Trazodone Hydrochloride (Trazodone Hydrochloride)

Trade Name : Trazodone Hydrochloride

KAISER FOUNDATION HOSPITALS

TABLET

Strength 50 mg/1

TRAZODONE HYDROCHLORIDE Serotonin Reuptake Inhibitor [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Trazodone Hydrochloride (Trazodone Hydrochloride) which is also known as Trazodone Hydrochloride and Manufactured by KAISER FOUNDATION HOSPITALS. It is available in strength of 50 mg/1 per ml. Read more

Trazodone Hydrochloride (Trazodone Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of trazodone hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Trazodone hydrochloride tablets are not approved for use in pediatric patients n n n .n n n
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
See full prescribing information for complete boxed warning
Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Trazodone is not approved for use in pediatric patients (n n n ).n n n

Trazodone Hydrochloride Tablets USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of Trazodone Hydrochloride Tablets USP has been established in trials with the immediate release formulation of trazodone n n n n
Trazodone Hydrochloride Tablets USP are indicated for the treatment of major depressive disorder (n n n ).n nn
u2022 Efficacy was established in trials of trazodone immediate release formulation in patients with major depressive disorder (n n n ).n nn

The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
Dose Selection
An initial dose of 150 mg/day in divided doses is suggested. The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses
Maintenance Treatment
The efficacy of trazodone hydrochloride tablets for the maintenance treatment of MDD has not been evaluated. While there is no body of evidence available to answer the question of how long a patient treated with trazodone hydrochloride tablets should continue the drug, it is generally recommended that treatment be continued for several months after an initial response. Patients should be maintained on the lowest effective dose and be periodically reassessed to determine the continued need for maintenance treatment.
Important Administration Instructions
Trazodone hydrochloride tablets are scored to provide flexibility in dosing.
Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line.
u2022 Starting dose: 150 mg in divided doses daily. May be increased by 50 mg per day every three to four days. Maximum dose: 400 mg per day in divided doses (n n n ).n nn
u2022 Trazodone hydrochloride tablets should be taken shortly after a meal or light snack (n n n ).n nn
u2022 Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed (n n n ).n nn
u2022 When discontinued, gradual dose reduction is recommended (n n n ).n nn

Trazodone hydrochloride tablets are available in the following strengths:
50 mg- White, round, compressed tablet, debossed u201cPLIVA 433u201d on one side and scored on the other side.
100 mg- White, round, compressed tablets, debossed u201cPLIVA 434u201d on one side and scored on the other side.
150 mg- White, trapezoid, flat-face, beveled edge tablet, scored and debossed as u201cPLIVAu201d bisect u201c441u201d on one side and tri-scored and debossed as u201c50u201d in each section on the other side.
Bisectable tablets of 50 mg, 100 mg and 150 mg (n n n ).n nn

None.
None (n n n ).n nn

u2022 Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicidal thinking and behavior (n n n ). n nn
u2022 Serotonin Syndrome or Neuroleptic Malignant Syndrome-Like n n n Reactions: Have been reported with antidepressants. Discontinue trazodone hydrochloride tablets and initiate supportive treatment (n n n , n n n ).n nn
u2022 Activation of Mania/Hypomania: Screen for bipolar disorder and monitor for mania/hypomania (n n n ).n nn
u2022 QT Prolongation: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval (n n n ).n nn
u2022 Use in Patients With Heart Disease: Use with caution in patients with cardiac disease (n n n ).n nn
u2022 Orthostatic Hypotension and Syncope: Have occurred. Warn patients of risk and symptoms of hypotension (n n n ).n nn
u2022 Abnormal Bleeding: May increase the risk of bleeding. Use with NSAIDs, aspirin, or other drugs that affect coagulation may compound this risk (n n n , n n n ).n nn
u2022 Interaction With MAOIs: Do not use concomitantly or within 14 days of monoamine oxidase inhibitors (n n n , n n n ).n nn
u2022 Priapism: Has occurred. Warn male patients of this risk and how/when to seek medical attention (n n n ).n nn
u2022 Hyponatremia: Can occur in association with SIADH (n n n ).n nn
u2022 Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery (n n n ).n nn
u2022 Discontinuation Symptoms: May occur with abrupt discontinuation and include anxiety and sleep disturbance. Upon discontinuation, taper trazodone hydrochloride tablets and monitor for symptoms (n n n ).n nn

The following serious adverse reactions are described elsewhere in the labeling:
u2022 Clinical Worsening and Suicide Risk n n n n n
u2022 Serotonin Syndrome or NMS-Like Reactions n n n n
u2022 QT Prolongation and Risk of Sudden Death n n n n
u2022 Orthostatic Hypotension n n n n
u2022 Abnormal Bleeding Events n n n n
u2022 Priapism n n n n
u2022 Hyponatremia n n n n
u2022 Cognitive and Motor Impairment n n n n
u2022 Discontinuation Symptoms n n n n
The most common adverse reactions (reported in u2265 5% and at twice the rate of placebo) are:
Somnolence/sedation, dizziness, constipation, vision blurred.
Table 2
u00a0Most common adverse reactions (incidence u2265 5% and twice that of placebo) are: somnolence/sedation, dizziness, constipation, vision blurred (n n n ).n nn
To report SUSPECTED ADVERSE REACTIONS, contact n n n n ;n n n
or FDA at 1-800-FDA-1088 or n n n n

MAOIs
MAOIs should not be used within 14 days of trazodone n n n n
Central Nervous System (CNS) Depressants
Trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.
Cytochrome P450 3A4 Inhibitors
In vitro n- [see Warnings andn- Precautions (n n n )] n n n
Cytochrome P450 Inducers (e.g., Carbamazepine)
Carbamazepine induces CYP3A4. Following coadministration of carbamazepine 400 mg per day with trazodone 100 mg to 300 mg daily, carbamazepine reduced plasma concentrations of trazodone and m-chlorophenlypiperazine (an active metabolite) by 76% and 60% respectively, compared to pre-carbamazepine values. Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taking both drugs.
Digoxin and Phenytoin
Increased serum digoxin or phenytoin levels have been reported in patients receiving trazodone concurrently with either of these drugs. Monitor serum levels and adjust dosages as needed.
Serotonergic Drugs
Based on the mechanism of action of trazodone and the potential for serotonin syndrome, caution is advised when trazodone is coadministered with other drugs that may affect the neurotransmitter systems [n n n ].n nn
NSAIDs, Aspirin, or Other Drugs Affecting Coagulation or Bleeding
Due to a possible association between serotonin modulating drugs and gastrointestinal bleeding, patients should be monitored for and cautioned about the potential risk of bleeding associated with the concomitant use of trazodone and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding [sn n n n ].n nn
Warfarin
There have been reports of altered (either increased or decreased) prothrombin times in taking both warfarin and trazodone.
u2022 CNS Depressants: Trazodone may enhance effects of alcohol, barbiturates, or other CNS depressants (n n n ).n nn
u2022 CYP3A4 Inhibitors: May necessitate lower dose of trazodone hydrochloride tablets (n n n ).n nn
u2022 CYP3A4 Inducers (e.g., Carbamazepine): May necessitate higher dose of trazodone hydrochloride tablets (n n n ).n nn
u2022 Digoxin or Phenytoin: Monitor for increased serum levels (n n n ).n nn
u2022 Warfarin: Monitor for increased or decreased prothrombin time (n n n ).n nn

u2022 Pregnancy: Based on animal data, may cause fetal harm (n n n ).n nn
u2022 Nursing Mothers: Use with caution (n n n ).n nn
u2022 Pediatric Patients: trazodone hydrochloride tablets are not approved in pediatric patients (n n n ).n nn
u2022 Renal or Hepatic Impairment: Use with caution (n n n , n n n ).n nn

No data

No data

Trazodone hydrochloride, USP is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4, 3-a]pyridin-3(2n n n )-one hydrochloride. It is a white, odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:n nn
Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

No data

No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving trazodone in daily oral doses up to 300 mg/kg for 18 months.

The efficacy and safety of trazodone hydrochloride was established from n n n trials of the trazodone immediate release formulation in the treatment of major depressive disorder.n nn

Trazodone Hydrochloride Tablets USP are available as follows:
50 mg: White, round, compressed tablet, debossed u201cPLIVA 433u201d on one side and scored on the other side. Available in bottles of 30, 50, 60 and 90.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

See FDA-approved Medication Guide
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with trazodone hydrochloride and should counsel them in its appropriate use.
Patients should be warned that:
Patients should be counseled that:
Important Administration Instructions:
u00a0
Manufactured In Croatia By:
PLIVA HRVATSKA d.o.o.
Zagreb, Croatia
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. D 1/2014
u00a0
Repackaged By:
KAISER FOUNDATION HOSPITALS
Livermore, CA 94551

Trazodone Hydrochloride (traz' oh done hye'' droe klor' ide) Tablets USP
Read the Medication Guide that comes with trazodone hydrochloride tablets before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk to your healthcare provider or pharmacist if there is something you do not understand or you want to learn about trazodone hydrochloride tablets.
What is the most important information I should know about trazodone hydrochloride tablets?
Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about:
u2022 All risks and benefits of treatment with antidepressant medicines
u2022 All treatment choices for depression or other serious mental illnesses
1. n n n .n nn
2. n n n . n n n . These include people who have or have a family history ofu00a0 bipolar illness (also called manic- depressive illness) or suicidal thoughtsu00a0 or actions.n nn
3. n n n n
Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
What else do I need to know about antidepressant medicines?
Never stop an antidepressant medicine without first talking to a healthcare provider
Antidepressants are medicines used to treat depression and other illnesses.
Antidepressant medicines have other side effects
Antidepressant medicines can interact with other medicines.
4. Trazodone hydrochloride tablets n n n Talk to your healthcare provider for more information.n nn
What are trazodone hydrochloride tablets?
Trazodone hydrochloride tablets are a prescription medicine used to treat major depressive disorder in adults.
What should I tell my healthcare provider before taking trazodone hydrochloride tablets?
Before you take trazodone hydrochloride tablets tell your healthcare provider if you:
u2022 have heart problems, including QT prolongation or a family history of it
u2022 have ever had a heart attack
u2022 have bipolar disorder
u2022 have liver or kidney problems
u2022 have other serious medical conditions
u2022 are pregnant or plan to become pregnant. Trazodone hydrochloride tablets may harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
u2022 are breastfeeding or plan to breastfeed. It is not known if trazodone hydrochloride passes into your breast milk. You and your healthcare provider should decide if you will take trazodone hydrochloride or breastfeed.
u2022 have taken a Monoamine Oxidase Inhibitor (MAOI) or if you have stopped taking an MAOI in the last 2 weeks.
Tell your healthcare provider about all the medicines you take
Using trazodone hydrochloride tablets with certain other medicines can affect each other causing serious side effects.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take trazodone hydrochloride tablets?
u2022 Take trazodone hydrochloride tablets exactly as your healthcare provider tells you.
u2022 Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
u2022 If you feel drowsy after taking trazodone hydrochloride tablets, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your trazodone hydrochloride tablets.
u2022 Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.
u2022 Trazodone hydrochloride tablets should be swallowed whole or broken in half along the score line. Do not chew or crush trazodone hydrochloride tablets. Tell your healthcare provider if you cannot swallow trazodone either whole or as a half tablet.
u2022 If you take too much trazodone hydrochloride, call your doctor or go to the nearest emergency room right away.
What should I avoid while taking trazodone hydrochloride tablets?
u2022 Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills.
u2022 Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness.
What are the possible side effects of trazodone hydrochloride tablets?
Trazodone hydrochloride tablets can cause serious side effects or death. See u201cWhat is the most important information I should know about trazodone hydrochloride tablets?u201d
Serious side effects include:
u2022 Serotonin syndrome. Symptoms of serotonin syndrome include: agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, nausea, vomiting, diarrhea.
u2022 Feeling high or in a very good mood, then becoming irritable, or having too much energy, feeling like you have to keep talking or do not sleep (mania).
u2022 Irregular or fast heartbeat or faint (QT prolongation).
u2022 Low blood pressure. You feel dizzy or faint when you change positions (go from sitting to standing).
u2022 Unusual bruising or bleeding.
u2022 Erection lasting for more than 6 hours (priapism).
u2022 Low sodium in your blood (hyponatremia). Symptoms of hyponatremia include: headache, feeling weak, feeling confused, trouble concentrating, memory problems and feeling unsteady when you walk.
u2022 Withdrawal symptoms. Symptoms of withdrawal can include anxiety, agitation, and sleep problems. Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of trazodone hydrochloride tablets include:
u2022 Sleepiness
u2022 Dizziness
u2022 Constipation
u2022 Blurry vision
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of trazodone hydrochloride tablets. For more information, ask your healthcare provider or pharmacistn n n n
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store trazodone hydrochloride tablets?
u2022 Store trazodone hydrochloride tablets between 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).
u2022 Keep in tight container
u2022 Keep out of the light
u2022 Safely throw away medicine that is out of date or no longer needed.
Keep trazodone hydrochloride tablets and all medicines out of the reach of children.
General information about the safe and effective use of trazodone hydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use trazodone hydrochloride tablets for a condition for which it was not prescribed. Do not give trazodone hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about trazodone hydrochloride tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about trazodone hydrochloride tablets that is written for health professionalsn n n n
For more information, call 1-888-838-2872.
What are the ingredients in trazodone hydrochloride tablets?
Active ingredient: trazodone hydrochloride
Inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
u00a0
Manufactured In Croatia By:
PLIVA HRVATSKA d.o.o.
Zagreb, Croatia
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. A. 1/2014

No data

No data

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Trazodone Hydrochloride (Trazodone Hydrochloride)

Trade Name : Trazodone Hydrochloride

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Trazodone Hydrochloride (Trazodone Hydrochloride)

Trade Name : Trazodone Hydrochloride

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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