Amiloride Hydrochloride And Hydrochlorothiazide (Amiloride Hydrochloride And Hydrochlorothiazide)

Trade Name : Amiloride Hydrochloride and Hydrochlorothiazide

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 550 mg/1mg/1

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amiloride Hydrochloride And Hydrochlorothiazide (Amiloride Hydrochloride And Hydrochlorothiazide) which is also known as Amiloride Hydrochloride and Hydrochlorothiazide and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 5; 50 mg/1; mg/1 per ml. Read more

Amiloride Hydrochloride And Hydrochlorothiazide (Amiloride Hydrochloride And Hydrochlorothiazide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 5 mg/50 mg
  • Rx only
  • Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP combine the potassium-conserving action of amiloride hydrochloride with the natriuretic action of hydrochlorothiazide.
  • Amiloride HCl, USP is designated chemically as -amidino-3,5,-diamino-6-chloropyrazine-carboxamide monohydrochloride dihydrate and its structural formula is:
  • Hydrochlorothiazide, USP is designated chemically as 6-chloro-3,4-dihydro-2-1, 2, 4-benzo-thiadiazine-7-sulfonamide 1, 1-dioxide. Its structural formula is:
  • It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution.
  • Each tablet, for oral administration, contains 5 mg of amiloride hydrochloride, USP (calculated on the anhydrous basis) and 50 mg of hydrochlorothiazide, USP.
  • Inactive Ingredients:
  • Amiloride hydrochloride and hydrochlorothiazide tablets provide diuretic and antihypertensive activity (principally due to the hydrochlorothiazide component), while acting through the amiloride component to prevent the excessive potassium loss that may occur in patients receiving a thiazide diuretic. Due to its amiloride component, the urinary excretion of magnesium is less with amiloride and hydrochlorothiazide than with a thiazide or loop diuretic used alone (see ). The onset of the diuretic action of this product is within 1 to 2 hours and this action appears to be sustained for approximately 24 hours.
  • Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, e.g., digitalized patients, or patients with significant cardiac arrhythmias.
  • The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet.
  • Amiloride hydrochloride and hydrochlorothiazide tablets may be used alone or as an adjunct to other antihypertensive drugs, such as methyldopa or beta blockers. Since amiloride hydrochloride and hydrochlorothiazide enhances the action of these agents, dosage adjustments may be necessary to avoid an excessive fall in blood pressure and other unwanted side effects.
  • The 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.
  • No data
  • No data
  • No data
  • Amiloride hydrochloride and hydrochlorothiazide is usually well tolerated and significant clinical adverse effects have been reported infrequently. The risk of hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) with amiloride hydrochloride and hydrochlorothiazide is about 1 to 2 percent in patients without renal impairment or diabetes mellitus (see ). Minor adverse reactions to amiloride hydrochloride have been reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride HCl is uncertain and the overall frequency was similar to hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to amiloride. Other adverse experiences that have been reported with amiloride and hydrochlorothiazide are generally those known to be associated with diuresis, thiazide therapy, or with the underlying disease being treated. Clinical trials have not demonstrated that combining amiloride and hydrochlorothiazide increases the risk of adverse reactions over those seen with the individual components.
  • The adverse reactions for amiloride and hydrochlorothiazide listed in the following table have been arranged into two groups: (1) incidence greater than one percent; and (2) incidence one percent or less. The incidence for group (1) was determined from clinical studies conducted in the United States (607 patients treated with amiloride and hydrochlorothiazide). The adverse effects listed in group (2) include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between amiloride and hydrochlorothiazide and these adverse reactions, some of which have been reported only rarely.
  • Other adverse reactions that have been reported with the individual components and within each category are listed in order of decreasing severity:
  • Body as a Whole:
  • Cardiovascular:
  • Digestive:
  • Hematologic:
  • Integumentary:
  • Nervous System/Psychiatric:
  • Respiratory:
  • Special Senses:
  • Urogenital:
  • Hydrochlorothiazide
  • Digestive:
  • Hematologic:
  • Hypersensitivity:
  • Metabolic:
  • Nervous System/Psychiatric:
  • Special Senses:
  • Urogenital:
  • No data are available in regard to overdosage in humans. The oral LD of the combination drug is 189 and 422 mg/kg for female mice and female rats, respectively.
  • It is not known whether the drug is dialyzable.
  • No specific information is available on the treatment of overdosage with amiloride and hydrochlorothiazide and no specific antidote is available. Treatment is symptomatic and supportive. Therapy with amiloride and hydrochlorothiazide should be discontinued and the patient observed closely. Suggested measures include the induction of emesis and/or gastric lavage.
  • Amiloride hydrochloride and hydrochlorothiazide tablets should be administered with food.
  • The usual starting dosage is 1 tablet a day. The dosage may be increased to 2 tablets a day, if necessary. More than 2 tablets of amiloride hydrochloride and hydrochlorothiazide daily usually are not needed and there is no controlled experience with such doses.
  • Hydrochlorothiazide can be given at doses of 12.5 to 50 mg per day when used alone. Patients usually do not require doses of hydrochlorothiazide in excess of 50 mg daily when combined with other antihypertensive agents. The daily dose is usually given as a single dose but may be given in divided doses. Once an initial diuresis has been achieved, dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.
  • Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP are available as:
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [See USP Controlled Room Temperature].
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Manufactured In Canada By:
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  • u00a0
  • u00a0Manufactured For:
  • u00a0n
  • North Wales, PAu00a0 19454
  • Rev. B 4/2019
  • NDCn- 0483
  • Amiloride
  • Hydrochloride and
  • Hydrochlorothiazide
  • Tablets USP
  • 5 mg/50 mg
  • Rx only
  • 100 TABLETS
  • TEVA
  • Arrayn- Array

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