Dulan Capsules(Duloxetine)THERAPEUTIC INDICATIONS:
Major depressive episodes.Diabetic peripheral neuropathic pain in adults.POSOLOGY AND METHOD OF ADMINISTRATION: For oral use.Adults: Major depressive episodes: The starting and recommended maintenance dose is 60mg once daily with or without food.
Dulan Capsules Dose
The doses above 60mg once daily and up to 120mg per day in divided doses have been evaluated from a 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.
DIABETIC PERIPHERAL NEUROPATHIC PAIN:
The starting and recommended maintenance dose is 60mg once daily or without food. The dose above 60mg once daily and up to 120 mg per day in divided doses have been evaluated from a safety point of view in the clinical trials. The plasma concentration of duloxetine varies from individual to individual, therefore, some patients might benefit from a higher dosage instead of a 60mg dose.ELDERLY: Major depressive episodes: No dose adjustment is needed for the elderly on the basis of age.
should be taken when treating the elderly.CHILDREN AND ADOLESCENTS: As the safety and efficacy of duloxetine have not been studied in these age groups, therefore, it is not to be given to children and adolescents.HEPATIC IMPAIRMENT: Duloxetine is not used in patients with liver disease resulting in hepatic impairment.RENAL INSUFFICIENCY: No dose adjustment is necessary for patients with mild to moderate renal dysfunction (creatinine clearance 30 to 80ml/min)DISCONTINUATION: Abrupt discontinuation of the treatment should be avoided.When stopping treatment with duloxetine the dose has to be gradual, reduced over a period of one to two weeks in order to reduce the risk of withdrawal reactions.
Dulan Capsules CONTRAINDICATION:
Hypersensitivity to the active substances or to any of its excipients. The use of nonselective, irreversible monoamine oxidase inhibitors (MAOLS) with duloxetine is contraindicated. Duloxetine is not to be used with fluvoxamine, ciprofloxacin, or enoxacin since these cause elevated plasma concentration of duloxetine Severe renal impairment (creatinine clearance <30ml/min)
DULAN CAPSULESSPECIAL WARNINGS AND PRECAUTIONS:
Mania and seizures. Duloxetine is to be used with caution in patients with mania or diagnosed with bipolar disorders and/or seizures.MYDRIASIS: Mydriasis has been reported with duloxetine, so to be used with caution in patients with increased intraocular pressure or those who are at risk of developing acute narrow glaucoma.BLOOD PRESSURE AND HEART RATE: Duloxetine is known to increase blood pressure in some patients which is due to the noradrenergic effects of duloxetine. Blood pressure monitoring is recommended in patients with hypertension and cardiac disease at the start of the treatment. RENAL IMPAIRMENT: Plasma concentration of duloxetine occurs in patients with severe renal impairment on hemodialysis (creatinine clearance <30ml/min). USE WITH ANTIDEPRESSANTS: Caution to be taken when using duloxetine in combination with antidepressants. The use of selective reversible MAQLs is not recommended.
Major depressive episodes: Depression is associated with an increased risk of suicidal thoughts. This risk persists till significant remission occurs. As the improvement may not occur during the first few weeks or more of treatment, patients need to be monitored until such improvements occur. Cases of suicidal ideation and suicidal behavior have been reported during duloxetine therapy. Close monitoring of the high-risk patient should accompany drug therapy. DIABETIC PERIPHERAL NEUROPATHIC PAIN: As with other medicines with similar actions like anti-depressants cases of suicidal ideation and suicidal behavior have been reported. Physician’s to ask patients to report any distressing thoughts or feelings. USE IN CHILDREN AND ADOLESCENTS: No clinical trials have been carried out with duloxetine in the pediatric population. Duloxetine is not to be used in the treatment of children and adolescents under the age of 18.
There have been reported rarely in the elderly with duloxetine. A cautionary note is required for patients with a high risk of developing hyponatremia. Hyponatremia may be due to a syndrome of antidiuretic hormone secretions. HEPATITIS LIVER ENZYMES: Cases of liver injury increase in the liver enzyme (<10 times the upper limit of normal), Hepatitis and jaundice have been reported with duloxetine. Duloxetine is to be used with caution in patients treated with other drugs associated with hepatic injury.
CNS DRUGS: Caution to be taken when duloxetine is given in combination with centrally acting medicines and substances like alcohol and sedatives including, benzodiazepines, morphinomimetics, antipsychotics, phenol orbital, sedative antihistamines.SEROTONIN SYNDROME: Serotonin syndrome has been reported in patients using SSRIs (paroxetine. Fluoxetine) along with serotonergic antidepressants like SSRIs, tricyclic-like clomipramine or amitriptyline, venlafaxine or triptans, tramadol, pethidine, and tryptophan.EFFECTS OF DULOXETINE ON OTHER DRUGS: DRUGS METABOLIZED BY CYP1A2: It was seen in a clinical study that pharmacokinetics of theophylline, a CYP2D6 substrate, were not affected by the administration of duloxetine 60 mg, two times a day.
DRUGS METABOLIZED BY CYP2D6:
Caution to be taken if duloxetine is given with medicines that are metabolized by CYP2D6 and have a narrow therapeutic index. EFFECT OF OTHER DRUGS ON DULOXETINE: Inhibitors of CYP1A2: The use of duloxetine with potent inhibitors warfarin shows an increase in INR.PREGNANCY AND LACTATION: PREGNANCY: No significant data is available on the use of duloxetine in pregnancy. Duloxetine is only to be used in pregnancy if the benefit justifies the risk to the fetus.BREASTFEEDING: Duloxetine is excreted in the milk of lactating women. Since there is no safety data on duloxetine in infants, therefore the use of duloxetine in breastfeeding is not advised.
EFFECTS WHILE DRIVING AND HANDLING equipment:
Duloxetine does not impair cognitive function memory or psychomotor performance. It may, however, be associated with sedation or dizziness. Caution to be taken while driving or handling heavy machinery. TOWARD EFFECTS: Patients being treated with duloxetine for depression reported the most common adverse 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. The untoward effects seen in patients with diabetic neuropathic pain were nausea, headaches, dizziness, and somnolence. Stopping treatment with duloxetine often leads to withdrawal symptoms. Gradual dose tapering is required when treatment with duloxetine is no longer needed. In patients with diabetic neuropathic pain, it was seen during the clinical trials that duloxetine had an elevation in fasting blood glucose levels. However, HbA1c was stable in both placebo and duloxetine-treated groups.
DULAN CAPSULES OVERDOSAGE:
Signs and symptoms of overdosage included serotonin syndrome, somnolence, vomiting, and seizures. The absence of any fatal incidents has been reported.