Mykrox (Oral)

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

Metolazone is also used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure increases the workload of the heart and arteries. If it lasts for 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 may also raise the risk of heart attacks. Controlling blood pressure may help reduce the chances of these problems.

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

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

It is very important that your doctor checks 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 happen, 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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about 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 conducted on the effects of metolazone in children. Safety and effectiveness have not been established.

Geriatric

Studies to date have not shown any specific problems in older adults that would limit the usefulness of metolazone. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require a dose adjustment for those taking metolazone.

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, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to adjust 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 chosen based on their potential significance and 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 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
• Bumetanide
• Buprenorphine
• Canagliflozin
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Clonixin
• Codeine
• Dapagliflozin
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Dofetilide
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Furosemide
• 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
• Torsemide
• 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 of the medicines.

• Aminolevulinic Acid
• Gossypol
• Licorice

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food since interactions may occur. Mixing alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected based on their potential significance and 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 change the dose or how often you take this medicine, or give you specific instructions about using food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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

• Anuria (not able to pass urine) or
• Severe liver disease (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 worsen these conditions.

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

Along with its intended effects, Mykrox (Oral) may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may require 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 sluggish
• 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 Mykrox (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, 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.

In the U.S.

• Mykrox
• Zaroxolyn

Available Dosage Forms:

• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Diuretic

Chemical Class: Thiazide Related

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.