| Product Name: | Buprenorphine and Naloxone Sublingual Tablets USP |
| Brand Name: | Generic |
| Strength: | (2mg+0.5mg) |
| Dosage Form: | Tablets (un-coated Sublingual) |
| 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: | CNS, Analgesic |
| Indication: | Buprenorphine and naloxone sublingual tablet are used to treat opioid (narcotic) dependence or addiction. Buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet is used for induction and maintenance treatment of opioid (narcotic) dependence. |
| Storage: | Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
2mg+0.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Buprenorphine and Naloxone Sublingual Tablets USP 2mg+0.5mg
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride USP
Eq. to Buprenorphine ……………2mg
Naloxone Hydrochloride dihydrate USP
Eq. to anhydrous Naloxone…….0.5mg
Excipients…………………………q.s.
THERAPEUTIC INDICATIONS:
Buprenorphine and naloxone sublingual tablet are used to treat opioid (narcotic) dependence or addiction. Buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet is used for induction and maintenance treatment of opioid (narcotic) dependence.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
Driving of vehicle and machine should be avoided after taking the medication
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
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). See USP controlled room temperature.
Store in dry place protected from light and moisture.
DOSAGE: As directed by the Physician.
Attach dispensing label as per end country.