Tol-Tab (Oral)

Tolbutamide is used to treat high blood sugar levels caused by type 2 diabetes mellitus (sugar diabetes). In type 2 diabetes, your body does not properly store excess sugar, resulting in sugar remaining in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future.

A proper diet is the first step in managing type 2 diabetes, but medicines are often needed to assist your body. Tolbutamide is part of 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. Patients with diabetes may also need special counseling about changes in their medicine dosing that might happen because of lifestyle changes, such as changes in exercise and diet. Additionally, counseling on contraception and pregnancy may be needed due to the issues that can arise for 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. Make allowances for changing time zones and try to keep your meal times as close as possible to your usual meal times.
• In case of emergency—You may need emergency help for a problem caused by your diabetes. Be prepared 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 states you have diabetes and lists all of your medicines.

Contact your doctor right away if you start experiencing chest pain or discomfort; nausea; pain or discomfort in arms, jaw, back, or neck; shortness of breath; sweating; or vomiting while using this medicine. These may be signs 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 before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important to learn which symptoms of low blood sugar you usually experience 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; continuing 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 must consider the risks of taking it against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other 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 done on how tolbutamide affects children. Safety and effectiveness have not been established.

Geriatric

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

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may adjust the dose or take other precautions. When you are taking this medicine, it is very important for your healthcare professional to know if you are also taking any of the medicines listed below. The following interactions have been chosen based on their potential importance 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 of 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 raise the risk of certain side effects, but using both drugs could be 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 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

Some medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines can also lead to interactions. The following interactions have been chosen based on their potential importance 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 of this medicine or provide special instructions about using food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

Having other medical issues may affect how this medicine works. Make 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 experience low blood sugar while taking tolbutamide.

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

• Fever or
• Infection or
• Surgery or
• Trauma—These issues may cause temporary problems with blood sugar control, and your doctor may suggest using insulin temporarily.

• Heart disease—Use with caution. This condition may worsen.

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

Along with its important benefits, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, you might need medical help.

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

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 right away if any of the following symptoms of overdose happen:

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 help. These side effects may go away as your body gets used to the medicine. Also, your health care professional may have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can 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.