Rispons tablets

Rispons

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

The active ingredient of Rispons 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

Rispons 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 Rispons include: oily skin; increase in amount of urine; decreased interest in sexual intercourse; weight loss; shuffling walk; prolonged, painful, inappropriate erection of the penis; stiffness or weakness of the arms or legs.

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What is risper >

Rispons is an antipsychotic medicine that works by changing the effects of chemicals in the brain.

Rispons is used to treat schizophrenia in adults and children who are at least 13 years old.

Rispons is also used to treat symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Rispons is also used to treat symptoms of irritability in autistic children who are 5 to 16 years old.

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 Rispons, -0.3 ziprasidone; a 5% increase in weight occurred after one year in 13% of placebo, 39% haloperidol, 20% ziprasidone, 45% Rispons and 60% olanzapine treated subjects).

What Are Side Effects Associated with Using Rispons?

Common side effects of Rispons include:

Less common side effects of Rispons include:

Other side effects of Rispons include:

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pharmacokinetic studies showed that RISPERDAL® M-TAB® Orally Disintegrating Tablets and RISPERDAL® Oral Solution are bioequivalent to RISPERDAL® Tablets.

Plasma concentrations of Rispons, its major metabolite, 9-hydroxyRispons, and Rispons plus 9-hydroxyRispons are dose proportional over the dosing range of 1 to 16 mg daily (0.5 to 8 mg twice daily). Following oral administration of solution or tablet, mean peak plasma concentrations of Rispons occurred at about 1 hour. Peak concentrations of 9-hydroxyRispons occurred at about 3 hours in extensive metabolizers, and 17 hours in poor metabolizers. Steady-state concentrations of Rispons are reached in 1 day in extensive metabolizers and would be expected to reach steady-state in about 5 days in poor metabolizers. Steady-state concentrations of 9-hydroxyRispons are reached in 5-6 days (measured in extensive metabolizers).

Food does not affect either the rate or extent of absorption of Rispons. Thus, RISPERDAL® can be given with or without meals.

Juvenile Animal Studies

Juvenile dogs were treated for 40 weeks with oral Rispons doses of 0.31, 1.25, or 5 mg/kg/day. Decreased bone length and density were seen, with a no-effect dose of 0.31 mg/kg/day. This dose produced plasma levels (AUC) of Rispons plus its active metabolite paliperidone (9-hydroxy-Rispons) 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 Rispons from days 12 to 50 of age, a reversible impairment of performance in a test of learning and memory was seen, in females only, with a no-effect dose of 0.63 mg/kg/day. This dose produced plasma levels (AUC) of Rispons 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 (1.25 mg/kg/day). This dose produced plasma levels (AUC) of Rispons plus paliperidone which were about two thirds of those observed in humans at the MRHD.

Introduction

Rispons is an atypical antipsychotic that is used widely in the treatment of mania and schizophrenia. Rispons therapy is associated with serum aminotransferase elevations and in rare instances has been linked to clinically apparent acute liver injury.

Outcome and Management

The serum aminotransferase elevations that occur on Rispons therapy are usually self-limited and often do not require dose modification or discontinuation of therapy. No instances of acute liver failure or vanishing bile duct syndrome have been attributed to Rispons. A single case of autoimmune hepatitis due to Rispons has been published. There may be some cross reactivity to liver injury between Rispons and quetiapine, but usually not with clozapine and olanzapine.

Do Other Drugs Affect the Way Rispons Works?

Many drugs may affect the way Rispons works, and the drug could also interfere with other medications. It's very important to let your doctor know about everything you take, including illegal drugs and any over-the-counter medications, herbs, or supplements.

Types of drugs that interact with Rispons (Risperdal) include:

  • Antidepressants, such as paroxetine (Paxil) and fluoxetine (Sarafem, Prozac)
  • Heartburn medications, such as ranitidine (Zantac) and cimetidine (Tagamet)
  • Certain drugs used to treat Parkinson's disease, including the dopamine agonists bromocriptine (Parlodel), cabergoline (Dostinex), and levodopa (Dopar, Larodopa)
  • Some drugs used to treat high blood pressure
  • Anti-seizure drugs, such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin)
  • Other medications for mental illness, including clozapine (Clozaril)
  • Certain antibiotics, such as rifampin (Rifadin, Rimactane)
  • Sedatives, sleeping pills, and tranquilizers

Background

Rispons (ris per' i done) is a benzisoxazole derivative which appears to act as a dopamine type 2 (D2) and serotonin (5-HT2) receptor antagonist. Rispons is indicated for treatment of schizophrenia and as monotherapy or combination therapy for acute manic or mixed episodes of bipolar I disorder in adults. Rispons is also used for management of irritability with autistic disorder in children and adolescents. Rispons was approved for use in the United States in 1993 and it is still widely used. Rispons is available as tablets of 0.25, 0.5, 1, 2, 3 and 4 mg generically and under the brand name of Risperdal. Oral solutions for pediatric use are available as are orally disintegrating tablets and formulations for parenteral administration. The typical initial dose in adults is 1 mg once or twice daily, with increase in dose to as high as 8 mg daily based upon indications, efficacy and tolerance. Common side effects include somnolence, fatigue, restlessness, dizziness, dry mouth, increased saliva, constipation, increased appetite and weight gain. Rare, but potentially severe adverse events include cerebrovascular events, tardive dyskinesia, neuroleptic malignant syndrome, orthostatic hypotension, suicidal ideation and behavior, seizures, diabetes and agranulocytosis.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to Rispons.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Nursing Mothers

Rispons and 9-hydroxyRispons are present in human breast milk. Because of the potential for serious adverse reactions in nursing infants from Rispons, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.


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