Description

Metolazone is used to treat fluid retention (edema) and swelling that is caused by congestive heart failure, kidney disease, or other medical conditions .

Metolazone is also used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the work load of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

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

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

This product is available in the following dosage forms:

Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of 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 performed on the relationship of age to the effects of metolazone in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of metolazone in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving metolazone .

Breastfeeding

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

Drug Interactions

Although certain 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 you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Isocarboxazid

Methenamine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acarbose

Aceclofenac

Acemetacin

Acetyldigoxin

Albiglutide

Albuterol

Alogliptin

Amtolmetin Guacil

Arsenic Trioxide

Articaine

Aspirin

Benzhydrocodone

Bepridil

Bromfenac

Bromocriptine

Bufexamac

Bumetanide

Buprenorphine

Canagliflozin

Cefepime

Celecoxib

Chlorpropamide

Choline Salicylate

Clonixin

Codeine

Dapagliflozin

Deslanoside

Desmopressin

Dexibuprofen

Dexketoprofen

Diazoxide

Diclofenac

Diflunisal

Digitalis

Digitoxin

Digoxin

Dihydrocodeine

Dipyrone

Dofetilide

Droperidol

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Using this medicine with any of the following medicines may cause an increased 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 use one or both of the medicines.

Aminolevulinic Acid

Gossypol

Licorice

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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 change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Anuria (not able to pass urine) or

Liver disease, severe (e.g., hepatic coma)—Should not be used in patients with these conditions .

Asthma or

Diabetes or

Gout or

Hypercalcemia (high calcium in the blood) or

Hyperuricemia (high uric acid in the blood) or

Hypochloremia (low chloride 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

Systemic lupus erythematosus—Use with caution. This medicine may make these conditions worse .

Kidney disease or

Liver disease—Use with caution. The effects of the medicine may be increased because of slower removal of the medicine from the body .

Proper Use

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 .

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way .

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, 5 to 20 milligrams (mg) once a day. Your doctor may adjust your dose if needed.

Children—Use and dose must be determined by your doctor .

For high blood pressure:

Adults—At first, 2.5 to 5 milligrams (mg) once a day. Your doctor may adjust your dose if 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.

Precautions

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

Check with your doctor right away if you have any of the following symptoms while taking this medicine: convulsions or seizures; decreased urine; drowsiness; dry mouth; excessive thirst; muscle pains or cramps; nausea or vomiting; increased heart rate or pulse; or unusual tiredness or weakness. These may be symptoms of a condition called hypokalemia or potassium loss .

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

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

This medicine may cause changes in your blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor .

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests (e.g., tests for parathyroid function) may be affected by this medicine .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .

Side Effects

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:

Incidence not known

Black, tarry stools

bleeding gums

blistering, peeling, or loosening of skin

bloating

blood in urine or stools

blurred vision

bone pain

chest pain

chills

clay-colored stools

cold sweats

coma

confusion

constipation

convulsions

cough

dark urine

decreased urine

diarrhea

dizziness, faintness, or lightheadedness when getting up from lying or sitting position

drowsiness

dry mouth

fast, irregular, pounding, or racing heartbeat or pulse

fever

flushed, dry skin

fruit-like breath odor

general tiredness and weakness

headache

incoherent speech

increased hunger

increased thirst

increased urination

indigestion

irritability

itching

joint or muscle pain

light-colored stools

loss of appetite

lower back or side pain

metallic taste

mood changes

muscle pain or cramps

nausea and vomiting

numbness or tingling in hands, feet, or lips

pain in lower legs

painful or difficult urination

pinpoint red spots on skin

rash

red irritated eyes

red skin lesions, often with a purple center

redness or swelling of lower leg

shortness of breath

sore throat

sores, ulcers, or white spots in mouth or on lips

sugar in the urine

sweating

swelling of face, ankles, or hands

swollen or painful glands

tightness in chest

trembling

troubled breathing

unexplained weight loss

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal pain

vomiting of blood

weak pulse

wheezing

yellow eyes and skin

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

Symptoms of overdose

Fainting

irregular, fast or slow, or shallow breathing

pale or blue lips, fingernails, or skin

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

weakness and heaviness of legs

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:

Incidence not known

Blue-green to black skin discoloration

burning, tingling, numbness, or pain in the hands, arms, feet, or legs

cracked, dry, or scaly skin

decreased interest in sexual intercourse

feeling of constant movement of self or surroundings

hives or welts

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

pain, redness, or sloughing of skin at place of injection

restlessness

sensation of pins and needles

sensation of spinning

stabbing pain

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.