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Rx Item-Trazodone Hcl Powder(Non-Sterile Pharmaceutical Grade ) 100Gm By M

NDC 38779-0559-05 UPC/GTIN No.0-38779-05595-2 Mfg.Part No.55905Medisca Inc.This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Trazodone Hcl Powder(Non-Sterile Pharmaceutical Grade ) 100Gm By M

$2675.79$196.46

Item No.:RX429621 NDC No. 38779-0559-05 UPC/GTIN No. 0-38779-05595-2 MPN 55905 Only Physician,Pharmacy or Licensed Facility can order this Rx Item No. Rx429621 Trazodone Hcl Powder (Non-Sterile Pharmaceutical Grade ) 100gm by Medisca Item No. 3429621 NDC No. 38779055905 UPC No. 038779055952 Other Name Desyrel,Oleptro,Trazodone Therapeutic Code 281604 Therapeutic Class Tricyclics & Other Norepineph.-Ru Inhib Item Class Non Controlled Rx. Case Qnty: 0 Therapeutic Code 281604 Tricyclics & Other N

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TRAZODONE HYDROCHLORIDE � trazodone hydrochloride tablet
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
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
DOSAGE AND ADMINISTRATION

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.
ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

� Clinical Worsening and Suicide Risk [see Boxed Warning and Warnings and Precautions (5.1) ]

� Serotonin Syndrome or NMS-Like Reactions [see Warnings and Precautions (5.2)]

� QT Prolongation and Risk of Sudden Death [see Warnings and Precautions (5.4)]

� Orthostatic Hypotension [see Warnings and Precautions (5.6)]

� Abnormal Bleeding Events [see Warnings and Precautions (5.7)]

� Priapism [see Warnings and Precautions (5.9)]

� Hyponatremia [see Warnings and Precautions (5.10)]

� Cognitive and Motor Impairment [see Warnings and Precautions (5.11)]

� Discontinuation Symptoms [see Warnings and Precautions (5.13)]

The most common adverse reactions (reported in ? 5% and at twice the rate of placebo) are:

Somnolence/sedation, dizziness, constipation, vision blurred.
OVERDOSAGE

10.1 Human Experience
Death from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate).

The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation. The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions.

10.2 Management of Overdose
There is no specific antidote for trazodone hydrochloride overdose.

Treatment should consist of those general measures employed in the management of overdosage with any drug effective in the treatment of major depressive disorder.

Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs.

General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. Forced diuresis may be useful in facilitating elimination of the drug.

In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose.

11 DESCRIPTION

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(2H)-one hydrochloride. It is a white, odorless crystalline powder which is freely soluble in water.
Each tablet, for oral administration, contains 50 mg, 100 mg and 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Each tablet, for oral administration, contains 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
The mechanism of trazodone�s antidepressant action is not fully understood, but is thought to be related to its potentiation of serotonergic activity in the CNS.
Information for Patients
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:

There is a potential for increased risk of suicidal thoughts especially in children, teenagers and young adults.
The following symptoms should be reported to the physician: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania and mania.
They should inform their physician if they have a history of bipolar disorder, cardiac disease or myocardial infarction.
Serotonin syndrome could occur and symptoms may include changes in mental status (e.g., agitation, hallucinations, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, and hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
Trazodone hydrochloride has been associated with the occurrence of priapism.
There is a potential for hypotension, including orthostatic hypotension and syncope.
There is a potential risk of bleeding (including life-threatening hemorrhages) and bleeding related events (including ecchymosis, hematoma, epistaxis, and petechiae) with the concomitant use of trazodone hydrochloride and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding.
Withdrawal symptoms including anxiety, agitation and sleep disturbances, have been reported with trazodone. Clinical experience suggests that the dose should be gradually reduced.
Patients should be counseled that:

Trazodone may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating hazardous machinery, including automobiles until they are reasonably certain that the drug treatment does not affect them.
Trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.
Women who intend to become pregnant or who are breastfeeding should discuss with a physician whether they should continue to use trazodone, since use in pregnant and nursing women is not recommended.
Important Administration Instructions:

Trazodone hydrochloride tablets should be swallowed whole or broken in half along the score line.
Trazodone hydrochloride tablets should be taken shortly after a meal or light snack

NDC 38779-0559-05 UPC/GTIN No.0-38779-05595-2 Mfg.Part No.55905
Trazodone Hcl Pwd 100gm by Medisca
NDC 38779-0559-05 UPC/GTIN No.0-38779-05595-2 Mfg.Part No.55905

This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).
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This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.