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Introduction About PALIP XR
PALIP XR contains Paliperidone which belongs to the group of medicines called Antipsychotics. It is used to manage schizophrenia in adults and adolescents aged 15 years and older. PALIP XR is also used to manage schizoaffective disorder (combination of schizophrenia and mood disorder symptoms) in adults.
Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech and behaviour and emotional flatness.
PALIP XR should be used with caution in patients with liver, kidney and heart disease, Parkinson’s disease or dementia, diabetes, fits. Consult your doctor before taking it.
PALIP XR is not recommended for use in pregnant and breastfeeding women, in children and adolescents under 15 years for the management of schizophrenia. PALIP XR is also not recommended for use in children and adolescents under 18 years of age for the management of schizoaffective disorder. Consult your doctor before taking PALIP XR.
The most common side effects of taking PALIP XR are difficulty falling or staying asleep, restlessness, feeling sleepy or less alert, headache. Contact your physician if any of the symptoms worsen.
Uses Of PALIP XR
To Manage:
- schizophrenia in adults and adolescents (above 15 years)
- schizoaffective disorder in adults (above 18 years)
How PALIP XR Works
PALIP XR acts in the brain by blocking the receptors for the chemicals called dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia. By blocking these receptors, PALIP XR helps to normalize the activity of the brain and reduce symptoms and stop your symptoms from coming back.
How to use PALIP XR
Take PALIP XR as advised by your physician. Swallow the medicine with water. Do not crush or chew the medicine. It can be taken with or without food.
Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking PALIP XR unless told to do so by your doctor. Otherwise, your symptoms may return.
Side Effects Of PALIP XR
Common
- difficulty falling or staying asleep
- parkinsonism (slow or impaired movement, sensation of stiffness or tightness of the muscles (jerky movements) and sometimes even a sensation of movement "freezing up" and then restarting
- restlessness
- feeling sleepy or less alert
- headache
- infection of the chest (bronchitis), common cold symptoms, sinus infection, urinary tract infection, flu-like symptoms
- weight gain or loss, change in appetite
- elated mood (mania), irritability, depression, anxiety
- dystonia (slow or sustained involuntary contraction of muscles, often involves muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw)
- dizziness
- blurry vision
- dyskinesia (involuntary muscle movements and can include repetitive, spastic or writhing movements or twitching)
- tremor (shaking)
- slow heart rate, rapid heart rate
- low blood pressure upon standing (feel faint, dizzy or may pass out when they stand up or sit up suddenly), high blood pressure
- sore throat, cough, stuffy nose
- abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
- itching, rash
- bone or muscle ache, back pain, joint pain
- loss of menstrual periods
- fever, weakness, fatigue (tiredness)
Uncommon
- pneumonia, infection of the breathing passages, bladder infection, ear infection, tonsillitis
- raise in level of a hormone called prolactin (in men- breast swelling, difficulty in getting or maintaining erections or other sexual dysfunction may occur), (in women breast discomfort, leakage of milk from the breasts, missed menstrual periods or other problems with your cycle)
- diabetes or worsening diabetes, increased waist size, loss of appetite resulting in malnutrition and low body weight
- sleep disorder, confusion, decreased sexual drive, inability to reach orgasm, nervousness, nightmares
- convulsion (fits), fainting, a restless urge to move parts of your body, dizziness upon standing, disturbance in attention, problems with speech, loss or abnormal sense of taste, reduced sensation of skin to pain and touch, a sensation of tingling, pricking or numbness of skin
- oversensitivity of the eyes to light, eye infection (pink eye), dry eye
- a sensation of spinning (vertigo), ringing in the ears, ear pain
- irregular heartbeat, a fluttering or pounding feeling in your chest (palpitations)
- low blood pressure
- shortness of breath, wheezing, nosebleeds
- swollen tongue, stomach or intestinal infection, difficulty swallowing, excessive passing of gas or wind
- hives, hair loss, eczema, acne
- muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
- incontinence (lack of control) of urine, frequent passing of urine, inability to pass urine, pain when passing urine
- erectile dysfunction, ejaculation disorder
- missed menstrual periods, leakage of milk from the breasts, sexual dysfunction, breast pain, breast discomfort
- swelling of the face, mouth, eyes or lips, swelling of the body, arms or legs
- chills, an increase in body temperature
- a change in the way you walk
- feeling thirsty
- chest pain, chest discomfort, feeling unwell
- fall
Rare
- eye infection, fungal infection of the nails, infection of the skin, skin inflammation caused by mites
- life threatening complications of uncontrolled diabetes
- dangerously excessive intake of water, low blood sugar, excessive drinking of water, increased cholesterol in your blood
- sleep walking
- not moving or responding while awake (catatonia)
- lack of emotion
- loss of consciousness, balance disorder, abnormal coordination
- blood vessel problems in the brain, coma due to uncontrolled diabetes, unresponsive to stimuli, low level of consciousness, shaking of the head
- glaucoma (increased pressure within the eyeball), increased tears, redness of the eyes, problems with movement of your eyes, eye rolling
- atrial fibrillation (an abnormal heart rhythm), rapid heartbeat upon standing
- decreased oxygen in parts of your body (because of decreased blood flow), flushing
- trouble breathing during sleep (sleep apnea), fast, shallow breathing
- pneumonia caused by inhaling food, congestion of breathing passages, voice disorder
- blockage in the bowels, stool incontinence, very hard stool, lack of bowel muscle movement that causes blockage
- yellowing of the skin and the eyes (jaundice)
- inflammation of the pancreas
- thickening of the skin, dry skin, skin redness, skin discolouration, flaky itchy scalp or skin, dandruff
- breakdown of muscle fibers and pain in muscles (rhabdomyolysis), abnormal posture
- development of breasts in men, enlargement of the glands in your breasts, discharge from the breasts, vaginal discharge
- a delay in menstrual periods, breast enlargement
- very low body temperature, a decrease in body temperature
Stop taking PALIP XR and contact your doctor immediately if you experience any of the following side effects:
- symptoms of blood clots in the veins, especially in the legs such as swelling, pain and redness in the leg, which may travel through blood vessels to the lungs causing chest pain and difficulty breathing
- dementia and a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side or slurred speech, even for a short period of time. These may be signs of a stroke
- fever, muscle stiffness, sweating or a lowered level of consciousness (a disorder called Neuroleptic Malignant Syndrome)
- prolonged or painful erection (priapism)
- tardive dyskinesia (involuntary rhythmic movements of the tongue, mouth and face)
- symptoms of a severe allergic reaction characterized by fever, swollen mouth, face, lip or tongue, throat, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an anaphylactic reaction)
How To Manage Side Effects
Headache:
Rest and relax. Drink plenty of fluids such as water or ORS (Oral Rehydrating Solution) and apply a pain-relieving balm on the head if necessary. Contact your doctor if the headache did not improve.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operate any machines while you are feeling dizzy. Do not drink alcohol, as it can aggravate your dizziness. Contact your doctor if your dizziness did not improve.
Itchy skin:
Avoid hot bath because hot water can irritate your skin further. Do not scratch the affected area. Use sunscreen and wear protective clothing while going outside. Use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if the itching worsens.
Nausea, vomiting:
Take PALIP XR, with or just after a meal. Stick to simple meals. Avoid eating oily or spicy food. Contact your doctor if nausea and vomiting did not improve.
Stomach pain:
Try to rest and relax. Eat small meals but take frequently. Keep a heat pad on your stomach. Contact your doctor if the stomach pain worsens.
Diarrhoea:
Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Do not take any medicine on your own for managing diarrhoea. Contact your doctor if your diarrhoea did not improve.
Constipation:
Eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals and drink plenty of water. Exercise more regularly. Contact your doctor if constipation persist.
Warning & Precautions
Pregnancy
PALIP XR is not recommended for use in pregnant women. If PALIP XR is used in last trimester (last three months of pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding can occur in newborn baby. Consult your doctor before taking PALIP XR.
Breastfeeding
PALIP XR is not recommended for use in breastfeeding women. Consult your doctor before taking PALIP XR.
Driving and Using Machines
Do not drive or use machines while taking PALIP XR as dizziness and vision problems may occur.
Alcohol
Avoid consumption of alcohol while taking PALIP XR.
Kidney
PALIP XR should be used with caution in patients with kidney disease and may need dose adjustment. Consult your doctor before taking PALIP XR.
Liver
PALIP XR should be used with caution in patients with liver disease. Consult your doctor before taking PALIP XR.
Allergy
Do not take PALIP XR if you are allergic to Paliperidone or any of the other ingredients of this medicine.
Heart Disease
PALIP XR should be used with caution in patients with heart disease. Consult your doctor before taking PALIP XR.
Others
Before taking PALIP XR, inform your doctor if you:
- have Parkinson’s disease or dementia
- have a condition with high temperature and muscle stiffness (Neuroleptic Malignant Syndrome)
- have abnormal movements of the tongue or face (Tardive Dyskinesia)
- have had low levels of white blood cells in the past
- are diabetic or prone to diabetes
- have epilepsy
- have a swallowing, stomach or intestinal disorder that reduces ability to swallow or pass foods by normal bowel movements
- have diseases associated with diarrhea
- have prolonged or painful erection
- have overheating or difficulty controlling body temperature
- have an abnormally high level of the hormone prolactin in blood or possible prolactin-dependent tumor
- or a family history of blood clots
- are planning to have an eye operation
- have intolerance to lactose or other sugars
Use in pediatrics:
PALIP XR is not recommended for use in children and adolescents under 15 years for the management of schizophrenia.
PALIP XR is also not recommended for use in children and adolescents who are under 18 years for the management of schizoaffective disorder. Consult your doctor before taking PALIP XR.
Use in geriatrics:
PALIP XR should be used with caution in elderly patients with dementia. Your doctor may adjust your dose if your kidney function is reduced. Consult your doctor before taking PALIP XR.
Interactions
A. Drug - Drug interactions:
Before taking PALIP XR, inform your doctor if you are taking any of the following medicine:
- metoclopramide (used to manage nausea and vomiting)
- valproate (used to manage fits)
- psychostimulants (medicines that increase the activity of the brain) Ex. methylphenidate (used to manage attention deficit hyperactivity disorder)
- medicines used to control heart rhythm (Ex. quinidine, disopyramide)
- medicines used to lower blood pressure (Ex. enalapril, metoprolol)
- antihistamines (medicines used to relive symptoms of allergies) Ex. chlorpheniramine
- antimalarials (medicines used to manage malaria) Ex. chloroquine, mefloquine
- antipsychotics (medicines used to manage schizophrenia and psychoses) Ex. chlorpromazine, haloperidol, risperidone
- levodopa (used to manage Parkinson’s disease and restless legs syndrome)
Overdosage:
If you or anyone else accidentally take too much of PALIP XR, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose of PALIP XR are sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure and abnormal heart beats.
Synopsis
| Drug | : | Paliperidone |
| Pharmacological Category | : | Antipsychotic drugs |
| Therapeutic Indication | : | Schizophrenia and Schizoaffective disorder |
| Dosage Forms | : | Tablet, Injection |
More Information
- Keep PALIP XR out of reach of children
- Store PALIP XR below 30°C
FAQs About PALIP XR
When is the best time to take PALIP XR?
Take PALIP XR as advised by your physician. Generally, it is taken once a day at breakfast time. It can be taken with or without food. Contact your doctor for advice before taking PALIP XR.
What happens when you take PALIP XR?
PALIP XR can make you dizzy and may cause vision problems, difficulty with thinking and movement. Hence, avoid driving or operate any machines after taking PALIP XR and try to rest and relax. Get enough sleep. Do not drink alcohol, as it can aggravate your dizziness. Contact your doctor if your symptoms did not improve.
Does PALIP XR cause weight gain?
PALIP XR may cause you to gain weight. Significant weight gain may adversely affect your health. Your doctor will help you to lose weight and regularly measures your body weight.
Does PALIP XR increase blood sugar level?
Yes, PALIP XR may increase blood sugar levels and patients with diabetes mellitus are increased risk of this side effect of PALIP XR, your doctor will check for signs of high blood sugar when you are managing with PALIP XR. In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.
How fast does PALIP XR work?
PALIP XR improve many symptoms quickly (hours to days) and other symptoms will improve over time (weeks to months). Your sleep and mood should improve within the first week or so. Your thoughts should get clearer and more organized slowly over 2–8 weeks of taking PALIP XR.
Can I stop using PALIP XR?
Do not stop taking PALIP XR since you will lose the effects of the medicine. You should not stop PALIP XR unless told to do so by your doctor. Otherwise, your symptoms may return.
References
1. Laurence L. Brunton, John S. Lazo, Keith L. Parker. Pharmacotherapy of psychosis and mania. Goodman Gilman’s The Pharmacological Basis of Therapeutics. Eleventh Edition. 2006. Page –461.
2. Jill A Fowler, Tawny L Bettinger, Tami R Argo. Paliperidone extended-release tablets for the acute and maintenance treatment of schizophrenia. NIH National Library of Medicine, National Center for Biotechnology Information. PubMed.gov. February 2008. [Accessed on 3rd June 2022] https://pubmed.ncbi.nlm.nih.gov/18343262/
3. Janicak PG, Winans EA. Paliperidone ER: a review of the clinical trial data. NIH National Library of Medicine, National Center for Biotechnology Information. PubMed Central. December 2007. [Accessed on 3rd June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2656329/
4. Janssen-Cilag SpA. Electronic Medicines Compendium (EMC). [Revised in May 2021] [Accessed on 3rd June 2022] https://www.medicines.org.uk/emc/files/pil.6816.pdf
5. ALZA Corporation. U.S. Food and Drug Administration. [Accessed on 3rd June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022043lbl.pdf
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