Trimethoprim and Sulfamethoxazole Tablets USP 80mg+400mg Technical Specification:
| Product Name: | Trimethoprim and Sulfamethoxazole Tablets USP 80mg+400mg |
| Brand Name: | Generics |
| Strength: | (80mg+400mg), (160mg+800mg) |
| Dosage Form: | Tablet (Un-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: | Antibiotics |
| Indication: | Sulfamethoxazole and trimethoprim combination is used to treat infections including urinary tract infections, middle ear infections (otitis media), bronchitis, traveler’s diarrhea, and shigellosis (bacillary dysentery). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Trimethoprim and Sulfamethoxazole Tablets USP 80mg+400mg
- Trimethoprim and Sulfamethoxazole Tablets USP 160mg+800mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Trimethoprim and Sulfamethoxazole Tablets USP 80mg+400mg
Each Un-coated Tablet contains:
Trimethoprim USP………………80mg
Sulfamethoxazole USP………………400mg
Excipients…………………………q.s.
- Trimethoprim and Sulfamethoxazole Tablets USP 160mg+800mg
Each Un-coated Tablet contains:
Trimethoprim USP………………160mg
Sulfamethoxazole USP………………800mg
Excipients…………………………q.s
THERAPEUTIC INDICATIONS:
Sulfamethoxazole and Trimethoprim combination is used to treat infections including urinary tract infections, middle ear infections (otitis media), bronchitis, traveler’s diarrhea, and shigellosis (bacillary dysentery).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a Tight, Light Resistant container.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Trimethoprim and Sulfamethoxazole Tablets USP 80mg+400mg
B. Trimethoprim and Sulfamethoxazole Tablets USP 160mg+800mg
B. Trimethoprim and Sulfamethoxazole Tablets USP 160mg+800mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Trimethoprim and Sulfamethoxazole Tablets USP 80mg+400mg
Each Un-coated Tablet contains:
Trimethoprim USP………………80mg
Sulfamethoxazole USP………………400mg
Excipients…………………………q.s.
b) Trimethoprim and Sulfamethoxazole Tablets USP 160mg+800mg
Each Un-coated Tablet contains:
Trimethoprim USP………………160mg
Sulfamethoxazole USP………………800mg
Excipients…………………………q.s
Each Un-coated Tablet contains:
Trimethoprim USP………………80mg
Sulfamethoxazole USP………………400mg
Excipients…………………………q.s.
b) Trimethoprim and Sulfamethoxazole Tablets USP 160mg+800mg
Each Un-coated Tablet contains:
Trimethoprim USP………………160mg
Sulfamethoxazole USP………………800mg
Excipients…………………………q.s
THERAPEUTIC INDICATIONS:
Sulfamethoxazole and Trimethoprim combination is used to treat infections including urinary tract infections, middle ear infections (otitis media), bronchitis, traveler's diarrhea, and shigellosis (bacillary dysentery).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in Tight, Light Resistant container.
Dosage: As directed by the Physician.
Dispense in Tight, Light Resistant container.
Dosage: As directed by the Physician.
