Trelstar

Generic Name: Triptorelin Pamoate
Class: Antineoplastic Agents
VA Class: AN500
Chemical Name: 6-d-Tryptophan luteinizing hormone-releasing factor (pig)
Molecular Formula: C₆₄H₈₂N₁₈O₁₃
CAS Number: 57773-63-4

Special Alerts:

[Posted 10/20/2010] ISSUE: Gonadotropin-Releasing Hormone (GnRH) agonists will have new safety information added to the Warnings and Precautions section of the drug labels. This new information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.

BACKGROUND: GnRH agonists are approved to treat the symptoms (palliative treatment) of advanced prostate cancer. The benefits of GnRH agonist use for earlier stages of prostate cancer that have not spread (non-metastatic prostate cancer) have not been established. FDA’s notification to manufacturers of GnRH agonists to add this safety information is based on the Agency’s review of several published studies. Most of the studies reviewed by FDA reported small but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists.

RECOMMENDATIONS: Healthcare professionals should evaluate patients for risk factors for these diseases and carefully weigh the benefits and risks of using GnRH agonists before determining appropriate treatment for prostate cancer. Patients who are receiving treatment with GnRH agonists should undergo periodic monitoring of blood glucose and/or glycosylated hemoglobin (HbA1c). Healthcare professionals should also monitor patients for signs and symptoms suggestive of development of cardiovascular disease and manage according to current clinical practice. For more information visit the FDA website at: and .

[Posted 05/03/2010] FDA notified healthcare professionals and patients of FDA’s preliminary and ongoing review which suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists, drugs that suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer.

Most of the studies reviewed by FDA reported small, but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists. FDA’s review is ongoing and the agency has not made any conclusions about GnRH agonists and whether they increase the risk of diabetes and cardiovascular disease in patients receiving these medications for prostate cancer.

Healthcare professionals and patients should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment choices. FDA recommends that patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease. Patients should not stop their treatment with GnRH agonists unless told to do so by their healthcare professional.

Some GnRH agonists are also used in women and in children for other indications than those above. There are no known comparable studies that have evaluated the risk of diabetes and heart disease in women and children taking GnRH agonists. For more information visit the FDA website at: and .

Introduction

Antineoplastic agent; synthetic decapeptide analog of gonadotropin-releasing hormone (GnRH, luteinizing hormone-releasing hormone, gonadorelin);^{1 7} structurally related to leuprolide and goserelin.^{1 2 3 4 6 7}

Uses for Trelstar

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.

Prostate Cancer

Palliative treatment of advanced prostate cancer; considered alternative therapy when orchiectomy or estrogen therapy is not appropriate or is unacceptable to the patient.^{1 7}

Trelstar Dosage and Administration

Administration

IM Administration

Administer by IM injection once monthly (every 28 days) as a depot 1-month formulation or every 84 days (12 weeks) as a long-acting 3-month formulation.^{1 7}

Inject IM into buttock; rotate injection sites periodically.^{1 7}

Administer under the supervision of a qualified clinician.^{1 7}

Reconstitution

Reconstitute powder just prior to administration.^{1 7} Discard suspension if not used immediately after reconstitution.^{1 7}

Using a syringe with 20-gauge needle, add 2 mL of sterile water for injection to vial containing the powder (1- or 3-month formulation); do not reconstitute with other diluents.^{1 7} Shake well to disperse particles and obtain a uniform, milky suspension.^{1 7}

If using the single-dose delivery system, add contents of the prefilled syringe (2 mL of sterile water for injection) to vial containing the powder according to the manufacturer’s instructions.^{1 7} Mix well.^{1 7}

Withdraw entire contents of vial and use immediately.^{1 7}

Dosage

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.

Available as triptorelin pamoate; dosage is expressed in terms of triptorelin.^{1 7}

Adults

Prostate Cancer

IM

3.75 mg every 28 days (monthly) as the 1-month formulation or 11.25 mg every 84 days (12 weeks) as the 3-month formulation.^{1 7}

Special Populations

Hepatic Impairment

Potential need for dosage adjustment not determined.¹

Renal Impairment

Potential need for dosage adjustment not determined.¹

Cautions for Trelstar

Contraindications

• 
  

  Known hypersensitivity to triptorelin or any other ingredient in the formulation, other GnRH agonists, or GnRH.^{1 7}

  
  


• 
  

  Known or suspected pregnancy.^{1 7}

  
  

Warnings/Precautions

Warnings

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.

Endocrine Effects

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 signs and/or symptoms of prostate cancer and/or development of new manifestations (e.g., bone pain, neuropathy, hematuria, urethral or bladder outlet obstruction) due to increases in serum testosterone concentrations during initial weeks of therapy.^{1 2 3 5 7}

Possible spinal cord compression contributing to paralysis; possibly fatal.^{1 2 5 7}

Increased risk of neurologic and/or genitourinary complications during initial therapy in patients with prostate cancer and metastatic vertebral lesions and/or urinary tract obstruction.^{1 7} Observe such patients closely during initial weeks of therapy.^{1 5 7}

If spinal cord compression or renal impairment develops, institute standard treatment of these complications; consider immediate orchiectomy in extreme cases.^{1 7}

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactic shock and angioedema reported rarely.^{1 7} If such reactions occur, discontinue immediately and provide supportive and symptomatic care.^{1 7}

Major Toxicities

Pituitary Apoplexy

Pituitary apoplexy, a clinical syndrome resulting from infarction of the pituitary gland, reported rarely.^{1 7} Most cases occur within 2 weeks of the first dose, sometimes within the first hour.^{1 7} If manifestations occur (e.g., sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, sometimes cardiovascular collapse), immediate medical attention required.^{1 7} In most cases, pituitary adenoma diagnosed.¹

General Precautions

Laboratory Monitoring

Periodically determine serum testosterone and prostate-specific antigen concentrations to monitor therapeutic response.^{1 7}

Specific Populations

Pregnancy

Category X.^{1 7} (See Contraindications under Cautions.)

Lactation

Not known whether distributed into milk; not recommended for use in nursing women.^{1 7}

Pediatric Use

Safety and efficacy not established in children.^{1 7}

Geriatric Use

Studies conducted principally in patients ≥65 years of age, since prostate cancer occurs mainly in an older patient population.^{1 7}

Common Adverse Effects

Temporary worsening of disease manifestations, hot flushes (flashes), skeletal pain, impotence, headache, pain at injection site, leg pain and edema, dysuria, hypertension.^{1 7}

Also observed with 3-month formulation: decreased hemoglobin and erythrocyte counts, increased BUN, increased serum concentrations of glucose, AST, ALT, and alkaline phosphatase.⁷

Interactions for Trelstar

Metabolism unlikely to involve CYP enzymes; effect of triptorelin on other drug-metabolizing enzymes unknown.⁷

Drugs That Induce Hyperprolactinemia

Potential pharmacologic interaction (possible decrease in triptorelin efficacy due to decreased number of GnRH receptors) with drugs such as antipsychotic agents, methyldopa, metoclopramide, and reserpine.^{1 6 7}

Trelstar Pharmacokinetics

Absorption

Bioavailability

Not active when administered orally.^{1 7}

Following IM administration as Trelstar Depot or Trelstar LA, peak plasma concentrations usually are attained within 1 or 3 hours, respectively.^{1 7}

Duration

Following IM injection of Trelstar Depot or Trelstar LA in males, therapeutic plasma concentrations persist for 1 or 3 months, respectively.^{1 7}

Distribution

Extent

Not known whether triptorelin is distributed into milk.^{1 7}

Plasma Protein Binding

No evidence that triptorelin binds to plasma proteins.^{1 7}

Elimination

Metabolism

Metabolism is unknown; involvement of CYP enzymes is unlikely.^{1 7} No metabolites identified to date.^{1 7}

Elimination Route

Hepatic and renal elimination.^{1 7}

Half-life

Approximately 3 hours.^{1 7}

Special Populations

In males with hepatic impairment or moderate or severe renal impairment, AUC increased 2- to 4-fold compared with healthy males.^{1 7}

Stability

Storage

Parenteral

Powder for Injection

20–25°C (may be exposed to 15–30°C).^{1 7} Do not freeze.⁷

Discard suspension if not used immediately after reconstitution.^{1 7}

ActionsActions

• 
  

  Potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses; greater activity than naturally occurring GnRH.^{1 7}

  
  


• 
  

  Transient surge in circulating levels of LH, FSH, testosterone, and estradiol observed after initial administration.^{1 7} Sustained decreases in LH and FSH secretion and reduced testicular and ovarian steroidogenesis observed following chronic, continuous administration (generally 2–4 weeks after initiation of therapy).^{1 4 7}

  
  


• 
  

  Reduction of serum testosterone in males comparable to effects achieved after surgical castration; results in inactivation of physiologic functions and tissues dependent on testosterone.^{1 2 4 7} These effects usually are reversible after cessation of therapy.^{1 7}

  
  

Advice to Patients

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.

• 
  

  Risk of worsening manifestations of prostate cancer during initial weeks of therapy.^{1 7}

  
  


• 
  

  Importance of promptly reporting weakness or paresthesia of lower limbs and/or worsening of urinary signs and symptoms to clinicians.⁶

  
  


• 
  

  Importance of promptly reporting sudden onset of headache, vomiting, or visual changes to clinicians.^{1 7}

  
  


• 
  

  Risk of anaphylactoid and other sensitivity reactions.^{1 7}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{1 7}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 7} If used during pregnancy, apprise of potential fetal hazard.⁷

  
  


• 
  

  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.

Triptorelin Pamoate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IM use only	3.75 mg (of triptorelin)	Trelstar Depot	Watson
			Trelstar Depot Clip’n’Ject	Watson
		11.25 mg (of triptorelin)	Trelstar LA	Watson
			Trelstar LA Clip’n’Ject	Watson

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 November 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Watson Pharma. Trelstar Depot 3.75 mg (triptorelin pamoate for injectable suspension) prescribing information. Corona, CA; 2006 Aug.

2. Parmar H, Phillips RH, Lightman SL et al. Randomised controlled study of orchidectomy vs long-acting D-Trp-6-LHRH microcapsules in advanced prostatic carcinoma. Lancet. 1985; 2:1201-5. [PubMed 2866289]

3. Mahler C. Is disease flare a problem? Cancer. 1993; 72:3799-802.

4. Rolandi E, Martorana G, Franceschini R et al. Treatment of prostatic cancer with a depot preparation of an LHRH analogue: endocrine effects. Curr Ther Res. 1985; 38:670-5.

5. Kahan A, Delrieu F, Amor B et al. Disease flare induced by D-Trp⁶-LHRH analogue in patients with metastatic prostatic cancer. Lancet. 1984; 1:971-2. [IDIS 184509] [PubMed 6143912]

6. Pharmacia & Upjohn, Kalomazoo, MI: Personal communication.

7. Watson Pharma. Trelstar LA 11.25 mg (triptorelin pamoate for injectable suspension) prescribing information. Corona, CA: 2006 Aug.

8. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52.

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

Treanda

Generic Name: bendamustine (BEN da MUS teen)

Brand Names: Treanda

What is bendamustine?

Bendamustine is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Bendamustine is used to treat chronic lymphocytic leukemia. Bendamustine is also used to treat indolent B-cell non-Hodgkin lymphoma after other medications have been tried without successful treatment of this condition.

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

What is the most important information I should know about bendamustine?

You should not receive this medication if you are allergic to bendamustine or mannitol (Osmitrol). Do not receive bendamustine if you are pregnant. It could harm the unborn baby.

Before you receive bendamustine, tell your doctor if you have a weak immune system, fever or other signs of infection, a metabolic disorder or electrolyte imbalance, liver or kidney disease, or if you smoke.

Tell your caregiver right away if you have a fever, chills, itching, or skin rash during or shortly after the injection.

Other serious side effects to tell your doctor about include fever, chills, cough, sore throat, feeling short of breath, pale skin, easy bruising or bleeding, unusual weakness, severe skin rash, weak pulse, muscle weakness, fast or slow heart rate, confusion, lower back pain, blood in your urine, urinating less than usual, or swelling, redness, or signs of where the medicine was injected.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

What should I discuss with my healthcare provider before I receive bendamustine?

You should not receive this medication if you are allergic to bendamustine or mannitol (Osmitrol).

To make sure you can safely receive bendamustine, tell your doctor if you have any of these other conditions:

• 
  

  a weak immune system;

  
  


• 
  

  fever or other signs of infection;

  
  


• 
  

  a metabolic disorder or electrolyte imbalance;

  
  


• liver disease;


• kidney disease; or


• 
  

  if you smoke.

  
  

FDA pregnancy category D. Do not receive bendamustine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether bendamustine passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

Some people receiving bendamustine have developed certain types of cancers. It is not known whether this medication causes cancer. Talk with your doctor about the risks and benefits of using bendamustine.

How is bendamustine given?

Bendamustine is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Bendamustine must be given slowly, and the IV infusion can take at least 30 minutes to complete.

Bendamustine is usually given for 2 days in a row every 21 to 28 days. You may receive up to 8 treatments total, depending on the condition being treated. Follow your doctor's instructions.

You may be given other medications to help prevent certain side effects of bendamustine.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your bendamustine injection.

What happens if I overdose?

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

Overdose symptoms may include drowsiness, tremors, slow or shallow breathing, loss of balance or coordination, or seizure (convulsions).

What should I avoid while receiving bendamustine?

Bendamustine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Bendamustine side effects

Some people receiving a bendamustine injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have fever, chills, itching, or skin rash during or shortly after the injection. 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. Tell your caregivers at once if you have a serious side effect such as:

• 
  

  fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  
  


• 
  

  pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  
  


• 
  

  easy bruising or bleeding, purple or red pinpoint spots under your skin, unusual weakness;

  
  


• 
  

  cold symptoms such as stuffy nose, sneezing, cough, sore throat;

  
  


• 
  

  lower back pain, blood in your urine, urinating less than usual or not at all;

  
  


• 
  

  numbness or tingly feeling around your mouth;

  
  


• 
  

  muscle weakness, tightness, or contraction, overactive reflexes;

  
  


• 
  

  fast or slow heart rate, weak pulse, confusion;

  
  


• 
  

  dry mouth, feeling very thirsty or hot, heavy sweating or hot and dry skin;

  
  


• 
  

  severe blistering, peeling, and red skin rash; or

  
  


• 
  

  pain, swelling, redness, skin changes, or signs of infection where the medicine was injected.

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, diarrhea, constipation, or upset stomach;

  
  


• 
  

  swelling in your hands or feet;

  
  


• 
  

  headache, dizziness, drowsiness;

  
  


• 
  

  loss of appetite, weight loss; or

  
  


• 
  

  mild skin rash.

  
  

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 bendamustine?

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

• 
  

  allopurinol (Zyloprim);

  
  


• 
  

  carbamazepine (Carbatrol, Equetro, Tegretol);

  
  


• 
  

  cimetidine (Tagamet);

  
  


• 
  

  ciprofloxacin (Cipro);

  
  


• 
  

  fluvoxamine (Luvox);

  
  


• 
  

  omeprazole (Prilosec);

  
  


• 
  

  thiabendazole (Mintezol); or

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), phenobarbital (Solfoton), and others.

  
  

This list is not complete and other drugs may interact with bendamustine. 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 Treanda resources

• Treanda Side Effects (in more detail)
• Treanda Use in Pregnancy & Breastfeeding
• Treanda Drug Interactions
• Treanda Support Group
• 1 Review for Treanda - Add your own review/rating

• Treanda Prescribing Information (FDA)


• Treanda Advanced Consumer (Micromedex) - Includes Dosage Information


• Treanda MedFacts Consumer Leaflet (Wolters Kluwer)


• Treanda Consumer Overview

Compare Treanda with other medications

• Chronic Lymphocytic Leukemia
• Non-Hodgkin's Lymphoma

Where can I get more information?

• Your doctor or pharmacist can provide more information about bendamustine.

See also: Treanda side effects (in more detail)

Travasol

Dosage Form: Injection

Travasol Description

10% Travasol®(Amino Acid) Injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.

The Viaflex® plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146® Plastic). Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological test for plastic containers as well as by tissue culture toxicity studies.

Each 100 mL of 10% Travasol® (Amino Acid) Injection contains:

Amino acids	10 g
Total nitrogen	1.65 g
pH	6.0 (5.0 to 7.0)

(pH adjusted with glacial acetic acid and may have been adjusted with sodium hydroxide.)

* Balanced by ions from amino acids. † derived from pH adjustment with glacial acetic acid ‡ contributed by the lysine hydrochloride
Essential Amino Acids
Leucine - C6H13NO2	730 mg
Isoleucine - C6H13NO2	600 mg
Lysine (added as the hydrochloride salt) - C6H14N2O2	580 mg
Valine - C5H11NO2	580 mg
Phenylalanine - C9H11NO2	560 mg
Histidine - C6H9N3O2	480 mg
Threonine - C4H9NO3	420 mg
Methionine - C5H11NO2S	400 mg
Tryptophan - C11H12N2O2	180 mg
Nonessential Amino Acids
Alanine - C3H7NO2	2.07 g
Arginine - C6H14N4O2	1.15 g
Glycine - C2H5NO2	1.03 g
Proline - C5H9NO2	680 mg
Serine - C3H7NO3	500 mg
Tyrosine - C9H11NO3	40 mg
Anion profiles per liter*
Acetate†	88 mEq
Chloride‡	40 mEq
Osmolarity (Calc.)	998 mOsmol/L

Travasol - Clinical Pharmacology

10% Travasol® (Amino Acid) Injection administered via central vein will provide biologically utilizable source material for protein synthesis when used with concentrated calorie sources (such as hypertonic dextrose or fat emulsion), electrolytes, vitamins, and minerals. Administered peripherally after appropriate dilution or with minimal calorie supplementation (such as 5% dextrose), it enhances the conservation of body protein.

Indications and Usage for Travasol

10% Travasol® (Amino Acid) Injection is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

Central Vein Administration:

Central vein infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis such as for hypercatabolic or depleted patients or those requiring long term parenteral nutrition.

Peripheral Vein Administration:

For patients in whom the central vein route is not indicated, amino acid solutions diluted with low dextrose concentrations may be infused by peripheral vein when supplemented with or without fat emulsion.

Protein-Sparing:

Dilute amino acid solutions for peripheral administration may be used in patients who exemplify no clinically significant protein malnutrition. The purpose of the solution is to replace protein losses which occur in relation to an intercurrent phenomenon which is known or suspected to be productive of a protein loss condition for a short or moderate period of time. Protein-sparing can be achieved by peripheral infusion of amino acid solutions with or without dextrose.

Contraindications

Hypersensitivity to one or more amino acids

Severe liver disease or hepatic coma

Anuria

Warnings

This injection is for compounding only, not for direct infusion.

Caution should be exercised when admixing 10% Travasol® (Amino Acid) Injection. Studies have shown that admixtures of Travasol® (Amino Acid) Injection, 10% and 20% Travamulsion® Intravenous Fat Emulsion injection and high concentration dextrose injection (10 to 70%), from Baxter Healthcare Corporation, are stable over short periods of time. These solutions should be used promptly after admixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours. Reference should be made to Travamulsion® injection and high concentration dextrose injection from Baxter Healthcare Corporation package inserts for detailed information on each component.

Proper administration of this injection requires knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.

Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor and coma.

Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.

Conservative doses of this injection should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient's clinical status reevaluated.

Administration of amino acid solutions in the presence of impaired renal function presents special issues associated with retention of electrolytes.

This injection should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Administration by central venous catheter should be used only by those familiar with this technique and its complications.

Precautions

It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis. Concentrated dextrose solutions are an effective source of such calories.

With the administration of 10% Travasol® (Amino Acid) Injection in combination with highly concentrated dextrose solutions, hyperglycemia, glycosuria and hyperosmolar syndrome may result. Blood and urine glucose should be monitored on a routine basis in patients receiving this therapy.

Sudden cessation in administration of a concentrated dextrose solution may result in insulin reaction due to continued endogenous insulin production. Parenteral nutrition mixtures should be withdrawn slowly.

Electrolytes may be added to this injection as dictated by the patient's electrolyte profile.

The metabolizable acetate anion and amino acid profile in this injection were designed to minimize or prevent occurrences of hyperchloremic metabolic acidosis and hyperammonemia. However, the physician should be aware of appropriate countermeasures if they become necessary.

Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.

Because of its antianabolic activity, concurrent administration of tetracycline may reduce the protein-sparing effects of infused amino acids.

Care should be taken to avoid excess fluid accumulation, particularly in patients with renal disease, pulmonary insufficiency and heart disease.

During protein-sparing therapy in the absence of supporting carbohydrate metabolism, an accumulation of ketone bodies in the blood often occurs. Correction of ketonemia usually can be accomplished by administering some carbohydrates.

Protein-sparing therapy is useful for periods up to 10 to 12 days. Patients requiring nutritional support thereafter should be placed on oral or parenteral regimens that employ adequate nonprotein calorie components.

Drug product contains no more than 25 µg/L of aluminum.

Laboratory Tests

Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration.

Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, hemogram, carbon dioxide combining power or content, serum osmolarities, blood cultures and blood ammonia levels

Carcinogenesis and Mutagenesis and Impairment of Fertility

Studies with 10% Travasol® (Amino Acid) Injection have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C.

Animal reproduction studies have not been conducted with 10% Travasol® (Amino Acid) Injection. It is also not known whether 10% Travasol® (Amino Acid) Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 10% Travasol® (Amino Acid) Injection should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when 10% Travasol® (Amino Acid) Injection is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of 10% Travasol® (Amino Acid) Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature. See DOSAGE AND ADMINISTRATION.

SPECIAL PRECAUTIONS

Administration of amino acid solutions and other nutrients via central or peripheral venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure. This includes attention to solution preparation, administration and patient monitoring. It is essential that a carefully prepared protocol, based on current medical practices, be followed, preferably by an experienced team.

Although a detailed discussion of the complications is beyond the scope of this insert, the following summary lists those based on current literature:

Technical:

The placement of a central venous catheter should be regarded as a surgical procedure. The physician should be fully acquainted with various techniques of catheter insertion as well as recognition and treatment of complications. For details of techniques and placement sites consult the medical literature. X-ray is the best means of verifying catheter placement. Complications known to occur from the placement of central venous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arterio-venous fistula, phlebitis, thrombosis, cardiac arrhythmia and catheter embolus.

Septic:

The constant risk of sepsis is present during administration of parenteral nutrition solutions. Since contaminated solutions and infusion catheters are potential sources of infection, it is imperative that the preparation of the solution and the placement and care of catheters be accomplished under controlled aseptic conditions. If fever develops, the solution, its delivery system and the site of the indwelling catheter should be changed.

Solutions ideally should be prepared in the hospital pharmacy under a laminar flow hood. The key factor in their preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients.

Metabolic:

The following metabolic complications have been reported: metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia and glycosuria, osmotic diuresis and dehydration, rebound hypoglycemia, elevated liver enzymes, hypo and hyper vitaminosis, electrolyte imbalances and hyperammonemia. Frequent clinical evaluation and laboratory determinations are necessary, especially during the first few days of therapy, to prevent or minimize these complications.

Adverse Reactions

See WARNINGS and SPECIAL PRECAUTIONS.

Infusion of any hypertonic solution can result in local inflammatory reactions. Policies and procedures should be established for the recognition and management of such reactions.

Overdosage

See CONTRAINDICATIONS and WARNINGS

Travasol Dosage and Administration

If a patient is unable to take enteral nourishment for a prolonged period of time, institution of total parenteral nutrition (TPN) with exogenous calories should be considered.

The total daily dose of 10% Travasol® (Amino Acid) Injection depends on the patient’s metabolic requirement and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual nitrogen requirements.

Recommended Dietary Allowances* of protein range from approximately 0.75 g/kg of body weight for adults to 1.68 g/kg for infants. It must be recognized, however, that protein as well as caloric requirements in traumatized or malnourished patients may be increased substantially. Daily amino acid doses of approximately 1.0 to 1.5 g/kg of body weight for adults with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance.

For the initial treatment of trauma or protein calorie malnutrition, higher doses of protein with corresponding quantities of carbohydrate will be necessary to promote adequate patient response to therapy. The severity of the illness being treated is the primary consideration in determining proper dose level. Such higher doses, especially in infants, must be accompanied by more frequent laboratory evaluation.

For protein-sparing in well-nourished patients not receiving significant additional calories, amino acid dosages of 1.0 to 1.7 g/kg/day reduce nitrogen losses and spare body protein. If daily increases in BUN in the range of 10 to 15 mg% for more than three days should occur, then protein-sparing therapy should be discontinued and a regimen with full nonprotein calorie substrates should be adopted.

Care should be exercised to insure the maintenance of proper levels of serum potassium. Quantities of 60 to 180 mEq of potassium per day have been used with adequate clinical effect. It may be necessary to add quantities of this electrolyte to this injection, depending primarily on the amount of carbohydrate administered to and metabolized by the patient.

This injection provides a concentrated source of amino acids to meet the protein requirements of patients that are fluid restricted (e.g., renal failure). Acceptable total daily administration volumes are dependent upon the fluid balance requirements of the patient. Extreme care should be given to prevent fluctuations of blood osmolarity and serum electrolyte concentrations. Frequent and careful monitoring is mandatory when fluid restricted patients are receiving intravenous nutrition.

Patients receiving this injection should be monitored (carefully) and their electrolyte requirements individualized.

Total daily fluid requirements can be met beyond the volume of amino acid solutions by supplementing with noncarbohydrate or carbohydrate-containing electrolyte solutions.

Maintenance vitamins, additional electrolytes and trace elements should be administered as required.

Fat emulsion coadministration should be considered when prolonged parenteral nutrition (more than 5 days) is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat free total parenteral nutrition.

Pediatric Use:

Use of 10% Travasol® (Amino Acid) Injection in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).

Central Vein Administration:

Hypertonic mixtures of amino acids and dextrose may be administered safely by continuous infusion through a central vein catheter with the tip located in the vena cava. In addition to meeting nitrogen needs, the administration rate is governed, especially during the first few days of therapy, by the patient’s tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of urine and blood sugar levels.

In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria.

Parenteral nutrition may be started with infusates containing lower concentrations of dextrose; dextrose content may be gradually increased to estimated caloric needs as the patient's glucose tolerance increases.

Sudden cessation in administration of concentrated dextrose solution may result in insulin reaction due to continued endogenous insulin production. Such solutions should be withdrawn slowly.

Peripheral Vein Administration:

For patients requiring parenteral nutrition in whom the central vein route is not indicated, this injection can be mixed with low concentration dextrose solutions and administered by peripheral vein in conjunction with or without fat emulsions. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

Intravenous fat emulsions provide approximately 1.1 kcal/mL (10%) or 2.0 kcal/mL (20%) and may be administered along with amino acid-dextrose solutions by means of a short Y-connector near the infusion site to supplement caloric intake. Fat, however, should not be the sole caloric intake since studies have indicated that glucose is more nitrogen sparing in the stressed patient.

Protein-Sparing:

For well-nourished patients who require short-term parenteral support, 10% Travasol® (Amino Acid) Injection can be administered peripherally with or without carbohydrate calories. Such infusates can be prepared by dilution of this injection with Sterile Water for Injection or 5% Dextrose Injection to prepare isotonic or slightly hypertonic solutions which may be administered by peripheral vein.

Depending upon the clinical condition of the patient, approximately 3 liters of solution may be administered per 24 hour period. When used postoperatively, the therapy should begin with 1000 mL on the first postoperative day. Thereafter, the dose may be increased to 3000 mL per day.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible.

Do not administer unless solution is clear and seal is intact.

A slight yellow color does not alter the quality and efficacy of the product.

10% Travasol® (Amino Acid) Injection in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of 10% Travasol® (Amino Acid) Injection.

Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.

DIRECTIONS FOR USE OF VIAFLEX® PLASTIC PHARMACY BULK PACKAGE CONTAINER

To Open

Tear overpouch down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

For compounding only, not for direct infusion.

Preparation for Admixing

1. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).

2. Suspend container from eyelet support.

3. Remove plastic protector from outlet port at bottom of container.

4. Attach solution transfer set. Refer to complete directions accompanying set. Note: The closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents.

5. Viaflex® containers should not be written on directly since ink migration has not been investigated. Affix accompanying label for date and time of entry,

6. Once container closure has been penetrated, withdrawal of contents should be completed without delay. After initial entry, maintain contents at room temperature (25ºC/77ºF) and dispense within 4 hours.

How is Travasol Supplied

10% Travasol® (Amino Acid) Injection is available in Viaflex® plastic Pharmacy Bulk Package containers as follows below.

1B6623	500 mL	NDC 0338-0644-03
1B6624	1000 mL	NDC 0338-0644-04
1B6626	2000 mL	NDC 0338-0644-06

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).

Do not remove container from overpouch until ready to use.

Do not use if overpouch has been previously opened or damaged.

*Food and Nutrition Board National Academy of Sciences - National Research Council (Revised 1989)

Baxter Healthcare Corporation

Clintec Nutrition Division

Deerfield, IL 60015 USA

07-19-12-844 Rev. July 2002

Travasol  leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, tyrosine, serine  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0338-0644 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Leucine (Leucine) Active 730 MILLIGRAM  In 100 MILLILITER Phenylalanine (Phenylalanine) Active 560 MILLIGRAM  In 100 MILLILITER Lysine hydrochloride (Lysine) Active 580 MILLIGRAM  In 100 MILLILITER Methionine (Methionine) Active 400 MILLIGRAM  In 100 MILLILITER Isoleucine (Isoleucine) Active 600 MILLIGRAM  In 100 MILLILITER Valine (Valine) Active 580 MILLIGRAM  In 100 MILLILITER Histidine (Histidine) Active 580 MILLIGRAM  In 100 MILLILITER Threonine (Threonine) Active 420 MILLIGRAM  In 100 MILLILITER Tryptophan (Tryptophan) Active 180 MILLIGRAM  In 100 MILLILITER Alanine (Alanine) Active 2.07 GRAM  In 100 MILLILITER Glycine (Glycine) Active 1.03 GRAM  In 100 MILLILITER Arginine (Arginine) Active 1.15 GRAM  In 100 MILLILITER Proline (Proline) Active 380 MILLIGRAM  In 100 MILLILITER Tyrosine (Tyrosine) Active 40 MILLIGRAM  In 100 MILLILITER Serine (Serine) Active 500 MILLIGRAM  In 100 MILLILITER Acetic Acid Inactive   Sodium Hydroxide Inactive   Water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0338-0644-03 500 mL (MILLILITER) In 1 BAG None 2 0338-0644-04 1000 mL (MILLILITER) In 1 BAG None 3 0338-0644-06 2000 mL (MILLILITER) In 1 BAG None

Revised: 11/2006Baxter Healthcare Corporation

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Trelstar LA

Pronunciation: TRIP-toe-REL-in
Generic Name: Triptorelin
Brand Name: Examples include Trelstar Depot and Trelstar LA

Trelstar LA is used for:

Treating symptoms of advanced prostate cancer. It may be used for other conditions as determined by your doctor.

Trelstar LA is a synthetic analogue of gonadotropin-releasing hormone (GnRH) agonist. It works by decreasing the production of certain hormones, which reduces testosterone levels in the body.

Do NOT use Trelstar LA if:

• you are allergic to any ingredient in Trelstar LA, to GnRH, or to another GnRH agonist (eg, goserelin)


• you are pregnant, may become pregnant, or are breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Trelstar LA:

Some medical conditions may interact with Trelstar LA. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history or urinary problems (eg, blockage of the bladder or ureters), spinal cord problems, abnormal growths on or near the spine or spinal cord, heart problems, blood vessel problems, a stroke, diabetes, or high blood sugar

Some MEDICINES MAY INTERACT with Trelstar LA. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Medicines that increase prolactin levels in the blood (eg, promethazine) because the effectiveness of Trelstar LA may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trelstar LA may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Trelstar LA:

Use Trelstar LA as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Trelstar LA is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Trelstar LA at home, a health care provider will teach you how to use it. Be sure you understand how to use Trelstar LA. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Trelstar LA is injected into the muscle.


• Rotate the injection site. Do not inject into an area of skin that is red, hard, or bruised, or has scars or stretch marks.


• Do not use Trelstar LA if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.


• If you miss a dose of Trelstar LA, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Trelstar LA.

Important safety information:

• Trelstar LA may cause dizziness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Trelstar LA with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Certain hormone levels may increase during the first few weeks of treatment with Trelstar LA. This may cause you to experience worsening symptoms or onset of new symptoms (eg, bone pain; blood in the urine; difficulty urinating; burning, numbness, or tingling) during the first few weeks of treatment. Patients with growths on or near the spine or spinal cord, or blockage of the bladder or ureters may be at greater risk of developing serious and sometimes fatal complications. Contact your doctor if any new or worsened symptoms occur while using Trelstar LA.


• Trelstar LA lowers the amount of certain hormones in your body. This may cause certain expected side effects to occur, such as breast enlargement, soreness, or tenderness; testicular changes, pain, or soreness; decreased sexual ability; hot flashes; or night sweats. Contact your doctor if you have questions or concerns or if you experience any of these side effects.


• A slight increase in the risk of stroke or serious and sometimes fatal heart problems has been reported with the use of GnRH agonists in men. Although the risk appears to be low, seek immediate medical attention if you experience chest, jaw, or left arm pain; confusion; fainting; numbness of an arm or leg; one-sided weakness; slurred speech; sudden, severe headache or vomiting; or vision changes. Discuss any questions or concerns with your doctor.


• Trelstar LA may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Rarely, a serious pituitary gland problem (pituitary apoplexy) may occur after you use Trelstar LA. This serious problem usually occurs shortly after you begin to use Trelstar LA. Contact your doctor immediately if you experience a sudden headache, vomiting, fainting, eye weakness, inability to move your eyes, mental status changes, or vision changes.


• Trelstar LA may interfere with certain lab tests, including certain hormone and pituitary gland function tests. Be sure your doctor and lab personnel know you are using Trelstar LA.


• Lab tests, including testosterone,prostate specific antigen (PSA) levels, hemoglobin A_1c, or blood glucose, may be performed while you use Trelstar LA. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Trelstar LA with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Trelstar LA may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Trelstar LA while you are pregnant. It is not known if Trelstar LA is found in breast milk. Do not breast-feed while using Trelstar LA.

Possible side effects of Trelstar LA:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in breast size; constipation; decreased sexual desire or ability; diarrhea; dizziness; headache; hot flashes; itching, pain, redness, or swelling at the injection site; loss of appetite; nausea; sleeplessness; stomach discomfort; tiredness or weakness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); back pain; blood in the urine or dark urine; bone pain; breast pain; burning, numbness, or tingling; calf or leg pain or tenderness; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mood or mental changes (eg, depression); painful urination; severe or persistent headache, drowsiness, or dizziness; severe or persistent joint, muscle, or back pain; severe or persistent leg cramps; shortness of breath; sudden, unusual weight gain; swelling of the hands, ankles, feet or legs; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech); trouble urinating or inability to urinate; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Trelstar LA side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Trelstar LA:

Store Trelstar LA at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Discard any medicine not used immediately after mixing. Keep Trelstar LA, as well as needles and syringes, out of the reach of children and away from pets.

General information:

• If you have any questions about Trelstar LA, please talk with your doctor, pharmacist, or other health care provider.


• Trelstar LA is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Trelstar LA. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Treagan Otic Solution

Dosage Form: otic solution
Treagan Otic Solution

Description

Each ml contains:

acetlc acid...........................................................  0.01%

antipyrine ..............................................................5.4%

benzocaine .......................................................... 1.4%

polycosanol 410 (synthetic mixture).......................  0.01%

Also contains aluminum acetate.

Inactive Ingredient: Glycerin.

TOPICAL ANESTHETIC, ANALGESIC AND ANTIBACTERIAL: An otic solution

containing acetic acid, antipyrine, benzocaine, polycosanol410 and aluminum

acetate. The solution congeals at 0oC (32oF) but returns to normal consistency,

unchanged at room temperature. The structures of the components are:

Clinical Pharmacology

Combines the property of acetic acid, polycosanol 410 and aluminum acetate with the analgesic action of antipyrine and the local anesthetic action of benzocaine to relieve pressure, reduce inflammation and

congestion, and alleviate pain and discomfort in acute otitis media. Does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.

Indications and Usage

Acute otitis media of various etiologies

• Prompt relief of pain and reduction of inflammation in the congestIve and

serous stages.

• Adjuvant therapy during systemic antibiotic administration for resolution

of the infection.

Because of the close anatomical relationship of the eustachian tube to the nasal cavity, otitis media is a frequent problem especially in children in whom the tube is shorter, wider and more horizontal than in adults.

Removal of cerumen;

• Facilitates the removal of excessive or impacted cerumen.

Contraindications

Hypersensitivity to any of the components or substances related to them. In the presence of spontaneous perforation or discharge.

Precautions

Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies in animals or humans have been conducted.

Pregnancy Category C: Animal reproduction studies have not been conducted with this preparation. It is also not known whether this product can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. This product should be given to a pregnant woman only if dearly needed. Nursing Mothers: It Is not known whether this drug is excreted In human milk. Caution should be exercised when this product Is administered to a nursing woman.

Dosage and Administration

Acute otItis media: Warm to body temperature. Instill the product permitting the solution to run along the wall of the canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with the product and insert into meatus, Repeat every one to two hours until pain and congestion are relieved.

Removal of cerumen:

Before: Instill three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal.

After:This product is useful for drying out the canal or relieving discomfort. Before and after removal of cerumen a cotton pledget moistened with the product should be inserted into the meatus following instillation.

How Supplied

Treagan Otic Solution is supplied in a 15 ml plastic bottle with dropper and package insert. (NDC 13811-512-15).

Store at 20-·250C (68--770F). See USP Controlled RoomTemperature. Protect from freezing.

Bottle label

Example of bottle label

TREAGAN OTIC  antipyrine benzocaine otic  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13811-512 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 14 mg  in 1 mL Antipyrine (Antipyrine) Antipyrine 54 mg  in 1 mL Acetic Acid (Acetic Acid) Acetic Acid 0.1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 13811-512-15 14 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/01/2009

Labeler - Trigen Laboratories, Inc. (830479668)

Revised: 04/2010Trigen Laboratories, Inc.

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