MedPath

Opium

Generic Name
Opium
Drug Type
Small Molecule
CAS Number
8008-60-4
Unique Ingredient Identifier
37M3MZ001L

Overview

Opium is the first substance of the diverse group of the opiates. It has been known for a long time, and the first evidence of a poppy culture dates from 5 thousand years by the Sumerians. During the years, opium was used as a sedative and hypnotic, but it was determined to be addictive. Opium is extracted from Papaver somniferum, which is more known as poppies. This plant is an integrant of the Papaveraceae family, and it is characterized by solitary leaves and capsulated fruits. Therefore, opium is a sticky brown resin obtained by collecting and drying the latex that exudes from the poppy pods. Once extracted, opium contains two main groups of alkaloids; the psychoactive constituents which are in the category of phenanthrenes and alkaloids that have no central nervous system effect in the category of isoquinolines. Morphine is the most prevalent and principal alkaloid in opium, and it is responsible for most of the harmful effects of opium. Opium has gradually been superseded by a variety of synthetic opioids and general anesthetics. Some of the isolated derivatives of opium are morphine, noscapine, strychnine, veratrine, colchicine, codeine, and quinine. Opium is a prohibited drug of abuse in most countries, but the illegal production of this drug and its derivatives keeps being registered. There is some legal production of opium in different countries for the obtention of alkaloids by extraction.

Indication

Opium and its derivatives are the most commonly used medications for the treatment of acute and chronic pain. Opium and its alkaloid-derivatives can also be used as tranquilizers, antitussives and in the treatment of diarrhea. The direct use of opium is not common nowadays but the use of some of its derivatives such as morphine and codeine, as well as the use of a tincture of opium for severe diarrhea can be seen in medical practice. Illegal use of opium has been registered to be for both recreational and medicinal purposes.

Associated Conditions

  • Severe Diarrhea

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Padagis US LLC
0574-7045
RECTAL
30 mg in 1 1
8/8/2018
Bryant Ranch Prepack
63629-8435
RECTAL
30 mg in 1 1
5/12/2021
Padagis US LLC
0574-7040
RECTAL
60 mg in 1 1
8/8/2018
Bryant Ranch Prepack
63629-8436
RECTAL
30 mg in 1 1
6/1/2021

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
DIBAN CAP
wyeth-ayerst canada inc.
02041626
Capsule - Oral
12 MG
2/18/1998
CAMPHORATED OPIUM TINCTURE
d.c. labs limited
00095680
Tincture - Oral
5 ML / 100 ML
12/31/1951
SANDOZ OPIUM & BELLADONNA
01901869
Suppository - Rectal
65 MG
12/31/1991
OPIUM TEINTURE
laboratoire atlas inc
00050830
Tincture - Oral
200 G / 1 L
12/31/1951
PAREGORIQUE
laboratoire atlas inc
00051330
Tincture - Oral
50 ML / 1 L
12/31/1951
DONNAGEL-PG LIQ
wyeth-ayerst canada inc.
02041634
Liquid - Oral
24 MG / 30 ML
12/31/1994
DIBAN CAP
ayerst laboratories
01909215
Capsule - Oral
12 MG
12/31/1992
OPIUM CAMPHRE TANIN TAB
rougier pharma division of ratiopharm inc
00779520
Tablet - Oral
15 MG
12/31/1951
OPIUM AND BELLADONNA SUP
smithkline beecham pharma division of smithkline beecham inc
01923463
Suppository - Rectal
65 MG
12/31/1993
PMS-OPIUM AND BELLADONA SUP
00815349
Suppository - Rectal
65 MG
12/31/1991

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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