Spiros

Spiros

spironolactone

Manufacturer:

Unicure

Distributor:

NextChem

Marketer:

Littman
Concise Prescribing Info
Contents
Spironolactone
Indications/Uses
Heart failure. Refractory edema & adjunct to standard therapy in lower doses. For refractory edema associated w/ cirrhosis of the liver or nephrotic syndrome & in cites associated w/ malignancy. Essential HTN. Diagnosis & treatment of primary aldosteronism.
Dosage/Direction for Use
Edema Initially 100 mg daily, subsequently adjusted as necessary, some may require up to 400 mg daily. Hepatic cirrhosis w/ ascites & edema Initially 100 mg daily in patients w/ urinary Na/K ratio >1 & 200-400 mg daily in ratio <1. Presumptive diagnosis of primary hyperaldosteronism 400 md daily. Pre-op management of hyperaldosteronism 100-400 mg daily. Long-term therapy & maintenance in the absence of surgery: Lowest effective dose. Heart failure, severe 25-50 mg in addition w/ ACE inhibitors & loop diuretics. Idiopathic hirsutism or polycystic ovary syndrome 50-200 mg daily preferably in combination w/ OCs.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Anuria; acute renal insufficiency, severe or rapidly progressing impairment of renal function; hyperkalemia; Addison's disease, DM (especially w/ confirmed or suspected renal insufficiency); diabetic nephropathy. Lactation.
Special Precautions
Patients diagnosed w/ porphyria & suffering from menstrual abnormalities or breast enlargement. Hyperkalemia, hypernatremia & increased blood urea. Evaluate for possible disturbances of fluid & electrolyte balance.
Adverse Reactions
Headache, drowsiness, GI disturbances including cramps, diarrhea, ataxia, mental confusion, skin rashes, gynecomastia, endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities, impotence; transient increase in BUN conc, mild acidosis, hyponatremia, breast cancer, agranulocytosis, effects on electrolyte balance, increased serum-cholesterol conc, lichen-planus-like skin eruptions & chloasma-like pigmentation on the face.
Drug Interactions
Decrease aldosterone production, severe hyperkalemia & enhanced hypotensive effect w/ ACE inhibitors. Increased risk of hyponatremia w/ chlorpropamide. Reduced diuretic effect w/ aspirin. May reduce vascular response to noradrenaline (norepinephrine); caution use w/ regional or general anesth. Antagonized diuretic effect by estrogen. Monitor prothrombin time ratio or INR w/ coumarins (warfarin) & reassess periodically.
MIMS Class
Diuretics
ATC Classification
C03DA01 - spironolactone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Presentation/Packing
Form
Spiros tab 25 mg
Packing/Price
100's (P1,206/box)
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