Esidrix

Frequent urination (having to pee often), one of the side effects of hydrochlorothiazide, should go away after you've been taking it for a few weeks. Tell your doctor if any of these symptoms are severe or do not go away:

• muscle weakness
• dizziness
• cramps
• constipation
• thirst
• stomach pain
• nausea
• vomiting
• diarrhea
• loss of appetite
• headache
• hair loss
• sexual dysfunction (impotence)

If you experience any of the following symptoms, call your doctor immediately:

• sore throat with fever
• unusual bleeding or bruising
• severe skin rash with peeling skin
• difficulty breathing or swallowing

This is not a complete list of hydrochlorothiazide side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines for high blood pressure 
• NSAIDs (such as ibuprofen, naproxen, others)
• corticosteroids (such as prednisone, hydrocortisone, others)
• lithium (Eskalith, Lithobid) 
• oral (taken by mouth) medications for diabetes 
• insulin
• narcotics such as hydrocodone, codeine, morphine, oxycodone
• barbiturates such as amobarbital (Amytal), butabarbital (Butisol Sodium), phenobarbital (Luminal), primidone (Mysoline), pentobarbital (Nembutal), thiopental (Pentothal)
• probenecid (Benemid)
• vitamins
• alcohol
• cholestyramine (Prevalite, Questran)
• colestipol (Colestid)

This is not a complete list of hydrochlorothiazide drug interactions. Ask your doctor or pharmacist for more information.

Before receiving this medication, tell your doctor if you are allergic to hydrochlorothiazide, sulfa drugs, or any other medication.

This medication may decrease your potassium levels. Symptoms of low potassium levels include:

• Abnormal heart rhythms, especially in people with heart disease
• Constipation
• Fatigue
• Muscle damage
• Muscle weakness or spasms
• Paralysis (which can include the lungs)

Hydrochlorothiazide can cause dizziness. Do not drive or operate heavy machinery until you know how hydrochlorothiazide affects you. Limit alcoholic beverages.

If you have diabetes, this medication may affect your glucose levels.

This medication may cause a decrease in kidney function, especially in certain groups (such as those with severe congestive heart failure). Tell your doctor if you have the following symptoms:

• decrease in urine output
• drowsiness 
• headache
• back pain

Tell your doctor if you have prolonged diarrhea or vomiting as this may lead to a serious loss of body water (dehydration) To prevent dehydration, drink plenty of fluids unless your doctor directs you otherwise.

Medicines 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 hydrochlorothiazide there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed. Hydrochlorothiazide is excreted in human breast milk. There is some evidence it may reduce the amount of breast milk produced by women who take it. Because of the possibility for serious adverse effects in nursing infants, you and your doctor will need to decide if you should stop breastfeeding or stop taking hydrochlorothiazide.

Esidrix®

hydrochlorothiazide USP

Tablets

Prescribing Information

Anuria; hypersensitivity to this or other sulfonamide-derived drugs.

General

All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia (see Laboratory Tests and Drug/Drug Interactions). Warning signs are dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbance such as nausea or vomiting.

      Hypokalemia may develop, especially with brisk diuresis or when severe cirrhosis is present.

      Interference with adequate oral intake of electrolytes will also contribute to hypokalemia. Hypokalemia may be avoided or treated by use of potassium supplements or foods with a high potassium content.

      Any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction rather than administration of salt, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

      Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.

      Latent diabetes may become manifest during thiazide administration (see Drug/Drug Interactions).

      The antihypertensive effects of the drug may be enhanced in the postsympathectomy patient.

      If progressive renal impairment becomes evident, withholding or discontinuing diuretic therapy should be considered.

      Calcium excretion is decreased by thiazides. Pathological changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. The common complications of hyperparathyroidism such as renal lithiasis, bone resorption, and peptic ulceration have not been seen.

      Thiazide diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

Information for Patients

Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.

Laboratory Tests

Initial and periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

      Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids.

Drug/Drug Interactions

Hypokalemia can sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability).

      Hypokalemia may develop during concomitant use of steroids or ACTH.

      Insulin requirements in diabetic patients may be increased, decreased, or unchanged.

      Thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

      Thiazide drugs may increase the responsiveness to tubocurarine.

      Lithium renal clearance is reduced by thiazides, increasing the risk of lithium toxicity.

      There have been rare reports in the literature of hemolytic anemia occurring with the concomitant use of hydrochlorothiazide and methyldopa.

      Concurrent administration of some nonsteroidal anti-inflammatory agents may reduce the diuretic, natriurefic and anti-hypertensive effects of thiazide diuretics.

      Cholestyramine and colestipol resins: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively.

Drug/Laboratory Test Interactions

Thiazides may decrease serum PBI levels without signs of thyroid disturbance.

      Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS, General, calcium excretion).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice.

      Hydrochlorothiazide was not genotoxic in in vitro assays using strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 of Salmonella typhimurium (Ames assay) and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in in vivo assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1300 µg/mL, and in the Aspergillus nidulans nondisjunction assay at an unspecified concentration.

      Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg/day, respectively, prior to mating and throughout gestation.

Pregnancy

Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg/kg/day, respectively, provided no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Nursing Mothers

Thiazides are excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Esidrix, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Applies to hydrochlorothiazide: oral capsule, oral solution, oral tablet

Along with its needed effects, hydrochlorothiazide (the active ingredient contained in Esidrix) 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 while taking hydrochlorothiazide:

• Abdominal or stomach pain
• back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• bloody urine
• blue lips and fingernails
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• chills
• clay-colored stools
• cloudy urine
• cold sweats
• confusion
• constipation
• cough or hoarseness
• coughing that sometimes produces a pink frothy sputum
• coughing up blood
• cracks in the skin
• darkened urine
• decrease in urine output or decrease in urine-concentrating ability
• decreased frequency or amount of urine
• diarrhea
• difficult, fast, or noisy breathing, sometimes with wheezing
• difficulty with breathing
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• dry mouth
• fast or irregular heartbeat
• fever
• flushed, dry skin
• fruit-like breath odor
• general body swelling
• general feeling of discomfort or illness
• general feeling of tiredness or weakness
• greatly decreased frequency of urination or amount of urine
• headache
• hives
• increased blood pressure
• increased hunger
• increased sweating
• increased thirst
• increased urination
• indigestion
• itching
• joint pain, stiffness, or swelling
• loss of appetite
• loss of heat from the body
• lower back or side pain
• muscle cramps or pain
• nausea or vomiting
• nosebleeds
• numbness, tingling, pain, or weakness in the hands or feet
• pain in the joints or muscles
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red, irritated eyes
• red skin lesions, often with a purple center
• red, swollen skin
• redness, soreness, or itching skin
• scaly skin
• seizures
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sores, welting, or blisters
• sugar in the urine
• swelling of the face, fingers, legs, ankles, feet, or lower legs
• swollen or painful glands
• tenderness of salivary glands
• thickening of bronchial secretions
• tightness in the chest
• trembling
• troubled breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• vomiting of blood
• weakness and heaviness of the legs
• weight gain
• wheezing
• yellow eyes or skin

Some side effects of hydrochlorothiazide 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
• hair loss or thinning of the hair
• inability to have or keep an erection
• increased sensitivity of the skin to sunlight
• loss in sexual ability, desire, drive, or performance
• muscle spasm
• pinpoint red or purple spots on the skin
• redness or other discoloration of the skin
• restlessness
• sensation of spinning
• severe sunburn
• weakness