctor’s advice if constipation doesn’t improve
Muscle pain:
Give your body a rest. Do not overexert or over stretch yourself. Do stress relieving activities such as yoga or meditation. If the symptom doesn’t improve, ask for your doctor’s advice.
WARNING & PRECAUTIONS
PREGNANCY
RISPERDAL CONSTA 50MG INJECTION(PFS) should be used with caution in pregnant women unless considered clearly necessary by the doctor. If RISPERDAL CONSTA 50MG INJECTION(PFS) is given in the last trimester of pregnancy it can cause agitation, hypertonia, hypotonia, tremor, sleepiness, respiratory distress, or feeding disorder in the newborn babies. Consult your doctor before receiving RISPERDAL CONSTA 50MG INJECTION(PFS).
BREASTFEEDING
RISPERDAL CONSTA 50MG INJECTION(PFS) should be used with caution in breast-feeding women. Consult your doctor before receiving RISPERDAL CONSTA 50MG INJECTION(PFS).
DRIVING AND USING MACHINES
Do not drive or use any tools and machines if you feel dizziness, tiredness, and vision problems after receiving RISPERDAL CONSTA 50MG INJECTION(PFS).
ALCOHOL
Avoid consumption of alcohol while receiving RISPERDAL CONSTA 50MG INJECTION(PFS).
KIDNEY
RISPERDAL CONSTA 50MG INJECTION(PFS) should be used with caution in patients with severe kidney disease. Consult your doctor before receiving it.
LIVER
RISPERDAL CONSTA 50MG INJECTION(PFS) should be used with caution in patients with severe liver disease. Consult your doctor before receiving it.
ALLERGY
Do not receive RISPERDAL CONSTA 50MG INJECTION(PFS) if you are allergic to Risperidone or any other ingredients of this medicine.
HEART DISEASE
RISPERDAL CONSTA 50MG INJECTION(PFS) should be used with caution if you have heart problems including an irregular heart rhythm, or if you are prone to low blood pressure. Consult your doctor before receiving RISPERDAL CONSTA 50MG INJECTION(PFS).
OTHERS
Before receiving RISPERDAL CONSTA 50MG INJECTION(PFS), inform your doctor if you:
- know any factors that would cause stroke like high blood pressure or blood vessel issues in the brain
- have ever had involuntary movements of the tongue, mouth and face
- have ever had a condition having symptoms like high temperature, muscle stiffness, sweating or a lowered level of consciousness (also known as Neuroleptic Malignant Syndrome)
- have Parkinson’s disease (shaking, stiffness, and difficulty with walking, balance, and coordination) or dementia (memory loss)
- are diabetic (having low blood sugar levels)
- have epilepsy (fits)
- are a man and you have ever experienced a prolonged or painful erection
- find it difficult controlling your body temperature or overheating
- have a tumour
- or any member of your family has a history of blood clots
- are about to have any eye operation
Use in paediatrics:
RISPERDAL CONSTA 50MG INJECTION(PFS) is not recommended for children and adolescents under 18 years of age. Consult with your child’s doctor before giving RISPERDAL CONSTA 50MG INJECTION(PFS) to your child.
Use in geriatrics:
RISPERDAL CONSTA 50MG INJECTION(PFS) is not recommended in elderly who have dementia induced by stroke and should be used with caution in other elderly patients. Consult your doctor before receiving RISPERDAL CONSTA 50MG INJECTION(PFS).
INTERACTIONS
A. Drug - Drug interactions:
Before receiving RISPERDAL CONSTA 50MG INJECTION(PFS), inform your doctor if you are taking any of the following medicine:
- benzodiazepines (used to calm you down) Ex. diazepam, lorazepam
- opiates (used to reduce pain) Ex. morphine, codeine
- antihistamines (used in allergies) Ex. brompheniramine, chlorpheniramine
- medicines used for heart conditions (to treat irregular heart rhythms, high blood pressure) Ex. quinidine, furosemide, chlorthiazide, verapamil
- antidepressants (used to treat depression) Ex. fluoxetine, paroxetine
- medicines that cause a slow heartbeat (Ex. Diltiazem, atenolol)
- anti-parkinsonian drugs (used to treat parkinsonism) Ex. Levodopa
- psychostimulants (used to treat attention deficit hyperactivity disorder (ADHD)) Ex. Methylphenidate
- rifampicin (used to treat infections)
- anti-epileptics (used to treat fits) Ex. carbamazepine, phenytoin, phenobarbital
- phenothiazines (used to treat psychosis or to calm down) Ex. Chlorpromazine, fluphenazine
- H2 blockers (used to treat peptic ulcers) Ex. cimetidine, ranitidine
- anti-fungals (used to treat fungal infections) Ex. itraconazole, ketoconazole
- anti-retrovirals (used to treat HIV/AIDS) Ex. ritonavir
- sertraline, fluvoxamine (used to treat depression and other psychiatric disorders)
Overdosage:
RISPERDAL CONSTA 50MG INJECTION(PFS) will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms while receiving RISPERDAL CONSTA 50MG INJECTION(PFS) like feeling sleepy or tired, or having abnormal body movements, problems standing and walking, feeling dizzy due to low blood pressure, or having abnormal heartbeats. Consult your doctor immediately.
SYNOPSIS
| Drug | : | Risperidone |
| Pharmacological Category | : | Atypical Antipsychotics |
| Therapeutic Indication | : | Schizophrenia |
| Dosage Forms | : | Tablet, Orally disintegrating tablets, Injection, Oral solution, Syrup |
MORE INFORMATION
- Keep RISPERDAL CONSTA 50MG INJECTION(PFS) out of reach of children
- Store RISPERDAL CONSTA 50MG INJECTION(PFS) at a temperature between 2-8°C
FAQs ABOUT RISPERDAL CONSTA 50MG INJECTION(PFS)
Can RISPERDAL CONSTA 50MG INJECTION(PFS) cause seizures?
Yes. Seizures are one of the serious side effects of RISPERDAL CONSTA 50MG INJECTION(PFS). Immediately consult your doctor if you feel any symptoms such as uncontrollable jerking movements of hands and legs, loss of consciousness, fear, anxiety or temporary confusion after taking RISPERDAL CONSTA 50MG INJECTION(PFS).
Can RISPERDAL CONSTA 50MG INJECTION(PFS) cause weight gain?
Yes. Weight gain is one of the common side effects of RISPERDAL CONSTA 50MG INJECTION(PFS). Consult your doctor if you feel like you are gaining weight or there is an increase in your appetite after taking RISPERDAL CONSTA 50MG INJECTION(PFS).
What precautions do I need to follow while receiving RISPERDAL CONSTA 50MG INJECTION(PFS)?
Patients receiving RISPERDAL CONSTA 50MG INJECTION(PFS) must inform their doctor about their pre-existing disease conditions like kidney, heart, or liver problems. Patients should also inform if they are pregnant, breast-feeding, or having any allergies. Avoid alcohol consumption. Consult your doctor immediately if you experience any unusual symptoms after receiving RISPERDAL CONSTA 50MG INJECTION(PFS).
Can RISPERDAL CONSTA 50MG INJECTION(PFS) be used on infants?
No. RISPERDAL CONSTA 50MG INJECTION(PFS) is not recommended for children and adolescents below 18 years of age. Ask for the advice of your child’s doctor to select a suitable alternative therapy for your child.
Can RISPERDAL CONSTA 50MG INJECTION(PFS) cause stroke?
Yes. It’s a serious side effect of RISPERDAL CONSTA 50MG INJECTION(PFS) that requires immediate hospitalization. A caution about increased risk of stroke in the elderly who are taking RISPERDAL CONSTA 50MG INJECTION(PFS) has been issued. Consult your doctor if you have dementia and experience a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, particularly on one side, or slurred speech, even for a small period of time.
How is RISPERDAL CONSTA 50MG INJECTION(PFS) administered?
RISPERDAL CONSTA 50MG INJECTION(PFS) must be given by a doctor or nurse into the muscle (intramuscularly) of either your arm or buttocks. Do not self-administer RISPERDAL CONSTA 50MG INJECTION(PFS). Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Can I have alcohol while receiving RISPERDAL CONSTA 50MG INJECTION(PFS)?
No. Alcohol is not recommended while receiving RISPERDAL CONSTA 50MG INJECTION(PFS) as it may cause unwanted side effects. Ask your doctor before receiving RISPERDAL CONSTA 50MG INJECTION(PFS) if you have a habit of consuming alcohol.
Will RISPERDAL CONSTA 50MG INJECTION(PFS) cause any reaction at the site of injection?
RISPERDAL CONSTA 50MG INJECTION(PFS) may cause rash, swelling, pain or itching at the site of injection. You can apply cold compress for relief. Consult your doctor before using any other product other than RISPERDAL CONSTA 50MG INJECTION(PFS), for the reaction.
REFERENCES
1. KD. Tripathi. Drugs Used in Mental Illness: Antipsychotic and Antimaniac Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 441, 446.
2. Michael K Rainer. Risperidone long-acting injection: a review of its long term safety and efficacy. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. October 2008. [Accessed on 11th April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2626917/
3. Arjun Saxena, Jeffery Grace, Josie L. Olympia, Eileen Trigoboff, Thomas Watson, Sharon Cushman, David Newcomer. Risperidone long-acting injections: successful alternative deltoid muscle injections for refractory schizophrenia. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. September 2008. [Accessed on 11th April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2687087/
4. Janssen Pharmaceutica NV. Electronic Medicines Compendium (EMC). [Revised in October 2018] [Accessed on 11th April 2022] https://www.medicines.org.uk/emc/files/pil.1690.pdf
5. Risperidal Consta. Risperidone. [Revised in February 2021] [Accessed on 11th April 2022] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RISPERDAL+CONSTA-pi.pdf
6. Risperidone- Pharmacodynamics. Drugbank. [Accessed on 11th April 2022] https://go.drugbank.com/drugs/DB00734
USEFUL DIAGNOSTIC TESTS
- Blood sugar level
- Prolactin levels
- EEG
PRODUCT DETAILS
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