proglycem
Proglycem (Diazoxide) is a medication used to treat Hyperphagia, Malignant Hypertension, Hypoglycemia.
Diazoxide · by Teva Branded Pharm
Key facts
- Active ingredient
- Diazoxide
- Form
- Suspension
- Strength
- Diazoxide 50MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- hyperphagia, malignant hypertension, hypoglycemia
- Manufacturer
- Teva Branded Pharm
- What the pharmacy pays
- ~$6.76 per ml — not your price
- FDA application
- NDA017453
What is Proglycem?
From the FDA label:PROGLYCEM ® (diazoxide) oral suspension is a nondiuretic benzothiadiazine derivative taken orally for the management of symptomatic hypoglycemia. PROGLYCEM oral suspension contains 50 mg of diazoxide in each milliliter and has a chocolate-mint flavor; alcohol content is approximately 7.25%. Other ingredients include sorbitol solution, chocolate cream flavor, propylene glycol, magnesium aluminum silicate, carboxymethylcellulose sodium, mint flavor, sodium benzoate, methylparaben, poloxamer 188, propylparaben, and purified water. Hydrochloric acid or sodium hydroxide may be added to adjust pH. Diazoxide has the following structural formula: Diazoxide is 7-chloro-3-methyl-2 H -1,2,4-benzothiadiazine 1,1-dioxide with the empirical formula C 8 H 7 ClN 2 O 2 S and the molecular weight 230.7. It is a white powder practically insoluble to sparingly soluble in water. Chemical Structure
How to use
Patients should be under close clinical observation when treatment with PROGLYCEM is initiated. Carefully monitor the clinical response and blood glucose until the patient’s condition has stabilized satisfactory; in most instances, this may be accomplished in several days. If administration of PROGLYCEM is not effective after 2 or 3 weeks, discontinue PROGLYCEM. Individualize the dosage of PROGLYCEM based on the severity of the hypoglycemic condition and the blood glucose level and clinical response of the patient. Adjust the dosage until the desired clinical and laboratory effects are produced with the least amount of PROGLYCEM. Take special care to ensure the accuracy of the dosage in infants and young children. Adults and children: The recommended starting dosage is 3 mg/kg/day, administered orally, divided into 3 equal doses every 8 hours or 2 equal doses every 12 hours. The dosage may be titrated to a maximum of 8 mg/kg/day. Patients with refractory hypoglycemia may require higher dosages. Infants and newborns: The recommended starting dosage is 8 mg/kg/day, administered orally, divided into 3 equal doses every 8 hours or 2 equal doses every 12 hours. The dosage may be titrated to a maximum of 15 mg/kg/day.
Side effects
Frequent and Serious: Sodium and fluid retention is most common in young infants and in adults and may precipitate congestive heart failure in patients with compromised cardiac reserve (see DRUG INTERACTIONS ). Infrequent but Serious: Diabetic ketoacidosis and hyperosmolar nonketotic coma may develop very rapidly. Monitor patients for up to 7 days due to the long half-life of PROGLYCEM (see OVERDOSAGE ). Other frequent adverse reactions: Hirsutism of the lanugo type, mainly on the forehead, back and limbs, occurs most commonly in children and women and may be cosmetically unacceptable. It subsides on discontinuation of PROGLYCEM. Hyperglycemia or glycosuria may require reduction in dosage in order to avoid progression to ketoacidosis or hyperosmolar coma. Gastrointestinal intolerance may include anorexia, nausea, vomiting, abdominal pain, ileus, diarrhea, transient loss of taste. Tachycardia, palpitations, increased levels of serum uric acid are common. Thrombocytopenia with or without purpura may require discontinuation of PROGLYCEM. Neutropenia is transient, is not associated with increased susceptibility to infection, and ordinarily does not require discontinuation of PROGLYCEM. Skin rash, headache, weakness, and malaise may also occur. Other adverse reactions: Cardiovascular: Hypotension occurs occasionally, which may be augmented by thiazide diuretics given concurrently.…
Warnings
Important safety information
The antidiuretic property of diazoxide may lead to significant fluid retention. In patients with compromised cardiac reserve, fluid retention may precipitate congestive heart failure. If fluid retention develops, manage according to standards of care. Co-administration of PROGLYCEM with thiazides may potentiate the hyperglycemic and hyperuricemic actions of diazoxide (see DRUG INTERACTIONS and ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY ). Ketoacidosis and nonketotic hyperosmolar coma have been reported in patients treated with PROGLYCEM, usually during intercurrent illness. Prompt recognition and treatment are essential (see OVERDOSAGE ), and prolonged surveillance following the acute episode is necessary because of the long drug half-life of approximately 30 hours. Advise patients to monitor urine glucose and ketones and to promptly report abnormal findings and symptoms of ketoacidosis to their healthcare provider. Transient cataracts occurred in association with hyperosmolar coma in an infant, and subsided on correction of the hyper-osmolarity. Cataracts have been observed in several animals receiving daily dosages of intravenous or oral diazoxide. The development of abnormal facial features in four children treated chronically (>4 years) with PROGLYCEM for hypoglycemia hyperinsulinism in the same clinic has been reported. Pulmonary Hypertension in Neonates and Infants There have been postmarketing reports of pulmonary hypertension occurring in infants and neonates treated with diazoxide. The cases were reversible upon discontinuation of diazoxide. Monitor patients, especially those with risk factors for pulmonary hypertension, for respiratory distress and discontinue PROGLYCEM if pulmonary hypertension is suspected.
Who should not take Proglycem
PROGLYCEM is contraindicated in patients with: Functional hypoglycemia Hypersensitivity to diazoxide, any of the excipients in PROGLYCEM, or other thiazides
Overdose — what happens if you take too much
An overdosage of PROGLYCEM causes marked hyperglycemia which may be associated with ketoacidosis. Because of the diazoxide’s long half-life (approximately 30 hours), the symptoms of overdosage require prolonged surveillance for periods up to 7 days until the blood glucose level stabilizes within the normal range. One investigator reported successful lowering of diazoxide blood levels by peritoneal dialysis in one patient and by hemodialysis in another.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Since diazoxide is highly bound to serum proteins, it may displace other substances which are also bound to protein, such as bilirubin or coumarin and its derivatives, resulting in higher blood levels of these substances. Concomitant administration of PROGLYCEM and diphenylhydantoin may result in a loss of seizure control. Consider these potential interactions when administering PROGLYCEM. The concomitant administration of thiazides or other diuretics may potentiate the hyperglycemic and hyperuricemic effects of PROGLYCEM.
Storing Proglycem, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store PROGLYCEM at 25°C (77°F) excursions permitted to 15°C to 30°C (59°F to 86°F).”
May treat (source: NIH RxClass)
Dosage forms
Suspension
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Proglycem treat?
- Proglycem (Diazoxide) may be used to treat hyperphagia, malignant hypertension, hypoglycemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Proglycem cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $6.76 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Epaned — about $0.07 on the same basis.
- Is there a coupon or discount for Proglycem?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Proglycem. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Proglycem?
- Proglycem is marketed by Teva Branded Pharm. You can see Teva Branded Pharm's full profile, rating, and other products on pharmaranks.
- Is Proglycem a brand-name or generic drug?
- Proglycem is a brand-name product with the active ingredient Diazoxide.
- Is Proglycem available over the counter?
- No. Proglycem is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Proglycem come in?
- Proglycem is currently marketed as suspension, per the FDA's National Drug Code Directory.
- Is Proglycem FDA-registered?
- Proglycem is on record with the U.S. FDA under application number NDA017453. You can verify this on its official FDA label.
- Is Proglycem safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Proglycem. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Proglycem?
- Proglycem's side effects are taken directly from its FDA label. From the label: Frequent and Serious: Sodium and fluid retention is most common in young infants and in adults and may precipitate congestive heart failure in patients with compromised cardiac reserve (see DRUG INTERACTIONS ).… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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