| Product Name: | Ethambutol Hydrochloride Tablet USP |
| Brand Name: | Generic |
| Strength: | 100mg, 400mg, 800mg |
| Dosage Form: | 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: | Anti-tuberculosis |
| Indication: | Ethambutol is used to treat tuberculosis (TB). It is used with other medicines for TB. Ethambutol eliminates certain bacteria that cause tuberculosis (TB). It is used with other medicines to treat tuberculosis and to prevent you from giving the infection to others. This medication is sometimes prescribed for other uses. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ethambutol Hydrochloride Tablet USP 100mg
- Ethambutol Hydrochloride Tablet USP 400mg
- Ethambutol Hydrochloride Tablet USP 800mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ethambutol Hydrochloride Tablet USP 100mg
Each Film-coated tablet contains:
Ethambutol Hydrochloride USP……….…100mg
Excipients……………………………………….……q.s.
Color: Ferric Oxide of Iron USP-NF - Ethambutol Hydrochloride Tablet USP 400mg
Each Film-coated tablet contains:
Ethambutol Hydrochloride USP……….…400mg
Excipients……………………………………….……q.s.
Color: Titanium Dioxide - Ethambutol Hydrochloride Tablet USP 800mg
Each Film-coated tablet contains:
Ethambutol Hydrochloride USP……….…800mg
Excipients……………………………………….……q.s.
Color: Titanium Dioxide and Ferric Oxide of Iron USP-NF
THERAPEUTIC INDICATIONS:
Ethambutol is used to treat tuberculosis (TB). It is used with other medicines for TB. Ethambutol eliminates certain bacteria that cause tuberculosis (TB). It is used with other medicines to treat tuberculosis and to prevent you from giving the infection to others. This medication is sometimes prescribed for other uses. This medicine may also be used for other problems as determined by your doctor.
CAUTION & WARNING:
CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read the enclosed leaflet before use.Keep the medicine out of reach of children.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician.