Luhan Pharmachem Co., Ltd.

Luhan pharmachem Co., Ltd. supplies Rufinamide bulk active pharmaceutical ingredient (API) to the pharmaceutical industry. Our Rufinamide is manufactured by cGMP compliant facility. Welcome to contact us for further details including current DMF status for the product and up to date regulatory status of the manufacturing facility. We look forward to assisting you with your research and development projects.

What is Rufinamide?

Rufinamide is an anticonvulsant medication. It is used in combination with other medication and therapy to treat Lennox¨CGastaut syndrome and various other seizure disorders. Rufinamide, a triazole derivative, was developed in 2004 by Novartis Pharma, AG, and is manufactured by Eisai.

Rufinamide was approved by the US Food and Drug Administration on November 14, 2008 as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults. Its official FDA-approved labeling does not mention use in the treatment of partial seizures inasmuch as clinical trials submitted to the FDA were marginal. However, several recent clinical trials suggest that the drug has efficacy for partial seizures. It is marketed under the brand name Banzel. It is also marketed in the European Union under the brand name Inovelon.

Indication

Rufinamide is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.

What is the mechanism of action?

The mechanism of action of rufinamide is unknown. However, it is presumed to involve stabilization of the sodium channel inactive state, effectively keeping these ion channels closed. Although the direct mechanism of action may be different, several other antiepileptic agents also stabilize a sodium channel inactive state including phenytoin, carbamazepine, and lacosamide (stabilizes the slow inactive state).

Administration of Rufinamide

Rufinamide tablets should be given with food. Tablets can be administered whole, as half tablets or crushed, for dosing flexibility.

Rufinamide tablets oral suspension should be shaken well before every administration. The provided adapter and calibrated oral dosing syringe should be used to administer the oral suspension. The adapter which is supplied in the product carton should be inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage of the bottle. The dosing syringe should be inserted into the adapter and the dose withdrawn from the inverted bottle.

What are the side effects of Rufinamide?

Rufinamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• sleepiness
• headache
• loss of coordination
• difficulty walking
• excessive movement or activity
• uncontrollable shaking of a part of the body
• uncontrollable movements of the eyes
• difficulty paying attention
• dizziness
• loss of appetite
• vomiting
• back pain
• stomach pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fever
• rash
• hives
• itching
• swelling of the face
• decreased ability to respond to others
• seizures
• blurred or double vision
• yellowing of the skin or eyes
• dark-colored urine
• light-colored stool

Storage

Keep Rufinamide in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed.

Disclaimer:

Information on this page is provided for general information purposes. You should not make a clinical treatment decision based on information contained in this page without consulting other references including the package insert of the drug, textbooks and where relevant, expert opinion. We cannot be held responsible for any errors you make in administering drugs mentioned on this page, nor for use of any erroneous information contained on this page.