Amisure
Generic Name
Aripiprazole
Manufacturer
General Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| amisure 5 mg injection | ৳ 60.00 | N/A |
Description
Overview of the medicine
Aripiprazole is an atypical antipsychotic medication used to treat schizophrenia and acute agitation associated with bipolar I disorder. The injection form is typically used for rapid control of agitation.
Uses & Indications
Dosage
Adults
For acute agitation: The usual initial dose for IM injection is 9.75 mg. However, 5 mg may be used depending on clinical judgment and product-specific guidelines. A second injection may be given after 2 hours, if needed, not to exceed a total of 30 mg/day (for all formulations combined).
Elderly
Lower initial doses and careful titration are recommended, especially for patients with dementia-related psychosis due to increased risk of adverse events.
Renal_impairment
No dosage adjustment is required for patients with renal impairment.
How to Take
Amisure 5 mg Injection is administered via intramuscular (IM) injection only. It should not be administered intravenously (IV) or subcutaneously (SC). The injection should be given slowly and deeply into the muscle.
Mechanism of Action
Aripiprazole acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and as an antagonist at serotonin 5-HT2A receptors. This unique pharmacological profile is thought to contribute to its efficacy in treating psychotic symptoms and mood disorders.
Pharmacokinetics
Onset
Onset of action for agitation relief is typically within 1-2 hours after IM injection.
Excretion
Approximately 55% is excreted in feces and 25% in urine, primarily as metabolites.
Half life
The elimination half-life is approximately 75 hours for aripiprazole and 94 hours for its active metabolite dehydro-aripiprazole.
Absorption
Rapidly absorbed after intramuscular (IM) administration, reaching peak plasma concentrations within 1-3 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP2D6 and CYP3A4 enzymes, to its active metabolite dehydro-aripiprazole.
Side Effects
Contraindications
- Hypersensitivity to aripiprazole or any component of the formulation.
- Use in elderly patients with dementia-related psychosis (due to increased mortality risk).
Drug Interactions
CNS Depressants (e.g., alcohol, benzodiazepines)
May potentiate the sedative effects of aripiprazole. Caution is advised.
CYP2D6 Inhibitors (e.g., quinidine, fluoxetine, paroxetine)
May increase aripiprazole plasma concentrations, requiring a dose reduction of aripiprazole.
CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
May increase aripiprazole plasma concentrations, requiring a dose reduction of aripiprazole.
CYP2D6 or CYP3A4 Inducers (e.g., rifampicin, carbamazepine, St. John's Wort)
May decrease aripiprazole plasma concentrations, requiring a dose increase of aripiprazole.
Storage
Store at controlled room temperature (20-25°C). Protect from light. Do not freeze. Reconstituted solution should be used promptly.
Overdose
Symptoms of overdose include somnolence, vomiting, tremor, and tachycardia. In massive overdose, coma, convulsions, and prolonged QTc interval have been reported. Treatment is supportive, including establishing and maintaining an airway, ensuring adequate oxygenation and ventilation, and monitoring cardiac function and vital signs. Activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Weigh the potential benefits against the risks. Neonates exposed to antipsychotics during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms. Aripiprazole is excreted in human milk; therefore, caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to aripiprazole or any component of the formulation.
- Use in elderly patients with dementia-related psychosis (due to increased mortality risk).
Drug Interactions
CNS Depressants (e.g., alcohol, benzodiazepines)
May potentiate the sedative effects of aripiprazole. Caution is advised.
CYP2D6 Inhibitors (e.g., quinidine, fluoxetine, paroxetine)
May increase aripiprazole plasma concentrations, requiring a dose reduction of aripiprazole.
CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
May increase aripiprazole plasma concentrations, requiring a dose reduction of aripiprazole.
CYP2D6 or CYP3A4 Inducers (e.g., rifampicin, carbamazepine, St. John's Wort)
May decrease aripiprazole plasma concentrations, requiring a dose increase of aripiprazole.
Storage
Store at controlled room temperature (20-25°C). Protect from light. Do not freeze. Reconstituted solution should be used promptly.
Overdose
Symptoms of overdose include somnolence, vomiting, tremor, and tachycardia. In massive overdose, coma, convulsions, and prolonged QTc interval have been reported. Treatment is supportive, including establishing and maintaining an airway, ensuring adequate oxygenation and ventilation, and monitoring cardiac function and vital signs. Activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Weigh the potential benefits against the risks. Neonates exposed to antipsychotics during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms. Aripiprazole is excreted in human milk; therefore, caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date, when stored as recommended.
Availability
Hospitals, Pharmacies
Approval Status
Approved by regulatory authorities
Patent Status
Patent expired
WHO Essential Medicine
YesClinical Trials
Aripiprazole has been extensively studied in numerous clinical trials for its efficacy and safety in treating schizophrenia, bipolar disorder, and other related conditions. Its injectable form has been specifically evaluated for rapid tranquilization of agitated patients.
Lab Monitoring
- Baseline and periodic monitoring of blood glucose levels (fasting plasma glucose)
- Lipid profile (total cholesterol, LDL, HDL, triglycerides)
- Weight and BMI
- Complete Blood Count (CBC) if signs of infection or blood dyscrasias develop
- ECG (especially in patients with cardiovascular risk factors)
Doctor Notes
- Monitor patients for extrapyramidal symptoms, particularly akathisia, and metabolic parameters (weight, blood glucose, lipids) regularly.
- Assess for suicidal ideation, especially at the initiation of treatment or during dose changes, in children, adolescents, and young adults.
- Consider the patient's cardiovascular status and risk factors before administering the injection.
Patient Guidelines
- Do not drive or operate heavy machinery if you experience sedation or dizziness.
- Report any involuntary movements, especially of the face or tongue, to your doctor.
- Avoid alcohol while on this medication.
- Inform your doctor about all other medications you are taking, including herbal supplements and over-the-counter drugs.
Missed Dose Advice
Amisure injection is typically used for acute, single-dose situations or as part of a scheduled regimen. If used as part of a scheduled regimen and a dose is missed, administer it as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume your regular schedule. Do not double the dose.
Driving Precautions
Amisure 5 mg Injection may cause drowsiness, dizziness, or visual disturbances. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that aripiprazole therapy does not adversely affect them.
Lifestyle Advice
- Maintain a healthy diet and engage in regular physical activity to help manage potential weight gain.
- Adhere strictly to your treatment plan as prescribed by your doctor to ensure optimal efficacy and minimize relapse.
- Regular follow-up appointments with your healthcare provider are crucial.
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