Thalitone (Oral)

Chlorthalidone is used on its own or with other medicines to treat high blood pressure (hypertension). High blood pressure puts extra strain on the heart and arteries. If it lasts a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. High blood pressure can also raise the risk of heart attacks. Controlling blood pressure may help reduce the chances of these problems.

Chlorthalidone is also used to treat fluid retention (edema) caused by congestive heart failure, severe liver disease (cirrhosis), kidney disease, or treatment with a hormone or steroid medicine.

Chlorthalidone is a diuretic (water pill). It lowers the amount of water in the body by increasing urine flow, which helps to lower blood pressure.

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

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

This medicine may cause you to lose more potassium from your body than normal (hypokalemia). Tell your doctor if you become sick with severe or continuing nausea, vomiting, or diarrhea, and drink fluids to prevent getting dehydrated. Check with your doctor right away if you have dry mouth, increased thirst, muscle cramps, or nausea or vomiting.

This medicine may cause some people to become dizzy. Do not drive, use machines, or do anything else that could be dangerous if you are dizzy.

Drinking alcoholic beverages may also make the dizziness worse. While you are taking this medicine, be careful to limit the amount of alcohol you drink.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it provides. This is a choice you will make with your doctor. For this medicine, you should think about the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional 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

Studies have not been done to determine the effects of chlorthalidone in children. Its safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of chlorthalidone. However, elderly patients are more likely to have kidney disease related to aging, which may require caution and a dose adjustment for those taking chlorthalidone.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all. In other cases, two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When taking this medicine, 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 selected based on their potential significance and are not necessarily all-inclusive.

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 change the dose or how often you take one or both medicines.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Albuterol
• Alogliptin
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Bepridil
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Clonixin
• Codeine
• Dapagliflozin
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Dofetilide
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Linagliptin
• Liraglutide
• Lithium
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methotrexate
• Metildigoxin
• Miglitol
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Pramlintide
• Proglumetacin
• Propyphenazone
• Proquazone
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Sulindac
• Tapentadol
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Valdecoxib
• Vildagliptin

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

• Aminolevulinic Acid
• Gossypol
• Licorice
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Anuria (not able to form urine)—Should not be used in patients with this condition.

• Asthma or
• Dehydration or
• Diabetes or
• Gout or
• Hypercalcemia (high calcium in the blood) or
• Hyperlipidemia (high cholesterol or triglycerides in the blood) or
• Hyperuricemia (high uric acid in the blood) or
• Hypochloremic alkalosis (low chlorine in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hyponatremia (low sodium in the blood) or
• Hypophosphatemia (low phosphorus in the blood) or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume) or
• Kidney failure or
• Systemic lupus erythematosus—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects of the medicine may be increased because the medicine is removed from the body more slowly.

Along with its necessary effects, Thalitone (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 right away if any of the following side effects occur:

Incidence not known

• Abdominal or stomach pain
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• chills
• clay-colored stools
• cold sweats
• confusion
• cough or hoarseness
• coughing up blood
• darkened urine
• diarrhea
• difficulty having a bowel movement (stool)
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast heartbeat
• fever
• flushed, dry skin
• fruit-like breath odor
• general feeling of tiredness or weakness
• headache
• increased hunger
• increased thirst
• increased urination
• indigestion
• itching or skin rash
• joint pain, stiffness, or swelling
• loss of appetite
• lower back or side pain
• nausea
• pain in the joints or muscles
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• red, irritated eyes
• red skin lesions, often with a purple center
• redness, soreness or itching skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sores, welting, or blisters
• sugar in the urine
• sweating
• swelling of the feet or lower legs
• swollen glands
• tightness in the chest
• troubled breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• vomiting
• vomiting of blood
• weight loss
• yellow eyes or skin

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 Thalitone (Oral). Your health care professional may also 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 or are bothersome, or if you have any questions about them:

Incidence not known

• Cramping
• decreased interest in sexual intercourse
• feeling of constant movement of self or surroundings
• hives
• inability to have or keep an erection
• increased sensitivity of the skin to sunlight
• loss in sexual ability, desire, drive, or performance
• muscle spasm
• redness or other discoloration of the skin
• restlessness
• sensation of spinning
• severe sunburn
• weakness

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 may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Thalitone

Available Dosage Forms:

• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Diuretic

Chemical Class: Thiazide Related

Take this medicine exactly as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium or potassium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

This medicine is usually taken in the morning with food.

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 fluid retention (edema): Adults—At first, 50 to 100 milligrams (mg) once a day, or 100 mg once every other day. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor. For high blood pressure: Adults— Chlorthalidone: At first, 25 milligrams (mg) once a day. Your doctor may adjust your dose if needed. Thalitone®: At first, 15 mg once a day. After 2 weeks, your dose may be increased to 25 mg per day as needed. 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.

• What is the best time of day to take blood pressure medication?