| Product Name: | Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP |
| Brand Name: | Generic |
| Strength: | 5mg+50mg |
| Dosage Form: | Tablets (uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antihypertensive |
| Indication: | 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. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in a dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP 5mg+50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP 5mg+50mg
Each uncoated tablet contains:
Amiloride Hydrochloride USP
Equivalent to Anhydrous Amiloride Hydrochloride………….5mg
Hydrochlorothiazide USP…………………………………………………50mg
Excipients…………………………………………………………………………q.s
Colour: Sunset yellow FCF.
THERAPEUTIC INDICATIONS:
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.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP USING A CHILD-RESISTANT CLOSURE.
KEEP THE CONTAINER TIGHTLY CLOSED.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68°F to 77°F)
Store in a dry place protected from light and moisture.
Dosage: As directed by the Physician.