Tarceva

Generic Name: Erlotinib
Class: Antineoplastic Agents
Chemical Name: N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-quinazolinamine hydrochloride
Molecular Formula: C₂₂H₂₃N₃O₄•HCl
CAS Number: 183319-69-9

Introduction

Antineoplastic agent; a kinase inhibitor.¹

Uses for Tarceva

Non-small Cell Lung Cancer

Treatment of locally advanced or metastatic non-small cell lung cancer that is refractory to at least one prior chemotherapy regimen.¹

Combination regimen of erlotinib with carboplatin and paclitaxel or with gemcitabine and cisplatin not effective as first-line therapy† for the treatment of locally advanced or metastatic non-small cell lung cancer;^{1 4 5} use in this setting not recommended.¹

Pancreatic Cancer

Used in combination with gemcitabine for first-line treatment of locally advanced, unresectable or metastatic pancreatic cancer.¹

Tarceva Dosage and Administration

Administration

Oral Administration

Administer orally once daily, at least 1 hour before or 2 hours after ingestion of food.¹

Dosage

Available as erlotinib hydrochloride; dosage expressed in terms of erlotinib.¹

Adults

Non-small Cell Lung Cancer

Second-line or Subsequent Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Oral

150 mg once daily.¹ Continue therapy until disease progression or unacceptable toxicity occurs; once disease progression occurs, there is no evidence that continued therapy is beneficial.¹ In principal efficacy study, therapy was continued for a median of 9.6 weeks.²

Pancreatic Cancer

First-line Therapy of Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

Oral

100 mg once daily, in combination with gemcitabine (1 g/m² IV once weekly [for 7 consecutive weeks of an 8-week cycle and thereafter for 3 consecutive weeks of a 4-week cycle]).¹ Continue therapy until disease progression or unacceptable toxicity occurs.¹

Dosage Modification for Toxicity

When dosage reduction is required, reduce dosage in 50-mg decrements.¹

Pulmonary Toxicity

Interrupt therapy pending diagnostic evaluation upon acute onset of new or progressive pulmonary manifestations.¹ Discontinue if interstitial lung disease is diagnosed.¹ (See Pulmonary Toxicity under Cautions.)

Dehydration and/or Renal Toxicity

Interrupt therapy and take appropriate measures to intensively rehydrate patient if dehydration occurs, particularly in patients at risk for renal failure.¹ (See Renal Failure under Cautions.)

Hepatic Toxicity

Consider interruption of therapy or dosage reduction with frequent monitoring of liver function tests if worsening of liver function test results occurs; consider such action before severe changes in test results occur.¹

Interrupt or discontinue therapy if severe changes in liver function test results occur in patients with normal hepatic function prior to treatment.^{1 8} (See Hepatic Toxicity under Cautions.)

Discontinue therapy if hepatic failure occurs.¹

GI Toxicity

Permanently discontinue therapy if GI perforation occurs.^{1 10}

Consider dosage reduction or temporary interruption of therapy if severe diarrhea (unresponsive to loperamide or resulting in dehydration) occurs.¹

Dermatologic Toxicity

Interrupt or discontinue therapy if severe bullous, blistering, or exfoliative reaction occurs.^{1 10}

Ocular Toxicity

Interrupt or discontinue therapy if acute or worsening ocular toxicity (e.g., eye pain) occurs.^{1 10}

Special Populations

Hepatic Impairment

Consider interruption or discontinuance of therapy if severe adverse effects occur.¹ (See Hepatic Impairment under Cautions.)

Geriatric Patients

No dosage adjustment required.¹

Cautions for Tarceva

Contraindications

• 
  

  No known contraindications according to manufacturer.¹

  
  

Warnings/Precautions

Pulmonary Toxicity

Serious, sometimes fatal, interstitial lung disease-like events reported, usually developing between 5 days to >9 months (median: 39 days) after initiating therapy.¹ Often associated with concomitant or prior chemotherapy, prior radiotherapy, preexisting parenchymal lung disease, metastatic lung disease, or pulmonary infections.¹

If acute onset of new or progressive pulmonary manifestations (e.g., dyspnea, cough, fever) occurs, interrupt therapy pending diagnostic evaluation.¹ If interstitial lung disease is diagnosed, discontinue erlotinib and institute appropriate treatment.¹

Renal Failure

Hepatorenal syndrome or acute renal failure, sometimes fatal, and renal insufficiency, with or without hypokalemia, have been reported.¹ Risk factors include baseline hepatic impairment; severe dehydration caused by diarrhea, vomiting, and/or anorexia; and concurrent chemotherapy.¹

If dehydration occurs, interrupt erlotinib therapy and initiate intensive rehydration measures, particularly in patients at risk for renal failure (e.g., those with preexisting renal disease, medical conditions or drugs that may lead to renal disease, or other predisposing conditions such as advanced age).¹

Periodically monitor renal function and serum electrolytes in patients at risk of dehydration.¹

Hepatic Toxicity

Hepatic failure and hepatorenal syndrome, sometimes fatal, have occurred, particularly in patients with hepatic impairment prior to treatment.¹ (See Hepatic Impairment under Cautions.)

Periodically monitor liver function tests (i.e., serum transaminase, bilirubin, and alkaline phosphatase concentrations).¹ In patients with worsening liver function test results, consider interruption of therapy or dosage reduction with frequent monitoring of liver function tests before changes become severe.¹ If liver function changes are severe (e.g., total bilirubin >3 times ULN and/or serum aminotransferase concentrations >5 times ULN in patients with normal pretreatment values), interrupt or discontinue therapy.¹ If hepatic failure occurs, discontinue therapy.¹

GI Perforation

GI perforation, sometimes fatal, has occurred.^{1 10} Often associated with history of peptic ulcer disease or diverticulitis and concomitant therapy with antiangiogenesis drugs, corticosteroids, NSAIAs, and/or taxane-based chemotherapy.^{1 10} If perforation occurs, permanently discontinue therapy.^{1 10}

Bullous and Exfoliative Skin Disorders

Bullous, blistering, and exfoliative skin reactions, including cases suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis, have occurred; sometimes fatal.^{1 10} If such reactions are severe, interrupt or discontinue therapy.^{1 10}

Myocardial Infarction/Ischemia

Among patients receiving erlotinib and gemcitabine for pancreatic cancer in a randomized trial, 6 patients (2.3%) experienced myocardial infarction/ischemia; one of these patients died.¹

Cerebrovascular Accident

Among patients receiving erlotinib and gemcitabine for pancreatic cancer in a randomized trial, 6 patients (2.3%) experienced cerebrovascular accidents, including one fatal hemorrhagic stroke.¹

Microangiopathic Hemolytic Anemia with Thrombocytopenia

Among patients receiving erlotinib and gemcitabine for pancreatic cancer in a randomized trial, 2 patients (0.8%) developed microangiopathic hemolytic anemia with thrombocytopenia.¹

Corneal Ulceration or Perforation

Corneal ulceration and perforation reported.^{1 10} Abnormal eyelash growth (e.g., ingrowing eyelashes, excessive growth, thickening of eyelashes), keratoconjunctivitis sicca (i.e., dry eye), and keratitis also reported and are potential risk factors for corneal ulceration or perforation.^{1 10} If acute or worsening ocular toxicity (e.g., eye pain) occurs, interrupt or discontinue therapy.^{1 10}

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; embryolethality demonstrated in animals.¹ Avoid pregnancy during therapy.¹ (See Advice to Patients.) If used during pregnancy, apprise of potential fetal hazard or risk for loss of the pregnancy.¹

Rash

Rash reported frequently.¹ Median time to onset is 8–10 days.¹ Typically is erythematous and maculopapular; may resemble acne with follicular pustules but is histopathologically different.¹ Commonly occurs on the face, upper chest, and back, but may be more generalized or severe (grade 3 or 4) with desquamation.¹ (See Bullous and Exfoliative Skin Disorders under Cautions.)

Based on severity, management may include use of topical corticosteroids or topical anti-infectives with anti-inflammatory properties.¹ (See Advice to Patients.) Dosage reduction or drug discontinuance required in some patients.¹

Diarrhea

Diarrhea frequently reported, including grade 3/4 diarrhea.¹ Median time to onset is 12–15 days.¹

Manage diarrhea with loperamide.¹ If diarrhea becomes severe and is unresponsive to loperamide or results in dehydration, consider reducing erlotinib dosage or temporarily interrupting therapy.¹

Elevated INR and Bleeding

Increased INR and infrequent bleeding (including GI and non-GI bleeding) reported; some of these patients were receiving concomitant warfarin or NSAIA therapy.¹ (See Interactions.)

Therapy Monitoring

Periodically monitor liver function tests (i.e., serum transaminases, bilirubin, and alkaline phosphatase).¹

Periodically monitor renal function and serum electrolytes in patients at risk of dehydration.¹

Specific Populations

Pregnancy

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

Lactation

Not known whether distributed into milk.¹ Discontinue nursing or the drug because of potential risk to nursing infants.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 2}

Geriatric Use

In clinical trial of erlotinib monotherapy for non-small cell lung cancer, no overall differences in safety and efficacy relative to younger adults.¹

In clinical trial for pancreatic cancer, survival benefit for erlotinib/gemcitabine versus placebo/gemcitabine was less clear in geriatric patients; no meaningful differences in safety or pharmacokinetics relative to younger adults.¹

Hepatic Impairment

Use with caution since erlotinib undergoes hepatic metabolism and biliary excretion;¹ extreme caution advised in patients with severe hepatic impairment (total bilirubin >3 times ULN).^{1 8} Close monitoring required in patients with total bilirubin exceeding ULN or Child-Pugh class A, B, or C.^{1 8} (See Special Populations under Pharmacokinetics.)

If worsening of liver dysfunction occurs, consider interruption of therapy or dosage reduction accompanied by frequent monitoring of liver function tests before changes in liver function become severe.¹ If severe changes in liver function test results (e.g., doubling of bilirubin, tripling of serum aminotransferase concentrations) occur in patients with hepatic dysfunction prior to treatment, interrupt or discontinue therapy.^{1 8}

Renal Impairment

Safety and efficacy not established.¹

Common Adverse Effects

Erlotinib monotherapy for non-small cell lung cancer: Rash,¹ diarrhea,¹ anorexia,¹ fatigue,¹ dyspnea,¹ cough,¹ nausea,¹ infection,¹ vomiting,¹ stomatitis,¹ pruritus,¹ dry skin,¹ conjunctivitis,¹ keratoconjunctivitis sicca,¹ abdominal pain.¹

Erlotinib and gemcitabine for pancreatic cancer: Fatigue,¹ rash,¹ nausea,¹ anorexia,¹ diarrhea,¹ abdominal pain,¹ vomiting,¹ decreased weight,¹ infection,¹ edema,¹ pyrexia,¹ constipation.¹

Interactions for Tarceva

Extensively metabolized by CYP isoenzymes, principally CYP3A4 and, to a lesser extent, CYP1A1 and CYP1A2.¹

Drugs and Foods Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma erlotinib concentrations).¹ Caution when used concomitantly with potent CYP3A4 inhibitors.¹ Consider reducing erlotinib dosage if severe adverse effects occur.¹ (See Specific Drugs and Foods under Interactions.)

Inhibitors of CYP3A4 and CYP1A2: Potential pharmacokinetic interaction (increased plasma erlotinib concentrations).¹ Consider reducing erlotinib dosage if severe adverse effects occur.¹ (See Specific Drugs and Foods under Interactions.)

Inducers of CYP3A4: Potential pharmacokinetic interaction (increased erlotinib clearance, resulting in decreased plasma erlotinib concentrations).¹ Avoid concomitant use.¹ If concomitant use cannot be avoided, consider increasing erlotinib dosage as tolerated at 2-week intervals with close monitoring; if the CYP3A4 inducer is discontinued, immediately reduce erlotinib dosage to the recommended starting dosage.¹ (See Specific Drugs and Foods under Interactions.)

Drugs Affecting Gastric Acidity

Pharmacokinetic interaction (decreased solubility and reduced oral bioavailability of erlotinib) with drugs that increase pH of upper GI tract (e.g., proton-pump inhibitors, histamine H₂-receptor antagonists).¹ (See Specific Drugs and Foods under Interactions.)

Specific Drugs and Foods

Drug or Food	Interaction	Comments
Antacids	Effect of antacids on erlotinib disposition not established1	Although effects on erlotinib not established, antacids may be considered as an alternative to histamine H2-receptor antagonists or proton-pump inhibitors; if use is necessary, separate antacid dose and erlotinib dose by several hours1
Antifungals, azoles (e.g., itraconazole, ketoconazole, voriconazole)	Possible increased plasma erlotinib concentrations; ketoconazole increased erlotinib AUC1	Use concomitantly with caution; consider reducing erlotinib dosage if severe adverse effects occur1
Antimycobacterials, rifamycins (e.g., rifabutin, rifampin, rifapentine)	Possible decreased plasma erlotinib concentrations1 Rifampin increased erlotinib clearance, resulting in decreased plasma erlotinib concentrations1	Avoid concomitant use; if concomitant use cannot be avoided, consider increasing erlotinib dosage as tolerated at 2-week intervals with close monitoring; if the rifamycin is discontinued, immediately reduce erlotinib dosage to recommended starting dosage1 Maximum erlotinib dose studied in combination with rifampin: 450 mg1
Carbamazepine	Possible decreased plasma erlotinib concentrations1	Avoid concomitant use; if concomitant use cannot be avoided, consider increasing erlotinib dosage as tolerated at 2-week intervals with close monitoring; if carbamazepine is discontinued, immediately reduce erlotinib dosage to recommended starting dosage1
Cigarette smoking	Decreased systemic exposure to erlotinib1	Advise patients to stop smoking1 If patient continues to smoke, consider increasing erlotinib dose (maximum 300 mg) with close monitoring; efficacy and safety of dosages exceeding the recommended starting dosage not established in smokers beyond 14 days1 Upon cessation of smoking, immediately reduce erlotinib dosage to recommended starting dosage1
Ciprofloxacin	Increased plasma erlotinib concentrations1	Use concomitantly with caution; consider reducing erlotinib dosage if severe adverse effects occur1
Clarithromycin	Possible increased plasma erlotinib concentrations1	Use concomitantly with caution; consider reducing erlotinib dosage if severe adverse effects occur1
Gemcitabine	Pharmacokinetic interaction unlikely1
Grapefruit or grapefruit juice	Possible increased plasma erlotinib concentrations1	Use concomitantly with caution; consider reducing erlotinib dosage if severe adverse effects occur1
Histamine H2-receptor antagonists	Decreased solubility and oral bioavailability of erlotinib1	Antacids may be considered as an alternative, but effect on erlotinib disposition not studied1 (see antacids entry in table)
HIV protease inhibitors (e.g., atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)	Possible increased plasma erlotinib concentrations1	Use concomitantly with caution; consider reducing erlotinib dosage if severe adverse effects occur1
Midazolam	Decreased systemic exposure to midazolam1
Nefazodone	Possible increased plasma erlotinib concentrations1	Use concomitantly with caution; consider reducing erlotinib dosage if severe adverse effects occur1
Phenobarbital	Possible decreased plasma erlotinib concentrations1	Avoid concomitant use; if concomitant use cannot be avoided, consider increasing erlotinib dosage as tolerated at 2-week intervals with close monitoring; if phenobarbital is discontinued, immediately reduce erlotinib dosage to recommended starting dosage1
Phenytoin	Possible decreased plasma erlotinib concentrations1	Avoid concomitant use; if concomitant use cannot be avoided, consider increasing erlotinib dosage as tolerated at 2-week intervals with close monitoring; if phenytoin is discontinued, immediately reduce erlotinib dosage to recommended starting dosage1
Proton-pump inhibitors	Decreased solubility and oral bioavailability of erlotinib1	If possible, avoid concomitant use1 Increasing erlotinib dosage is not likely to compensate for the decrease in systemic exposure; separation of doses may not eliminate the interaction because of prolonged effect of proton-pump inhibitors on gastric pH1 Antacids may be considered as an alternative, but effect on erlotinib disposition not studied1 (see antacids entry in table)
St. John’s wort (Hypericum perforatum)	Possible decreased plasma erlotinib concentrations1	Avoid concomitant use; if concomitant use cannot be avoided, consider increasing erlotinib dosage as tolerated at 2-week intervals with close monitoring; if St. John's wort is discontinued, immediately reduce erlotinib dosage to recommended starting dosage1
Telithromycin	Possible increased plasma erlotinib concentrations1	Use concomitantly with caution; consider reducing erlotinib dosage if severe adverse effects occur1
Troleandomycin	Possible increased plasma erlotinib concentrations1	Use concomitantly with caution; consider reducing erlotinib dosage if severe adverse effects occur1
Warfarin or other coumarin-derivative anticoagulants	Increased INR and possible bleeding (including GI and non-GI bleeding)1 2	Monitor PT or INR regularly1

Tarceva Pharmacokinetics

Absorption

Bioavailability

Approximately 60% absorbed from the GI tract.¹

Peak plasma concentrations occur at 4 hours following oral administration.¹

Food

Presence of food in the GI tract increases oral bioavailability to almost 100%.¹

Distribution

Plasma Protein Binding

Approximately 93% (mainly to albumin and α₁-acid glycoprotein).¹

Elimination

Metabolism

Extensively metabolized by CYP isoenzymes, principally CYP3A4 and, to a lesser extent, CYP1A1 and CYP1A2.¹

Elimination Route

Excreted mainly as metabolites in feces (83%) via biliary excretion and in urine (8%).¹

Half-life

Approximately 36 hours.¹

Special Populations

Clearance rate is approximately 24% higher in smokers.¹

Although erlotinib is eliminated mainly by the liver, systemic exposure was not substantially altered in patients with Child-Pugh class B hepatic impairment relative to those with adequate hepatic function (including individuals with primary liver cancer or hepatic metastases).¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Antineoplastic agent; a kinase inhibitor.¹

  
  


• 
  

  Exact mechanism of antineoplastic activity not fully elucidated.¹ Appears to inhibit intracellular phosphorylation of tyrosine kinase associated with epidermal growth factor receptor (EGFR), which is expressed on the surface of normal and cancer cells.¹ Specificity with regard to other tyrosine kinase receptors not fully characterized.¹

  
  

Advice to Patients

• 
  

  Risk of adverse pulmonary, dermatologic, GI, or ocular effects.¹ Importance of seeking medical advice promptly if the following manifestations occur: new onset or exacerbation of unexplained shortness of breath or cough; onset or exacerbation of rash; severe or persistent diarrhea, nausea, anorexia, or vomiting; or ocular pain or irritation.¹

  
  


• 
  

  Importance of skin care (e.g., alcohol-free emollient cream, use of sunscreen or avoidance of sun exposure), to minimize the risk of skin reactions; avoidance of acne preparations with drying properties, which may aggravate dry skin and erythema.¹

  
  


• 
  

  Advise smokers to stop smoking; smoking may reduce efficacy of erlotinib.¹ (See Specific Drugs and Foods under Interactions.)

  
  


• 
  

  Importance of women using an effective method of contraception during and for at least 2 weeks after discontinuance of therapy.¹ If pregnancy occurs, advise patient of risk to the fetus.¹

  
  


• 
  

  Importance of women informing clinicians if they plan to breast-feed.¹

  
  


• 
  

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

  
  


• 
  

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

  
  

Preparations

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

Erlotinib Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	25 mg (of erlotinib)	Tarceva	Genentech
		100 mg (of erlotinib)	Tarceva	Genentech
		150 mg (of erlotinib)	Tarceva	Genentech

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.

Tarceva 100MG Tablets (GENENTECH): 30/$4153.17 or 90/$12258.63

Tarceva 150MG Tablets (GENENTECH): 30/$4721.64 or 90/$13865.33

Tarceva 25MG Tablets (GENENTECH): 30/$1523.87 or 90/$4454.7

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 October 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. Genentech. Tarceva (erlotinib) tablets prescribing information. South San Francisco, CA; 2009 Apr.

2. Genentech, South San Francisco, CA: Personal communication.

3. Shepherd FA, Pereira J, Ciuleanu TE et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005; 353: 123-32.

4. Herbst RS, Prager D, Hermann R et al. TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2005; 23:5892-9. [PubMed 16043829]

5. Gatzemeier U, Pluzanska A, Szczesna A et al. Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: the Tarceva Lung Cancer Investigation Trial. J Clin Oncol. 2007; 25:1545-52. [PubMed 17442998]

6. Moore MJ, Goldstein D, Hamm J et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007; 25:1960-6. [PubMed 17452677]

7. Makris D, Scherpereel A, Copin MC et al. Fatal interstitial lung disease associated with oral erlotinib therapy for lung cancer. BMC Cancer. 2007; 7:150. [PubMed 17683587]

8. Witt K, Barron H. Dear healthcare provider letter: important safety information regarding the use of Tarceva (erlotinib) in patients with hepatic impairment and other safety-related updates. South San Francisco, CA: Genentech/Melville, NY: OSI Pharmaceuticals; 2008 Sep.

10. Witt K, Barron H. Dear healthcare provider letter: important safety information regarding GI perforations, serious skin toxicity, and ocular disorders with the use of Tarceva (erlotinib). South San Franciso, CA: Genentech/Melville, NY: OSI Pharmaceuticals; 2009 Apr.

More Tarceva resources

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

• Tarceva Prescribing Information (FDA)


• Tarceva Consumer Overview


• Tarceva Advanced Consumer (Micromedex) - Includes Dosage Information


• Tarceva MedFacts Consumer Leaflet (Wolters Kluwer)


• Erlotinib Professional Patient Advice (Wolters Kluwer)

Compare Tarceva with other medications

• Non-Small Cell Lung Cancer
• Pancreatic Cancer
• Renal Cell Carcinoma

Mucopolysaccharidosis Type I Medications

Drugs associated with Mucopolysaccharidosis Type I

The following drugs and medications are in some way related to, or used in the treatment of Mucopolysaccharidosis Type I. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Aldurazyme

Lazer Creme (obsolete) topical

Generic Name: vitamins A, D, and E (topical) (VYE ta mins A, D, and E TOP i kal)

Brand Names: A & D, Aloe Grande, Lazer Creme (obsolete), Vita-Ray, Vitamin A & D, Topical

What is Lazer Creme (obsolete) (vitamins A, D, and E (topical))?

Vitamins A, D, and E topical (for the skin) is a skin protectant. It works by moisturizing and sealing the skin, and aids in skin healing.

This medication is used to treat diaper rash, dry or chafed skin, and minor cuts or burns.

Vitamins A, D, and E may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Lazer Creme (obsolete) (vitamins A, D, and E (topical))?

You should not use this medication if your child is allergic to it. Do not apply vitamins A, D, and E topical without a rubber glove or finger cot if you are allergic this medication.

Ask a doctor or pharmacist if it is safe for you to use this medication on your child if the child is allergic to any medicines or skin products, including soaps, oils, lotions, or creams.

Stop using the medication and call your doctor at once if your child has a serious side effect such as warmth, redness, oozing, or severe irritation where the medicine is applied.

Keep the baby's diaper area as dry as possible. Change wet or soiled diapers immediately to keep wetness and bacteria from irritating the baby's skin. Always put on a new diaper when the baby first wakes up in the morning, and also just before putting the baby to bed each night.

What should I discuss with my health care provider before using Lazer Creme (obsolete) (vitamins A, D, and E (topical))?

You should not use this medication if your child is allergic to it. Do not apply vitamins A, D, and E topical without a rubber glove or finger cot if you are allergic this medication.

Ask a doctor or pharmacist if it is safe for you to use this medication on your child if the child is allergic to any medicines or skin products, including soaps, oils, lotions, or creams.

How should I use Lazer Creme (obsolete) (vitamins A, D, and E (topical))?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Keep the baby's diaper area as dry as possible. Change wet or soiled diapers immediately to keep wetness and bacteria from irritating the baby's skin. Always put on a new diaper when the baby first wakes up in the morning, and also just before putting the baby to bed each night.

At each diaper changing, clean the baby's skin thoroughly with a disposable baby wipe or clean wet washcloth. Gently wipe inside the skin folds between the thighs and genitals.

When cleaning the diaper area of a boy, gently clean under the scrotum and beneath the foreskin of the penis. When cleaning the diaper area of a girl, always wipe from front.

Call your doctor if symptoms do not improve, or if they get worse after 1 week of treatment.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if any accidentally swallows this medicine.

What should I avoid while using Lazer Creme (obsolete) (vitamins A, D, and E (topical))?

Avoid using other medications on the areas you treat with vitamins A, D, and E topical unless you doctor tells you to.

Avoid excessive wetness of the skin areas you are treating. Keep clothing and diapers as dry as possible.

Lazer Creme (obsolete) (vitamins A, D, and E (topical)) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using the medication and call your doctor at once if your child has a serious side effect such as warmth, redness, oozing, or severe irritation where the medicine is applied.

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 Lazer Creme (obsolete) (vitamins A, D, and E (topical))?

It is not likely that other drugs you take orally or inject will have an effect on topically applied vitamins A, D, and E. But many drugs can interact with each other. 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 Lazer Creme (obsolete) resources

• Lazer Creme (obsolete) Support Group
• 0 Reviews for Lazer Creme (obsolete) - Add your own review/rating

Compare Lazer Creme (obsolete) with other medications

• Diaper Rash

Where can I get more information?

• Your pharmacist can provide more information about vitamins A, D, and E topical.

Fluarix

Generic Name: influenza virus vaccine (Intradermal route, Intramuscular route)

in-floo-EN-za VYE-rus VAX-een (sub-VEER-ee-on)

Commonly used brand name(s)

In the U.S.

• Afluria


• Fluarix


• Flulaval


• Fluvirin


• Fluzone


• Fluzone High-Dose


• Fluzone Pediatric

Available Dosage Forms:

• Suspension


• Solution

Therapeutic Class: Vaccine

Uses For Fluarix

Influenza virus vaccine is used to prevent infection by the influenza viruses. The vaccine works by causing your body to produce its own protection (antibodies) against the disease. It is also known as a “flu shot”.

There are many kinds of influenza viruses, but not all will cause problems in any given year. Therefore, before the influenza vaccine is produced each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses will most likely cause influenza infections for that year. The antigens, which are substances that cause protective antibodies to be formed, for these viruses are included in the influenza vaccine. Usually, the U.S. and Canada use the same influenza vaccine; however, they are not required to do so.

It is necessary to receive an influenza vaccine injection each year, since influenza infections are usually caused by different kinds of viruses and the protection gained by the vaccine lasts less than a year.

Influenza is a virus infection of the throat, bronchial tubes, and lungs. Influenza infection causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. In addition, adults and children weakened by other diseases or medical conditions, and persons 50 years of age and over, even if they are healthy, may get a much more serious illness that may have to be treated in a hospital. Each year thousands of people die as a result of an influenza infection.

The best way to help prevent influenza infections is to get an influenza vaccination each year, usually in early November. Immunization (getting a vaccine) against influenza is approved for infants 6 months of age and older, all children, and all adults (including 65 years of age and older).

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using Fluarix

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, 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 Agriflu®, Flulaval™, Fluzone® High-Dose, or Fluzone® Intradermal in the pediatric population. Safety and efficacy have not been established.

Afluria® is not indicated in children younger than 5 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluvirin® in children younger than 4 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluarix® in children younger than 3 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluzone® in children younger than 6 months of age. 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 influenza virus vaccine in the elderly.

Appropriate studies have not been performed on the relationship of age to the effects of Fluzone® Intradermal in the geriatric population. Safety and efficacy have not been established.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to eggs, egg products, or chicken proteins, history of—Usually should not be used in patients with this condition.

• Bleeding problems (e.g., hemophilia, thrombocytopenia)—Use with caution. May have an increased risk of bleeding at the injection site.

• Guillain-Barré syndrome (GBS, a severe nerve and muscle problem), history of—Use with caution. May cause the symptoms of this condition to return.

• Illness with fever, moderate or severe—You may need to wait until you feel better before you receive the vaccine.

• Immune system problems from a disease or medicine—May not work as well in patients with this condition.

• Kanamycin, neomycin, or polymyxin allergy, history of—Only certain brands of the influenza vaccine can be used. Talk with your doctor about this.

Proper Use of influenza virus vaccine

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

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles or into your skin, usually in the shoulder area.

Sometimes there is not enough flu vaccine for everyone. If this happens and you are a healthy adult, you might need to wait until later in the flu season before getting your vaccination.

You need to get the flu vaccine every year to protect you from the flu.

Some children may need a second dose of the vaccine. If your child needs a second dose of this medicine, it is very important for your child to receive the second dose on schedule. If you must cancel the appointment, make another appointment as soon as possible.

Precautions While Using Fluarix

It is very important that your child return to your doctor’s office at the right time if your child needs a second dose of the vaccine. Be sure to notify your doctor of any side effects that occur after you or your child receive this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or troubled breathing after you get the injection.

Children who have received a certain brand of the influenza vaccine (Afluria®) have developed a fever and in some cases a fever with seizures. Talk with your doctor if you have concerns about this.

If you are very sick and have a high fever, you will probably need to wait until you are well before your receive this vaccine.

Influenza virus vaccine may not protect everyone who receives the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.

The tip cap of the prefilled syringe for certain brands of the injection (Agriflu®, Fluarix®, Fluvirin®, Fluzone®, Fluzone® High-Dose) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you receive this vaccine.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving Fluzone® Intradermal vaccine.

Make sure your doctor knows if you or your child are using a medicine or treatment that weakens your immune system, such as a steroid, radiation, or cancer treatment. This vaccine may not work as well if you are also using these medicines. Your doctor may still want you to get the vaccine because it can give you some protection.

Fluarix Side Effects

In 1976, a number of people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), which is a disease that may cause paralysis. Most of these people were over 25 years of age. Although only 10 out of every one million people who received the vaccine actually developed GBS, this number was 6 times higher than would normally have been expected. Most of the people who got GBS recovered completely.

It is assumed that the “swine flu” virus included in the 1976 vaccine caused the problem, but this has not been proven. Since that time, studies have shown that the risk of acquiring GBS from an influenza vaccine is very low (one out of every million people).

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:

More common

• Cough


• diarrhea


• fever


• headache


• irritability


• loss of appetite


• muscle aches


• redness of the eyes


• sneezing


• sore throat


• stuffy or runny nose


• vomiting

Less common

• Body aches or pain


• chills


• difficulty with breathing


• earache


• ear congestion


• loss of voice


• shivering


• swelling or puffiness of the face


• tightness in the chest


• unusual tiredness or weakness

Rare

• Difficulty with swallowing


• dizziness


• fast heartbeat


• hives


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• noisy breathing


• puffiness or swelling of the eyelids or around the eyes, lips, or tongue


• shortness of breath


• skin rash


• wheezing

Incidence not known

• Agitation


• back pain, sudden and severe


• back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, itching, lumps, numbness, scarring, soreness, stinging, tingling, ulceration, or warmth at the injection site


• blindness


• blistering, peeling, or loosening of the skin


• blood in the urine or stools


• blurred vision


• bruising, inflammation, rash, redness, swelling, tenderness, or pain at the injection site


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• burning, dry, or itching eyes


• change in color vision


• change in walking and balance


• chest pain


• clumsiness or unsteadiness


• cold, clammy skin


• coma


• confusion


• dark urine


• discharge or excessive tearing


• drowsiness


• dryness of the throat


• eye pain


• fainting


• fast, weak pulse


• feeling hot


• feeling of constant movement of self or surroundings


• feeling unusually cold


• general body swelling


• general feeling of discomfort or illness


• hallucinations


• inability to move the arms and legs


• increased sensitivity of the eyes to sunlight


• irritation


• joint pain, stiffness, or swelling


• lack or loss of strength


• large, flat, blue, or purplish patches in the skin


• lightheadedness


• mood or mental changes


• muscle weakness, sudden and progressing


• nausea


• nerve pain


• nosebleeds


• pain, redness, soreness, swelling, tenderness, or warmth on the skin


• painful knees and ankles


• paleness of the skin


• pinpoint red spots on the skin


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


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


• seizures


• sensation of spinning


• shakiness in the legs, arms, hands, or feet


• sores, ulcers, or white spots in the mouth or on the lips


• stabbing pain


• stiff neck


• stomach pain, soreness, or discomfort


• sweating


• swelling of the face, hands, or feet


• swelling of the mouth or throat


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• trouble with sleeping


• troubled breathing or swallowing


• unusual bleeding or bruising


• voice changes


• weakness of the muscles in your face


• yellowing of the eyes or skin

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:

Incidence not known

• Sleepiness or unusual drowsiness

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: Fluarix side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Fluarix resources

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

• Fluarix MedFacts Consumer Leaflet (Wolters Kluwer)


• Fluarix Consumer Overview


• Fluarix Prescribing Information (FDA)


• Afluria Prescribing Information (FDA)


• Afluria Consumer Overview


• Afluria MedFacts Consumer Leaflet (Wolters Kluwer)


• Agriflu MedFacts Consumer Leaflet (Wolters Kluwer)


• Agriflu Consumer Overview


• FluLaval MedFacts Consumer Leaflet (Wolters Kluwer)


• FluLaval Consumer Overview


• Flulaval Prescribing Information (FDA)


• Fluvirin Prescribing Information (FDA)


• Fluvirin MedFacts Consumer Leaflet (Wolters Kluwer)


• Fluzone Prescribing Information (FDA)


• Fluzone MedFacts Consumer Leaflet (Wolters Kluwer)


• Influenza Virus Vaccine Inactivated Monograph (AHFS DI)


• Influenza Virus Vaccine Live Intranasal Monograph (AHFS DI)

Compare Fluarix with other medications

• Influenza Prophylaxis

Impetex

Impetex may be available in the countries listed below.

Ingredient matches for Impetex

Chlorquinaldol

Chlorquinaldol is reported as an ingredient of Impetex in the following countries:

• Italy

Diflucortolone

Diflucortolone 21-valerate (a derivative of Diflucortolone) is reported as an ingredient of Impetex in the following countries:

• Italy

International Drug Name Search

Simple Linctus Sugar Free (Pinewood Healthcare)

1. Name Of The Medicinal Product

Simple Linctus Sugar Free

2. Qualitative And Quantitative Composition

Simple Linctus Sugar Free: Citric Acid Monohydrate 125 mg/5 ml equivalent to 114.29mg/5ml Anhydrous Citric Acid.

3. Pharmaceutical Form

Clear Pink Sugar Free Syrup

4. Clinical Particulars

4.1 Therapeutic Indications

For the management of a mild non-specific cough.

4.2 Posology And Method Of Administration

Adults: One 5 ml spoonful orally 3-4 times daily.

Children: Not appropriate

4.3 Contraindications

Not known

4.4 Special Warnings And Precautions For Use

This medicine contains maltitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None Known

4.6 Pregnancy And Lactation

No data available

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

Not Applicable

4.9 Overdose

Sufficient prolonged overdose of citric acid may cause erosion of the teeth and have a local irritant action.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Absorption: Citric Acid Monohydrate is absorbed after oral administration.

Distribution: Citric Acid is found naturally in the body and is widely distributed, about 70% of the citric acid in the body is in hard bone and this accounts for 1.5% of bone content.

Metabolic Reactions: It is an important intermediate in carbohydrate metabolism and its major role is in the tricarboxylic acid cycle (Krebs citric acid cycle); it is metabolised to carbon dioxide and water.

Excretion: Citric acid is normally excreted in the urine in amounts ranging from 0.4 to 1.5g daily and this amount is not increased unless very large doses are administered. The urinary excretion of citric acid is increased in alkaline urine

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol (E422)

Sodium Carboxymethylcellulose

Sodium Benzoate (E211)

Saccharin Sodium (E954)

Lycasin 80/55 (E965)

Ethanol (96%)

Anise Oil

Chloroform

Natural Red DI (E163)

Purified Water

6.2 Incompatibilities

Not appropriate

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Do not Store above 25°C.

6.5 Nature And Contents Of Container

Amber glass bottles with pilfer screw closure

High density Polyethylene with screw on closure

Pack sizes of 100ml, 125ml, and 200ml for Amber Glass Bottles

Pack size of 2000ml for High Density Polyethylene dispensary pack.

6.6 Special Precautions For Disposal And Other Handling

As with all medicines.

7. Marketing Authorisation Holder

Pinewood Laboratories Limited

Ballymacarbry

Clonmel

Co Tipperary

8. Marketing Authorisation Number(S)

PL 04917/0006

9. Date Of First Authorisation/Renewal Of The Authorisation

28 August 1991

10. Date Of Revision Of The Text

November 2008

Aerrane Inhalation Anesthetic

Dosage Form: FOR ANIMAL USE ONLY
AERRANE (isoflurane, USP) Inhalation Anesthetic For Use in Horses and Dogs

WARNING:  Not for use in horses intended for food

CAUTION:  Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Aerrane Inhalation Anesthetic Description

AERRANE (isoflurane, USP) is a nonflammable, nonexplosive general inhalation anesthetic agent.  Its chemical name is 1-chloro-2,2,2-trifluoroethyl difluoromethyl ether, and its structural formula is:

Each mL contains 99.9% isoflurane.


Some  physical constants are:

Molecular weight		184.5
Boiling point at 760 mmHg		48.5°C (uncorr.)
Refractive i n d e x n 20/D		1.2990-1.3005
Specific gravity 25°/25°C		1.496
Vapor pressure in mmHg**		20°C           238
		25°C           295
		30°C           367
		35°C           450

**Equation for vapor pressure calculation:

log10Pvap = A + B/T


          where: A = 8.056

          B = -1664.58

          T = °C + 273.16 (Kelvin)

Partition coefficients at 37°C

Water/gas	0.61
Blood/gas	1.43
Oil/gas	90.8
Partition coefficients at 25°C - rubber and plastic
Conductive rubber/gas	62.0
Butyl rubber/gas	75.0
Polyvinyl chloride/gas	110.0
Polyethylene/gas	~2.0
Polyurethane/gas	~1.4
Polyolefin/gas	~1.1
Butyl acetate/gas	~2.5
Purity by gas chromatography	>99.9%
Lower limit of flammability in oxygen or nitrous oxide at 9 joules/sec. and 23°C	None
Lower limit of flammability in oxygen or nitrous oxide at 900 joules/sec. and 23°C	Greater than useful concentration in anesthesia.

MAC (Minimum Alveolar Concentration) is 1.31% in horses1 and 1.28 in dogs6.


Isoflurane is a clear, colorless, stable liquid containing no additives or chemical stabilizers. Isoflurane has a mildly pungent, musty, ethereal odor. Samples stored in indirect sunlight in clear, colorless glass for five years, as well as samples directly exposed for 30 hours to a 2 amp, 115 volt, 60 cycle long wave U.V. light were unchanged in composition as determined by gas chromatography. Isoflurane in one normal sodium methoxide-methanol solution, a strong base, for over six months consumed essentially no alkali, indicative of strong base stability. Isoflurane does not decompose in the presence of soda lime (at normal operating temperatures), and does not attack aluminum, tin, brass, iron or copper.

Aerrane Inhalation Anesthetic - Clinical Pharmacology

AERRANE (isoflurane, USP) is an inhalation anesthetic. Inductionand recovery from anesthesia with isoflurane are rapid.2,5  The level of anesthesia may be changed rapidly with isoflurane. Isoflurane is a profound respiratory depressant. RESPIRATION MUST BE MONITORED CLOSELY IN THE HORSE AND DOG AND SUPPORTED WHEN NECESSARY. As anesthetic dose is increased, both tidal volume and respiratory rate decrease.3,6.  This depression is partially reversed by surgical stimulation, even at deeper levels of anesthesia.


Blood pressure decreases with induction of anesthesia but returns toward normal with surgical stimulation. Progressive increases in depth of anesthesia produce corresponding decreases in blood pressure; however, heart rhythm is stable and cardiac output is maintained with controlled ventilation and normal PaCO2 despite increasing depth of anesthesia. The hypercapnia which attends spontaneous ventilation during isoflurane anesthesia increases heart rate and raises cardiac output above levels observed with controlled ventilation.3 Isoflurane does not sensitize the myocardium to exogenously administered epinephrine in the dog.

Muscle relaxation may be adequate for intra-abdominal operations at normal levels of anesthesia. However, if muscle relaxants are used to achieve greater relaxation, it should be noted that: ALL COMMONLY USED MUSCLE RELAXANTS ARE MARKEDLY POTENTIATED WITH ISOFLURANE, THE EFFECT BEING MOST PROFOUND WITH THE NONDEPOLARIZING TYPE. Neostigmine reverses the effect of nondepolarizing muscle relaxants in the presence of isoflurane but does not reverse the direct neuromuscular depression of isoflurane.

INDICATIONS

AERRANE (isoflurane, USP) is used for induction and maintenance of general anesthesia in horses and dogs.

Contraindications

AERRANE (isoflurane, USP) is contraindicated in horses and dogs with known sensitivity to isoflurane or to other halogenated agents.

Warnings

Increasing depth of anesthesia with AERRANE (isoflurane, USP) may increase hypotension and respiratory depression. The electroencephalographic pattern associated with deep anesthesia is characterized by burst suppression, spiking, and isoelectric periods.4


Since levels of anesthesia may be altered easily and rapidly, only vaporizers producing predictable percentage concentrations of isoflurane should be used (see DOSAGE AND ADMINISTRATION).

The action of nondepolarizing relaxants is augmented by isoflurane. Less than the usual amounts of these drugs should be used. If the usual amounts of nondepolarizing relaxants are given, the time for recovery from myoneural blockade will be longer in the presence of isoflurane than in the presence of other commonly used anesthetics. Not for use in horses intended for food.

Precautions

AERRANE (isoflurane, USP), like some other inhalational anesthetics, can react with desiccated carbon dioxide (CO2) absorbents to produce carbon monoxide which may result in elevated carboxyhemoglobin levels in some patients. Case reports suggest that barium hydroxide lime and soda lime become desiccated when fresh gases are passed through the CO2 absorber cannister at high flow rates over many hours or days. When a clinician suspects that CO2 absorbent may be desiccated, it should be replaced before the administration of AERRANE.

Usage in Pregnancy:

Reproduction studies have been performed in mice and rats with no evidence of fetal malformation attributable to AERRANE (isoflurane, USP). Adequate data concerning the safe use of isoflurane in pregnant and breeding horses and dogs have not been obtained.

Adverse Reactions

Hypotension, respiratory depression and arrhythmias have been reported.

Overdosage

In the event of overdosage, or what may appear to be overdosage, the following action should be taken: Stop drug administration, establish that the airway is clear and initiate assisted or controlled ventilation with pure oxygen as circumstances dictate.

Aerrane Inhalation Anesthetic Dosage and Administration

Caution: Operating rooms should be provided with adequate ventilation to prevent the accumulation of anesthetic vapors.


Premedication: A premedication regimen, which may be employed depending upon the patient status, to avert excitement during induction, might include an anticholinergic, a tranquilizer, a muscle relaxant, and a short-acting barbiturate.

Inspired Concentration: The delivered concentration of AERRANE (isoflurane, USP) should be known. Isoflurane may be vaporized using a flow-through vaporizer specifically calibrated for isoflurane. Vaporizers delivering a saturated vapor which then is diluted (e.g., Vernitrol® Vaporizer) also may be used. The delivered concentration from such a vaporizer may be calculated using the formula: 

Isoflurane contains no stabilizer. Nothing in the drug product alters calibration or operation of these vaporizers.

Induction:

Horses: Inspired concentrations of 3.0 to 5.0% isoflurane alone with oxygen following a barbiturate anesthetic induction are usually employed to induce surgical anesthesia

in the horse.

Dogs: Inspired concentrations of 2.0 to 2.5% isoflurane alone with oxygen following a barbiturate anesthetic induction are usually employed to induce surgical anesthesia in the dog.

These concentrations can be expected to produce surgical anesthesia in 5 to 10 minutes.

Maintenance: The concentration of vapor necessary to maintain anesthesia is much less than that required to induce it.

Horses: Surgical levels of anesthesia in the horse may be sustained with a 1.5 to 1.8% concentration of isoflurane in oxygen.

Dogs: Surgical levels of anesthesia in the dog may be sustained with a 1.5 to 1.8% concentration of isoflurane in oxygen.


The level of blood pressure during maintenance is an inverse function of isoflurane concentration in the absence of other complicating problems. Excessive decreases, unless related to hypovolemia, may be due to depth of anesthesia and in such instances may be corrected by lightening the level of anesthesia. Recovery from isoflurane anesthesia is typically uneventful.2

How is Aerrane Inhalation Anesthetic Supplied

AERRANE (isoflurane, USP) is packaged in 100 mL and 250 mL

amber-colored bottles.

100 mL - NDC 10019-773-40

250 mL - NDC 10019-773-60

Storage

Store at room temperature 15°-30°C (59°-86°F).

REFERENCES

1. Steffey, E.P., Howland, D. Jr., Giri, S. and Eger, E.I.II. Enflurane,Halothane and Isoflurane Potency in Horses. Am. J. Vet. Res.1977; 38(7):1037-1039.


2. Auer, J.A., Garner, H.E., Amend, J.F., Hutcheson, D.P. and Salem, C.A. Recovery from Anesthesia in Ponies: A Comparative Study of the Effects of Isoflurane, Enflurane, Methoxyflurane and Halothane. Equine Vet. J. 1978; 10(1): 18-23.


3. Steffey, E.P., and Howland, D. Jr. Comparison of Circulatory and Respiratory Effects of Isoflurane and Halothane Anesthesia in Horses. Am. J. Vet. Res. 1980;41(5): 821-825.


4. Auer, J.A., Amend, J.F., Garner, H.E., Hutcheson, D.P. and Salem, C.A. Electroencephalographic Responses During Volatile Anesthesia in Domestic Ponies: A Comparative Study of Isoflurane, Enflurane, Methoxyflurane, and Halothane. Equine Practice 1979; 3: 130-134.


5. Klide, A.M. Cardiopulmonary Effects of Enflurane and Isoflurane in the Dog. Am. J. Vet. Res. 1976; Vol 37, No 2: 127-131.


6. Steffey, E.P., and Howland, D. Jr. Isoflurane Potency in the Dog and Cat. Am. J. Vet. Res. 1977; Vol 38, No 11: 1833-1836.
   

[NADA 135-773, Approved by FDA]

Baxter and AErrane are trademarks of Baxter International Inc.


 

Baxter logo

Manufactured for

Baxter Healthcare Corporation

Deerfield, IL 60015 USA


To report adverse reaction or obtain MSDS,

call 1 800 ANA DRUG (1-800-262-3784)

Revised: August 2006

400-226-08

PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

NDC 10019-773-40

AERRANE

(isoflurane, USP)

For Use In Horses and Dogs

Caution: Federal law restricts this drug

to use by or on order of

a licensed veterinarian.

[NADA 135-773, Approved by FDA]

Baxter logo

Manufactured for

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

400-224-07

A nonflammable, nonexplosive

inhalation anesthetic

Each mL container 99.9% isofurane.

Caution:Operating rooms should be pro-

vided with adequate ventilation to prevent the

accumulation of anesthetic vapors.

Store at room temperature 15°-30°C

(59°-86°F).

IMPORTANT: See package insert for dosage

and directions for use.

To report adverse reaction or obtain MSDS,

call 1 800 ANA DRUG (1-800-262-3784)

Baxter and Aerrane are trademarks of Baxter

International Inc.

100 mL

WARNING:

Not for Use

in horses

intended

for food.

N3 10019 77340 7

AERRANE

(isoflurane, USP)

NDC 10019-773-40

6 x 100 mL Bottles

For use in Horses and Dogs

Store at room temperature 15°-30°C (59°-86°F).

Exp 10 2007

Lot A111A111

(17) 071000(10) A111A111

(01) 5 0310019 77340 2(30) 0006

Mfd. for Baxter Healthcare Corporation, Deerfield, IL 60015 USA

0001

475-235-04

AERRANE  isoflurane  inhalant

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 10019-773 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Isoflurane (Isoflurane) Isoflurane 1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10019-773-40 100 mL In 1 BOTTLE, GLASS None 2 10019-773-60 250 mL In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA135773	07/25/2008

Labeler - BAXTER HEALTHCARE CORPORATION (005083209)

Establishment
Name	Address	ID/FEI	Operations
BAXTER HEALTHCARE SA, dba Baxter Healthcare of Puerto Rico		154731033	manufacture

Revised: 11/2010BAXTER HEALTHCARE CORPORATION

Icyfrot

Icyfrot may be available in the countries listed below.

Ingredient matches for Icyfrot

Methyl Salicylate

Methyl Salicylate is reported as an ingredient of Icyfrot in the following countries:

• Peru

International Drug Name Search

Xylocaine Topical Solution

Generic Name: lidocaine hydrochloride

Dosage Form: topical solution
Xylocaine

Topical Solution

Rx only

Xylocaine Topical Solution Description

4% Xylocaine (lidocaine HCl) Topical Solution contains a local anesthetic agent and is administered topically.  See INDICATIONS for specific uses.

4% Xylocaine Topical Solution contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula:

The 50 mL screw-cap bottle should not be autoclaved, because the closure employed cannot withstand autoclaving temperatures and pressures.  Composition of 4% Xylocaine (lidocaine HCl) Topical Solution:  Each mL contains lidocaine HCl, 40 mg, methylparaben, and sodium hydroxide and/or hydrochloric acid to adjust pH to 6.0–7.0.

An aqueous solution.  NOT FOR INJECTION.

Xylocaine Topical Solution - Clinical Pharmacology

Mechanism of Action

Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.

Hemodynamics

Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure.  These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system.

Pharmacokinetics and Metabolism

Lidocaine HCl may be absorbed following topical administration to mucous membranes, its rate of absorption and percent of dose absorbed depending upon concentration and total dose administered, the specific site of application and duration of exposure.  In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine HCl is well-absorbed from the gastrointestinal tract, but little intact drug appears in the circulation because of biotransformation in the liver.

Lidocaine HCl is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidney. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide.  The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine HCl.  Approximately 90% of lidocaine HCl administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged.  The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline.

The plasma binding of lidocaine HCl is dependent on drug concentration, and the fraction bound decreases with increasing concentration.  At concentrations of 1 to 4 mcg of free base per mL, 60 to 80 percent of lidocaine HCl is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein.

Lidocaine HCl crosses the blood-brain and placental barriers, presumably by passive diffusion.

Studies of lidocaine HCl metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine HCl is metabolized, any condition that affects liver function may alter lidocaine HCl kinetics.  The half-life may be prolonged two-fold or more in patients with liver dysfunction.  Renal dysfunction does not affect lidocaine HCl kinetics but may increase the accumulation of metabolites.

Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine HCl required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 mcg free base per mL.  In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for convulsive activity.

Indications and Usage for Xylocaine Topical Solution

4% Xylocaine (lidocaine HCl) Topical Solution is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.

Contraindications

Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of 4% Xylocaine Topical Solution.

Warnings

IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS, RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS MUST BE IMMEDIATELY AVAILABLE WHEN LOCAL ANESTHETIC AGENTS, SUCH AS LIDOCAINE HCl, ARE ADMINISTERED TO MUCOUS MEMBRANES.

4% Xylocaine Topical Solution should be used with extreme caution if there is sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.

Precautions

General

The safety and effectiveness of lidocaine HCl depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies.  Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use (see WARNINGS and ADVERSE REACTIONS).  The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects.  Repeated doses of lidocaine HCl may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient.  Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status. Lidocaine HCl should also be used with caution in patients with severe shock or heart block.

4% Xylocaine Topical Solution should be used with caution in patients with known drug sensitivities.  Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine HCl.

Although it has been shown that the rate of absorption of lidocaine HCl after spraying the laryngotracheal mucosa with a solution of the local anesthetic agent is normally relatively slow, there is the attendant risk that occasionally some of the solution may gravitate into the lower respiratory tract where surface area for absorption and tissue blood flow are markedly greater.  This can result in unexpectedly rapid and high blood levels, and this possibility must be kept in mind whenever 4% Xylocaine Topical Solution is administered.

Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia.  Since it is not known whether amide-type local anesthetics may trigger this reaction and since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for management should be available.  Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the suspect triggering agent(s) and institution of treatment, including oxygen therapy, indicated supportive measures and dantrolene (consult dantrolene sodium intravenous package insert before using).

Information for Patients

When topical anesthetics are used in the mouth, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration.  For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area.  This is particularly important in children because of their frequency of eating.

Numbness of the tongue or buccal mucosa may enhance the danger of unintentional biting trauma.  Food and chewing gum should not be taken while the mouth or throat area is anesthetized.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of lidocaine HCl in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Use in Pregnancy

Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine HCl.  There are, however, no adequate and well-controlled studies in pregnant women.  Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine HCl to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

Labor and Delivery

Lidocaine HCl is not contraindicated in labor and delivery. Should 4% Xylocaine Topical Solution be used concomitantly with other products containing lidocaine HCl, the total dose being administered must be kept in mind.

Nursing Mothers

It is not known whether this drug is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when lidocaine HCl is administered to a nursing woman.

Pediatric Use

Dosages in children should be reduced, commensurate with age, body weight and physical condition (see DOSAGE AND ADMINISTRATION).

Adverse Reactions

Adverse experiences following the administration of lidocaine HCl are similar in nature to those observed with other amide local anesthetic agents.  These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.  Serious adverse experiences are generally systemic in nature.  The following types are those most commonly reported:

Central Nervous System

CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest.  The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine HCl is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

Cardiovascular System

Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.

Allergic

Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to other ingredients in the formulation.  Allergic reactions as a result of sensitivity to lidocaine HCl are extremely rare and, if they occur, should be managed by conventional means.  The detection of sensitivity by skin testing is of doubtful value.

Overdosage

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics (see ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS).

Management of Local Anesthetic Emergencies

The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic administration.  At the first sign of change, oxygen should be administered.

The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously.  Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously.  The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (eg, ephedrine).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.

Dialysis is of negligible value in the treatment of acute overdosage with lidocaine HCl.

The intravenous LD50 of lidocaine HCl in female mice is 26 (21 to 31) mg/kg and the subcutaneous LD50 is 264 (203 to 304) mg/kg.

Xylocaine Topical Solution Dosage and Administration

When 4% Xylocaine Topical Solution is used concomitantly with other products containing lidocaine HCl, the total dose contributed by all formulations must be kept in mind.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia.  The lowest dosage needed to provide effective anesthesia should be administered.  Dosages should be reduced for children and for elderly and debilitated patients.  The maximum dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight.  Although the incidence of adverse effects with 4% Xylocaine Topical Solution is quite low, caution should be exercised, particularly when employing large volumes, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

The dosages recommended below are for normal, healthy adults:

When used as a spray, or when applied by means of cotton applicators or packs, as when instilled into a cavity, the suggested dosage of 4% Xylocaine Topical Solution is 1 to 5 mL (40 to 200 mg lidocaine HCl), ie, 0.6 to 3 mg/kg or 0.3 to 1.5 mg/lb body weight.

NOTE: The solution may be applied with a sterile swab which is discarded after a single use.  When spraying, transfer the solution from the original container to an atomizer.

MAXIMUM RECOMMENDED DOSAGES

Normal Healthy Adults

The maximum recommended dose of 4% Xylocaine Topical Solution should be such that the dose of lidocaine HCl is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

Children

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight.  For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (eg, Clark’s rule).  For example, in a child of five years weighing 50 lbs, the dose of lidocaine HCl should not exceed 75 to 100 mg when calculated according to Clark’s rule.  In any case, the maximum dose of 4% Xylocaine Topical Solution with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight.  When used without epinephrine, the amount of 4% Xylocaine Topical Solution administered should be such that the dose is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

How is Xylocaine Topical Solution Supplied

4% Xylocaine (lidocaine HCl) Topical Solution NOT FOR INJECTION.

Product No.	NDC No.	Strength
491750	63323-497-50	4% (40 mg/mL)	50 mL screw-cap bottle, packaged individually.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

All trademarks are the property of APP Pharmaceuticals, LLC

Manufactured for:

451173

Revised: March 2009

PACKAGE LABEL - PRINCIPAL DISPLAY - Xylocaine® 50 mL Vial Label

NDC 63323-497-50

491750

Xylocaine® (lidocaine HCl)

4% Topical Solution

Not for Injection

50 mL

 

PACKAGE LABEL - PRINCIPAL DISPLAY - Xylocaine® 50 mL Carton Label

NDC 63323-497-50

491750

Xylocaine® (lidocaine HCl)

Topical Solution

4% (40 mg/mL)

Not for Injection

Rx only

50 mL

XYLOCAINE  lidocaine hydrochloride  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63323-497 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 40 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength METHYLPARABEN 1 mg  in 1 mL SODIUM HYDROXIDE   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63323-497-50 1 BOTTLE In 1 BOX contains a BOTTLE 1 50 mL In 1 BOTTLE This package is contained within the BOX (63323-497-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA010417	11/11/2009

Labeler - APP Pharmaceuticals, LLC (608775388)

Establishment
Name	Address	ID/FEI	Operations
AstraUSA, Inc		176500158	MANUFACTURE

Revised: 11/2009APP Pharmaceuticals, LLC

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