Arpolax20 mg

Established / FDA-Approved Use

• Major Depressive Disorder (MDD) in adults: Arpolax is FDA-approved for the acute and maintenance treatment of major depressive disorder in adult patients.

Guideline-Supported / Commonly Used Off-Label Uses

Arpolax is not FDA-approved for the indications below, but is supported by clinical evidence and commonly prescribed off-label by physicians, usually after first-line options are considered:

• Panic disorder (with or without agoraphobia)
• Generalized anxiety disorder (GAD)
• Obsessive-compulsive disorder (OCD)
• Post-traumatic stress disorder (PTSD)

Use for these off-label indications should be individualized and directed by a qualified physician.

Each film-coated tablet contains Citalopram Hydrobromide equivalent to citalopram base, commonly available in strengths of 10 mg, 20 mg, and 40 mg. An oral solution containing citalopram base equivalent to 10 mg/5 mL is also available in some markets. Citalopram Hydrobromide is the salt form used in the finished pharmaceutical product; the active moiety is citalopram base.

Arpolax is a bicyclic phthalane derivative and a selective serotonin reuptake inhibitor (SSRI) antidepressant. It is chemically distinct from tricyclic, tetracyclic, and other available antidepressant agents. Arpolax is used clinically for the treatment of major depressive disorder and, off-label, for several anxiety-spectrum disorders. As with other SSRIs, its antidepressant effect is thought to be related to potentiation of serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin.

Arpolax belongs to the Selective Serotonin Reuptake Inhibitor (SSRI) class of antidepressants.

Citalopram Hydrobromide selectively inhibits the presynaptic reuptake of serotonin (5-hydroxytryptamine) in the central nervous system, increasing serotonergic neurotransmission at the synapse. It has minimal effect on norepinephrine or dopamine reuptake and negligible affinity for histaminergic, cholinergic, and adrenergic receptors, which accounts for its comparatively favorable side-effect profile relative to older antidepressant classes.

Citalopram Hydrobromide is well absorbed after oral administration, with peak plasma concentrations reached in approximately 2-4 hours; absorption is not significantly affected by food. It undergoes hepatic metabolism, primarily via CYP2C19, with additional contribution from CYP3A4 and CYP2D6, to form desmethylcitalopram and other metabolites with substantially weaker pharmacologic activity. The elimination half-life is approximately 35 hours, supporting once-daily dosing. Elimination occurs via both hepatic metabolism and renal excretion.

• Arpolax is administered orally, once daily, in the morning or evening, with or without food.
• Tablets should be swallowed with a glass of water; they may be taken with food if stomach upset occurs.
• Dose increases should not occur more frequently than once weekly.
• Do not stop Arpolax suddenly without consulting a physician; a gradual dose taper is recommended when discontinuing.
• If a dose is missed, it should be taken as soon as remembered unless it is close to the time of the next dose, in which case the missed dose should be skipped — do not double the dose.

Common Side Effects

Serious but Less Common Side Effects

• Serotonin syndrome (agitation, hallucinations, fever, tachycardia, muscle rigidity/twitching, loss of coordination)
• Dose-dependent QT-interval prolongation and, rarely, torsades de pointes (see Precautions and Warnings)
• Hyponatremia, including SIADH, particularly in elderly patients
• Activation of mania or hypomania in patients with underlying bipolar disorder
• Abnormal bleeding (bruising, gastrointestinal bleeding)
• Angle-closure glaucoma
• Increased risk of suicidal thinking and behavior, particularly in children, adolescents, and young adults under 25 (boxed warning — see Precautions and Warnings)

Pregnancy: Arpolax should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under close medical supervision. Use of SSRIs, including Arpolax, in the third trimester has been associated with neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, including neonatal adaptation syndrome and, less commonly, persistent pulmonary hypertension of the newborn (PPHN). Arpolax should not be stopped without consulting a physician, as untreated depression itself carries risks in pregnancy.

Lactation: Arpolax and its metabolites are present in human breast milk. Breastfed infants should be monitored for sedation, poor feeding, and inadequate weight gain. A physician should be consulted to weigh the benefits of breastfeeding against the potential risk of infant exposure.

Boxed Warning: Suicidality

Antidepressants, including Arpolax, increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (under age 25), especially during the first few months of treatment and following dose changes. All patients started on Arpolax should be monitored closely for clinical worsening, unusual behavior changes, and suicidality. Arpolax is not approved for use in pediatric patients.

QT Interval Prolongation

Arpolax causes dose-dependent prolongation of the QT interval, which can lead to torsades de pointes, ventricular tachycardia, and sudden death. Doses above 40 mg/day should be avoided in all patients. Arpolax is not recommended in patients with congenital long QT syndrome, bradycardia, hypokalemia, hypomagnesemia, recent myocardial infarction, uncompensated heart failure, or concomitant use of other QT-prolonging drugs; ECG monitoring should be considered in these situations.

Serotonin Syndrome

Concomitant use with other serotonergic agents can cause serotonin syndrome, a potentially life-threatening condition. Patients should be monitored for agitation, hallucinations, autonomic instability, and neuromuscular abnormalities.

Hyponatremia

Hyponatremia, sometimes severe, may occur, particularly in elderly patients and those on diuretics or with volume depletion; discontinuation should be considered in symptomatic cases.

Discontinuation Symptoms

Abrupt discontinuation can cause dizziness, sensory disturbances, anxiety, and irritability. The dose should be tapered gradually under medical supervision rather than stopped suddenly.

Other Precautions

• May activate mania or hypomania in patients with bipolar disorder; screen for bipolar history before starting.
• May increase risk of abnormal bleeding, especially with concurrent NSAIDs, aspirin, or anticoagulants.
• May precipitate angle-closure glaucoma in susceptible patients.
• Use with caution in patients with a history of seizures.
• Dose adjustment is required in hepatic impairment, elderly patients, and CYP2C19 poor metabolizers (see Dosage and Administration).

Overdose with Arpolax may cause dizziness, tremor, drowsiness, sinus tachycardia, QT and QRS interval prolongation, arrhythmias including torsades de pointes, seizures, and, rarely, coma or serotonin syndrome. Overdose severity may increase when combined with alcohol or other CNS depressants.

Suspected overdose is a medical emergency. Seek immediate medical attention or contact emergency services / a poison control center right away. Cardiac (ECG) monitoring is typically required, and treatment is supportive, provided under medical supervision; no specific antidote is available.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Pediatric Use

Safety and effectiveness of Arpolax have not been established in patients under 18 years of age. Arpolax carries a boxed warning for increased suicidal thinking/behavior in pediatric and young adult patients and is not FDA-approved for pediatric use.

Geriatric Use (Elderly)

Patients over 60 years are more susceptible to QT prolongation and hyponatremia; the maximum recommended dose in this group is 20 mg once daily. See Dosage and Administration.

Hepatic Impairment

Maximum recommended dose is 20 mg once daily due to reduced clearance.

Renal Impairment

No adjustment generally required in mild-to-moderate impairment; caution is advised in severe renal impairment.

Pregnancy and Lactation

See Pregnancy and Lactation section for detailed guidance.

For major depressive disorder, an adequate treatment trial with Arpolax is generally 4-6 weeks at an effective dose before assessing full response. Once a response is achieved, treatment is typically continued for at least 6-9 months to reduce the risk of relapse, and longer in patients with a history of recurrent depression. The need for continued treatment should be reassessed periodically by the prescribing physician. Arpolax should not be discontinued abruptly; a gradual dose taper is recommended (see Precautions and Warnings).

Selective Serotonin Reuptake Inhibitor (SSRI)

Citalopram Hydrobromide selectively and potently inhibits the reuptake of serotonin (5-HT) at the presynaptic neuronal membrane in the central nervous system, increasing the availability of serotonin in the synaptic cleft and enhancing serotonergic neurotransmission, which is believed to underlie its antidepressant and anxiolytic effects. It has minimal affinity for norepinephrine and dopamine transporters and negligible activity at histaminergic, muscarinic-cholinergic, and adrenergic receptors compared with older antidepressant classes.

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The safety and effectiveness of Arpolax have not been established in pediatric patients, and it is not FDA-approved for any indication in children or adolescents. Arpolax carries a boxed warning regarding increased risk of suicidal thinking and behavior in pediatric and young adult patients (under 25 years), which was identified in placebo-controlled trials of antidepressants in this age group. If a physician determines that treatment with Arpolax is necessary in a pediatric patient despite the lack of established safety and efficacy, close monitoring for clinical worsening and emergence of suicidality is essential, especially during the first few months of treatment and after dose changes.