Tolbutamide (Oral)

Tolbutamide is used to treat high blood sugar levels caused by a type of diabetes mellitus (sugar diabetes) known as type 2 diabetes. In type 2 diabetes, your body does not store excess sugar properly, and the sugar stays in your bloodstream. Long-term high blood sugar can lead to serious health issues in the future.

A proper diet is the first step in managing type 2 diabetes, but often medicines are necessary to assist your body. Tolbutamide belongs to a group of drugs called sulfonylureas. It makes your pancreas release more insulin into the bloodstream.

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

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood 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 occur. Additionally, patients with diabetes may need special counseling about changes in their diabetes medicine dosing due to lifestyle changes, such as changes in exercise and diet. Counseling on contraception and pregnancy may also be needed because of the issues that can arise 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 emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or necklace at all times. Also, carry an ID card in your wallet or purse that states 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 your arms, jaw, back, or neck; shortness of breath; sweating; or vomiting while using this medicine. These may be symptoms of a serious heart problem, including a heart attack.

Tolbutamide can cause 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 tolbutamide with another type of diabetes medicine. The symptoms of low blood sugar must be treated quickly to prevent unconsciousness (passing out). Different people experience different symptoms of low blood sugar. It is important for you to learn which symptoms you usually have so you can address them quickly.

Symptoms of low blood sugar include anxiety; behavior change that seems like being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty thinking; drowsiness; excessive hunger; fast heartbeat; persistent 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 emergencies when severe symptoms such as seizures (convulsions) or unconsciousness occur. Keep 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 compare the risks of taking the medicine with the benefits it may provide. Here are some important things to consider 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, let your healthcare professional know 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 are no appropriate studies on how tolbutamide affects children. Its safety and effectiveness in children have not been established.

Geriatric

There is no information on how tolbutamide affects older adults. However, elderly patients are more likely to have heart, liver, or kidney issues related to aging, which may require changes in dosage for those taking tolbutamide.

Breast Feeding

There are no adequate studies in women to determine the risk to the infant when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In these cases, your doctor may 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 while using this medicine. The following interactions are based on their potential significance and do not include all possible interactions.

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 how often you take one or both medicines.

• Abiraterone Acetate
• Acarbose
• Alogliptin
• Aspirin
• Bexagliflozin
• Capecitabine
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorthalidone
• Ciprofloxacin
• Dabrafenib
• Delafloxacin
• Desmopressin
• Disopyramide
• Dulaglutide
• Enoxacin
• Entacapone
• Fluconazole
• 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
• Mavacamten
• Metformin
• Methotrexate
• Metolazone
• Moxifloxacin
• Nitisinone
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Phenobarbital
• Pioglitazone
• Polythiazide
• Porfimer
• Pramlintide
• Primidone
• Semaglutide
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Sparsentan
• Thioctic Acid
• Tocilizumab
• Triamterene
• Trovafloxacin

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

• Acebutolol
• Aminolevulinic Acid
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Chloramphenicol
• Dicumarol
• Esmolol
• Fenugreek
• Fosphenytoin
• Ginkgo Biloba
• Glucomannan
• Guar Gum
• Isocarboxazid
• Ketoconazole
• Labetalol
• Levobunolol
• Linezolid
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Penbutolol
• Phenelzine
• Phenytoin
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifapentine
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Sulfaphenazole
• Timolol
• Tirzepatide
• Tranylcypromine
• Trimethoprim
• Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtimes or with specific types of food due to possible interactions. Drinking alcohol or using tobacco with some medicines can also cause interactions. The following interactions are based on their potential significance and do not include all possible interactions.

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 how often you take this medicine, or provide you with specific instructions regarding food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Alcohol intoxication or
• Underactive adrenal glands or
• Underactive pituitary glands or
• Undernourished condition or
• Weakened physical condition or
• Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking tolbutamide.

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

• Fever or
• Infection or
• Surgery or
• Trauma—These conditions may temporarily affect blood sugar control, and your doctor may need to treat you temporarily with insulin.

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

• Kidney disorder or
• Liver disorder—Higher blood levels of this medicine may occur, which could lead to serious problems.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

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

Rare

• Abdominal or stomach pain
• chills
• clay-colored stools
• dark urine
• diarrhea
• dizziness
• fever
• headache
• itching
• loss of appetite
• nausea
• rash
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood

Incidence not known

• Agitation
• back or leg pains
• bleeding gums
• blood in urine or stools
• bloody, black, or tarry stools
• chest pain
• coma
• confusion
• convulsions
• cough or hoarseness
• decreased urine output
• depression
• difficulty breathing
• fast or irregular heartbeat
• fatigue
• fever with or without chills
• fluid-filled skin blisters
• general body swelling
• general feeling of tiredness or weakness
• high fever
• hostility
• increased thirst
• irritability
• lethargy
• light-colored stools
• lower back or side pain
• muscle pain or cramps
• muscle twitching
• nosebleeds
• painful or difficult urination
• pale skin
• pinpoint red spots on skin
• rapid weight gain
• seizures
• sensitivity to the sun
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• swelling of face, ankles, or hands
• swollen or painful glands
• tightness in the chest
• unexplained bleeding or bruising
• wheezing
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Anxiety
• blurred vision
• cold sweats
• cool, pale skin
• increased hunger
• nervousness
• nightmares
• shakiness
• slurred speech

Some side effects may happen 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 inform 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

• Belching
• indigestion
• pain in the chest below the breastbone
• passing of gas
• stomach pain, fullness, or discomfort

Less common

• Flushing or redness of skin
• unusually warm skin

Incidence not known

• Change in taste or bad, unusual, or unpleasant (after)taste
• increased sensitivity of skin to sunlight
• redness or other discoloration of 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.

• Tol-Tab

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: 1st Generation Sulfonylurea

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

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 type 2 diabetes:For oral dosage form (tablets): Adults—At first, 1000 to 2000 milligrams (mg) per day, taken in the morning or in divided doses. Your doctor may adjust your dose if needed. The dose is usually not more than 3000 mg per day. Children—Use and dose must be determined by your doctor.