Description
Diazoxide choline is used to treat hyperphagia (extreme hunger, constant thoughts about food, and constant urge to eat that cannot be satisfied with food) in patients with Prader-Willi syndrome (a genetic disorder).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Extended Release
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 have not been performed on the relationship of age to the effects of diazoxide choline in children younger than 4 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diazoxide choline 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Isocarboxazid
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.
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Adagrasib
- Albuterol
- Alosetron
- Amiloride
- Amphetamine
- Amtolmetin Guacil
- Arsenic Trioxide
- Aspirin
- Bemetizide
- Bendroflumethiazide
- Benzhydrocodone
- Benzphetamine
- Benzthiazide
- Boceprevir
- Bromfenac
- Bufexamac
- Bumetanide
- Buprenorphine
- Canrenoate
- Canrenone
- Cefepime
- Celecoxib
- Ceritinib
- Chlorothiazide
- Chlorthalidone
- Choline Salicylate
- Ciprofloxacin
- Clarithromycin
- Clomipramine
- Clonixin
- Clopamide
- Clozapine
- Cobicistat
- Codeine
- Cyclopenthiazide
- Cyclothiazide
- Desmopressin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aminolevulinic Acid
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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Caffeine
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:
- Alcohol use disorder or
- Dehydration or
- Illness or
- Surgery—Use with caution. May increase risk for more serious side effects (eg, diabetic ketoacidosis).
- Diabetes or
- Fluid retention (edema), history of or
- Heart disease—Use with caution. May make these conditions worse.
- Hyperinsulinemic hypoglycemia (low blood sugar caused by excess insulin) or
- Kidney disease or
- Liver disease—Use is not recommended in patients with these conditions.
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 should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Swallow the extended-release tablet whole. Do not split, crush, or chew it.
The dose of this medicine is different from diazoxide oral liquid. Do not change between this medicine and other diazoxide products.
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 (extended-release tablets):
- For hyperphagia:
- Adults and children 4 years of age and older—Take this medicine once a day. Dose is based on body weight and must be determined by your doctor. Your doctor may adjust your dose as needed and tolerated.
- Weighing 135 kilograms (kg) or more—The starting dose is 150 milligrams (mg) on Weeks 1 and 2, followed by 300 mg on Weeks 3 and 4, then 450 mg on Weeks 5 and 6, and a maintenance dose of 525 mg.
- Weighing 100 kg to less than 135 kg—The starting dose is 150 mg on Weeks 1 and 2, followed by 300 mg on Weeks 3 and 4, then 375 mg on Weeks 5 and 6, and a maintenance dose of 450 mg.
- Weighing 65 kg to less than 100 kg—The starting dose is 150 mg on Weeks 1 and 2, followed by 225 mg on Weeks 3 and 4, then 300 mg on Weeks 5 and 6, and a maintenance dose of 375 mg.
- Weighing 40 kg to less than 65 kg—The starting dose is 75 mg on Weeks 1 and 2, followed by 150 mg on Weeks 3 and 4, then 225 mg on Weeks 5 and 6, and a maintenance dose of 225 mg.
- Weighing 30 kg to less than 40 kg—The starting dose is 75 mg on Weeks 1 and 2, followed by 150 mg on Weeks 3 and 4, then 150 mg on Weeks 5 and 6, and a maintenance dose of 150 mg.
- Weighing 20 kg to less than 30 kg—The starting dose is 25 mg on Weeks 1 and 2, followed by 50 mg on Weeks 3 and 4, then 75 mg on Weeks 5 and 6, and a maintenance dose of 100 mg.
- Children younger than 4 years of age or weighing less than 20 kg—Use and dose must be determined by your doctor.
- Adults and children 4 years of age and older—Take this medicine once a day. Dose is based on body weight and must be determined by your doctor. Your doctor may adjust your dose as needed and tolerated.
- For hyperphagia:
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.
If you miss a dose of 7 days or more, call your doctor or pharmacist for instructions.
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.
Keep the extended-release tablets in its original container. Do not remove desiccant (drying agent).
Precautions
It is very important that your doctor check your or your child's progress at regular visits, especially during the first few weeks of treatment, to make sure that this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.
This medicine may cause hyperglycemia (high blood sugar). Check with your doctor right away if you have blurred vision, drowsiness, dry mouth, flushed and dry skin, a fruit-like breath odor, increased frequency and amount of urination, ketones in the urine, loss of appetite, nausea or vomiting, rapid and deep breathing, tiredness, or unusual thirst. If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.
This medicine may cause fluid overload (too much fluid in the body). Check with your doctor right away if you have a decrease in amount of urine, swelling of the fingers, hands, feet, or lower legs, tingling of the hands or feet, trouble breathing, or weight gain or loss.
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.
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.
Check with your doctor immediately if any of the following side effects occur:
More common
- Blistering, peeling, red skin rash
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blue lips and fingernails
- blurred vision
- chest pain
- chills
- coughing that sometimes produces a pink frothy sputum
- diarrhea
- dry mouth
- fever
- headache
- increased hunger
- increased sweating
- increased thirst
- increased urination
- joint pain
- loss of appetite
- muscle aches and pains
- nausea
- pale skin
- rapid weight gain
- shivering
- sore throat
- stomach pain
- stuffy or runny nose
- swelling in the legs and ankles
- tingling of the hands or feet
- trouble breathing
- trouble sleeping
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
Less common
- Anger
- anxiety
- body aches or pain
- compulsive hoarding
- depression with thoughts of suicide
- ear congestion
- loss of voice
Incidence not known
- Black, tarry stools
- bleeding gums
- blindness
- blood in the urine or stools
- decreased vision
- fast heartbeat
- lower back or side pain
- pinpoint red spots on the skin
- skin itching, rash, or redness
- swelling of the face, throat, or tongue
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
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
- Difficulty in moving
- increased hair growth, especially on the forehead, back, arms, and legs
- joint pain
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.
DRG-80003855
