Description and composition of Debixa
Table of Contents
Debixa is a second generation antipsychotic and antimanic agent which contains Aripiprazole as its active ingredient. It also contains inactive ingredients called excipients in sufficient quantitie.
Debixa comes in different pharmaceutical dosage forms including tablets, oral solution and injections.
It also comes in different strengths. The commonly available strength of Aripiprazole are:
- Tablets Debixa: 2 mg, 5 mg, 10 mg, 15, 20mg and 30mg.
- Oral solution Debixa: 1mg/mL
- Injections Debixa: 300mg/vial or prefilled dual chamber syringe, 400mg/vial or prefilled dual chamber syringe etc
Debixa acts as a partial agonist at the dopamine D2 and the serotonin 5-HT1A receptors, and as a strong antagonist at serotonin 5-HT2A receptor. Has binding affinity for other receptors e.g., 1-receptor blockade.
It is effective in treating the negative and depressive symptoms of schizophrenia. It is dosed once daily usually in the morning as it can be stimulating.
Aripiprazole is metabolized in the liver via CYP2D6 and CYP3A4 to active metabolite dehydro-aripiprazole. It has unique long half-life and dosage changes should be made at an interval of at least 2 weeks.
Uses of Debixa
Debixa is used for the treatment of Schizophrenia; Moderate to severe manic episodes of bipolar disorder.
It is also used as an adjunctive treatment of major depressive disorder (MDD).
Dosage of Debixa
- Initially 10 to 15 mg once daily; this may be increased at an interval of at least 2 weeks to a maximum of 30 mg once daily.
- Efficacy of Aripiprazole is not much greater at dosages above 15 mg/day.
Bipolar I disorder (acute manic or mixed episodes):
- Monotherapy, Initially 15 mg once daily; this may be increased to a maximum of 30 mg once daily as needed.
Bipolar I disorder:
- Adjunct to lithium or valproic acid, Initially 10 to 15 mg once daily; it may be increased to a maximum of 30 mg once daily as needed.
Major depressive disorder:
Adjunctive with antidepressants, Initially 2 to 5 mg once daily; dose may be adjusted up to 5 mg/day at intervals of ≥1 week. Max. 15 mg/day.
An antipsychotic should be continued at optimum dose for 4-6 weeks before assessing response to treatment
Side Effects of Debixa
The following are common side effects associated with Debixa:
- Nausea and vomiting
- Extrapyramidal symptoms (akathisia, parkinsonism)
- Orthostatic hypotension
- Insomnia and
This preparation is contraindicated in patients who are hypersensitive to Aripiprazole and any of the components used in formulating it.
It is also contraindicated in the elderly with dementia-related psychosis.
Debixa should be used with caution when any of the following conditions or cases is true
- Cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities)
- Cerebrovascular disease, conditions which predispose to hypotension (dehydration, hypovolemia) or hypertension
- Venous thromboembolism (VTE);
- Family history of QT prolongation
- Tardive dyskinesia and other EPS;
- Neuroleptic Malignant Syndrome (NMS)
- History of seizure disorder or associated conditions (e.g., head trauma)
- Elderly patients with dementia-related psychosis (increased mortality)
- Hyperglycaemia and diabetes mellitus
- Dysphagia especially in patients at risk for aspiration pneumonia;
- Pathological gambling
- Severe hepatic impairment
- Pregnancy; Lactation
Debixa tablets and oral solution: Administer without regard to meals. Give in the morning as it may be stimulating. An antipsychotic should be continued at optimum dose for 4-6 weeks before assessing response to treatment.
Advice to patients
Caution patients about operating motor vehicles, machinery or other hazardous tasks.
Antipsychotics generally may cause somnolence and impairment of judgement, thinking or motor skills.
Recommendations on the use of Debixa in Pregnancy and Lactation
Debixa has been associated with developmental toxicity in animals.
Limited experience with its use in humans; no teratogenic effects have been reported following its use.
However, it is known to cause extrapyramidal effects and withdrawal syndrome in neonates exposed during the third trimester.
It should be avoided during pregnancy except if potential benefit outweighs risk.
Interactions of Debixa with other drugs
- Substrate of both CYP2D6 (major) and CYP3A4 (major): Increased plasma levels with CYP3A4 inhibitors (e.g., Ketoconazole, Clarithromycin) or CYP2D6 inhibitors (e.g., Quinidine). Decreased plasma levels with CYP2D6 or CYP3A4 inducers (e.g., Carbamazepine, Phenytoin).
- It may enhance effects of antihypertensives (due to a1-receptor blockade).
- It enhances sedation with other CNS agents (e.g., alcohol, benzodiazepines).
- It increases risk of serotonin syndrome with SSRIs.
How to Store Debixa
Store at 25°C.