Praxal-5

Praxal-5 Uses, Dosage, Side Effects, Food Interaction and all others data.

Praxal-5 (Praxal-5) is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.

Praxal-5 has high affinity for serotonin type 2 (5HT2), dopamine type 2 (D2), alpha1 and 2 adrenergic, and H1 histaminergic receptors. It also acts on a number of other receptors with lower affinity. The exact method by which aripiprazole's action on these receptors translates to a clinically relevant effect is not yet known.

Trade Name Praxal-5
Availability Prescription only
Generic Aripiprazole
Aripiprazole Other Names Aripiprazol, Aripiprazole, Aripiprazolum
Related Drugs Rexulti, Vraylar, sertraline, trazodone, fluoxetine, Lexapro, venlafaxine, Zoloft, citalopram, quetiapine
Weight 5mg
Type Tablet
Formula C23H27Cl2N3O2
Weight Average: 448.385
Monoisotopic: 447.148032537
Protein binding

>99%.

Groups Approved, Investigational
Therapeutic Class Atypical neuroleptic drugs
Manufacturer Stallion Laboratories Pvt Ltd
Available Country India, Nigeria
Last Updated: September 19, 2023 at 7:00 am
Praxal-5
Praxal-5

Uses

Schizophrenia

Schizoaffective disorder

Acute manic and mixed episodes associated with Bipolar I Disorder

Maintaining efficacy in patients with Bipolar I Disorder who are stabilized

Praxal-5 is also used to associated treatment for these conditions: Agitation, Bipolar 1 Disorder, Irritability, Major Depressive Disorder (MDD), Mixed manic depressive episode, Psychosis, Psychotic Depression, Schizophrenia, Tourette's Disorder (TD), Acute Manic episode

How Praxal-5 works

The antipsychotic action of aripiprazole is likely due to the agonism of D2 and 5-HT1A receptors though the exact mechanism has not been defined. Some adverse effects may be due to action on other receptors. For example, orthostatic hypotension may be explained by antagonism of the adrenergic alpha1 receptors.

Dosage

Praxal-5 dosage

For Schizophrenia:

Adults-10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.

For Bipolar mania:

Adults- 30 mg, once daily, without regard to food.

Side Effects

Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.

Toxicity

Studies on the safety and effectiveness of aripiprazole in pregnancy have not been performed, though there is currently a national pregnancy registry for mothers currently taking aripiprazole in pregnancy. In other studies of antipsychotic medication in pregnancy, children are at risk of extrapyramidal or withdrawal symptoms. In animal studies of pregnancy, aripiprazole was associated with a number of malformations and fetal death at doses higher than the maximum recommended human dose. Praxal-5 should only be prescribed in pregnancy if the benefits outweigh the risks. Neonates with third trimester exposure to aripiprazole may show extrapyramidal or withdrawal symptoms of varying severity. These symptoms may resolve in hours or require extended hospital care. Praxal-5's effect on labor and delivery has not been investigated. Praxal-5 is present in human breast milk and so patients should either stop breastfeeding or stop taking aripiprazole depending on the risk and benefit to mother and child. Pharmacokinetic properties in patients 10-17 years of age are similar to that of adults once body weight has been corrected for. No dosage adjustment is necessary in elderly patients however aripiprazole is not approved for Alzheimer's associated psychosis. Patients calssified as CYP2D6 poor metabolizers should be prescribed half the regular dose of aripiprazole. Hepatic and renal function as well as sex, race, and smoking status do not affect dosage requirements for aripiprazole.

Precaution

Praxal-5 may be associated with orthostatic hypotension (orthostatic lightheadedness).

Praxal-5 should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer\\\'s dementia.

Praxal-5 is not approved for the treatment of patients with dementia-related psychosis.

Interaction

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Food Interaction

  • Avoid alcohol. Alcohol may increase CNS effects.
  • Drink plenty of fluids. Drink water to avoid dehydration while taking aripiprazole.
  • Take with or without food. Food does not affect absorption.

[Moderate] GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents.

Use in combination may result in additive central nervous system depression and
MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol.

Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.

Praxal-5 Cholesterol interaction

[Moderate] Atypical antipsychotic drugs have been associated with undesirable alterations in lipid levels.

While all agents in the class have been shown to produce some changes, each drug has its own specific risk profile.

Before or soon after initiation of antipsychotic medication, obtain a fasting lipid profile at baseline and monitor periodically during treatment.

Volume of Distribution

404L or 4.9L/kg.

Elimination Route

Praxal-5 tablets are 87% bioavailable and reach peak plasma concentrations in 3 to 5 hours. These tablets can be taken with or without food, but a high fat meal can delay the time to max concentration by 3 hours and up to 12 hours for the active metabolite.

Half Life

The half life of aripiprazole is 75 hours while the half life of the active metabolite is 94 hours. For populations that are poor CYP2D6 metabolizers, the half life of aripiprazole is 146 hours and these patients should be treated with half the normal dose. Other studies have reported a half life of 61.03±19.59 hours for aripiprazole and 279±299 hours for the active metabolite.

Clearance

0.8mL/min/kg. Other studies have reported a clearance rate of 3297±1042mL/hr.

Elimination Route

25% of a given dose will be eliminated in urine and 55% in the feces. Label,4.

Pregnancy & Breastfeeding use

Praxal-5 should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast-feed an infant if they are taking aripiprazole.

Contraindication

Praxal-5 is contraindicated in patients who are hypersensitive to it or to any component of this product.

Acute Overdose

Praxal-5 at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

Interaction with other Medicine

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Innovators Monograph

You find simplified version here Praxal-5

Praxal-5 contains Aripiprazole see full prescribing information from innovator Praxal-5 Monograph, Praxal-5 MSDS, Praxal-5 FDA label

FAQ

What is Praxal-5 used for?

Praxal-5 is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder). It may also be used in combination with other medication to treat depression. It is primarily used in the treatment of schizophrenia and bipolar disorder.

How safe is Praxal-5?

The overall safety and tolerability of Praxal-5 is favorable compared to other atypical antipsychotics across the approved indications. Praxal-5 showed a minimal propensity for clinically significant weight gain and metabolic disruption.

How does Praxal-5 work?

Praxal-5 works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters).

What are the common side effects of Praxal-5?

Common side effects of Praxal-5 are include:

  • headache
  • nervousness
  • restlessness
  • dizziness, feeling unsteady, or having trouble keeping your balance
  • heartburn
  • constipation
  • diarrhea
  • stomach pain
  • weight gain
  • changes in appetite
  • increased salivation
  • pain, especially in the arms, legs, or joints
  • tiredness

Is Praxal-5 safe during pregnancy?

There is currently no suggestion of any link between Praxal-5 use in pregnancy and birth defects in general, or heart defects specifically in the baby.

Is Praxal-5 safe during breastfeeding?

Limited information indicates that maternal doses of Praxal-5 up to 15 mg daily produce low levels in milk, but until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Can I drink alcohol with Praxal-5?

Alcohol can increase the nervous system side effects of Praxal-5 such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience impairment in thinking and judgment. You should avoid or limit the use of alcohol while being treated with Praxal-5.

Can I drive after taking Praxal-5?

Do not drive a car or ride a bike just after you start taking Praxal-5. Taking Praxal-5 may make you feel very tired or dizzy and affect your eyesight when you start taking it.

What time of day should I take Praxal-5?

You can take Praxal-5 either before or after meals. Try to get into the habit of taking your doses at the same time of day each day, as this will help you to remember to take it.

How often can I take Praxal-5?

Praxal-5 tablets and suspension are usually taken 1 time per day with or without food.

How long does Praxal-5 take to work?

It can take a few days, or sometimes a few weeks, for Praxal-5 to start helping you. You may not feel the full to effects of the medication for four to six weeks.

How long does Praxal-5 stay in your system?

The elimination half-lives are about 75 hours and 94 hours Praxal-5 will stay in your system for about 16 days.

Can I take Praxal-5 for a long time?

Long-term adjunctive Praxal-5 therapy was well tolerated with an acceptable long-term safety and tolerability profile in patients with major depressive disorder who had not responded to treatment with one or more antidepressant therapies.

How long Praxal-5 should be taken?

It can take a few days, or sometimes a few weeks, for Praxal-5 to start helping you. You may not feel the full to effects of the medication for four to six weeks.

Who should not take Praxal-5?

You should not take Praxal-5 if you are allergic to it.
Praxal-5 is not approved for use in children or teenagers with major depression. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Praxal-5 in children 6 to 17 years of age with autistic disorder.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention. Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), weak or shallow breathing, fainting, or coma.

What happen If I stop taking Praxal-5?

If you stop taking it suddenly, the balance starts to change, and your old symptoms could return. You could also experience some unpleasant withdrawal symptoms like headache, feeling sick and sleep problems. You can stop taking Praxal-5 safely with your doctor's help.

Can Praxal-5 affect my fertility?

Praxal-5 like other antipsychotics, may cause hyperprolactinemia which is associated with galactorrhea, menstrual irregularities, and infertility.

Can Praxal-5 affects my heart ?

Praxal-5 is a low-risk antipsychotic regarding cardiac safety in healthy patients.

Does Praxal-5 affect kidney function?

Praxal-5 treatment also decreased the volume of kidney necrosis.

Can Praxal-5 affects my liver?

Despite good tolerance and few side effects, Praxal-5 can also lead to severe drug-induced liver injury.

*** Taking medicines without doctor's advice can cause long-term problems.
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