Launch of "Tramal® Capsule" for the treatment of cancer pain
Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan; President: Shigenobu Maekawa) announced the launch of “Tramal® Capsule 25mg” and “Tramal® Capsule 50mg”(generic name: tramadol hydrochloride) for the treatment of cancer pain today.
“Tramal® Capsule” is a nonnarcotic opioid analgesic which acts as μ-opioid receptor agonist and monoaminergic action (reuptake inhibition of noradorenalin and serotonin). Tramadol hydrochloride was approved and launched in more than 100 countries in the world.
The product has the following features.
・ Analgesic effect based on three mode of actions (opioid receptor agonism,
noradorenalin reuptake inhibition, serotonin reuptake inhibition).
・ A good efficacy for mild to moderate cancer pain which is insufficiently controlled by
non-opioids (NSAIDs etc.).
・ Less side effects such as constipation compared to morphine.
・ Not assigned as a scheduled drug and/or a psychoactive drug.
Currently in Japan, narcotic opioid analgesics such as codeine, morphine, oxycodone and fentanyl are recommended to use for cancer pain insufficiently controlled by NSAIDs or moderate to severe cancer pain.
Since the product is assigned as nonnarcotic opioid analgesic, it does not need to be handled as narcotics. In addition, from the aspects of safety and efficacy, it will be one of the options for cancer pain treatment as a bridge between non-opioids and narcotic opioids.
By the launch of “Tramal® Capsule”, Nippon Shinyaku expects to contribute more to the patients who are suffering from cancer pain.
【Brand name】 “Tramal® Capsule 25mg”, “Tramal® Capsule 50mg”
【Manufactured and distributed by】 Nippon Shinyaku Co., Ltd.
【Approval number】 Tramal® Capsule 25mg 22200AMX00872000,
Tramal® Capsule 50mg 22200AMX00873000
【Composition】 Tramal® Capsule 25mg ; 25mg of tramadol is contained in a capsule. ,
Tramal® Capsule 50mg ; 50mg of tramadol is contained in a capsule.
【Generic name】 Tramadol hydrochloride
Indication: mild to moderate cancer pain
【Dosage and administration】 Generally, 300mg ~ 400mg of tramadol hydrochloride is orally administered divided into four doses per day. The dosage may be adjusted according to the symptoms. However, the daily dosage is up to 400 mg.
【Approval date】 July 23, 2010
NHI price listing date: September 17, 2010
【NHI price】 37.70Yen / 25mg capsule, 65.90Yen / 50mg capsule
Package: Bottle of 500 capsules, PTP 100 capsules (PTP 10capsules×10), PTP 500 capsules (PTP 10capsules×50), PTP 1000 capsules (PTP 10capsules×100)