Brand Name

    US Brand Name

    Proglycem


    Description

    Diazoxide is used to manage symptoms of hypoglycemia (low blood sugar) that is caused by pancreas cancer, surgery, or other conditions. Diazoxide works by preventing release of insulin from the pancreas.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Suspension

    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 diazoxide in children.

    Geriatric

    No information is available on the relationship of age to the effects of diazoxide in geriatric patients.

    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.

    • Aceclofenac
    • Acemetacin
    • Albuterol
    • Amphetamine
    • Amtolmetin Guacil
    • Arsenic Trioxide
    • Aspirin
    • Benzhydrocodone
    • Benzphetamine
    • Bromfenac
    • Bufexamac
    • Buprenorphine
    • Cefepime
    • Celecoxib
    • Choline Salicylate
    • Clonixin
    • Codeine
    • Desmopressin
    • Dexibuprofen
    • Dexketoprofen
    • Dextroamphetamine
    • Diclofenac
    • Diflunisal
    • Dihydrocodeine
    • Dipyrone
    • Dofetilide
    • Droxicam
    • Epinephrine
    • Etodolac
    • Etofenamate
    • Etoricoxib
    • Felbinac
    • Fenoprofen
    • Fentanyl
    • Fepradinol
    • Feprazone
    • Floctafenine
    • Flufenamic Acid
    • Flurbiprofen
    • Formoterol

    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
    • Trichlormethiazide

    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:

    • Bilirubinemia (high bilirubin in the blood) or
    • Cataracts or
    • Congestive heart failure or
    • Fluid retention (edema) or
    • Gout, history of or
    • Pulmonary hypertension—Use with caution. May make these conditions worse.
    • Hypoglycemia, functional—Should not be used in patients with this condition.
    • Kidney disease—Use with caution. The effects of diazoxide may be increased because of slower removal of the medicine from the body.

    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.

    Follow carefully the special diet your doctor gave you. This is an important part of controlling your condition, and is necessary if the medicine is to work properly.

    Test for sugar in your urine or blood with a diabetic urine or blood test kit as directed by your doctor. This is a convenient way to make sure your condition is being controlled, and it provides an early warning when it is not. Your doctor may also want you to test your urine for acetone.

    This medicine comes in two forms: capsules and suspension. Do not switch from one dosage form to another unless your doctor tells you to do so.

    Take this medicine at the same time each day.

    Swallow the capsule whole. Do not crush, break, or chew it.

    Measure the oral suspension with a marked dropper that comes with the package. The average household teaspoon may not hold the right amount of liquid. Shake well before each use.

    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 forms (capsules or suspension):
      • For low blood sugar:
        • Adults and children—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 3 to 8 milligram (mg) per kilogram (kg) of body weight, divided into two or three doses, taken every 8 to 12 hours. Your doctor may increase your dose as needed and tolerated.
        • Newborn babies and infants—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 8 to 15 mg per kg of body weight, divided into two or three doses, taken every 8 to 12 hours. Your doctor may increase your dose as needed and tolerated.

    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.

    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.

    Protect the medicine from light. Do not freeze the oral suspension.


    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.

    Before you have any kind of medical tests, surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine.

    Hyperglycemia (high blood sugar) may occur if you have a fever or infection. Symptoms of high blood sugar include 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.

    Symptoms of both low blood sugar and high blood sugar must be corrected before they progress to a more serious condition. In either situation, check with your doctor immediately.

    Do not take any other medicine, unless prescribed or approved by your doctor, since some may interfere with this medicine's effects. This especially includes over-the-counter (OTC) or nonprescription medicine such as that for colds, cough, asthma, hay fever, or appetite control.


    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:

    Rare

    • Chest pain

    Incidence not known

    • Abdominal or stomach pain
    • black, tarry stools
    • blood in the urine
    • bloody nose
    • blurred vision
    • confusion
    • dizziness
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • dry mouth
    • extreme thirst
    • fast, irregular, pounding, or racing heartbeat or pulse
    • fever
    • flushed, dry skin
    • fruit-like breath odor
    • heavier menstrual periods
    • increased hunger
    • increased thirst
    • increased urination
    • loss of consciousness
    • nausea
    • pinpoint red spots on the skin
    • seizures
    • skin rash
    • stomachache
    • sweating
    • troubled breathing
    • unexplained weight loss
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • urinating large amounts or urinating very little
    • vomiting
    • weakness

    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

    • Increased hair growth, especially on the forehead, back, arms, and legs

    Incidence not known

    • Loss of appetite
    • loss of taste
    • weight loss

    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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