Oxycodone Hydrochloride Extended-Release Tablet 80mg Technical Specification:
Product Name: | Oxycodone Hydrochloride Extended-Release Tablet |
Brand Name: | OXYCONTEX |
Strength: | 10mg, 20mg, 30mg, 40mg, 80mg |
Dosage Form: | Extended-Release Tablets (film-coated) |
Route of Administration: | Via Oral Route |
Packing: | 10s, 20s, 30s, 50s, 150s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Narcotic Analgesics, Central Nervous System |
Indication: | Oxycodone is used to relieve moderate to severe pain. Oxycodone extended-release tablets are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. |
Storage: | Store at 20° to 25°C (68° to 77°F). Protect from light & moisture. Keep in a cool & dry place. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Oxycodone Hydrochloride Extended-Release Tablet 10mg
- Oxycodone Hydrochloride Extended-Release Tablet 20mg
- Oxycodone Hydrochloride Extended-Release Tablet 30mg
- Oxycodone Hydrochloride Extended-Release Tablet 40mg
- Oxycodone Hydrochloride Extended-Release Tablet 80mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Oxycodone Hydrochloride Extended-Release Tablet 10mg
Each film-coated Extended-Release tablet contains:
Oxycodone Hydrochloride USP….10mg
Excipients…………………………q.s.
Color: Sunset yellow FCF - Oxycodone Hydrochloride Extended-Release Tablet 20mg
Each film-coated Extended-Release tablet contains:
Oxycodone Hydrochloride USP….20mg
Excipients…………………………q.s.
Color: Titanium Dioxide USP - Oxycodone Hydrochloride Extended-Release Tablet 30mg
Each film-coated Extended-Release tablet contains:
Oxycodone Hydrochloride USP….30mg
Excipients…………………………q.s.
Color: Iron oxide Red - Oxycodone Hydrochloride Extended-Release Tablet 40mg
Each film-coated Extended-Release tablet contains:
Oxycodone Hydrochloride USP….40mg
Excipients…………………………q.s.
Color: Iron oxide Black - Oxycodone Hydrochloride Extended-Release Tablet 80mg
Each film-coated Extended-Release tablet contains:
Oxycodone Hydrochloride USP….80mg
Excipients…………………………q.s.
Color: Iron oxide Black
THERAPEUTIC INDICATIONS:
Oxycodone is used to relieve moderate to severe pain. Oxycodone extended-release tablets are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications.
CAUTION & WARNING:
CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take the whole tablet with water.
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).
Protect from light & moisture.
Keep in a cool & dry place.
Dosage:
As directed by the Physician.
Note:
To be sold to Hospitals and Institutes only.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Oxycodone Hydrochloride Extended-Release Tablet 10mg
B) Oxycodone Hydrochloride Extended-Release Tablet 20mg
C) Oxycodone Hydrochloride Extended-Release Tablet 30mg
D) Oxycodone Hydrochloride Extended-Release Tablet 40mg E) Oxycodone Hydrochloride Extended-Release Tablet 80mg
B) Oxycodone Hydrochloride Extended-Release Tablet 20mg
C) Oxycodone Hydrochloride Extended-Release Tablet 30mg
D) Oxycodone Hydrochloride Extended-Release Tablet 40mg E) Oxycodone Hydrochloride Extended-Release Tablet 80mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Oxycodone Hydrochloride Extended-Release Tablet 10mg
Each film -coated Extended-Release tablet contain:
Oxycodone Hydrochloride USP….10mg
Excipients…………………………q.s.
Colour: Sunset yellow FCF
B) Oxycodone Hydrochloride Extended-Release Tablet 20mg
Each film -coated Extended-Release tablet contain:
Oxycodone Hydrochloride USP….20mg
Excipients…………………………q.s.
Colour: Titanium Dioxide USP
C) Oxycodone Hydrochloride Extended-Release Tablet 30mg
Each film -coated Extended-Release tablet contain:
Oxycodone Hydrochloride USP….30mg
Excipients…………………………q.s.
Colour: Iron oxide Red
D) Oxycodone Hydrochloride Extended-Release Tablet 40mg
Each film -coated Extended-Release tablet contain:
Oxycodone Hydrochloride USP….40mg
Excipients…………………………q.s.
Colour: Iron oxide Black
E) Oxycodone Hydrochloride Extended-Release Tablet 80mg
Each film -coated Extended-Release tablet contain:
Oxycodone Hydrochloride USP….80mg
Excipients…………………………q.s.
Colour: Iron oxide Black
Each film -coated Extended-Release tablet contain:
Oxycodone Hydrochloride USP….10mg
Excipients…………………………q.s.
Colour: Sunset yellow FCF
B) Oxycodone Hydrochloride Extended-Release Tablet 20mg
Each film -coated Extended-Release tablet contain:
Oxycodone Hydrochloride USP….20mg
Excipients…………………………q.s.
Colour: Titanium Dioxide USP
C) Oxycodone Hydrochloride Extended-Release Tablet 30mg
Each film -coated Extended-Release tablet contain:
Oxycodone Hydrochloride USP….30mg
Excipients…………………………q.s.
Colour: Iron oxide Red
D) Oxycodone Hydrochloride Extended-Release Tablet 40mg
Each film -coated Extended-Release tablet contain:
Oxycodone Hydrochloride USP….40mg
Excipients…………………………q.s.
Colour: Iron oxide Black
E) Oxycodone Hydrochloride Extended-Release Tablet 80mg
Each film -coated Extended-Release tablet contain:
Oxycodone Hydrochloride USP….80mg
Excipients…………………………q.s.
Colour: Iron oxide Black
THERAPEUTIC INDICATIONS:
Oxycodone is used to relieve moderate to severe pain. Oxycodone extended-release tablets are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications.
CAUTION & WARNING:
CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take whole tablet with water.
Read enclosed leaflet before use.
WARNING:
To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take whole tablet with water.
Read enclosed leaflet before use.
WARNING:
To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Storage:
Store at 20° to 25°C (68° to 77°F).
Protect from light & moisture.
Keep in a cool & dry place.
Dosage:
As directed by the Physician
Note: To be sold to Hospitals and Institutes only.
Store at 20° to 25°C (68° to 77°F).
Protect from light & moisture.
Keep in a cool & dry place.
Dosage:
As directed by the Physician
Note: To be sold to Hospitals and Institutes only.