Generic Duloxetine (Duzela Capsules)

Generic Duloxetine Capsules

Clearsky Pharmacy

Generic Duloxetine (Duzela Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) antidepressants used to treat Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Diabetic Peripheral Neuropathic Pain (DPNP), Fibromyalgia (FM) and Chronic Musculoskeletal Pain.

Duzela Capsules

Clearsky Pharmacy

Duzela Capsules are manufactured by Sun Pharmaceutical Industries Ltd.(Website: www.sunpharma.com)

Duloxetine Hydrochloride Tablets Brand Names

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Duloxetine Hydrochloride tablets are available as Cymbalta, Irenka, Duzela, Dutin, Dulojoy, Dumore, Ariclaim, Xeristar and Yentreve.

Active Ingredient

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The active ingredient contained in Duzela capsules is Duloxetine Hydrochloride. Each Duzela 60 mg capsules contains enteric-coated pellets of Duloxetine Hydrochloride equivalent to 60 mg of Duloxetine.

Chemical Structure

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The structure of Duloxetine Hydrochloride is given below:

Uses of Duzela Capsules

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Generic Duloxetine (Duzela Capsules) is used to treat Anxiety, Back Pain, Bipolar Disorder, Chronic Fatigue Syndrome, Chronic Pain, Depression, Diabetic Peripheral Neuropathy, Dysthymia, Fibromyalgia, Generalized Anxiety Disorder, Hot Flashes, Major Depressive Disorder, Osteoarthritis, Pain, Peripheral Neuropathy, Small Fiber Neuropathy, Somatoform Pain Disorder and Urinary Incontinence.

Storage Instructions

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Generic Duloxetine (Duzela Capsules) have to be stored at controlled room temperature i.e. from 20C to 25C (68F to 77F) with excursions permitted between 15 to 30C (59 to 86F). Keep this as well as all other medicines away from children and pets.

Warnings

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Warnings associated with Generic Duloxetine (Duzela Capsules) use are given below:Suicidality: Monitor for clinical worsening and suicide risk. Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with Duzela.Orthostatic Hypotension and Syncope: Cases have been reported with Generic Duloxetine therapy.

Warnings

Clearsky Pharmacy

Warnings associated with Generic Duloxetine (Duzela Capsules) use are given below:Serotonin Syndrome, or Neuroleptic Malignant Syndrome (NMS)-like reactions: Serotonin syndrome or NMS-like reactions have been reported with SSRIs and SNRIs. Discontinue Duzela and initiate supportive treatment.Abnormal Bleeding: Cymbalta may in crease the risk of bleeding events. Discontinuation: May result in symptoms, including dizziness, nausea, headache, paresthesia, fatigue, vomiting, irritability, insomnia, diarrhea, anxiety, and hyperhidrosis.

Warnings

Clearsky Pharmacy

Warnings associated with Generic Duloxetine (Duzela Capsules) use are given below:Activation of mania or hypomania has occurred Blood Pressure: Monitor blood pressure prior to initiating treatment and periodically throughout treatment.Inhibitors of CYP1A2 or Thioridazine: Should not administer with Generic Duloxetine. Hyponatremia: Cases of hyponatremia have been reported. Hepatic Insufficiency and Severe Renal Impairment: Should ordinarily not be administered to these patients. Controlled Narrow-Angle Glaucoma: Use cautiously in these patients.

Warnings

Clearsky Pharmacy

Warnings associated with Generic Duloxetine (Duzela Capsules) use are given below:Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose, HbA1c, and total cholesterol have been observed. Conditions that Slow Gastric Emptying: Use cautiously in these patients. Urinary Hesitation and Retention

Generic Duloxetine (Duzela Capsules) Dosage

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Dosage for Treatment of Major Depressive Disorder (MDD):

Starting Dose: 40mg/day to 60mg/day

Target Dose Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily);

Target Dose Maintenance Treatment: 60 mg/day

Take Duzela capsules once daily, with or without food. Swallow Generic Duloxetine capsules whole.The dosage of Duzela Capsules (Duloxetine Hydrochloride) is given below:

Generic Duloxetine Dosage

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Dosage for Treatment of Diabetic Peripheral Neuropathic Pain (DPNP):

Starting Dose: 60mg/day

Target Dose: 60 mg/day (once daily)

Dosage for Treatment of Generalized Anxiety Disorder (GAD):

Starting Dose:60mg/day

Target Dose: 60 mg/day (once daily)

Dosage for Treatment of Fibromyalgia (FM):

Starting Dose:30mg/day

Target Dose: 60 mg/day (once daily)

The dosage of Generic Duloxetine tablets (Duzela Capsules) is given below:

Duzela Capsules

Clearsky Pharmacy

Contraindications

Duzela is contraindicated in patients with a hypersensitivity to Duloxetine Hydrochloride or any other component of this medication.Generic Duloxetine is contraindicated in patients with hepatic impairment. Generic Duloxetine should not be used in combination with potent CYP1A2 inhibitors. Use of Monoamine Oxidase Inhibitors (MAOIs) to treat psychiatric disorders along with Generic Duloxetine or within five days of stopping treatment with Generic Duloxetine is contraindicated.Starting treatment with Duzela in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated.

Generic Duloxetine Side Effects

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The most common Generic Duloxetine side effects with an incidence rate of of at least 5% and at least twice the incidence of placebo patients can include nausea, dry mouth, somnolence, fatigue, constipation, decreased appetite, and hyperhidrosis.

In a trial conducted for mild major depressive disorder (MDD), the most commonly reported treatment-emergent adverse events among duloxetine-treated patients were nausea (34.7%), dry mouth (22.7%), headache (20.0%) and dizziness (18.7%).

Duloxetine and SSRIs have been shown to cause sexual side effects in some patients, both males and females.

Generic Duloxetine Side Effects

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The following side effects were reported very rarely: rash, alanine aminotransferase increased, alkaline phosphatase increased, anaphylactic reaction, angioneurotic edema, aspartate aminotransferase increased, bilirubin increased, glaucoma, hepatitis, hyponatremia, jaundice, orthostatic hypotension, Stevens-Johnson syndrome, syncope, and urticaria.

Duzela Overdose

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Fatal outcomes have been reported for acute overdoses, primarily with mixed overdoses, but also with Generic Duloxetine only, at doses as low as 1000 mg. Signs and symptoms of overdose (Duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting.

Duzela Overdose

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In case of acute Duzela overdose, treatment should consist of those general measures employed in the management of overdose with any medicine.An adequate airway, oxygenation, and ventilation should be assured, and cardiac rhythm and vital signs must be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting absorption of Duloxetine from the gastrointestinal tract.

Duloxetine During Pregnancy

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Duzela (Duloxetine Hydrochloride capsules) has been classified by the US FDA as Pregnancy Category C. There are no adequate and well-controlled studies of Duloxetine administration in pregnant women. In animal studies with Duloxetine, there was no evidence of teratogenicity in pregnant rats and rabbits at oral doses administered during the period of organogenesis up to 4 and 7 times the maximum recommended human dose. Generic Duloxetine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Duzela Capsules

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Clearsky Pharmacy

Duzela (Duloxetine Hydrochloride Capsules) by Sun Pharmaceutical Industries Ltd., India.