Winperid tablets

Winperid

  • Active Ingredient: Risperidone
  • 4 mg, 2 mg, 1 mg
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What is Winperid?

The active ingredient of Winperid brand is risperidone. Risperidone is a antipsychotic medicine. It works by changing the effects of chemicals in the brain. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl . Risperidone tablets, USP are for oral administration and available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. Inactive ingredients are lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol 400. The 0.25 mg, 0.5 mg, 3 mg and 4 mg tablets contain D&C Yellow # 10 aluminum lake. The 0.5 mg and 4 mg tablets also contain FD&C Blue # 2 aluminum lake. The 2 mg tablets contain iron oxide yellow, iron oxide red, and iron oxide black.

Used for

Winperid is used to treat diseases such as: Agitation, Anxiety, Asperger Syndrome, Autism, Bipolar Disorder, Body Dysmorphic Disorder, Borderline Personality Disorder, Depression, Head Injury, Mania, Nightmares, Paranoid Disorder, Post Traumatic Stress Disorder, Schizoaffective Disorder, Schizophrenia, Severe Mood Dysregulation, Social Anxiety Disorder, Tic Disorder.

Side Effect

Possible side effects of Winperid include: restlessness or need to keep moving (severe); skin rash or itching; difficulty speaking or swallowing; unusual breast milk production; difficulty concentrating; drowsiness; loss of appetite.

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Side Effects

Drowsiness, dizziness, lightheadedness, drooling, nausea, weight gain, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: difficulty swallowing, muscle spasms, shaking (tremor), mental/mood changes (such as anxiety, restlessness), interrupted breathing during sleep.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

Winperid may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face, lips, mouth, tongue, arms or legs).

This medication may increase a certain natural substance (prolactin) made by your body. For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.

Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, seizures.

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

DESCRIPTION

RISPERDAL® contains Winperid, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyridopyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:

Winperid is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.

RISPERDAL® Tablets are for oral administration and available in 0.25 mg (dark yellow), 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. RISPERDAL® tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and starch (corn). The 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg tablets also contain talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.

RISPERDAL® is also available as a 1 mg/mL oral solution. RISPERDAL® Oral Solution contains the following inactive ingredients: tartaric acid, benzoic acid, sodium hydroxide, and purified water.

RISPERDAL® M-TAB® Orally Disintegrating Tablets are available in 0.5 mg (light coral), 1 mg (light coral), 2 mg (coral), 3 mg (coral), and 4 mg (coral) strengths. RISPERDAL® M-TAB® Orally Disintegrating Tablets contain the following inactive ingredients: Amberlite® resin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame, red ferric oxide, and peppermint oil. In addition, the 2 mg, 3 mg, and 4 mg RISPERDAL® M-TAB® Orally Disintegrating Tablets contain xanthan gum.

Risper > Winperid is a benzisoxazole derivative approved by the FDA for treatment of schizophrenia in 1994, for short-term treatment of the mixed and manic states of bipolar disorder in 2003, and for treatment of irritability in children with autism in 2006. In 2007 it was approved as a treatment for schizophrenia and bipolar disorder in children. Its pharmacology is characterized by binding affinity for 5-HT 2A receptors that is 20 times that for D2-dopamine receptors. D2-receptor affinity is approximately 50 times, and 5-HT2A receptor affinity approximately 20 times that of clozapine. Winperid also has strong affinity for α1-/α2-adrenergic and H1-histamine receptors. Affinity for D1 receptors is low, and it has no affinity at muscarinic receptors. Protein binding is 90%, and it is metabolized by CYP 2D6. D2-receptor occupancy at therapeutic doses is 63% to 89%, which would be expected to be associated with a significant incidence of EPS. 110 The addition of strong serotonergic antagonism, with a 5-HT2 receptor occupancy of 95%, is thought to confer protection against D2 antagonist effects on the nigrostriatal pathway, and the incidence of EPS is low. Nonetheless, unlike other SGAs with relatively lower affinities for D2 receptors that permit dynamic responses to surges in dopamine, Winperid is tightly bound and does cause significant hyperprolactinemia. 111,112 It can also cause orthostatic hypotension during early treatment. Winperid does not cause prolongation of the QTc and is less arrhythmogenic than other antipsychotics. It carries a boxed warning for increased risk of death in older patients receiving antipsychotics for dementia-related psychosis.

COMMON BRAND(S): Risperdal

GENERIC NAME(S): Winperid

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

If you are using Winperid in combination with other medication to treat depression, also carefully read the drug information for the other medication.

Winperid is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, irritability associated with autistic disorder). This medication can help you to think clearly and take part in everyday life.

Winperid belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

Animal Toxicology

Juvenile dogs were treated for 40 weeks with oral Winperid doses of 0.31, 1.25, or 5 mg/kg/day. Decreased bone length and density were observed with a no-effect dose of 0.31 mg/kg/day. This dose produced plasma AUC levels of Winperid plus its active metabolite paliperidone (9-hydroxy-Winperid) which were similar to those in children and adolescents receiving the maximum recommended human dose (MRHD) of 6 mg/day. In addition, a delay in sexual maturation was seen at all doses in both males and females. The above effects showed little or no reversibility in females after a 12 week drug-free recovery period.

In a study in which juvenile rats were treated with oral Winperid from days 12 to 50 of age, a reversible impairment of performance in a test of learning and memory was observed in females only with a no-effect dose of 0.63 mg/kg/day. This dose produced plasma AUC levels of Winperid plus paliperidone about half those observed in humans at the MRHD. No other consistent effects on neurobehavioral or reproductive development were seen up to the highest testable dose of 1.25 mg/kg/day. This dose produced plasma AUC levels of Winperid plus paliperidone which were about two thirds of those observed in humans at the MRHD.

SGAs Included in RCTs

Winperid is the most studied SGA in children for treatment of ASDs and DBDs, with 12 of 17 RCTs identified during this review pertaining to Winperid. In other therapeutic domains such as schizophrenia and bipolar disorder, Winperid is also commonly used. A large part of the reason for the disproportional number of studies involving Winperid is that it was the first SGA to market, other than clozapine. Due to the risk for agranulocytosis (a severe deficiency of infection-fighting granulocytes, or neutrophils, in the blood) clozapine use has been restricted and extra monitoring is required. In North America, this rare but potentially fatal adverse effect sharply limits clozapine prescribing to only approved indications of schizophrenia and schizoaffective disorder, and only after two other antipsychotic trials are undertaken. These risks and precautions along with its high adverse effect burden make clozapine an unsuitable candidate for treatment of ASDs and DBDs. Winperid was still under U.S. patent protection when the BPCA, with its incentivization of pediatric medication trials, was signed into law in 2002. Winperid was the first SGA to obtain FDA approval for treatment of irritability of autism in 2006, followed by aripiprazole in 2009.

No RCTs for ASDs or DBDs were identified involving asenapine, clozapine, lurasidone, paliperidone, or ziprasidone. Other than clozapine (see reasons limiting its use detailed above), the other four drugs are relative newcomers to the SGA market, with market release dates subsequent to publication of the bulk of the RCT data detailed in this chapter. Despite the lack of regulatory approval in Canada, Winperid and aripiprazole are in some ways now considered established treatments for ASDs and DBDs, and there may be less clinical interest in studying the newer SGAs for these indications. Winperid is now available in generic formulations in both Canada and the United States, and the drug cost is a fraction of that of branded treatments still under patent protection such as aripiprazole and other newer SGAs.

Why is this medication prescribed?

Winperid is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used to treat episodes of mania (frenzied, abnormally excited, or irritated mood) or mixed episodes (symptoms of mania and depression that happen together) in adults and in teenagers and children 10 years of age and older with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Winperid is also used to treat behavior problems such as aggression, self-injury, and sudden mood changes in teenagers and children 5 to 16 years of age who have autism (a condition that causes repetitive behavior, difficulty interacting with others, and problems with communication). Winperid is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

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Interactions that increase your risk of side effects

Taking Winperid with certain medications raises your risk of side effects from Winperid. This is because the amount of Winperid in your body is increased, or both medications may cause the same side effects. Examples of these drugs include:

  • Anxiety drugs, such as alprazolam, clonazepam, diazepam, chlordiazepoxide, and lorazepam. You may have more sedation and drowsiness.
  • Muscle relaxants, such as baclofen, cyclobenzaprine, methocarbamol, tizanidine, carisoprodol, and metaxalone. You may have more sedation and drowsiness.
  • Pain drugs, such as morphine, oxycodone, fentanyl, hydrocodone, tramadol, and codeine. You may have more sedation and drowsiness.
  • Antihistamines, such as hydroxyzine, diphenhydramine, chlorpheniramine, and brompheniramine. You may have more sedation and drowsiness.
  • Sedative/hypnotics, such as zolpidem, temazepam, zaleplon, and eszopiclone. You may have more sedation and drowsiness.
  • Fluoxetine. You may have increased risk of QT interval prolongation, irregular heart rhythm, and other side effects of Winperid. Your doctor may decrease your Winperid dose.
  • Paroxetine. You may have increased risk of QT interval prolongation, irregular heart rhythm, and other side effects of Winperid. Your doctor may decrease your Winperid dose.
  • Clozapine. You may have parkinsonism (trouble moving), sleepiness, anxiety, blurred vision, and other side effects of Winperid. Your doctor will monitor you closely for side effects and toxicity.
  • Blood pressure drugs, such as amlodipine, lisinopril, losartan, or metoprolol. You may have low blood pressure.
  • Parkinson’s disease drugs,such as levodopa, pramipexole, or ropinirole. You may have more Parkinson’s disease symptoms.

ANNOTATED BIBLIOGRAPHY

References updated: 04 June 2018

15 months; only 1 had ALT elevation , degree of surveillance unclear; abstract only).

1 month after discontinuation).

4 years; ultrasound suggested fatty liver).

3300 patients]; average monthly weight gain in pounds was +0.1 with placebo, +0.8 olanzapine, 0.6 Winperid, -0.3 ziprasidone; a 5% increase in weight occurred after one year in 13% of placebo, 39% haloperidol, 20% ziprasidone, 45% Winperid and 60% olanzapine treated subjects).

How to use Winperid

Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily.

If you are using the liquid form of this medication, carefully measure the dose using the special measuring device that is provided. Do not use a household spoon because you may not get the correct dose. If directed, you may mix the measured dose with a small amount of liquid (3 to 4 ounces/about 100 milliliters) such as water, coffee, orange juice, or low-fat milk. Do not mix with cola or tea. Take all of the mixture right away. Do not prepare a supply in advance. Consult your pharmacist if you have any questions.

The dosage is based on your age, medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without consulting your doctor.

Tell your doctor if your condition persists or worsens.

Important Information

Winperid may increase the risk of death in older adults with dementia-related conditions and is not approved for this use.

Do not give Winperid to a child without a doctor's advice.

While you are taking this medicine, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medication.

Winperid may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of this medicine.

Stop using this medicine and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

No specific pharmacokinetic study was conducted to investigate race and gender effects, but a population pharmacokinetic analysis did not identify important differences in the disposition of Winperid due to gender (whether corrected for body weight or not) or race.

What brand names are available for Winperid?

Risperdal, Risperdal Consta, Risperdal M-TAB

CONTRAINDICATIONS

RISPERDAL® is contraindicated in patients with a known hypersensitivity to either Winperid or paliperidone, or to any of the excipients in the RISPERDAL® formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with Winperid and in patients treated with paliperidone. Paliperidone is a metabolite of Winperid.


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