What is Ariclaim?
Ariclaim is a medicine that contains the active substance duloxetine. It is available in the form of gastro-resistant capsules (white and blue: 30 mg; green and blue: 60 mg). "Gastroresistant" means that the contents of the capsules pass through the stomach and remain intact until it reaches the intestine, thus preventing the active ingredient from being destroyed by the acid present in the stomach.
What is Ariclaim used for?
Ariclaim is indicated for the treatment of pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities, which can occur in patients with diabetes).
The medicine can only be obtained with a prescription.
How is Ariclaim used?
The recommended dose of Ariclaim is 60 mg once a day, but some patients may need a higher dose of 120 mg a day. Response to treatment should be assessed two months after initiation of treatment. If treatment is effective, it should be evaluated at least every three months. Ariclaim can be taken with or without food. The dose should be gradually reduced when treatment is stopped. .
How does Ariclaim work?
The active substance in Ariclaim, duloxetine, is a serotonin and norepinephrine reuptake inhibitor. It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and norepinephrine from being re-taken up in nerve cells in the brain and spinal cord. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. By preventing their reuptake, duloxetine increases the number of neurotransmitters in the spaces between nerve cells, increasing the level of communication between cells.
Since these neurotransmitters are also involved in the reduction of pain sensation, preventing their reuptake into nerve cells also helps to relieve the symptoms of neuropathic pain.
How has Ariclaim been studied?
Ariclaim has been studied in two 12-week studies in 809 adults with diabetes who had been in pain every day for at least six months.
Three different doses of Ariclaim were compared with that of placebo. The main measure of effectiveness was the change in pain severity each week, as reported by patients on an 11-point scale in a daily diary.
What benefit has Ariclaim shown during the studies?
Ariclaim at a dose of 60 mg once or twice a day was more effective than placebo in reducing pain. In both studies, pain relief was observed from the first week of treatment up to a maximum period of 12 weeks, and patients treated with Ariclaim reported a pain score 1.17-1.45 points lower than the pain score. of patients treated with placebo.
What is the risk associated with Ariclaim?
The most common side effects with Amiclaim (seen in more than 1 in 10 patients) are headache, sleepiness, dizziness, nausea and dry mouth. Many of them were mild or moderate and manifested early in treatment becoming more moderate as treatment continued. For the full list of side effects reported with Ariclaim, see the Package Leaflet.
Ariclaim must not be used in people who are hypersensitive (allergic) to duloxetine or any of the other ingredients. Ariclaim must not be used in patients with certain types of liver disease or in patients with severe kidney disease. It must not be used together with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotics). Treatment should not be initiated in patients with uncontrolled high blood pressure due to the risk of hypertensive crisis (sudden and sometimes dangerous rise in blood pressure).
Why has Ariclaim been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ariclaim's benefits are greater than its risks for the treatment of diabetic peripheral neuropathic pain in adults. The committee recommended the granting of a marketing authorization for Ariclaim.
Ariclaim was also originally authorized at strengths of 20 mg and 40 mg for the treatment of moderate to severe stress urinary incontinence (SUI), but the company withdrew these strengths when the marketing authorization was granted. It was renewed in August 2009. Stress urinary incontinence means accidental loss of urine during physical exertion or as a result of coughing, laughing, sneezing, lifting or exercising.
Other information about Ariclaim:
On 11 August 2004, the European Commission issued a "Marketing Authorization" for Ariclaim, valid throughout the European Union. The marketing authorization holder is Eli Lilly Nederland B.V. The marketing authorization was renewed on 11 August 2009.
Last update of this summary: 08-2009
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