| Product Name: | Nitrofurantoin Sustained Release Tablet |
| Brand Name: | Generic |
| Strength: | 50mg,100mg |
| Dosage Form: | Sustained Release Tablets (Film coated) |
| 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: | Antibiotic |
| Indication: | Nitrofurantoin is used to treat urinary tract infections. Nitrofurantoin is in a class of medications called antibiotics. It works by killing bacteria that cause infection. Antibiotics such as nitrofurantoin will not work for colds, flu, or other viral infections. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in cool, dry & dark place Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Nitrofurantoin Sustained Release Tablets 50mg
- Nitrofurantoin Sustained Release Tablets 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Nitrofurantoin Sustained Release Tablets 50mg
Each Film-coated Sustained-Release Tablets contains:
Nitrofurantoin IP..…………………………………50mg
Excipients……………………………………………….q.s.
Colour: Titanium Dioxide IP - Nitrofurantoin Sustained Release Tablets 100mg
Each Film-coated Sustained-Release Tablets contains:
Nitrofurantoin IP..…………………………………100mg
Excipients……………………………………………….q.s.
Colour: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Nitrofurantoin is used to treat urinary tract infections. Nitrofurantoin is in a class of medications called antibiotics. It works by killing bacteria that cause infection. Antibiotics such as nitrofurantoin will not work for colds, flu, or other viral infections.
CAUTION & SCHEDULE:
CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Store in cool, dry & dark place Protect from Light & moisture.
Dosage: As directed by the Physician