Asprito Tablets (Generic Aripiprazole Tablets)

Asprito Tablets (Generic Aripiprazole Tablets)
© The Swiss Pharmacy

Asprito (Generic Aripiprazole Tablets) is used for the
treatment of schizophrenia including maintenance of clinical
improvement during continuation therapy. Asprito tablets
monotherapy is indicated for acute and maintenance
treatment of manic and mixed episodes with Bipolar I
Disorder with or without psychotic features. Asprito is
indicated as an adjunctive therapy to either lithium or
valproate for the acute treatment of manic and mixed
episodes associated with Bipolar I Disorder with or
without psychotic features.

Asprito Tablets are manufactured by Intas
Pharmaceuticals Limited, India in the strengths of 2 mg,
10 mg, 15 mg, 20 mg and 30 mg.

Chemical Structure

The active ingredient contained in Asprito tablets
is Aripiprazole .
Each Asprito tablet contains 2 mg, 10 mg, 15 mg,
20 mg or 30 mg of Aripiprazole.

Uses of Asprito 2mg, 10mg, 15mg, 20mg and 30mg Tablets:
Asprito tablets contain the active substance Aripiprazole and belong
to a group of medicines called antipsychotics.
Asprito (Generic Aripiprazole Tablets) is used alone or together with
other medicines to treat mental conditions such as bipolar I disorder
(manic-depressive illness), major depressive disorder, and
schizophrenia.
This medicine is also used in children to treat irritability associated
with autistic disorder and Tourette syndrome. Aripiprazole works in
the brain to change how certain chemicals affect patients.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9495_Aripiprazole-Tablets.html

Recommended Adult Dosage
For most adult patients, the starting dose of Asprito Tablets
(Generic Aripiprazole Tablets) to treat Schizophrenia is 10 or
15 mg/day administered on a once-a-day schedule without
regard to meals. Doses in the range of 10 to 30 mg/day
have been effective in clinical trials.
Daily dosage may be adjusted on the basis of individual
clinical status within the range of 10 mg to 30 mg daily.
Dosage increases should not be made before 2 weeks, the
time needed to achieve steady state.

Recommended Adult Dosage
The recommended starting dose for Asprito for acute
treatment of Bipolar Disorder in adults as well as target dose
is 15mg as monotherapy or as adjunctive therapy with lithium or
valproate given once a day, without regard to meals. The dose
can be increased to 30mg/day based on clinical response.
Maintenance of efficacy in Bipolar I disorder was
demonstrated in a trial involving patients who had been
symptomatically stable on Aripiprazole tablets (15 mg/day
or 30 mg/day, as monotherapy) for at least 6 consecutive
weeks.

Contraindications
➔
Asprito tablets are contraindicated in patients with a known
hypersensitivity to Aripiprazole or any component of the tablet.
Reactions have ranged from pruritus / urticaria to anaphylaxis.

Storage Instructions
Asprito Tablets (Generic Aripiprazole Tablets) have to be stored at
controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with
excursions permitted between 15° to 30°C (59° to 86°F). Keep this as
well as all other medicines away from children and pets.

Warnings
Elderly patients with dementia treated with atypical antipsychotic
drugs are at an increased risk of death compared to placebo.
Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-
Related Psychosis: Increased incidence of cerebrovascular adverse
reactions (e.g., stroke, transient ischemic attack, including fatalities)
Neuroleptic Malignant Syndrome: Manage with immediate
discontinuation and close monitoring.
Tardive Dyskinesia: Discontinue if clinically appropriate.
Metabolic Changes: Atypical antipsychotic drugs have been associated
with metabolic changes that include hyperglycemia/diabetes mellitus,
dyslipidemia, and body weight gain.

Warnings
Orthostatic Hypotension: Monitor heart rate and blood pressure and
warn patients with known cardiovascular or cerebrovascular disease,
and risk of dehydration or syncope
Leukopenia, Neutropenia, and Agranulocytosis: have been reported
with antipsychotics including Asprito (Aripiprazole tablets). Patients
with a history of a clinically significant low white blood cell count
(WBC) or a drug-induced leukopenia/neutropenia should have their
complete blood count (CBC) monitored frequently during the first few
months of therapy and discontinuation of Asprito tablets should be
considered at the first sign of a clinically significant decline in WBC in
the absence of other causative factors.

Warnings
Seizures/Convulsions: Use cautiously in patients with a history of
seizures or with conditions that lower the seizure threshold.
Potential for Cognitive and Motor Impairment: Use caution when
operating machinery.
Suicide: The possibility of a suicide attempt is inherent in schizophrenia
and bipolar disorder. Closely supervise high-risk patients.

Driving And Using Machines
Dizziness and vision problems may occur during treatment with Asprito
(Aripiprazole tablets). Avoid driving vehicles or operating heavy
machines while taking this medication as it can cause dizziness and
blurred vision. This should be considered in cases where full alertness
is required, e.g. when driving a car or handling machines.
Do not drive a car or operate machinery until you know how this
medication affects you. you should know that alcohol can add to the
drowsiness caused by this medication.

Possible Side Effects
Most common Aripiprazole tablets (Asprito) side effects in adult
patients during clinical trials with an incidence rate of greater than or
equal to 10% include were nausea, vomiting, constipation, headache,
dizziness, akathisia, anxiety, insomnia, and restlessness.
Most common Aripiprazole tablets (Asprito) side effects in pediatric
patients during clinical trials with an incidence rate of greater than or
equal to 10% include somnolence, headache, vomiting,
extrapyramidal disorder, fatigue, increased appetite, insomnia,
nausea, nasopharyngitis, and weight increased.

Possible Side Effects
Less common Aripiprazole tablets (Asprito) side effects in adult patients
during clinical trials with an incidence rate of greater than or equal to 2%
and more than placebo:
Blurred Vision, Nausea, Constipation, Vomiting, Dyspepsia, Dry Mouth,
Toothache, Abdominal Discomfort, Stomach Discomfort, Fatigue, Pain,
Musculoskeletal Stiffness, Pain in Extremity, Myalgia, Muscle Spasms,
Headache, Dizziness, Akathisia, Sedation, Extrapyramidal Disorder, Tremor,
Somnolence, Agitation, Insomnia, Anxiety, Restlessness,
Pharyngolaryngeal Pain and Cough.

Overdosage
Common adverse reactions (reported in at least 5% of all overdose
cases) reported with oral Aripiprazole (Asprito tablets) overdosage
(alone or in combination with other substances) include vomiting,
somnolence, and tremor. Other clinically important signs and
symptoms observed in one or more patients with aripiprazole
overdoses (alone or with other substances) include acidosis,
aggression, aspartate aminotransferase increased, atrial fibrillation,
bradycardia, coma, confusional state, convulsion, blood creatine
phosphokinase increased, depressed level of consciousness,
hypertension, hypokalemia, hypotension, lethargy, loss of
consciousness, QRS complex prolonged, QT prolonged, pneumonia
aspiration, respiratory arrest, status epilepticus, and tachycardia.

Treatment of Asprito Overdosage
No specific information is available on the treatment of overdose with
Aripiprazole (Asprito tablets). An electrocardiogram should be
obtained in case of overdosage and if QT interval prolongation is
present, cardiac monitoring should be instituted.
Otherwise, management of overdose should concentrate on
supportive therapy, maintaining an adequate airway, oxygenation and
ventilation, and management of symptoms.
Close medical supervision and monitoring must continue until the
patient recovers.

Asprito Tablets During Pregnancy
Aripiprazole (Asprito tablets) has been classified by the US FDA as
Pregnancy Category C.
Neonates exposed to antipsychotic medicines including Aripiprazole
tablets (Asprito) during the third trimester of pregnancy are at risk for
extrapyramidal and/or withdrawal symptoms. Adequate and well
controlled studies with Aripiprazole tablets have not been
conducted in pregnant women.

Asprito Tablets During Pregnancy
Oral and intravenous Aripiprazole administration during
organogenesis in rats and/or rabbits at doses higher than the
maximum recommended human dose (MRHD) produced fetal death,
decreased fetal weight, undescended testicles, delayed skeletal
ossification, skeletal abnormalities, and diaphragmatic hernia. Oral
and intravenous Aripiprazole administration during the pre- and
post-natal period in rats at doses higher than the maximum
recommended human dose (MRHD) produced prolonged gestation,
stillbirths, decreased pup weight, and decreased pup survival.
Asprito can be administered during pregnancy only if the potential
benefit justifies the potential risk to the fetus.

Asprito Tablets (Aripiprazole Tablets) are manufactured
by Intas Pharmaceuticals Limited, India.

Asprito Tablets (Generic Aripiprazole Tablets)

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