Duloxetine Hydrochloride Capsules

Duzela Capsules (Generic Duloxetine Hydrochloride Capsules) - Product Information

Duzela (Generic Duloxetine Hydrochloride Capsules) is used to treat depression and anxiety. It is also used for pain caused by nerve damage associated with diabetes (diabetic peripheral neuropathy).
Duloxetine is also used to treat fibromyalgia (muscle pain and stiffness) and chronic (long-lasting) pain that is related to muscles and bones.
Duzela capsules (Duloxetine Delayed release Capsules) are manufactured by Sun Pharmaceutical Industries Limited, India in the strengths of 20 mg, 40 mg and 60 mg.
We also have in stock Venlafaxine Hydrochloride Capsules (Venlor XR) which is also used for the treatment of major depressive disorder and panic disorder.

Name of the Drug

Duzela Capsules.

Manufacturer of Duzela Capsules

Sun Pharmaceutical Industries Limited, India  
Website: sunpharma.com

Active Pharmaceutical Ingredient

The active ingredient present in Duzela capsules is Duloxetine Hydrochloride. Each capsule of Duzela contains Duloxetine Hydrochloride equivalent to 20 mg, 40 mg or 60 mg of Duloxetine (as delayed release) respectively.

Uses of Generic Duloxetine Hydrochloride Capsules (Duzela Capsules)

Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Duloxetine affects chemicals in the brain that may be unbalanced in people with depression. Duloxetine Hydrochloride Capsules are used to treat:

• Major Depressive Disorder (MDD). Efficacy was established in four short-term and one maintenance trial in adults.
• Generalized Anxiety Disorder (GAD) in adults and children who are at least 7 years old. Efficacy was established in three short-term and one maintenance trial in adults.
• Diabetic Peripheral Neuropathic Pain (DPNP)
• Chronic Musculoskeletal Pain or joint pain (such as low back pain and osteoarthritis pain).
• Fibromyalgia (FM)

Duzela Capsules (Generic Duloxetine Hydrochloride Capsules) - Dosage

Generic Duloxetine Hydrochloride Capsules should be administered exactly as suggested by your doctor. Your doctor may recommend a dosage of tablets depending on your age, medical requirement, body weight, other medical conditions, and current medications. Duzela should generally be administered once daily without regard to meals. Duzela Capsules should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents be sprinkled on food or mixed with liquids.
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
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)
Dosage for Treatment of Chronic Musculoskeletal Pain:
Starting Dose: 30mg/day
Target Dose: 60 mg/day (once daily)
Duzela Capsules work effectively if the amount of Duloxetine is maintained at a constant level in the body. You should be systematic about the daily schedule for the medication such that you take tablets at about the same time every day, to get the maximum benefit of the medication. Continue taking Duzela Capsules without missing any doses for the recommended treatment period and do not stop the treatment suddenly even if you feel better.

Please consult your doctor for exact dosing instructions. Duzela Capsules (Generic Duloxetine Hydrochloride capsules) should be administered in the dose prescribed by the doctor and for the duration recommended by the doctor.

Missed Dose

If you forget to take your regular Duzela Capsules dose on time, take it whenever you remember.
If you remember the next day, skip the missed dose and take your scheduled dose. Do not take a double dose to compensate the missed dose.

Duloxetine Hydrochloride Capsules Mechanism of Action – How do Duzela Capsules Work?

Duloxetine Hydrochloride is a serotonin and norepinephrine reuptake inhibitor (SNRI) that works by increasing the levels of the neurotransmitters serotonin and norepinephrine in the central nervous system (CNS).
Detailed Mechanism of Action
Inhibition of Reuptake:
Duloxetine selectively blocks the reuptake transporters for serotonin and norepinephrine on the presynaptic neurons. This action prevents these neurotransmitters from being quickly reabsorbed, thereby increasing their concentration and activity within the synaptic cleft (the space between nerve cells).
Neurotransmitter Potentiation:
The increased levels of serotonin and norepinephrine potentiate their effects in the brain and spinal cord.
Modulation of Pain Pathways:
This action is particularly relevant for duloxetine's use in managing various pain conditions (such as diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain). Serotonin and norepinephrine are key mediators in the body's descending pain inhibitory pathways. By increasing their concentration, duloxetine enhances the body's ability to dampen pain signals from the periphery to the brain, thus providing an analgesic effect independent of its mood effects.
Effect on Mood and Anxiety:
The increased serotonergic and noradrenergic activity in the CNS also helps regulate mood and alleviate symptoms of depression and anxiety.
Stress Urinary Incontinence (SUI):
For SUI, duloxetine's effect is associated with potentiation of serotonin and norepinephrine activity in Onuf's nucleus of the sacral spinal cord. This increases the activity and tone of the urethral sphincter muscles, enhancing urethral closure forces and reducing involuntary urine loss.

Storage Instructions for Duzela Capsules (Generic Duloxetine Hydrochloride Capsules)

Store Duzela Capsules at controlled room temperature (20°C to 25°C),protected from heat, moisture, and sunlight. Excursions are permitted from 15°C to 30°C.
Retain the original packing of the medication and do not consume past its expiration date printed on the blister pack. Keep the pack of Generic Duloxetine Hydrochloride Capsules away from the reach of children and pets. Do not dispose Duzela Capsules along with domestic waste or sewage. Consult your doctor or pharmacist about the correct method of disposal.

Contraindications

Duzela Capsules tablets are contraindicated in patients with a hypersensitivity to Duloxetine Hydrochloride or any inactive ingredient present in Duzela Capsules . Duzela Capsules are also contraindicated in the following cases:
Use of a monoamine oxidase inhibitor concomitantly or in close temporal proximity
Use in patients with uncontrolled narrow-angle glaucoma

Overdose

Cases of overdoses, alone or in combination with other drugs, with Duloxetine doses of 5400mg have been reported. Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000mg.
Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia.

Warnings and Precautions

Hepatotoxicity:
Hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine delayed-release capsules. Duloxetine delayed-release capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Duzela Capsules should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease
Orthostatic Hypotension, Falls and Syncope:
Cases have been reported with duloxetine delayed-release capsules therapy
Serotonin Syndrome:
Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue Duzela Capsules and initiate supportive treatment
Increased Risk of Bleeding:
Duloxetine may increase the risk of bleeding events. Concomitant use of NSAIDs, aspirin, other antiplatelet drugs, warfarin, and anticoagulants may increase this risk
Severe Skin Reactions:
Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with duloxetine. Duzela Capsules should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified
Discontinuation Syndrome:
Taper dose when possible and monitor for discontinuation symptoms
Activation of Mania or Hypomania:
Use cautiously in patients with bipolar disorder. Cautions patients about the risk of activation of mania/hypomania
Angle-Closure Glaucoma:
Avoid use of antidepressants, including Duzela Capsules, in patients with untreated anatomically narrow angles
Seizures:
Prescribe with care in patients with a history of seizure disorder
Blood Pressure:
Monitor blood pressure prior to initiating treatment and periodically throughout treatment
Hyponatremia:
Can occur in association with SIADH. Cases of hyponatremia have been reported
Glucose Control in Diabetes:
In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose, and HbA1c have been observed.

Side Effects of Duloxetine Hydrochloride Capsules (GDuzela Capsulese)

Most common side effects with an incidence rate of 5% or greater and at least twice the incidence of placebo patients were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis

Duloxetine Hydrochloride Capsules During Pregnancy

Duloxetine Hydrochloride has been classified by the US FDA as Pregnancy Category C.
Data from published observational studies with Duloxetine use in pregnant women have not identified a clear drug-associated risk of major birth defects or adverse developmental outcomes.
There are risks associated with untreated depression in pregnancy and with exposure to SNRIs and SSRIs, including duloxetine delayed-release capsules, during pregnancy (see Clinical Considerations).
In rats and rabbits treated with duloxetine during the period of organogenesis, fetal weights were decreased but there was no evidence of developmental effects at doses up to 3 and 6 times, respectively, the maximum recommended human dose (MRHD) of 120 mg/day given to adolescents on a mg/m2 basis.
Do not use this medicine without your doctor's consent in case you are pregnant. Stop using this medication and inform your doctor immediately if you become pregnant during treatment.

Nursing Considerations

Data from the published literature report the presence of duloxetine in human milk. There are no data on the effect of Duloxetine on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Duloxetine delayed-release capsules and any potential adverse effects on the breastfed child from the Duloxetine delayed-release capsules or from the underlying maternal condition
Do not use this medication without telling your doctor if you are breast-feeding a baby.

Buy Generic Duloxetine 20 mg 40 mg and 60 mg Capsules Online From Only $0.54 per Pill

You can buy Generic Duloxetine Capsules online from Everest Online Pharmacy at a cheap price. Duzela 20 mg, 40 mg and 60 mg pills, manufactured by Sun Pharmaceutical Industries Limited, India, are supplied in a blister strip of 10 capsules. The 20 mg capsules cost only $0.54 per unit when you place an order for 300 capsules .

Disclaimer

The above information is provided to the best of our knowledge and in good faith. It is without a warrant of any kind, expressed or implied.

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