Medicine Information

Azonox-Ultra

Name: Azonox-Ultra
Brand: Azonox-Ultra
Rating: 4.5 (117 reviews)

Capsule65 mgAntidepressantsATC: N06AX21

Generic Name

Duloxetine

Manufacturer

Hypothetical Pharmaceuticals Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
azonox ultra 65 mg capsule	৳ 20.00	৳ 140.00

Description

Overview of the medicine

Azonox-Ultra 65 mg capsule contains Duloxetine, an antidepressant primarily used to treat major depressive disorder, generalized anxiety disorder, and various chronic pain conditions, including diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. It helps improve mood and reduce pain by affecting certain neurotransmitters in the brain.

Uses & Indications

Major depressive disorder (MDD)

Generalized anxiety disorder (GAD)

Diabetic peripheral neuropathic pain (DPNP)

Fibromyalgia

Chronic musculoskeletal pain (including chronic low back pain and chronic osteoarthritis pain)

Dosage

Adults

The usual starting dose for many indications is 30 mg once daily, increasing to 60 mg once daily. For the 65 mg capsule, it is typically administered once daily, as prescribed by a physician, based on the specific condition and patient response.

Elderly

Initiate treatment with a lower dose (e.g., 20-30 mg once daily) and titrate gradually under close medical supervision due to increased sensitivity and potential for adverse effects.

Renal_impairment

Not recommended in patients with severe renal impairment (CrCl <30 mL/min). For moderate impairment, careful monitoring and possible dose reduction may be necessary.

How to Take

Take orally, with or without food. Swallow the capsule whole; do not chew, crush, or open it, as this may affect the delayed-release properties of the medicine. It should be taken at approximately the same time each day.

Mechanism of Action

Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It increases the levels of serotonin and norepinephrine in the central nervous system by blocking their reuptake into nerve cells, which leads to enhanced neurotransmission and helps alleviate symptoms of depression, anxiety, and pain.

Pharmacokinetics

Onset

Antidepressant and anxiolytic effects typically manifest after 2-4 weeks of consistent treatment. Pain relief may be observed earlier.

Excretion

Primarily excreted in the urine as inactive metabolites (approximately 70%), with a smaller amount (approximately 20%) excreted in feces.

Half life

The elimination half-life is approximately 12 hours (range 8-17 hours).

Absorption

Well absorbed after oral administration, with peak plasma concentrations occurring 6-10 hours post-dose. Bioavailability is approximately 50%.

Metabolism

Extensively metabolized in the liver primarily by CYP1A2 and CYP2D6 enzymes into inactive metabolites.

Side Effects

Contraindications

Hypersensitivity to duloxetine or any component of the formulation
Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI
Uncontrolled narrow-angle glaucoma
Severe hepatic impairment or end-stage renal disease (CrCl <30 mL/min)

Drug Interactions

MAOIs

Risk of serotonin syndrome, which can be life-threatening.

Anticoagulants (e.g., warfarin) and antiplatelet agents

Increased risk of bleeding due to duloxetine's effect on platelet aggregation.

CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine)

Can increase duloxetine levels, especially at higher doses.

CYP1A2 inhibitors (e.g., fluvoxamine, cimetidine, quinolone antibiotics)

Increased duloxetine plasma levels, potentially leading to adverse effects.

Other serotonergic drugs (SSRIs, SNRIs, triptans, opioids like tramadol)

Increased risk of serotonin syndrome.

Drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants, phenothiazines)

Duloxetine can inhibit CYP2D6, increasing the plasma levels of these co-administered drugs.

Storage

Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children. Do not freeze.

Overdose

Symptoms of overdose may include somnolence, coma, seizures, serotonin syndrome, vomiting, and tachycardia. Management involves supportive and symptomatic treatment. Gastric lavage and activated charcoal may be considered. Continuous ECG monitoring is recommended.

Pregnancy & Lactation

Not recommended during pregnancy, especially in the third trimester, due to potential risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome. Use only if potential benefit outweighs the risk and under strict medical supervision. Duloxetine is excreted in breast milk; therefore, it is generally not recommended during breastfeeding. Consult a healthcare professional for personalized advice.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

10 capsules (1x10 blister pack)30 capsules (3x10 blister pack)

Shelf Life

Generally 24 months from the date of manufacture when stored under recommended conditions.

Availability

Pharmacies, hospitals

Approval Status

Approved by regulatory bodies for Duloxetine

Patent Status

Generic available

Clinical Trials

Extensive clinical trials have established the efficacy and safety of duloxetine for its approved indications. These trials involved thousands of patients across various demographics and disease states.

Lab Monitoring

Liver function tests (especially in patients with pre-existing liver disease or heavy alcohol use)
Renal function tests (for severe renal impairment)
Blood pressure and heart rate monitoring
Assessment for suicidal ideation, especially during initial therapy or dose changes

Doctor Notes

Counsel patients on the importance of adherence and gradual discontinuation to avoid withdrawal symptoms.
Monitor for emergent suicidality, especially in young adults, during initiation and dose adjustments.
Assess for potential drug-drug interactions, particularly with other serotonergic agents, MAOIs, and CYP1A2/2D6 substrates/inhibitors.

Patient Guidelines

Take Azonox-Ultra exactly as prescribed by your doctor. Do not change the dose or stop the medication without consulting your doctor.
Swallow the capsule whole; do not chew, crush, or open it.
Do not stop taking this medicine abruptly, as it can lead to withdrawal symptoms. Your doctor will gradually reduce the dose if discontinuation is necessary.
Report any unusual mood changes, agitation, or thoughts of self-harm to your doctor immediately.

Missed Dose Advice

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Driving Precautions

Azonox-Ultra may cause dizziness, drowsiness, or blurred vision, especially when starting treatment or after a dose change. Avoid driving or operating heavy machinery until you know how this medication affects you.

Lifestyle Advice

Avoid or limit alcohol consumption while taking Azonox-Ultra, as it can increase the risk of liver problems.
Maintain a healthy diet and engage in regular physical activity to support overall well-being and potentially enhance treatment outcomes.
Practice stress-reduction techniques like mindfulness or meditation.