SPS Suspension

Pronunciation: SOE-dee-um POL-ee-STYE-reen SUL-foe-nate
Generic Name: Sodium Polystyrene Sulfonate
Brand Name: Examples include Kionex and SPS

SPS Suspension is used for:

Treating high potassium levels in the blood.

SPS Suspension is a potassium-removing resin. It works by drawing potassium into the large intestine and then removing it from the body.

Do NOT use SPS Suspension if:

• you are allergic to any ingredient in SPS Suspension


• you have low potassium levels in the blood


• you have not yet had a bowel movement after recent surgery or if you have abnormal bowel function


• you have obstructive bowel disease, constipation, or are at risk of constipation or impaction (eg, a history of impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, previous bowel surgery, a bowel blockage)


• the patient is a newborn with decreased bowel activity


• you are taking magnesium hydroxide or sorbitol

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

Before using SPS Suspension:

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

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


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


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


• if you have swelling or fluid retention (edema), congestive heart failure, or high blood pressure


• if you have kidney problems, dehydration, low blood volume, or abnormal blood electrolyte (eg, sodium, magnesium, calcium) levels


• if you have a history of constipation, or bowel problems or surgery


• if the patient is a premature newborn


• if you are on a low-salt (sodium) diet or you are taking digoxin

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

• Sorbitol because the risk of severe bowel problems (eg, bleeding, inflammation, tearing) may be increased


• Magnesium hydroxide because severe side effects (eg, seizures) may occur


• Aluminum hydroxide because bowel blockage may occur


• Lithium or thyroxine because their effectiveness may be decreased by SPS Suspension

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

How to use SPS Suspension:

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

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


• SPS Suspension can be taken orally, as an enema, or through a feeding tube, as directed by your doctor.


• Shake well before each use.


• If you take antacids or laxatives, ask your doctor or pharmacist how to take them with SPS Suspension. Do not take magnesium hydroxide with SPS Suspension.


• Do not heat SPS Suspension. It may not work as well.


• Check with your doctor about what you should do if you miss a dose of SPS Suspension.

Ask your health care provider any questions you may have about how to use SPS Suspension.

Important safety information:

• Follow the diet program given to you by your health care provider. Avoid eating or drinking anything that contains the sweetener sorbitol.


• Serious and sometimes fatal bowel problems (eg, bleeding, inflammation, tearing) have been reported with the use of SPS Suspension. Most of the patients who developed these problems while taking SPS Suspension were also taking sorbitol. The risk of bowel problems may also be increased if you have low blood volume, kidney problems, or a history of bowel problems or surgery. Contact your doctor immediately if you experience black, tarry, or bloody stools; constipation; stomach pain; swelling of the stomach; or vomit that looks like coffee grounds.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• Lab tests, including blood potassium and other blood electrolyte levels, and electrocardiograms (ECGs), may be performed while you use SPS Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use SPS Suspension with caution in CHILDREN and the ELDERLY; they may be more sensitive to its effects, especially bowel problems.


• SPS Suspension should not be used by mouth in NEWBORNS; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if SPS Suspension can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using SPS Suspension while you are pregnant. It is not known if SPS Suspension is found in breast milk. If you are or will be breast-feeding while you use SPS Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of SPS Suspension:

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

Appetite loss; nausea; upset stomach; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; changes in emotions, mood, or behavior; confusion; constipation; dizziness; fast, slow, or irregular heartbeat; muscle cramps, pain, spasms, or weakness; seizures; severe or watery diarrhea; stomach pain; swelling of the feet or hands; swelling of the stomach; trouble breathing; trouble thinking or concentrating; vomit that looks like coffee grounds.

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

See also: SPS side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; dizziness; irregular heartbeat; irritability; muscle, cramps, pain, weakness, or paralysis; trouble breathing; trouble thinking or concentrating.

Proper storage of SPS Suspension:

Store SPS Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Protect from excessive heat. Store away from heat, moisture, and light. Do not store in the bathroom. Keep SPS Suspension out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More SPS resources

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

Compare SPS with other medications

• Hyperkalemia

Siladryl Allergy

Generic Name: diphenhydramine (DYE fen HYE dra meen)

Brand Names: Aler-Tab, Allergy, Allermax, Altaryl, Benadryl Allergy, Benadryl DF, Benadryl Dye Free Allergy, Benadryl Ultratab, Children's Allergy, Diphen Cough, Diphenhist, Dytuss, PediaCare Children's Allergy, Q-Dryl, Q-Dryl A/F, Siladryl, Siladryl Allergy, Silphen Cough, Simply Sleep, Sleep-ettes, Sleep-ettes D, Sominex Maximum Strength Caplet, Theraflu Thin Strips Multi Symptom, Triaminic Thin Strips Cough & Runny Nose, Unisom Sleepgels Maximum Strength, Valu-Dryl

What is Siladryl Allergy (diphenhydramine)?

Diphenhydramine is an antihistamine. Diphenhydramine blocks the effects of the naturally occurring chemical histamine in the body.

Diphenhydramine is used to treat sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.

Diphenhydramine is also used to suppress coughs, to treat motion sickness, to induce sleep, and to treat mild forms of Parkinson's disease.

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

What is the most important information I should know about Siladryl Allergy (diphenhydramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

What should I discuss with my healthcare provider before taking Siladryl Allergy (diphenhydramine)?

Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  glaucoma or increased pressure in the eye;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  an enlarged prostate, bladder problems or difficulty urinating;

  
  


• 
  

  an overactive thyroid (hyperthyroidism);

  
  


• 
  

  hypertension or any type of heart problems; or

  
  


• 
  

  asthma.

  
  

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

Diphenhydramine is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take diphenhydramine without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of antihistamines, and side effects could occur in a breast-feeding baby. Do not take diphenhydramine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from diphenhydramine. You may require a lower dose of this medication.

How should I take Siladryl Allergy (diphenhydramine)?

Take diphenhydramine exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Diphenhydramine can be taken with or without food.

For motion sickness, a dose is usually taken 30 minutes before motion, then with meals and at bedtime for the duration of exposure.

As a sleep aid, diphenhydramine should be taken approximately 30 minutes before bedtime.

To ensure that you get a correct dose, measure the liquid forms of diphenhydramine with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is prescribed for you. The maximum amount of diphenhydramine that you should take in any 24-hour period is 300 mg.

Store diphenhydramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a diphenhydramine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking Siladryl Allergy (diphenhydramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

Siladryl Allergy (diphenhydramine) side effects

Stop taking diphenhydramine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

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

• 
  

  sleepiness, fatigue, or dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

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 Siladryl Allergy (diphenhydramine)?

Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These products may contain medicines similar to diphenhydramine, which could lead to an antihistamine overdose.

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• 
  

  anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);

  
  


• 
  

  medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or

  
  


• 
  

  any other medications that make you feel drowsy, sleepy, or relaxed.

  
  

Drugs other than those listed here may also interact with diphenhydramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Siladryl Allergy resources

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

• Banophen MedFacts Consumer Leaflet (Wolters Kluwer)


• Ben-Tann Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Benadryl Consumer Overview


• Benadryl Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Benadryl Allergy Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Children's Allergy Prescribing Information (FDA)


• Diphen Advanced Consumer (Micromedex) - Includes Dosage Information


• Diphenhydramine MedFacts Consumer Leaflet (Wolters Kluwer)


• Diphenhydramine Prescribing Information (FDA)


• Diphenhydramine Hydrochloride Monograph (AHFS DI)


• Diphenoxylate Hydrochloride Monograph (AHFS DI)


• Dytuss Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Simply Sleep MedFacts Consumer Leaflet (Wolters Kluwer)


• Sominex MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Siladryl Allergy with other medications

• Allergic Reactions
• Cold Symptoms
• Cough
• Extrapyramidal Reaction
• Hay Fever
• Insomnia
• Motion Sickness
• Nausea/Vomiting
• Pruritus
• Urticaria

Where can I get more information?

• Your pharmacist can provide more information about diphenhydramine.

See also: Siladryl Allergy side effects (in more detail)

Trisenox

Generic Name: Arsenic Trioxide
Class: Antineoplastic Agents
VA Class: AN900
CAS Number: 1327-53-3

• Experience of Supervising Clinician


• 
  

  Use under the supervision of a qualified clinician experienced in the management of acute leukemia.¹

  
  

• Acute Promyelocytic Leukemia (APL) Differentiation Syndrome


• 
  

  Risk of developing potentially fatal APL differentiation syndrome.¹

  
  


• 
  

  If signs or symptoms suggestive of APL differentiation syndrome (e.g., unexplained fever, dyspnea, weight gain, abnormal chest auscultatory findings, radiographic abnormalities) occur, initiate high-dose corticosteroid therapy (e.g., dexamethasone phosphate 10 mg IV twice daily for 3 days or longer until symptoms resolve) immediately regardless of the patient's leukocyte count; discontinuance of arsenic trioxide generally is not required.¹

  
  

• ECG Abnormalities


• 
  

  Risk of potentially fatal atypical ventricular tachycardia (torsades de pointes) and complete atrioventricular block,^{1 4 6 8 10} particularly in patients with a history of torsades de pointes, CHF, or preexisting QT interval prolongation, and in those receiving drugs that might prolong the QT interval or produce electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia).¹

  
  

• ECG and Electrolyte Monitoring


• 
  

  Prior to initiation of therapy, perform baseline ECG and determine serum electrolyte (potassium, calcium, and magnesium) and creatinine concentrations.^{1 6 7}

  
  


• 
  

  If baseline QT_c interval >500 msec, institute appropriate corrective measures and reassess with serial ECGs prior to considering arsenic trioxide therapy.¹

  
  


• 
  

  Correct preexisting electrolyte abnormalities; if possible, discontinue drugs known to prolong the QT interval.¹

  
  


• 
  

  During therapy, maintain serum potassium concentrations >4 mEq/L and serum magnesium concentrations >1.8 mg/dL and monitor ECGs weekly (more frequently in clinically unstable patients).^{1 10}

  
  


• 
  

  If QT interval >500 msec during therapy, correct any concomitant risk factors immediately and weigh the risks/benefits of continued therapy.^{1 11}

  
  


• 
  

  If syncope and/or rapid or irregular heartbeat occurs, hospitalize patient for careful monitoring; discontinue arsenic trioxide until QT_c interval decreases to <460 msec, electrolyte abnormalities are corrected, and syncope and irregular heartbeat resolve.¹

  
  

Introduction

Antineoplastic agent.¹

Uses for Trisenox

Refractory or Relapsed Acute Promyelocytic Leukemia

Induction of remission and consolidation of acute promyelocytic leukemia (APL) that is refractory to retinoid and anthracycline therapy or has relapsed following such therapy;^{1 4 16 17} used in patients whose disease is characterized by the presence of the t(15;17) translocation or promyelocytic leukemia-retinoic acid receptor (PML-RAR)-α gene expression.^{1 5}

Actuarial 18-month relapse-free survival rate: 56%.¹⁷

Newly Diagnosed Acute Promyelocytic Leukemia

As a component of therapy for newly diagnosed APL† in combination with other agents and consolidation chemotherapy.^{17 20 25}

Combination therapy with arsenic trioxide and tretinoin has been used as an alternative to chemotherapy for induction and postremission therapy in newly diagnosed APL†; may consider use of these regimens in select patients who cannot tolerate standard anthracycline-containing chemotherapy (e.g., geriatric patients with poor performance or patients with cardiac dysfunction).^{27 28 29}

Trisenox Dosage and Administration

General

• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.¹

  
  

Administration

Administer by IV infusion.¹

IV Administration

For solution compatibility information, see Compatibility under Stability.

IV solutions of the drug contain no preservatives; discard any unused portion of single-use ampul.¹

Do not mix with other drugs.¹

Dilution

Immediately after withdrawing the appropriate dose of the drug from the ampul, dilute with 100–250 mL of 5% dextrose injection or 0.9% sodium chloride injection.¹

Rate of Administration

Administer by IV infusion over 1–2 hours; if acute vasomotor reactions occur, longer infusion periods (e.g., up to 4 hours) may be used.¹

Dosage

Pediatric Patients

Acute Promyelocytic Leukemia

Induction Therapy

IV

In children ≥5 years of age, 0.15 mg/kg daily.¹ Continue until bone marrow remission occurs or for a maximum of 60 doses.¹

Consolidation Therapy

IV

In children ≥5 years of age, 0.15 mg/kg daily for 25 doses, administered over a period of up to 5 weeks.¹ Initiate 3–6 weeks after completion of induction therapy.¹

Adults

Acute Promyelocytic Leukemia

Induction Therapy

IV

0.15 mg/kg daily.¹ Continue until bone marrow remission occurs or for a maximum of 60 doses.¹

Consolidation Therapy

IV

0.15 mg/kg daily for 25 doses, administered over a period of up to 5 weeks.¹ Initiate 3–6 weeks after completion of induction therapy.¹

Cautions for Trisenox

Contraindications

• 
  

  Known hypersensitivity to arsenic trioxide or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

For warnings regarding experience of supervising clinician, APL differentiation syndrome, ECG abnormalities, and ECG and electrolyte monitoring, see Boxed Warning.

Hyperleukocytosis

Possible hyperleukocytosis (leukocyte count ≥10,000/mm³).^{1 11}

Carcinogenicity

Carcinogenicity studies not performed using IV arsenic trioxide; however, arsenic trioxide is a human carcinogen.¹

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; avoid pregnancy during therapy.¹ If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.¹

General Precautions

Adequate Patient Monitoring

Perform hematologic and coagulation tests and determine serum electrolyte concentrations at least twice weekly during induction therapy (more frequently in clinically unstable patients) and at least weekly during consolidation therapy.¹

Monitor ECG weekly (more frequently in clinically unstable patients) during induction and consolidation therapy.¹

Specific Populations

Pregnancy

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

Lactation

Arsenic is distributed into milk in humans;¹ discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children <5 years of age.¹

Used in 7 children 5–16 years of age with APL in one study and in 13 children and young adults 4–21 years of age with refractory or relapsed APL in another study; 5 and 11 achieved complete responses, respectively.^{1 11 26}

Hepatic Impairment

Not studied in patients with hepatic impairment.¹

Renal Impairment

Not studied in patients with renal impairment.¹

Potential for prolonged elimination.¹ Use with caution in patients with renal failure.¹

Common Adverse Effects

Leukocytosis, GI effects (nausea, vomiting, diarrhea, abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, dizziness.¹

Interactions for Trisenox

Extensively metabolized in the liver.¹ Methyltransferases involved in metabolism of arsenic trioxide are not CYP isoenzymes.¹

Has no inhibitory effects on metabolism of substrates of major CYP isoenzymes (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11).¹

No formal drug interaction studies to date.¹

Drugs that Prolong the QT Interval

Potential pharmacologic interaction (additive effects on prolongation of the QT interval).^{14 15}

Drugs that May be Associated with Electrolyte Abnormalities

Potential pharmacologic interaction (additive effects on prolongation of the QT interval).¹

Specific Drugs

Drug	Interaction	Comments
Amphotericin B	Additive effects on prolongation of QT interval1	Use with caution1
Antiarrhythmics producing QT-interval prolongation	Additive effects on prolongation of QT interval1	Use with caution1
Diuretics (potassium-wasting)	Additive effects on prolongation of QT interval1	Use with caution1
Pimozide	Additive effects on prolongation of QT interval14 15	Concomitant use not recommended14 15
Thioridazine	Additive effects on prolongation of QT interval1	Use with caution1
Ziprasidone	Additive effects on prolongation of QT interval14 15	Concomitant use not recommended14 15

Trisenox Pharmacokinetics

Pharmacokinetics of trivalent arsenic have not been characterized.¹

Distribution

Extent

Arsenic is stored mainly in liver, kidney, heart, lung, hair, and nails.¹

Inorganic arsenical preparations cross the placenta in animals.¹

Elimination

Metabolism

Arsenic trioxide is extensively metabolized via reduction by arsenate reductase and methylation (mainly in the liver) by methyltransferases.¹

Elimination Route

Trivalent arsenic is excreted in urine.¹

Stability

Storage

Parenteral

Solution

25°C (may be exposed to 15–30°C).¹ Do not freeze.¹

Chemically and physically stable after dilution for 24 hours at room temperature and 48 hours when refrigerated.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible1
Dextrose 5% in water
Sodium chloride 0.9%

ActionsActions

• 
  

  Mechanism of action not fully elucidated.^{1 5}

  
  


• 
  

  Believed to induce apoptosis (programmed cell death) of promyelocytic leukemia cells.^{1 5}

  
  

Advice to Patients

• 
  

  Importance of informing clinicians if unexplained fever, dyspnea, or weight gain occurs.¹

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Boxed Warning and see Cautions.)

  
  

Preparations

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

Arsenic Trioxide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV use only	1 mg/mL (10 mg)	Trisenox	Cephalon

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 January 2010. 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.

1. Cephalon. Trisenox (arsenic trioxide) injection prescribing information. Frazer, PA; 2006 Jul.

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

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

4. Anon. FDA approves arsenic trioxide for leukemia treatment in record time for a cancer drug development program. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2000 Sep 26.

5. Soignet SL, Maslak P, Wang ZG et al. Complete remission after treatment of acute promyelocytic leukemia with arsenic trioxide. N Engl J Med. 1998; 339:1341-8. [IDIS 430941] [PubMed 9801394]

6. Food and Drug Administration. Torsades de pointes arrhythmia and sudden death associated with the use of arsenic trioxide. Medwatch safety information summaries 2001. Rockville, MD; March 2001. From FDA website ()

7. Food and Drug Administration: Healthcare providers reminded to closely monitor patients on arsenic trioxide. Medwatch safety information summaries 2001. Rockville, MD; March 2001. From FDA website () Correction.

8. Dear health care provider letter regarding the importance of close monitoring of patients on arsenic trioxide. Seattle, WA: Cell Therapeutics; 2001 March.

9. Unnikrishnan D, Dutcher JP, Varshneya N et al. Torsades de pointes in 3 patients with leukemia treated with arsenic trioxide. Blood. 2001; 97:1514-6. [IDIS 459938] [PubMed 11222403]

10. Ohnishi K, Yoshida H, Shigeno K et al. Prolongation of the QT interval and ventricular tachycardia in patients treated with arsenic trioxide for acute promyelocytic leukemia. Ann Intern Med. 2000; 133:881-5. [IDIS 456624] [PubMed 11103058]

11. Cell Therapeutics, Seattle, WA: Personal communication.

12. Westervelt P, Brown RA, Adkins DR et al. Sudden death among patients with acute promyelocytic leukemia treated with arsenic trioxide. Blood. 2001; 98:266-71. [IDIS 466692] [PubMed 11435292]

13. Dear doctor letter commenting on the report of sudden death in 3 patients receiving arsenic trioxide. Seattle, WA: Cell Therapeutics; 2001 Jul 24.

14. Food and Drug Administration. MedWatch—Safety-related drug labeling changes: Geodon (ziprasidone) capsules [February 15, 2002]. From FDA web site .

15. Food and Drug Administration. MedWatch—Safety-related drug labeling changes: Omap (pimozide) [November 14, 2002]. From FDA web site .

16. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52. [PubMed 15529105]

17. Adult acute myeloid leukemia. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 Aug 8.

18. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97[[030]]414). Rockville, MD; [May 5, 2003]. From FDA web site .

19. Soignet SL, Frankel SR, Douer D et al. United States multicenter study of arsenic trioxide in relapsed acute promyelocytic leukemia. J Clin Oncol. 2001; 19:3852-60. [IDIS 469715] [PubMed 11559723]

20. Childhood acute myeloid leukemia/other myeloid malignancies. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 Aug 18.

21. Shen ZX, Shi ZZ, Fang J et al. All-trans retinoic acid/As2O3 combination yields a high quality remission and survival in newly diagnosed acute promyelocytic leukemia. Proc Natl Acad Sci U S A. 2004; 101:5328-35. [PubMed 15044693]

22. Hussein MA, Saleh M, Ravandi F et al. Phase 2 study of arsenic trioxide in patients with relapsed or refractory multiple myeloma. Br J Haematol. 2004; 125:470-6. [PubMed 15142117]

23. Munshi NC, Tricot G, Desikan R et al. Clinical activity of arsenic trioxide for the treatment of multiple myeloma. Leukemia. 2002; 16:1835-7. [PubMed 12200700]

24. Sekeres MA. Arsenic trioxide as a treatment for myelodysplastic syndrome. Curr Hematol Rep. 2005; 4:59-63. [PubMed 15610661]

25. Powell BL, Moser B, Stock W et al. Effect of consolidation with arsenic trioxide (As₂O₃) on event-free survival (EFS) and overall survival (OS) among patients with newly diagnosed acute promyelocytic leukemia (APL): North American Intergroup Protocol C9710. Proc ASCO. 2007; Abstract No. 2..

26. Fox E, Razzouk BI, Widemann BC et al. Phase I trial and pharmacokinetic study of arsenic trioxide in children and adolescents with refractory or relapsed acute leukemia, including acute promyelocytic leukemia or lymphoma. Blood. 2008; 111:566-73. [PubMed 17959855]

27. Estey E, Garcia-Manero G, Ferrajoli A et al. Use of all-trans retinoic acid plus arsenic trioxide as an alternative to chemotherapy in untreated acute promyelocytic leukemia. Blood. 2006; 107:3469-73. [PubMed 16373661]

28. Mathews V, George B, Lakshmi KM et al. Single-agent arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia: durable remissions with minimal toxicity. Blood. 2006; 107:2627-32. [PubMed 16352810]

29. Douer D. ATO: the forefront of APL treatment? Blood. 2006; 107:2588-2589.

HID. Trissel LA. Handbook on injectable drugs. 14th ed; Bethesda, MD: American Society of Health-System Pharmacists; 2007:171.

More Trisenox resources

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

• Trisenox Prescribing Information (FDA)


• Trisenox MedFacts Consumer Leaflet (Wolters Kluwer)


• Trisenox Concise Consumer Information (Cerner Multum)


• Trisenox Advanced Consumer (Micromedex) - Includes Dosage Information


• Arsenic Trioxide Professional Patient Advice (Wolters Kluwer)

Compare Trisenox with other medications

• Acute Promyelocytic Leukemia

Sulfoxyl Strong

Generic Name: benzoyl peroxide and sulfur topical (BEN zoe ill per OX ide and SULL fur)

Brand Names: NuOx, Sulfoxyl Regular, Sulfoxyl Strong

What is Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect that decreases oiliness of the skin.

When sulfur is applied topically, it causes drying and peeling of the skin. This allows excess oils and dirt to be easily washed away.

Benzoyl peroxide and sulfur topical is used to treat acne.

Benzoyl peroxide and sulfur topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Do not use benzoyl peroxide and sulfur topical on sunburned, windburned, dry, chapped, or irritated skin or on an open wound.

Avoid abrasive, harsh, or drying soaps and cleansers while using benzoyl peroxide and sulfur topical.

Avoid contact with clothing and hair. Benzoyl peroxide may cause bleaching.

Avoid combining PABA-containing sunscreens and benzoyl peroxide and sulfur topical. Temporary skin discoloration may occur if they are used together.

Who should not use Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Do not use benzoyl peroxide and sulfur topical on sunburned, windburned, dry, chapped, or irritated skin. It could make these conditions much worse. Also avoid using benzoyl peroxide and sulfur topical in wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Do not use benzoyl peroxide and sulfur topical during treatment with tretinoin (Retin-A). The combination could lead to severe skin irritation.

It is not known whether benzoyl peroxide and sulfur topical will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether benzoyl peroxide and sulfur topical passes into breast milk. Do not use benzoyl peroxide and sulfur topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Use benzoyl peroxide and sulfur topical exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after applying this medication.

Clean and dry the area of skin where you will apply benzoyl peroxide and sulfur topical. Apply the medication to the affected area. When applying benzoyl peroxide and sulfur topical, avoid your eyes, the inside of your nose and mouth, your lips, and areas where the skin is broken to prevent excessive irritation. If you get medication in any of these areas, rinse it off with water. Do not cover the affected area after applying benzoyl peroxide and sulfur topical. Doing so could cause too much medicine to be absorbed by your body and could be harmful. It may take several weeks or more to see the effects of this drug. Do not stop using benzoyl peroxide and sulfur topical if you do not see results immediately.

Apply benzoyl peroxide and sulfur topical less often if you experience excessive burning, dryness, or irritation.

Store benzoyl peroxide and sulfur topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only your next regularly scheduled dose.

What happens if I overdose?

An overdose of benzoyl peroxide and sulfur topical is unlikely to occur. If you do suspect an overdose, or if benzoyl peroxide and sulfur topical has been ingested, call a poison control center or an emergency room for advice.

What should I avoid while using Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Do not use benzoyl peroxide and sulfur topical on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid using other topical products on the same area at the same time unless directed to do so by your doctor. They may interfere with the effects or absorption of benzoyl peroxide and sulfur topical.

Do not cover the area after applying benzoyl peroxide and sulfur topical. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area you are treating.

Avoid contact with clothing and hair. Benzoyl peroxide may cause bleaching.

Avoid combining PABA-containing sunscreens and benzoyl peroxide and sulfur topical. Temporary skin discoloration may occur if they are used together.

Sulfoxyl Strong (benzoyl peroxide and sulfur topical) side effects

Serious side effects are not likely to occur. Stop using benzoyl peroxide and sulfur topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

You may experience some burning, stinging, tingling, itching, redness, dryness, peeling, or irritation while you are using benzoyl peroxide topical. If these side effects are excessive, apply benzoyl peroxide and sulfur topical less often.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sulfoxyl Strong (benzoyl peroxide and sulfur topical)?

Do not use benzoyl peroxide and sulfur topical during treatment with tretinoin (Retin-A). The combination could lead to severe skin irritation.

Do not use other topical prescription or over-the-counter products unless directed to do so by your doctor. They may interfere with your treatment or increase irritation to your skin.

Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area you are treating.

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

More Sulfoxyl Strong resources

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

• Sulfoxyl Strong Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• NuOx Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Sulfoxyl Strong with other medications

• Acne

Where can I get more information?

• Your pharmacist has additional information about benzoyl peroxide and sulfur topical written for health professionals that you may read.

See also: Sulfoxyl Strong side effects (in more detail)

Soloxine

Dosage Form: FOR ANIMAL USE ONLY
Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

Description

Each Soloxine® (Levothyroxine Sodium, USP) Tablet provides synthetic crystalline levothyroxine sodium (L-thyroxine).

The structural formula for levothyroxine sodium is:

Levothyroxine Sodium Action

Levothyroxine sodium acts, as does endogenous thyroxine, to stimulate metabolism, growth, development and differentiation of tissues. It increases the rate of energy exchange and increases the maturation rate of the epiphyses. Levothyroxine sodium is absorbed rapidly from the gastrointestinal tract after oral administration. Following absorption, the compound becomes bound to the serum alpha globulin fraction. For purposes of comparison, 0.1 mg of levothyroxine sodium elicits a clinical response approximately equal to that produced by one grain (65 mg) of desiccated thyroid.

Indications

Provides thyroid replacement therapy in all conditions of inadequate production of thyroid hormones. Hypothyroidism is the generalized metabolic disease resulting from deficiency of the thyroid hormones levothyroxine (T4) and liothyronine (T3). Soloxine (levothyroxine sodium) will provide levothyroxine (T4) as a substrate for the physiologic deiodination to liothyronine (T3). Administration of levothyroxine sodium alone will result in complete physiologic thyroid replacement.

Canine hypothyroidism is usually primary, i.e., due to atrophy of the thyroid gland. In the majority of cases the atrophy is associated with lymphocytic thyroiditis and in the remainder it is non-inflammatory and as of yet unknown etiology. Less than 10 percent of cases of hypothyroidism are secondary, i.e., due to deficiency of thyroid stimulating hormone (TSH). TSH deficiency may occur as a component of congenital hypopituitarism or as an acquired disorder in adult dogs, in which case it is invariably due to the growth of a pituitary tumor.

Hypothyroidism in the Dog

Hypothyroidism usually occurs in middle-aged and older dogs although the condition will sometimes be seen in younger dogs of the larger breeds. Neutered animals of either sex are also frequently affected, regardless of age. The following are clinical signs of hypothyroidism in dogs:

 

Lethargy, lack of endurance, increased sleeping

 

Reduced interest, alertness and excitability

 

Slow heart rate, weak apex beat and pulse, low voltage on ECG

 

Preference for warmth, low body temperature, cool skin

 

Increased body weight

 

Stiff and slow movements, dragging of front feet

 

Head tilt, disturbed balance, unilateral facial paralysis

 

Atrophy of epidermis, thickening of dermis

 

Surface and follicular hyperkeratosis, pigmentation

 

Puffy face, blepharoptosis, tragic expression

 

Dry, coarse, sparse coat, slow regrowth after clipping

 

Retarded turnover of hair (carpet coat of boxers)

 

Shortening or absence of estrus, lack of libido

 

Dry feces, occasional diarrhea

 

Hypercholesterolemia

 

Normochromic, normocytic anemia

 

Elevated serum creatinine phosphokinase

Contraindications

Levothyroxine sodium therapy is contraindicated in thyrotoxicosis, acute myocardial infarction and uncorrected adrenal insufficiency. Use in pregnant bitches has not been evaluated.

Precautions

The effects of levothyroxine sodium therapy are slow in being manifested. Overdosage of any thyroid drug may produce the signs and symptoms of thyrotoxicosis including, but not limited to: polydipsia, polyuria, polyphagia, reduced heat tolerance and hyperactivity or personality change. Administer with caution to animals with clinically significant heart disease, hypertension or other complications for which a sharply increased metabolic rate might prove hazardous.

Adverse Reactions

There are no particular adverse reactions associated with levothyroxine sodium therapy at the recommended dosage levels. Overdosage will result in the signs of thyrotoxicosis listed above under precautions.

Dosage

The initial recommended dose is 0.1 mg/10 lb. (4.5 kg) body weight twice daily. Dosage is then adjusted by monitoring the thyroid blood levels of the dog every four weeks until an adequate maintenance dose is established. The usual maintenance dose is 0.1 mg/10 lb. (4.5 kg) once daily.

A maximum of 0.8 mg to 1.0 mg total daily dose will be sufficient in most dogs over 80 pounds in body weight.

Administration

Soloxine tablets may be administered orally or placed in the food.

Dosage forms available

0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg and 1.0 mg tablets in bottles of 250 and 1,000.

Storage

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

References

1. Evinger, J.V. and Nelson, R.W.; JAVMA 314. 1984, pg 185, 314-316.


2. Richard Nelson, DVM; Current Veterinary Therapy X. Edited by R. W. Kirk, W. B. Saunders, Co., Philadelphia, PA 1989, pg 994.


3. Edward Feldman, DVM and Richard Nelson, DVM; Canine and Feline Endocrinology and Reproduction. W. B. Saunders 1987, pg 82.

Virbac AH, Inc.

Fort Worth, TX 76137

For More Information Call

1-800-338-3659

11/09

301787-02

PRINCIPAL DISPLAY PANEL - 0.1 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-831-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.1 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-832-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.2 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.3 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-833-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.3 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.4 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-834-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.4 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-835-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.5 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.6 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-836-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.6 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.7 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-837-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.7 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 0.8 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-838-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

0.8 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

PRINCIPAL DISPLAY PANEL - 1.0 mg Tablet Bottle Label

Virbac

ANIMAL HEALTH

NDC 051311-830-25

Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

1.0 mg

250 TABLETS

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Virbac AH, Inc. • P.O. Box 162059

Fort Worth, TX 76161 • (800) 338-3659

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-831 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.1 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;1 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-831-10 1000 TABLET In 1 BOTTLE None 2 51311-831-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-832 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.2 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PINK Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-832-10 1000 TABLET In 1 BOTTLE None 2 51311-832-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-833 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.3 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color GREEN Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;3 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-833-10 1000 TABLET In 1 BOTTLE None 2 51311-833-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-834 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.4 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color RED (Maroon) Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;4 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-834-10 1000 TABLET In 1 BOTTLE None 2 51311-834-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-835 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.5 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;5 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-835-10 1000 TABLET In 1 BOTTLE None 2 51311-835-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-836 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.6 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PURPLE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;6 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-836-10 1000 TABLET In 1 BOTTLE None 2 51311-836-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-837 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.7 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color ORANGE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;7 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-837-10 1000 TABLET In 1 BOTTLE None 2 51311-837-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-838 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.8 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BLUE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;8 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-838-10 1000 TABLET In 1 BOTTLE None 2 51311-838-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-830 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 1 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN (Beige) Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 1 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-830-10 1000 TABLET In 1 BOTTLE None 2 51311-830-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Labeler - Virbac AH, Inc. (131568396)

Establishment
Name	Address	ID/FEI	Operations
Virbac Bridgeton		808558100	MANUFACTURE

Revised: 12/2009Virbac AH, Inc.