Triamterene and hydrochlorothiazide

GENERIC AVAILABLE: Yes

Tablets: 37.5/25, 75/50 mg. Capsules: 37.5/25, 50/25 mg.

Triamterene/hydrochlorothiazide should be store at room temperature, 15 C - 30 C (59 F - 86 F).

Triamterene and hydrochlorothiazide combination is used alone or with other medicines to treat water retention (edema) or high blood pressure (hypertension). High blood pressure adds to the workload 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.

Triamterene and hydrochlorothiazide are both diuretic medicines (water pills). They reduce the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure. Triamterene helps prevent your body from absorbing too much salt and keeps your potassium levels from getting too low.

triamterene and hydrochlorothiazide is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to make sure triamterene and hydrochlorothiazide is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Make sure your doctor knows if you are also taking potassium supplements or salt substitutes containing potassium, or certain diuretics such as amiloride (Midamor®, Moduretic®), spironolactone (Aldactazide®, Aldactone®), or other products containing triamterene. Using these medicines together may cause serious problems.

triamterene and hydrochlorothiazide may increase the amount of potassium in your blood (hyperkalemia). Stop using triamterene and hydrochlorothiazide and check with your doctor right away if you are having abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeats; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Stop using triamterene and hydrochlorothiazide and check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

triamterene and hydrochlorothiazide may affect blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

triamterene and hydrochlorothiazide may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. Dizziness may be worse if you lose too much water from your body. You can lose water by sweating, having diarrhea, or vomiting. Tell your doctor if triamterene and hydrochlorothiazide makes you feel lightheaded or dizzy after you have been vomiting or had diarrhea.

Check with your doctor right away if you experience drowsiness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium, potassium, or magnesium in the body).

Make sure any doctor or dentist who treats you knows that you are using triamterene and hydrochlorothiazide. You may need to stop using triamterene and hydrochlorothiazide several days before having surgery or medical tests. The results of some tests may be affected by triamterene and hydrochlorothiazide.

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

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
• agitation
• back or leg pains
• black, tarry stools
• bleeding gums
• blisters, hives, or itching
• bloating
• blood in the urine or stools
• 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
• coma
• confusion
• constipation
• convulsions
• cough or hoarseness
• coughing that sometimes produces a pink frothy sputum
• dark urine
• decreased urine output
• depression
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• drowsiness
• dry mouth
• fast, slow, or irregular heartbeat
• fever with or without chills
• flushed, dry skin
• fruit-like breath odor
• general body swelling
• general feeling of discomfort, illness, or weakness
• greatly decreased frequency of urination or amount of urine
• headache
• hostility
• incoherent speech
• increased hunger
• increased sweating
• increased thirst
• increased urination
• indigestion
• irritability
• joint pain, stiffness, or swelling
• lethargy
• loss of appetite
• loss of consciousness
• lower back or side pain
• metallic taste
• mood changes
• muscle pain, cramps, weakness, or twitching
• nausea or vomiting
• nervousness
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• pain in the groin or genitals
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red or purple spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seizures
• sharp back pain just below the ribs
• shortness of breath
• skin rash
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomachache
• stupor
• sugar in the urine
• swelling of the face, ankles, hands, feet, or lower legs
• swollen or painful glands
• thickening of bronchial secretions
• tightness in the chest
• troubled breathing
• unexplained weight loss
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood
• weak pulse
• weakness or heaviness of the legs
• wheezing
• yellow eyes or skin

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

• Face is warm or hot to touch
• frequent urination
• increased volume of pale, dilute urine
• loss of strength or energy
• pain or weakness in the hands or feet
• redness to face
• reflexes are unusually strong
• trembling

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:

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

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.

Triamterene and Hydrochlorothiazide is a diuretic, antihypertensive drug product, principally due to its hydrochlorothiazide component; the triamterene component reduces the excessive potassium loss which may occur with hydrochlorothiazide use.

Hydrochlorothiazide

Hydrochlorothiazide is a diuretic and antihypertensive agent. It blocks the renal tubular absorption of sodium and chloride ions. This natriuresis and diuresis is accompanied by a secondary loss of potassium and bicarbonate. Onset of hydrochlorothiazide's diuretic effect occurs within 2 hours and the peak action takes place in 4 hours. Diuretic activity persists for approximately 6 to 12 hours.

The exact mechanism of hydrochlorothiazide's antihypertensive action is not known although it may relate to the excretion and redistribution of body sodium. Hydrochlorothiazide does not affect normal blood pressure.

Following oral administration, peak hydrochlorothiazide plasma levels are attained in approximately 2 hours. It is excreted rapidly and unchanged in the urine.

Well controlled studies have demonstrated that doses of hydrochlorothiazide as low as 25 mg given once daily are effective in treating hypertension, but the dose-response has not been clearly established.

Triamterene

Triamterene is a potassium-conserving (antikaliuretic) diuretic with relatively weak natriuretic properties. It exerts its diuretic effect on the distal renal tubule to inhibit the reabsorption of sodium in exchange for potassium and hydrogen. With this action, triamterene increases sodium excretion and reduces the excessive loss of potassium and hydrogen associated with hydrochlorothiazide. Triamterene is not a competitive antagonist of the mineralocorticoids and its potassium-conserving effect is observed in patients with Addison's disease, i.e., without aldosterone. Triamterene's onset and duration of activity is similar to hydrochlorothiazide. No predictable antihypertensive effect has been demonstrated with triamterene.

Triamterene is rapidly absorbed following oral administration. Peak plasma levels are achieved within one hour after dosing. Triamterene is primarily metabolized to the sulfate conjugate of hydroxytriamterene. Both the plasma and urine levels of this metabolite greatly exceed triamterene levels.

The amount of triamterene added to 50 mg of hydrochlorothiazide in Triamterene and Hydrochlorothiazide tablets was determined from steady-state dose-response evaluations in which various doses of liquid preparations of triamterene were administered to hypertensive persons who developed hypokalemia with hydrochlorothiazide (50 mg given once daily). Single daily doses of 75 mg triamterene resulted in greater increases in serum potassium than lower doses (25 mg and 50 mg), while doses greater than 75 mg of triamterene resulted in no additional elevations in serum potassium levels. The amount of triamterene added to the 25 mg of hydrochlorothiazide in Triamterene and Hydrochlorothiazide tablets was also determined from steady-state dose-response evaluations in which various doses of liquid preparations of triamterene were administered to hypertensive persons who developed hypokalemia with hydrochlorothiazide (25 mg given once daily). Single daily doses of 37.5 mg triamterene resulted in greater increases in serum potassium than a lower dose (25 mg), while doses greater than 37.5 mg of triamterene, i.e., 75 mg and 100 mg, resulted in no additional elevations in serum potassium levels. The dose-response relationship of triamterene was also evaluated in patients rendered hypokalemic by hydrochlorothiazide given 25 mg twice daily. Triamterene given twice daily increased serum potassium levels in a dose-related fashion. However, the combination of Triamterene and Hydrochlorothiazide given twice daily also appeared to produce an increased frequency of elevation in serum BUN and creatinine levels. The largest increases in serum potassium, BUN and creatinine in this study were observed with 50 mg of triamterene given twice daily, the largest dose tested. Ordinarily, triamterene does not entirely compensate for the kaliuretic effect of hydrochlorothiazide and some patients may remain hypokalemic while receiving Triamterene and Hydrochlorothiazide. In some individuals, however, it may induce hyperkalemia (see WARNINGS).

The Triamterene and Hydrochlorothiazide components of this product are well absorbed and are bioequivalent to liquid preparations of the individual components administered orally. Food does not influence the absorption of triamterene or hydrochlorothiazide from Apotex’s Triamterene and Hydrochlorothiazide 37.5 mg/25 mg or 75 mg/50 mg tablets. The hydrochlorothiazide component of Triamterene and Hydrochlorothiazide tablets is bioequivalent to single entity hydrochlorothiazide tablet formulations.

No specific data are available regarding Triamterene and Hydrochlorothiazide overdosage in humans and no specific antidote is available.

Fluid and electrolyte imbalances are the most important concern. Excessive doses of the triamterene component may elicit hyperkalemia, dehydration, nausea, vomiting and weakness and possibly hypotension. Overdosing with hydrochlorothiazide has been associated with hypokalemia, hypochloremia, hyponatremia, dehydration, lethargy (may progress to coma) and gastrointestinal irritation. Treatment is symptomatic and supportive. Therapy with Triamterene and Hydrochlorothiazide should be discontinued. Induce emesis or institute gastric lavage. Monitor serum electrolyte levels and fluid balance.

Institute supportive measures as required to maintain hydration, electrolyte balance, respiratory, cardiovascular and renal function.

Triamterene and Hydrochlorothiazide Tablets, USP, 37.5 mg/ 25 mg are available for oral administration as green, oval bioconvex tablets, scored and engraved “37.5” bisect “25” on one side, “APO” on the other side. They are supplied as follows:

Bottles of 100 (NDC 68001-327-00)

Bottles of 500 (NDC 68001-327-03)

Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg are available for oral administration as yellow, oval bioconvex tablets, scored and engraved “75” bisect “50” on one side, “APO” on the other side. They are supplied as follows:

Bottles of 100 (NDC 68001-328-00)

Bottles of 500 (NDC 68001-328-03)

Dispense with a child-resistant closure in a tight, light-resistant container.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from light.

APOTEX INC.

TRIAMTERENE HYDROCHLOROTHIAZIDE TABLETS, USP

37.5 mg/25 mg and 75 mg/50 mg

Revised April 2017

Rev. 2a

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

NDC 68001-328-00

Triamterene and Hydrochlorothiazide Tablets, USP

75 mg/50 mg

Rx

100 bottle count