GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Buprenorphine and Naloxone Sublingual Tablets USP 0.4mg+0.1mg
2. Buprenorphine and Naloxone Sublingual Tablets USP 2mg+0.5mg
2. Buprenorphine and Naloxone Sublingual Tablets USP 2mg+0.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Buprenorphine and Naloxone Sublingual Tablets USP 0.4mg+0.1mg
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride IP
Eq. to Buprenorphine ……………0.4mg
Naloxone Hydrochloride IP
Eq. to anhydrous Naloxone…….0.1mg
Excipients…………………………q.s.
2. Buprenorphine and Naloxone Sublingual Tablets USP 2mg+0.5mg
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride IP
Eq. to Buprenorphine ……………2mg
Naloxone Hydrochloride IP
Eq. to anhydrous Naloxone…….0.5mg
Excipients…………………………q.s.
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride IP
Eq. to Buprenorphine ……………0.4mg
Naloxone Hydrochloride IP
Eq. to anhydrous Naloxone…….0.1mg
Excipients…………………………q.s.
2. Buprenorphine and Naloxone Sublingual Tablets USP 2mg+0.5mg
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride IP
Eq. to Buprenorphine ……………2mg
Naloxone Hydrochloride IP
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 & SCHEDULE:
CAUTION: Do not use if seal over bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep store in tightly closed container.
DO NOT BREAK OR CRUSH TABLET.
Driving of vehicle and machine should be avoided after taking the medication
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a “Registered Medical Practitioner”.
Dispense in a tight, light-resistance, container.
Keep store in tightly closed container.
DO NOT BREAK OR CRUSH TABLET.
Driving of vehicle and machine should be avoided after taking the medication
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a “Registered Medical Practitioner”.
STORAGE & DOSAGE:
STORAGE: Protect from Light & moisture at temperature not exceeding 30°C. Keep in cool & Dry place.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read enclosed leaflet before use.
DOSAGE: AS DIRECTED BY THE PHYSICIAN.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read enclosed leaflet before use.
DOSAGE: AS DIRECTED BY THE PHYSICIAN.
Buprenorphine and Naloxone Sublingual Tablets USP 0.4mg+0.1mg Technical Specification:
| Product Name: | Buprenorphine and Naloxone Sublingual Tablets USP |
| Brand Name: | Generic |
| Strength: | (0.4mg+0.1mg), (2mg+0.5mg) |
| Dosage Form: | Uncoated Sub-lingual Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| 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: | Protect from Light & moisture at temperature not exceeding 30°C. Keep in cool & Dry place. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Buprenorphine and Naloxone Sublingual Tablets USP 0.4mg+0.1mg
2. Buprenorphine and Naloxone Sublingual Tablets USP 2mg+0.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Buprenorphine and Naloxone Sublingual Tablets USP 0.4mg+0.1mg
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride IP
Eq. to Buprenorphine ……………0.4mg
Naloxone Hydrochloride IP
Eq. to anhydrous Naloxone…….0.1mg
Excipients…………………………q.s.
2. Buprenorphine and Naloxone Sublingual Tablets USP 2mg+0.5mg
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride IP
Eq. to Buprenorphine ……………2mg
Naloxone Hydrochloride IP
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 & SCHEDULE:
CAUTION: Do not use if seal over bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep store in tightly closed container.
DO NOT BREAK OR CRUSH TABLET.
Driving of vehicle and machine should be avoided after taking the medication.
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a “Registered Medical Practitioner”.
STORAGE & DOSAGE:
STORAGE: Protect from Light & moisture at temperature not exceeding 30°C. Keep in cool & Dry place.
Keep medicine out of reach of children.
Read enclosed leaflet before use.
Dosage: AS DIRECTED BY THE PHYSICIAN.
