Triamterene And Hydrochlorothiazide

Triamterene And Hydrochlorothiazide

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Questions & Answers

Side Effects & Adverse Reactions

Hyperkalemia:

Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing diuretic combinations, including triamterene and hydrochlorothiazide. 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 first receiving triamterene and hydrochlorothiazide, when dosages are changed or with any illness that may influence renal function.

If hyperkalemia is suspected (warning signs include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia, and shock), an electrocardiogram (ECG) should be obtained. However, it is important to monitor serum potassium levels because hyperkalemia may not be associated with ECG changes.

If hyperkalemia is present, triamterene and hydrochlorothiazide should be discontinued immediately and a thiazide alone should be substituted. If the serum potassium exceeds 6.5 mEq/liter more vigorous therapy is required. The clinical situation dictates the procedures to be employed. These include the intravenous administration of calcium chloride solution, sodium bicarbonate solution, and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation. Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered. Persistent hyperkalemia may require dialysis.

The development of hyperkalemia associated with potassium-sparing diuretics is accentuated in the presence of renal impairment (see CONTRAINDICATIONS section). Patients with mild renal functional impairment should not receive this drug without frequent and continuing monitoring of serum electrolytes. Cumulative drug effects may be observed in patients with impaired renal function. The renal clearances of hydrochlorothiazide and the pharmacologically active metabolite of triamterene, the sulfate ester of hydroxytriamterene, have been shown to be reduced and the plasma levels increased following triamterene and hydrochlorothiazide administration to elderly patients and patients with impaired renal function.

Hyperkalemia has been reported in diabetic patients with the use of potassium-sparing agents even in the absence of apparent renal impairment. Accordingly, serum electrolytes must be frequently monitored if triamterene and hydrochlorothiazide is used in diabetic patients.

Metabolic or Respiratory Acidosis

Potassium-sparing therapy should also be avoided in severely ill patients in whom respiratory or metabolic acidosis may occur. Acidosis may be associated with rapid elevations in serum potassium levels. If triamterene and hydrochlorothiazide is employed, frequent evaluations of acid/base balance and serum electrolytes are necessary.

Acute Myopia and Secondary Angle-Closure Glaucoma

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.

Triamterene and hydrochlorothiazide capsules are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.

Triamterene and hydrochlorothiazide capsules are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.

Triamterene and hydrochlorothiazide may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance the action of these agents, dosage adjustments may be necessary.

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 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.

History

There is currently no drug history available for this drug.

Other Information

Triamterene is an antikaliuretic agent and hydrochlorothiazide is a diuretic/antihypertensive agent.

At 50°C, triamterene is practically insoluble in water (less than 0.1%). It is soluble in formic acid, sparingly soluble in methoxyethanol, and very slightly soluble in alcohol.

Triamterene is 2,4,7-triamino-6-phenylpteridine with a chemical formula of C12H11N7 and a molecular weight of 253.27. The structural formula for triamterene is:

Triamterene Chemical Fromula

TRIAMTERENE

TRIAMTERENE

Hydrochlorothiazide is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide, and dimethylformamide. It is sparingly soluble in methanol.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2, 4-benzothiadiazine-7-sulfonamide 1,1-dioxide with a chemical formula of C7H8ClN3O4S2 and a molecular weight of 297.75. The structural formula for hydrochlorothiazide is:

Hydrochlorothiazide Chemical Structure

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

Each capsule, for oral administration, contains 37.5 mg triamterene and 25 mg hydrochlorothiazide or 50 mg triamterene and 25 mg hydrochlorothiazide.

The 37.5 mg triamterene and 25 mg hydrochlorothiazide capsule inactive ingredients include: citric acid, corn starch, glycine, anhydrous lactose, magnesium stearate, Polysorbate 80, povidone, and sodium starch glycolate. The capsule shells and imprinting inks contain: D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, FD & C Blue #2 Aluminum Lake, FD & C Red #40 Aluminum Lake, gelatin, pharmaceutical glaze, propylene glycol, synthetic black iron oxide, and titanium dioxide.

The 37.5 mg triamterene and 25 mg hydrochlorothiazide capsule meets USP Dissolution Test 3.

The 50 mg triamterene and 25 mg hydrochlorothiazide capsule inactive ingredients include: lactose monohydrate, magnesium stearate, povidone, corn starch. The capsule shells and imprinting inks contain: D&C Red # 40, gelatin, titanium dioxide, pharmaceutical glaze, propylene glycol and simethicone.

The 50 mg triamterene and 25 mg hydrochlorothiazide capsule meets USP Dissolution Test 2.

Triamterene And Hydrochlorothiazide Manufacturers


  • Proficient Rx Lp
    Triamterene And Hydrochlorothiazide Capsule [Proficient Rx Lp]
  • American Health Packaging
    Triamterene And Hydrochlorothiazide Capsule [American Health Packaging]
  • Northwind Pharmaceuticals, Llc
    Triamterene And Hydrochlorothiazide Tablet [Northwind Pharmaceuticals, Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Triamterene And Hydrochlorothiazide Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Blenheim Pharmacal, Inc.
    Triamterene And Hydrochlorothiazide Tablet [Blenheim Pharmacal, Inc.]
  • Blenheim Pharmacal, Inc.
    Triamterene And Hydrochlorothiazide Tablet [Blenheim Pharmacal, Inc.]
  • Watson Laboratories, Inc.
    Triamterene And Hydrochlorothiazide (Triamterene And Hydrochlorothiazide) Tablet [Watson Laboratories, Inc.]
  • State Of Florida Doh Central Pharmacy
    Triamterene And Hydrochlorothiazide (Hydrochlorothiazide And Triamterene) Capsule [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Triamterene And Hydrochlorothiazide Tablet [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Triamterene And Hydrochlorothiazide Capsule [State Of Florida Doh Central Pharmacy]
  • Rebel Distributors Corp
    Triamterene And Hydrochlorothiazide Capsule [Rebel Distributors Corp]
  • Udl Laboratories, Inc.
    Triamterene And Hydrochlorothiazide Capsules Capsule [Udl Laboratories, Inc.]
  • Remedyrepack Inc.
    Triamterene And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Udl Laboratories, Inc.
    Triamterene And Hydrochlorothiazide Tablet [Udl Laboratories, Inc.]
  • Apotex Corp.
    Triamterene And Hydrochlorothiazide Tablet [Apotex Corp.]
  • Pd-rx Pharmaceuticals, Inc.
    Triamterene And Hydrochlorothiazide Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Triamterene And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Triamterene And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Sandoz Inc
    Triamterene And Hydrochlorothiazide Capsule [Sandoz Inc]
  • Pd-rx Pharmaceuticals, Inc.
    Triamterene And Hydrochlorothiazide Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Triamterene And Hydrochlorothiazide Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Triamterene And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Preferred Pharmaceuticals, Inc
    Triamterene And Hydrochlorothiazide Tablet [Preferred Pharmaceuticals, Inc]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Triamterene And Hydrochlorothiazide Capsule [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Physicians Total Care, Inc.
    Triamterene And Hydrochlorothiazide Capsule [Physicians Total Care, Inc.]
  • Watson Laboratories, Inc.
    Triamterene And Hydrochlorothiazide Tablet [Watson Laboratories, Inc.]
  • Avkare, Inc.
    Triamterene And Hydrochlorothiazide (Triamterene And Hydrochlorothiazide) Capsule [Avkare, Inc.]
  • Lannett Company, Inc.
    Triamterene And Hydrochlorothiazide Capsule [Lannett Company, Inc.]
  • Stat Rx Usa Llc
    Triamterene And Hydrochlorothiazide Tablet [Stat Rx Usa Llc]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Triamterene And Hydrochlorothiazide Capsule [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Kaiser Foundation Hospitals
    Triamterene And Hydrochlorothiazide Tablet [Kaiser Foundation Hospitals]
  • Pd-rx Pharmaceuticals, Inc.
    Triamterene And Hydrochlorothiazide Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Bryant Ranch Prepack
    Triamterene And Hydrochlorothiazide Capsule [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Triamterene And Hydrochlorothiazide Capsule [Bryant Ranch Prepack]
  • Remedyrepack Inc.
    Triamterene And Hydrochlorothiazide Capsule [Remedyrepack Inc. ]
  • St Marys Medical Park Pharmacy
    Triamterene And Hydrochlorothiazide Tablet [St Marys Medical Park Pharmacy]
  • Remedyrepack Inc.
    Triamterene And Hydrochlorothiazide Capsule [Remedyrepack Inc. ]
  • Lake Erie Medical Dba Quality Care Products Llc
    Triamterene And Hydrochlorothiazide Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Triamterene And Hydrochlorothiazide Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Remedyrepack Inc.
    Triamterene And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Triamterene And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • A-s Medication Solutions Llc
    Triamterene And Hydrochlorothiazide Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Triamterene And Hydrochlorothiazide Tablet [A-s Medication Solutions Llc]
  • Unit Dose Services
    Triamterene And Hydrochlorothiazide Tablet [Unit Dose Services]
  • Aidarex Pharmaceuticals Llc
    Triamterene And Hydrochlorothiazide Tablet [Aidarex Pharmaceuticals Llc]
  • Preferred Pharmaceuticals, Inc.
    Triamterene And Hydrochlorothiazide Tablet [Preferred Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Triamterene And Hydrochlorothiazide Tablet [Remedyrepack Inc. ]
  • Aphena Pharma Solutions – Tennessee, Llc
    Triamterene And Hydrochlorothiazide Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • St Marys Medical Park Pharmacy
    Triamterene And Hydrochlorothiazide (Triamterene, Hydrochlorothiazide) Capsule [St Marys Medical Park Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Triamterene And Hydrochlorothiazide Tablet [State Of Florida Doh Central Pharmacy]
  • Preferred Pharmaceuticals, Inc.
    Triamterene And Hydrochlorothiazide Tablet [Preferred Pharmaceuticals, Inc.]
  • Mylan Pharmaceuticals Inc.
    Triamterene And Hydrochlorothiazide Capsule [Mylan Pharmaceuticals Inc.]
  • American Health Packaging
    Triamterene And Hydrochlorothiazide Tablet [American Health Packaging]
  • Northwind Pharmaceuticals
    Triamterene And Hydrochlorothiazide Tablet [Northwind Pharmaceuticals]
  • Mylan Pharmaceuticals Inc.
    Triamterene And Hydrochlorothiazide Tablet [Mylan Pharmaceuticals Inc.]
  • Bryant Ranch Prepack
    Triamterene And Hydrochlorothiazide Tablet [Bryant Ranch Prepack]
  • Avkare, Inc.
    Triamterene And Hydrochlorothiazide (Triamterene And Hydrochlorothiazide) Tablet [Avkare, Inc.]
  • Medsource Pharmaceuticals
    Triamterene And Hydrochlorothiazide Capsule [Medsource Pharmaceuticals]

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