Technical Correction: Standard tablet dosages for Clonidine are typically 100 mcg (0.1 mg), 150 mcg (0.15 mg), or 200 mcg (0.2 mg). A dose of 150 mg would be 1,000 times the standard therapeutic dose and would be considered a lethal overdose. I will proceed with the technical profile for the 150 mcg (0.15 mg) strength, which is a common international standard.
Primary Clinical Uses
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Hypertension: Used as a second-line treatment for high blood pressure, particularly in cases of “resistant hypertension” where other agents have failed.
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ADHD (Attention Deficit Hyperactivity Disorder): Used (often as an extended-release formulation) to treat ADHD in children and adults, frequently as an adjunct to stimulants to manage impulsivity and sleep issues.
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Withdrawal Management: Extensively utilized to manage the physical symptoms of opioid, alcohol, and nicotine withdrawal (such as tachycardia, sweating, and agitation).
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Pain Management: Used off-label for chronic pain conditions, including neuropathic pain and migraine prophylaxis.
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Menopausal Symptoms: Occasionally prescribed to reduce the frequency and severity of hot flashes.
Mechanism of Action
Clonidine acts by stimulating $\alpha_2$-adrenoceptors in the brainstem (specifically the vasomotor center of the medulla).
This stimulation results in a reduction of sympathetic outflow from the central nervous system to the heart, kidneys, and peripheral vasculature. The result is a decrease in peripheral resistance, a decrease in heart rate, and a decrease in blood pressure. It essentially “quiets” the body’s adrenaline-driven stress response at the source.
The Manufacturer’s Perspective: Formulation & Export
From a manufacturing and global trade standpoint, Clonidine is a high-precision, low-dose molecule:
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Micro-Dose Content Uniformity: Since the active ingredient is in micrograms, as a WHO-GMP manufacturer, we utilize validated trituration and geometric dilution processes. This ensures the minute amount of API is perfectly distributed across the excipient matrix to avoid batch failure.
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Stability & Shelf Life: While the molecule is relatively stable, we prioritize Alu-Alu blister packaging to protect against moisture and light, ensuring a 36-month shelf life for export to Zone IVb regions.
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B2B & Niche Demand: While not a “mass-market” drug, it is a high-value niche product for psychiatric and hypertension clinics. Our Mumbai-based facility provides the CTD/eCTD Dossiers required for international registration.
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Safety Warning (Rebound Hypertension): As a pharmacist, you are aware that abrupt cessation can cause a hypertensive crisis. We ensure our professional labeling and Product Information Leaflets (PIL) carry clear warnings regarding gradual tapering.