Drugs Details

Drugs Info of Opium Deodorized, Paregoric
Drugs Details
  • Drugs Type  : Multum
  • Date : 6th Mar 2015 05:51 am
  • Brand Name : Opium Deodorized, Paregoric
  • Generic Name : opium preparation (Pronunciation: OH pee um
Descriptions

PAREGORIC (anhydrous morphine) , USP
(anhydrous morphine)

Each 5 mL (one teaspoonful) contains:

Anhydrous Morphine (from Opium) .............................................. 2 mg

WARNING: May be habit forming.

Inactive Ingredients:

Alcohol 45 percent, anise oil, benzoic acid, glycerin, and purified water.

What are the possible side effects of opium preparation (Opium Deodorized, Paregoric)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe constipation, bloating, stomach cramps;
  • urinating less than usual or not at all;
  • fast, pounding, or uneven heartbeats;
  • feeling like you might pass out;
  • weak or shallow breathing; or
  • seizure (convulsions).

Less serious side effects may include:

  • upset...

Read All Potential Side Effects and See Pictures of Paregoric »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Paregoric (anhydrous morphine) is useful for the treatment of diarrhea.

Dosage Administration

Usual Pediatric Dosage:

0.25 to 0.5 mL/kg of body weight 1 to 4 times a day.

Usual Adult Dosage:

5 to 10 mL (1 to 2 teaspoonfuls) 1 to 4 times a day.

How Supplied

Paregoric (anhydrous morphine) , USP contains Anhydrous Morphine 2 mg/5 mL (from Opium); Alcohol 45 percent and is available in a pint (473 mL) bottle.

Store at controlled room temperature 59°-86° F (15°-30° C). Protect from light.

NOTE: This product may deposit a sediment if exposed to low temperatures. Filter if necessary.

Dispense in a tight, light-resistant container as defined in the USP

CAUTION: Federal law prohibits dispensing without prescription.


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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.

Other adverse reactions include euphoria, dysphoria, constipation, and pruritus.

DRUG ABUSE AND DEPENDENCE

Controlled Substance:

Paregoric (anhydrous morphine) is a Schedule III narcotic.

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.

Read the Paregoric (anhydrous morphine) Side Effects Center for a complete guide to possible side effects

Interactions

Morphine in combination with other narcotic analgesics, general anesthetics, phenothiazines, tranquilizers, sedative/hypnotics or other CNS depressants (including alcohol) has additive depressant effects, and the patient should be so advised. When such combination therapy is contemplated, the dosage of one or both agents should be reduced.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

No information provided.

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 given with caution to certain patients, such as the elderly or debilitated and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, and prostatic hypertrophy or urethral stricture.

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: The administration of morphine may result in severe hypotension in the postoperative patient or any individual whose ability to maintain blood pressure has been compromised by a depleted blood volume or the administration of such drugs as the phenothiazines or certain anesthetics.

Supraventricular Tachycardias: Because of a possible vagolytic action that may produce a significant increase in the ventricular response rate, morphine should be used with caution in patients with atrial flutter and other 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Paregoric (anhydrous morphine) has no known carcinogenic or mutagenic potential. However no longterm animal studies are available to support this observation.

Usage in Pregnancy

Pregnancy Category 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 (anhydrous morphine) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

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


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Signs and Symptoms

Serious overdosage of morphine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin and sometimes bradycardia and hypotension. In severe overdosage apnea, circulatory collapse, cardiac arrest and death may occur.

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.

ContrainDications

ypersensitivity to morphine. Because of its stimulating effect on the spinal cord, morphine should not be used in convulsive states, such as those occurring in status epilepticus, tetanus, and strychnine poisoning.

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

 


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

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.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Opium Deodorized, Paregoric

Generic Name: opium preparation (Pronunciation: OH pee um)

  • What is opium preparation (Paregoric)?
  • What are the possible side effects of opium preparation (Paregoric)?
  • What is the most important information I should know about opium preparation (Paregoric)?
  • What should I discuss with my health care provider before taking opium preparation (Paregoric)?
  • How should I take opium preparation (Paregoric)?
  • What happens if I miss a dose (Paregoric)?
  • What happens if I overdose (Paregoric)?
  • What should I avoid while taking opium preparation (Paregoric)?
  • What other drugs will affect opium preparation (Paregoric)?
  • Where can I get more information?

What is opium preparation (Paregoric)?

Opium is a narcotic derived from the seed pod of a poppy plant. It works by increasing smooth muscle tone and decreasing fluid secretions in the intestines. This slows the movement of bowel matter through the intestines.

Opium preparation (sometimes called "opium tincture" or "paregoric") is used to treat diarrhea. Opium preparation is sometimes given with other anti-diarrhea medication such as kaolin and pectic (Kaopectate).

Opium preparation may also be used for other purposes not listed in this medication guide.

What are the possible side effects of opium preparation (Paregoric)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe constipation, bloating, stomach cramps;
  • urinating less than usual or not at all;
  • fast, pounding, or uneven heartbeats;
  • feeling like you might pass out;
  • weak or shallow breathing; or
  • seizure (convulsions).

Less serious side effects may include:

  • upset stomach, nausea, vomiting, loss of appetite;
  • constipation;
  • dizziness, drowsiness, feeling tired or restless;
  • increased sweating; or
  • warmth, redness, or tingly feeling under your skin.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Paregoric (anhydrous morphine) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about opium preparation (Paregoric)?

You should not use this medication if you have ever had an allergic reaction to a narcotic medicine, if you are having an asthma attack, or if you have a bowel obstruction called paralytic ileus.

Before you take an opium preparation, tell your doctor if you have bloody diarrhea, diarrhea with fever, diarrhea caused by taking antibiotics, inflammatory bowel disease, toxic megacolon, asthma or other breathing disorder, liver or kidney disease, a seizure disorder, enlarged prostate, urination problems, or a history of drug or alcohol addiction.

Do not drink alcohol while you are taking this medication. Dangerous side effects or death can occur when alcohol is combined with opium preparation. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Many drugs can interact with opium preparation. Tell your doctor about all the prescription and over-the-counter medications you use.

Never take this medication in larger amounts, or use it for longer than recommended by your doctor.

Side Effects Centers
  • Paregoric

Patient Detailed How Take

What should I discuss with my health care provider before taking opium preparation (Paregoric)?

You should not use this medication if you have ever had an allergic reaction to a narcotic medicine (examples include codeine, methadone, morphine, Oxycontin, Darvocet, Percocet, Vicodin, Lortab, and many others). You should also not take opium preparation if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take an opium preparation, tell your doctor if you have:

  • bloody diarrhea, or diarrhea with fever;
  • diarrhea caused by taking antibiotics;
  • inflammatory bowel disease, toxic megacolon;
  • asthma, COPD, sleep apnea, or other breathing disorders;
  • liver or kidney disease;
  • epilepsy or other seizure disorder;
  • enlarged prostate or urination problems; or
  • a history of drug or alcohol addiction.

FDA pregnancy category C. Taking opium preparation during pregnancy may cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Opium can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more like to have side effects of this medication.

Opium preparation may be habit-forming when used over a long period of time. This medication should be used only by the person it was prescribed for. Opium preparation should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

How should I take opium preparation (Paregoric)?

Take this medication exactly as it was prescribed for you. Never take an opium preparation in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

This medication is usually taken 1 to 4 times daily to treat diarrhea. Follow your doctor's instructions.

If you switch from using opium tincture to using paregoric, your dose will not be the same because each preparation contains a different amount of opium. Opium tincture is much stronger than paregoric and taking too much may cause serious harm.

Your doctor may occasionally change your dose to make sure you get the best results.

Do not stop using opium preparation suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop taking this medication.

Store opium preparation at room temperature away from moisture and heat.

Side Effects Centers
  • Paregoric

Patient Detailed Avoid Taking

What happens if I miss a dose (Paregoric)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Paregoric)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of opium could be fatal.

Overdose symptoms may include extreme drowsiness, feeling restless or nervous, confusion, cold and clammy skin, pinpoint pupils, seizure (convulsions), shallow breathing, slow heartbeat, fainting, or breathing that stops.

What should I avoid while taking opium preparation (Paregoric)?

Avoid using any other anti-diarrhea medications that your doctor has not prescribed.

Do not drink alcohol while you are taking this medication. Dangerous side effects or death can occur when alcohol is combined with opium preparation. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What other drugs will affect opium preparation (Paregoric)?

Before using this medication, tell your doctor if you regularly use cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Also tell your doctor if you are using:

  • atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
  • bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
  • cimetidine (Tagamet);
  • glycopyrrolate (Robinul);
  • mepenzolate (Cantil);
  • metoclopramide (Reglan);
  • naloxone (Narcan), naltrexone (ReVia);
  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine);
  • an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril).

This list is not complete and there may be other drugs that can interact with opium preparation. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about opium preparation.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.03. Revision date: 12/15/2010.

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