Tobramycin Injection

toe-bra-MYE-sin

Injection route(Solution)

Therapy has been associated with potential neurotoxicity, ototoxicity, and nephrotoxicity. Patients with impaired renal function, advanced age, dehydration, and those who receive high dosage or prolonged therapy are at an increased risk of toxicity. Monitor renal and auditory function during therapy and discontinue therapy or adjust dose if there is evidence of ototoxicity or nephrotoxicity. Aminoglycoside-induced ototoxicity is usually irreversible. Serum concentrations of aminoglycosides should be monitored periodically to assure adequate levels and to avoid potentially toxic levels. Concurrent use of other potentially neurotoxic or nephrotoxic agents, or potent diuretics should be avoided. Tobramycin should be used with caution in premature and neonatal infants because of their renal immaturity and the resulting prolongation of serum half-life of the drug. Aminoglycosides can cause fetal harm when administered to a pregnant woman .

Commonly used brand name(s)

In the U.S.

• Nebcin

Available Dosage Forms:

• Solution


• Powder for Solution

Therapeutic Class: Antibiotic

Chemical Class: Aminoglycoside

Uses For tobramycin

Tobramycin injection is used to treat serious bacterial infections in many different parts of the body.

Tobramycin belongs to the class of medicines known as aminoglycoside antibiotics. It works by killing bacteria or preventing their growth. However, tobramycin will not work for colds, flu, or other virus infections.

Tobramycin injection is usually used for serious bacterial infections for which other medicines may not work. However, it may also cause some serious side effects, including damage to your hearing, sense of balance, and kidneys. These side effects may be more likely to occur in elderly patients and newborn infants. You and your doctor should talk about the benefits of tobramycin as well as the risks.

tobramycin is to be administered only by or under the immediate supervision of your doctor.

Before Using tobramycin

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tobramycin 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tobramycin injection in children. However, tobramycin should be used with caution in premature and newborn infants.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tobramycin injection in the elderly. However, elderly patients are more likely to develop unwanted effects and to have kidney problems, which may require caution and an adjustment in the dose for patients receiving tobramycin injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

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

Interactions with Medicines

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

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

• Alcuronium


• Atracurium


• Cidofovir


• Cisatracurium


• Colistimethate Sodium


• Decamethonium


• Doxacurium


• Ethacrynic Acid


• Fazadinium


• Furosemide


• Gallamine


• Hexafluorenium


• Lysine


• Metocurine


• Mivacurium


• Pancuronium


• Pipecuronium


• Rapacuronium


• Rocuronium


• Succinylcholine


• Tacrolimus


• Tubocurarine


• Vancomycin


• Vecuronium

Using tobramycin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cisplatin


• Cyclosporine

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 tobramycin. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Sulfite allergy, history of—tobramycin contains sodium bisulfite which may cause an allergic reaction in patients with these conditions.

• Burns, extensive or


• Cystic fibrosis—Use with caution. Your doctor may need to change your dose if you have these conditions.

• Kidney disease—Higher blood levels of tobramycin may result, which increases the risk of serious side effects.

• Kidney disease, severe or


• Muscle problems or


• Myasthenia gravis (severe muscle weakness) or


• Nerve problems or


• Parkinson's disease—Use with caution. May make these conditions worse.

Proper Use of tobramycin

A nurse or other trained health professional will give you tobramycin. tobramycin is given as a shot into a muscle or into a vein. tobramycin should not be given into the eyes.

To help clear up your infection completely, keep using tobramycin for the full time of treatment, even if you begin to feel better after a few days. Also, tobramycin works best when there is a constant amount in the blood. To help keep the amount constant, you must receive tobramycin on a regular schedule.

To keep your kidneys working well and help prevent kidney problems, drink extra fluids so you will pass more urine while you are receiving tobramycin.

Precautions While Using tobramycin

Your doctor will check your progress closely while you or your child are receiving tobramycin. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood, urine, hearing, and nerve tests may be needed to check for unwanted effects. Electrolytes (e.g., calcium, magnesium, and potassium) in the blood should also be monitored by your doctor.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using tobramycin while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

tobramycin may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have blistering, peeling, or loosening of the skin; itching; hives; hoarseness; shortness of breath; sores, ulcers, or white spots in the mouth or on the lips; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive tobramycin.

Stop using tobramycin and check with your doctor right away if you or your child have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Tell your doctor if you or your child have dizziness or lightheadedness; feeling of constant movement of self or surroundings; or sensation of spinning. These may be symptoms of damage to your hearing or sense of balance.

Check with your doctor right away if you or your child have blood in the urine, change in frequency of urination or amount of urine, difficulty with breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of feet or lower legs, or weakness. These may be symptoms of a serious kidney problem.

tobramycin may cause nerve problems. Check with your doctor right away if you or your child have numbness, skin tingling, muscle twitching, or seizures.

Make sure your doctor knows that you or your child are using tobramycin before having a surgery or other procedures that require you to receive a numbing medicine (e.g., anesthetics, neuromuscular blocking agents). Using tobramycin injection together with numbing medicines may increase your risk of having difficulty in breathing, drowsiness, inability to breathe without assistance, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

tobramycin Side Effects

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

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

Incidence not known

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• chills


• cloudy urine


• clumsiness


• continuing ringing or buzzing or other unexplained noise in the ears


• cough


• cracks in the skin


• decrease in the amount of urine


• dizziness or lightheadedness


• feeling of constant movement of self or surroundings


• feeling of fullness in the ears


• fever


• loss of balance


• loss of heat from the body


• loss or change in hearing


• nausea


• pale skin


• pinpoint red spots on the skin


• red, swollen skin


• scaly skin


• sensation of spinning


• shortness of breath


• sore throat


• trouble in hearing


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unsteadiness


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting

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

Symptoms of overdose

• Inability to breath without assistance

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

• Confusion about identity, place, and time


• diarrhea


• headache


• hives or welts


• itching


• pain at the injection site


• redness of the skin


• skin rash


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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.

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.

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More tobramycin Injection resources

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Tamoxifen Citrate

Class: Antineoplastic Agents
VA Class: AN500
Chemical Name: 2-Hydroxy-1,2,3-propanetricarboxylate-(Z)-2-[4-(1,2-diphyl-1-butenyl)phenoxy]-N,Ndimethyl ethanamine
Molecular Formula: C₂₆H₂₉NO•C₆H₈O₇
CAS Number: 54965-24-1
Brands: Nolvadex

• 
  

  For women with ductal carcinoma in situ (DCIS) and women at high risk for breast cancer: serious and life-threatening events associated with tamoxifen in the risk reduction setting include uterine malignancies, stroke, and pulmonary embolism.^a Incidence rates for these events have been estimated from the NSABP P-1 trial (median length of follow-up 6.9 years).^a

  
  

  Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1000 women-years of 2.2 for tamoxifen versus 0.71 for placebo) and uterine sarcoma (incidence rate per 1000 women-years of 0.17 for tamoxifen versus 0 for placebo).

  
  

  For stroke, the incidence rate per 1000 women-years was 1.43 for tamoxifen versus 1 for placebo.^a

  
  

  For pulmonary embolism, the incidence rate per 1000 women-years was 0.75 for tamoxifen versus 0.25 for placebo.^a

  
  


• 
  

  Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer.^a

  
  


• 
  

  The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.^a

  
  

Introduction

A nonsteroidal estrogen agonist-antagonist; an antineoplastic agent.¹²⁸

Uses for Tamoxifen Citrate

Breast Cancer

An adjuvant to surgery and radiation therapy for the treatment of breast cancer in women with negative axillary lymph nodes and in postmenopausal women with positive axillary lymph nodes.^{110 121 128 130 133 136 194 195 196 198 204 205 253 254 258} Also reduces the occurrence of contralateral breast cancer in these women.^{128 253 254 258}

Reduction of risk of invasive breast cancer in patients with DCIS following surgery and radiation therapy.^a

Palliative treatment of metastatic breast cancer in men and women.¹²⁸ An alternative to ovarian ablative therapy (oopherectomy or radiation) in premenopausal women.^{128 133 158 159 160 161 162 163 164 165 166 167 168 169 183}

Reduction in the incidence of breast cancer in women at high risk for developing the disease.^{128 293}

Albright’s Syndrome

Has been used to reduce the frequency of vaginal bleeding episodes and to reduce the rate of increase in bone age in girls with Albright’s syndrome (McCune-Albright syndrome†) and precocious puberty.^a

Long-term effects not established.^a

Tamoxifen Citrate Dosage and Administration

General

• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.

  
  

Administration

Administered orally as a single daily dose or in divided doses; dosages exceeding 20 mg daily should be given in divided doses (morning and evening).¹²⁸

Initiate therapy during menstruation when used to reduce the incidence of breast cancer in sexually active women.^a In women with menstrual irregularity, a negative β-human chorionic gonadotropin test immediately prior to therapy is sufficient.^a

Dosage

Available as tamoxifen citrate; dosage expressed in terms of tamoxifen.¹²⁸

Adults

Breast Cancer

Adjuvant Therapy

Oral

20–40 mg daily.^{100 102 110 121 128 129 130 194 195 196 205} Current data from clinical studies support 5 years of adjuvant therapy.^{128 194 195 196 253 254 256 257 291 328}

Ductal Carcinoma in Situ

Oral

20 mg daily for 5 years.^a

Metastatic Breast Cancer

Oral

20–40 mg daily.¹²⁸

Reduction in the Incidence of Breast Cancer in Women at High Risk

Oral

20 mg daily for 5 years.^{128 270 284 291}

Prescribing Limits

Adults

Breast Cancer

Adjuvant Therapy

Oral

No evidence that dosages >20 mg daily are more effective.^{112 128}

Cautions for Tamoxifen Citrate

Contraindications

• 
  

  Known hypersensitivity to tamoxifen or any ingredient in the formulation.¹²⁸

  
  


• 
  

  When used in women with DCIS and women at high risk for breast cancer, history of DVT or pulmonary embolism.^a

  
  


• 
  

  When used in women with DCIS and women at high risk for breast cancer, concurrent anticoagulant therapy with a warfarin derivative.^{a 278 293 309}

  
  

Warnings/Precautions

Warnings

Hypercalcemia

Hypercalcemia reported in patients with metastatic breast cancer who have bone metastases.^{128 129} If hypercalcemia occurs, take appropriate measures; if severe, discontinue tamoxifen.¹²⁸

Effects on the Uterus

Increased incidence of uterine malignancies, sometimes fatal, reported.^{128 330} Most uterine malignancies have been classified as adenocarcinoma of the endometrium; rare uterine sarcomas also reported.^{128 330} (See Boxed Warning.) Gynecologic symptoms (i.e., menstrual irregularities, abnormal vaginal bleeding, changes in vaginal discharge, pelvic pain or pressure) should be promptly evaluated.^{128 163 183}

Endometrial changes, including hyperplasias and polyps, endometriosis and uterine fibroids reported.^{128 180 258 259 274} Ovarian cysts reported in a small number of premenopausal women with advanced breast cancer.¹²⁸

Cardiovascular Effects

Increased incidence of thromboembolic events, including DVT^{128 293} and pulmonary embolism; ^{269 270 293} stroke also reported.^{128 269 277 293} Some cases of stroke and pulmonary emboli have been fatal.¹²⁸ (See Boxed Warning.) Concomitant use with chemotherapy may increase incidence of these events.¹²⁸

Hepatic Effects

Liver cancer reported.¹²⁸

Changes in AST, ALT, bilirubin and/or alkaline phosphatase concentrations reported; severe hepatic abnormalities including fatty changes in the liver, cholestasis, hepatitis, and hepatic necrosis (some fatal) reported rarely.¹²⁸

Ocular Effects

Visual disturbances, decrement in color vision perception, corneal changes, cataracts, optic neuritis, retinal vein thrombosis, intraretinal crystals, posterior subcapsular opacities, and/or retinopathy reported.^{128 190 191 192 193 258 268 326}

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.¹²⁸ If inadvertently used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard, including possible long-term risk of a diethylstilbestrol-like syndrome.¹²⁸

General Precautions

Hematologic Effects

Thrombocytopenia, neutropenia, pancytopenia, and leukopenia reported; caution in patients with leukopenia or thrombocytopenia.¹²⁸ Periodic CBCs, including platelet count recommended.¹²⁸

Specific Populations

Pregnancy

Category D.¹²⁸ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether tamoxifen is distributed into milk.¹²⁸ Discontinue nursing or the drug because of potential risk to nursing infant.¹²⁸

Pediatric Use

Safety and efficacy in girls 2–10 years of age with Albright’s syndrome and precocious puberty not studied beyond 1 year; long-term effects not established and continued monitoring recommended.^a (See Special Populations under Pharmacokinetics.)

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.^a

Common Adverse Effects

Hot flashes, vaginal discharge, menstrual irregularities, weight loss.¹²⁸

Interactions for Tamoxifen Citrate

A substrate of CYP3A, 2C9, 2D6.^a

Effect of tamoxifen on drugs that require mixed function oxidases for activation unknown.^a

Cytotoxic Agents

Increased risk of thromboembolic events.¹²⁸

Specific Drugs

Drug	Interaction	Comments
Aminoglutethimide	Decreased plasma tamoxifen and N-desmethyltamoxifen concentrations128
Anticoagulants (e.g., warfarin)	Enhanced warfarin effects128 170 171 172	Careful monitoring of PT is recommended128 170 171 172 When used in women with DCIS or at high risk for breast cancer, concomitant use contraindicateda
Bromocriptine	Increased plasma tamoxifen and N-desmethyltamoxifen concentrations128
Cyclosporine	Competitively inhibited formation of N-desmethyltamoxifen in vitroa	Clinicial importance unknowna
Diltiazem	Competitively inhibited formation of N-desmethyltamoxifen in vitroa	Clinicial importance unknowna
Erythromycin	Competitively inhibited formation of N-desmethyltamoxifen in vitroa	Clinicial importance unknowna
Letrozole	Decreased plasma letrozole concentrationsa
Medroxyprogesterone	Decreased plasma N-desmethyltamoxifen concentrations but did not reduce plasma tamoxifen concentrationsa
Nifedipine	Competitively inhibited formation of N-desmethyltamoxifen in vitroa	Clinicial importance unknowna
Phenobarbital	Decreased plasma tamoxifen concentrations128	Clinical importance unknown128
Rifampin	Decreased plasma tamoxifen and N-desmethyltamoxifen concentrationsa

Tamoxifen Citrate Pharmacokinetics

Absorption

Bioavailability

Absorbed slowly following oral administration; peak serum concentrations of tamoxifen occur about 3–6 hours after a single dose.^{128 137 138 139 140 141}

Plasma Concentrations

Steady-state concentrations of tamoxifen are attained after 3–4 weeks and those of N-desmethyltamoxifen, an active metabolite, are attained after 3–8 weeks.^{128 137 140 143 145}

Distribution

Extent

Not fully characterized.¹²⁸

Not known whether tamoxifen is distributed into milk.¹²⁸

Elimination

Metabolism

Rapidly and extensively metabolized.^{26 28 140 142 143 144 145 146 148 149 150 151} The major metabolite, N-desmethyltamoxifen,^{128 140 143 144 145 146 148 150 151} has biologic activity similar to that of the parent drug.¹²⁸

Elimination Route

Excreted principally in feces as polar conjugates.¹²⁸

Half-life

Tamoxifen: 5–7 days.^{28 137 139 145}

N-Desmethyltamoxifen: 9–14 days.^{128 139 145}

Special Populations

Clearance higher in female children 2–10 years of age than in women; exposure to N-desmethyltamoxifen in these pediatric patients similar to adults.^a

Stability

Storage

Oral

Tablets

Well-closed, light-resistant containers 20–25°C.¹²⁸

ActionsActions

• 
  

  Acts as an estrogen antagonist on breast tissue and in the CNS and as an estrogen agonist on endometrium, bone, and lipids.³¹¹

  
  


• 
  

  In breast epithelial tissue, increases production of inhibitory factors and decreases production of stimulatory factors that influence breast cell growth.^{271 286 287 323}

  
  


• 
  

  Reduces bone resorption and bone turnover.^{265 266 267 316}

  
  


• 
  

  Decreases total and LDL-cholesterol concentrations.^{318 319 320} Less favorably, decreases HDL-cholesterol concentrations and increases triglyceride concentrations.^{318 319 320}

  
  


• 
  

  Acts as an estrogen agonist on the uterus and exhibits proliferative and tumor-promoting effects on the endometrium.³¹¹

  
  

Advice to Patients

• 
  

  Importance of receiving routine gynecologic care and of immediately informing clinician if any new breast lumps or abnormal gynecologic symptoms, including abnormal vaginal bleeding, change in vaginal discharge, menstrual irregularities, or pelvic pain/pressure occur.^{128 163 183}

  
  


• 
  

  Importance of informing clinician of any changes in vision.^{128 190 191 192 193 258 268}

  
  


• 
  

  Importance of immediately informing clinician of unexplained shortness of breath or leg swelling/tenderness.¹²⁸

  
  


• 
  

  Importance of periodic monitoring, including liver function test monitoring and blood counts.¹²⁸

  
  


• 
  

  Advise patients at high risk of breast cancer that tamoxifen may decrease the incidence of breast cancer, but may not eliminate the risk of the disease.¹²⁸

  
  


• 
  

  Importance of women informing clinicians immediately if they are or plan to become pregnant; importance of avoiding pregnancy during therapy;^{119 128 243} importance of using effective nonhormonal contraception while receiving tamoxifen and for 2 months after discontinuing the drug.^a Necessity of advising pregnant patients of the risk to the fetus.¹²⁸

  
  


• 
  

  Importance of reading the medication guide; the guide is for women using tamoxifen to lower their risk of breast cancer or with DCIS.¹²⁸

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹²⁸

  
  


• 
  

  Importance of women informing clinicians if they are or plan to breast-feed.¹²⁸

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹²⁸ (See Cautions.)

  
  

Preparations

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

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

Tamoxifen Citrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	10 mg (of tamoxifen)*	Nolvadex	AstraZeneca
			Tamoxifen Citrate Tablets	Aegis, Andrx, Barr, Mylan, Roxane, Teva
		20 mg (of tamoxifen)*	Nolvadex	AstraZeneca
			Tamoxifen Citrate Tablets	Aegis, Andrx, Barr, Mylan, Roxane, Teva

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.

Nolvadex 20MG Tablets (ASTRAZENECA): 30/$120.99 or 60/$239.98

Tamoxifen Citrate 20MG Tablets (TEVA PHARMACEUTICALS USA): 30/$21.99 or 90/$49.97

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 July 2006. 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

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

26. Fromson JM, Sharp DS. The selective uptake of tamoxifen by human uterine tissue. J Obstet Gynaecol Br Comm. 1974; 81:321-3.

28. Fromson JM, Pearson S. The metabolism of tamoxifen (I.C.I. 46,474). Part II: in female patients. Xenobiotica. 1973; 3:711-4. [PubMed 4783632]

100. Nolvadex Adjuvant Trial Organisation. Controlled trial of tamoxifen as adjuvant agent in management of early breast cancer: interim analysis at four years. Lancet. 1983; 1:257-61. [IDIS 164603] [PubMed 6130291]

101. Nolvadex Adjuvant Trial Organisation. Improved survival amongst patients treated with adjuvant tamoxifen after mastectomy for early breast cancer. Lancet. 1983; 2:450.

102. Ribeiro G, Palmer MK. Adjuvant tamoxifen for operable carcinoma of the breast: report of clinical trial by the Christie Hospital and Holt Radium Institute. BMJ. 1983; 286:827-30. [IDIS 168605] [PubMed 6403101]

103. Brinkley D. Adjuvant questions. BMJ. 1984; 288:1709-10. [PubMed 6428507]

104. Patterson JS, Battersby LA, Bach BK. Use of tamoxifen in advanced male breast cancer. Cancer Treat Rep. 1980; 64:801-4. [PubMed 7427964]

105. Becher R, Höffken K, Pape H et al. Tamoxifen treatment before orchiectomy in advanced breast cancer in men. N Engl J Med. 1981; 305:169-70. [IDIS 133415] [PubMed 7242589]

106. Hortobagyi GN, Distefano A, Legha SS et al. Hormonal therapy with tamoxifen in male breast cancer. Cancer Treat Rep. 1979; 63:539-41. [IDIS 112371] [PubMed 221118]

107. Stathopoulos GP, Karvountzis GG, Yiotis J. Tamoxifen in carcinoid syndrome. N Engl J Med. 1981; 305:52. [IDIS 133352] [PubMed 7231519]

108. Myers CF, Ershler WB, Tannenbaum MA et al. Tamoxifen and carcinoid tumor. Ann Intern Med. 1982; 96:383. [IDIS 146199] [PubMed 7059114]

109. Moertel CG, Engstrom PF, Schutt AJ. Tamoxifen therapy for metastatic carcinoid tumor: a negative study. Ann Intern Med. 1984; 100:531-2. [IDIS 183832] [PubMed 6200021]

110. Nolvadex Adjuvant Trial Organisation. Controlled trial of tamoxifen as single adjuvant agent in management of early breast cancer: analysis at six years. Lancet. 1985; 1:836-40. [IDIS 199145] [PubMed 2858709]

111. Rose C, Thorpe SM, Andersen KW et al. Beneficial effect of adjuvant tamoxifen therapy in primary breast cancer patients with high oestrogen receptor values. Lancet. 1985; 1:16-9. [PubMed 2856949]

112. National Institutes of Health Office of Medical Applications of Research. Consensus conference: adjuvant chemotherapy for breast cancer. JAMA. 1985; 254:3461-3. [IDIS 207936] [PubMed 4068189]

113. Ludwig Breast Cancer Study Group. Randomised trial of chemo-endocrine therapy, endocrine therapy, and mastectomy alone in postmenopausal patients with operable breast cancer and axillary node metastasis. Lancet. 1984; 1:1256-60. [IDIS 186376] [PubMed 6144974]

114. Fisher B, Fisher ER, Redmond C. A brief overview of findings from NSABP trials of adjuvant therapy. Recent Results Cancer Res. 1984; 96:55-65. [PubMed 6101262]

115. Hubay CA, Gordon NH, Crowe JP et al. Antiestrogen-cytotoxic chemotherapy and Bacillus Calmette-Guerin vaccination in stage II breast cancer: seventy-two-month follow-up. Surgery. 1984; 96:61-72. [PubMed 6740497]

116. Cummings FJ, Gray R, Davis TE et al. Adjuvant tamoxifen treatment of elderly women with Stage II breast cancer: a double-blind comparison with placebo. Ann Intern Med. 1985; 103:324-9. [IDIS 205815] [PubMed 3896085]

117. Gau T (Stuart Pharmaceuticals, Wilmington, DE): Personal communication; 1986 Jan 13.

118. Kaiser-Kupfer MI, Lippman ME. Tamoxifen retinopathy. Cancer Treat Rep. 1978; 62:315-20. [PubMed 647693]

119. Diver JMJ, Jackson IM, Fitzgerald JD. Tamoxifen and non-malignant indications. Lancet. 1986; 1:733. [IDIS 213703] [PubMed 2870236]

120. Kaiser-Kupfer MI, Kupfer C, Rodrigues MM. Tamoxifen retinopathy: a clinicopathologic report. Ophthalmology. 1981; 88:89-93. [PubMed 7243233]

121. Report from the Breast Cancer Trials Committee, Scottish Cancer Trials Office (MRC), Edinburgh. Adjuvant tamoxifen in the management of operable breast cancer: the Scottish trial. Lancet. 1987; 2:171-5. [IDIS 233071] [PubMed 2885637]

122. Fisher B, Brown A, Wolmark N et al. Prolonging tamoxifen therapy for primary breast cancer: findings from the National Surgical Adjuvant Breast and Bowel Project Clinical Trial. Ann Intern Med. 1987; 106:649-54. [IDIS 229430] [PubMed 3551710]

123. Tormey DC. Long-term adjuvant therapy with tamoxifen in breast cancer: how long is long? Ann Intern Med. 1987; 106:762-4. Editorial.

124. Zielinski CC, Kubista E, Salzer H et al. Adjuvant chemotherapy combined with tamoxifen in postmenopausal patients with stage II breast cancer. Lancet. 1986; 2:1164. [IDIS 223328] [PubMed 2877314]

125. Fentiman IS, Caleffi M, Brame E et al. Double-blind controlled trial of tamoxifen therapy for mastalgia. Lancet. 1986; 1:287-8. [IDIS 211071] [PubMed 2868162]

126. Fentiman IS. Tamoxifen and mastalgia: an emerging indication. Drugs. 1986; 32:477-80. [IDIS 223766] [PubMed 3539572]

127. Fisher B, Redmond C, Brown A et al. Influence of tumor estrogen and progesterone receptor levels on the response to tamoxifen and chemotherapy in primary breast cancer. J Clin Oncol. 1983; 1:227-41. [PubMed 6366135]

128. Zeneca Pharmaceuticals. Nolvadex (tamoxifen citrate) prescribing information. Wilmington, DE; 1998 Oct 28.

129. Legha SS. Tamoxifen in the treatment of breast cancer. Ann Intern Med. 1988; 109:219-28. [IDIS 244745] [PubMed 3291659]

130. National Cancer Institute. Clinical alert on breast cancer. Bethesda, MD: National Cancer Institute; 1988 May 18.

131. Bradbeer JW, Kyngdon J. Primary treatment of breast cancer in elderly women with tamoxifen. Clin Oncol. 1983; 9:31-4. [PubMed 6851305]

132. Taylor SG IV, Gelman RS, Falkson G et al. Combination chemotherapy compared to tamoxifen as initial therapy for stage IV breast cancer in elderly women. Ann Intern Med. 1986; 104:455-61. [IDIS 213853] [PubMed 3513684]

133. Glick JH. Meeting highlights: adjuvant therapy for breast cancer. J Natl Cancer Inst. 1988; 80:471-5. [PubMed 3367387]

134. Delozier T, Julien JP, Juret P et al. Adjuvant tamoxifen in postmenopausal breast cancer: preliminary results of a randomized trial. Breast Cancer Res Treat. 1986; 7:105-10. [PubMed 3521767]

135. Fisher B, Redmond C, Brown A et al. Adjuvant chemotherapy with and without tamoxifen in the treatment of primary breast cancer: 5-year results from the National Surgical Adjuvant Breast and Bowel Project Trial. J Clin Oncol. 1986; 4:459-71. [PubMed 2856857]

136. Early Breast Cancer Trialists’ Collaborative Group. Effects of adjuvant tamoxifen and of cytotoxic therapy on mortality in early breast cancer: an overview of 61 randomized trials among 28,896 women. N Engl J Med. 1988; 319:1681-92. [IDIS 248808] [PubMed 3205265]

137. Fabian C, Sternson L, Barnett M. Clinical pharmacology of tamoxifen in patients with breast cancer: comparison of traditional and loading dose schedules. Cancer Treat Rep. 1980; 64:765-73. [PubMed 7427961]

138. Adam HK, Gay MA, Moore RH. Measurement of tamoxifen in serum by thin-layer densitometry. J Endocrinol. 1980; 84:35-42. [PubMed 7359080]

139. Adam HK, Patterson JS, Kemp JV. Studies on the metabolism and pharmacokinetics of tamoxifen in normal volunteers. Cancer Treat Rep. 1980; 64:761-4. [PubMed 7427960]

140. McVie JG, Simonetti GPC, Stevenson D et al. The bioavailability of Tamoplex(tamoxifen). Part 1: a pilot study. Methods Find Exp Clin Pharmacol. 1986; 8:505-12. [PubMed 3747644]

141. Wilkinson P, Ribeiro G, Adam H et al. Clinical pharmacology of tamoxifen and N-desmethyltamoxifen in patients with advanced breast cancer. Cancer Chemother Pharmacol. 1980; 5:109-11. [PubMed 7471314]

142. Fromson JM, Pearson S, Bramah S. The metabolism of tamoxifen (I.C.I. 46,474). Part I: in laboratory animals. Xenobiotica. 1973; 3:693-709. [PubMed 4361333]

143. Milano G, Etienne MC, Frenay M et al. Optimised analysis of tamoxifen and its main metabolites in the plasma and cytosol of mammary tumours. Br J Cancer. 1987; 55:509-12. [PubMed 3606944]

144. Daniel P, Gaskell SJ, Bishop H et al. Determination of tamoxifen and biologically active metabolites in human breast tumours and plasma. Eur J Cancer Clin Oncol. 1981; 17:1183-9. [PubMed 7199465]

145. Jordan VC. Metabolites of tamoxifen in animals and man: identification, pharmacology, and significance. Breast Cancer Res Treat. 1982; 2:123-38. [PubMed 6184101]

146. Soininen K, Kleimola T, Elomaa I et al. The steady-state pharmacokinetics of tamoxifen and its metabolites in breast cancer patients. J Int Med Res. 1986; 14:162-5. [PubMed 3522312]

147. Ribeiro GG, Wilkinson PM. A clinical assessment of loading dose tamoxifen for advanced breast carcinoma. Clin Oncol. 1984; 10:363-7. [PubMed 6509818]

148. Adam HK, Douglas EJ, Kemp JV. The metabolism of tamoxifen in humans. Biochem Pharmacol. 1979; 27:145-7.

149. Bain RR, Jordan VC. Identification of a new metabolite of tamoxifen in patient serum during breast cancer therapy. Biochem Pharmacol. 1983; 32:373-5. [PubMed 6870963]

150. Jordan VC, Bain RR, Brown RR et al. Determination and pharmacology of a new hydroxylated metabolite of tamoxifen observed in patient sera during therapy for advanced breast cancer. Cancer Res. 1983; 43:1446-50. [IDIS 165659] [PubMed 6825112]

151. Murphy C, Fotsis T, Pantzar P et al. Analysis of tamoxifen and its metabolites in human plasma by gas chromatography-mass spectrometry (GC-MS) using selected ion monitoring (SIM). J Steroid Biochem. 1987; 26:547-55. [PubMed 3586671]

152. Kemp JV, Adam HK, Wakeling AE et al. Identification and biological activity of tamoxifen and metabolites in human serum. Biochem Pharmacol. 1983; 32:2045-52. [PubMed 6870933]

153. Jordan VC, Collins MM, Rowsby L et al. A monohydroxylated metabolite of tamoxifen with potent antioestrogenic activity. J Endocrinol. 1977; 75:305-16. [PubMed 591813]

154. Wakeling AE, Slater SR. Estrogen-receptor binding and biologic activity of tamoxifen and its metabolites. Cancer Treat Rep. 1980; 64:741-4. [PubMed 7427959]

155. Fabian C, Tilzer L, Sternson L. Comparative binding affinities of tamoxifen, 4-hydroxytamoxifen, and desmethyltamoxifen for estrogen receptors isolated from human breast carcinoma: correlation with blood levels in patients with metastatic breast cancer. Biopharm Drug Dispos. 1981; 2:381-90. [IDIS 143191] [PubMed 7317574]

156. Borgna JL, Rochefort H. Hydroxylated metabolites of tamoxifen are formed in vivo and bound to estrogen receptor in target tissues. J Biol Chem. 1981; 256:859-68. [PubMed 7451477]

157. Coezy E, Borgna JL, Rochefort H. Tamoxifen and metabolites in MCF, cells: correlation between binding to estrogen receptor and inhibition of cell growth. Cancer Res. 1982; 42:317-23. [PubMed 7053859]

158. Pritchard KI, Thomson DB, Myers RE et al. Tamoxifen therapy in premenopausal patients with metastatic breast cancer. Cancer Treat Rep. 1980; 64:787-96. [PubMed 7427962]

159. Manni A, Pearson OH. Antiestrogen-induced remissions in premenopausal women with stage IV breast cancer: effects on ovarian function. Cancer Treat Rep. 1980; 64:779-85. [PubMed 6775808]

160. Sawka CA, Pritchard KI, Paterson AH et al. Role and mechanism of action of tamoxifen in premenopausal women with metastatic breast carcinoma. Cancer Res. 1986; 46:3152-6. [IDIS 217168] [PubMed 3084082]

161. Ingle JN, Krook JE, Green SJ et al. Randomized trial of bilateral oophorectomy versus tamoxifen in premenopausal women with metastatic breast cancer. J Clin Oncol. 1986; 4:178-85. [PubMed 3511184]

162. Buchanan RB, Blamey RW, Durrant KR et al. A randomized comparison of tamoxifen with surgical oophorectomy in premenopausal patients with advanced breast cancer. J Clin Oncol. 1986; 4:1326-30. [PubMed 3528402]

163. Legha SS. Tamoxifen in the treatment of breast cancer. Ann Intern Med. 1988; 109:219-28. [IDIS 244745] [PubMed 3291659]

164. Hoogstraten B, Fletcher WS, Gad-el-Mawla N et al. Tamoxifen and oophorectomy in the treatment of recurrent breast cancer. A Southwest Oncology Group study. Cancer Res. 1982; 42:4788-91. [IDIS 159551] [PubMed 7127314]

165. Yoshida M, Murai H, Miura S. Tamoxifen therapy for premenopausal and postmenopausal Japanese females with advanced breast cancer. Jpn J Clin Oncol. 1982; 12:57-63.

166. Margreiter R, Wiegele J. Tamoxifen (Nolvadex) for premenopausal patients with advanced breast cancer. Breast Cancer Res Treat. 1984; 4:45-8. [PubMed 6365211]

167. Planting AS, Alexieva-Figusch J, Blonk-VdWijst J et al. Tamoxifen therapy in premenopausal women with metastatic breast cancer. Cancer Treat Res. 1985; 69:363-8.

168. Wada T, Koyama H, Terasawa T. Effect of tamoxifen in premenopausal Japanese women with advanced breast cancer. Cancer Treat Rep. 1981; 65:728-9. [IDIS 137005] [PubMed 7248991]

169. Hoogstraten B, Gad-el-Mawla N, Maloney TR et al. Combined modality therapy for first recurrence of breast cancer. A Southwest Oncology Group study. Cancer. 1984; 54:2248-56. [IDIS 193333] [PubMed 6488144]

170. Lodwick R, McConkey B, Brown AM. Life threatening interaction between tamoxifen and warfarin. BMJ. 1987; 295:1141. [IDIS 235136] [PubMed 3120919]

171. Tenni P, Lalich DL, Byrne MJ. Life threatening interaction between tamoxifen and warfarin. BMJ. 1989; 298:93. [IDIS 249683] [PubMed 2493305]

172. Ritchie LD, Grant SMT. Tamoxifen–Warfarin interaction: the Aberdeen hospitals drug file. BMJ. 1989; 298:1253.

173. Fornander T, Rutquist LE, Cedermark B et al. Adjuvant tamoxifen in early breast cancer: occurrence of new primary cancers. Lancet. 1989; 1:117-20. [IDIS 249801] [PubMed 2563046]

174. Hardell L. Tamoxifen as risk factor for carcinoma of corpus uteri. Lancet. 1988; 2:563. [IDIS 245548] [PubMed 2900934]

175. Killackey MA, Hakes TB, Pierce VK. Endometrial adenocarcinoma in breast cancer patients receiving antiestrogens. Cancer Treat Rep. 1985; 69:237-8. [IDIS 196903] [PubMed 3971394]

176. Jordan VC. Tamoxifen and endometrial cancer. Lancet. 1989; 1:733-4. [IDIS 254039] [PubMed 2564550]

177. Gottardis MM, Robinson SP, Satyaswaroop PG et al. Contrasting actions of tamoxifen on endometrial and breast tumor growth in the athymic mouse. Cancer Res. 1988; 48:812-5. [PubMed 3338079]

178. Neven P, De Muylder X, Van Belle Y et al. Tamoxifen and the uterus and endometrium. Lancet. 1989; 1:375. [IDIS 250800] [PubMed 2563519]

179. Stewart HJ, Knight GM. Tamoxifen and the uterus and endometrium. Lancet. 1989; 1:375-6. [PubMed 18446929]

180. Cano A, Matallin P, Legua V et al. Tamoxifen and the uterus and endometrium. Lancet. 1989; 1:376. [PubMed 18446930]

181. Boccardo F, Bruzzi P, Rubagotti A et al. Estrogen-like action of tamoxifen on vaginal epithelium in breast cancer patients. Oncology. 1981; 38:281-5. [PubMed 7266969]

182. Boccardo F, Guarneri D, Rubagotti A et al. Endocrine effects of tamoxifen in postmenopausal breast cancer patients. Tumori. 1984; 70:61-8. [PubMed 6538707]

183. Buckley MMT, Goa KL. Tamoxifen: a reappraisal of its pharmacodynamic and pharmacokinetic properties, and therapeutic use. Drugs. 1989; 37:451-90. [IDIS 257967] [PubMed 2661195]

184. Cuzick J, Baum M. Tamoxifen and contralateral breast cancer. Lancet. 1985; 2:282. [IDIS 203072] [PubMed 2862460]

185. Brun LD, Gagne C, Rousseau C et al. Severe lipemia induced by tamoxifen. Cancer. 1986; 57:2123-6. [IDIS 216127] [PubMed 3697911]

186. Noguchi M, Taniya T, Tajiri K et al. Fatal hyperlipaemia in a case of metastatic breast cancer treated by tamoxifen. Br J Surg. 1987; 74:586-7. [PubMed 3620865]

187. Taniya T, Noguchi M, Tajiri K et al. [A case report of hyperlipemia with giant fatty liver during adjuvant endocrine therapy by tamoxifen]. Gan No Rinsho. 1987; 33:300-4. [PubMed 3108557]

188. Rossner S, Wallgren A. Serum lipoproteins and proteins after breast cancer surgery and effects of tamoxifen. Atherosclerosis. 1984; 52:339-46. [PubMed 6497936]

189. McKeown CA, Swartz M, Blom J et al. Tamoxifen retinopathy. Br J Ophthalmol. 1981; 65:177-9. [PubMed 7225310]

190. Vinding T, Nielsen NV. Retinopathy caused by treatment with tamoxifen in low dosage. Acta Ophthalmol. 1983; 61:45-50.

191. Griffiths MF. Tamoxifen retinopathy at low dosage. Am J Ophthalmol. 1987; 104:185-6. [IDIS 232920] [PubMed 3039846]

192. Ashford AR, Donev I, Tiwari RP et al. Reversible ocular toxicity related to tamoxifen therapy. Cancer. 1988; 61:33-5. [IDIS 237645] [PubMed 3334951]

193. Pugesgaard T, Von Eyben FE. Bilateral optic neuritis evolved during tamoxifen treatment. Cancer. 1986; 58:383-6. [IDIS 218074] [PubMed 3719532]

194. National Institutes of Health Office of Medical Applications of Research. Consensus conference: treatment of early-stage breast cancer. JAMA. 1991; 265:391-5. [PubMed 1984541]

195. Fisher B, Redmond C, Wickerham L et al. Systemic therapy in patients with node-negative breast cancer: a commentary based on two national surgical adjuvant breast and bowel project (NSABP) clinical trials. Ann Intern Med. 1989; 111:703-12. [IDIS 260416] [PubMed 2679288]

196. Fisher B, Costantino J, Redmond C et al. A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med. 1989; 320:479-84. [IDIS 308825] [PubMed 2644532]

197. Rosner D, Lane WW. One-third of node-negative breast cancer patients are highly curable by surgery alone, without need for adjuvant systemic therapy. Proc Annu Meet Am Soc Clin Oncol. 1990; 9:A63.

198. Redmond CK, Fisher B, Costantino J et al. Treatment of stage I breast cancer: the NSABP experience. Horm Res. 1989; 32(Suppl 1):175-80. [PubMed 2613203]

199. Hillner BE, Smith TJ. Efficacy and cost effectiveness of adjuvant chemotherapy in women with node-negative breast cancer. N Engl J Med. 1991; 324:160-8. [IDIS 276489] [PubMed 1898533]

200. Anon. Adjuvant tamoxifen in early breast cancer. Lancet. 1987; 2:191-2. [PubMed 2885643]

201. McGuire WL. Adjuvant therapy of node-negative breast cancer. N Engl J Med. 1989; 320:525-7. [PubMed 2915655]

202. DeVita VT Jr. Breast cancer therapy: exercising all our options. N Engl J Med. 1989; 320:527-9. [PubMed 2915656]

203. Wolmark N. 1989: The year of adjuvant therapy in node-negative breast cancer. Cancer: Princ Pract Oncol Updates. 1989; 3:1-10.

204. Anon. Tamoxifen for node-negative breast cancer. FDA Drug Bull. 1990; 20:5.

205. Bianco AR, De Placido S, Gallo C et al. Adjuvant therapy with tamoxifen in operable breast cancer. Lancet. 1988; 2:1095-9. [IDIS 247823] [PubMed 2903322]

206. McGuire WL. Adjuvant therapy of node-negative breast cancer: another point of view. J Natl Cancer Inst. 1988; 80:1075-6. [

Supracaine

Generic Name: tetracaine (Topical application route)

TE-tra-kane

Commonly used brand name(s)

In the U.S.

• Cepacol Viractin


• Pontocaine

In Canada

• Supracaine

Available Dosage Forms:

• Cream


• Ointment


• Gel/Jelly


• Solution

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Ester

Uses For Supracaine

Tetracaine is used in different parts of the body to cause numbness or loss of feeling in some patients before having a medical test or procedure.

Tetracaine belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. This medicine does not cause unconsciousness as general anesthetics do when used for surgery.

This medicine is available only with your doctor's prescription.

Before Using Supracaine

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

Allergies

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

Pediatric

No information is available on the relationship of age to the effects of tetracaine in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of tetracaine in geriatric patients.

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain or spinal problems or


• Eye problems or


• Heart and blood vessel problems—Use with caution. May make these conditions worse.

• Infection at or near the place of application or


• Large sores, broken skin, or severe injury at the area of application—The chance of side effects may be increased.

Proper Use of tetracaine

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

A nurse or other trained health professional will give you this medicine. This medicine is for use on the skin only.

Be careful not to get any of this medicine in your nose, mouth, and especially in your eyes, because it can cause severe eye irritation. If any of the medicine does get into these areas especially the eyes, wash it with water and check with your doctor right away.

Precautions While Using Supracaine

It is very important that your doctor check you closely for any problems or unwanted effects that may be caused by this medicine.

Stop using this medicine and check with your doctor right away if you have a skin rash, burning, stinging, swelling, or irritation of your skin.

Do not use cosmetics or other skin care products on the treated skin areas.

Supracaine Side Effects

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

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

Incidence not known

• Blurred vision


• chest pain or discomfort


• confusion


• dizziness


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


• fainting


• fast or irregular heartbeat


• lightheadedness or fainting


• no blood pressure or pulse


• no breathing


• numbness


• seizures


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


• shortness of breath


• slow or irregular heartbeat


• stopping of heart


• sweating


• trembling or shaking of the hands or feet


• unconsciousness


• unusual tiredness or weakness

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

• Continuing ringing or buzzing or other unexplained noise in the ears


• fear or nervousness


• hearing loss


• restlessness


• sleepiness

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.

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 Supracaine resources

• Supracaine Support Group
• 1 Review for Supracaine - Add your own review/rating

Compare Supracaine with other medications

• Allergic Urticaria
• Cold Sores
• Local Anesthesia
• Skin Rash
• Urticaria

Sun Defense Cream

Generic Name: homosalate, octinoxate, octisalate and titanium dioxide

Dosage Form: cream

Natura Bisse Barcelona

Sun Defense SPF 50 Plus Ultra

Sun Defense Cream, Sunscreen for sensitive and sun reactive skin, water resistant

Net Wt. 2.5 Oz e 75 mL

Not tested on animals

Made in Spain by Natura Bisse Int. S.A., Pque. Techol. del Valles, Cerdanyola, 08290 Barcelona

Lot no.

Product Made in Spain and exported by Natura Bisse Int., S.A. Barcelona Espana

Imported and Distributed in Mexico for Natura Bisse Internacional S.A. de C.V., Herschel No. 50 Colonia Anzures, Delegacion Miguel Hidalgo, C.P. 11590 Mexico, D.F. RFC NBIO402132P0

Other Information: Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.  High sun protection product.

This product can be sold only by authorized Natura Bisse retailers.

Active ingredients: Homosalate (3%), Octinoxate (7.5%), Octisalate (5%), Titanium Dioxide (12.3%)

Other Ingredients: Water, Isononyl Isononanoate, Polyglyceryl-4 Isostearate, Glycerin, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Stearic Acid, Aluminum Hydroxide, Pisum Sativum (Pea) Extract, Aloe Barbadensis Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Yeast (Faex) Extract, Sodium Chloride, Aluminum Stearate, Ascorbic Acid, Citric Acid, Disodium EDTA, Potassium Sorbate, Sodium Benzoate, Chlorphenesin, Imidazolidinyl Urea, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Fragrance, Linalool, Limonene, Citronellol, Iron Oxides, Alumina.

Uses: Helps prevent sunburn.  Higher SPF give more sunburn protection.

Warnings:

For external use only.  When using this product: Keep out of eyes.  Rinse with water to remove.  Stop use and ask doctor if rash or irritation develops and lasts.  Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.  If pregnant or breast-feeding, ask a health professional before use.

Directions: Apply evenly 30 minutes before sun exposure and reapply every 2-3 hours.  Children under 6 months of age: ask a doctor.

Sun Defense Cream  homosalate, octinoxate, methoxycinnamate, octisalate, titanium dioxide  cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 63730-206 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (Homosalate) Homosalate 2 mL  in 75 mL Octinoxate (Octinoxate) Octinoxate 6 mL  in 75 mL Octisalate (Octisalate) Octisalate 4 mL  in 75 mL Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 9 g  in 75 mL

Inactive Ingredients Ingredient Name Strength Water   ISONONYL ISONONANOATE   POLYGLYCERYL-4 ISOSTEARATE   Glycerin   C12-15 ALKYL BENZOATE   Hexyl Laurate   Stearic Acid   Aluminum Hydroxide   Snow Pea   Aloe   Helianthus Annuus   Yeast   Sodium Chloride   Aluminum Stearate   Ascorbic Acid   Citric Acid Monohydrate   Edetate Disodium   Potassium Sorbate   Sodium Benzoate   Chlorphenesin   IMIDUREA   Phenoxyethanol   Methylparaben   Butylparaben   Ethylparaben   Propylparaben   Isobutylparaben   Linalool, DL-   Limonene, D-   Citronellol, DL-   ALUMINUM OXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63730-206-01 75 mL In 1 CARTON None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2004

Labeler - Natura Bisse International (464431576)

Establishment
Name	Address	ID/FEI	Operations
Natura Bisse International		464431576	manufacture

Revised: 02/2010Natura Bisse International

More Sun Defense Cream resources

• Sun Defense Cream Side Effects (in more detail)
• Sun Defense Cream Support Group
• 0 Reviews · Be the first to review/rate this drug

Superdophilus

Generic Name: lactobacillus acidophilus (LAK toe ba SIL us AS sid OFF il us)

Brand Names: Acidophilus, Acidophilus Extra Strength, Bacid, Flora-Q 2, Novaflor, RisaQuad, RisaQuad 2, Superdophilus

What is Superdophilus (lactobacillus acidophilus)?

Lactobacillus acidophilus is a bacteria that exists naturally in the body, primarily in the intestines and the vagina. Lactobacillus acidophilus helps maintain an acidic environment in the body, which can prevent the growth of harmful bacteria.

Lactobacillus acidophilus has been used to treat or prevent vaginal yeast infections, yeast infections of the mouth, diarrhea caused by taking antibiotics, and urinary tract infections. Lactobacillus acidophilus may work by helping the body maintain normal consistency of bacteria in the stomach, intestines, and vagina.

Lactobacillus acidophilus has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.

Lactobacillus acidophilus has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of lactobacillus acidophilus may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Lactobacillus acidophilus may also have be used for other purposes not listed in this product guide.

What is the most important information I should know about Superdophilus (lactobacillus acidophilus)?

Lactobacillus acidophilus has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.

Lactobacillus acidophilus has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of lactobacillus acidophilus may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Talk to your doctor before taking lactobacillus acidophilus if you have any other medical conditions, allergies, or if you take other medicines or herbal/health supplements. Under certain conditions, it may be dangerous for you to take lactobacillus acidophilus.

Do not take lactobacillus acidophilus without first talking to your doctor if you are pregnant or may become pregnant during treatment. Do not take lactobacillus acidophilus without first talking to your doctor if you are breast-feeding a baby. Do not give any herbal/health supplement to a child without the advice of a doctor.

What should I tell my healthcare provider before taking Superdophilus (lactobacillus acidophilus)?

Talk to your doctor before taking lactobacillus acidophilus if you have any other medical conditions, allergies, or if you take other medicines or herbal/health supplements. Under certain conditions, it may be dangerous for you to take lactobacillus acidophilus.

Do not take lactobacillus acidophilus without first talking to your doctor if you are pregnant or may become pregnant during treatment. Do not take lactobacillus acidophilus without first talking to your doctor if you are breast-feeding a baby. Do not give any herbal/health supplement to a child without the advice of a doctor.

How should I take Superdophilus (lactobacillus acidophilus)?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

Do not take more of this product than is directed.

If you choose to take lactobacillus acidophilus, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

Lactobacillus acidophilus is available in capsule and tablet form. Powder or liquid forms may also be available. Some dairy products, especially yogurt, also contain lactobacillus acidophilus.

Do not use many different forms (such as tablets, topical formulations, and others) of lactobacillus acidophilus at the same time, unless your healthcare professional has told you to. You may get too much of this product if you use different forms together.

Store lactobacillus acidophilus in a sealed container as directed on the product label, away from moisture, heat, and light.

What happens if I miss a dose?

No information is available about missing a dose of lactobacillus acidophilus. Consult your doctor, pharmacist, or healthcare provider for instructions if you miss a dose.

What happens if I overdose?

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

What should I avoid while taking Superdophilus (lactobacillus acidophilus)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using lactobacillus acidophilus.

Superdophilus (lactobacillus acidophilus) side effects

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

Less serious side effects may be more likely, and you may have none at all.

Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Superdophilus (lactobacillus acidophilus)?

There may be other drugs that can interact with lactobacillus acidophilus. Tell your healthcare provider about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your healthcare provider.

More Superdophilus resources

• Superdophilus Support Group
• 0 Reviews for Superdophilus - Add your own review/rating

• Lactobacillus Acidophilus Monograph (AHFS DI)


• Acidophilus Natural MedFacts for Professionals (Wolters Kluwer)


• Acidophilus Natural MedFacts for Consumers (Wolters Kluwer)


• Acidophilus Consumer Overview

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Where can I get more information?

• Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

Sotradecol

tetradecyl hydrogen sulfate (ester)

Dosage Form: injection, solution
Sotradecol® (Sodium Tetradecyl Sulfate Injection)

Sotradecol Description

Sodium tetradecyl sulfate is an anionic surfactant which occurs as a white, waxy solid. The structural formula is as follows:  

C14H29NaSO4 7-Ethyl-2-methyl-4-hendecanol sulfate sodium salt MW 316.44

Sotradecol® (sodium tetradecyl sulfate injection) is a sterile nonpyrogenic solution for intravenous use as a sclerosing agent.

1% (10 mg/mL): Each mL contains sodium tetradecyl sulfate 10 mg, benzyl alcohol 0.02 mL and dibasic sodium phosphate, anhydrous 4.0 mg in Water for Injection. pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.

3% (30 mg/mL): Each mL contains sodium tetradecyl sulfate 30 mg, benzyl alcohol 0.02 mL and dibasic sodium phosphate, anhydrous 9.0 mg in Water for Injection. pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.

Sotradecol - Clinical Pharmacology

Sotradecol® (sodium tetradecyl sulfate injection) is a sclerosing agent. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein. Subsequent formation of fibrous tissue results in partial or complete vein obliteration that may or may not be permanent.

Indications and Usage for Sotradecol

Sotradecol® (sodium tetradecyl sulfate injection) is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.

Contraindications

Sotradecol® (sodium tetradecyl sulfate injection) is contraindicated in previous hypersensitivity reactions to the drug; in acute superficial thrombophlebitis; valvular or deep vein incompetence; huge superficial veins with wide open communications to deeper veins; phlebitis migrans; acute cellulitis; allergic conditions; acute infections; varicosities caused by abdominal and pelvic tumors unless the tumor has been removed; bedridden patients; such uncontrolled systemic diseases as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.

Warnings

Sotradecol® (sodium tetradecyl sulfate injection) should only be administered by a health care professional experienced in venous anatomy and diagnosis and treatment of conditions affecting the venous system and familiar with proper injection technique. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, extreme care in intravenous needle placement and using the minimal effective volume at each injection site are important. Emergency resuscitation equipment should be immediately available. Allergic reactions, including fatal anaphylaxis, have been reported. As a precaution against anaphylactic shock, it is recommended that 0.5 mL of Sotradecol® be injected into a varicosity, followed by observation of the patient for several hours before administration of a second or larger dose. The possibility of an anaphylactic reaction should be kept in mind, and the physician should be prepared to treat it appropriately.

Because of the danger of thrombosis extension into the deep venous system, thorough preinjection evaluation for valvular competency should be carried out and slow injections with a small amount of the preparation should be injected into the varicosity. Deep venous patency must be determined by noninvasive testing such as duplex ultrasound out and slow injections with a small amount (not over 2 mL) of the preparation should be injected into the varicosity. Deep venous patency must be determined by angiography or noninvasive testing such as duplex ultrasound. Venous sclerotherapy should not be undertaken if tests such as Trendelenberg and Perthes, and angiography show significant valvular or deep venous incompetence.

The development of deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of uperficial varicosities. Patients should have post-treatment follow-up of sufficient duration to assess for the development of deep vein thrombosis. Embolism may occur as long as four weeks after injection of sodium tetradecyl sulfate. Adequate post-treatment compression may decrease the incidence of deep vein thrombosis.

Precautions

GENERAL PRECAUTIONS

Extreme caution must be exercised in the presence of underlying arterial disease such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease).

Drug Interactions

No well-controlled studies have been performed on patients taking antiovulatory agents. The physician must use judgment and evaluate any patient taking antiovulatory drugs prior to initiating treatment with Sotradecol®. (See ADVERSE REACTIONS Section).  Heparin should not be included in the same syringe as Sotradecol®, since the two are incompatible.

CARCINOGENESIS AND MUTAGENESIS AND IMPAIRMENT OF FERTILITY

When tested in the L5178YTK +/- mouse lymphoma assay, sodium tetradecyl sulfate did not induce a dose-related increase in the frequency of thymidine kinase-deficient mutants and, therefore, was judged to be nonmutagenic in this system. However, no long-term animal carcinogenicity studies with sodium tetradecyl sulfate have been performed.

PREGNANCY

Teratogenic Effects – Pregnancy Category C. Animal reproduction studies have not been conducted with Sotradecol®. It is also not known whether Sotradecol® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sotradecol® should be given to a pregnant woman only if clearly needed and the benefits outweigh the risks.

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 Sotradecol® is administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Local reactions consisting of pain, urticaria or ulceration may occur at the site of injection. A permanent discoloration may remain along the path of the sclerosed vein segment. Sloughing and necrosis of tissue may occur following extravasation of the drug. (See WARNINGS section).

Allergic reactions such as hives, asthma, hay fever and anaphylactic shock have been reported. Mild systemic reactions that have been reported include headache, nausea and vomiting. (See WARNINGS section).

At least six deaths have been reported with the use of Sotradecol®. Four cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol®. One of these four patients reported a history of asthma, a contraindication to the administration of Sotradecol®. (See WARNINGS section). One death has been reported in a patient who received Sotradecol® and who had been receiving an antiovulatory agent. Another death (fatal pulmonary embolism) has been reported in a 36-year-old female treated with sodium tetradecyl acetate and who was not taking oral contraceptives.

Sotradecol Dosage and Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if precipitated or discolored.

Sotradecol® (sodium tetradecyl sulfate injection) is for intravenous use only. The strength of solution required depends on the size and degree of varicosity. In general, the 1% solution will be found most useful with the 3% solution preferred for larger varicosities. The dosage should be kept small,   using 0.5 to 2 mL (preferably 1 mL maximum) for each injection, and the maximum single treatment should not exceen 10 mL.

How is Sotradecol Supplied

Sotradecol® (sodium tetradecyl sulfate injection)

1% (10 mg/mL) - 2 mL vials; in packages of 5 (NDC 67457-162-02)

3% (30 mg/mL) - 2 mL vials; in packages of 5 (NDC 67457-163-02)

STORAGE

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

ANIMAL TOXICOLOGY

The intravenous LD50 of sodium tetradecyl sulfate in mice was reported to be 90 ± 5 mg/kg.

In the rat, the acute intravenous LD50 of sodium tetradecyl sulfate was estimated to be between 72 mg/kg and 108 mg/kg.

Purified sodium tetradecyl sulfate was found to have an LD50 of 2 g/kg when administered orally by stomach tube as a 25% aqueous solution to rats. In rats given 0.15g/kg in drinking water for 30 days, no appreciable toxicity was seen, although some growth inhibition was discernible.

Manufactured for:                                             Manufactured by Bioniche Teo

Bioniche Pharma U.S.A. LLC.                        Inverin, Co. Galway, Ireland

Lake Forest, IL 60045

PRINCIPAL DISPLAY PANEL - 10 mg/mL Vial Label

2 mL Vial

NDC 67457-162-02

Sotradecol® 1%

(SODIUM TETRADECYL

SULFATE INJECTION)

10 mg/mL

FOR IV USE ONLY

DO NOT USE IF

PRECIPITATED

Rx Only

Bioniche Pharma USA LLC,

Lake Forest, IL 60045

Made in Ireland.

PRINCIPAL DISPLAY PANEL - 30 mg/mL Vial Label

2 mL Vial

NDC 67457-163-02

Sotradecol® 3%

(SODIUM TETRADECYL

SULFATE INJECTION)

30 mg/mL

FOR IV USE ONLY

DO NOT USE IF

PRECIPITATED

Rx Only

Bioniche Pharma USA LLC,

Lake Forest IL 60045

Made in Ireland.

Sotradecol  tetradecyl hydrogen sulfate (ester)  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67457-162 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tetradecyl hydrogen Sulfate (Ester) (Tetradecyl hydrogen Sulfate (Ester)) Tetradecyl hydrogen Sulfate (Ester) 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Benzyl Alcohol 0.02 mL  in 1 mL Sodium Phosphate, Dibasic anhydrous 4 mg  in 1 mL Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67457-162-02 5 VIAL In 1 CARTON contains a VIAL, GLASS 1 2 mL In 1 VIAL, GLASS This package is contained within the CARTON (67457-162-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040541	05/30/2008

Sotradecol  tetradecyl hydrogen sulfate (ester)  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67457-163 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tetradecyl hydrogen Sulfate (Ester) (Tetradecyl hydrogen Sulfate (Ester)) Tetradecyl hydrogen Sulfate (Ester) 30 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Benzyl Alcohol 0.02 mL  in 1 mL Sodium Phosphate, Dibasic anhydrous 9 mg  in 1 mL Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67457-163-02 5 VIAL In 1 CARTON contains a VIAL, GLASS 1 2 mL In 1 VIAL, GLASS This package is contained within the CARTON (67457-163-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040541	05/30/2008

Labeler - Bioniche Pharma USA LLC (790384503)

Establishment
Name	Address	ID/FEI	Operations
Bioniche Teoranta		896321325	MANUFACTURE

Revised: 11/2009Bioniche Pharma USA LLC

More Sotradecol resources

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

• Sotradecol Concise Consumer Information (Cerner Multum)


• Sotradecol Advanced Consumer (Micromedex) - Includes Dosage Information


• Sotradecol MedFacts Consumer Leaflet (Wolters Kluwer)


• Sodium Tetradecyl Sulfate Professional Patient Advice (Wolters Kluwer)

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