Zydus Trazodone Hydrochloride 50 mg – 8 05 Pill – 68382-0805 white round, 8mm

Pill with imprint 8 05 is White, Round and has been identified as Trazodone Hydrochloride 50 mg. It is supplied by Zydus Pharmaceuticals (USA) Inc.

Trazodone is used in the treatment of Depression; Sedation; Major Depressive Disorder and belongs to the drug class phenylpiperazine antidepressants. Risk cannot be ruled out during pregnancy. Trazodone 50 mg is not a controlled substance under the Controlled Substances Act (CSA).

 

Trazodone Hydrochloride

Imprint

8 05

Strength

50 mg

Color

White

Size

8.00 mm

Shape

Round

Availability

Prescription only

Drug Class

Phenylpiperazine antidepressants

Pregnancy Category

C – Risk cannot be ruled out

CSA Schedule

Not a controlled drug

Labeler / Supplier

Zydus Pharmaceuticals (USA) Inc.

Manufacturer

Cadila Healthcare Limited

National Drug Code (NDC)

68382-0805

Inactive Ingredients

silicon dioxide, magnesium stearate, microcrystalline cellulose, corn starch, sodium lauryl sulfate, sodium starch glycolate type A potato

Note: Inactive ingredients may vary.

Uses of Trazodone:

1. Depression: Trazodone is mainly used to treat depression, particularly when it is associated with insomnia.
2. Anxiety Disorders: It can help reduce symptoms of anxiety.
3. Insomnia: Trazodone is often prescribed off-label to treat insomnia due to its sedative effects.
4. Chronic Pain: It may be used as an adjunct to manage chronic pain in certain conditions.

How to Take Trazodone:

• Dosage: The dosage of trazodone varies based on the condition being treated, the patient’s age, and other factors. It is typically taken once or twice a day, often after a meal or a snack to reduce the risk of stomach upset.
  • For Depression: The starting dose is usually around 150 mg per day, which may be gradually increased by the doctor. The dose may range from 150 to 400 mg daily, divided into smaller doses or as a single dose at bedtime.
  • For Insomnia: A lower dose is usually prescribed, often around 25 to 100 mg before bedtime.
• Administration: Trazodone should be taken as prescribed by a healthcare provider. It is important to follow the dosing instructions carefully to avoid potential side effects or complications.
  • Swallowing: Take the medication whole with a glass of water. Do not crush or chew the tablets, especially if they are extended-release.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Do not double up on doses to make up for a missed one.

Precautions:

• Alcohol: Avoid consuming alcohol while taking trazodone, as it can increase drowsiness and the risk of side effects.
• Interactions: Inform your doctor of any other medications or supplements you are taking, as trazodone can interact with other drugs, potentially leading to serious side effects.
• Side Effects: Common side effects include drowsiness, dizziness, dry mouth, blurred vision, and constipation. Severe side effects, such as changes in heart rhythm, should be reported to a healthcare provider immediately.

Trazodone Hydrochloride Off-label Usages

Trazodone Hydrochloride is primarily approved for the treatment of major depressive disorder, but it is also widely used off-label for several other conditions due to its pharmacological effects. Here are some of the common off-label uses:

1. Insomnia:

• Primary Off-Label Use: Trazodone is frequently prescribed for insomnia, especially when it is associated with depression or anxiety. Its sedative properties make it effective for helping patients fall asleep and stay asleep.

2. Anxiety Disorders:

• Trazodone can be used to manage generalized anxiety disorder (GAD), social anxiety disorder, and other anxiety-related conditions. It helps reduce anxiety symptoms by increasing serotonin levels in the brain.

3. Chronic Pain:

• It is sometimes used as an adjunct treatment for chronic pain conditions, particularly when these are associated with sleep disturbances or depression. Trazodone may help improve sleep quality and pain perception.

4. PTSD (Post-Traumatic Stress Disorder):

• Trazodone is used off-label to help manage symptoms of PTSD, particularly insomnia and nightmares. Its calming effects can be beneficial for patients with this condition.

5. Fibromyalgia:

• Patients with fibromyalgia, a condition characterized by widespread pain, may benefit from trazodone’s sleep-improving properties, which can indirectly reduce pain perception.

6. Migraine Prophylaxis:

• In some cases, trazodone is used off-label to help prevent migraines, particularly when they are associated with sleep disorders.

7. Alcohol Withdrawal:

• Trazodone may be prescribed to help manage symptoms of alcohol withdrawal, such as anxiety, agitation, and insomnia, although this use is less common.

8. Agitation in Dementia:

• In some cases, trazodone is used to manage agitation or behavioral disturbances in patients with dementia. However, this use requires careful monitoring due to the increased risk of falls and other side effects in elderly patients.

9. Panic Disorder:

• Trazodone may be used off-label to treat panic disorder, often in combination with other medications.

10. Eating Disorders:

• While not common, trazodone may be used as part of a treatment plan for eating disorders, particularly when these are associated with depression or anxiety.

Important Considerations:

• Efficacy and Safety: The effectiveness and safety of trazodone for these off-label uses can vary, and it is typically used when first-line treatments are ineffective or unsuitable.
• Consultation: Always consult with a healthcare provider before using trazodone for any off-label purpose, as the dosage and potential side effects may differ from its use in treating depression.

How Does Trazodone Hydrochloride Work ?

Trazodone Hydrochloride is an antidepressant that works by influencing neurotransmitters in the brain, particularly serotonin. Its mechanism of action is complex and involves several processes that contribute to its therapeutic effects.

Mechanism of Action:

1. Serotonin Reuptake Inhibition:
   • Trazodone primarily works as a serotonin reuptake inhibitor (SRI). It prevents the reabsorption (reuptake) of serotonin, a neurotransmitter, into neurons, making more serotonin available in the brain. Increased levels of serotonin can help improve mood, reduce anxiety, and alleviate symptoms of depression.
2. Serotonin Receptor Antagonism:
   • Trazodone also acts as a serotonin receptor antagonist, particularly at the 5-HT2A and 5-HT2C receptors. By blocking these receptors, trazodone helps modulate the activity of serotonin, reducing anxiety and depressive symptoms. This antagonism is also thought to contribute to its sedative effects.
3. Histamine and Alpha-1 Adrenergic Receptor Blockade:
   • Histamine H1 Receptor Antagonism: Trazodone has strong antihistaminic properties due to its ability to block histamine H1 receptors. This action contributes to its sedative effects, making it effective for treating insomnia.
   • Alpha-1 Adrenergic Receptor Antagonism: Trazodone also blocks alpha-1 adrenergic receptors, which can cause vasodilation (widening of blood vessels) and may contribute to some of the drug’s side effects, such as orthostatic hypotension (a sudden drop in blood pressure when standing up).
4. Impact on Sleep:
   • Due to its combined actions on serotonin, histamine, and adrenergic receptors, trazodone has a notable sedative effect. This makes it effective for improving sleep quality in patients with depression, anxiety, or insomnia.

Summary of Effects:

• Antidepressant Effects: By increasing serotonin levels and modulating serotonin receptor activity, trazodone helps alleviate symptoms of depression.
• Anxiolytic Effects: The drug’s action on serotonin receptors also contributes to its ability to reduce anxiety.
• Sedative Effects: The antihistaminic and alpha-1 adrenergic receptor blockade lead to significant sedative properties, which are beneficial in treating insomnia but can also cause drowsiness as a side effect.

Zydus Pharmaceuticals (USA) Inc.

Zydus Pharmaceuticals (USA) Inc. is the U.S. subsidiary of Cadila Healthcare Limited, an Indian multinational pharmaceutical company widely known as Zydus Cadila. Zydus Pharmaceuticals (USA) Inc. is a key player in the generic pharmaceutical market in the United States, offering a broad range of high-quality, affordable medications.

Key Facts About Zydus Pharmaceuticals (USA) Inc.:

1. Parent Company:
   • Parent Company: Zydus Cadila (Cadila Healthcare Limited), headquartered in Ahmedabad, Gujarat, India.
   • Founded: Cadila Healthcare was established in 1952 by Ramanbhai Patel, a renowned Indian pharmaceutical entrepreneur.
2. Establishment and Headquarters:
   • Established: Zydus Pharmaceuticals (USA) Inc. was founded as the U.S. subsidiary to extend Zydus Cadila’s operations into the North American market.
   • Headquarters: Pennington, New Jersey, USA.
3. Product Portfolio:
   • Generic Medications: Zydus Pharmaceuticals (USA) Inc. offers a wide range of generic pharmaceutical products across multiple therapeutic categories, including cardiovascular, anti-infective, gastrointestinal, central nervous system, oncology, dermatology, and more.
   • Over-the-Counter (OTC) Products: In addition to prescription generics, the company also provides over-the-counter medications.
   • Biosimilars and Specialty Products: The company is expanding its portfolio to include biosimilars and specialty products to meet evolving healthcare needs.
4. Manufacturing and Quality Control:
   • Manufacturing Facilities: Zydus operates state-of-the-art manufacturing facilities in the United States, which are approved by the U.S. Food and Drug Administration (FDA). These facilities adhere to stringent quality control measures to ensure the safety and efficacy of their products.
   • Global Manufacturing Network: In addition to its U.S. facilities, Zydus leverages its global manufacturing network, including facilities in India, to supply products to the U.S. market.
5. Research and Development:
   • Zydus Pharmaceuticals (USA) Inc. benefits from the extensive R&D capabilities of its parent company, Zydus Cadila. The company is involved in the development of complex generics, novel drug delivery systems, and biosimilars.
   • Innovation: Zydus is committed to innovation and invests heavily in R&D to bring new and improved therapies to market, particularly in areas of unmet medical need.
6. Regulatory Compliance and Approvals:
   • Zydus Pharmaceuticals (USA) Inc. has a strong track record of regulatory compliance, with numerous products receiving FDA approval. The company is known for its rigorous adherence to regulatory standards, which ensures the consistent quality of its products.
7. Market Presence:
   • Zydus Pharmaceuticals (USA) Inc. is one of the leading suppliers of generic drugs in the United States. Its products are distributed through various channels, including wholesalers, pharmacies, and healthcare providers.
8. Commitment to Affordable Healthcare:
   • Zydus is dedicated to making high-quality healthcare affordable and accessible. The company’s extensive portfolio of generic medications helps reduce healthcare costs for patients and healthcare systems in the U.S.

Current Status:

Zydus Pharmaceuticals (USA) Inc. continues to grow as a key player in the U.S. pharmaceutical market. It is recognized for its commitment to quality, innovation, and affordable healthcare. The company is actively expanding its product offerings, including the development of biosimilars and specialty medications, to address a broader range of medical conditions and enhance its position in the competitive U.S. market.