Skip to content
MedsAcross

Molecule

Amifampridine

Also known as amifampridine phosphate
Available on requestOrphanNeurology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Amifampridine is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. It is available as tablets for oral use. MedsAcross supplies Amifampridine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Potassium Channel Blocker, Potassium Channel Antagonists
ATC classification
N07XX05 Amifampridine · Other nervous system medicines, subgroup N07X, subgroup N07XX
US FDA first approval
28 November 2018
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII RU4S6E2G0JRxCUI 2106338CAS 54-96-6DrugBank DB11640Q411707

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

FIRDAPSE ® is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older.

Source: US FDA prescribing information

How it works

The mechanism by which amifampridine exerts its therapeutic effect in LEMS patients has not been fully elucidated. Amifampridine is a broad-spectrum potassium channel blocker.

Source: US FDA prescribing information

Dosing overview

Administer orally in divided doses (3 to 5 times daily). The recommended starting dosage for adults (any weight) and pediatric patients weighing 45 kg or more is 15 mg to 30 mg daily, in divided doses. Dosage can be increased by 5 mg daily every 3 to 4 days. The maximum single dose is 20 mg. Dosage is not to exceed a maximum of 100 mg daily. The recommended starting dosage for pediatric patients weighing less than 45 kg is 5 mg to 15 mg daily, in divided doses. Dosage can be increased by 2.5 mg daily every 3 to 4 days. The maximum single dose is 10 mg. Dosage is not to exceed a maximum of 50 mg daily. The recommended starting dosage for adult and pediatric patients with renal impairment, hepatic impairment, and in known N-acetyltransferase 2 (NAT2) poor metabolizers is the lowest recommended initial daily dosage.

Source: US FDA prescribing information

Contraindications

FIRDAPSE is contraindicated in patients with: A history of seizures Hypersensitivity to amifampridine phosphate or another aminopyridine FIRDAPSE is contraindicated in patients with: A history of seizures. Hypersensitivity to amifampridine or another aminopyridine

Source: US FDA prescribing information

Warnings and precautions

Seizures: FIRDAPSE can cause seizures. Consider discontinuation or dose-reduction of FIRDAPSE in patients who have a seizure while on treatment. Hypersensitivity reactions: If a hypersensitivity reaction such as anaphylaxis occurs, FIRDAPSE should be discontinued and appropriate therapy initiated.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are described elsewhere in the labeling: Seizures Hypersensitivity The most common (> 10%) adverse reactions are: paresthesia, upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache, elevated liver enzymes, back pain, hypertension, and muscle spasms.

Source: US FDA prescribing information

Interactions

Drugs that lower seizure threshold: Concomitant use may lead to an increased risk of seizures. Drugs with cholinergic effects (e.g., direct or indirect cholinesterase inhibitors): Concomitant use may increase the cholinergic effects of FIRDAPSE and of those drugs and increase the risk of adverse reactions.

Source: US FDA prescribing information

Storage

Store FIRDAPSE tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F). See Dosage and Administration for storage instructions for FIRDAPSE prepared suspension.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Amifampridine, sorted by availability.

MedicineManufacturerRegisterAvailability
Firdapse 10 mg tabletOralCatalyst PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 28 November 2018Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Amifampridine available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Amifampridine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Amifampridine have?

The catalogue lists 1 brand names for Amifampridine, including Firdapse.

Is Amifampridine approved by the US FDA?

Yes. The US FDA first approved Amifampridine on 28 November 2018, according to Drugs@FDA.

Is Amifampridine authorised in the European Union?

Yes. Amifampridine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Amifampridine need cold chain shipping?

No listed presentation of Amifampridine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Amifampridine in?

Amifampridine is classified under ATC code N07XX05 (Amifampridine).

References

  1. Firdapse prescribing information (Catalyst Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 16 April 2026
  2. Firdapse (previously Zenas): European public assessment report (EPAR). European Medicines Agency. Retrieved 18 December 2024
  3. Amifampridine SERB: European public assessment report (EPAR). European Medicines Agency. Retrieved 24 May 2022

Request Amifampridine for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.