Scored tablet — Kaliumbromid DESITIN — Germany
- Strengths
- 850 mg
- Product note
- Human medicinal product; specialist monitoring required.
Potassium bromide
Kaliumbromid DESITIN (Germany)
Seizure aggravation / coverage
The German label states that bromide is ineffective for absence, myoclonic and tonic seizures and may provoke these seizures. The Dravet syndrome listing concerns tonic-clonic seizures.
The German label states that bromide is ineffective for absence, myoclonic and tonic seizures and may provoke these seizures. The Dravet syndrome listing concerns tonic-clonic seizures.
Antiseizure indications · Germany product label
Indication / use
- Label / evidence summary
- No US antiseizure indication. Germany: Kaliumbromid DESITIN is labeled for primary and secondary generalized tonic-clonic seizures in early-childhood grand mal epilepsy and severe childhood myoclonic syndromes, including Dravet syndrome, especially when other antiseizure medicines are insufficient.
- Role
- Maintenance · Germany label
- Class
- Bromide salt
No US antiseizure indication. Germany national product labeling is summarized here; this is not an EU-wide authorization. Other countries and products may have different indications.
- Kaliumbromid DESITIN 850 mg tablets · Germany Germany label
Generalized tonic-clonic seizures, Dravet syndrome · Specified childhood epilepsies; adult continuation permitted when childhood epilepsy persists · MaintenanceNo US antiseizure indication. German label: tonic-clonic seizures in specified childhood epilepsies, particularly after inadequate response to other treatments. Dravet syndrome is not an indication for every seizure type. Evidence for monotherapy is insufficient.
Formulations & strengths
Germany product label; strengths per dosage unit.
Brand & formulation labels
Each link names the product and formulation it covers. Archived labels do not establish current availability.
Dosing & administration
- Adult / product-specific schedule
- German label: 30–50 mg/kg/day when childhood epilepsy persists and treatment continues into adulthood; maximum 4,000 mg/day. This is not a general adult-onset epilepsy indication.
- Pediatric
- German maintenance schedule: 0.5–3 years / 7–15 kg, 50–70 mg/kg/day; 4–8 years / 16–28 kg and 9–15 years / 29–58 kg, 40–60 mg/kg/day. Maximum 4,000 mg/day; divide into 2–3 doses. These dosing bands are not approved age limits.
- Titration / repeat dosing
- Specialist supervision and serum bromide measurements are essential. Infection, dehydration or altered salt intake may require dose adjustment; consult the label’s illness instructions.
- Dose basis
- Germany product label; not a US dosing recommendation.
Practical administration
- Product instructions
- 850 mg scored tablets, after meals with liquid; may be dispersed in lukewarm water or tea.
Dose adjustment & concentrations
- Renal impairment
- Contraindicated in renal insufficiency; assess renal function and electrolytes before treatment.
- Hepatic impairment
- No numeric adjustment schedule is provided in the cited label.
- Serum reference information
- Targets depend on the assay. X-ray fluorescence and photometric results are not interchangeable; use the method-specific ranges in the label. Check at least every four weeks for the first three months, then at least every three months.
Safety
- Boxed warning
- No US approved human label; consult the linked national label for serious precautions.
- Contraindications
- Renal insufficiency, pregnancy, breastfeeding, bromide intolerance or product hypersensitivity. The label also advises against use with asthma or malnutrition.
- Serious precautions & monitoring
- Accumulation can cause bromism with cognitive or motor impairment. Monitor skin toxicity, respiratory secretions, potassium and fluid / salt balance.
Common / selected adverse effects
- Sedation / cognitive slowing
- Ataxia
- Gastrointestinal irritation
- Bromacne / bromoderma
- Respiratory secretions
Selected label-reported effects; frequencies cannot be compared across drugs.
Drug interactions: toxicity & clinical action
| Partner / combination | Clinical effect | Clinical action |
|---|---|---|
| Salt intake / dehydration | Changes can alter bromide clearance and accumulation. | Maintain appropriate hydration and consistent salt intake; review serum levels. |
| Saluretic diuretics | Can increase bromide elimination. | Review concentrations and seizure control. |
| Other sedating medicines | May increase CNS impairment. | Review combined effects and tolerability. |
Selected interactions; consult the full product label.
Pregnancy & contraception
- Fetal / neonatal risk
- Contraindicated during pregnancy and breastfeeding in the German label. Bromide crosses the placenta and enters breast milk.
Clinical evidence
Research summaries describe studied populations and outcomes; they do not add indications or constitute treatment recommendations.
Extrapolation
Trial summary
- Study design / duration
- Retrospective series of 32 people with SCN1A-related Dravet syndrome (2012); not a randomized trial.
- Primary endpoint
- No single pivotal endpoint is identified in the cited source.
- Results
- More than 50% seizure reduction was reported in 18/32 patients at three months and 15/32 at twelve months; adverse effects led to discontinuation in five. Uncontrolled findings do not establish comparative efficacy.
Trial publications
Comparative evidence
- Findings
- No randomized head-to-head efficacy comparison is summarized.
Mechanism of action
- Bromide is the active ion. Membrane hyperpolarization and enhanced GABA-A-mediated anion currents are proposed; the exact clinical antiseizure mechanism is unknown.
Pharmacology
Adult values unless specified. Vd/F denotes apparent oral distribution volume.
Pharmacokinetics
- Bioavailability
- Rapid, complete gastrointestinal absorption is described. The cited 96% estimate comes from a sodium-bromide study, not a direct potassium-bromide formulation study.
- Elimination half-life
- Approximately 12 days in humans; adult steady state takes about 30–40 days.
- Volume of distribution
- Distributes in extracellular fluid; no numerical volume is specified.
- Active metabolite(s)
- No active metabolites; bromide itself is the active ion.
- Active-metabolite half-life
- Not applicable: no active metabolite identified.
- Protein binding
- No protein or fat binding described.
- Metabolism / elimination
- Not metabolized; excreted predominantly unchanged by the kidneys.
Product-label values depend on population and study conditions.
Molecular structure
NIH PubChem structure and record ↗
Product history
- Initial U.S. approval
- No US antiseizure indication. German human-product authorization: 2201990.00.00, granted 7 January 2019; renewed 22 May 2023.
- Market / formulation history
- Germany national authorization; this does not establish EU-wide authorization or availability in other countries.
- Brands
- Kaliumbromid DESITIN (Germany)
- Manufacturer / marketer
- DESITIN Arzneimittel GmbH
- Generic availability
- Availability and product labeling are country-specific.
- Related drugs
- Not summarized.
Sources & review status
Germany label checked: 2026-09-27. Other profile sources reviewed: 2026-09-27 · label revision noted at that review: German prescribing information, April 2024.. This is a draft reference; final review is pending.