Paregoric

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Paregoric
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

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Overview

Paregoric is a antidiarrheal that is FDA approved for the treatment of diarrhea. Common adverse reactions include apnea, drug withdrawal, hypotension, respiratory depression, seizure, tachycardia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Diarrhea
  • Paregoric is useful for the treatment of diarrhea.
Usual Adult Dosage
  • 5 to 10 mL (1 to 2 teaspoonfuls) 1 to 4 times a day or as directed by a physician.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Paregoric in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Paregoric in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Diarrhea
  • Paregoric is useful for the treatment of diarrhea.
Usual Pediatric Dosage
  • 0.25 to 0.5 mL/kg of body weight 1 to 4 times a day or as directed by a physician.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Paregoric in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Paregoric in pediatric patients.

Contraindications

  • This preparation should not be used in diarrhea caused by poisoning until the toxic material is eliminated from the gastrointestinal tract.

Warnings

Precautions

General
  • Head Injury and Increased Intracranial Pressure
  • The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal-fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, narcotics produce additional effects that may obscure the clinical course in patients with head injuries.
  • Acute Abdominal Conditions
  • The administration of morphine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
Special-Risk Patients
  • Morphine should be used with extreme caution in patients with disorders characterized by hypoxia, since even usual therapeutic doses of narcotics may decrease respiratory drive to the point of apnea while simultaneously increasing airway resistance.
  • Hypotensive Effect
  • Supraventricular Tachycardias
  • Convulsions
  • Morphine may aggravate preexisting convulsions in patients with convulsive disorders. If dosage is escalated substantially above recommended levels because of tolerance development, convulsions may occur in individuals without a history of convulsive disorders.

Adverse Reactions

Clinical Trials Experience

  • The most frequent adverse reactions include lightheadedness, dizziness, sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Paregoric in the drug label.

Drug Interactions

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • Animal reproduction studies have not been conducted with morphine. It is not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Paregoric should be given to a pregnant woman only if clearly needed.


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Paregoric in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Paregoric during labor and delivery.

Nursing Mothers

  • Morphine appears in the milk of nursing mothers. Caution should be exercised when paregoric is administered to a nursing woman.

Pediatric Use

There is no FDA guidance on the use of Paregoric with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Paregoric with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Paregoric with respect to specific gender populations.

Race

There is no FDA guidance on the use of Paregoric with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Paregoric in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Paregoric in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Paregoric in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Paregoric in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

There is limited information regarding Monitoring of Paregoric in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Paregoric in the drug label.

Overdosage

Controlled Substance
Dependence
  • Morphine can produce drug dependence and, therefore, has the potential for being abused. Patients receiving therapeutic dosage regimens of 10 mg every 4 hours for 1 to 2 weeks have exhibited mild withdrawal symptoms. Development of the dependent state is recognizable by an increased tolerance to the analgesic effect and the appearance of purposive phenomena (complaints, pleas, demands, or manipulative actions) shortly before the time of the next scheduled dose. A patient in withdrawal should be treated in a hospital environment. Usually, it is necessary only to provide supportive care with administration of a tranquilizer to suppress anxiety. Severe symptoms of withdrawal may require administration of a replacement narcotic.
Signs and Symptoms
Treatment
  • Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against the respiratory depression that may result from overdosage or unusual sensitivity to narcotics. Therefore, an appropriate dose of the antagonist should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of morphine may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.
  • Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.

Pharmacology

There is limited information regarding Paregoric Pharmacology in the drug label.

Mechanism of Action

  • Morphine produces its major effects on the central nervous system (CNS) and on the bowel.

Structure

  • Each 5 mL (teaspoonful) contains:
  • Anhydrous Morphine . . . . . . . . . . . . . . . . . ……. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 mg (from opium tincture)
  • Alcohol . . . . . . . . . . . . . . . . . . . . . . .... . . . . . . . . . . . . . . . . . . . . . . . . . . . . not more than 47.0%
  • Inactive Ingredients: anise oil, benzoic acid, camphor, alcohol, glycerin, and purified water.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Paregoric in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Paregoric in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Paregoric has no known carcinogenic or mutagenic potential. However, no long-term animal studies are available to support this observation.

Clinical Studies

There is limited information regarding Clinical Studies of Paregoric in the drug label.

How Supplied

  • Paregoric, USP contains anhydrous morphine 2 mg/5 mL (from opium tincture); alcohol not more than 47.0% and is available in 16 fl. oz. (473 mL) bottles.

tore at controlled room temperature, 15°-30°C (59°-86°F) [see USP].

  • PROTECT FROM LIGHT
  • AVOID EXCESSIVE HEAT
  • Dispense in a tight, light-resistant container as defined in the USP. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by the purchaser.

Storage

There is limited information regarding Paregoric Storage in the drug label.

Images

Drug Images

Package and Label Display Panel

Paregoric03.png
This image of the FDA label is provided by the National Library of Medicine.
Paregoric04.png
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

  • Information for Patients
  • Morphine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery.

Precautions with Alcohol

  • Alcohol-Paregoric interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • OPIUM

Look-Alike Drug Names

There is limited information regarding Paregoric Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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