Sodium Polystyrene Sulfonate Oral Powder

Sodium Polystyrene

Sulfonate Suspension, USP

Sorbitol Free

Sodium Polystyrene Sulfonate Oral Powder Description

Sodium Polystyrene Sulfonate Suspension, USP can be administered orally or in an enema. It is a raspberry-flavored suspension containing 15 grams of cation-exchange resin (sodium polystyrene sulfonate, USP); 0.12 mL (0.2%) of alcohol per 60 mL of suspension. Also contains purified water, propylene glycol, magnesium aluminum silicate, xanthan gum, sodium saccharin, citric acid, methylparaben, propylparaben, and flavor.

Sodium polystyrene sulfonate is a benzene, diethenyl-, polymer with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:

The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with anin-vitroexchange capacity of approximately 3.1 mEq (in-vivoapproximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema.

Sodium Polystyrene Sulfonate Oral Powder - Clinical Pharmacology

As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. For the most part, this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable. It commonly approximates the order of 33%, but the range is so large that definitive indices of electrolyte balance must be clearly monitored.

Metabolic data are unavailable.

INDICATION AND USAGE

Sodium Polystyrene Sulfonate Suspension, USP is indicated for the treatment of hyperkalemia.

Contraindications

Sodium Polystyrene Sulfonate Suspension, USP is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, oral or rectal administration in neonates (particularly in premature infants), and in any post-operative patient until normal bowel function resumes (seePRECAUTIONS).

Warnings

Alternative Therapy in Severe Hyperkalemia

Since the effective lowering of serum potassium with sodium polystyrene sulfonate may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.

Hypokalemia

Serious potassium deficiency can occur from sodium polystyrene sulfonate therapy. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with sodium polystyrene sulfonate should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient's clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes.

Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis.

Electrolyte Disturbances

Like all cation-exchange resins, sodium polystyrene sulfonate is not totally selective (for potassium) in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving sodium polystyrene sulfonate should be monitored for all applicable electrolyte disturbances.

Systemic Alkalosis

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with sodium polystyrene sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative (seePRECAUTIONS, Drug Interactions).

Colonic Necrosis

Cases of colonic necrosis and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with sodium polystyrene sulfonate use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. Concomitant administration of sorbitol is not recommended (seePRECAUTIONS, Drug Interactions).

Precautions

Caution is advised when sodium polystyrene sulfonate is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances, compensatory restriction of sodium intake from other sources may be indicated.

Caution is advised when Sodium Polystyrene Sulfonate Suspension, USP is administered to patients with end stage diabetic renal disease.

Sodium Polystyrene Sulfonate Suspension, USP should not be administered to patients following surgery until normal bowel function resumes.

Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

In the event of clinically significant constipation, treatment with Sodium Polystyrene Sulfonate Suspension, USP should be discontinued until normal bowel motion is resumed. Magnesium-containing laxatives should not be used (seePRECAUTIONS, Drug Interactions).

Drug Interactions

Antacids

The simultaneous oral administration of sodium polystyrene sulfonate with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability.

Non-absorbable cation-donating antacids and laxatives

Systemic alkalosis has been reported after cation exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with sodium polystyrene sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative.

Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate has been reported.

Digitalis

The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the "normal range" (seeWARNINGS).

Sorbitol

Concomitant use of sorbitol with Sodium Polystyrene Sulfonate Suspension, USP is not recommended.

Lithium

Sodium Polystyrene Sulfonate Suspension, USP may decrease absorption of lithium.

Thyroxine

Sodium Polystyrene Sulfonate Suspension, USP may decrease absorption of thyroxine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed.

Pregnancy Category C

Animal reproduction studies have not been conducted with sodium polystyrene sulfonate. It is also not known whether sodium polystyrene sulfonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium polystyrene sulfonate should be given to a pregnant woman only if clearly needed.

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 sodium polystyrene sulfonate is administered to a nursing woman.

Pediatric Use

The effectiveness of Sodium Polystyrene Sulfonate Suspension, USP in pediatric patients has not been established. The use of Sodium Polystyrene Sulfonate Suspension, USP is contraindicated in neonates and especially in premature infants. In children, particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin. Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

Adverse Reactions

Sodium Polystyrene Sulfonate Suspension, USP may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, and significant sodium retention, and their related clinical manifestations, may occur (seeWARNINGS). Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction (seePRECAUTIONS). Rare instances of colonic necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with sodium polystyrene sulfonate, has been reported.

The following events have been reported from worldwide post marketing experience:

• Fecal impaction following rectal administration, particularly in children;


• Gastrointestinal concretions (bezoars) following oral administration;


• Gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation; and


• Rare cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of polystyrene sulfonate.

Overdosage

Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea.

Electrocardiographic changes may be consistent with hypokalemia or hypercalcemia; cardiac arrhythmias may occur. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.

Sodium Polystyrene Sulfonate Oral Powder Dosage and Administration

The average daily adult dose is 15 g (60 mL) to 60 g (240 mL) of suspension. This is best provided by administering 15 g (60 mL) of Sodium Polystyrene Sulfonate Suspension, USP one to four times daily. Each 60 mL of Sodium Polystyrene Sulfonate Suspension, USP contains 1500 mg (65 mEq) of sodium. Since thein-vivoefficiency of sodium-potassium exchange resins is approximately 33%, about one-third of the resin's actual sodium content is being delivered to the body.

In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation.

Sodium Polystyrene Sulfonate Suspension, USP may be introduced into the stomach through a plastic tube and, if desired, given with a diet appropriate for a patient in renal failure.

Sodium Polystyrene Sulfonate Suspension, USP may also be given, although with less effective results, as an enema consisting (for adults) of 30 g (120 mL) to 50 g (200 mL) every six hours. The enema should be retained as long as possible and followed by a cleansing enema.

After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped into place. The suspension is introduced at body temperature by gravity. The suspension is flushed with 50 or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. The suspension is kept in the sigmoid colon for several hours, if possible. Then the colon is irrigated with a sodium-free cleansing enema at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used.

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

Sodium Polystyrene Sulfonate Suspension, USP should not be heated for to do so may alter the exchange properties of the resin.

How is Sodium Polystyrene Sulfonate Oral Powder Supplied

Sodium Polystyrene Sulfonate Suspension, USP is a light brown, raspberry-flavored suspension supplied as follows:

480 mL (16 Fluid Ounce)	NDC 0574-2003-16
Unit-Dose 60 mL (2 Fluid Ounce), 10 bottles per carton	NDC 0574-2003-02

Dispense in tight container, as defined in the USP. If repackaging into other containers, store in refrigerator and use within 14 days of packaging.

SHAKE WELL BEFORE USING.

Store at 20 to 25 C (68 to 77 F) [see USP controlled room temperature].

Paddock Laboratories, Inc.

Minneapolis, MN 55427

(04-11A)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

NDC 0574-2003-02

SODIUM POLYSTYRENE

SULFONATE SUSPENSION, USP

15 g/60 mL

Does not contain Sorbitol

Dispense in tight container.

SHAKE WELL BEFORE USING

See package insert for complete prescribing information.

FOR ORAL OR RECTAL USE

Protect from freezing and excessive heat.

NET CONTENTS 60 mL (2 fl oz)

Rx ONLY

Paddock

Laboratories, Inc.

SODIUM POLYSTYRENE SULFONATE  sodium polystyrene sulfonate  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0574-2003 Route of Administration ORAL, RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Polystyrene Sulfonate (Sodium Cation) Sodium Polystyrene Sulfonate 15 g  in 60 mL

Inactive Ingredients Ingredient Name Strength Alcohol 0.12 mL  in 60 mL water   propylene glycol   magnesium aluminum silicate   xanthan gum   saccharin sodium   citric acid monohydrate   methylparaben   propylparaben

Product Characteristics Color BROWN (Light-brown) Score      Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0574-2003-02 60 mL In 1 BOTTLE None 2 0574-2003-16 480 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090590	09/21/2011

Labeler - Paddock Laboratories, LLC (967694121)

Establishment
Name	Address	ID/FEI	Operations
Paddock Laboratories, LLC		967694121	Manufacture

Revised: 09/2011Paddock Laboratories, LLC

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Trimethoprim

Pronunciation: trye-METH-oh-prim
Generic Name: Trimethoprim
Brand Name: Proloprim

Trimethoprim is used for:

Treating infections caused by certain bacteria.

Trimethoprim is an antibiotic. It works by killing sensitive bacteria.

Do NOT use Trimethoprim if:

• you are allergic to any ingredient in Trimethoprim or to similar medicines


• you are taking dofetilide


• you have anemia caused by low levels of folate in the blood

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

Before using Trimethoprim:

Some medical conditions may interact with Trimethoprim. 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 liver or kidney problems or blood problems (eg, anemia, porphyria)


• if you have or are at risk for low levels of folate in the blood (eg, you have alcoholism, are elderly, you do not absorb nutrients from food properly, you are in a poor nutritional state, you are taking medicine for seizures)

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

• Dofetilide because risk of severe heart problems may be increased by Trimethoprim


• Methotrexate, phenytoin, or sulfones (eg, dapsone) because their actions and the risk of their side effects may be increased by Trimethoprim


• Cyclosporine because its effectiveness may be decreased and risk of liver side effects may be increased by Trimethoprim

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trimethoprim 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 Trimethoprim:

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

• Take Trimethoprim by mouth with or without food.


• Trimethoprim works best if it is taken at the same time each day.


• To clear up your infection completely, use Trimethoprim for the full course of treatment. Keep using it even if you feel better in a few days.


• If you miss a dose of Trimethoprim, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Trimethoprim may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Trimethoprim. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Be sure to use Trimethoprim for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Trimethoprim only works against bacteria; it does not treat viral infections (eg, the common cold).


• Long-term or repeated use of Trimethoprim may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Trimethoprim may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Trimethoprim.


• Lab tests, including complete blood cell counts, may be performed while you use Trimethoprim. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Trimethoprim with caution in ELDERLY; they may be more sensitive to the effects of Trimethoprim.


• Trimethoprim should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• Use Trimethoprim with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Trimethoprim while you are pregnant. Trimethoprim is found in breast milk. If you are or will be breast-feeding while you use Trimethoprim, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Trimethoprim:

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:

Nausea; skin sensitivity to sunlight; stomach upset; 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); blistered, peeling, red, or swollen skin; bloody or black, tarry stools; chest pain; chills, fever, or sore throat; decreased urination; joint or muscle pain; irregular heartbeat; painful or stiff neck; purple patches under the skin; seizures; severe diarrhea; shortness of breath; stomach cramps/pain; unusual bruising or bleeding; unusual tiredness or weakness; unusually pale skin; vaginal irritation or discharge; yellowing of the skin or eyes.

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: Trimethoprim 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; depression; dizziness; drowsiness; fever, chills, or sore throat; loss of consciousness; severe nausea or vomiting; severe or prolonged headache; unusual bruising or bleeding.

Proper storage of Trimethoprim:

Store Trimethoprim at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Keep in a tight, light-resistant container. Do not store in the bathroom. Keep Trimethoprim out of the reach of children and away from pets.

General information:

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


• Trimethoprim 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 Trimethoprim. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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• 0 Reviews for Trimethoprim - Add your own review/rating

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• Trimethoprim Prescribing Information (FDA)


• trimethoprim Concise Consumer Information (Cerner Multum)


• trimethoprim Advanced Consumer (Micromedex) - Includes Dosage Information


• Proloprim Prescribing Information (FDA)

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Senokot Liquid

Pronunciation: SEN-oh-sides
Generic Name: Sennosides
Brand Name: Examples include Senexon and Senokot

Senokot Liquid is used for:

Treating constipation.

Senokot Liquid is a stimulant laxative. It works by irritating bowel tissues, resulting in bowel movements.

Do NOT use Senokot Liquid if:

• you are allergic to any ingredient in Senokot Liquid


• you have had recent abdominal surgery or require immediate abdominal surgery


• you have appendicitis; bleeding of the stomach, intestine, or rectum; or an obstruction in your intestines (fecal impaction)

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

Before using Senokot Liquid:

Some medical conditions may interact with Senokot Liquid. 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 congestive heart failure, you are experiencing nausea or vomiting, or you have undiagnosed stomach pain

Some MEDICINES MAY INTERACT with Senokot Liquid. However, no specific interactions with Senokot Liquid are known at this time.

Ask your health care provider if Senokot Liquid 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 Senokot Liquid:

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

• Take Senokot Liquid by mouth with or without food.


• Take Senokot Liquid with a full glass of water (8 oz/240 mL). Drinking extra fluids while you are taking Senokot Liquid is recommended. Check with your doctor for instructions.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• It is best to take Senokot Liquid at bedtime.


• If you miss a dose of Senokot Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Senokot Liquid.

Important safety information:

• A bowel movement usually occurs in 6 to 12 hours.


• Do not use for longer than 1 week without checking with your doctor.


• Using Senokot Liquid for a long time may result in loss of normal bowel function.


• Do not take additional laxatives or stool softeners with Senokot Liquid unless directed by your doctor.


• If you notice a sudden change in bowel habits that lasts for 2 weeks or more, stop using Senokot Liquid and check with your doctor.


• Senokot Liquid may discolor the urine pink to red, or yellow to brown.


• Senokot Liquid should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


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

Overuse of laxatives can lead to a DEPENDENCE on laxatives to have a bowel movement. In severe overuse cases, some laxatives have caused damage to the intestines and bowel.

Possible side effects of Senokot Liquid:

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:

Abdominal discomfort or cramping; diarrhea; nausea.

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); kidney inflammation; poor bowel function; rectal bleeding.

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: Senokot side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Senokot Liquid:

Store Senokot Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Senokot Liquid out of the reach of children and away from pets.

General information:

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


• Senokot Liquid 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 Senokot Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Taclonex Scalp Suspension

Pronunciation: BAY-ta-METH-a-sone/KAL-si-poe-TRYE-een
Generic Name: Betamethasone/Calcipotriene
Brand Name: Taclonex Scalp

Taclonex Scalp Suspension is used for:

Treating a certain type of psoriasis (psoriasis vulgaris) on the scalp. It may also be used for other conditions as determined by your doctor.

Taclonex Scalp Suspension is a combination of a topical corticosteroid and an agent that is similar to vitamin D. Exactly how it works to treat psoriasis is not known.

Do NOT use Taclonex Scalp Suspension if:

• you are allergic to any ingredient in Taclonex Scalp Suspension


• you have a known or suspected calcium metabolism disorder, high levels of calcium or vitamin D in the blood, or high levels of calcium in the urine


• you have certain other types of psoriasis (erythrodermic, exfoliative, pustular)


• you have thin skin or a skin infection on the scalp


• you have severe kidney or liver disease

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

Before using Taclonex Scalp Suspension:

Some medical conditions may interact with Taclonex Scalp 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 liver or kidney problems or kidney stones


• if you have diabetes


• if you have any cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; have an infection; or have had a positive tuberculosis test


• if you are taking prednisone or a similar medicine, or you are having any kind of phototherapy treatment for psoriasis

Some MEDICINES MAY INTERACT with Taclonex Scalp Suspension. Because little, if any, of Taclonex Scalp Suspension is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Taclonex Scalp 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 Taclonex Scalp Suspension:

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

• An extra patient leaflet is available with Taclonex Scalp Suspension. Talk to your pharmacist if you have questions about this information.


• Shake well before each use.


• Wash your hands before and after using Taclonex Scalp Suspension


• Apply a small amount of medicine to the affected area on the scalp and gently rub it in.


• Do not bandage or cover the treated skin area unless directed by your doctor.


• Do not wash your hair right after you apply Taclonex Scalp Suspension.


• Do not apply Taclonex Scalp Suspension within 12 hours before or after any chemical treatments to your hair.


• If you miss a dose of Taclonex Scalp Suspension, apply it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not apply 2 doses at once.

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

Important safety information:

• Taclonex Scalp Suspension is for external use only. Do not get Taclonex Scalp Suspension in the eyes, nose, or mouth. If you get Taclonex Scalp Suspension in your eyes or on your face, rinse immediately with cool water.


• Do NOT use more than the recommended dose or use for longer than 8 weeks without checking with your doctor.


• Taclonex Scalp Suspension is for use on the scalp only. Do not use Taclonex Scalp Suspension on the face, under your arms, or on your groin.


• Taclonex Scalp Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Taclonex Scalp Suspension. Use a sunscreen or wear a hat if you must be outside for more than a short time.


• Talk with your doctor before you receive any vaccine while using Taclonex Scalp Suspension.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Taclonex Scalp Suspension has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Lab tests, including blood calcium level and adrenal gland function, may be performed while you use Taclonex Scalp Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Taclonex Scalp Suspension should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Taclonex Scalp Suspension.


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

Possible side effects of Taclonex Scalp 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:

Mild burning, itching, pain, or redness at the application site.

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); acne-like rash; confusion; eye irritation; increased thirst or urination; inflamed hair pores; muscle weakness; persistent headache; severe burning, cracking, irritation, redness, or peeling skin not present before you began using Taclonex Scalp Suspension; severe or persistent dizziness, drowsiness, or weakness; severe or persistent vomiting; thinning, softening, or discoloration of the skin; unusual or easy bruising; unusual weight gain, especially in the face.

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: Taclonex Scalp 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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Taclonex Scalp Suspension:

Store Taclonex Scalp Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not refrigerate. Store away from heat, moisture, and light. Use within 3 months after opening. Keep Taclonex Scalp Suspension out of the reach of children and away from pets.

General information:

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


• Taclonex Scalp 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 Taclonex Scalp 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 Taclonex Scalp resources

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

Compare Taclonex Scalp with other medications

• Psoriasis

Tonopaque Suspension

barium sulfate

Dosage Form: oral or rectal suspension
LAFAYETTE

TONOPAQUE™

BARIUM SULFATE FOR SUSPENSION


Rx only

Tonopaque Suspension Description

Tonopaque is a cherry flavored barium sulfate formulation for use as a contrast medium during x-ray diagnosis of the gastrointestinal tract. An aqueous suspension of the product is to be prepared at the time of administration.

The contrast medium contains 95% barium sulfate, sorbitol, suspending agents, potassium sorbate, simethicone, flavoring and saccharin sodium. Barium sulfate has the empirical formula of BaSO4.

Tonopaque Suspension - Clinical Pharmacology

Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.

Indications and Usage for Tonopaque Suspension

Tonopaque is indicated for use as a contrast medium in x-ray diagnosis of the gastrointestinal tract.

Contraindications

Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, suspected tracheoesophageal fistula, obstructing lesions of the small intestine, pyloric stenosis, inflammation or neoplastic lesions of the rectum, recent rectal biopsy, or known hypersensitivity to barium sulfate formulations.

Barium sulfate suspensions should not be used for infants with swallowing disorders or for newborns with complete duodenal or jejunal obstruction or when distal small bowel or colon obstruction is suspected. Barium sulfate suspension is not recommended for very small preterm infants and young babies requiring small volumes of contrast media or for infants and young children when there is a possibility of leakage from the gastrointestinal tract, such as necrotizing enterocolitis, unexplained pneumoperitoneum, gasless abdomen, other bowel perforation, esophageal perforation or post operative anastomosis.

Known hypersensitivity or allergy to latex is a contraindication for the use of balloon retention enema tips containing latex. The use of a retention cuff enema tip is not necessary or desirable in patients with normal sphincter tone. The presence of adequate sphincter tone can be judged by preliminary rectal digital examination.

Warnings

Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities.

Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to be likely to result in aspiration into the tracheobronchial tree. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Aspiration of smaller amounts may cause inflammation.

Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.

Barium sulfate suspension has been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis. It has also been reported to cause fluid overload from the absorption of water during studies in infants when Hirschsprung’s Disease is suspected.

Barium sulfate suspension intravasation can be a serious complication. Mortality has been reported as a result of vaginal or rectal intravasation and is believed to be due to massive pulmonary embolism occurring within minutes of the inciting event.

In patients with increased cranial pressure, barium sulfate suspension enemas present an additional risk of further increasing intracranial pressure.

Care must be taken during the insertion of an enema tip into the patient to prevent application of pressure to the vagus nerve which can lead to vasovagal reactions and syncopal episodes. Cardiac arrhythmia or other cardiovascular side effects can occur as a result of colon distention.

Precautions

General

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.

Anaphylactic and allergic reactions have been reported during double contrast examinations in which glucagon has been used.

An increased risk of perforation has been reported in neonates with intussusception. In patients with cystic fibrosis or blind loops of the bowel or ileus, there is a risk of inspissation leading to partial or complete obstruction.

In neonates and infants with motility disorders such as Hirschsprung’s Disease retention of large amounts of barium sulfate suspension may result in absorption of water from the suspension and fluid overload. The addition of small amounts of salt to the barium sulfate suspension has been reported to reduce the problem.

Ingestion of barium sulfate suspension is not recommended in patients with a history of food aspiration. If barium sulfate suspension is aspirated into the larynx, further administration of the suspension should be immediately discontinued.

Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract. In patients with reduced colon motility, saline cathartics may be required after the barium sulfate suspension enema. Saline cathartics are recommended on a routine basis in patients with a history of constipation unless clinically contraindicated.

Where enema tips are used, care must be taken during insertion into the patient, since forceful or too deep insertion may cause tearing or perforation of the rectum. Insertion of an enema tip should be done only after digital examination by qualified medical personnel. When balloon retention tips are used, care should be taken to avoid overinflation of the balloon, since overfilling or asymmetrical filling may cause displacement of the tip. Such a displacement can lead to rectal perforation or barium sulfate granulomas. Inflation of the balloon should be done under fluoroscopic control by qualified medical personnel. Do not unnecessarily move the enema tip once inserted.

A specially designed enema tip is required for a barium sulfate suspension examination of a colostomy patient.

Intubation of an enteroclysis catheter should be done by qualified medical personnel. Perforation of the duodenum has been reported.

Because of reported anaphylactoid reactions to latex, the use of non-latex gloves during the procedure should be considered.

Pregnancy

Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Elective radiography of the abdomen is considered to be contraindicated during pregnancy due to the risk to the fetus from radiation exposure. Radiation is known to cause harm to the unborn fetus exposed in utero.

Pediatric Use

The radiographic contrast agents used for examination of children do not differ substantially from those used for adults. The variation in physical sizes of pediatric patients requires more thorough attention to individualizing dosage. The volume of barium sulfate suspension and the barium sulfate content required will also depend upon the technique used and the clinical need.

Adverse Reactions

Adverse reactions accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. EKG changes have been shown to occur following or during barium sulfate suspension enemas. It is of the utmost importance to be completely prepared to treat any such occurrence.

Due to the increased likelihood of allergic reactions in atopic patients, a complete history of known and suspected allergies as well as allergic-like symptoms, such as rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure.

Aspiration of large amounts of barium sulfate suspension may cause pneumonitis or nodular granulomas of interstitial lung tissues and lymph nodes; asphyxiation and death have been reported.

Transient bacteremia, beginning almost immediately and lasting up to 15 minutes, may also occur during rectal administration of barium sulfate suspension, and rarely septicemia has been reported.

A rare mild allergic reaction would most likely be generalized pruritis, erythema or urticaria (approximately 1 in 100,000 reactions). Such reactions will often respond to an antihistamine. More serious reactions (approximately 1 in 500,000) may result in laryngeal edema, bronchospasm or hypotension.

Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, bronchospasm, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately according to established standard of care.

Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature.

Allergic reactions to the enema accessories, in particular to retention catheters (tips) with latex cuffs, can occur. Such reactions could occur immediately and result in the previously mentioned acute allergic-like responses or might be delayed in appearance and result in a contact dermatitis. Known atopic patients, particularly those with a history of asthma or eczema, should be evaluated for alternative methods of administration in order to avoid these adverse reactions. These plastic/rubber accessories are disposable, single-use devices that must not be reused or left in the body cavity for an extended period of time.

Postmarketing Experiences

The following adverse experiences have been reported in patients receiving products containing barium sulfate. These adverse experiences are listed alphabetically: abdominal cramping, abdominal pain, diarrhea, fever, foreign body trauma relating to procedural complications, headache, laryngeal burning and irritation, leukocytosis, nausea, procedural site reactions, rash and vomiting.

Overdosage

In rare instances, immediate repeat oral examinations utilizing standard dosages may lead to severe stomach cramps and diarrhea. Cases reported in adults implicate a total dose in the range of 30 ounces (900 mL) of suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.

Tonopaque Suspension Dosage and Administration

Individual technique will determine the suspension quantity and concentration to be used.

Patient Preparation

Successful examination of the upper gastrointestinal tract requires that the stomach be empty and essentially free of fluid. This can usually be accomplished by instructing the patient to abstain from eating or drinking anything after the evening meal before the examination. The preparation for small bowel examinations done separately or combined with an upper gastrointestinal series is the same.

For examinations of the colon, the patient should be given a low solid diet for a minimum of 24 hours before the examination. Laxatives should also be used to clean the colon. In order to obtain thorough cleansing of the colon, a 2 liter water enema one hour before the examination may be necessary.

Administration

Orally administered suspension may be served chilled for more rapid transit from the stomach into the small bowel. Rectally administered suspension should be at room temperature to body temperature.

Suspension Preparation

Mix Tonopaque and water vigorously. For accurate suspension preparation, measure the water and the Tonopaque separately.

Prepared suspension may be used for up to 72 hours if stored in a tightly closed container and refrigerated.

Remix prior to use.

The following tables will serve as a guide for suspension preparation.

TONOPAQUE DILUTION TABLE
Suspension Concentration % w/v: % w/w:	100 60	80 50	68 45	60 40
Tonopaque Wt.	Water required to prepare suspension in mLs:
180 gm 1200 gm	120 800	180 1200	220 1465	270 1800

Tonojug™ suspensions may be prepared using the volume marks on the bottle. First add 800 mL water (27 fl. oz.) to the bottle, cap and shake vigorously for 30 seconds. For optimum suspension quality, allow to stand for 5 minutes, then add water to the desired volume (see table below for final concentrations) and mix.

Total Volume 2000 mL 1800 mL 1500 mL 1200 mL

%w/v 60% 66% 80% 100%

COMPARISON (% w/v vs. % w/w vs. specific gravity)
% w/v: % w/w:	100 60	80 50	68 45	60 40
Specific Gravity	1.80	1.67	1.59	1.50

Pediatric Use

The quantity of suspension used and the barium sulfate concentration will depend upon patient size, technique used and clinical need.

Shake well before using. Use within 72 hours of preparation.

For single patient use only. Properly discard unused portion.

How is Tonopaque Suspension Supplied

Catalog No. 179606. NDC 68240-223-36. 180 gm bottle; thirty-six (36) bottles with straws per case.

Catalog No. 139542. Tonojug. NDC 68240-226-08. 1200 gm per bottle; eight (8) bottles per case.

Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59° to 86°F).

Tonopaque and Tonojug are trademarks of Lafayette Pharmaceuticals, Incorporated.

Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

MID 1295050 Rev 04/2009

SINGLE CONTRAST

G.I. EXAMS

• Mix-to-need


• Flavored

tyco

Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 180 gm Bottle

L A F A Y E T T E


TONOPAQUE™

BARIUM SULFATE FOR SUSPENSION


Catalog No. 179606


SINGLE CONTRAST / UPPER G.I. EXAMS


Rx only


180 gm


TONOPAQUE

Barium Sulfate for Suspension


NDC 68240-223-36

Catalog No. 179606


A cherry flavored 95% w/w barium sulfate formulation for aqueous suspension and use in x-ray diagnosis of the upper gastrointestinal tract.


Contents: Barium sulfate, sorbitol, suspending agents, potassium sorbate, simethicone, flavoring and saccharin sodium.


Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.


Dosage and Administration: See package insert for complete instructions.


Mixing Directions: For accurate suspension preparation, measure water and add to contents of bottle. The dilution marks may be used for approximate suspension volume (level will fall after mixing).


40% w/w (60% w/v) - 270 mL water

45% w/w (68% w/v) - 220 mL water

50% w/w (80% w/v) - 180 mL water

60% w/w (100% w/v) - 120 mL water

• Add water and shake vigorously for 30 seconds.


• Remix prior to use.


• Prepared suspension may be used for up to 72 hours if stored in a tightly closed container and refrigerated.

For single patient use only. Properly discard unused portion.


Storage: Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59° to 86°F).


Net Contents: 180 gm


Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com


MID 1170115

Rev 05/2009

tyco

Healthcare

Mallinckrodt

Package Label - Principal Display Panel - Tonojug 1200 gm Bottle

L A F A Y E T T E

TONOJUG™

TONOPAQUE™ BARIUM SULFATE FOR SUSPENSION

SINGLE CONTRAST / UPPER G.I. EXAMS

Rx only

NDC 68240-226-08

Catalog No. 139542

A cherry flavored 95% w/w barium sulfate formulation for aqueous suspension and use in x-ray diagnosis of the esophagus, stomach and small bowel.

Contents: Barium sulfate, sorbitol, suspending agents, potassium sorbate, simethicone, flavoring and saccharin sodium.

Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.

Dosage and Administration: See package insert for complete instructions.

Mixing Directions: Add 800 mL water (27 fl. oz.) to bottle, cap and shake vigorously for 30 seconds. For optimum suspension quality, allow to stand for 5 minutes, then add water to the appropriate volume mark:

60% w/v - 2000 mL

66% w/v - 1800 mL

80% w/v - 1500 mL

100% w/v - 1200 mL

• Shake thoroughly before each use.


• Prepared suspension may be used for up to 72 hours if stored in a tightly closed container and refrigerated.

For single patient use only. Properly discard unused portion.

Storage: Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF).

Net Contents: 1200 gm

Made in Mexico

Manufactured by Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

MID 1295125

Rev 04/2009

tyco

Healthcare

Mallinckrodt

TONOPAQUE  barium sulfate  for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68240-223 Route of Administration ORAL, RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE .95 g  in 1 g

Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM   POTASSIUM SORBATE   SORBITOL   SODIUM CITRATE   PECTIN   TRAGACANTH

Product Characteristics Color      Score      Shape Size Flavor CHERRY (CHERRY) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68240-223-36 36 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 1 180 g In 1 BOTTLE, PLASTIC This package is contained within the CASE (68240-223-36)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2009	11/30/2012

TONOJUG  barium sulfate  for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68240-226 Route of Administration ORAL, RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE .95 g  in 1 g

Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM   POTASSIUM SORBATE   SORBITOL   SODIUM CITRATE   PECTIN   TRAGACANTH

Product Characteristics Color      Score      Shape Size Flavor CHERRY (CHERRY) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68240-226-08 36 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 1 1200 g In 1 BOTTLE, PLASTIC This package is contained within the CASE (68240-226-08)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2009	09/30/2012

Labeler - Mallinckrodt Inc. (810407189)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt Medical, S.A. de C.V.		810407189	manufacture, analysis

Revised: 08/2010Mallinckrodt Inc.

More Tonopaque Suspension resources

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

Compare Tonopaque Suspension with other medications

• Computed Tomography

Tricaine-S

Dosage Form: FOR ANIMAL USE ONLY
Tricaine-S Brand of Tricaine Methanesulfonate For Anesthesia and Tranquilization of Fishes and Other Cold-Blooded Animals

Description

Tricaine-S is intended for the temporary immobilization of fish, amphibians, and other aquatic, cold-blooded animals. It has long been recognized as a valuable tool for the proper handling of these animals during manual spawning (fish stripping), weighing, measuring, marking, surgical operations, transport, photography, and research.

Chemistry

Tricaine-S is the methanesulfonate of meta-amino benzoic acid ethylester, or simply ethyl m-amino benzoate. It is thus an isomer of benzocaine having the formula C9H11O2N + CH3SO3H

Tricaine-S is a fine white crystalline powder. Its molecular weight is 261.3. Soluble to 11%, it forms clear, colorless acid solutions in water.

Warnings

Do not use within 21 days of harvesting fish for food.

When used in food fish, use should be restricted to Ictaluridae, Salmonidae, Esocidae, and Percidae and water temperature should exceed 10° C. (50° F.).

In other fish and other cold-blooded animals (poikilotherms), Tricaine-S should be limited to hatchery or laboratory use.

Toxicology

Comparative toxicological studies carried out on fish and frogs gave the following results:


FISH TOXICITY STUDIES - The toxicity of Tricaine-S was measured by standard methods in laboratory bioassays with rainbow trout, brown trout, brook trout, lake trout, northern pike, channel catfish, bluegill, largemouth bass, and walleye. The 24, 48, and 96 hour LC50 (lethal concentration for 50 per cent of the animals) values for trout ranged from 52 to 31 mg/liter; for northern pike, from 56 to 48 mg/liter; for catfish, from 66 to 50 mg/liter; for bluegill and largemouth bass, from 61 to 39 mg/liter; for the walleye, the values were 49 to 46 mg/liter. Safety index: The safety indices for Tricaine-S refer to the margin between concentrations which cause anesthesia and mortality. They expressed by the quotient of the lethal concentration for 50 per cent of the fish (LC50) and the effective concentration for 50 per cent of the fish (EC50).

                         Safety Indices for Rainbow Trout and Channel Catfish at 12°C (54°F)

Species	Exposure (min.)	LC50 (mg/liter)	EC50 (mg/liter)	Index
Rainbow Trout1	15	65	32	2.0
Rainbow Trout1	30	57	32	1.8
Rainbow Trout1	60	56	29	1.9
Channel Catfish2	15	139	47	3.0
Channel Catfish2	30	118	45	2.6
Channel Catfish2	60	110	46	2.4

FROG TOXICITY STUDIES3 - Frogs were put into various concentrations of Tricaine-S for 30 minutes and then transferred to tap water in order to determine the LC50. The LC50 was 6.2 per cent Tricaine-S. Therefore, the anesthetic must be used in very high concentration before it is fatal to frogs.

Precautions

1. Avoid inhaling Tricaine-S or getting it into the eyes.

2. Always conduct preliminary tests with Tricaine-S to determine desired rates

of anesthesia and optimal length of exposure.

3. Do not overexpose fish to lethal levels of Tricaine-S.

4. Do not anesthetize more fish than can be handled effectively.

5. Do not contaminate eggs or sperm with Tricaine-S when stripping fish.

6. Do note use water containing chlorine, or other toxic agents.

7. Insure adequate oxygen in anesthetic solution.

8. Discard anesthetic solutions when fouled with mucus or metabolic wastes.

9. Do not discard Tricaine-S solutions into water supplies of natural waters.

10. Store Tricaine-S solutions in a cool place away from light.*

11. Discard stock solutions of Tricaine-S after several days.*

12. Treated fish destined for food must be held in fresh water above 10°C. (50°F.) For 21 days before use.

*The color of Tricaine-S solutions may change rapidly to yellow or brown when exposed to light. This does not affect activity in any significant way. However, for best results use freshly prepared solutions. A 10 per cent solution stored at room temperature shows no significant loss of potency after three days, but after 10 days, a brownish color and an activity decrease of about 5 per cent is observed.

References

1. Marking, L.L.: Investigations in Fish Control. 12. Toxicity of MS-222 to Selected Fishes, U.S. Bureau of Sport Fisheries and Wildlife, Resource Publication 18, 1966.

2. Schoettger, R.A., Walker, C.R., marking, L.L., and Julin, A.M.: MS-222 as an Anesthetic for Channel Catfish; its Toxicity, Efficacy, and Muscle Residues, U.S.Bureau of Sport Fisheries and Wildlife, Resource Publication 33, 1967.

3. Personal communications:

    a. Bernheimer, W.M., New York University College of Medicine, NewYork, N.Y.

    b. Butler, E.G., Princeton University, Dept. of Biology, Princeton, N.J.

    c. Dalton, H.D., and Charipper, H.A., Washington Square College, Dept.Of Biology, New York, N.Y.

    d. Etkin, W., City College, Dept. Of Biology, New York, N.Y.

    e. Goss, R.J., Brown University, Providence, R.I.

    f. Kollros, J.J., State University, Iowa City, Iowa.

    g. Manner, H.W.: Anaesthetize those planaria. Turtox New 35:135, 1957.

    h. Rose, S.M., University of Illinois, Urbana, Ill.

    i. Schatzmann, J.H., Harvard Medical School, Boston, Mass.

    j. Taylor, A.C., Rockefeller Institute of Medical Research, New York, N.Y.

    k. Thornton, C.S., Kenyon College, Dept. of Biology, Gambier, Ohio.

    l. Van Stone, J.M., Trinity College, Dept. of Biology, Hartford, Conn.

Cited in Bove, F.J.: MS-222 Sandoz-the anesthetic of choice for fish and other cold-blooded organisms, Sandoz News, no. 3. 12;., 1962.

4. Schoettger, R.A., and Julin, A.M.: Investigations in Fish control: 13. Efficacy of MS-222 as an Anesthetic on Four Salmonids, U.S. Bureau of Sport Fisheries and Wildlife, Resource Publication 19, 1966.

5. Schottger, R.A.: Efficacy of MS-222 as an Anesthetic for Northern Pike, Muskellunge and Walleye, U.S. Bureau of Sport Fisheries and Wildlife, to be published.

6. Knight, A.E.: Intracellular hemoglobin crystallization in two centrarchid, the large-mouth bass and the bluegill, Progressive Fish-Culturist 26:115 (no. 3) 1964.

7. Lumb, W.V.:Anesthesia of Laboratory and Zoo Animals, in: Small Animal Anesthesia, Philadelphia, Lea and Febiger, 1963, pp. 269-310.

8. Webb, R.T., Distribution of Bluegill treated with tricaine methanesulfonate (MS- 222), Progressive Fish-Culturist 20:69 (no. 2) 1958.

9. Klontz, G.W.: Anesthesia f fishes, Proceedings of the Symposium on Experimental Animal Anesthesiology, Brooks Air Force Base, Dec. 14-16, 13 p., 1964.

10. Gilbert, P.W., and Wood, F.G.: Methods of anaesthetizing large sharks and rays safely and rapidly. Science 126:212, 1957.

11. Mann, H., and Rajbanshi, K.G.: Anesthetic and Tranquilizer for Fish, Frogs and other Cold-blooded Organisms, Sandiz Bulletin No. 3350/182 e. Basie, Switzerland.

12. Tuumanen, P.: Experiments with MS-222 Sandoz in the Shipment of Live Trout in Plastic Pouches,Kalataloudellisen tukimostoimiston, Tiedomantoja, no.2, 1966.

13. Lemarque, P.,: Anesthesie et transport, Bull. Inf. Cons. Sup. Peche 55:5, 1964.

14. Walker, C.R., and Schoettger, R.A.: Investigations in Fish Control: 15. Residues of MS-222 in Four Salmonids Following Anesthesia, U.S. Bureau of Sport Fisheries and Wildlife, Resource Publication 21, 1966.

15. Correspondence: Bureau of Fisheries, U.S. Department of Interior, 1968.

Directions for Use

I. DIRECTIONS FOR USE ON FISH

CONCENTRATIONS

Tricaine-S is effective and safe for the anesthesia of fish when used as directed. Its use is governed by, and can be tailored to, the needs of individual fishery personnel. Sedation and various rates of anesthetization are controlled by the concentration. The versatility of Tricaine-S is demonstrated by the fact that it has been used in fisheries at levels ranging from 10 to 1,000 mg/liter3. The action of the anesthetic is slowed at cooler temperatures, in extremely soft water (approximately 10 mg/liter of CaCO3, or less), and in larger fish4. Also, efficacy may vary with species4. Thus, it is imperative that preliminary tests of anesthetic to determines the desired rates of anesthesia and exposure times for the specific lots of fish under prevailing

conditions.

The following tables may be used as guidelines in selecting concentrations of Tricaine-S for the anesthetization of various fishes:

Table 1: Concentration Required for Rapid Anesthesia

(Induction time less than 2-5 minutes; used in spawning, marking, measuring, and some surgical operations)

Table 2: Concentration Required for Moderately Rapid Anesthesia

(Induction time less than 15-20 minutes; used in surgical operations and in spawning and marking where longer exposures are more important than rapid immobilization)

*Maximum tolerated exposure time (in minutes) of fish to Tricaine-S solution.

Table 3: Concentration MS-222 Required for Sedation

(Induction within 15 minutes; used in fish transport)

IMPORTANT: Since, in many cases, relatively rapid rates of anesthesia can be achieved only by exceeding the lethal concentration of Tricaine-S, it is necessary to return anesthetized fish to fresh water before they are overexposed.  Excessive exposures are avoided by bserving the following sensory and motor responses of the fish which characterize progressively deeper levels of anesthesia.

    Sedation - Decreased reactivity to visual and vibrational stimuli; opercular activity reduced.

    Total loss of equilibrium - Fish turns over; locomotion increases; fish swims or extends fins in response to pressure on caudal fin or peduncle.

    Total loss of reflex - No response to pressure on caudal fin or peduncle; opercular rate slow and erratic.

    Medullary collapse - Opercular activity ceases.

Laboratory and field investigations3,9, have shown that the action of Tricaine-S is readily reversed when the fish are transferred to fresh water before opercular activity ceases. Additional exposure following medullary collapse may result in mortality. A rough estimate of the safe total exposure can be made by multiplying the time required for anesthesia by a factor of 2 or 3.

WATER

Since Tricaine-S is very soluble (1:9) in water, it dissolves with equal readiness in spring water, tap water, or seawater. Do not use distilled or deionized water, or water containing chlorine, heavy metals (copper, zinc, etc.), or other toxic contaminants. The anesthetic solution should be well oxygenated, and its temperature should be similar to that of the water from which fish are

taken. In the field, many water quality problems are eliminated by using natural water to which the fish are acclimated, provided the water does not possess high chemical or biologic oxygen demand.

METHODS OF APPLICATION

1. General anesthesia: - For most situations where rapid or moderately rapid anesthesia is required, Tricaine-S may be applied in a bath, i.e., the fish are immersed in the anesthetic solution. Containers may be of glass, plastic, steel, aluminum, or other suitable material. However, do not use galvanized or brass containers unless treated or sealed to prevent dissolution of zinc. Size of container is determined by individual needs, but t he fish should not be overcrowded. Discard anesthetic solutions when a loss in potency is noted, or when the solutions become fouled with mucus or excrement.

2. For surgery and certain physiologic studies, the fish may be anesthetized to loss of reflex, removed from the anesthetic, and then positioned so that the gills are bathed in a sedating concentration of Tricaine-S. Some investigators have developed flowing, recirculating systems for bathing the gills with anesthetic during surgery.

Large fishes such as sharks and rays are anesthetized within minutes by spraying the gills with a 1g./liter solution of Tricaine-S10 . The application is made by means of a water pistol, bulb syringe, hand pump, etc.

3. Transport - Tricaine-S has been used to sedate fish during transport. It is more successful in cold than in warm water, and it is instrumental in reducing injuries because of hyperactivity. Fish are usually transported by means of distribution units (tank trucks), or by air in plastic bags11,12. In either case, the fish should be fasted before-hand to reduce metabolic wastes. Also, some workers suggest pre-transport sedation for several hours to lower metabolism.  With distribution units, the fish may be fasted and sedated prior to loading. Theanesthetic solution is prepared in the distribution unit and oxygenated. Then, the fish are added and temperature acclimated.  In air shipments, the anesthetic solution is placed in a suitable plastic bag, the sedated fish are added, the bag inflated with oxygen, tied securely, and placed in a second bag. This bag is also tied, and then placed on ice in an insulated container13. A modification of this method involves complete anesthesia of the fish, and placing them in water bags which contain no anesthetic. In any case, upon arrival, the fish should be acclimated slowly to new environmental

temperatures.

PREPARATION OF Tricaine-S® SOLUTIONS

Prior to use, Tricaine-S may be weighed out into amounts which are convenient for the volume of water to be used. A handy unit is 2 g. since this quantity in 5 gallons of water yields a concentration of about 100 mg/liter. For rough approximations, one level teaspoonful contains 2.0 to 2.5 g. Thus a level teaspoonful of anesthetic in 5 gallons gives a concentration of about 120 mg/liter.

To convert mg/liter into g/gal.: multiply number of mg. by 0.00378

    e.g. 80 mg/liter = 80 x 0.00378 = .0302 g./gal.

To convert mg/liter into a ratio of Tricaine-S to water: divide 1,000,000 by the number of mg.

    e.g. 80 mg/liter = 1,000,000 / 80 = 1:12,500

LIMITATIONS IN USE

Since Tricaine-S is taken up into the blood of fish, residues of the drug may occur in edible tissues. However, the residues dissipate rapidly after the fish are placed in fresh water14. Thus, treated fish which may be used for food must be held in fresh water above 10°C. (50°F.) for a perio d of 21 days.  Withdrawal in fresh water is unnecessary for non food fishes such as goldfish, bait fish, and ornamentals. Also, withdrawal is unnecessary for sublegal sizes of the following species of fish because they are not used as food immediately following anesthesia (Table 4).

Table 4 - Sublegal Sizes of Fish Species not used as Food Immediately after Anesthesia 15

II. GUIDELINES FOR USE ON AMPHIBIANS

Table 5. Effects of Varying Concentrations of Tricaine-S on Salamanders

*When an individual of any of the species listed is exposed at the designated concentration, the data available suggest that the animal may be safely maintained under anesthesia for the time noted. Prolonging exposure to the anesthetic beyond the time indicated may cause deaths. See PRECAUTIONS.

Table 6 - Effects of Varying Concentrations of Tricaine-S on Frogs

* When an individual of any of the species listed is exposed at the designated concentration, the data available suggest that the animal may be safely maintained under anesthesia for the time noted. Prolonging exposure to theanesthetic beyond the time indicated may cause deaths. See PRECAUTIONS.

Tricaine-S Label

Tricaine-S  tricaine  powder, for solution

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50378-011 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tricaine (Tricaine) Tricaine 1000 mg  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50378-011-02 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC (50378-011-01) 1 50378-011-01 1 g In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50378-011-02) 2 50378-011-02 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC (50378-011-05) 2 50378-011-05 5 g In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50378-011-02) 3 50378-011-02 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC (50378-011-10) 3 50378-011-10 10 g In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50378-011-02) 4 50378-011-99 100 g In 1 BOTTLE, PLASTIC None 5 50378-011-91 1000 g In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200-226	11/27/1997

Labeler - Western Chemical Inc. (085803500)

Registrant - Western Chemical Inc. (085803500)

Revised: 05/2009Western Chemical Inc.