Tagitol V

Name: Tagitol V

Description

TAGITOL V (barium sulfate) is a radiographic contrast agent that is supplied as a 40% w/v, off-white to lightly colored, free-flowing, ready-to-use suspension with an apple aroma for oral administration.  The active ingredient barium sulfate is designated chemically as BaSO4  with a molecular weight of 233.4 g/mol and the following chemical structure:

TAGITOL V contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, maltodextrin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum, and xylitol.

Clinical pharmacology

Mechanism of Action

Due to its high atomic number, barium (the active ingredient in TAGITOL V) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.

Pharmacodynamics

Barium sulfate is biologically inert and has no known pharmacological effects.

Pharmacokinetics

Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in pharmacologically insignificant amounts.

Uses For Tagitol V

Barium sulfate is used to help diagnose or find problems in the esophagus, stomach, and bowels. It is a radiographic contrast agent. Contrast agents are used to create a clear picture of the different parts of the body.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using Tagitol V

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of barium sulfate oral suspension in children 12 years of age and older. However, safety and efficacy of this medicine have not been established in children younger than 12 years of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of barium sulfate oral paste in children 6 months of age and older. However, safety and efficacy of this medicine have not been established in children younger than 6 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of barium sulfate oral suspension or paste in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Allergy to other contrast agents, recent or
  • Asthma, hay fever, or other allergies, history of—May increase risk for allergic reaction to occur again.
  • Appendicitis (inflammation of the appendix) or
  • Cancer or
  • Inflammatory bowel disease or
  • Stomach or bowel problems (eg, diverticulitis, fistula, stenosis, ulcer)—May cause barium to leak in the stomach in patients with these conditions.
  • Cystic fibrosis or
  • Dehydration or
  • Electrolyte imbalance or
  • Stomach or bowel problems (eg, Hirschsprung disease, severe stenosis)—May increase risk for more serious side effects.
  • Fructose intolerance (genetic disease), history of—The oral suspension contains sorbitol, which can make this condition worse.
  • Radiation treatment on the pelvis (hip area), recent or
  • Stomach or bowel blockage, known or suspected or
  • Stomach or bowel perforation, known or suspected or
  • Stomach or bowel problems (eg, bleeding, injury, ischemia, severe ileus, toxic megacolon) or
  • Stomach or bowel surgery or
  • Trouble swallowing—Should not be used in patients with these conditions.

Proper Use of barium sulfate

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

A doctor or other trained health professional will give you or your child this medicine in a hospital. This medicine is given by mouth. You will swallow the barium liquid or paste just before a CT scan or x-ray.

Your doctor may tell you not to eat or drink anything the night before your test. Barium will work better if your stomach and bowels are empty.

It is important to drink plenty of liquids during and after the test. Barium sulfate may cause severe constipation.

Barium sulfate is also available as an enema and given through the rectum.

Precautions While Using Tagitol V

Your doctor will check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it.

Serious allergic reactions may occur while you are receiving this medicine. Tell your doctor right away if you have a rash, itching, noisy breathing, trouble breathing, lightheadedness, dizziness, or fainting after receiving this medicine.

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

How is this medicine (Tagitol V) best taken?

Use Tagitol V as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Follow what your doctor has told you to do.
  • Shake well before use.
  • Most of the time, this medicine is taken by mouth. Take as you have been told by your doctor.
  • Some brands of Tagitol V are to be taken with food. Some brands may be taken with or without food. Ask your pharmacist if you need to take your brand with food.
  • Some products may be used as an enema. If you are using this medicine as an enema, it will be given rectally by your doctor.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

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:

  • 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.
  • Very hard stools (constipation).
  • Very bad belly pain.
  • Shortness of breath.
  • Very bad dizziness or passing out.
  • A heartbeat that does not feel normal.
  • Flushing.
  • Fast or slow heartbeat.
  • Feeling agitated.
  • Feeling confused.
  • Blue or gray skin color.
  • Feeling very tired or weak.
  • Pale skin.
  • Ringing in ears.
  • Sweating a lot.
  • Chest pain or pressure.
  • Coughing up blood.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tagitol V?

  • Most of the time, Tagitol V (barium suspension) will be given in a hospital or doctor's office. If stored at home, follow how to store as you were told by the doctor.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
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