Dominal

Instructions for use: Dominal

Brief reference information compiled from official German sources (Gelbe Liste, Fachinfo, Apotheken Umschau). It does not replace a doctor’s consultation or the package insert. This is a prescription medicine — use it only as directed by a doctor.

Active substance

Prothipendyl (as prothipendyl hydrochloride monohydrate) — a mild first-generation tricyclic antipsychotic of the azaphenothiazine group with a pronounced sedative effect (ATC N05AX07). It blocks dopamine D1/D2 receptors and, to a lesser extent, serotonin 5-HT2A receptors.

Available forms

In Germany (per Gelbe Liste and the Teva Fachinformation) the following are registered: Dominal 40 mg — coated tablets; Dominal forte 80 mg — film-coated tablets; Dominal Tropfen — oral drops (solution, 50 mg of prothipendyl/ml). However, Dominal Tropfen drops have now been withdrawn from sale (status «Außer Handel»): the form remains in the current Teva Fachinformation but is not available in the actual German range (the Gelbe Liste page for the drops returns a 404, Shop-Apotheke marks them as «Außer Handel», and a Lieferengpass was previously recorded). Thus, only Dominal 40 mg and Dominal forte 80 mg tablets are actually available. A solution for injection is not listed in the current German range. The marketing authorisation holder per the current Fachinformation is Teva GmbH (Ulm).

Indications

• Psychomotor agitation and states of agitation in mental illness — the official indication per the German prescribing information (Fachinformation/Beipackzettel)
• States of restlessness and anxiety in psychoses and anxiety disorders (per Gelbe Liste data on the active substance)
• Sleep disturbances — owing to the sedative-hypnotic effect (per Gelbe Liste data on the active substance)
• Prevention of nausea; sometimes prescribed for motion sickness (per Gelbe Liste data on the active substance)

How to take

According to the official instructions, the usual dose for adults is: Dominal 40 mg — 2 tablets (80 mg) 3–4 times a day; Dominal forte 80 mg — 1 tablet 3–4 times a day (i.e. usually 240–320 mg of prothipendyl per day). It is taken regardless of meals, with liquid (for example, a glass of water). The dose, regimen and duration of treatment are determined only by the doctor; any change of dose should be agreed with the doctor. It must not be stopped abruptly — the dose is reduced gradually.

Contraindications

• Hypersensitivity to prothipendyl or the medicine’s components
• Acute poisoning with alcohol, hypnotics, analgesics and psychotropic agents
• Manic psychoses
• Profound impairment of consciousness (coma)
• Children and adolescents under 18 years (generally not used)
• Breastfeeding (use is not recommended); during pregnancy — only after consulting a doctor

Possible side effects

• A drop in blood pressure on standing up (orthostatic hypotension), dizziness
• Rapid heartbeat (tachycardia)
• Dry mouth
• Weight gain
• Movement disorders, tremor (extrapyramidal symptoms)
• Increased skin photosensitivity
• Seizures and allergic reactions are possible

Special precautions

Prescription medicine — in Germany it is dispensed only on a doctor’s prescription (verschreibungspflichtig). It has a pronounced sedative effect: it reduces reaction speed even when taken correctly, so during treatment you should refrain from driving and operating machinery. Alcohol is not permitted while taking it. Intense ultraviolet exposure (tanning beds, prolonged sun) should be avoided because of photosensitisation. Discontinuation should be gradual only, under the doctor’s supervision.

Sources: www.gelbe-liste.de, www.gelbe-liste.de, www.gelbe-liste.de, www.gelbe-liste.de, www.apotheken-umschau.de, www.apotheken-umschau.de, www.shop-apotheke.com, www.teva.de