OPIUM TINCTURE, USP (DEODORIZED) CII Rx only | Opium Tincture Deodorized [Edenbridge Pharmaceuticals, LLC] | BioPortfolio

13:20 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Opium Tincture, USP (Deodorized), is for oral administration. It is freed from unpleasant odor or nauseating substances by “denarcotization” with a petroleum distillate. Opium tincture is a clear, reddish-brown hydroalcoholic solution.

Each 100 mL contains 1 g of anhydrous morphine (represents the equivalent of 10 g of Powdered Opium, USP), alcohol, 19%, and water.

Opium has a very characteristic odor and a very bitter taste. The opiates are the most effective and prompt-acting nonspecific antidiarrheal agents.

The opiates act by enhancing tone in the long segments of longitudinal muscle and by inhibiting propulsive contraction of both circular and longitudinal muscles.

Clinical evidence indicates that the analgesic activity of opium preparations is due to their morphine content. Relatively small doses that do not produce significant analgesia are effective in controlling diarrhea. The papaverine content of the mixed alkaloids is too small to have demonstrable spasmolytic activity.

Following oral administration, morphine is well absorbed from the gastrointestinal tract. It is rapidly metabolized following oral administration, however, and plasma levels of unconjugated morphine are lower than those achieved after parenteral administration. Like other narcotic analgesics, opium preparations are metabolized in the liver. Morphine undergoes conjugation with glucuronic acid at the 3-hydroxyl group. Secondary conjugation may also occur at the 6-hydroxyl group to form the 3,6-diglucuronide. Morphine is excreted in the urine mainly as morphine-3-glucuronide and smaller amounts of morphine-3,6-diglucuronide and unchanged drug. Approximately 75% of a dose of morphine is excreted in the urine within 48 hours.

Opium tincture is useful for the treatment of diarrhea.

This preparation is not recommended for use in children. It should not be used in diarrhea caused by poisoning until the toxic material is eliminated from the gastrointestinal tract.

Addiction can result from opium usage. Opium preparations should be given in the smallest effective dose and as infrequently as possible to minimize the development of tolerance and physical dependence.

General – Opium should be used with caution in the elderly, in debilitated individuals, and in patients with increased intracranial pressure, cerebral arteriosclerosis, hepatic cirrhosis or liver insufficiency, gastrointestinal hemorrhage, myxedema, emphysema, and bronchial asthma.

Drug Interactions – When preparations containing opium are administered in combination with other drugs, the cautions applicable to each ingredient should be borne in mind. Reduced dosage is indicated in poor-risk patients, in the very young or very old patient, and in those who are receiving other central-nervous system depressants.

Usage in Pregnancy - Pregnancy Category C – Animal reproduction studies have not been conducted with Opium Tincture USP (Deodorized). It is also not known whether Opium Tincture, USP (Deodorized), can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Opium Tincture, USP (Deodorized), should be given to a pregnant woman only if clearly needed.

Nursing Mothers – Caution should be exercised when Opium Tincture, USP (Deodorized), is administered to a nursing woman.

Usage in Children – Safety and effectiveness in children have not been established. See CONTRAINDICATIONS.

Constipation, nausea, and vomiting may occur in some patients. Pruritus and urticaria have been observed.

Controlled Substance – Opium Tincture, USP (Deodorized), is a Schedule II drug. See WARNINGS.

Signs and Symptoms – Symptoms of toxicity are those of morphine and alcohol, such as nausea, vomiting, miosis, cool and clammy skin, respiratory and CNS depression, bradycardia, hypotension, and skeletal muscle flaccidity. Noncardiogenic pulmonary edema may develop after opioid overdose and monitoring of heart filling pressure may be helpful. Ethanol has been demonstrated to cause hypoglycemia in children or adults with limited glycogen stores. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.

Treatment – To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

Initial management of opioid overdose should emphasize establishment of a secure airway and support of ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, blood glucose, etc. Naloxone antagonizes most effects of opioids. Protect the airway as naloxone may induce vomiting. Since naloxone has a shorter duration of action than opioids, repeated doses may be needed. In patients who abuse opioids chronically, a withdrawal syndrome may be manifest on administration of naloxone. This may include yawning, tearing, restlessness, sweating, dilated pupils, piloerection, vomiting, diarrhea, and abdominal cramps. This syndrome usually abates quickly as the effect of naloxone dissipates.

Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Since opium tincture can delay gastric emptying, evacuation of the stomach may be beneficial. Safeguard the patient’s airway when employing gastric emptying or charcoal. Monitor for and treat hypoglycemia.

The use of forced diuresis, peritoneal dialysis, hemodialysis or charcoal hemoperfusion has not been established to be beneficial.

Usual Adult Dose – 0.6 mL orally 4 times a day.

Opium Tincture, USP (Deodorized), is supplied as: NDC 42799-217-01 Bottles of 4 fl oz NDC 42799-217-02 Bottles of 16 fl oz

Store at controlled room temperature, 68° to 77°F (20° to 25°C) (see USP).

Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 USA 877-381-3336 Rev. 02/16 500445-02


Edenbridge Pharmaceuticals, LLC

Active Ingredients


Drugs and Medications [8 Associated Drugs and Medications listed on BioPortfolio]

Opium tincture deodorized [valeant pharmaceuticals north america llc]


Opium tincture deodorized [ani pharmaceuticals, inc.]

Opium Tincture, USP (Deodorized) CII Rx Only

Belladonna and opium [paddock laboratories, llc]

These highlights do not include all the information needed to use BELLADONNA and OPIUM Suppositories safely and effectively. See full prescribing information for BELLADONNA and OPIUM Suppositories. BE...

Paregoric [hi-tech pharmacal co., inc.]

Paregoric, USP

Hydrocodone bitartrate and homatropine methylbromide [atlantic biologicals corps]


Clinical Trials [11 Associated Clinical Trials listed on BioPortfolio]

A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals

MP-101 will be evaluated in this study to see if it is safe, tolerable, and can help people with Short Bowel Syndrome. This study will also find out if taking MP-101 can improve the sympt...

A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001

MP-101 will be evaluated in this study to see if it is safe and tolerable.

Comparing Opium Tincture (OT) With Methadone for Substitution Treatment of Opioid Dependence

Opioid-dependent patients seeking maintenance treatment will be recruited. Each participant will be allocated to one of the two study groups with the equal chance of receiving either opium...

Effects of Perioperative Belladonna and Opium Suppositories on Postoperative Pain and Morphine Consumption on Patients After Robotic Assisted Laparoscopic Radical Prostatectomy

This study is evaluating the effect of a Belladonna and Opium suppository administered intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate cancer....

The Use of Belladonna and Opium Suppository in the Treatment of Postoperative Stent Pain

The purpose of this study is to determine if preemptive B&O suppository placement will decrease post-operative pain in patients undergoing ureteral stent placement.

PubMed Articles [18 Associated PubMed Articles listed on BioPortfolio]

DARK Classics in Chemical Neuroscience: Opium, a Friend or Foe.

Opium has found great use medicinally for its analgesic properties and has been witnessed as one of the most popular medications used in psychiatry. Opium derivatives have been shown efficacious for r...

DARK Classics in Chemical Neuroscience: Opium, a historical perspective.

Opium is the latex from the opium poppy Papaver somniferum L. which man has utilized since ancient Mesopotamia all the way to modern times. Opium used to be surrounded in divine mystery or magic like ...

Internalized stigma and its correlates among treatment seeking opium users in India: A cross-sectional observational study.

Opium has been used in India since ancient times for social, recreational, religious and medicinal purposes. Opium users seem to constitute a distinct sub-population among opioid users, who have minim...

Association of opium addiction with rupture of intracranial aneurysms: A case-control study.

Disorders related to opioid use account for the most substantial burden of disease attributable to drug use disorders. We aimed to justify if there is an association between either opium consumption o...

Association Between GSTP1 Ile105Val Genetic Polymorphism and Dependency to Heroin and Opium.

Relationship between glutathione S-transferase P1 (GSTP1, OMIM: 134660) variants and the risk of drug dependency is unknown. Chronic use of illegal drugs leads to oxidative stress, which can be allevi...

Quick Search


Relevant Topics

Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...

Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Drugs and Medication Quicklinks

Searches Linking to this Drug Record