- Ambalta 30mg Capsule contains
Ambalta is a combined serotonin and nor adrenaline reuptake inhibitor. It inhibits dopamine reuptake without having any affinity for histamine, dopamine, cholinergic and adrenergic receptors. In several pre-clinical models of neuropathic pain, Ambalta normalized the pain thresholds and also weakened the pain behavior in a model of persistent pain.
What is Ambalta used for?
- Major Depressive Episodes
The efficacy of Ambalta (duloxetine) at 60mg dose once a day has been demonstrated in three out of three randomized, double blind, placebo controlled, fixed dose acute studies with major depressive disorders.
Ambalta has superior efficacy over placebo as measured in both emotional and somatic symptoms of depression.
The tolerability of Ambalta 60 mg once a day in elderly group of patients was compared to that seen in the younger adults.
The data in the elderly group of patients exposed to120 mg per day is limited so caution is to be taken when rendering treatment to the elderly group.
- Diabetic Peripheral Neuropathic Pain
The effect of Ambalta was studied in 2 randomized, double blind, placebo controlled, fixed dose trial having diabetic neuropathic pain for 6 months.
Both the studies for Ambalta 60 mg once daily and 60 mg twice daily showed reduced pain when compared to placebo.
Dosage of Ambalta Capsules in Major Depressive Episodes
The starting and recommended maintenance dose of Ambalta is 60 mg once daily with or without food. The doses above 60 mg once daily and up to120 mg per day in divided doses have been evaluated from safety point of view in the clinical trials.
There is no clinical evidence that patients not responding to the initial recommended dose may benefit from dose up-titrations. Therapeutic response is seen within 15-30 days of treatment. It is recommended to continue the treatment for several months in order to avoid relapse.
Dosage of Ambalta in Diabetic Peripheral Neuropathic Pain
The starting and recommended maintenance dose is 60 mg once daily with or without food. The doses above 60 mg once daily and up to120 mg per day in divided doses have been evaluated from safety point of view in the clinical trials.
The plasma concentration of Ambalta (duloxetine) varies from individual to individual, therefore, some patients might benefit from a higher dosage instead of 60 mg dose.
When to avoid Ambalta?
Ambalta Capsules should be avoided in case of hypersensitivity to Duloxetine or to any of its excipients. Use of non-selective, irreversible Monoamine Oxidase Inhibitors (MAOIs) with Ambalta is also contraindicated. Ambalta is not to be used with fluvoxamine, ciprofloxacin or enoxacin since these cause elevated plasma concentrations of duloxetine.
Possible Side Effects of Ambalta
Patients being treated with Ambalta for depression, reported most commonly with side effects like nausea, dry mouth, headache and constipation. Mild to moderate side effects were seen early during the therapy and subsided as the therapy progressed on.
The side effects of Ambalta seen in patients with diabetic neuropathic pain were nausea, headache, dizziness and somnolence. Stopping treatment with Ambalta, often leads to withdrawal symptoms. Gradual dose tapering is required when treatment with Ambalta is no longer needed.
In patients with diabetic neuropathic pain, it was seen during the clinical trials that Ambalta (duloxetine) had an elevation in fasting blood glucose levels. However, HbA1c was stable in both placebo and Ambalta (duloxetine) treated groups.