Tolinase (Oral)

Tolazamide is used to treat high blood sugar levels caused by type 2 diabetes mellitus (sugar diabetes). In type 2 diabetes, your body does not handle excess sugar properly, causing it to stay in your bloodstream. Long-term high blood sugar can lead to serious health issues later on.

A proper diet is the first step in managing type 2 diabetes, but often you will need medicines to assist your body. Tolazamide is part of a group of drugs known as sulfonylureas. It helps your pancreas release more insulin into the bloodstream.

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

Your doctor will want to check your progress at regular visits to ensure that this medicine is working properly. Blood tests may be needed to monitor for unwanted effects.

Contact your doctor immediately if you experience chest pain or discomfort; nausea; pain or discomfort in the 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.

It is very important to closely 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 understand how to prevent side effects or assist with side effects if they occur. Additionally, patients with diabetes may require special counseling regarding changes in diabetes medicine dosing due to lifestyle changes, such as alterations in exercise and diet. Counseling on contraception and pregnancy may also be necessary because of the issues that can arise in patients with diabetes during pregnancy.
• Travel—Keep your recent prescription and medical history with you. Be prepared for emergencies as you would normally. Account for time zone changes and try to keep your meal times as close as possible to your usual schedule.
• In case of emergency—There may be times when you need emergency assistance for a problem related to your diabetes. You should be prepared for these emergencies. It is advisable 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.

Taking too much tolazamide can lead to low blood sugar (hypoglycemia) under certain conditions. Symptoms of low blood sugar must be treated before they result in unconsciousness. Different people may experience different symptoms of low blood sugar. It is important for you to learn which symptoms of low blood sugar you typically have so you can treat it quickly and reach out to your health care team for advice when needed.

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; persistent headache; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If you experience symptoms of low blood sugar, consume 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 occur. Keep a glucagon kit on hand, along with a syringe or needle, and know how to use it. Members of your household should also be aware of how to use it.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care 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 closely.

Pediatric

There have not been proper studies on how tolazamide affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the use of tolazamide. However, older patients are more likely to have liver or kidney problems related to age, which may require a dosage adjustment for those taking tolazamide.

Breast Feeding

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

Interactions with Medicines

Certain medicines should not be taken together, while others may be used together even if there is a risk of interaction. In these cases, your doctor may adjust the dose or take other precautions. It is important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are important but may 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, your doctor may change the dose or frequency for one or both medicines.

• 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
• 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 using both may be necessary for your treatment. If both medicines are prescribed, your doctor may change the dose or frequency for one or both medicines.

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

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. Drinking alcohol or using tobacco with certain medicines can also cause interactions. The following interactions are important but may 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 give you special instructions about food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Other medical problems may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, especially:

• Alcohol intoxication or
• Underactive adrenal glands or
• Underactive pituitary gland or
• Undernourished condition or
• Weakened physical condition or
• Any other condition that causes low blood sugar—Patients with these conditions may be at higher risk for low blood sugar while taking tolazamide.

• 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 issues may temporarily affect blood sugar control, and your doctor might want to treat you temporarily with insulin.

• Heart disease—Use with caution. This condition may get worse.

• Kidney disease or
• Liver disease—Higher levels of this medicine may occur, leading to serious problems.

Along with its required effects, this medicine 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 right away if any of the following side effects occur:

Rare

• Abdominal or stomach pain
• chills
• clay-colored stools
• dark urine
• diarrhea
• difficulty swallowing
• dizziness
• fast heartbeat
• fever
• headache
• hives
• itching
• loss of appetite
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• shortness of breath
• skin rash
• tightness in chest
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting blood
• wheezing
• yellow eyes or skin

Incidence not known

• Agitation
• back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in urine or 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
• hostility
• increased thirst
• irritability
• itching of the skin
• lethargy
• light-colored stools
• lower back or side pain
• muscle pain or cramps
• muscle twitching
• nausea or vomiting
• nosebleeds
• painful or difficult urination
• pale skin
• pinpoint red spots on skin
• rapid weight gain
• seizures
• sensitivity to the sun
• skin thinness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• swelling of the face, ankles, or hands
• swollen or painful glands
• unusual bleeding or bruising

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

Symptoms of overdose

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

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 healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Indigestion
• passing gas

Rare

• Feeling of constant movement of self or surroundings
• sensation of spinning

Incidence not known

• 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.

• Tolinase

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 oral dosage form (tablets):For type 2 diabetes: Adults—At first, 100 to 250 milligrams (mg) once a day taken with breakfast or the first main meal. Your doctor may adjust your dose if needed. The dose is usually not more than 1000 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not keep outdated medicine or medicine no longer needed.