NDC 0187-4203 Opium Tincture Deodorized

NDC Product Code 0187-4203

NDC 0187-4203-04

Package Description: 118.3 mL in 1 BOTTLE, GLASS

NDC 0187-4203-16

Package Description: 473.2 mL in 1 BOTTLE, GLASS

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Opium Tincture Deodorized with NDC 0187-4203 is a product labeled by Valeant Pharmaceuticals North America Llc. The generic name of Opium Tincture Deodorized is . The product's dosage form is and is administered via form.

Labeler Name: Valeant Pharmaceuticals North America Llc

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Valeant Pharmaceuticals North America Llc
Labeler Code: 0187
Start Marketing Date: 09-17-2008 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Opium Tincture Deodorized Product Label Images

Opium Tincture Deodorized Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

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.

Clinical Pharmacology

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.

Indications And Usage

Opium tincture is useful for the treatment of diarrhea.

Contraindications

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.

Warnings

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.

Precautions

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.

Adverse Reactions

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

Drug Abuse And Dependence

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

Overdosage

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.

Dosage And Administration

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

How Supplied

  • Tincture: •4 fl oz (NDC 0187-4203-04) •16 fl oz (NDC 0187-4203-16)Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Distributed by: Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Valeant Pharmaceuticals North America LLCRev. 07/20151014-009471200

Package/Label Display Panel -

NDC 0187-4203-16OPIUM CII POISONTINCTURE, USP(DEODORIZED)10 mg/mLof anhydrous morphineRx only473 mL (16 fl oz) (1 pt)

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