Diabinese (Oral)

Chlorpropamide is used to treat high blood sugar levels caused by a type of diabetes called type 2 diabetes. In type 2 diabetes, your body does not properly store extra sugar, leading to high sugar levels in your blood. High blood sugar for a long time can cause serious health issues.

A proper diet is the first step in managing type 2 diabetes, but often medicines are necessary. Chlorpropamide is part of a group of drugs called sulfonylureas. It helps your pancreas release more insulin, which assists your body in storing sugar. This also lowers the sugar level in your blood and helps your body use food to create energy.

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

It is very important that your doctor checks your progress at regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep taking it. Blood and urine tests may be needed to check for unwanted effects.

It is very important to carefully follow any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they happen. Also, patients with diabetes may need special counseling about changes in diabetes medicine dosing that might occur due to lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can happen in patients with diabetes during pregnancy.
• Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you normally would. Adjust for changing time zones and try to keep your meal times as close as possible to your usual meal times.
• In case of an emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be ready for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and lists all of your medicines.

Check with your doctor right away if you start having chest pain or discomfort; nausea; pain or discomfort in arms, jaw, back, or neck; shortness of breath; sweating; or vomiting while you are using this medicine. These may be signs of a serious heart problem, including a heart attack.

Chlorpropamide can cause hypoglycemia (low blood sugar). However, this can also happen if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take chlorpropamide with another type of diabetes medicine. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior changes similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty thinking; drowsiness; excessive hunger; fast heartbeat; ongoing headache; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness happen. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household should also know how to use it.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how chlorpropamide affects children. Its safety and effectiveness in children have not been established.

Geriatric

While there have not been specific studies on how chlorpropamide affects older adults, there are no expected problems that would limit its usefulness in this age group. However, older patients are more likely to have liver or kidney issues related to aging, which may require a dose adjustment for those taking chlorpropamide.

Breast Feeding

There are not enough studies to determine if using this medication while breastfeeding poses a risk to infants. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together, while others can be used together even if there may be interactions. In such cases, your doctor might adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen for their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both.

• Abiraterone Acetate
• Acarbose
• Alogliptin
• Aspirin
• Bexagliflozin
• Chloroquine
• Chlorothiazide
• Chlorthalidone
• Ciprofloxacin
• Delafloxacin
• Desmopressin
• Disopyramide
• Dulaglutide
• Enoxacin
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Lanreotide
• Levofloxacin
• Liraglutide
• Lixisenatide
• Lomefloxacin
• Metformin
• Methotrexate
• Metolazone
• Metreleptin
• Moxifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pioglitazone
• Polythiazide
• Porfimer
• Pramlintide
• Semaglutide
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Thioctic Acid
• Triamterene
• Trovafloxacin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both medicines may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both.

• Acebutolol
• Aminolevulinic Acid
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Chloramphenicol
• Clofibrate
• Esmolol
• Fenugreek
• Garlic
• Glucomannan
• Guar Gum
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifampin
• Rifapentine
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Tirzepatide
• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. The following interactions have been chosen for their potential significance and are not necessarily a complete list.

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 adjust the dose or frequency for this medicine or provide special instructions regarding food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Make sure you inform your doctor about any other medical problems, especially:

• Alcohol intoxication or
• Underactive adrenal glands or
• Underactive pituitary gland or
• Undernourished condition or
• Weakened physical condition—May cause side effects to worsen.

• Diabetic ketoacidosis (ketones in the blood) or
• Type I diabetes—Should not be used in patients with these conditions.

• Glucose 6-phosphate dehydrogenase (G6PD) deficiency (an enzyme issue)—Use with caution. May cause hemolytic anemia (blood disorder) in patients with this condition.

• Heart or blood vessel disease—Use with caution. May worsen this condition.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

Along with its needed effects, Diabinese (Oral) may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Abdominal or stomach pain
• agitation
• black, tarry stools
• chills
• clay-colored stools
• coma
• confusion
• continuing diarrhea
• continuing stomach pain
• convulsions
• dark urine
• decreased urine output
• depression
• diarrhea
• dizziness
• fast or irregular heartbeat
• fever
• headache
• hostility
• increased thirst
• irritability
• itching
• lethargy
• loss of appetite
• muscle pain or cramps
• muscle twitching
• nausea or vomiting
• rapid weight gain
• rash
• seizures
• shortness of breath
• stupor
• swelling of the face, ankles, or hands
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Anxiety
• back, leg, or stomach pains
• bleeding gums
• blood in the urine or stools
• blurred vision
• chest pain
• cold sweats
• cool, pale skin
• cough or hoarseness
• depression
• difficulty with breathing
• fever with or without chills
• fluid-filled skin blisters
• general body swelling
• general feeling of tiredness or weakness
• headache
• high fever
• increased hunger
• lower back or side pain
• nervousness
• nightmares
• nosebleeds
• painful or difficult urination
• pinpoint red spots on the skin
• sensitivity to the sun
• shakiness
• skin thinness
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen or painful glands
• tightness in the chest
• unusual bleeding or bruising
• wheezing

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 Diabinese. Your health care professional may also be able to tell you how 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

• Indigestion
• passing of gas

Less common

• Hives or welts
• redness of the skin
• weight loss

Rare

• Blistering, peeling, or loosening of the skin
• cracks in the skin
• loss of heat from the body
• red, irritated eyes
• red, swollen skin
• scaly skin

Incidence not known

• Increased sensitivity of the skin to sunlight
• redness or other discoloration of the skin
• severe sunburn

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.

In the U.S.

• Diabinese

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: 1st Generation Sulfonylurea

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

You should take your medicine each morning with breakfast.

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 (tablets):For type 2 diabetes: Adults—At first, 250 milligrams (mg) once a day. Your doctor may adjust your dose as needed. The dose is usually not more than 750 mg per day. Children—Use and dose must be determined by your doctor.

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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.