Reagila capsules (Hard Gelatin)
Cariprazine
1.5mg
HIKMA PHARMACEUTICALS LLC
| Pack size | 28's (7's Blister x 4 ) |
|---|---|
| Dispensing mode | ALPHAMED DRUG STORE |
| Source | |
| Agent | UAE |
| Retail Price | 439.50 AED |
Available as:
Indications
Reagila capsules (Hard Gelatin) is used for:
Schizophrenia, Indicated for acute treatment of manic or mixed episodes associated with, bipolar disorder
Adult Dose
Adults
Schizophrenia
Starting dose: 1.5 mg PO qDay
Dose may be increased to 3 mg/day on Day 2
Depending upon clinical response and tolerability, further dose adjustments can be made in 1.5 to 3-mg increments
Dosage range: 1.5-6 mg PO qDay
Bipolar Disorder
Indicated for acute treatment of manic or mixed episodes associated with bipolar I disorder
Starting dose: 1.5 mg PO qDay
Dose should be increased to 3 mg/day on Day 2
Depending on clinical response and tolerability, further dose adjustments can be made in 1.5 to 3-mg increments
Dosage range: 3-6 mg PO qDay
Hepatic impairment
Mild-to-moderate (Child-Pugh score 5-9): No dosage adjustment required
Severe (Child-Pugh score 10-15): Not recommended
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate (CrCl ?30 mL/min): No dosage adjustment required
Severe (CrCl <30 mL/min): Not recommended; safety and efficacy has not been established
Administration
Take orally with or without food
Contra Indications
History of hypersensitivity to cariprazine
Precautions
Antipsychotic drugs increase the all-cause risk of death in elderly patients with dementia-related psychosis; a higher incidence of stroke and TIA, including fatal stroke, was also observed (see Black Box Warnings)
Hypersensitivity reactions have ranged from rash, pruritus, urticaria, and events suggestive of angioedema (eg, swollen, tongue, lip swelling, face edema, pharyngeal edema, facial swelling)
Neuroleptic malignant syndrome reported; monitor for hyperpyrexia, muscle rigidity, delirium, and autonomic instability; other signs include increased CPK, myoglobinuria (rhabdomyolysis), and acute renal failure; if NMS is suspected, immediately discontinue treatment
Tardive dyskinesia, a potentially irreversible, involuntary, dyskinetic movement syndrome, may develop in patients treated with antipsychotics
May cause seizures; risk is greatest with history of seizures or conditions that lower seizure threshold
May cause cognitive and motor impairment
May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; for patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy
Lactation
Unknown if distributed in human breast milk
Pregnancy-Lactation
Pregnancy
Neonates exposed to antipsychotic drugs during third trimester of pregnancy are at risk for extrapyramidal symptoms or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU support and prolonged hospitalization
Lactation
Unknown if distributed in human breast milk
Present in rat milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
Coadministration with a strong CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of cariprazine alone
Adverse Effects
Side effects of Cariprazine :
>10% (Schizophrenia)
Extrapyramidal symptoms, all (24-33%)
Parkinsonism (13-18%)
Headache (9-18%)
Akathisia (9-14%)
Insomnia (11-13%)
>10% (Bipolar Disorder)
Extrapyramidal symptoms, all (41-45%)
Parkinsonism (21-26%)
Akathisia (20-21%)
Headache (13-14%)
Nausea (11-13%)
Constipation (6-11%)
1-10% (Schizophrenia)
Constipation (6-10%)
Somnolence (5-10%)
Nausea (5-8%)
Abdominal pain (3-7%)
Restlessness (4-6%)
Anxiety (3-6%)
Toothache (3-6%)
Hypertension (2-6%)
Dyspepsia (4-5%)
Vomiting (4-5%)
Dizziness (3-5%)
Agitation (3-5%)
Diarrhea (1-5%)
Pain in extremity (2-4%)
Cough (1-4%)
Tachycardia (2-3%)
Increased weight (2-3%)
Decreased appetite (1-3%)
Dry mouth (1-3%)
Fatigue (1-3%)
Increased CPK (1-3%)
Musculoskeletal stiffness (1-3%)
Back pain (1-3%)
Dystonia (2%)
Tachycardia (1-2%)
Arthralgia (1-2%)
Increased LFTs (1-2%)
Nasopharyngitis (1-2%)
Urinary tract infections (1-2%)
Rash (1-2%)
1-10% (Bipolar Disorder)
Vomiting (8-10%)
Insomnia (8-9%)
Dyspepsia (7-9%)
Somnolence (7-8%)
Abdominal pain (6-8%)
Restlessness (7%)
Dizziness (6-7%)
Diarrhea (5-6%)
Hypertension (4-5%)
Fatigue (4-5%)
Dystonia (3-5%)
Blurred vision (4%)
Decreased appetite (3-4%)
Toothache (3-4%)
Pain in extremity (2-4%)
Pyrexia (1-4%)
Weight increased (2-3%)
Increased CPK (2-3%)
Dry mouth (2-3%)
Oropharyngeal pain (1-3%)
Back pain (1-3%)
Increased LFTs (1-3%)
Musculoskeletal stiffness (2%)
Mechanism of Action
Precise mechanism by which cariprazine works for schizophrenia or bipolar disorder is unknown
Efficacy could be mediated through a combination of partial agonist activity at central dopamine (D2) and serotonin 5-HT1A receptors
Forms 2 major metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), that have in vitro receptor binding profiles similar to the parent drug
Note
Reagila 1.5mg capsules (Hard Gelatin) manufactured by HIKMA PHARMACEUTICALS LLC. Its generic name is Cariprazine. Reagila is availble in United Arab Emirates.
Farmaco UAE drug index information on Reagila capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.