Mirtazapine Powder
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Mirtazapine Powder

Mirtazapine Powder

1.General Specification(in stock)
(1)API(Pure powder)
(2)Tablets
(3)Ointment
(4)Liquid
2.Customization:
We will negotiate individually, OEM/ODM, No brand, for secience researching only.
Internal Code:BM-1-146
Mirtazapine CAS 85650-52-8
Main market: USA, Australia, Brazil, Japan, Germany, Indonesia, UK, New Zealand , Canada etc.
Manufacturer: BLOOM TECH Xi’an Factory
Analysis: HPLC, LC-MS, HNMR
Technology support: R&D Dept.-4

Shaanxi BLOOM Tech Co., Ltd. is one of the most experienced manufacturers and suppliers of mirtazapine powder in China. Welcome to wholesale bulk high quality mirtazapine powder for sale here from our factory. Good service and reasonable price are available.

 

Mirtazapine Powder is a white crystalline chemical substance with the chemical formula C ₁₇ H ₁₉ N ∝, molecular weight 265.35 g/mol, CAS accession number 61337-67-5. It belongs to the tetracycline class of antidepressants (TeCA) and is also the world's first norepinephrine and specific 5-hydroxytryptamine antidepressant (NaSSA), exerting antidepressant effects by regulating multiple neurotransmitters. It can enhance the neurotransmission of norepinephrine (NE) and serotonin (5-HT), antagonize central alpha ₂ receptors, inhibit negative feedback, promote NE release, specifically block 5-HT ₂ and 5-HT ∝ receptors, regulate 5-HT function, and enhance antidepressant effects. Antihistamine (H ₁) receptors can cause drowsiness and are commonly used to improve insomnia. Anti 5-HT ₂/5-HT ∝ receptors can alleviate anxiety, nausea, and improve appetite.

 
Our product
 
Mirtazapine  | Shaanxi BLOOM Tech Co., Ltd Mirtazapine  | Shaanxi BLOOM Tech Co., Ltd Mirtazapine  | Shaanxi BLOOM Tech Co., Ltd Mirtazapine  | Shaanxi BLOOM Tech Co., Ltd

 Produnct Introductionproduct-15-15

Product Name Mirtazapine Powder Mirtazapine Tablets 30mg
Product Type Powder Tablet
Product Purity ≥99% ≥99%
Product Specifications 100g/1kg/etc. 15mg/30mg
Product Form Organic synthesis Take Orally

Mirtazapine  COA

Mirtazapine  | Shaanxi BLOOM Tech Co., Ltd
Certificate of Analysis
Compound name Mirtazapine
Grade Pharmaceutical grade
CAS No. 85650-52-8
Quantity 337.3kg
Packaging standard 25kg/drum
Manufacturer Shaanxi BLOOM TECH Co., Ltd
Lot No. 202501090047
MFG Jan 9th 2025
EXP Jan 8th 2028
Structure

Mirtazapine  | Shaanxi BLOOM Tech Co., Ltd

Item Enterprise standard Analysis result
Appearance White or almost white powder Conformed
Water content ≤5.0% 0.49%
Loss on drying ≤1.0% 0.30%
Heavy Metals Pb≤0.5ppm N.D.
As≤0.5ppm N.D.
Hg≤0.5ppm N.D.
Cd≤0.5ppm N.D.
Purity (HPLC) ≥99.0% 99.90%
Single impurity <0.8% 0.49%
Total microbial count ≤750cfu/g 80
E. Coli ≤2MPN/g N.D.
Salmonella N.D. N.D.
Ethanol (by GC) ≤5000ppm 500ppm
Storage Store in a sealed, dark, and dry place below 2-8°C

Mirtazapine  | Shaanxi BLOOM Tech Co., Ltd

Mirtazapine Powder COA | Shaanxi BLOOM Tech Co., Ltd

Applications

Mirtazapine Powder, also known as Mirtazapine, is a psychoactive ingredient with significant application value in the medical field. Its unique pharmacological mechanism of action makes it play a key role in the treatment of various mental disorders and related symptoms, and it also has specific uses in the production of pharmaceutical preparations and other fields.

Core medical use: the main drug for antidepressant treatment

Standard treatment for depression
 

Mirtazapine powder, as a tetracyclic antidepressant (NaSSA class), is the world's first antidepressant drug that regulates neurotransmitters through a dual mechanism. Its core mechanism of action includes:
Alpha ₂ receptor antagonism: Blocking central presynaptic membrane alpha ₂ receptors, relieving negative feedback inhibition of norepinephrine (NE) release, significantly enhancing adrenergic nerve conduction.
5-hydroxytryptamine receptor regulation: Specifically blocks 5-HT ₂ and 5-HT ∝ receptors, allowing 5-hydroxytryptamine (5-HT) to primarily act on 5-HT-A receptors, optimizing serotonin function.
Histamine H ₁ receptor antagonism: produces sedative effects and improves sleep quality.
Approved by the US FDA in 1996, it has been used in over 70 countries for the treatment of major depressive disorder (MDD).
The German S3 guideline states that its relief rate for symptoms such as lack of pleasure, psychomotor inhibition, early awakening, and weight loss is 68% -75%.
Compared to SSRI drugs such as fluoxetine, Mirtazapine Powder has a faster onset of action (1-2 weeks) and has less impact on sexual function.

Mirtazapine Powder use | Shaanxi BLOOM Tech Co., Ltd

Collaborative treatment with accompanying symptoms

 

Mirtazapine Powder use | Shaanxi BLOOM Tech Co., Ltd

Anxiety disorder with insomnia: Improving sleep latency, duration, and quality through sedative effects, especially suitable for patients with comorbid depression and anxiety.
Post traumatic stress disorder (PTSD): Some guidelines recommend it as an adjuvant therapy drug to alleviate emotional fluctuations and sleep disorders.
Cancer related symptoms:
Improve chemotherapy-induced nausea and vomiting (CINV), with significant 5-HT receptor antagonism.
Relieve appetite loss and promote weight recovery in cancer patients, with clinical trials showing an average weight gain of 2.3kg/month.

Special populations and indications expansion

 
 

The preferred medication for elderly patients

Dose adjustment: The German FORTA list classifies it as Class C (efficacy to risk ratio needs to be closely monitored), with a recommended initial dose of 7.5-15mg/day and a maximum dose not exceeding 30mg/day.
Advantage:
The cognitive side effects are relatively mild, making it suitable for sleep disorder patients with concomitant dementia.
Almost no anticholinergic effect, reducing the risk of dry mouth, constipation, urinary retention, etc.
The cardiovascular impact is minimal, and hypertensive patients have good tolerance.

 
 
 

Adjuvant treatment for patients with chronic diseases

Chronic kidney disease (CKD): To improve appetite loss and malnutrition in patients with end-stage kidney disease, the dosage needs to be adjusted according to creatinine clearance rate (such as reducing by 50% when GFR<30ml/min).
Congestive heart failure: Relieve appetite loss and nausea caused by the disease, but monitor the risk of orthostatic hypotension.
Liver failure: Patients with liver dysfunction due to CYP3A4 metabolism need to extend the dosing interval (such as once every 48 hours).

 
 
 

Application of Veterinary Medicine

Cat and dog appetite suppressants:
Dosage: 0.6mg/kg orally for cats, once every 3 days; Dogs are classified by weight (<9kg 3.75mg/day, 9-23kg 7.5mg/day,>23kg 15mg/day).
Indications: Postoperative loss of appetite, chronic kidney disease, liver tumors, pyometra, etc.
Antiemetic treatment: Used in combination with ondansetron to alleviate chemotherapy-induced nausea and vomiting, with an effective rate increased to 82%.

 

Clinical Practice of Off label Use

1. Treatment of Simple Insomnia
Dosage: 3.75-7.5mg/day (much lower than the antidepressant dose), taken before bedtime.
Mechanism: Shorten sleep onset time (average reduction of 22 minutes) and prolong total sleep time (increase of 1.1 hours) through H ₁ receptor antagonism.
Evidence: The German S3 guidelines recommend second-line medication for patients with SSRI drug intolerance.
2. Treatment of chronic pruritus
Dosage: 15-30mg/day, treatment course 4-8 weeks.
indication:Inflammatory skin disease associated itching (such as atopic dermatitis).Pruritus due to cholestasis.Itching related to renal failure.
Mechanism: Indirectly relieving itching by inhibiting 5-HT3 receptors to reduce itch signal transmission and improving sleep quality.

Mirtazapine Powder use | Shaanxi BLOOM Tech Co., Ltd
Mirtazapine Powder use | Shaanxi BLOOM Tech Co., Ltd

3. Adjuvant treatment for substance abuse disorders
Methamphetamine addiction: Animal experiments have shown that it can reduce drug seeking behavior, and clinical studies are exploring its role in reducing withdrawal symptoms and improving remission rates.
Alcohol dependence: Used in combination with naltrexone to improve sleep and appetite, and reduce relapse rates.

Pharmacokinetic characteristics and medication guidance

Absorption and metabolism

Oral bioavailability: 50% (food does not affect absorption).
Peak time: 2 hours (fasting), 4 hours (after meals).
Half life: 20-40 hours (with significant individual differences), requiring daily medication at a fixed time.
Metabolic pathway:
Mainly metabolized by CYP2D6 and CYP3A4 enzymes, producing demethylazepine (active metabolite).
75% is excreted through urine and 25% through feces.

Principle of dose adjustment

Initial treatment: 15mg/day, taken before bedtime.
Dose escalation: Increase by 15mg every 1-2 weeks, with a maximum dose of 45mg per day.
Special populations:
Elderly individuals: initial dose of 7.5mg/day, maximum dose of 15mg/day.
Liver and kidney dysfunction: When creatinine clearance rate is less than 30ml/min, the dose is halved; Patients with Child Pugh C liver function are prohibited from using it.

Adverse reactions and risk management

Common adverse reactions (incidence>10%)

Central nervous system: drowsiness (54%), dizziness (12%).
Metabolic system: increased appetite (32%), weight gain (average 2.8kg/month).
Digestive system: dry mouth (11%), constipation (8%).

 

Serious adverse reactions (incidence rate<1%)

Hematological system: Neutropenia (0.3%) requires regular monitoring of blood routine.
Cardiovascular system: orthostatic hypotension (2%), especially when combined with antihypertensive drugs.
Psychological symptoms: Anxiety and agitation (5%), often seen during the dose adjustment period.

 

Drug interactions

Taboo combination:Monoamine oxidase inhibitors (MAOIs): spaced at least 14 days apart.Serotonin drugs (such as SSRIs and tramadol): increase the risk of serotonin syndrome.
Cautious combination:
Benzodiazepines: aggravate central inhibition and require reduced dosage.
Warfarin: INR value may increase, coagulation function needs to be monitored.
CYP3A4 inhibitors (such as ketoconazole): As the blood drug concentration increases, the dosage needs to be adjusted.

 

Patient education and long-term management

 
 

Improvement of medication adherence

Time guidance: Take medication before bedtime to avoid drowsiness caused by daytime medication.
Dose adjustment: Emphasize slow increments and evaluate efficacy every 2 weeks.
Lifestyle intervention:Avoid drinking alcohol (exacerbating central inhibition).Be cautious when driving or operating machinery (which may affect attention in the early stages).

 
 
 

Long term monitoring plan

Laboratory examination:
Baseline period: blood routine, liver function, electrolytes.
Monthly: weight, blood pressure, heart rate.
Every 3 months: Blood routine (with a focus on monitoring neutrophils).
Symptom assessment:Use the PHQ-9 scale to assess depressive symptoms on a monthly basis.Record sleep quality (time to fall asleep, number of awakenings at night).

 
 
 

Medication discontinuation and withdrawal symptoms

Discontinuation principle: Gradually reduce dosage (50% every 3 days) to avoid sudden discontinuation.
Withdrawal symptoms:Headache (38%), fatigue (25%), insomnia (18%).Anxiety and agitation (12%), nausea (9%).
Solution:
Mild symptoms: symptomatic support (such as acetaminophen pain relief).
For those with severe symptoms: restore the original dose and slowly reduce the dosage.

 

 

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