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MIDAMOR (AMILORIDE HCL): PRESCRIBING INFORMATION

DESCRIPTION

Amiloride Hydrochloride, an antikaliuretic-diuretic agent, is a pyrazine-carbonyl-guanidine that is unrelated chemically to other known antikaliuretic or diuretic agents. It is the salt of a moderately strong base (pKa 8.7). It is designated chemically as 3,5-diamino-6-chloro-N-(diaminomethylene) pyrazinecarboxamide monohydrochloride, dihydrate and has a molecular weight of 302.12. Its empirical formula is C6H8ClN7OxHClx2H2O.

Midamor (Amiloride HCl) is available for oral use as tablets containing 5 mg of anhydrous amiloride HCl. Each tablet contains the following inactive ingredients: calcium phosphate, iron oxide, D&C Yellow 10, lactose, magnesium stearate and starch.


CLINICAL PHARMACOLOGY

Midamor clinical pharmacology


INDICATIONS AND USAGE

Amiloride Hydrochloride (Midamor) is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to:

  • help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic;
  • prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, 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. Midamor (Amiloride) has little additive diuretic or antihypertensive effect when added to a thiazide diuretic.

    This drug should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including Midamor (Amiloride HCl), result in an increased risk of hyperkalemia (approximately 10% with amiloride).

    This medicine should be used alone only when persistent hypokalemia has been documented and only with careful titration of the dose and close monitoring of serum electrolytes.


    CONTRAINDICATIONS

    Midamor contraindications


    WARNINGS

    Midamor warnings


    PRECAUTIONS

    Midamor precautions


    ADVERSE REACTIONS

    Midamor adverse reactions


    OVERDOSAGE

    No data are available in regard to overdosage in humans.

    The oral LD50 of Amiloride Hydrochloride (calculated as the base) is 56 mg / kg in mice and 36 to 85 mg / kg in rats, depending on the strain.

    It is not known whether the drug is dialyzable.

    The most likely signs and symptoms to be expected with overdosage are dehydration and electrolyte imbalance. These can be treated by established procedures. Therapy with Midamor (Amiloride HCl) should be discontinued and the patient observed closely. There is no specific antidote. Emesis should be induced or gastric lavage performed. Treatment is symptomatic and supportive. If hyperkalemia occurs, active measures should be taken to reduce the serum potassium levels.


    DOSAGE AND ADMINISTRATION

    Midamor dosage and administration


    HOW SUPPLIED / STORAGE

    Tablets Midamor (Amiloride Hydrochloride), 5 mg, are yellow, diamond-shaped, compressed tablets, coded "MSD 92" on one side and "Midamor" on the other. They are supplied in bottles of 100 pills.

    Storage

    Protect from moisture, freezing and excessive heat.

    Manufactured and distributed by Merck pharmaceutical company and its divisions.

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