Pliva 433
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Pliva 433 is a generic form of trazodone hydrochloride, an oral prescription medication used to treat depression. It can also alleviate anxiety, psychological symptoms of fibromyalgia, and insomnia associated with depression. This medicine treats major depressive disorder in adults only. Additionally, it can improve mood, increase energy levels, and enhance appetite in some people.
- Each tablet contains 50 mg of trazodone.
- The other ingredient is hydrochloride salt, which possesses both antidepressant and sedative properties.
Uses
As a serotonin modulator, it is primarily used to treat major depressive disorder. However, due to its sedative properties, it is often prescribed off-label to treat insomnia, especially when associated with depression.
Half-Life
Trazodone has a mean half-life of approximately 5 to 9 hours in healthy individuals, although this can be increased in patients with liver disease. The major route of elimination is renal, with about 70-75% of the dose recovered in urine as metabolites.
Side Effects
The potential reactions are similar to those associated with most antidepressants including:
- Nausea
- Diarrhea
- Constipation
- Dizziness
- Drowsiness
- Dry mouth
- Muscle aches
Ingestion may also cause:
- heart palpitations
- rapid heartbeat
- migraines
- visual disturbances
Dosage adjustments may be necessary to mitigate complications.
Mechanism of Action
This medication works by antagonizing serotonin receptors and inhibiting the reuptake of serotonin, norepinephrine, or dopamine. This mitigates depression and anxiety by preventing receptor action on specific brain cells. It belongs to the class of Selective Serotonin Reuptake Inhibitors (SSRI).
Serotonin is a primary neurotransmitter, moderating:
- mood
- sleep
- appetite
- motivation
- libido
Guidelines
According to the FDA, the following guidelines should be adhered to when using this drug:
- Take them shortly after a meal or light snack.
- Tablets should be swallowed whole or broken in half along the scoreline.
Dependency
This medicine is not physically or psychologically addictive. However, if you suddenly stop taking it after several months, you could experience antidepressant discontinuation syndrome as your brain tries to adjust to reduced serotonin levels.
Many patients suffer from this syndrome due to non-adherence to the therapy. Symptoms may include:
- extreme dizziness
- anxiety
- insomnia
- flu-like symptoms
Facts
- The FDA approved it in 1981.
- This medication was the first non-tricyclic antidepressant approved in the United States.
- It is classified as a second-generation antidepressant.
- Overdosing is rare.
Classification
Second-generation antidepressants have fundamentally similar chemical structures and pharmacological effects. Researchers developed it based on studies indicating that depression arises from an individual’s inability to manage pain. However, in contrast to other antidepressants at that time, it had minimal impact on specific neurotransmitter receptors involved in depression.
Serotonin Syndrome
Taking it with other SSRIs can potentially lead to a severe condition known as serotonin syndrome, which may cause agitation, headaches, vomiting, fast heartbeat, and profuse sweating. This occurs when an excess of serotonin floods the brain. Severe cases of serotonin syndrome may require emergency treatment, including forced diuresis (stomach pumping) or the administration of activated charcoal to counteract toxic serotonin levels in the brain.
Off-Label
Though initially developed to treat depression, it is also prescribed “off-label” as a sleep aid. When drugs are prescribed off-label, doctors recommend them for conditions not initially approved by the FDA due to the proven effectiveness for a particular health issue. The DEA does not list it as a controlled substance as it does not act on the “reward” center in the brain like opioids and alcohol.
Summary
Below is a table summarizing the key facts.
| Feature | Information |
| Ingredients: | Trazodone Hydrochloride 50 mg |
| Uses: | Major depressive disorder, insomnia |
| Contraindications: | Allergy to Trazodone, MAOI use within 14 days |
| Drug class: | Serotonin antagonist and reuptake inhibitor (SARI) |
| Availability: | Prescription |
| Administration: | Oral |
| Markings: | “PLIVA 433” |
| Color: | White |
| Shape: | Round |
| Size: | 8 mm |
| CSA classification: | Not a controlled substance |
| Warnings: | Risk of serotonin syndrome, suicidal thoughts |
| Mechanism of action: | Serotonin reuptake inhibition |
| Packaging: | Bottles of 100 tablets |
| Storage: | Room temperature, away from light and moisture |
| Pregnancy: | (Category C) |
| FDA approved: | Yes |
| NDC code: | Varies by supplier |
| Supplier: | Various |
National Drug Code
The National Drug Code (NDC) is a division of the FDA. All drugs get a unique, three-digit number called the National Drug Code (NDC), which the FDA uses for identification.
| National Drug Code | # Pills per Bottle |
| 50111-433-01 | 100 |
| 50111-433-02 | 500 |
| 50111-433-03 | 1000 |
