Chlorthalidone

Common Side Effects of Chlorthalidone (Thalitone):

• Low levels of potassium, sodium, and magnesium in the body
• High calcium and uric acid levels in the body
• High blood sugar levels in those with diabetes
• Dizziness, lightheadedness
• Drowsiness
• Headache
• Fatigue
• Nausea
• Vomiting
• Abdominal pain
• Constipation

Serious Side Effects of Chlorthalidone (Thalitone):

Call your doctor immediately if you experience any of the following serious side effects:

• Sore throat with fever
• Unusual bruising or bleeding
• Severe skin rash with peeling skin
• Difficulty swallowing or breathing

Thalitone® (chlorthalidone USP) should be used with caution in severe renal disease. In patients with renal disease, chlorthalidone or related drugs may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Chlorthalidone should be used with caution in patients with impaired hepatic function or progressive liver disease, because minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with thiazide diuretics which are structurally related to chlorthalidone. However, systemic lupus erythematosus has not been reported following chlorthalidone administration.

Chlorthalidone is a prescription medication used to treat high blood pressure and fluid retention caused by congestive heart failure and other conditions. Chlorthalidone belongs to a group of drugs called diuretics ("water pills") which help the body get rid of excess fluid by increasing the amount of salt and water the kidneys remove from the blood.

This medication comes in tablet form and is usually taken once daily, with or without food. 

Common side effects include stomach pain, vomiting, and diarrhea. Chlorthalidone can also cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of chlorthalidone, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving chlorthalidone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have had an allergic reaction to chlorthalidone or other diuretics or if you have asthma
• have kidney disease
• have liver disease
• have gout
• have systemic lupus erythematosus
• are pregnant or breastfeeding

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal products.

• Take chlorthalidone exactly as prescribed.
• This medication comes in tablet form and is usually taken once daily.
• Chlorthalidone can be taken with or without food.
• Because chlorthalidone increases urination, it is best taken in the morning to avoid having to get up in the night to urinate.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Your pharmacist can provide more information about chlorthalidone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Drinking alcohol with this medicine can cause side effects.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

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

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 health care professional may be able to tell 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:

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

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.

• It is used to treat high blood pressure.
• It is used to get rid of extra fluid.
• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hard stools (constipation).
• Dizziness.
• Headache.
• Not hungry.
• Upset stomach or throwing up.
• Stomach cramps.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Symptoms of acute overdosage include nausea, weakness, dizziness, and disturbances of electrolyte balance. The oral LD50 of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. The minimum lethal dose (MLD) in humans has not been established. There is no specific antidote, but gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.

Biochemical studies in animals have suggested reasons for the prolonged effect of Chlorthalidone. Absorption from the gastrointestinal tract is slow due to its low solubility. After passage to the liver, some of the drug enters the general circulation, while some is excreted in the bile, to be reabsorbed later. In the general circulation, it is distributed widely to the tissue, but is taken up in highest concentrations by the kidneys, where amounts have been found 72 hours after ingestion, long after it has disappeared from other tissues. The drug is excreted unchanged in the urine.

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Rev 04, May 2017

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Generic: 25 mg, 50 mg, 100 mg [DSC]

Sulfonamide-derived diuretic that inhibits sodium and chloride reabsorption in the cortical-diluting segment of the ascending loop of Henle

Metabolism

Hepatic

Excretion

Urine (primarily as unchanged drug)

Calcium nephrolithiasis

Data from a prospective, double-blind, randomized, placebo-controlled study supports the use of chlorthalidone for the prevention of recurrent calcium nephrolithiasis [Ettinger 1988]. Additional trials may be necessary to further define the role of chlorthalidone in the treatment of this condition.

Based on the American Urologic Association (AUA) guidelines for the medical management of kidney stones, chlorthalidone is effective and recommended for the prevention of recurrent calcium stones in patients with high or relatively high urine calcium concentrations.

Hypersensitivity to chlorthalidone, other sulfonamide-derived drugs, or any component of the formulation; anuria

Note: Although the FDA approved product labeling states this medication is contraindicated with other sulfonamide-containing drug classes, the scientific basis of this statement has been challenged. See "Warnings/Precautions" for more detail.

Documentation of allergenic cross-reactivity for drugs thiazide-type diuretics is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Adverse events have not been observed in animal reproduction studies. Chlorthalidone crosses the placenta and can be detected in cord blood. Maternal use may cause fetal or neonatal jaundice, thrombocytopenia, or other adverse events observed in adults. Use of thiazide diuretics to treat edema during normal pregnancies is not appropriate; use may be considered when edema is due to pathologic causes (as in the nonpregnant patient); monitor. Untreated chronic maternal hypertension is associated with adverse events in the fetus, infant, and mother. Women who require thiazide diuretics for the treatment of hypertension prior to pregnancy may continue their use (ACOG 2013).

Summary of Use during Lactation

Although amounts of chlorthalidone in milk are not great, its slow clearance may lead to accumulation in the infant, especially while nursing a newborn or preterm infant. It may also suppress lactation. An alternate drug may be preferred.

Drug Levels

Maternal Levels. In 7 women taking 50 mg of oral chlorthalidone daily prior to and after delivery, milk levels 3 days after delivery (collection times unspecified) ranged from 90 to 860 mcg/L. The authors estimated that the infant would receive about 180 mcg daily of chlorthalidone from milk at this maternal dosage.[1] This would amount to about 6% of the maternal weight-adjusted dosage.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Chlorthalidone has been used successfully to suppress lactation by giving 200 mg orally right after delivery, followed by 100 mg dailyy for 3 days in conjunction with fluid restriction and breast binding.[2] However, a comparative study found no difference between chlorthalidone 200 mg daily for 7.6 days and placebo in milk leakage and breast engorgement and pain.[3] The added contribution of the diuretic to fluid restriction and breast binding, which are effective in suppressing lactation, has not been studied. There are no data on the effects of diuretics on established, ongoing lactation.

Alternate Drugs to Consider

Chlorothiazide, Hydrochlorothiazide

References

1. Mulley BA, Parr GD, Pau WK et al. Placental transfer of chlorthalidone and its elminination in maternal milk. Eur J Clin Pharmacol. 78;13:129-31. PMID: 658109

2. Reiher KH. [Suppression of lactation by stimulation of diuresis]. Zentralbl Gynakol. 1963;85:188-90. PMID: 13973786

3. Vercruysse J. [Inhibition of lactation. Comparative study of an estro-androgen and of a diuretic]. Brux Med. 1966;46:1258-66. PMID: 6011090