Patient information: uses, side effects, how to take - Tirosint SOL
What is the most important information I should know about TIROSINT-SOL?
Do not use TIROSINT-SOL to treat weight problems or weight loss.
What is TIROSINT-SOL?
TIROSINT-SOL is a prescription medicine that contains a hormone called levothyroxine which is normally produced by the thyroid gland. TIROSINT-SOL is used:
- to replace or give extra levothyroxine in people whose thyroid does not produce enough of this hormone; or
- with surgery and radiodine therapy to manage a type of thyroid cancer called thyroid-dependent well-differentiated thyroid cancer.
TIROSINT-SOL should not be used to treat people who are recovering from swelling of the thyroid gland (thyroiditis) and whose bodies do not produce enough levothyroxine for a short time.
Do not take TIROSINT-SOL:
- if you are allergic to glycerol the inactive ingredient in TIROSINT-SOL; or
- if your adrenal glands are not working well and you have not been treated for this problem.
Before you take TIROSINT-SOL, tell your doctor about all of your medical conditions, including if you:
- have or have had heart problems
- have or have had thyroid nodules
- have adrenal or pituitary gland problems
- have any food or drug allergies
- have low red blood cell count (anemia)
- have diabetes
- have weak bones (osteoporosis)
- have or had a history of blood clotting problems
- have recently received radiation therapy with iodine (such as I-131)
are pregnant or plan to become pregnant. Your doctor may need to change your TIROSINT-SOL dose while you are pregnant.
- are breastfeeding. TIROSINT-SOL can pass into your milk. Talk to your doctor about the best way to feed your baby if you take TIROSINT-SOL.
Tell your doctor about all the medicines you are taking including prescription and over-the-counter medicines, vitamins and herbal supplements. TIROSINT-SOL may affect the way other medicines work, and other medicines may affect how TIROSINT-SOL works so your doctor may have to adjust the amount of medicines you take. You can ask your doctor or pharmacist for a list of medicines that interact with TIROSINT-SOL.
How should I take TIROSINT-SOL?
- TIROSINT-SOL is for oral use only. Do not inhale, inject, or place TIROSINT-SOL in the eyes.
- See the detailed " Instructions for Use" that come with TIROSINT-SOL for information on the right way to take your dose of TIROSINT-SOL oral solution.
- Take TIROSINT-SOL exactly as your doctor tells you to take it.
- Your doctor will tell you how much TIROSINT-SOL to take each day.
- Your doctor may change your dose, if needed.
Take your dose of TIROSINT-SOL 1 time each day 15 minutes before breakfast on an empty stomach.
Certain medicines can interfere with how TIROSINT-SOL is absorbed by your body. Take TIROSINT-SOL:
- at least 4 hours before or after you take medicines that contain calcium carbonate or iron (ferrous sulfate); and
at least 4 hours before you take medicines that contain bile acid sequestrants or ion exchange resins.
Know the medicines you take. Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
- Certain foods including soybean flour, cotton seed meal, walnuts, and dietary fiber can affect your treatment and dose of TIROSINT-SOL. Talk to your doctor if you eat or drink these foods.
- Do not remove TIROSINT–SOL ampules from the sealed aluminum foil pouch until you are ready to use them .
- Use all 5 TIROSINT-SOL ampules within three (3) months after opening the aluminum foil pouch.
- Your doctor should do certain blood tests while you are taking TIROSINT-SOL and may change your daily dose of TIROSINT-SOL as needed. Keep taking TIROSINT-SOL unless your doctor tells you to stop or to change your dose.
It may take weeks before you notice your symptoms getting better. Keep using this medicine even if you feel well. If you take too much TIROSINT-SOL, call your doctor, your Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
What are the possible side effects of TIROSINT-SOL?
TIROSINT-SOL may cause serious side effects, including:
- heart problems. You may experience an increased heart rate, chest pain and irregular heartbeat. Your risk of developing heart problems may be greater if you are elderly, you have heart problems, or you take too much TIROSINT-SOL. Your doctor may reduce your dose or stop treatment with TIROSINT-SOL for a while if you develop heart problems.
- worsening diabetic control. If you are diabetic, it may be harder to control your blood sugar levels causing hyperglycemia while taking TIROSINT-SOL. Check your blood sugar levels closely after starting, changing, or stopping treatment with TIROSINT-SOL. Your doctor may have to change your diabetes treatment plan.
- weak or brittle bones. Your risk of developing weak or brittle bones may be greater if you are post-menopausal or you take too much TIROSINT-SOL.
The most common side effects of TIROSINT-SOL include:
- fast or irregular heartbeat
- chest pain
- shortness of breath
- leg cramps
- headache
- nervousness
- hives or skin rash
- irritability
- sleep problems (insomnia)
- tremors
- muscle weakness
- change in appetite
- weight loss
- vomiting
- diarrhea
- sweating a lot
- heat intolerance
- fever
- changes in menstrual period
Other side effects may include partial hair loss during the first months of treatment with TIROSINT-SOL. This usually lasts a short period of time (temporary).
These are not all the possible side effects of TIROSINT-SOL. Call your doctor for medical advice about side effects. You may report side effects to IBSA Pharma Inc. at 1-800-587-3513 or FDA at 1-800-FDA-1088.
How should I store TIROSINT-SOL?
- Store TIROSINT-SOL at room temperature between 68°F to 77°F (20°C to 25°C).
- Use TIROSINT-SOL within three (3) months after opening the pouch. Keep TIROSINT-SOL in the original closed pouch until you are ready to use it as important information may be lost (i.e., manufacturer/distributor names and distributor contact phone number.
- Do not store the diluted or mixed TIROSINT-SOL solution.
Keep TIROSINT-SOL and all medicines out of the reach of children.
General information about the safe and effective use of TIROSINT-SOL
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TIROSINT-SOL for a condition for which it was not prescribed. Do not give TIROSINT-SOL to other people, even if they have the same symptoms as you. It may harm them. You can ask your pharmacist or doctor for information about TIROSINT-SOL that is written for health professionals.
What are the ingredients in TIROSINT- SOL oral solution?
Active ingredient: levothyroxine sodium
Inactive ingredients: glycerol, and water
Manufactured by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland
Marketed and distributed by: IBSA Pharma Inc, Parsippany, NJ 07054 USA
For more information, go to www.tirosintsol.com or call 1-800-587-3513.
Instructions for Use
TIROSINT ®-SOL (tee-row-sent-sōl)
(levothyroxine sodium)
oral solution
Read this Instructions for Use before you start taking TIROSINT-SOL and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
Important Information:
- TIROSINT-SOL is for oral use only. Do not inhale, inject, or place TIROSINT-SOL in the eyes.
TIROSINT-SOL can be taken:
- by diluting or mixing in water first or
- by directly squeezing into the mouth or onto a spoon.
- Do not dilute or mix TIROSINT-SOL with any liquid other than water.
- Open the ampule and prepare the solution right before you take TIROSINT-SOL.
- After you have diluted or mixed TIROSINT-SOL it must be taken or thrown away.
Step 1. Using scissors, open the aluminum pouch by cutting the edge along the dotted line (See Figure A) .
Figure A
Step 2. Remove 1 ampule from the strip to be used right away (See Figure B) . Return the unused ampules back into the pouch before storing.
Figure B
Step 3. Hold the TIROSINT-SOL ampule upright (cap on top) between the first finger and thumb without squeezing the ampule. Open the ampule by twisting off the top (See Figure C) .
Figure C
Step 4.
Taking TIROSINT-SOL by diluting or mixing:
- Turn the ampule upside down.
- Squeeze the middle, softer part of the ampule between the first finger and thumb slowly to release the liquid medicine into a glass or cup containing water, then release the pressure and wait a few seconds (See Figure D).
- Keeping the ampule upside down, repeat this step for a minimum of 5 times, until no more liquid medicine comes out of the ampule.
- Stir the solution.
- Drink all the liquid medicine right away.
- Rinse the glass or cup with more water and drink to make sure all the medicine has been taken.
Figure D
Taking TIROSINT-SOL directly into the mouth or by spoon:
- Turn the ampule upside down.
- Squeeze the middle, softer part of the ampule between the first finger and thumb slowly to release the liquid medicine into the mouth or onto a spoon, then release the pressure and wait a few seconds (See Figure E).
- Keeping the ampule upside down, repeat this step for a minimum of 5 times, until no more liquid medicine comes out of the ampule.
Figure E
Step 5. Throw away (discard) the empty ampule.
How should I store TIROSINT-SOL?
- Store TIROSINT-SOL at room temperature between 68°F to 77°F (20°C to 25°C).
- Use TIROSINT-SOL within three (3) months after opening the pouch. Keep TIROSINT-SOL in the original closed pouch until you are ready to use it as important information may be lost (i.e., manufacturer/distributor names and distributor contact phone number.
- Do not store the diluted or mixed TIROSINT-SOL solution.
Keep TIROSINT-SOL and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufacturer: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland
Marketed and Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054 USA
Issued: July 2024
FI/169 (USA) 5000003397 Rev. 06 06.24