Oxycodone Hydrochloride Extended-Release Tablet 40mg 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

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

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.

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.