Blog Greenland: 2016

Thursday, October 27, 2016

Trelstar

Generic Name: triptorelin (Intramuscular route)

trip-toe-REL-in

Commonly used brand name(s)

In the U.S.

Trelstar

Trelstar Depot

Trelstar LA

Available Dosage Forms:

Powder for Suspension

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

Uses For Trelstar

Triptorelin is used to treat advanced prostate cancer in men. It is a hormone that is similar to the one normally released from the hypothalamus gland in the brain. When given on a regular basis to men, triptorelin decreases testosterone levels which helps treat prostate cancer.

This medicine is to be given only by or under the supervision of a doctor.

Before Using Trelstar

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of triptorelin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of triptorelin in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of triptorelin

This section provides information on the proper use of a number of products that contain triptorelin. It may not be specific to Trelstar. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into your muscle (usually in the buttocks). This medicine needs to be given on a fixed schedule. Make sure you keep all of your appointments.

Precautions While Using Trelstar

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.

When you first start using this medicine, some of your symptoms might get worse or you might have new symptoms for a short time. Tell your doctor right away if you have bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating.

This medicine may cause changes in your blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

This medicine may increase your risk of having a heart attack or stroke. Call your doctor right away if you have chest pain or discomfort; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; nausea; sweating; or vomiting.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Trelstar Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blurred vision

burning while urinating

chest pain

cough producing mucus

decrease in urine volume or frequency of urination

difficult or labored breathing

difficult, burning, or painful urination

difficulty in passing urine

dizziness

dry mouth

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

headache

high blood pressure

increased hunger

increased thirst

increased urination

loss of consciousness

lower back or side pain

nausea

nervousness

pale skin

pounding in the ears

rapid weight gain

shortness of breath

slow or fast heartbeat

stomachache

sweating

tightness in the chest

tingling of the hands or feet

troubled breathing

troubled breathing with exertion

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

wheezing

Incidence not known

Anxiety

changes in skin color

changes in vision

chest discomfort

cold, clammy, or pale skin

confusion

dizziness or lightheadedness

fainting

inability to speak

irregular heartbeats

numbness or tingling in the face, arms, or legs

pain

pain or discomfort in the arms, jaw, back, or neck

pain, redness, or swelling in the arm or leg

seizures

severe or sudden headache

slow heart rate

slurred speech

sudden shortness of breath or troubled breathing

temporary blindness

tenderness

trouble speaking, thinking, or walking

weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bone pain

chills

decrease in testicle size

diarrhea

fever

decreased interest in sexual intercourse

feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest

general feeling of discomfort or illness

inability to have or keep an erection

joint pain

leg pain

loss in sexual ability, desire, drive, or performance

loss of appetite

muscle aches and pains

redness of the face, neck, arms, and occasionally, upper chest

runny nose

shivering

sore throat

sudden sweating

trouble sleeping

Less common

Acid or sour stomach

back pain

belching

body aches or pain

breast pain

burning, dry, or itching eyes

congestion

crying

depersonalization

difficulty having a bowel movement (stool)

difficulty with moving

discharge or excessive tearing

dysphoria

euphoria

eye pain

heartburn

hoarseness

indigestion

injection site pain

itching

lack or loss of strength

leg cramps

loss of appetite

mental depression

muscle aching or cramping

muscle pains or stiffness

pain

paranoia

quick to react or overreact emotionally

rapidly changing moods

rash

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

runny nose

sleeplessness

stomach discomfort, upset, or pain

swelling of the breasts or breast soreness in both females and males

swollen joints

tender, swollen glands in the neck

trouble with swallowing

voice changes

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Trelstar side effects (in more detail)

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More Trelstar resources

Trelstar Side Effects (in more detail)
Trelstar Use in Pregnancy & Breastfeeding
Trelstar Drug Interactions
Trelstar Support Group
0 Reviews for Trelstar - Add your own review/rating

Compare Trelstar with other medications

Prostate Cancer

Tretinoin

Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: Retinoic Acid
Molecular Formula: C₂₀H₂₈O₂
CAS Number: 302-79-4
Brands: Vesanoid

Limit to Qualified Personnel

Administer only to patients with acute promyelocytic leukemia (APL) under the strict supervision of a qualified clinician experienced in the management of patients with acute leukemia.¹

Appropriate diagnostic and treatment facilities must be readily available in case the patient develops severe toxicity, including respiratory compromise.¹

Use only when the potential benefits are thought to outweigh the possible risks of therapy.¹

Retinoic Acid-APL (RA-APL) Syndrome

Clinical manifestations of the syndrome (fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multiorgan failure), with or without leukocytosis, have occurred in about 25% of patients.¹

Occasionally accompanied by impaired myocardial contractility and episodic hypotension.¹

Progressive hypoxemia has required endotracheal intubation and mechanical ventilation and may be fatal (due to multiorgan failure).¹

High-dose corticosteroid therapy administered at first suspicion of the syndrome may reduce morbidity or mortality. (See RA-APL Syndrome under Cautions.)¹

Leukocytosis

Rapidly evolving leukocytosis occurs in approximately 40% of patients and is associated with an increased risk of life-threatening complications.¹

High leukocyte count (i.e., >5000/mm³) at diagnosis increases risk of further rapid increase of leukocyte count.¹

Initiate high-dose corticosteroid treatment immediately if leukocytosis and signs or symptoms of RA-APL syndrome are present together.¹

Consider adding full-dose chemotherapy (including an anthracycline) to tretinoin. (See Leukocytosis under Cautions.)¹

Teratogenic Effects

Known teratogen; special precautions and instruction are necessary in women of childbearing potential or pregnant women receiving the drug. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)¹

Inform patients of the risks of fetal harm and contraceptive failure.¹

Introduction

Antineoplastic agent; retinoid.¹ ²

Uses for Tretinoin

Acute Promyelocytic Leukemia

Used to induce remission in acute promyelocytic leukemia (APL), French-American-British classification M3 including the M3 variant, characterized by the presence of certain genetic markers (i.e., 15;17 chromosomal translocation and/or PML/RAR-α gene) in patients with relapsed or refractory disease following anthracycline-based chemotherapy or in patients for whom anthracycline therapy is contraindicated.¹ ¹⁶

Most clinicians recommend addition of tretinoin to induction combination chemotherapy (anthracycline-based)³⁹ ⁴⁰ ⁴¹ ^c as initial† treatment for APL in patients with previously untreated disease.⁶ ⁷ ⁸ ¹³ ¹⁵ ¹⁶ ⁴¹

May initiate tretinoin therapy based on the morphologic diagnosis of APL, but perform cytogenetic evaluation to confirm presence of the 15;17 translocation, and if absent, perform molecular diagnostic testing for the PML/RAR-α fusion protein.¹

May be ineffective when these genetic markers are absent; consider alternative therapy.¹ ² ¹⁹ ⁴¹ ^c

Tretinoin Dosage and Administration

General

Tretinoin apparently induces its own metabolism;¹ ⁴ ⁵ ³⁴ clinical failure may be related to a lack of sustained effective concentrations during prolonged treatment.⁴ ⁵ (See Plasma Concentrations under Pharmacokinetics.) Increasing dosage to compensate does not increase response.¹

Administration

Oral Administration

Administer orally in 2-equally divided doses.¹

Manufacturer makes no specific recommendations regarding administration with meals; however, food has enhanced absorption of other retinoids.¹ (See Absorption under Pharmacokinetics.)

Dosage

Discontinue tretinoin and consider alternative treatment if the presence of 15;17 chromosomal translocation and/or PML/RAR-α gene is not confirmed and the disease is not responding.¹

Unless contraindicated, administer consolidation and/or maintenance chemotherapy to all patients following tretinoin induction therapy.¹

Consider temporary discontinuance if serum transaminase concentrations >5 times the ULN.¹ (See Hepatic Effects under Cautions.)

Consider temporary discontinuance in patients with moderate or severe retinoic acid-APL syndrome.¹ (See RA-APL Syndrome under Cautions.)

Pediatric Patients

Acute Promyelocytic Leukemia

Oral

45 mg/m² daily administered in 2 evenly divided doses.¹

Continue until 30 days after complete remission is achieved, or for a total of 90 days, whichever occurs first.¹ Some clinicians recommend continuing until complete remission is achieved, or for a total of 90 days (whichever occurs first).⁴¹

Consider dosage reduction if serious or intolerable drug toxicity; however, safety and efficacy of dosages <45 mg/m² daily have not been established.¹

Adults

Acute Promyelocytic Leukemia

Oral

45 mg/m² daily administered in 2 evenly divided doses.¹

Prescribing Limits

Pediatric Patients

Acute Promyelocytic Leukemia

Oral

Safety and efficacy of dosages <45 mg/m² daily have not been established.¹

Maximum duration: 30 days after complete remission, up to 90 days of therapy.¹ ⁴¹

Adults

Acute Promyelocytic Leukemia

Oral

Maximum duration: 30 days after complete remission, up to 90 days of therapy.¹ ⁴¹

Cautions for Tretinoin

Contraindications

Known hypersensitivity to tretinoin or other retinoids, parabens, or any other ingredient in the formulation.¹

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and embryotoxicity demonstrated in animals.¹ ³⁰ ³¹

Limited experience in pregnant women, but other retinoids are associated with increased spontaneous abortions and major and sometimes fatal fetal abnormalities (e.g., abnormalities of the CNS, musculoskeletal system, external ear, eye, thymus, and great vessels; facial dysmorphia; cleft palate; parathyroid hormone deficiency; low IQ scores (i.e., <85), with or without obvious CNS abnormalities).¹

High risk of severely deformed infants in pregnant women; use during pregnancy only in life-threatening situations, or for severe disease for which safer drugs cannot be used or are ineffective.¹ ³⁰ Currently there is no antepartum method for determining whether a fetus is affected.¹

Exclude pregnancy using a reliable blood or urine pregnancy test with a sensitivity of ≥50 mIU/mL within 1 week before initiating tretinoin;¹ delay tretinoin initiation (whenever possible) until pregnancy test is negative; if delay is not feasible, place on 2 reliable forms of contraception.¹ Repeat pregnancy tests and contraception counseling monthly during therapy.¹

All women (including those with a history of infertility or menopause) must use 2 reliable forms of contraception simultaneously during therapy and for 1 month following discontinuance, unless a hysterectomy has been performed.¹ Progestin-only preparations (i.e., minipill) may be an inadequate method of contraception during tretinoin therapy.¹

Cytogenetic Confirmation of Diagnosis

May initiate therapy based on the morphologic diagnosis of APL.¹ However, confirm diagnosis by performing cytogenetic evaluation to confirm presence of the 15;17 translocation; if absent, perform molecular diagnostic testing for the PML/RAR-α fusion protein.¹

Consider alternative therapy when these genetic markers are absent; efficacy not established in acute myelogenous leukemia (AML) subtypes other than APL.¹ ² ¹⁹ ⁴¹ ^c

RA-APL Syndrome

Possible RA-APL syndrome (APL differentiation syndrome), characterized by fever, dyspnea, acute respiratory distress, weight gain, pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multiorgan failure occasionally accompanied by impaired myocardial contractility and episodic hypotension; can occur with or without concomitant leukocytosis.¹ ⁶ ²⁰ Onset generally occurs within the first month of treatment, but can occur after the first dose.¹ (See Retinoic Acid-APL [RA-APL] Syndrome in Boxed Warning.)

Progressive hypoxemia requiring endotracheal intubation and mechanical ventilation may occur in severe cases; deaths reported secondary to progressive hypoxemia and multiorgan failure.¹

If signs or symptoms of the syndrome (e.g., fever, dyspnea, weight gain, abnormal chest auscultatory findings, radiographic abnormalities) occur, immediately institute high-dose corticosteroid treatment (e.g., dexamethasone 10 mg IV every 12 hours for at least 3 days or until resolution of symptoms), regardless of leukocyte count; may reduce morbidity and mortality.¹ ⁶ ²⁰ If syndrome recurs, initiate another course of corticosteroid treatment.⁹ ⁴¹

Tretinoin discontinuance not required in most patients during RA-APL syndrome treatment; however, consider temporary interruption of therapy in moderate and severe cases.¹

Leukocytosis

Possible rapidly evolving leukocytosis; may be associated with an increased risk of life-threatening complications.¹

The optimal management of leukocytosis not established, ⁸ ²⁰ but initiate high-dose corticosteroid treatment immediately if leukocytosis and signs or symptoms of RA-APL syndrome develop together.¹

Lower incidence of the RA-APL syndrome reported with routine addition of chemotherapy agents to tretinoin when baseline leukocyte count >5000/mm³, or when initial leukopenia exists and subsequent rapid increase in leukocyte count develops.¹ ¹⁵

Consider adding full-dose chemotherapy (including anthracycline, unless contraindicated) to tretinoin therapy on day 1 or 2 if baseline leukocyte count is >5000/mm³.¹

Immediately initiate chemotherapy if baseline leukocyte count of <5000/mm³ subsequently increases to >6000/mm³ by day 5, 10,000/mm³ by day 10, or 15,000/mm³ by day 28.¹

Pseudotumor Cerebri

Possible pseudotumor cerebri (benign intracranial hypertension), especially in pediatric patients.¹ ⁶ Increased risk possible with concomitant use of other agents known to cause pseudotumor cerebri or intracranial hypertension.¹ (See Specific Drugs under Interactions.)

Evaluate for pseudotumor cerebri if signs or symptoms (e.g., papilledema, headache, nausea, vomiting, visual disturbances) occur; if present, treat appropriately (including neurological assessment).¹ Opiate analgesics, corticosteroids, and lumbar puncture may be required.¹ ⁹

Lipids

Possible reversible hypercholesterolemia and/or hypertriglyceridemia.¹

Clinical importance of transient lipid elevations unknown, but venous thrombosis and MI reported in otherwise low-risk patients.¹

Hepatic Effects

Possible elevated liver function tests; test abnormalities usually resolve during or after treatment.¹

Consider temporary discontinuance if serum transaminase concentrations are >5 times the ULN.¹

General Precautions

Laboratory Tests

Frequently monitor hematologic profile, coagulation profile, liver function tests, and serum cholesterol and triglyceride concentrations, and clinically assess cardiac status during tretinoin therapy.¹

Thrombosis

Venous or arterial thrombosis involving any organ system (e.g., cerebrovascular accident, MI, renal infarct) reported during first month of treatment.¹ Use caution if used concomitantly with antifibrinolytic agents.¹ (See Specific Drugs under Interactions.)

Specific Populations

Pregnancy

Category D. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)¹

Lactation

Not known whether tretinoin is distributed into milk.¹ Discontinue nursing because of potential for serious adverse effects in nursing infants.¹

Pediatric Use

Use with increased caution in pediatric patients;¹ limited clinical data for use in children.¹ ⁶ ¹³

Safety and efficacy not established in infants <1 year of age.¹

Increase risk of severe headache and pseudotumor cerebri, requiring treatment with analgesics and lumbar puncture.¹ ¹² (See Pseudotumor Cerebri under Cautions.)

Dosage reduction may be appropriate if severe adverse effects occur, but safety and efficacy of dosages <45 mg/m² daily have not been established.¹

Geriatric Use

Safety and efficacy in those ≥60 years of age similar to those in younger adults, but increased sensitivity cannot be ruled out.¹

Common Adverse Effects

Respiratory effects (upper respiratory tract disorders, dyspnea, respiratory insufficiency), headache, dizziness, paresthesias, anxiety, insomnia, depression, confusion, skin/mucous membrane dryness, rash, pruritus, increased sweating, alopecia, skin changes, GI effects (nausea and vomiting, GI hemorrhage, mucositis, abdominal pain, diarrhea, constipation), bone pain, myalgia, peripheral edema, chest discomfort, edema, arrhythmias, flushing, hypotension, hypertension, phlebitis, renal insufficiency, earache, feeling of fullness in the ears, visual disturbances, fever, malaise, shivering.¹

Interactions for Tretinoin

Metabolized by CYP isoenzymes.¹

Drugs Affecting Hepatic Microsomal Enzymes

Concomitant use of drugs that affect CYP isoenzymes (e.g., CYP3A4, CYP2C8, CYP2E) may alter metabolism of tretinoin; not known whether concomitant use of drugs affecting the CYP enzyme system alters the efficacy or toxicity of tretinoin.¹ ¹

Inducers of CYP isoenzymes: Potential pharmacokinetic interaction (decreased plasma tretinoin concentrations).¹

Inhibitors of CYP isoenzymes: Potential pharmacokinetic interaction (increased plasma tretinoin concentrations).¹

Specific Drugs

Drug	Interaction	Comments
Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid, aprotinin)	Fatal thrombotic complications reported with concomitant use¹	Use concomitantly with caution¹
Cimetidine	Possible increased plasma tretinoin concentrations¹
Corticosteroids	Possible decreased plasma tretinoin concentrations¹
Cyclosporine	Possible increased plasma tretinoin concentrations¹
Diltiazem	Possible increased plasma tretinoin concentrations¹
Erythromycin	Possible increased plasma tretinoin concentrations¹
Hydroxyurea	Concurrent use may cause a synergistic effect leading to massive cell lysis²⁹ Bone marrow necrosis, sometimes fatal, has been reported²⁹	Use concomitantly with caution ²⁹ ⁴¹
Ketoconazole	Possible increased plasma tretinoin concentrations; administration of ketoconazole 1 hour prior to day 29 tretinoin dose associated with 72% increase in mean tretinoin AUC¹
Pentobarbital	Possible decreased plasma tretinoin concentrations¹
Phenobarbital	Possible decreased plasma tretinoin concentrations¹
Rifampin	Possible decreased plasma tretinoin concentrations¹
Tetracyclines	Increased risk of pseudotumor cerebri or intracranial hypertension¹
Verapamil	Possible increased plasma tretinoin concentrations¹
Vitamin A	Concurrent use may aggravate symptoms of hypervitaminosis A¹	Avoid concomitant use¹

Tretinoin Pharmacokinetics

Absorption

Bioavailability

About 50%;² marked interpatient variation.² ⁴

Food

Effect of food on tretinoin absorption not evaluated;¹ generally, retinoid absorption is enhanced by food.¹ Tretinoin is fat soluble; fat-restricted diet may cause reduced bioavailability.⁹

Plasma Concentrations

Decreased over time by tretinoin's apparent induction of its own metabolism.¹ ⁴ ⁵ ¹² After 1 week of continuous therapy, concentrations decrease to about one-third of those on the first day.¹ ⁴ In pediatric patients, mean AUC on day 28 was about one-fifth that determined on day 1.¹²

Distribution

Extent

Not fully characterized.¹

Crosses the placenta in animals;¹ ³⁵ ³⁶ not known whether tretinoin distributes into milk.¹

Plasma Protein Binding

>95% (mainly albumin).¹

Elimination

Metabolism

Evidence that tretinoin induces its own metabolism.¹

Precise metabolic pathway not fully elucidated.¹ In the liver, stereoisomerization followed by oxidation occurs; CYP isoenzymes (e.g., CYP3A4, CYP2C8, CYP2E) are implicated in oxidation.¹ ² ³⁴

Various metabolites identified,² ³⁴ but activity mainly results from the parent drug.¹

Elimination Route

>90% in urine and feces;¹ 63% in urine within 72 hours, and 31% in feces within 6 days.¹ Metabolites (glucuronide conjugates) excreted in urine and bile.²

Half-life

0.5–2 hours after initial dose.¹

Special Populations

The effect of renal or hepatic impairment not established.¹

Stability

Storage

Oral

Capsules

15–30°C.¹ Protect from light.¹

ActionsActions

Not a cytolytic agent; precise mechanism(s) of action not fully elucidated.¹ ¹⁰

PML/RAR-α fusion protein resulting from 15;17 chromosomal translocation apparently blocks myeloid differentiation at the promyelocyte stage;² induces cellular differentiation and decreases proliferation of APL cells.¹ ¹⁰

Causes initial maturation of primitive promyelocytes (derived from the cellular leukemic clone) followed by normal, polyclonal hematopoietic cell repopulation of bone marrow and peripheral blood.¹

Apoptosis (programmed cell death) may be a mechanism for eliminating malignant cells.⁹

Tretinoin alone does not eradicate the leukemic clone because PML/RAR-α fusion protein usually can be detected following induction.²

High initial complete response rate, but remissions induced and maintained by tretinoin alone are short (median: 3.5 months).¹¹

Clinical resistance occurs with prolonged administration; increased tretinoin metabolism and clearance with resultant, reduction in plasma concentrations, may contribute to resistance.⁴ ⁵

Advice to Patients

Importance of advising patients of adverse effects and associated manifestations.¹

Importance of advising patients that their ability to drive or operate machinery might be impaired, especially if experiencing dizziness or severe headache.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

Importance of women using effective contraception (i.e., 2 reliable forms of contraception simultaneously unless abstinence is the chosen method) during tretinoin therapy and for 1 month following discontinuance, unless a hysterectomy has been performed.¹ Importance of informing women that progestin-only preparations (i.e., minipill) may be an inadequate method of contraception during tretinoin therapy and for 1 month following discontinuance.¹

Importance of fully informing women of high risk of fetal harm and risks of contraceptive failure, discussing desirability of continuing or terminating pregnancy when administered during pregnancy or when woman becomes pregnant while receiving the drug.¹

Importance of performing pregnancy testing before initiation of tretinoin, and repeating pregnancy testing and contraception counseling monthly during tretinoin therapy.¹

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Tretinoin
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	10 mg	Vesanoid	Roche

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Vesanoid 10MG Capsules (ROCHE): 30/$808.87 or 90/$2302.72

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Roche. Vesanoid (tretinoin) capsules prescribing information. Nutley, NJ; 2004 Oct.

2. Gillis JC, Goa KL. Tretinoin: a review of its pharmacodynamic and pharmacokinetic properties and use in the management of acute promyelocytic leukemia. Drugs. 1995; 50:897-923. [PubMed 8586032]

3. Takada S, Matumoto K, Sakura T et al. Sweet’s syndrome followed by retinoic acid syndrome during the treatment of acute promyelocytic leukemia with all-trans retinoic acid. Int J Hematol. 1999; 70:26-9. [PubMed 10446491]

4. Muindi J, Frankel S, Huselton C et al. Clinical pharmacology of oral all-trans retinoic acid in patients with acute promyelocytic leukemia. Cancer Res. 1992; 52:2138-42. [IDIS 294599] [PubMed 1559217]

5. Muindi J, Frankel SR, Miller WH et al. Continuous treatment with all- trans retinoic acid causes a progressive reduction in plasma drug concentrations: implications for relapse and retinoid “resistance” in patients with acute promyelocytic leukemia. Blood. 1992; 79:299-303. [IDIS 290351] [PubMed 1309668]

6. Tallman MS, Andersen JW, Schiffer CA et al. All-trans-retinoic acid in acute promyelocytic leukemia. N Engl J Med. 1997; 337:1021-8. [IDIS 393094] [PubMed 9321529]

7. Fenaux P, Degos L. Differentiation therapy for acute promyelocytic leukemia. N Engl J Med. 1997; 337:1076-7. [IDIS 393097] [PubMed 9321537]

8. Adult acute myeloid leukemia. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2003 Jun 5.

9. Warrell RP Jr, De The H, Wang ZY et al. Acute promyelocytic leukemia. N Engl J Med. 1993; 329:177-89. [IDIS 317168] [PubMed 8515790]

10. Chomienne C, Ballerini P, Balitrand N et al. All-trans retinoic acid in acute promyelocytic leukemias. II. In vitro studies: structure-function relationship. Blood. 1990; 76:1710-7. [PubMed 2224120]

11. Frankel SR, Eardley A, Heller G et al. All-trans retinoic acid for acute promyelocytic leukemia: results of the New York study. Ann Intern Med. 1994; 120:278-86. [IDIS 325528] [PubMed 8291820]

12. Smith MA, Adamson PC, Balis FM et al. Phase I and pharmacokinetic evaluation of all-trans retinoic acid in pediatric patients with cancer. J Clin Oncol. 1992; 10:1666-73. [PubMed 1403049]

13. Childhood acute myeloid leukemia/other myeloid malignancies. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2003 Jun 18.

14. Runde V, Aul C, Sudhoff T et al. Retinoic acid in the treatment of acute promyelocytic leukemia: inefficacy of the 13-cis isomer and induction of complete remission by the all-trans isomer complicated by thromboembolic events. Ann Hematol. 1992; 64:270-2. [PubMed 1637880]

15. Fenaux P, Le Deley MC, Castaigne S et al. Effect of all transretinoic acid in newly diagnosed acute promyelocytic leukemia: results of a multicenter randomized trial. Blood. 1993; 82:3241-9. [IDIS 323282] [PubMed 8241496]

16. Anon. Drugs of choice for cancer. Treatment Guidelines from Med Lett. 2003; 1:41-52.

17. de Lacerda JF, do Carmo JA, Guerra ML et al. Multiple thrombosis in acute promyelocytic leukaemia after tretinoin. Lancet. 1993; 342:114-5. [PubMed 8100880]

18. Levi I, Raanani P, Shalmon B et al. Acute neutrophilic dermatosis induced by all-trans-retinoic acid treatment for acute promyelocytic leukemia. Leuk Lymphoma. 1999; 34:401-4. [PubMed 10439378]

19. Licht JD, Chomienne C, Goy A et al. Clinical and molecular characterization of a rare syndrome of acute promyelocytic leukemia associated with translocation (11;17). Blood. 1995; 85:1083-94. [PubMed 7849296]

20. Frankel SR, Eardley A, Lauwers G et al. The “retinoic acid syndrome” in acute promyelocytic leukemia. Ann Intern Med. 1992; 117:292-6. [IDIS 300294] [PubMed 1637024]

21. Paydas S, Sahin B, Zorludemir S et al. All trans retinoic acid as the possible cause of necrotizing vasculitis. Leuk Res. 1998; 22:655-7. [PubMed 9680118]

22. Hashimoto S, Koike T, Tatewaki W et al. Fatal thromboembolism in acute promyelocytic leukemia during all-trans retinoic acid therapy combined with antifibrinolytic therapy for prophylaxis of hemorrhage. Leukemia. 1994; 8:1113-5. [PubMed 8035603]

23. Tomita N, Kanamori H, Fujita H et al. Granulomatous tubulointerstitial nephritis induced by all-trans retinoic acid. Anticancer Drugs. 2001; 12:677-80. [PubMed 11604554]

24. Charles KS, Kanaa M, Winfield DA et al. Scrotal ulceration during all- trans retinoic acid (ATRA) therapy for acute promyelocytic leukaemia. Clin Lab Haematol. 2000; 22:171-4. [PubMed 10931168]

25. Giralt S, O’Brien S, Weeks E et al. Leukemia cutis in acute promyelocytic leukemia: report of three cases after treatment with all-trans retinoic acid. Leuk Lymphoma. 1994; 14:453-6. [PubMed 7812204]

26. Mori A, Tamura S, Katsuno T et al. Scrotal ulcer occurring in patients with acute promyelocytic leukemia during treatment with all-trans retinoic acid. Oncol Rep. 1999; 6:55-8. [PubMed 9864401]

27. Hakimian D, Tallman MS, Zugerman C et al. Erythema nodosum associated with all-trans-retinoic acid in the treatment of acute promyelocytic leukemia. Leukemia. 1993; 7:758-9. [PubMed 8483331]

28. Latagliata R, Petti MC, Fenu S et al. Therapy-related myelodysplastic syndrome-acute myelogenous leukemia in patients treated for acute promyelocytic leukemia: an emerging problem. Blood. 2002; 99:822-4. [IDIS 477401] [PubMed 11806982]

29. Limentani SA, Pretell JO, Potter D et al. Bone marrow necrosis in two patients with acute promyelocytic leukemia during treatment with all-trans retinoic acid. Am J Hematol. 1994; 47:50-5. [PubMed 8042616]

30. Food and Drug Administration. Labeling and prescription drug advertising; content and format for labeling for human prescription drugs. 21 CFR Parts 201 and 202. Final Rule. [Docket No. 75N-0066] Fed Regist. 1979; 44:37434-67.

31. Department of Health and Human Services, Food and Drug Administration. Subpart B—Labeling requirements for prescription drugs and/or insulin. (21 CFR Ch. 1 (4-1-87 Ed.)). 1987:18-24.

32. Stentoft J, Nielsen JL, Hvidman LE. All-trans retinoic acid in acute promyelocytic leukemia in late pregnancy. Leukemia. 1994; 8:1585-8. [PubMed 8090035]

33. Harrison P, Chipping P, Fothergill GA. Successful use of all-trans retinoic acid in acute promyelocytic leukemia presenting during the second trimester of pregnancy. Br J Haematol. 1994; 86:681-2. [PubMed 8043456]

34. Regazzi MB, Iacona I, Geruasutti C et al. Clinical pharmacokinetics of tretinoin. Clin Pharmacokinet. 1997; 32:382-401. [PubMed 9160172]

35. Tzimas G, Collins MD, Burgin H et al. Embryotoxic doses of vitamin A to rabbits result in low plasma but high embryonic concentrations of all-trans-retinoic acid: risk of vitamin A exposure in humans. J Nutr. 1996; 126:2159-71. [PubMed 8814204]

36. Ward SJ, Morriss-Kay GM. Distribution of all-trans-, 13-cis- and 9-cis-retinoic acid to whole rat embryos and maternal serum following oral administration of a teratogenic dose of all-trans-retinoic acid. Pharmacol Toxicol. 1995; 76:196-201. [PubMed 7617545]

37. Tallman MS, Andersen JW, Schiffer CA et al. All-trans retinoic acid in acute promyelocytic leukemia: long-term outcome and prognostic factor analysis from the North American Intergroup protocol. Blood. 2002; 100:4298-302. [IDIS 494816] [PubMed 12393590]

38. Fenaux P, Chevret S, Guerci A et al. Long-term follow-up confirms the benefit of all-trans retinoic acid in acute promyelocytic leukemia. European APL group. Leukemia. 2000; 14:1371-7. [PubMed 10942231]

39. Fenaux P, Chastang C, Chevret S et al. A randomized comparison of all transretinoic acid (ATRA) followed by chemotherapy and ATRA plus chemotherapy and the role of maintenance therapy in newly diagnosed acute promyelocytic leukemia. The European APL Group. Blood. 1999; 94:1192-1200. [IDIS 432150] [PubMed 10438706]

40. Burnett AK, Grimwade D, Solomon E et al. Presenting white blood cell count and kinetics of molecular remission predict prognosis in acute promyelocytic leukemia treated with all-trans retinoic acid: results of the randomized MRC trial. Blood. 1999; 93:4131-4143. [IDIS 431958] [PubMed 10361110]

41. Reviewers’ comments (personal observations).

42. Muindi J, Frankel SR, Miller WH Jr et al. Continuous treatment with all-trans retinoic acid causes a progressive reduction in plasma drug concentrations: implications for relapse and retinoid “resistance” in patients with acute promyelocytic leukemia. Blood. 1992; 79:299-303. [IDIS 290351] [PubMed 1309668]

a. AHFS drug information 2008. McEvoy GK, ed. Tretinoin. Bethesda, MD: American Society of Health-System Pharmacists; 2008:1253-7..

c. Adult acute myeloid leukemia. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2003 Oct 20.

More Tretinoin resources

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Drug Images
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Acute Promyelocytic Leukemia

Trental

Generic Name: pentoxifylline (pen tox I fi leen)

Brand Names: Pentoxil, TRENtal

What is Trental (pentoxifylline)?

Pentoxifylline changes the shape of red blood cells in your blood. This makes it easier for these blood cells to fit into small arteries (blood vessels).

Pentoxifylline is used to improve blood flow. Improved blood flow helps to reduce leg cramps and other symptoms of vascular disease (disease related to veins and arteries).

Pentoxifylline may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Trental (pentoxifylline)?

Do not break, crush, or chew the tablets. Swallow them whole. They are specially coated to protect your stomach.

Do not stop taking this medication suddenly. It may take up to 8 weeks for you to see beneficial effects from pentoxifylline.

Tobacco may worsen your condition or decrease the beneficial effects of pentoxifylline by narrowing your blood vessels. Talk to your doctor or pharmacist if you have a tobacco habit.

What should I discuss with my healthcare provider before taking Trental (pentoxifylline)?

You cannot take pentoxifylline if you have recently hemorrhaged (bled) in the eye or brain, or if you have an allergy to caffeine, theophylline (Theo-Dur, Theo-Bid), or theobromine.

Before taking this medication, tell your doctor if you

have an ulcer disease (stomach or duodenal ulcer);

have recently had any type of surgery (including dental);

have recently had a bleeding disorder; or

have any type of liver disease.

You may not be able to take pentoxifylline, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Pentoxifylline is in the FDA pregnancy category C. This means that it is not known whether pentoxifylline will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Pentoxifylline passes into breast milk and may affect a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Trental (pentoxifylline)?

Take pentoxifylline exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass (8 ounces) of water. Take pentoxifylline with food or an antacid to lessen stomach upset.

Pentoxifylline is usually taken three times a day. Follow your doctor's instructions. If you experience side effects, talk to your doctor. You may only need to take pentoxifylline twice a day.

Do not break, crush, or chew the tablets. Swallow them whole. They are specially coated to protect your stomach.

Do not stop taking this medication suddenly. It may take up to 8 weeks for you to see the beneficial effects of pentoxifylline, although you may begin to feel better as soon as 2 weeks after starting therapy.

Store pentoxifylline at room temperature away from moisture and heat.

What happens if I miss a dose?

If you do miss a dose, take it as soon as you remember up to 3 hours late. If more than 3 hours have passed, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a pentoxifylline overdose include seizures, agitation, fever, loss of consciousness, a flushed face, and drowsiness.

What should I avoid while taking Trental (pentoxifylline)?

Tobacco may worsen your condition or decrease the beneficial effects of pentoxifylline by narrowing your blood vessels. Talk to your doctor or pharmacist if you have a tobacco habit.

Trental (pentoxifylline) side effects

If you experience any of the following serious side effects, stop taking pentoxifylline and seek medical attention:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

chest pain or an irregular heartbeat;

severe dizziness, headache, nosebleeds, or blurred vision;

nausea or vomiting; or

swollen feet or ankles.

Other, less serious side effects may be more likely to occur. Continue to take pentoxifylline and talk to your doctor if you experience

insomnia,

red eyes, or

nervousness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Trental (pentoxifylline)?

Before taking pentoxifylline, tell your doctor if you are taking warfarin (Coumadin). Pentoxifylline may increase the effects of anticoagulants such as warfarin, which may result in bleeding.

Theophylline (Theo-Dur, Theo-Bid, Theolair, Theochron, Elixophyllin, Slo-Phyllin, others), aminophylline (Phyllocontin, Truphylline), dyphylline (Lufyllin, Dylix, Dilor, Neothylline), and oxtriphylline (Choledyl) may cause dangerous side effects if taken while you are taking pentoxifylline. Your dosage of these drugs may have to be reduced or blood levels closely monitored. Talk to your doctor if you are currently taking any of these medicines.

Tobacco may worsen your condition or decrease the beneficial effects of pentoxifylline by narrowing your blood vessels. Talk to your doctor or pharmacist if you use tobacco.

Drugs other than those listed here may also interact with pentoxifylline. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines.

More Trental resources

Trental Side Effects (in more detail)
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Drug Images
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2 Reviews for Trental - Add your own review/rating

Trental MedFacts Consumer Leaflet (Wolters Kluwer)

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Compare Trental with other medications

Intermittent Claudication

Where can I get more information?

Your pharmacist can provide more information about pentoxifylline.

See also: Trental side effects (in more detail)

treprostinil

Generic Name: treprostinil injection (tre PROS ti nil)

Brand Names: Remodulin

What is treprostinil injection?

Treprostinil dilates (or widens) the arteries and decreases the amount of blood clotting platelets in your body. These effects lower blood pressure in the pulmonary artery that leads from the heart to the lungs.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

Treprostinil may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about treprostinil injection?

Before using this medication, tell your doctor if you have low blood pressure, liver disease, or a bleeding or blood clotting disorder.

Your doctor may want you to be in a hospital when you start using treprostinil. This is so you can be watched for any signs of serious side effects from the medicine.

You will probably have to use this medicine for several months or years to control your condition and keep it from getting worse.

Use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup infusion pump and infusion sets available so as not to interrupt your treatment if one infusion pump stops working.

Call your doctor if your symptoms do not improve or if they get worse.

What should I discuss with my healthcare provider before using treprostinil injection?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication:

low blood pressure;

liver disease; or

bleeding or blood clotting disorder.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether treprostinil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is treprostinil injection given?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Treprostinil is given as an continuous (around-the-clock) injection using an infusion pump. The medicine enters the body through a catheter placed under your skin or into a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how to use an infusion pump and inject your medicine. Do not give yourself an injection if you do not understand these instructions. Call your doctor, nurse, or pharmacist for help with injection instructions.

Your doctor may want you to be in a hospital when you start using treprostinil. This is so you can be watched for any signs of serious side effects from the medicine.

You will probably have to use this medicine for several months or years to control your condition and keep it from getting worse.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Store unopened vials (bottles) of treprostinil at room temperature away from moisture and heat. After the medicine has been placed into a syringe or pump, it should be given within 72 hours. If the medicine has been diluted (mixed with a liquid), you must use the medicine within 48 hours after mixing. Call your doctor if your symptoms do not improve or if they get worse.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of treprostinil.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include warmth and redness or tingling under your skin, headache, feeling light-headed, fainting, nausea, vomiting, diarrhea, or seizure (convulsions).

What should I avoid while using treprostinil injection?

Do not stop using treprostinil without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Treprostinil injection side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin;

swelling in your hands or feet; or

feeling like you might pass out.

Less serious side effects may include:

pain, swelling, redness, bleeding, or a hard lump where your catheter is placed;

dizziness;

mild skin rash;

headache or jaw pain;

flushing (warmth, redness or tingling); or

diarrhea or nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Treprostinil Dosing Information

Usual Adult Dose for Pulmonary Hypertension:

Infusion:
Initial dose: 1.25 nanogram/kg per minute by continuous infusion. The subcutaneous route is preferred but the drug may be administered by a central intravenous line if the subcutaneous route is not tolerated. The rate may be decreased to 0.625 nanogram/kg/minute if the initial dose is not tolerated by the patient.
Maintenance dose: The infusion rate may be increased in increments of no more than 1.25 nanogram/kg/minute per week for the first 4 weeks, and thereafter by no more than 2.5 nanograms/kg/minute per week. Dosage adjustments should be titrated to a dose where PAH symptoms are improved and adverse effects are minimized (headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction). Although doses of up to 100 nanograms/kg/minute have been reported, there is little experience with doses greater than 40 nanograms/kg/minute.

Inhalation:
Use only with the Tyvaso Inhalation System. Administer undiluted, as supplied. A single breath of Tyvaso delivers approximately 6 mcg of treprostinil
Initial dosage: 3 breaths [18 mcg] per treatment session. If 3 breaths are not tolerated, reduce to 1 or 2 breaths. Administer in 4 separate treatment sessions each day approximately four hours apart, during waking hours.
Maintenance dose: Dosage should be increased by an additional 3 breaths at approximately 1-2 week intervals, if tolerated. Titrate to target maintenance dosage of 9 breaths or 54 mcg per treatment session as tolerated.

Usual Pediatric Dose for Pulmonary Hypertension:

Inhalation:
Less than 16 years: Safety and efficacy have not been established.
16 to 18 years:
Initial dose: 1.25 nanogram/kg per minute by continuous infusion. The subcutaneous route is preferred but the drug may be administered by a central intravenous line if the subcutaneous route is not tolerated. The rate may be decreased to 0.625 nanogram/kg/minute if the initial dose is not tolerated by the patient.
Maintenance dose: The infusion rate may be increased in increments of no more than 1.25 nanogram/kg/minute per week for the first 4 weeks, and thereafter by no more than 2.5 nanograms/kg/minute per week. Dosage adjustments should be titrated to a dose where PAH symptoms are improved and adverse effects are minimized (headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction). There is little experience with doses greater than 40 nanograms/kg/minute.

What other drugs will affect treprostinil injection?

Tell your doctor about all other medicines you use, especially:

gemfibrozil (Lopid);

a blood thinner such as warfarin (Coumadin);

blood pressure medication such as a diuretic (water pill); or

medication used to prevent blood clots, such as alteplase (Activase), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine), ticlopidine (Ticlid), and urokinase (Abbokinase).

This list is not complete and other drugs may interact with treprostinil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More treprostinil resources

Treprostinil Side Effects (in more detail)
Treprostinil Dosage
Treprostinil Use in Pregnancy & Breastfeeding
Treprostinil Drug Interactions
Treprostinil Support Group
4 Reviews for Treprostinil - Add your own review/rating

treprostinil Inhalation Advanced Consumer (Micromedex) - Includes Dosage Information

Treprostinil Professional Patient Advice (Wolters Kluwer)

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Remodulin Monograph (AHFS DI)

Remodulin Prescribing Information (FDA)

Remodulin Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Remodulin Advanced Consumer (Micromedex) - Includes Dosage Information

Tyvaso Prescribing Information (FDA)

Tyvaso Consumer Overview

Compare treprostinil with other medications

Pulmonary Arterial Hypertension

Where can I get more information?

Your doctor or pharmacist can provide more information about treprostinil injection.

See also: treprostinil side effects (in more detail)

treprostinil Inhalation

tre-PROST-i-nil

Commonly used brand name(s)

In the U.S.

Tyvaso

Available Dosage Forms:

Solution

Pharmacologic Class: Prostaglandin

Uses For treprostinil

Treprostinil inhalation is used to treat the symptoms of pulmonary arterial hypertension. This is the high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Treprostinil works by blocking a hormone (a naturally occurring substance), that is found in the blood and lungs in large quantities of the people with pulmonary arterial hypertension. Treprostinil helps by increasing the supply of blood to the lungs and reducing the workload of the heart.

treprostinil is available only with your doctor's prescription.

Before Using treprostinil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For treprostinil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to treprostinil or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of treprostinil inhalation in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of treprostinil inhalation in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems which may require caution and an adjustment in the dose for patients receiving treprostinil inhalation.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking treprostinil, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using treprostinil with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alteplase, Recombinant

Interactions with Food/Tobacco/Alcohol

Proper Use of treprostinil

Treprostinil inhalation should be taken when you wake up and also before any physical activity, but not more than every 4 hours. Do not change your dose without talking to your doctor.

Treprostinil is breathed into your lungs with Tyvaso® inhalation System. This system consists of the Optineb-ir device and its accessories. Carefully follow your doctor's instructions for using the medicine and operating and cleaning the equipment. Do not put other medicines into this equipment.

Do not drink treprostinil. Do not allow the inhalation solution to come into contact with your skin or eyes. If it does, rinse it off with water right away.

To avoid missing a dose or any possible problems with the drug delivery device you are using, you should have a back-up with Optineb-ir device.

Dosing

The dose of treprostinil will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of treprostinil. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For inhalation dosage form (solution):
- For pulmonary arterial hypertension:
  - Adults—At first, 18 micrograms (mcg) or three breaths, per treatment session, 4 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 9 breaths per treatment session, 4 times a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of treprostinil, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Protect the medicine from direct light. Keep your medicine in the unopened foil pouch until you are ready to use it. Once the foil pack is opened, the ampules should be used within 7 days.

Precautions While Using treprostinil

It is very important that your doctor check your progress at regular visits to make sure that treprostinil is working properly.

It is very important that your doctor check your blood pressure regularly while you are taking treprostinil. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away.

Patients may have a drop in blood pressure, and may become dizzy, lightheaded, or faint. Make sure you know how you react to treprostinil before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. You should stand up slowly when you get out of a chair or bed.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Your doctor may adjust the doses of all the medicines you are taking or monitor you carefully for side effects.

treprostinil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Cough

fainting

feeling of warmth

redness of the face, neck, arms and occasionally, upper chest

sore throat

Incidence not known

Bloody nose

chest pain

coughing or spitting up blood

difficulty in breathing or troubled breathing

fever or chills

shortness of breath

sneezing

tightness in the chest

troubled breathing

wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

confusion

diarrhea

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

headache

nausea

sweating

unusual tiredness or weakness

vomiting

More common

Abdominal or stomach cramps, discomfort or pain

back pain

constipation

indigestion

loss of appetite

muscle, jaw, or bone pain

swollen mouth and tongue

unpleasant taste

urge to have bowel movement

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: treprostinil Inhalation side effects (in more detail)

More treprostinil Inhalation resources

Treprostinil Inhalation Side Effects (in more detail)
Treprostinil Inhalation Use in Pregnancy & Breastfeeding
Treprostinil Inhalation Drug Interactions
Treprostinil Inhalation Support Group
4 Reviews for Treprostinil Inhalation - Add your own review/rating

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Pulmonary Arterial Hypertension

Trazodone Hydrochloride

Class: Serotonin Modulators
VA Class: CN609
CAS Number: 25332-39-2

Special Alerts:

[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: , and .

REMS:

FDA approved a REMS for trazodone to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Suicidality in Children and Adolescents

Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder and other psychiatric disorders (see Pediatric Use under Cautions); balance this risk with clinical need.²¹² Trazodone is not approved for use in pediatric patients.^a

Closely monitor pediatric patients who are started on trazodone therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.²¹² (See Worsening of Depression and Suicidality Risk under Cautions.)

Introduction

Antidepressant; serotonin modulator.²⁰¹ ^b

Uses for Trazodone Hydrochloride

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Major Depressive Disorder

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Management of major depressive disorder with or without anxiety.²⁰¹

Effective in both inpatient and outpatient settings.²⁰¹

Schizophrenic Disorder

Has been used for the short-term management of depressive episodes in patients with schizophrenia†.^b ^d

Alcohol Dependence

Has been used as adjunctive therapy for the management of alcohol dependence†.^b

Anxiety States

Has been used for the management of anxiety states†.^b

Trazodone Hydrochloride Dosage and Administration

General

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Individualize dosages according to individual requirements and response.^b

Monitor for possible worsening of depression or suicidality, especially at the beginning of therapy or during periods of dosage adjustments.²¹² (See Worsening of Depression and Suicidality Risk under Cautions.)

Sustained therapy may be required;²⁰¹ use lowest effective dose and monitor periodically for need for continued therapy.²⁰¹

Administration

Oral Administration

Administer orally after a meal or a light snack.²⁰¹

If drowsiness occurs, administer a major portion of the daily dosage at bedtime or reduce dosage.²⁰¹

Dosage

Available as trazodone hydrochloride; dosage is expressed in terms of the salt.²⁰¹

Adults

Major Depressive Disorder

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Oral

Initially, 150 mg daily, given in divided doses.²⁰¹ Daily dosage may be increased in 50-mg increments every 3 or 4 days based on patient’s response and tolerance.²⁰¹

Prescribing Limits

Adults

Major Depressive Disorder

Outpatients

Oral

Maximum 400 mg daily.²⁰¹

Hospitalized Patients

Oral

Maximum 600 mg daily.²⁰¹

Cautions for Trazodone Hydrochloride

Contraindications

Known hypersensitivity to trazodone or any ingredient in the formulation.²⁰¹

Warnings/Precautions

Warnings

Worsening of Depression and Suicidality Risk

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) in both adult and pediatric patients; may persist until clinically important remission occurs with therapy.²¹² Closely supervise pediatric patients receiving trazodone for any reason and adult patients with major depressive disorder or other psychiatric illness with comorbid depression during initiation of therapy and during periods of dosage adjustments.²¹² (See Boxed Warning.)

If anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and/or mania occur, consider changing or discontinuing therapy, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.²¹²

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.²⁰¹ ²¹²

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.²¹²

Bipolar Disorder

May unmask bipolar disorder.²¹² Trazodone is not approved for use in treating bipolar depression.^a

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.²¹²

Priapism

Risk of developing priapism; may require surgical or pharmacologic (e.g., epinephrine) intervention and result in impotence or permanent impairment of erectile function.²⁰¹

Perform pharmacologic or surgical interventions under the supervision of a urologist or a physician familiar with the procedure; procedures should not be initiated without a urologic consultation if priapism persists for >24 hours.^a

Discontinue immediately if prolonged or inappropriate erections occur.²⁰¹

Cardiovascular Effects

Possible cardiac arrhythmias (e.g., PVCs, VT); use with caution in patients with preexisting cardiovascular disease.²⁰¹

Do not use during initial recovery phase of MI.²⁰¹

Hypotension, including orthostatic hypotension and syncope, reported.²⁰¹

Concomitant administration of antihypertensive therapy may require a reduction in dosage of the antihypertensive agent(s).²⁰¹

General Precautions

Elective Surgery

Discontinue several days prior to surgery requiring general anesthesia whenever possible.²⁰¹

CNS Effects

Drowsiness reported in up to 50% of patients.²⁰¹

Performance of activities requiring mental alertness and physical coordination may be impaired.²⁰¹

Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT have not been systematically evaluated; avoid concomitant use.²⁰¹

Specific Populations

Pregnancy

Category C.²⁰¹

Lactation

Not known whether trazodone is distributed into milk; caution advised.²⁰⁰ ²⁰¹

Pediatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Safety and efficacy not established in children <18 years of age.²⁰¹

Greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, obsessive-compulsive disorder, or other psychiatric disorders based on pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).²¹² No suicides occurred in these trials.²¹² If considering use of trazodone in a child or adolescent, balance potential risks with clinical need.²¹² (See Worsening of Depression and Suicidality Risk under Cautions.)

Common Adverse Effects

Drowsiness, dry mouth, dizziness or lightheadedness, headache, blurred vision, nausea or vomiting.²⁰¹

Interactions for Trazodone Hydrochloride

Metabolized by CYP3A4.²¹⁰ ²¹¹

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors or inducers of CYP3A4: Potential pharmacokinetic interaction (altered plasma trazodone concentrations).²¹⁰ ²¹¹

Specific Drugs

Drug	Interaction	Comments
Anesthetics, general	Experience limited²⁰¹	Discontinue trazodone for as long as clinically feasible prior to elective surgery^b
Antifungals, azoles (e.g., itraconazole, ketoconazole)	Substantially increased plasma trazodone concentrations possible, with potential for adverse effects²¹⁰ ²¹¹	If used concomitantly, consider reduction in trazodone dosage²¹⁰ ²¹¹
Carbamazepine	Substantially decreased plasma concentrations of trazodone and active metabolite, m-chlorophenylpiperazine²¹⁰ ²¹¹	Closely monitor during concomitant use; increase trazodone dosage if necessary²¹⁰ ²¹¹
CNS depressants (e.g., alcohol, anesthetics, barbiturates, opiates or other analgesics, other sedatives)	Additive CNS depressant effects (e.g., sedation)²⁰¹	Use with caution²⁰¹
Digoxin	Increased serum digoxin concentrations²⁰¹	Monitor for digoxin toxicity²⁰¹
Fluoxetine	Increased plasma trazodone concentrations²⁰⁵ ²⁰⁹ Potential for serotonin syndrome²⁰¹	Observe for adverse effects; monitor trazodone concentrations; adjust dosages as needed²⁰⁴ ²⁰⁷
Hypotensive agents	Potential additive hypotensive effects²⁰¹	Adjust dosages as needed²⁰¹
Indinavir	Substantially increased plasma trazodone concentrations possible, with potential for adverse effects²¹⁰ ²¹¹	If used concomitantly, consider reduction in trazodone dosage²¹⁰ ²¹¹
MAO inhibitors	Limited experience²⁰¹	Initiate trazodone therapy cautiously if MAO inhibitors are discontinued shortly before or are to be given concomitantly with trazodone²⁰¹
Nefazodone	Substantially increased plasma trazodone concentrations possible, with potential for adverse effects²¹⁰ ²¹¹	If used concomitantly, consider reduction in trazodone dosage²¹⁰ ²¹¹
Phenytoin	Increased serum phenytoin concentrations^b	Monitor for phenytoin toxicity^a
Ritonavir	Increased peak plasma concentration, AUC, and half-life and decreased clearance of trazodone; increased incidence of adverse effects of trazodone also observed²¹⁰ ²¹¹	If used concomitantly, consider reduction in trazodone dosage²¹⁰ ²¹¹
Serotonergic agents (e.g., buspirone, dextropropoxyphene, phenelzine)	Potential for serotonin syndrome²⁰¹	Caution^b
Warfarin	Increased or decreased PT^a	Monitor PT closely and adjust warfarin dosages as needed^a

Trazodone Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed from the GI tract; ^b peak plasma concentration usually attained within 1–2 hours.²⁰¹

Onset

Antidepressant effects evident within 1 week; optimal antidepressant effects usually attained after 2–4 weeks.²⁰¹

Food

Food reduces peak plasma concentrations, delays time to peak plasma concentration, and increases extent of absorption.^b

Distribution

Extent

Distribution into human body tissues and fluids not determined.^b

Widely distributed; crosses the blood-brain barrier and the placenta in animals.^b

Distributed into milk in rats; not known whether trazodone is distributed into milk in humans.²⁰¹

Plasma Protein Binding

89–95%.^b

Elimination

Metabolism

Extensively metabolized in the liver via hydroxylation, oxidation, N-oxidation, and splitting of the pyridine ring.^b In vitro studies indicate metabolism by CYP3A4 to an active metabolite, m-chlorophenylpiperazine; other metabolic pathways not well characterized.²¹⁰ ²¹¹

Elimination Route

Excreted principally in urine (70–75%) as metabolites and in feces via biliary elimination.^b

Half-life

5–9 hours.²⁰¹

Stability

Storage

Oral

Tablets

Room temperature.²⁰¹ Protect from temperatures >40°C.²⁰¹

Actions

Mechanism of action as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the CNS resulting from inhibition of reuptake of serotonin (5-HT) at the presynaptic neuronal membrane.^b

Does not influence reuptake of dopamine or norepinephrine; does not inhibit MAO; does not stimulate the CNS; exhibits little anticholinergic activity.^b

Produces varying degrees of sedation resulting from its central α₁-adrenergic and/or histamine blocking activity.^b

Advice to Patients

Risk of suicidality; importance of patient, family, or caregiver immediately reporting emergence of suicidality, worsening depression, or other manifestations associated with increased risk of worsening depression or suicidality.²¹² ²¹⁸ FDA recommends providing written patient information (medication guide) explaining risks in pediatric patients each time the drug is dispensed.²¹² ²¹³ ²¹⁸

Importance of men discontinuing the drug and notifying clinician if prolonged or inappropriate penile erection occurs.²⁰¹

Risks associated with concomitant use with alcohol, barbiturates, and other CNS depressants.²⁰¹

Potential for drug to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual are known.²⁰¹

Importance of taking trazodone shortly after a meal or light snack to enhance absorption and to minimize risk of dizziness/lightheadedness.²⁰¹

Importance of continuing trazodone therapy even if improvement is evident within 2 weeks, unless directed otherwise by their clinician.²⁰¹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.²⁰¹

Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.²⁰¹

Importance of informing patients of other important precautionary information.²⁰¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Trazodone Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	150 mg*	Trazodone Hydrochloride Dividose (with povidone; scored)	Sandoz
		300 mg*	Trazodone Hydrochloride Tablets	Barr
	Tablets, film-coated	50 mg*
		100 mg*

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Oleptro 150MG 24-hr Tablets (ANGELINI LABOPHARM): 30/$109.99 or 90/$299.98

TraZODone HCl 100MG Tablets (TEVA PHARMACEUTICALS USA): 30/$13.99 or 60/$18.98

TraZODone HCl 150MG Tablets (TEVA PHARMACEUTICALS USA): 30/$20.87 or 90/$62.61

TraZODone HCl 300MG Tablets (TEVA PHARMACEUTICALS USA): 100/$402.20 or 300/$1,206.61

TraZODone HCl 50MG Tablets (TEVA PHARMACEUTICALS USA): 30/$11.99 or 90/$33.98

Disclaimer

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

200. Verbeeck RK, Ross SG, McKenna EA. Excretion of trazodone in breast milk. Br J Clin Pharmacol. 1986; 22:367-70. [IDIS 221469] [PubMed 3768252]

201. Mead Johnson Pharmaceutical. Desyrel prescribing information. In: Huff BB, ed. Physicians’ desk reference. 40th ed. Oradell NJ: Medical Economics Company Inc; 1986:1123-4.

202. Gartrell N. Increased libido in women receiving trazodone. Am J Psychiatry. 1986; 143:781-2. [IDIS 216844] [PubMed 3717405]

203. Jani NN, Wise TN, Kass E et al. Trazodone and anorgasmia. Am J Psychiatry. 1988; 145:896. [IDIS 243207] [PubMed 3381940]

204. Vaughan DA. Interaction of fluoxetine with tricyclic antidepressants. Am J Psychiatry. 1988; 145:1478. [IDIS 248155] [PubMed 3263809]

205. Aranow RB, Hudson JI, Pope HG Jr et al. Elevated antidepressant plasma levels after addition of fluoxetine. Am J Psychiatry. 1989; 146:911-3. [IDIS 257880] [PubMed 2787124]

206. Downs JM, Downs AD, Rosenthal TL et al. Increased plasma tricyclic antidepressant concentrations in two patients concurrently treated with fluoxetine. J Clin Psychiatry. 1989; 50:226-7. [IDIS 256111] [PubMed 2785987]

207. Tricyclic antidepressants/fluoxetine. In: Tatro DS, Olin BR, eds. Drug interaction facts. St. Louis: JB Lippincott Co; 1990 (Apr):743a.

208. Swerdlow NR, Andia AM. Trazodone-fluoxetine combination for treatment of obsessive-compulsive disorder. Am J Psychiatry. 1989; 146:1637. [IDIS 261543] [PubMed 2589561]

209. Metz A, Shader RI. Adverse interactions encountered when using trazodone to treat insomnia associated with fluoxetine. Int Clin Psychopharmacol. 1990; 5:191-4. [PubMed 2230063]

210. Lewis-Hall FC. Dear healthcare professional: changes to labeling for Desyrel (trazodone hydrochloride) tablets. Princeton, NJ: Bristol-Myers Squibb Company; 2004. From the FDA website.

211. Bristol-Myers Squibb Company. Desyrel (trazodone) tablets prescribing information. Princeton, NJ; 2003 Sep

212. Food and Drug Administration. Class suicidality labeling language for antidepressants. From the FDA website.

213. Food and Drug Administration. Public health advisory: suicidality in children and adolescents being treated with antidepressant medications. Rockville, MD; 2004 Oct 15. From the FDA website.

214. Anon. FDA statement on recommendations of the psychopharmacologic drugs and pediatric advisory committees. Rockville, MD; 2004 Sep 16. From the FDA website.

215. American Psychiatric Association (APA). APA responds to FDA’s new warning on antidepressants. Arlington, VA; 2004 Oct. 15. From the APA website.

216. American Academy of Child and Adolescent Psychiatry (AACAP). AACAP responds to the new FDA warnings on pediatric antidepressant medications. Washington, D.C; 2004 Oct 15. From the AACAP website.

217. American Academy of Pediatrics (AAP). Children, antidepressants and a black box warning. Washington, D.C; 2004 Oct. 15. From the AAP web site.

218. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Rockville, MD; 2005 Jan 16. From the FDA website.

a. Mead Johnson Pharmaceutical. Desyrel (trazodone hydrochloride) prescribing information. Princeton, NJ; 1993 Oct.

b. AHFS drug information 2001. McEvoy GK, ed. Trazodone hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2001:2209-13.

d. American Psychiatric Association. Practice guideline for the treatment of patients with bipolar disorder (revision). Am J Psychiatr. 2002; 159(4 Suppl):1-50.

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Trazodone Hydrochloride Side Effects (in more detail)
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Trazodone Hydrochloride Use in Pregnancy & Breastfeeding
Drug Images
Trazodone Hydrochloride Drug Interactions
Trazodone Hydrochloride Support Group
195 Reviews for Trazodone Hydrochloride - Add your own review/rating

Desyrel Prescribing Information (FDA)

Desyrel Advanced Consumer (Micromedex) - Includes Dosage Information

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Thursday, October 27, 2016

Trelstar

Commonly used brand name(s)

Uses For Trelstar

Before Using Trelstar

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of triptorelin

Precautions While Using Trelstar

Trelstar Side Effects

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Tretinoin

Introduction

Uses for Tretinoin

Acute Promyelocytic Leukemia

Tretinoin Dosage and Administration

General

Administration

Oral Administration

Dosage

Pediatric Patients

Acute Promyelocytic Leukemia

Oral

Adults

Acute Promyelocytic Leukemia

Oral

Prescribing Limits

Pediatric Patients

Acute Promyelocytic Leukemia

Oral

Adults

Acute Promyelocytic Leukemia

Oral

Cautions for Tretinoin

Contraindications

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

Cytogenetic Confirmation of Diagnosis

RA-APL Syndrome

Leukocytosis

Pseudotumor Cerebri

Lipids

Hepatic Effects

General Precautions

Laboratory Tests

Thrombosis

Specific Populations

Pregnancy

Lactation

Pediatric Use

Geriatric Use

Common Adverse Effects

Interactions for Tretinoin

Drugs Affecting Hepatic Microsomal Enzymes

Specific Drugs

Tretinoin Pharmacokinetics

Absorption

Bioavailability

Food

Plasma Concentrations

Distribution

Extent

Plasma Protein Binding

Elimination

Metabolism

Elimination Route

Half-life

Special Populations

Stability

Storage

Oral

Capsules