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Obsenil

Obsenil (Clomipramine 10–75 mg) — most serotonergic TCA for OCD refractory to two SSRIs. highest evidence-based OCD efficacy of any drug.

Medicinsk gennemgået af Morgan Ellis — Apoteksforsker · 8 års erfaring  · Sidst gennemgået: maj 2026

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Obsenil (Clomipramine 10 / 25 / 50 / 75 mg) is a tricyclic antidepressant. Most effective antidepressant for OCD; reserved for SSRI-refractory disease because of side-effect burden.

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What Obsenil is and how it works

Obsenil is a Clomipramine-containing tablet supplied by Sun Pharma. Available strengths: 10 / 25 / 50 / 75 mg.

Clomipramine is the most serotonergic TCA and the most effective antidepressant of any class for OCD. The CMI-Collaborative Study (1991) and subsequent meta-analyses show clomipramine outperforms SSRIs for OCD by approximately 5–10 percentage points on response rate. It is reserved for OCD that has failed at least two adequate SSRI trials (including high-dose) because of its tolerability burden.

Tricyclic antidepressants block the reuptake of serotonin and noradrenaline at presynaptic transporters, similar to SSRIs and SNRIs. Their tolerability disadvantage comes from off-target receptor blockade: muscarinic (anticholinergic side effects), histaminergic H1 (sedation, weight gain), and α1-adrenergic (orthostatic hypotension). They also block fast sodium channels in cardiac tissue — the basis for both their analgesic action and their cardiac toxicity in overdose.

Clomipramine + SSRI combinations are sometimes used for severe refractory OCD but require careful TDM and serotonin-syndrome monitoring.

Indikationer og dosering

IndikationStartdosisMåldosisMaksimal dosis
OCD (adult)25 mg HS × 1 wk100–250 mg/day250 mg
OCD (paediatric ≥10 y)25 mg HS3 mg/kg or 100 mg (lower)200 mg
Major depression / panic25 mg HS100–225 mg/day250 mg
Premature ejaculation (off-label)10–25 mg PRN or 25 mg/day

Vigtige sikkerhedsovervejelser

Cardiac risk and overdose toxicity

TCAs prolong QRS and QT, and overdose is life-threatening — historically the most common cause of antidepressant fatalities. Baseline ECG before initiating in patients with known cardiac disease, on QT-prolonging therapy, or in older adults. Do not start in recent MI, conduction abnormality, uncompensated heart failure, or congenital long QT. Limit dispense quantities in patients at suicide risk — the therapeutic-to-toxic ratio is narrow.

Anticholinergic burden

Dry mouth, constipation, blurred vision, urinary hesitancy, cognitive slowing — universal at therapeutic doses. Avoid in narrow-angle glaucoma, BPH with significant retention, and dementia. Pair with chewing gum / sugar-free lozenges, fibre + fluid, and stool softeners.

Selvmordstendens sortboks (under 25 år)

All antidepressants carry an FDA black-box warning for increased suicidal ideation in patients under 25 — particularly relevant for clomipramine in adolescent OCD.

Almindelige bivirkninger

  • Anticholinergic: dry mouth, constipation, blurred vision, urinary hesitancy.
  • Sedation: particularly doxepin and clomipramine; bedtime dosing helps.
  • Cardiovascular: orthostatic hypotension (α1 block), tachycardia, conduction-interval prolongation.
  • Metabolic: weight gain (5–10 kg over 12 months in many patients), increased appetite.
  • Sexual: reduced libido, delayed ejaculation (sometimes used clinically for premature ejaculation), erectile difficulty.
  • Withdrawal: taper over 4 weeks; abrupt cessation produces flu-like symptoms, GI upset, and sleep disturbance.

Lægemiddelinteraktioner

  • MAOIs — absolute contraindication. 14-day washout each direction.
  • SSRIs / SNRIs — additive serotonergic risk; CYP2D6 inhibition by fluoxetine and paroxetine raises TCA levels.
  • QT-forlængende lægemidler (azoles, macrolides, amiodarone, sotalol, methadone, ondansetron, antipsychotics) — additive risk.
  • Other anticholinergics (oxybutynin, benztropine, antihistamines, clozapine, olanzapine) — additive burden in older adults.
  • CNS depressants — additive sedation.
  • Tramadol, bupropion, fluoroquinolones — lower seizure threshold; additive seizure risk.

Graviditet, amning, pædiatrisk

TCAs are FDA pregnancy category C. Late-pregnancy exposure can produce neonatal anticholinergic withdrawal. Lactation: TCAs pass into breast milk in small amounts; nortriptyline and imipramine are the most-studied. Paediatric: imipramine is licensed from age 6 (enuresis) and clomipramine from age 10 (OCD); doxepin in adolescents only with specialist input.

Opbevaring

Store at 15–30 °C, away from direct sunlight, in original packaging. Keep out of reach of children — TCA paediatric ingestion is a medical emergency.

Ofte stillede spørgsmål

How long until Obsenil works?

TCAs typically show benefit within 2–4 weeks. The sleep and anxiety improvements often appear in week 1; the antidepressant effect builds over 4–6 weeks. For OCD, allow 8–12 weeks at therapeutic dose before judging response.

Why bedtime dosing?

Doxepin, clomipramine, and imipramine are all sedating. Bedtime dosing recruits the sedation as a side-effect benefit (sleep) instead of a side-effect burden (daytime drowsiness). It also reduces orthostatic hypotension by sleeping through the peak.

Is Obsenil safe in older adults?

TCAs are on the Beers Criteria list of potentially inappropriate medications in older adults because of anticholinergic burden, orthostatic hypotension, and cardiac risk. They are not absolutely contraindicated but are generally second-line — SSRIs/SNRIs are preferred unless a specific benefit (e.g. pain, sleep) outweighs the risks.

Can I drink alcohol on Obsenil?

Alcohol amplifies TCA sedation and orthostatic effects. Limit to occasional and modest consumption; avoid binge drinking entirely. The combination is not usually dangerous in moderation but feels worse than either alone.

What is the overdose risk?

TCAs are among the most lethal classes of medication in overdose — cardiac conduction collapse, seizures, and coma can occur at relatively low multiples of the therapeutic dose. Limit dispense quantities in patients at any suicide risk. If overdose is suspected, present to emergency immediately — sodium bicarbonate is the antidote for the cardiac toxicity but timing matters.

Will Obsenil affect my driving?

Sedation and reaction-time impairment are common in the first 1–2 weeks. Avoid driving until steady-state tolerability is known. Some patients tolerate full doses indefinitely without driving impairment; others remain too sedated even at low doses.

Can Obsenil be combined with an SSRI?

Generally no — combination raises serotonin syndrome risk and serum TCA levels (particularly with fluoxetine and paroxetine). The combination is sometimes used in refractory OCD or depression under specialist supervision with TDM, never empirically.

How do I taper Obsenil?

Reduce by approximately 25–50% of the dose every 2 weeks. Withdrawal (sometimes called “TCA flu”) produces malaise, GI upset, and sleep disturbance — manageable with slower tapers. Talk to the prescriber before stopping.

Does Obsenil cause weight gain?

Yes — most TCAs cause meaningful weight gain over 6–12 months, often 5–10 kg. Doxepin and amitriptyline are the worst; nortriptyline less so. If this is a major concern, raise it before initiation — an SSRI/SNRI may be a better fit.

Can Obsenil be used for chronic pain?

Yes — TCAs (especially amitriptyline, nortriptyline, and imipramine) at low doses (10–75 mg) are first-line for diabetic peripheral neuropathy, post-herpetic neuralgia, and tension-type chronic headache. Sodium-channel blockade is the dominant mechanism. The analgesic effect is independent of the antidepressant effect and appears earlier (1–2 weeks).

Andre Mental Sundhedsmedicin

Medicinsk ansvarsfraskrivelse. Denne side er udelukkende til informationsformål og er ikke erstatning for individuel lægevejledning. Behandling med psykofarmaka bør iværksættes, overvåges og tilpasses af en kvalificeret kliniker. Hvis du eller nogen du kender er i akut selvmordskrise, skal du kontakte lokale akutteams eller ringe til din lands selvmordsforebyggende kriselinje (US/Canada: 988; UK: Samaritans 116 123; international liste: findahelpline.com).

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Styrke

10 mg, 25 mg, 50 mg

Antal

30 Tablet/s, 60 Tablet/s, 90 Tablet/s, 180 Tablet/s

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