Description
Triheptanoin is used to treat long-chain fatty acid oxidation disorders (LC-FAOD). LC-FAOD is a genetic metabolic disorder that prevents the body from breaking down fats into energy. This medicine works by providing a source of calories and fats needed for the body's energy production.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, 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 triheptanoin in the pediatric population. Safety and efficacy have been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of triheptanoin in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Orlistat
Other Interactions
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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Pancreas problems (eg, pancreatic insufficiency)—Use with caution. May cause absorption problems in patients with this condition.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine with food. You may mix it with semi-solid food or other liquids (eg, fat free yogurt, milk, formula, or cottage cheese, whole grain cereal, fat free low carbohydrate pudding, smoothies, applesauce, or baby food) using a silicone or polyurethane feeding tube. Take this mixture within 24 hours.
Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup made only of stainless steel, glass, polyethylene, polypropylene, polyurethane, or silicone. Do not use this medicine with polystyrene or PVC plastic. Do not add this medicine to the feeding bag.
To take this medicine using a feeding tube:
- Using a slip tip syringe, inject the mixed solution into the feeding tube port.
- Flush the feeding tube port with about 5 to 30 milliliters (mL) of water to get all of the medicine.
- Throw away any unused mixed solution. Do not save for later use.
Carefully follow your doctor’s instructions about any special diet.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (solution):
- For long-chain fatty acid oxidation disorder (LC-FAOD):
- Adults and children—Dose is based on your daily caloric intake and must be determined by your doctor. The dose is usually given in at least 4 divided doses. Your doctor may adjust your dose as needed and tolerated.
- For long-chain fatty acid oxidation disorder (LC-FAOD):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Take the missed doses 3 to 4 hours apart. If it is not possible to take all of the scheduled doses for the day, skip the missed dose and go back to your regular dosing schedule.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store the opened bottles for up to 9 months after first opening it. Do not freeze.
You may store the unused mixture for up to 24 hours in the refrigerator. Throw away unused mixture if not used within 24 hours. Do not store for later use.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
This medicine may cause feeding tubes to not work as well or stop working over time. Only use feeding tubes made of silicone or polyurethane. Check the feeding tube before and after every use to make sure it is working properly.
This medicine may cause absorption problems when used in patients with pancreas problems (eg, pancreatic insufficiency), and may affect how this medicine works. Talk to your doctor if you have any concerns.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Diarrhea
- full or bloated feeling
- nausea
- pressure in the stomach
- stomach discomfort, swelling, or pain
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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