Tri-Thiazid Reserpin

Hydrochlorothiazide:

• Tri-Thiazid Reserpin information
• Tri-Thiazid Reserpin indications
• Tri-Thiazid Reserpin warnings
• Tri-Thiazid Reserpin intake guidelines
• Tri-Thiazid Reserpin dosage
• Tri-Thiazid Reserpin overdose
• Tri-Thiazid Reserpin missed dose
• Tri-Thiazid Reserpin side effects
• Tri-Thiazid Reserpin drug reactions
• Tri-Thiazid Reserpin (Hydrochlorothiazide) reviews

Tri-Thiazid Reserpin information

Tri-Thiazid Reserpin (Hydrochlorothiazide) is an antihypertensive, diuretic drug that acts on the electrolyte reabsorption in the renal tubular mechanism increasing the excretion of chloride and sodium in equivalent amounts. The exact mechanism of its antihypertensive action is not known at this time.

Tri-Thiazid Reserpin indications

Tri-Thiazid Reserpin (Hydrochlorothiazide) is typically employed for the treatment of patients suffering from hypertension, either as monotherapy or in combination with other antihypertensive medication. It is also employed in some cases as a diuretic agent. Tri-Thiazid Reserpin (Hydrochlorothiazide) therapy may also be prescribed for the treatment of hepatic cirrhosis, edema (in patients suffering from congestive heart failure), nephrotic syndrome, drug induced edema, chronic renal failure or acute glomerulonephritis. Health care professionals may prescribe this drug in order to treat other medical conditions as well; if you would like to know more about the reasons you have been prescribed this drug, it is advised to ask your personal physician.

Tri-Thiazid Reserpin warnings

Tri-Thiazid Reserpin (Hydrochlorothiazide) may not be used in the treatment of patients who are allergic to this drug, any of its components or other sulfonamide-derived medication. Also, this drug may not be suitable for use in patients that are suffering from anuria, azotemia or impaired renal functions. Caution should be employed if the patient is suffering from hepatic disease. Other medical conditions may also influence the examining health care provider's decision of prescribing Tri-Thiazid Reserpin (Hydrochlorothiazide); it is strongly recommended to make sure that the health care professional is fully aware of your health condition and medical history before starting a treatment with this drug.

Use of Tri-Thiazid Reserpin (Hydrochlorothiazide) during pregnancy or breast-feeding is also not recommended. This medicine may affect an unborn baby and it also passes into breast milk. As such, use of this drug in pregnant women or breast-feeding mothers should not be employed.

Tri-Thiazid Reserpin intake guidelines

You should always take Tri-Thiazid Reserpin (Hydrochlorothiazide) as you have been directed by the prescribing health care specialist. While in some cases daily administration of the drug is recommended, other patients may be prescribed an intermittent therapy. Also, the number of daily doses may vary. As such, it is best that you do not follow another patient's intake schedule. If you have difficulties understanding the intake guidelines that your prescribing health care professional has provided, you should ask for further explanations from an authorized health care specialist - such as a pharmacist, a doctor or a nurse.

Tri-Thiazid Reserpin dosage

The exact Tri-Thiazid Reserpin (Hydrochlorothiazide) dosage may vary greatly from one case to another, depending on the condition being treated, on the patient's medical history and general health condition, on his or her age as well as on a number of other factors. As such you are advised to use the exact Tri-Thiazid Reserpin (Hydrochlorothiazide) dosage that has been prescribed to you and never use the dosage prescribed to another patient or a dosage that you have been prescribed in the past. Taking a different Tri-Thiazid Reserpin (Hydrochlorothiazide) dose may cause the treatment to not have the desired effect, and if you take this drug in larger doses you may have a higher risk of developing side effects, or you may suffer from an overdose.

Tri-Thiazid Reserpin overdose

You should never exceed the Tri-Thiazid Reserpin (Hydrochlorothiazide) prescribed dosage, in order to avoid an overdose with this medication. However, if you consider that you are affected by an overdose with this drug it is advised to immediately consult your personal health care provider, the local poisons center or to go to the nearest medical facility to seek emergency medical attention. The common symptoms of an overdose with Tri-Thiazid Reserpin (Hydrochlorothiazide) are dehydration and cardiac arrhythmia. The patient may also suffer from electrolyte depletion and thus may present the relevant signs and symptoms.

Tri-Thiazid Reserpin missed dose

In case you have missed a dose of Tri-Thiazid Reserpin (Hydrochlorothiazide), it is advised that you take the dose as soon as you remember. If the moment when you remember is too close to another intake of the medication, you should completely skip the missed Tri-Thiazid Reserpin (Hydrochlorothiazide) dose and take the next scheduled dose on time. You should never take a larger dose of the drug in order to make up for a missed dose, unless your prescribing health care provider directs you to do so.

Tri-Thiazid Reserpin side effects

In some patients Tri-Thiazid Reserpin (Hydrochlorothiazide) may cause side effects. While they are not very common, it is recommended to let your personal health care provider know if you begin experiencing any side effects. Several types of symptoms are possible: dizziness, headache, paresthesias, gastric irritation, anorexia, nausea and vomiting, diarrhea or constipation, pancreatitis, jaundice, hypotension. Metabolic side effects may include glycosuria, hyperglycemia, hyperuricemia, hypokalemia or hyponatremia. Renal failure or dysfunction may develop, as well as interstitial nephritis. Some patients reported experiencing muscle spasms, restlessness, unusual weakness and blurred vision. In some cases photosensitivity, anaphylactic reactions, respiratory distress, fever, rashes, vasculitis or toxic epidermal necrolysis have occurred.

Tri-Thiazid Reserpin drug reactions

Tri-Thiazid Reserpin (Hydrochlorothiazide) may interact with barbiturates and narcotics, as well as with alcohol. If you are also following a treatment course with antidiabetic drugs, their dosage may need to be adjusted before starting to take Tri-Thiazid Reserpin (Hydrochlorothiazide). This drug may have an additive effect with other antihypertensive medication. ACE inhibitors, ACTH, corticosteroids and skeletal muscle relaxants may also interact with this drug causing unwanted effects. This drug may not be properly absorbed if the patient is also taking Colestipol resins or Cholestyramine. NSAIDs, lithium and Pressor amines may affect or be affected by Tri-Thiazid Reserpin (Hydrochlorothiazide), and as such it is strongly recommended to let the prescribing health care provider know if you are taking these or any other drugs before starting a therapy course with this medicine. Other drug interactions that are not listed here are also possible.

Reserpine:

• Tri-Thiazid Reserpin (Reserpine) reviews

Indication: Foe the treatment of hypertension

Tri-Thiazid Reserpin (Reserpine) is an adrenergic blocking agent used to treat mild to moderate hypertension via the disruption of norepinephrine vesicular storage. The antihypertensive actions of Tri-Thiazid Reserpin (Reserpine) are a result of its ability to deplete catecholamines from peripheral sympathetic nerve endings. These substances are normally involved in controlling heart rate, force of cardiac contraction and peripheral resistance.

Triamterene:

• Warnings
• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Precautionsgeneral
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Storage
• Tri-Thiazid Reserpin (Triamterene) reviews

Warnings

Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including Tri-Thiazid Reserpin (Triamterene). Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients receiving Tri-Thiazid Reserpin (Triamterene), when dosages are changed or with any illness that may influence renal function.

DESCRIPTION

Each capsule for oral use, with opaque red cap and body, contains Tri-Thiazid Reserpin (Triamterene) USP, 50 or 100 mg, and is imprinted with the product name, Tri-Thiazid Reserpin (Triamterene), strength (50 mg or 100 mg) and WPC 002 (for the 50-mg strength) and WPC 003 (for the 100-mg strength). Inactive ingredients consist of D&C Red No. 33, FD&C Yellow No. 6, Gelatin NF, Lactose NF, Magnesium Stearate NF, Sodium Lauryl Sulfate NF, Titanium Dioxide USP and Silicon Dioxide NF.

Tri-Thiazid Reserpin (Triamterene) is 2,4,7-triamino-6-phenyl-pteridine:

Its molecular weight is 253.27. At 50°C, Tri-Thiazid Reserpin (Triamterene) is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide and dimethylformamide. It is sparingly soluble in methanol.

Tri-Thiazid Reserpin (Triamterene) Chemical Structure

CLINICAL PHARMACOLOGY

Tri-Thiazid Reserpin has a unique mode of action; it inhibits the reabsorption of sodium ions in exchange for potassium and hydrogen ions at that segment of the distal tubule under the control of adrenal mineralocorticoids (especially aldosterone). This activity is not directly related to aldosterone secretion or antagonism; it is a result of a direct effect on the renal tubule.

The fraction of filtered sodium reaching this distal tubular exchange site is relatively small, and the amount which is exchanged depends on the level of mineralocorticoid activity. Thus, the degree of natriuresis and diuresis produced by inhibition of the exchange mechanism is necessarily limited. Increasing the amount of available sodium and the level of mineralocorticoid activity by the use of more proximally acting diuretics will increase the degree of diuresis and potassium conservation.

Tri-Thiazid Reserpin (Triamterene) occasionally causes increases in serum potassium which can result in hyperkalemia. It does not produce alkalosis, because it does not cause excessive excretion of titratable acid and ammonium.

Tri-Thiazid Reserpin (Triamterene) has been shown to cross the placental barrier and appear in the cord blood of animals.

Pharmacokinetics

Onset of action is 2 to 4 hours after ingestion. In normal volunteers the mean peak serum levels were 30 ng/mL at 3 hours. The average percent of drug recovered in the urine (0 to 48 hours) was 21%. Tri-Thiazid Reserpin (Triamterene) is primarily metabolized to the sulfate conjugate of hydroxytriamterene. Both the plasma and urine levels of this metabolite greatly exceed Tri-Thiazid Reserpin (Triamterene) levels. Tri-Thiazid Reserpin (Triamterene) is rapidly absorbed, with somewhat less than 50% of the oral dose reaching the urine. Most patients will respond to Tri-Thiazid Reserpin (Triamterene) (triamterene) during the first day of treatment.

Maximum therapeutic effect, however, may not be seen for several days. Duration of diuresis depends on several factors, especially renal function, but it generally tapers off 7 to 9 hours after administration.

INDICATIONS AND USAGE

Tri-Thiazid Reserpin (Triamterene) (triamterene) is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism.

Tri-Thiazid Reserpin (Triamterene) may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism.

Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.

Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy (however, see PRECAUTIONS below) when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

CONTRAINDICATIONS

Anuria. Severe or progressive kidney disease or dysfunction, with the possible exception of nephrosis. Severe hepatic disease. Hypersensitivity to the drug or any of its components.

Tri-Thiazid Reserpin (triamterene) should not be used in patients with pre-existing elevated serum potassium, as is sometimes seen in patients with impaired renal function or azotemia, or in patients who develop hyperkalemia while on the drug. Patients should not be placed on dietary potassium supplements, potassium salts or potassium-containing salt substitutes in conjunction with Tri-Thiazid Reserpin (Triamterene).

Tri-Thiazid Reserpin (Triamterene) should not be given to patients receiving other potassium-sparing agents, such as spironolactone, amiloride hydrochloride, or other formulations containing Tri-Thiazid Reserpin (Triamterene). Two deaths have been reported in patients receiving concomitant spironolactone and Tri-Thiazid Reserpin (Triamterene) or Dyazide^®. Although dosage recommendations were exceeded in one case and in the other serum electrolytes were not properly monitored, these two drugs should not be given concomitantly.

WARNINGS

Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including Tri-Thiazid Reserpin (Triamterene). Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients receiving Tri-Thiazid Reserpin (Triamterene), when dosages are changed or with any illness that may influence renal function.

There have been isolated reports of hypersensitivity reactions; therefore, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver damage or other idiosyncratic reactions.

Periodic BUN and serum potassium determinations should be made to check kidney function, especially in patients with suspected or confirmed renal insufficiency. It is particularly important to make serum potassium determinations in elderly or diabetic patients receiving the drug; these patients should be observed carefully for possible serum potassium increases.

If hyperkalemia is present or suspected, an electrocardiogram should be obtained. If the ECG shows no widening of the QRS or arrhythmia in the presence of hyperkalemia, it is usually sufficient to discontinue Tri-Thiazid Reserpin (Triamterene) (triamterene) and any potassium supplementation, and substitute a thiazide alone. Sodium polystyrene sulfonate (Kayexalate^®, Sanofi Synthelabo) may be administered to enhance the excretion of excess potassium. The presence of a widened QRS complex or arrhythmia in association with hyperkalemia requires prompt additional therapy. For tachyarrhythmia, infuse 44 mEq of sodium bicarbonate or 10 mL of 10% calcium gluconate or calcium chloride over several minutes. For asystole, bradycardia or A-V block transvenous pacing is also recommended.

The effect of calcium and sodium bicarbonate is transient and repeated administration may be required. When indicated by the clinical situation, excess K+ may be removed by dialysis or oral or rectal administration of Kayexalate^®. Infusion of glucose and insulin has also been used to treat hyperkalemia.

PRECAUTIONS

General

Tri-Thiazid Reserpin (triamterene) tends to conserve potassium rather than to promote the excretion as do many diuretics and, occasionally, can cause increases in serum potassium which, in some instances, can result in hyperkalemia. In rare instances, hyperkalemia has been associated with cardiac irregularities.

Electrolyte imbalance often encountered in such diseases as congestive heart failure, renal disease or cirrhosis may be aggravated or caused independently by any effective diuretic agent includingDyrenium. The use of full doses of a diuretic when salt intake is restricted can result in a low-salt syndrome.

Tri-Thiazid Reserpin (Triamterene) can cause mild nitrogen retention, which is reversible upon withdrawal of the drug, and is seldom observed with intermittent (every-other-day) therapy.

Tri-Thiazid Reserpin (Triamterene) may cause a decreasing alkali reserve, with the possibility of metabolic acidosis.

By the very nature of their illness, cirrhotics with splenomegaly sometimes have marked variations in their blood. Since Tri-Thiazid Reserpin (Triamterene) is a weak folic acid antagonist, it may contribute to the appearance of megaloblastosis in cases where folic acid stores have been depleted. Therefore, periodic blood studies in these patients are recommended. They should also be observed for exacerbations of underlying liver disease.

Tri-Thiazid Reserpin (Triamterene) has elevated uric acid, especially in persons predisposed to gouty arthritis.

Tri-Thiazid Reserpin (Triamterene) has been reported in renal stones in association with other calculus components. Tri-Thiazid Reserpin (Triamterene) should be used with caution in patients with histories of renal stones.

Information for Patients

To help avoid stomach upset, it is recommended that the drug be taken after meals.

If a single daily dose is prescribed, it may be preferable to take it in the morning to minimize the effect of increased frequency of urination on nighttime sleep.

If a dose is missed, the patient should not take more than the prescribed dose at the next dosing interval.

Laboratory Tests

Hyperkalemia will rarely occur in patients with adequate urinary output, but it is a possibility if large doses are used for considerable periods of time. If hyperkalemia is observed, Tri-Thiazid Reserpin (triamterene) should be withdrawn. The normal adult range of serum potassium is 3.5 to 5.0 mEq per liter, with 4.5 mEq often being used for a reference point. Potassium levels persistently above 6 mEq per liter require careful observation and treatment. Normal potassium levels tend to be higher in neonates (7.7 mEq per liter) than in adults. Serum potassium levels do not necessarily indicate true body potassium concentration. A rise in plasma pH may cause a decrease in plasma potassium concentration and an increase in the intracellular potassium concentration. Because Tri-Thiazid Reserpin (Triamterene) conserves potassium, it has been theorized that in patients who have received intensive therapy or been given the drug for prolonged periods, a rebound kaliuresis could occur upon abrupt withdrawal. In such patients, withdrawal of Tri-Thiazid Reserpin (Triamterene) should be gradual.

Drug Interactions

Caution should be used when lithium and diuretics are used concomitantly because diuretic-induced sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. Patients receiving such combined therapy should have serum lithium levels monitored closely and the lithium dosage adjusted if necessary.

A possible interaction resulting in acute renal failure has been reported in a few subjects when indomethacin, a nonsteroidal anti-inflammatory agent, was given with Tri-Thiazid Reserpin (Triamterene). Caution is advised in administering nonsteroidal anti-inflammatory agents with Tri-Thiazid Reserpin (Triamterene).

The effects of the following drugs may be potentiated when given together with Tri-Thiazid Reserpin (Triamterene): antihypertensive medication, other diuretics, preanesthetic and anesthetic agents, skeletal muscle relaxants (nondepolarizing).

Potassium-sparing agents should be used with caution in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to an increased risk of hyperkalemia.

The following agents, given together with Tri-Thiazid Reserpin (Triamterene), may promote serum potassium accumulation and possibly result in hyperkalemia because of the potassium-sparing nature of Tri-Thiazid Reserpin (Triamterene), especially in patients with renal insufficiency: blood from blood bank (may contain up to 30 mEq of potassium per liter of plasma or up to 65 mEq per liter of whole blood when stored for more than 10 days); low-salt milk (may contain up to 60 mEq of potassium per liter); potassium-containing medications (such as parenteral penicillin G potassium); salt substitutes (most contain substantial amounts of potassium).

Tri-Thiazid Reserpin (Triamterene) (triamterene) may raise blood glucose levels; for adult-onset diabetes, dosage adjustments of hypoglycemic agents may be necessary during and/or after therapy; concurrent use with chlorpropamide may increase the risk of severe hyponatremia.

Drug/Laboratory Test Interactions

Tri-Thiazid Reserpin and quinidine have similar fluorescence spectra;thus, Tri-Thiazid Reserpin (Triamterene) will interfere with the fluorescent measurement of quinidine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: In studies conducted under the auspices of the National Toxicology Program, groups of rats were fed diets containing 0, 150, 300 or 600 ppm of Tri-Thiazid Reserpin (Triamterene), and groups of mice were fed diets containing 0, 100, 200 or 400 ppm Tri-Thiazid Reserpin (Triamterene). Male and female rats exposed to the highest tested concentration received Tri-Thiazid Reserpin (Triamterene) at about 25 and 30 mg/kg/day, respectively. Male and female mice exposed to the highest tested concentration received Tri-Thiazid Reserpin (Triamterene) at about 45 and 60 mg/kg/day, respectively.

There was an increased incidence of hepatocellular neoplasia (primarily adenomas) in male and female mice at the highest dosage level. These doses represent 7.5X and 10X the Maximum Recommended Human Dose (MRHD) of 300 mg/kg/day (or 6 mg/kg/day based on a 50 kg patient) for male and female mice, respectively, when based on body weight and 0.7X and 0.9X the MRHD when based on body-surface area.

Although hepatocellular neoplasia (exclusively adenomas) in the rat study was limited to triamterene-exposed males, incidence was not dose dependent and there was no statistically significant difference from control incidence at any dose level.

Mutagenesis: Tri-Thiazid Reserpin (Triamterene) was not mutagenic in bacteria (Salmonella typhimurium strains TA98, TA100, TA1535 or TA1537) with or without metabolic activation. It did not induce chromosomal aberrations in Chinese hamster ovary (CHO) cells in vitro with or without metabolic activation, but it did induce sister chromatid exchanges in CHO cells in vitro with and without metabolic activation.

Impairment of Fertility: Studies of the effects of Tri-Thiazid Reserpin (Triamterene) on animal reproductive function have not been conducted.

Pregnancy: Category C

Teratogenic Effects:

Reproduction studies have been performed in rats at doses as high as 20 times the Maximum Recommended Human Dose on the basis of body weight, and 6 times the MRHD on the basis of body-surface area, without evidence of harm to the fetus due to Tri-Thiazid Reserpin (Triamterene). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nonteratogenic Effects:

Tri-Thiazid Reserpin (Triamterene) has been shown to cross the placental barrier and appear in cord blood. The use of Tri-Thiazid Reserpin (Triamterene) in pregnant women requires that the anticipated benefits be weighed against possible hazards to the fetus. These possible hazards include adverse reactions which have occurred in the adult.

Nursing Mothers:

Tri-Thiazid Reserpin has not been studied in nursing mothers. Triamtereneappears in animal milk and is likely present in human milk. If use of thedrug product is deemed essential, the patient should stop nursing.

Pediatric Use:

Safety and effectiveness in pediatricpatients have not been established.

ADVERSE REACTIONS

Adverse effects are listed in decreasing order of frequency; however, the most serious adverse effects are listed first, regardless of frequency. All adverse effects occur rarely (that is, 1 in 1000, or less).

Hypersensitivity: anaphylaxis, rash, photosensitivity.

Metabolic: hyperkalemia, hypokalemia.

Renal: azotemia, elevated BUN and creatinine, renal stones, acute interstitial nephritis (rare), acute renal failure (one case of irreversible renal failure has been reported).

Gastrointestinal: jaundice and/or liver enzyme abnormalities, nausea and vomiting, diarrhea.

Hematologic: thrombocytopenia, megaloblastic anemia.

Central Nervous System: weakness, fatigue, dizziness, headache, dry mouth.

OVERDOSAGE

In the event of overdosage, it can be theorized that electrolyteimbalance would be the major concern, with particular attention to possiblehyperkalemia. Other symptoms that might be seen would be nausea and vomiting,other G.I. disturbances and weakness. It is conceivable that some hypotensioncould occur. As with an overdose of any drug, immediate evacuation of thestomach should be induced through emesis and gastric lavage. Careful evaluationof the electrolyte pattern and fluid balance should be made. There is no specificantidote.

Reversible acute renal failure followingingestion of 50 tablets of a product containing a combination of 50 mg triamtereneand 25 mg hydrochlorothiazide has been reported.

Theoral LD50 in mice is 380 mg/kg. The amount of drug in a single dose ordinarilyassociated with symptoms of overdose or likely to be life-threatening is notknown.

Although Tri-Thiazid Reserpin (Triamterene) is 67% protein bound, theremay be some benefit to dialysis in cases of overdosage.

DOSAGE AND ADMINISTRATION

Adult Dosage

Dosageshould be titrated to the needs of the individual patient. When used alone,the usual starting dose is 100 mg twice daily after meals. When combined withanother diuretic or antihypertensive agent, the total daily dosage of eachagent should usually be lowered initially and then adjusted to the patient’sneeds. The total daily dosage should not exceed 300 mg. Please refer to PRECAUTIONS−General.

WhenDyrenium (triamterene) is added to other diuretic therapy or when patientsare switched to Tri-Thiazid Reserpin (Triamterene) from other diuretics, all potassium supplementationshould be discontinued.

HOW SUPPLIED

Capsules: 50 mg in bottles of 100, and 100 mg in bottles of 100.

STORAGE

Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). Dispense in a tight, light resistant container.

50 mg 100s: NDC 65197-002-01

100 mg 100s: NDC 65197-003-01

DATE OF ISSUANCE MARCH 2009

©WellSpring, 2009

Manufactured for

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243 USA

By WellSpring Pharmaceutical Canada Corp.

Oakville, Ontario L6H 1M5 Canada

Rev. 03/09