- 1 What is Abilify Tablets used for and indication ?
- 2 Contraindications
- 3 What is the most common side effect of Abilify?
- 4 abilify drug interactions
- 5 Abilify Tablets Warnings and Precautions
- 6 Drive and use machines
- 7 Abilify Tablets and PREGNANCY / Breastfeeding
- 8 What should I do if I miss a dose?
- 9 What happens if I overdose from Abilify ?
what is abilify Tablets ?
- Aripiprazole inhibits delusions, hallucinations and tics.
- In psychoses, such as schizophrenia, and mania. Sometimes also with unrest, depression and tics.
- It works within a few hours and for about a day.
- Take the tablets with half a glass of water.
- In schizophrenia, severe anxiety or tics, use is usually several years.
- In case of mania or psychosis due to depression, use is usually during the manic or psychotic period.
- Side effects that can occur: a feeling of emptiness restlessness, headaches, sexual disorders and gastrointestinal complaints. Consult your doctor if you suffer from this.
- You may experience movement disorders such as muscle twitching, stiff muscles and can not sit still. Consult your doctor.
- You may see blurred or drowsy, drowsy or dizzy. Do not drive a car for the first few days and then not as long as you continue to suffer from these side effects. Watch out with alcohol. This can still make you suffer.
- Have you been using aripiprazole for a few weeks? Do not stop at once. Build it slowly in consultation with your doctor or pharmacist.
What is Abilify Tablets used for and indication ?
- Abilify (Aripiprazole) Tablets is indicated for the treatment of schizophrenia in adults and adolescents aged 15 years and older.
- Abilify (Aripiprazole) Tablets is indicated for the treatment of moderate to severe manic episodes of bipolar I disorder and for the prevention of recurrence of manic episodes in adults with predominantly manic episodes and for whom manic episodes have responded to treatment. by aripiprazole (Pharmacodynamic properties ).
- Abilify (Aripiprazole) Tablets is indicated for the treatment of moderate to severe manic episodes of bipolar I disorder in adolescents 13 years of age and older for up to 12 weeks.
abilify doses for adults
- Schizophrenia: The recommended starting dose of Abilify (Aripiprazole) Tablets is 10 or 15 mg / day with a maintenance dose of 15 mg / day in one dose, during or after meals. Abilify (Aripiprazole) Tablets is effective in a dose range of 10 to 30 mg / day. An increase in efficacy for doses above the recommended 15 mg daily dose has not been demonstrated, however some patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg.
- Manic Episodes in Bipolar I Disorders: The recommended starting dose for Abilify (Aripiprazole) Tablets is 15 mg once daily during or after meals, monotherapy or combination therapy (see section 5.1 Pharmacodynamic properties ). Some patients may receive a higher dose. The maximum daily dose should not exceed 30 mg.
- Prevention of recurrence of manic episodes in bipolar I disorder: For the prevention of recurrence of manic episodes in patients treated with aripiprazole monotherapy or in combination, treatment will be maintained at the same dose. The daily dosage may be adapted, a dose reduction may be considered depending on the clinical condition of the patient.
- Schizophrenia in Adolescents Aged 15 Years and Older : The recommended dose of Abilify (Aripiprazole) Tablets is 10 mg / day administered once daily during or after meals. Treatment is initiated at a dose of 2 mg (using Abilify (Aripiprazole) Tablets oral solution 1 mg / ml) for two days, titrated to 5 mg for two additional days to reach the recommended daily dosage of 10 mg. Depending on the case, the following dose increases are administered in 5 mg increments, without exceeding the maximum daily dose of 30 mg (see section 5.1).). Abilify (Aripiprazole) Tablets is effective between 10 to 30 mg / day. Increased efficacy at doses above the 10 mg daily dose has not been demonstrated, although each patient may benefit at a higher dose.
- The use of Abilify (Aripiprazole) Tablets is not recommended in schizophrenia patients under 15 years of age because the available data on safety and efficacy are insufficient (see sections 4.8 Undesirable effects and Pharmacodynamic properties ).
- Manic episodes in bipolar I disorder in adolescents aged 13 years and older: the recommended dose of Abilify (Aripiprazole) Tablets is 10 mg / day given as a single dose during or after meals. Treatment is initiated at a dose of 2 mg (using Abilify (Aripiprazole) Tablets oral solution 1 mg / ml) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dosage of 10 mg. The duration of treatment should be as short as necessary to control symptoms and should not exceed 12 weeks. Increased efficacy at doses above the 10 mg daily dose has not been demonstrated and a daily dose of 30 mg has been associated with a substantial increase in the incidence of significant adverse events including extrapyramidal symptoms (EPS), fatigue and weight gain (see section 4.8).). Therefore, doses greater than 10 mg / day should be used for exceptional cases and associated with close clinical monitoring (see Warnings and Precautions , Adverse Reactions and Pharmacodynamic Properties sections ). Younger patients have a higher risk of developing adverse events associated with aripiprazole. Therefore, the use of Abilify (Aripiprazole) Tablets is not recommended in patients younger than 13 years of age (see sections 4.8 Undesirable effects and Pharmacodynamic properties ).
- Irritability associated with autistic disorder : The safety and efficacy of Abilify (Aripiprazole) Tablets in children and adolescents under 18 years of age have not been established. Currently available data are described in the Pharmacodynamic Properties section but no dosage recommendation can be given.
- Tics associated with Tourette’s syndrome: The safety and efficacy of Abilify (Aripiprazole) Tablets in children and adolescents aged 6 to 18 years have not been established. Currently available data are described in the Pharmacodynamic properties section but no dosage recommendation can be made.
- No dosage adjustment is required in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, there is insufficient data to make recommendations. Administration should be cautious in these patients. However, the maximum daily dose of 30 mg may be used with caution in patients with severe hepatic impairment .
- No dose adjustment is required in patients with renal impairment.
abilify dosing elderly
The efficacy of Abilify (Aripiprazole) Tablets in the treatment of schizophrenia and bipolar I disorder in patients aged 65 years and older has not been established. Due to the greater sensitivity of this population, a lower initial dose should be considered when clinical reasons warrant (see Warnings and Precautions ) section.
- No dosage adjustment is required in women compared to men .
- No dosage adjustment is required for smokers based on the metabolism of aripiprazole .
Dose adjustments related to interactions
- When concomitant use of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole, the aripiprazole dose should be reduced. When the CYP3A4 inhibitor or CYP2D6 is discontinued, the aripiprazole dose should be increased .
- When co-administering CYP3A4 inducers with aripiprazole, the aripiprazole dose should be increased. When the CYP3A4 inducer is stopped, the aripiprazole dose should be reduced to the recommended dosage .
- Abilify (Aripiprazole) Tablets is for oral use.
- Orodispersible tablets or Abilify (Aripiprazole) Tablets oral solution can be used as an alternative to tablets in patients with difficulty swallowing Abilify (Aripiprazole) Tablets tablets (see Pharmacokinetics ).
Hypersensitivity to the active substance or to any of the excipients.
What is the most common side effect of Abilify?
In addition to the desired effect, this can cause drug side effects.
The main side effects are the following.
Sometimes (from 10 to 30 people in 100)
- Flattening of the emotional life , loss of initiative and activity, feeling trapped and a sense of emptiness.
- Movement disorders , such as restlessness (akathisia), sudden muscle twitches in the head, mouth or face (dystonia) and muscle stiffness (parkinsonism).
Akathisia can also express itself in being unable to sit still, wiggling with foot or hand, feeling uneasy. And parkinsonism in trembling, difficulty in moving, walking or speaking.
These side effects can also cause muscle or joint pain.
Some movement disorders start within a few days after the first dose or after a dose increase. It can also occur after long-term use, or only after stopping. Sometimes it disappears within a few days.
Rarely arise ‘late movement disorders’(tardive dyskinesia). You notice them in the first instance sucking, chewing and tasting movements, movements of the tongue and grimaces and tics of the face. Or bending and stretching movements of fingers and toes, dance-like movements of arms and legs and swinging or turning movements of the shoulders and pelvis.
If these side effects occur, it is usually after prolonged use (several months). Sometimes they only come to light when you have stopped taking this medicine. After stopping the symptoms decrease over time, but in some people this side effect is not completely over.
Consult with your doctor if you notice movement disorders. Sometimes your doctor may reduce the dose or prescribe a different medication that you are less troubled by. Medications are also possible that prevent movement disorders.
Consult your doctor if you suffer from Parkinson’s disease or if you already have a movement disorder . The symptoms can be aggravated by this medication. Maybe the doctor can prescribe another medication.
Rarely (from 1 to 10 in 100 people)
- Headache, selessness and depression .
- Gastrointestinal complaints such as nausea and abdominal pain. These side effects occur especially at the beginning of treatment. Usually it helps if you take the medicine with some food. Will you continue to suffer from it after a few days? Then contact your doctor.
- Constipation (constipation). Eat high-fiber foods and drink a lot.
- Drooling , especially during sleep. Consult your doctor if you have a lot of problems with this.
- Dry eyes, blurred vision and very rare double vision. If you have Sjögren’s syndrome , a condition in which the mucous membranes of, for example, eyes and mouth are drier than normal: you may develop more symptoms. This medication reduces the production of tears and saliva. Contact your doctor if you have more eye irritation or a dry mouth.
- Drowsiness, drowsiness, dizziness and reduction of reaction, concentration and coordination capacity. Prevent accidents in traffic, as well as other activities at home and at work, for example when you climb a ladder, operate devices and monitor or control something at work. Even if you have to get out of bed at night to go to the toilet, you can have less control over your muscles and therefore fall faster.
- Problems with sex . In men: getting an erection more difficult. In women: getting an orgasm more difficult. In men and women: less sense to make love.
- Weight gain , due to an increase in appetite and a changed metabolism or weight loss .
Because the weight gain comes partly from an increase in appetite, it is important to eat less than you would like. That is very difficult for many people. Consult your doctor or a dietitian if you are over-arriving or waste too much. They can help you deal with this.
- Pissing problems , due to less control over the muscles of the bladder. As a result, you may suffer from unwanted urine loss, but also have trouble with urinating or to empty the bladder completely. These symptoms worsen with an enlarged prostate. By keeping urine in the bladder behind, you are more likely to have bladder infections. Contact your doctor if you have problems with urination. The complaints usually pass if you have become accustomed to this medication.
- Too fast heartbeat and very rarely palpitations.
Very rare (affects less than 1 in 100 people)
- An increased risk of cardiac arrhythmia . You may suffer from sudden dizziness or briefly become unconscious. This is especially important for people with a certain heart rhythm disorder, namely the extended QT interval . Do NOT use this medicine if you have this cardiac arrhythmia. Consult with your doctor. You may be able to switch to another means.
- Dizziness , especially when getting up from bed or from a chair. This is generally about if your body has adjusted to the medication. This is usually within a few days to weeks. People with heart failure can have more problems with this. If you feel dizzy, do not get up too quickly from a bed or chair. You can then lie down best and place the legs a bit higher, for example on a pillow. If you continue to suffer, discuss this with your doctor. You may be able to take the medicine in the evening, then you will have less dizziness during the day.
- Neuroleptic malignant syndrome . This can be seen in inexplicable fever, very stiff muscles, drowsiness, palpitations and severe sweating. Contact your doctor immediately if these symptoms occur. If it occurs, it usually occurs during the first 2 weeks of use or within 2 weeks after a dose increase.
- Blood clots in the bloodstream ( thrombosis ). This increases the risk of vascular diseases, such as thrombosis or stroke. The symptoms of thrombosis can be painful swelling of the leg or sudden shortness of breath. Contact your doctor immediately with these symptoms. People who have had thrombosis before or who are taking medicines for thrombosis have a greater chance of this. This can be recognized by a thick, hard, red and sore spot on the leg, sometimes pain in the calf and a heavy feeling in the leg, rarely from sudden shortness of breath, sometimes with pain or coughing up blood. In these cases, notify a doctor immediately, or go to the First Aid Service immediately.
- An attack can be triggered in people with epilepsy . Consult with your doctor if you can use this medication.
- Too much cholesterol and other fats in the blood. These can accumulate in the blood vessels, causing thrombosis (see very rare). Your doctor will check your cholesterol and / or fat content annually and more often in the first year of treatment. If you already have a high cholesterol and / or fat level in your blood, your doctor will check you extra for this.
- Swallowing problems. You may suffer from choking. When ingested, food can end up in the trachea instead of in the esophagus. You can get pneumonia because of this. Contact your doctor if you find that you have difficulty swallowing.
- Liver disorders . You may notice this by a sensitive swollen belly or a yellow discolouration of the whites or the skin. Then warn a doctor.
- Hair loss and hypersensitivity to sunlight .
- Blood disorders . If you get unpredictable fever, sore throat or blisters in the mouth and throat, sudden bruises or nosebleeds, this may indicate blood disorders. Then tell your doctor.
- Hypersensitivity to this medication. You will notice this by gallops or itching. Consult your doctor for these symptoms. Tell the pharmacy that you are hypersensitive to aripiprazole. The pharmacy team can then make sure that you do not get the medicine again. In rare cases angioedema develops: a swelling of the face, lips, mouth, tongue or throat. You can be very stuffy. If this happens, you should immediately seek out a doctor or go to the First Aid Service.
Consult your doctor if you suffer too much from one of the above mentioned side effects or if you experience other side effects that you are worried about.
There are many different types of antipsychotics. These do have the same effect, but different updating patterns. Possibly another antipsychotic is more suitable for you.
abilify drug interactions
Due to its 1- adrenergic receptor antagonist activity , aripiprazole may increase the effect of some antihypertensives.
In view of the main effects of aripiprazole on the central nervous system, caution is advised when combined with alcohol or other centrally acting medicinal products with side effects that add to those of aripiprazole, such as sedation .
Caution should be exercised when concomitant administration of aripiprazole with drugs known to cause QT prolongation or electrolyte imbalance.
Potential interactions affecting aripiprazole
- Famotidine, an antihistamine H 2 inhibitor of gastric acid secretion, reduces the absorption rate of aripiprazole, but this effect is not considered clinically significant. Aripiprazole is metabolized by multiple pathways involving CYP2D6 and CYP3A4 but not CYP1A enzymes. Therefore, no dosage adjustment is required for smokers.
Quinidine and other CYP2D6 inhibitors
- In a clinical study in healthy volunteers, a potent inhibitor of CYP2D6 (quinidine) increased the AUC of aripiprazole by 107%, while the C max was unchanged. The AUC and C max of the active metabolite, dehydro-aripiprazole, were decreased by 32% and 47%, respectively. The prescribed dose of aripiprazole should be reduced by approximately one-half when concomitant administration of aripiprazole with quinidine. Other potent CYP2D6 inhibitors, such as fluoxetine and paroxetine, are likely to have similar effects, and therefore the same dose reductions apply.
Ketoconazole and other CYP3A4 inhibitors
- In a clinical study in healthy volunteers, a potent inhibitor of CYP3A4 (ketoconazole) increased AUC and C max of aripiprazole by 63% and 37%, respectively. The AUC and C max of dehydro-aripiprazole were increased by 77% and 43%, respectively. In CYP2D6 poor metabolisers, concomitant use of strong CYP3A4 inhibitors may lead to higher plasma concentrations of aripiprazole compared to CYP2D6 rapid metabolisers.
- Co-administration of ketoconazole or other potent CYP3A4 inhibitors with aripiprazole is only considered if the expected benefits outweigh the risks. The prescribed dose of aripiprazole should be reduced by approximately one-half when concomitant administration of aripiprazole with ketoconazole. Other potent CYP3A4 inhibitors, such as itraconazole and PIs, are likely to have similar effects, and therefore the same dose reductions are recommended.
- When treatment with the CYP2D6 inhibitor or CYP3A4 is stopped, the dose of aripiprazole should be adjusted to the dosage used prior to initiation of concomitant therapy.
- When concomitant use of weak CYP3A4 inhibitors (eg, diltiazem or escitalopram) or CYP2D6 with Abilify (Aripiprazole) Tablets, moderate increases in aripiprazole concentrations may be expected.
Carbamazepine and other inducers of CYP3A4
- Concomitant administration of carbamazepine, a potent inducer of CYP3A4, resulted in a 68% and 73% decrease in geometric mean Cmax and aripiprazole AUC compared to aripiprazole (30 mg) alone. Similarly, the geometric mean Cmax and AUC of dehydro-aripiprazole were decreased by 69% and 71%, respectively, when co-administered with carbamazepine compared with aripiprazole alone.
- The dose of aripiprazole should be doubled when aripiprazole is co-administered with carbamazepine. Other potent inducers of CYP3A4, such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John’s wort, are likely to have similar effects, and therefore the same dose increases are recommended. Upon discontinuation of the potent CYP3A4 inducer, the dose of aripiprazole should be reduced to the recommended dosage.
Valproate and lithium
- Clinically significant changes in aripiprazole concentrations were not observed when valproate or lithium was concomitantly administered with aripiprazole.
- Cases of serotonin syndrome have been reported in aripiprazole-treated patients, and signs and symptoms of serotonin syndrome may occur, particularly when co-administered with serotonergic drugs such as SSRIs / NSRIs or medicines known to increase the concentrations of aripiprazole (see section 4.8 ).
Potential effects of aripiprazole on other medicines
- In clinical studies, aripiprazole at doses ranging from 10 to 30 mg / day had no significant effect on the metabolism of CYP2D6 substrates (dextromethorphan / 3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole) and CYP3A4 (dextromethorphan). In addition, aripiprazole and dehydro-aripiprazole did not demonstrate a potential for alteration of CYP1A2-dependent metabolism in vitro. As a result, it is unlikely that aripiprazole will cause clinically significant drug interactions involving these enzymes.
- No clinically significant changes in valproate, lithium or lamotrigine concentrations were observed when aripiprazole was co-administered with valproate, lithium or lamotrigine.
Abilify Tablets Warnings and Precautions
During an antipsychotic treatment, the improvement of the clinical state of the patient may take several days or even weeks. Patients should be closely monitored throughout this period.
- The occurrence of suicidal behavior is inherent in psychosis and mood disorders and in some cases has been reported rapidly after initiation or change of antipsychotic treatment, including with aripiprazole treatment .
- Close supervision of high-risk patients should accompany antipsychotic treatment.
- The results of an epidemiological study suggested that there was no increased risk of suicidal behavior with aripiprazole compared to other antipsychotics in adult patients with schizophrenia or bipolar disorder. Pediatric data are insufficient to assess this risk in younger patients (aged less than 18 years), but it has been shown that the risk of suicide persists beyond the first 4 weeks of treatment with atypical antipsychotics, including including aripiprazole.
- Aripiprazole should be used with caution in patients with known cardiovascular pathology (history of myocardial infarction or ischemic heart disease, heart failure, or conduction disorders), cerebrovascular disease, any pathology that may promote hypotension ( dehydration, hypovolemia, and treatment with antihypertensive drugs) or accelerated or malignant hypertension. Cases of thromboembolic events (ETEV) have been reported with antipsychotics. Since patients treated with antipsychotics often have risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with aripiprazole and preventive measures should be taken.
QT interval prolongation
- In clinical studies with aripiprazole, the incidence of QT prolongation was comparable to placebo. As with other antipsychotics, aripiprazole should be used with caution in patients with a family history of QT prolongation .
- In pre-market clinical studies of less than or equal to one year, reported cases of dyskinesia during aripiprazole treatment were infrequent. If signs and symptoms of tardive dyskinesia develop in a patient taking aripiprazole, dose reduction or discontinuation should be considered (see section 4.8 ). These symptoms may temporarily worsen or even occur after stopping treatment.
Other extrapyramidal symptoms
- In pediatric clinical studies with aripiprazole, symptoms such as akathisia and parkinsonism have been observed. If other extrapyramidal signs and symptoms occur in a patient treated with aripiprazole, a dose reduction and close clinical monitoring should be considered.
Neuroleptic malignant syndrome (NMS)
- SMN is a potentially fatal syndrome associated with antipsychotic treatments. In pre-market clinical studies, rare cases of NMS have been reported during aripiprazole treatment. The clinical signs of NMS are hyperthermia, muscle rigidity, impaired mental faculties and signs of neurovegetative instability (instability of pulse or blood pressure, tachycardia, sweating and cardiac arrhythmias). Signs such as increased CPK, myoglobinuria (rhabdomyolysis) and acute renal failure may be added. However, CPK elevation and rhabdomyolysis, not necessarily related to NMS, have also been reported. If a patient has signs or symptoms suggestive of NMS,
In pre-market clinical studies, uncommon cases of seizures have been reported during aripiprazole treatment. Therefore, aripiprazole should be used with caution in patients with a history of seizures or with a condition with associated seizures.
Elderly patients with psychotic condition associated with dementia
Increase in mortality
In three controlled clinical trials aripiprazole versus placebo (n = 938; mean age 82.4 years, range 56-99 years), in elderly patients with psychosis associated with Alzheimer’s disease, patients treated with aripiprazole had a higher mortality risk compared to placebo. The incidence of deaths in the aripiprazole-treated group was 3.5% compared to 1.7% in the placebo group. Although the causes of death were varied, most of these deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg pneumonia) .
Cerebrovascular adverse effects
In these same clinical studies, cerebrovascular adverse events (eg cerebrovascular accident, transient ischemic attack), some of which were fatal, were reported in these patients (mean age 84 years, range 78-88 years). In these studies, cerebrovascular adverse events were reported in 1.3% of aripiprazole-treated patients compared to 0.6% of placebo-treated patients. This difference was not statistically significant. However, in the fixed-dose study, a significant dose-dependence effect was observed in the occurrence of cerebrovascular adverse events in aripiprazole-treated patients .
Aripiprazole is not indicated for the treatment of psychotic states associated with dementia.
Hyperglycemia and diabetes
Cases of hyperglycaemia, sometimes serious and associated with ketoacidosis or coma, with fatal outcome in some cases, have been reported in patients treated with atypical antipsychotic drugs, including aripiprazole. Obesity and a family history of diabetes are risk factors that can lead to complications. In clinical studies with aripiprazole, there was no significant difference between aripiprazole and placebo groups in the incidence of hyperglycemia-related adverse events (including diabetes), or abnormal glucose. The data necessary for a precise estimate of the risk of occurrence of Hyperglycemia-related adverse events in patients treated with aripiprazole and any other atypical antipsychotics, allowing for direct comparison, are not available. Signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and fatigue) should be sought in patients treated with atypical antipsychotics, including aripiprazole. Regular monitoring is recommended to detect abnormal blood glucose levels in patients with diabetes or with risk factors that may promote the development of diabetes (see section 4.8). polyphagia and fatigue) should be sought in patients treated with atypical antipsychotics, including aripiprazole. Regular monitoring is recommended to detect abnormal blood glucose levels in patients with diabetes or with risk factors that may promote the development of diabetes (see section 4.8). polyphagia and fatigue) should be sought in patients treated with atypical antipsychotics, including aripiprazole. Regular monitoring is recommended to detect abnormal blood glucose levels in patients with diabetes or with risk factors that may promote the development of diabetes (see section 4.8).Side effects).
As with other medicines, allergic-type hypersensitivity reactions may occur with aripiprazole .
Weight gain is often observed in schizophrenic patients and bipolar patients with manic episodes due to comorbidities, the use of antipsychotics known to cause weight gain and poor lifestyle, which may lead to serious complications. Weight gain has been reported in patients treated with aripiprazole after marketing. When weight gain was observed, these were typically patients who had significant risk factors such as a history of diabetes, a thyroid disorder, or a pituitary adenoma. In clinical studies, aripiprazole did not result in clinically significant weight gain in). In clinical studies in bipolar adolescent patients following a manic episode, weight gain was associated with the use of aripiprazole after 4 weeks of treatment. Weight gain should be monitored in bipolar adolescent patients during manic episodes. If weight gain is clinically significant, a decrease in dosage should be considered (see section 4.8 ).
Esophageal transit disorders and inhalations of gastric contents have been associated with the use of antipsychotic drugs, including aripiprazole. Aripiprazole and other antipsychotic active substances should be used with caution in patients at risk of swallowing pneumonia.
Cases of pathological gambling have been reported in patients treated with aripiprazole after marketing, whether or not these patients have a history of pathological gambling. Patients with a history of pathological gambling may be at higher risk and should be closely monitored (see section 4.8 ).
Abilify (Aripiprazole) Tablets tablets contains lactose. This drug is contraindicated in patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. (rare hereditary diseases).
Patient with associated ADHD
Despite the high frequency of bipolar I disorder associated with ADHD, clinical safety data are very limited regarding the concomitant use of aripiprazole and psychostimulants; therefore, extreme caution should be exercised when these drugs are coadministered.
Drive and use machines
As with other antipsychotics, patients should be cautioned about the use of machinery, including driving motor vehicles, until they are reasonably certain that aripiprazole not affect adversely. Some pediatric patients with bipolar I disorder have a higher incidence of somnolence and fatigue (see section 4.8 ).
Abilify Tablets and PREGNANCY / Breastfeeding
- No specific controlled studies have been conducted with aripiprazole in pregnant women. Congenital anomalies have been reported; however, a causal relationship with aripiprazole could not be established. Studies in animals have not been able to exclude potential toxicity to development ( see Preclinical Safety ). Patients should be advised of the need to inform their physician of any pregnancy or desire for pregnancy during aripiprazole therapy. Due to insufficient information on tolerance in humans and questions raised by reproduction studies in animals, the drug should not be administered during pregnancy,
- Infants exposed to antipsychotics (including aripiprazole) during the third trimester of pregnancy have a risk of adverse reactions including extrapyramidal symptoms and / or withdrawal symptoms, which may vary in severity and duration after delivery. The following reactions have been reported: agitation, hypertonia, hypotonia, tremor, drowsiness, respiratory distress, eating disorder. As a result, newborns must be closely monitored.
- Aripiprazole is excreted in breast milk. Breast-feeding should therefore not be recommended for patients being treated with aripiprazole.
What should I do if I miss a dose?
It is important to take this medicine consistently. If you have forgotten a dose.
- You use this medicine once a day : does it take more than 8 hours before you take the next dose normally? Take the forgotten dose as yet. Does it take less than 8 hours? Skip the dose you missed.
What happens if I overdose from Abilify ?
Signs and symptoms:
In clinical and post-marketing studies, acute, accidental or intentional overdose with aripiprazole alone at doses up to 1260 mg has been reported in adult patients with no fatal outcome. Significant signs and symptoms that were observed included lethargy, increased blood pressure, drowsiness, tachycardia, nausea and vomiting, and diarrhea. In addition, cases of accidental overdose with aripiprazole alone (at doses up to 195 mg) have been reported in children with no fatal outcome. The potentially serious clinical signs and symptoms that were reported included somnolence, transient loss of consciousness, and extrapyramidal symptoms.
- The management of overdose is mainly symptomatic, by the maintenance of respiratory function, oxygenation and ventilation, and the management of symptoms. The possibility of polymedicidal intoxication should be considered. Therefore, cardiovascular monitoring should be initiated immediately and should include continuous electrocardiogram recording for arrhythmias. After any overdose confirmed or suspected with aripiprazole, close medical and cardiovascular monitoring should be continued until the patient is cured.
- The administration of 50 g of activated charcoal, one hour after the administration of aripiprazole, decreased the Cmax of aripiprazole by approximately 41% and AUC by approximately 51%, suggesting that anthrax can be effective for the treatment of overdose.
- Although there is no information regarding the benefit of hemodialysis in the treatment of an overdose with aripiprazole, it is unlikely that hemodialysis will be useful for the management of overdosage since aripiprazole is strongly bound to plasma proteins.
What is Forms and Composition ?
5 mg tablet (rectangular, engraved “A-007” and “5” on one side, blue): Box of 28, in blister packs, pre-cut in unit doses. 10 mg tablet (rectangular, engraved “A-008” and “10” on one side, pink): Box of 28, in blister packs, pre-cut in unit doses. 15 mg tablet (round, engraved “A-009” and “15” on one side, yellow): Box of 28, in blister packs, pre-cut in unit doses. 10 mg orodispersible tablet (round, engraved “A” above “640” on one side and “10” on the other, pink): Box of 28, in blister packs, pre-cut in single doses.
Orodispersible 15 mg tablet (round, engraved “A” above “641” on one side and “15” on the other side, yellow): Box of 28, in blister packs, pre-cut in unit doses.
1 mg / ml oral solution (clear, colorless to light yellow): Bottle of 150 ml closed with a stopper * with child safety closure + graduated dosing system * + graduated dosing cap * , unitary box.
* In polypropylene.
Solution for injection at 7.5 mg / ml (clear, colorless aqueous): 1.3 ml single-use vial with bromobutyl stopper + flipp-off capsule, unit box.
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