MD-Gastroview

• It is used before an x-ray or an alike test.

All products:

• If you have an allergy to diatrizoate meglumine, diatrizoate sodium, or any other part of MD-Gastroview (diatrizoate meglumine and diatrizoate sodium).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are dehydrated, have been eating poorly, or have used a laxative or water pill before this medicine.
• If you have had a skin reaction to MD-Gastroview or another drug like it in the past.
• If you are taking metformin, talk with doctor.

Oral liquid:

• If you have a health problem that connects the windpipe (trachea) to the swallowing tube (esophagus) called esophagotracheal fistula.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take MD-Gastroview with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

All products:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Shortness of breath.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Injection:

• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Seizures.
• Very bad headache.
• Feeling agitated.
• Feeling confused.
• Chest pain or pressure.
• Blue or gray skin color.
• Pain where the shot was given.

This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

All products:

• Upset stomach or throwing up.

Injection:

• Flushing.
• Feeling of warmth.

All other liquid products:

• Stomach cramps.
• Heartburn.
• Dizziness.
• Headache.
• Loose stools (diarrhea).

Rectal:

• Rectal irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store MD-Gastroview at home, talk with your doctor, nurse, or pharmacist about how to store it.

The most important characteristic of contrast media is the iodine content. The relatively high atomic weight of iodine contributes sufficient radiodensity for radiographic contrast with surrounding tissues.

Diagnostic enteral radiopaque agents have few known pharmacological effects. Diatrizoate meglumine and diatrizoate sodium exert a mild laxative effect attributable to their high osmolarity.

Diatrizoate meglumine and diatrizoate sodium are sparingly absorbed from the intact gastrointestinal tract, and therefore permit gastrointestinal opacification and delineation after oral or rectal administration. Oral administration is used for radiographic evaluation of the esophagus, stomach and proximal small intestine. Rectal administration is used for examination of the colon; however, visualization of the distal small bowel is generally unsatisfactory, since the hypertonicity of the medium causes intraluminal diffusion of water with subsequent dilution of the medium. Enough absorption from the gastrointestinal tract to permit incidental visualization of the urinary tract has been reported; this should also be considered when thyroid testing is being contemplated, since iodine-mediated thyrotropic effects may occur (see PRECAUTIONS).

Do not administer to patients with a known hypersensitivity to MD-Gastroview or any of its components.

Most adverse reactions to enteral diagnostic radiopaque agents are mild and transitory. Nausea, vomiting and/or diarrhea, urticaria with erythema, hypoxia, acute dyspnea, tachyarrhythmia, and anaphylaxis have occurred following ingestion of the contrast medium, particularly when high concentrations or large volumes of solution are administered. Severe changes in serum osmolarity and electrolyte concentrations may produce shock-like states (see WARNINGS). It should be kept in mind that serious or anaphylactoid reactions that may occur with intravascular administration of radiopaque contrast agents are theoretically possible following administration by other routes.

General

This medium is not to be used for the preparation of solutions for parenteral administration. Oral or rectal use only.

The routine preparatory measures employed for barium studies are also appropriate for this agent.

For pediatric and severely cachectic patients, the maintenance of an intravenous fluid line may be advisable.

Radiographic Examination of Segments of the Gastrointestinal Tract

Oral Administration: Adult oral dosage may range from 30 to 90 mL (11 to 33 g iodine), depending on the nature of the examination and the size of the patient. For infants and children less than 5 years of age, 30 mL (11 g iodine) are usually adequate; for children 5 to 10 years of age, the suggested dose is 60 mL (22 g iodine). These pediatric doses may be diluted 1:1, if desired, with water, carbonated beverage, milk, or mineral oil. When used in infants, the solution may be given in a nursing bottle. Pediatric doses may also be used in dehydrated and/or debilitated adult patients. A 1:1 dilution is also recommended when the contrast medium is used in elderly cachectic individuals.

For very young (under 10 kg) and debilitated children the dose should be diluted: 1 part MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution) in 3 parts water is recommended.

For Enemas or Enterostomy Instillations: MD-Gastroview should be diluted when it is used for enemas and enterostomy instillations.

When used as an enema, the suggested dilution for adults is 240 mL (88 g iodine) in 1,000 mL of tap water. For children under 5 years of age, a 1:5 dilution in tap water is suggested; for children over 5 years of age, 90 mL (33 g iodine) in 500 mL of tap water is a suitable dilution.

Tomography (Body Imaging)

A usual adult dose is 240 mL of a dilute MD-Gastroview solution prepared by diluting 25 mL (9.17 g iodine) to one liter with tap water. Less dilute solutions [up to 77 mL (28.26 g iodine) diluted to one liter with tap water] may be used when indicated. The dose is administered orally about 15 to 30 minutes prior to imaging in order to permit the contrast medium to reach the pelvic loops.

MD-Gastroview®
30 mL
NDC 0019-4816-04

Diatrizoate Meglumine and Diatrizoate Sodium Solution U.S.P.
37% Organically Bound Iodine For Gastrointestinal Radiography

Not For Parenteral Use
Rx Only

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]; Avoid excessive heat.

Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium. Each 30 mL contains approximately 11 grams organically bound iodine, pH adjusted to 6 to 7.6 with sodium hydroxide. Inactive ingredients: Edetate Disodium Dihydrate, Lemon-Vanilla Flavor, Sodium Citrate, Sodium Hydroxide, Sodium Saccharin, Water for Injection.

Single-Unit Container • Dilute before Use
Discard unused portion • Protect from light

Usual Dosage: See Package Insert. Dispense in Tight, Light Resistant Containers. Oral or rectal use only.

Manufactured by: Liebel-Flarsheim
Company LLC, Raleigh, NC 27616
Made in USA

11030916