Sinografin

What is Sinografin used for?

Sinografin is a prescription medicine that is used before an x-ray of the uterus and fallopian tubes. Sinografin may be given to you for other reasons.

Description

Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is a sterile, nonpyrogenic, essentially colorless to pale yellow, aqueous radiopaque contrast medium for intrauterine instillation. Each mL provides 527 mg diatrizoate meglumine and 268 mg iodipamide meglumine with 3.2 mg sodium citrate as a buffer, and 0.4 mg edetate disodium; pH has been adjusted to 7.0 to 7.8 with meglumine and diatrizoic acid. Each mL contains approximately 0.91 mg (0.04 mEq) sodium and 380 mg organically bound iodine. At the time of manufacture, the air in the container is replaced with nitrogen.

Diatrizoate meglumine is designated chemically as 1-deoxy-1-( methylamino)-D-glucitoI 3,5- diacetamido-2,4,6- triiodobenzoate (salt); iodipamide meglumine is 1-deoxy-1- (methylamino)-DglucitoI 3,3’-(adipoyldiimino)bis[2,4,6- triiodobenzoate] (2:1) (salt). Structural formulas:

diatrizoate meglumine C₁₁H₉I₃N₂O₄ • C₇H₁₇NO₅MW 809.13

Organically Bound Iodine: 47.1% CAS-131-49-7

diodipamide meglumine C₂₀H₁₄I₆N₂O₆ • 2C₇H₁₇NO₅ MW 1530.20

Organically Bound Iodine: 49.8% CAS-3521-84-4

Before taking Sinografin, tell your doctor:

• If you are allergic to Sinografin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are having your menstrual period or you have a genital infection.
• If you have had a type of tissue taken out (curettage) or a type of cervix biopsy (conization) within the past 30 days.
• If you are pregnant or may be pregnant. Do not use Sinografin if you are pregnant.
• If you have had a pregnancy ended within the past 6 months.

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 Sinografin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Sinografin?

• Tell all of your health care providers that you take Sinografin. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• Thyroid problems have happened after use of Sinografin. Some people had to be treated for these thyroid problems. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Sinografin.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Sinografin best taken?

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

• This medicine will be put into the cervix by a doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Sinografin that I need to call my doctor about immediately?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Slow heartbeat.
• Very bad dizziness or passing out.
• Chest pain or pressure.
• Sweating a lot.
• Flushing.
• Joint pain.
• Shortness of breath.

What are some other side effects of Sinografin?

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:

• Dizziness.
• Fever or chills.
• Upset stomach or throwing up.
• Belly pain.

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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 Sinografin?

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

SRC: NLM .