Schedule H

Oral

Formulation Strengths Available

Tablets 150 mg, 300 mg

Note: Availability is limited and varies significantly by state; not widely marketed across all Indian regions.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Major Depressive Disorder (Unipolar)

Parameter Recommendation

Starting dose 300 mg/day in 2 divided doses (150 mg BD)

Titration May increase to 600 mg/day after 1 week if inadequate response

Usual maintenance dose 300–600 mg/day in 2–3 divided doses

Maximum dose 600 mg/day

Clinical Notes:

• Response typically observed within 2–4 weeks

• Lower incidence of sexual dysfunction and weight gain compared to SSRIs

• Administer doses after meals to reduce GI upset

1. Social Anxiety Disorder

Parameter Recommendation

Starting dose 150 mg twice daily

Titration Adjust to 300–600 mg/day based on efficacy and tolerability

Usual maintenance dose 300–600 mg/day in divided doses

Maximum dose 600 mg/day

Clinical Notes:

• Useful alternative when SSRIs are not tolerated

• Less sedating profile than tricyclics

• Minimum 8–12 weeks trial recommended for anxiety disorders

Secondary Indications – Adults (Off-label)

Indication Dose Duration Notes

Atypical Depression (OFF-LABEL) 300–600 mg/day in 2–3 divided doses Based on clinical response Specialist only; supported by small RCTs; rare use in India

Dysthymia / Persistent Depressive Disorder (OFF-LABEL) Starting: 150 mg BD; Titrate up to 600 mg/day Long-term, based on response Specialist only; alternative to SSRIs where RIMA profile preferred

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

NOT RECOMMENDED in children or adolescents under 18 years due to lack of safety and efficacy data in Indian or global paediatric populations.

Secondary Indications – Paediatric (Off-label)

Not applicable.

No established off-label paediatric indications exist. Use in patients <18 years is not advised except under psychiatry specialist supervision in exceptional circumstances.

• Known hypersensitivity to moclobemide or any excipients

• Acute confusional states

• Concurrent use with other MAO inhibitors (including selegiline, rasagiline)

• Concurrent use with SSRIs, SNRIs, or clomipramine (washout of at least 2 weeks required before switching)

• Concurrent use with pethidine (meperidine) or tramadol

• Phaeochromocytoma

• Thyrotoxicosis (uncontrolled)

• History of bipolar disorder (risk of manic switch/hypomania)

• Concurrent serotonergic agents (risk of serotonin syndrome)

• Tyramine-rich foods: less critical than with irreversible MAOIs, but caution advised particularly at doses >450 mg/day

• Hepatic impairment (see dosing adjustments)

• Suicidal ideation: monitor closely during early treatment phases (first 4–6 weeks)

• Agitation or anxiety at initiation

• Concurrent use of sympathomimetic agents

• History of seizures

Parameter Details

Risk category Not formally classified in India; limited human data available

Overall safety Use discouraged unless potential benefit clearly justifies fetal risk

Preferred alternatives SSRIs (particularly sertraline) generally preferred in Indian obstetric psychiatric practice

When may be used Only if benefit outweighs risk; requires specialist psychiatric and obstetric input

Monitoring required Fetal growth surveillance; neonatal observation for withdrawal symptoms and poor adaptation syndrome if used near term

Parameter Details

Compatibility Not established; likely low levels excreted in breast milk

Preferred alternatives Sertraline preferred if antidepressant required during lactation

Expected drug levels in milk Low (based on limited data)

Monitoring in infant Observe for feeding difficulties, sedation, irritability, weight gain patterns

Parameter Recommendation

Starting dose 150 mg/day in divided doses

Titration Slower titration advised (increase every 2 weeks rather than weekly)

Maximum dose Consider limiting to ≤450 mg/day in frail individuals

Special considerations Monitor for orthostatic hypotension, agitation, confusion, and CNS effects; assess fall risk

SSRIs (fluoxetine, sertraline, paroxetine) Serotonin syndrome ⛔ CONTRAINDICATED; 2-week washout required (5 weeks for fluoxetine)

SNRIs (venlafaxine, duloxetine) Serotonin syndrome ⛔ CONTRAINDICATED

Clomipramine / Tricyclic antidepressants Serotonin syndrome, seizures ⛔ CONTRAINDICATED

Pethidine (meperidine) CNS toxicity, serotonin syndrome ⛔ CONTRAINDICATED

Tramadol Serotonin syndrome, seizures ⛔ CONTRAINDICATED

Selegiline, rasagiline Additive MAO inhibition, hypertensive crisis ⛔ CONTRAINDICATED

Sympathomimetics (pseudoephedrine, phenylephrine) Hypertensive reactions ⛔ Avoid combination

Dextromethorphan Serotonin syndrome ⛔ Avoid combination

Interacting Drug/Class Effect/Risk Recommendation

Cimetidine Increased moclobemide levels via CYP inhibition Use lower dose of moclobemide; monitor for adverse effects

Alcohol Enhanced CNS depressant effects Discourage use; counsel patients

Antiepileptics (phenytoin, carbamazepine) Altered moclobemide metabolism via CYP induction Monitor therapeutic efficacy

Rifampicin Decreased moclobemide levels via CYP induction Monitor for reduced efficacy; may need dose adjustment

Opioids (morphine, codeine) Enhanced CNS depression Use with caution; reduced opioid doses may be required

Buspirone Potential for enhanced serotonergic effects Use with caution; monitor

• Nausea

• Insomnia

• Dizziness

• Dry mouth

• Headache

• Restlessness/agitation

• Tremor

• Constipation

Adverse Effect Action Required

Serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability) Discontinue immediately; supportive care; may require hospitalisation

Hepatotoxicity (rare) Monitor LFTs if symptomatic (jaundice, abdominal pain); discontinue if confirmed

Hypomania/manic switch Discontinue; evaluate for bipolar disorder; mood stabiliser may be required

Hypertensive crisis (rare; at high tyramine loads) Discontinue; manage hypertension; rare with moclobemide compared to irreversible MAOIs

Severe skin reactions (rare) Discontinue; dermatology referral

Phase Parameters

Baseline Mental health evaluation; suicide risk assessment; hepatic function (LFTs); blood pressure

After initiation Mood, sleep, suicidality — review biweekly for first 4 weeks

Ongoing LFTs if symptomatic; blood pressure in patients with hypertension; review for drug interactions at every new prescription

Long-term Periodic mental status evaluation; assess need for continued therapy

Brand Name Manufacturer Notes

Depnil Intas Pharmaceuticals Available in select regions

Moclob Limited availability Regional distribution

Note: Availability varies significantly by state. Not consistently stocked across all regions. May require special order.

• NLEM status: Not included in NLEM

• DPCO/price control: Not under price control

• Government supply: Not routinely available in government supply chains

1. Dietary flexibility: Moclobemide has significantly lower tyramine dietary restrictions compared to classical irreversible MAOIs (phenelzine, tranylcypromine); however, advise caution with large quantities of aged cheeses and fermented foods at doses >450 mg/day.

1. Favourable tolerability profile: Lower incidence of sexual dysfunction and weight gain compared to SSRIs — consider in patients where these are concerns.

1. Washout periods are critical: Before switching to/from other serotonergic antidepressants, observe adequate washout (minimum 24–48 hours after stopping moclobemide; 2 weeks before starting moclobemide after SSRIs; 5 weeks after fluoxetine).

1. Limited use in Indian practice: Rarely used as first-line; mostly specialist prescription for treatment-resistant or atypical depression.

1. Not for rapid stabilisation: Requires gradual titration; not suitable for patients requiring immediate mood stabilisation.

1. Hypertensive crisis risk is low but not absent: Considerably safer than non-selective irreversible MAOIs, but vigilance still required especially with sympathomimetics.

moclobemide; RIMA; reversible MAO-A inhibitor; antidepressant; major depressive disorder; social anxiety disorder; serotonin syndrome; psychiatry; Schedule H; specialist-only

RxIndia v1.0 — 12 May 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• API Textbook of Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• AIIMS Psychopharmacology protocols (internal reference)

• Select RCTs/meta-analyses — referenced for off-label indications only