Normoretic Amiloride Hydrochloride and Hydrochlorothiazide Tablets

NORMORETIC™ TABLETS
(Amiloride Hydrochloride + Hydrochlorothiazide)

For Oral use

 

DESCRIPTION

Normoretic (Amiloride HCI USP and Hydrochlorothiazide USP) is a dual action antihypertensive agent combining the potent diuretic action of hydrochlorothiazide with the potassium sparing action of Amiloride HCI.

Amiloride Hydrochloride: N-Amidino-3, 5-diamino-6-Chloropyrazinecarboxamide Monohydrochloride dehydrate.

Hydrochlorothiazide: 6-Chloro-3, 4-dihydro-2H-1,2,4-benzothiadiazine-7-Sulfonamide-1, 1-dioxide.

 

ACTIONS

Normoretic diuretic and antihypertensive action is due primarily to the hydrochlorothiazide component while its Amiloride component prevents the excessive potassium loss that may occur in patients on thiazide diuretics. Thus, Normoretic achieves the overall effrct of the mild diuretic and hypertensive actions of Amiloride HCI with the natriuretic, diuretic and antihypertensive activity of the hydrochlorothiazide while minimizing the loss of Potassium and Bicarbonate and lessening the event of Acid-base imbalance.

Normoretic achieves onset of diuretic action within 2 hours and this is sustained for approximately 24 hours.

 

Amiloride HCl

Amiloride HCI is a Potassium – sparing drug which possesses mild natriuretic, diuretic and antihypertensive activity. The principal function is to conserve Potassium in patients receiving diuretic agents in whom excessive Potassium losses occur or are expected.

Amiloride HCI usually begins to act within 2 hours after an oral dose, its effect on electrolyte excretion reaches a peak between 6 and 10 hours and lasts about 24 hours and the plasma half life varies from 6 to 9 hours.

 

Hydrochlorothiazide

This is an orally effective diuretic and antihypertensive. Onset of action following oral administration occurs in 2 hours and reaches a peak effect in about 4 hours. The diuretic action persists for approximately 6 to 12 hours. Hydrochlorothiazide does not affect normal blood pressure.

 

INDICATIONS

Normoretic is indicated in the treatment of hypertension, oedema of cardiac origin, and hepatic cirrhosis with ascites and oedema.

It can be used alone or as an adjunct to other antihypertensive agents.

Normoretic is also indicated in patients in whom Potassium depletion might be suspected or anticipated.

The combination of Amiloride HCI and Hydrochlorothiazide minimizes the possibility of the development of excessive Potassium loss in patients during vigorous diuresis for prolonged periods.

 

CONTRAINDICATIONS

* Hyperkalemia, other concomittant antikaiuretic therapy or potassium Supplementation.

* Renal insufficiency.

* Hypersensitivity to any of the components or other sulphonamide derived drugs.

* Pregnancy.

* Nursing mothers and children.

* Concurrent administration of lithium.

 

WARNINGS AND PRECAUTIONS

– Hyperkalemia: The risk of Hyperkalemia is high in patients with renal impairment or diabetes mellitus (even without recognised diabetic nephropathy). Hyperkalemia, if uncorrected is potentially fatal hence it is essential to monitor serum Potassium levels in patients receiving Normoretic therapy particularly during first administration and during any illness that could affect renal function.

– Amiloride HCL: Concommitant administration with an angiotensin converting enzyme inhibitor increases the risk of hyperkalemia hence they should be used with caution.

– Hydrochlorothiazide: Alcohol, barbiturates or narcotics when used with thiazide diuretics, orthostatic hypotension may occur.

 

ADVERSE REACTIONS

Headache, Fatigue, Chest pain, Rash, Arrhythmia, Tachycardia, Nausea, Vomiting, Abdominal pain, Insomnia, Nervousness, Mental confusion may occur.

 

OVERDOSAGE

There are no available data as regards overdosage in humans and no specific antidote is available. The treatment of overdosage is symptomatic, and supportive; and therapy with Normoretic should be discontinued. Suggested measures include induction of emesis and/or gastric lavage.

 

DOSAGE AND ADMINISTRATION

The dosage is based on the disease condition being treated thus:

Hypertension

One tablet of Normoretic is administered once a day or in divided doses.

Edema of Cardiac Origin

Treatment commences at a dosage of one tablet daily, with a maximum of two tablets daily.

Hepatic Cirrhosis with Ascites

Treatment commences with one tablet daily, maximum recommended daily dosage is two tablets.

 

PRESENTATION

Normoretic is supplied in blister packs of 100s (10 x 10 strips), jar of 200s and 1000s. Each tablet contain 5mg Amiloride Hydrochloride and 50mg Hydrochlorothiazide.

 

KEEP OUT OF THE REACH OF CHILDREN

 

Manufactured by

NEIMETH INT’L PHARM. PLC. IKEJA, NIGERIA.

Plot 16, Akanni Doherty Layout, Oregun, Lagos, Nigeria.