Sample PLR Content Directory Idaho

Friday, 27 August 2010

Lorantis

Lorantis may be available in the countries listed below.

Ingredient matches for Lorantis

Loratadine

Loratadine is reported as an ingredient of Lorantis in the following countries:

Turkey

International Drug Name Search

Thursday, 26 August 2010

Boceprevir

Pronunciation: boe-SE-pre-vir
Generic Name: Boceprevir
Brand Name: Victrelis

Boceprevir is used for:

Treating chronic hepatitis C virus (HCV) infection in certain patients. It must be used in combination with peginterferon and ribavirin.

Boceprevir is a hepatitis C protease inhibitor. It reduces the amount of HCV in the body by preventing the spread of the HCV within the body.

Do NOT use Boceprevir if:

you are allergic to any ingredient in Boceprevir

you are taking alfuzosin, certain anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), certain benzodiazepines (eg, midazolam, triazolam), cisapride, drospirenone, ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), lurasidone, pimozide, rifampin, or St. John's wort

you take sildenafil or tadalafil for pulmonary arterial hypertension (PAH)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Boceprevir:

Some medical conditions may interact with Boceprevir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have HIV infection or other immune system problems; or certain blood problems, such as anemia, low blood platelet levels, or low white blood cell levels (neutropenia)

if you have other liver problems (eg, cirrhosis, hepatitis B infection)

if you have had an organ transplant

if you will be having surgery

Some MEDICINES MAY INTERACT with Boceprevir. Tell your health care provider if you are taking any other medicines, especially any of the following:

Certain anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), rifampin, or St. John's wort because they may decrease Boceprevir's effectiveness

Alfuzosin, certain benzodiazepines (eg, midazolam, triazolam), cisapride, drospirenone, ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), lurasidone, or pimozide because the risk of their side effects may be increased by Boceprevir

Sildenafil or tadalafil (when used to treat PAH) because the risk of their side effect may be increased by Boceprevir

Hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Boceprevir

Many prescription medicines (eg, used for asthma or breathing problems, anxiety, blood thinning, blood flow, cancer, diabetes, enlarged prostate, erectile dysfunction, gout, heart problems, HIV, immune suppression, infections, inflammation, infection, irregular heartbeat, high blood pressure, high cholesterol, mental or mood problems, opioid dependence, pain [eg, narcotics], PAH, sleep) may interact with Boceprevir, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Boceprevir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Boceprevir:

Use Boceprevir as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

Boceprevir comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Boceprevir refilled.

Boceprevir must be taken with peginterferon and ribavirin, which come with their own Medication Guides. Be sure to read those Medication Guides each time you get them filled.

Take Boceprevir by mouth with food (a meal or light snack).

Boceprevir is packaged into bottles that contain enough capsules for an entire day. Be sure you know how many capsules to take for each dose.

Boceprevir works best if it is taken at the same times each day.

Continue to take Boceprevir even if you feel well. Do not miss any doses.

If you miss a dose of Boceprevir, and it is more than 2 hours before your next dose, take the missed dose with food and go back to your regular dosing schedule. If you miss a dose of Boceprevir, and it is less than 2 hours before your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Boceprevir.

Important safety information:

Boceprevir may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Boceprevir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Boceprevir may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

Boceprevir may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

Boceprevir does not stop you from spreading HCV to others through sexual contact, sharing needles, or being exposed to your blood. Use barrier methods of birth control (eg, condoms) if you have HCV infection. Talk with your doctor about safe sexual practices that protect your partner. Never share needles or other injection supplies. Do not share personal items that may have blood or body fluids on them, like toothbrushes or razors.

Do not change your dose without checking with your doctor.

Boceprevir is not a cure for HCV infection. Remain under the care of your doctor.

When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Boceprevir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.

Women who may become pregnant and men who use Boceprevir must use 2 effective forms of birth control while they take Boceprevir with ribavirin and for 6 months after treatment is stopped. Hormonal birth control (eg, birth control pills) may not be as effective while you are using Boceprevir. Talk with your doctor if you have questions about effective birth control.

Tell your doctor or dentist that you take Boceprevir before you receive any medical or dental care, emergency care, or surgery.

Lab tests, including complete blood cell counts and HCV antibody levels, may be performed while you use Boceprevir and for several months after you stop Boceprevir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Boceprevir with caution in the ELDERLY; they may be more sensitive to its effects.

Boceprevir should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Boceprevir must be used with ribavirin. Ribavirin use during pregnancy has resulted in birth defects and fetal death. If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while using Boceprevir. If you become pregnant, contact your doctor immediately. You will need to discuss the benefits and risks of using Boceprevir while you are pregnant. It is not known if Boceprevir is found in breast milk. Do not breast-feed while taking Boceprevir.

Possible side effects of Boceprevir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in taste; decreased appetite; diarrhea; dizziness; dry mouth; dry skin; hair loss; headache; irritability; joint pain; nausea; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark, tarry, or bloody stools; fainting; fast or irregular heartbeat; feeling cold, especially in the hands or feet; fever, chills, or sore throat; pale skin; severe or persistent dizziness; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Boceprevir side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Boceprevir:

Store Boceprevir in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Boceprevir may also be stored at room temperature up to 77 degrees F (25 degrees C) for 3 months. Keep Boceprevir in the original container. Avoid exposure to excessive heat. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Boceprevir out of the reach of children and away from pets.

General information:

If you have any questions about Boceprevir, please talk with your doctor, pharmacist, or other health care provider.

Boceprevir is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Boceprevir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Boceprevir resources

Boceprevir Side Effects (in more detail)
Boceprevir Use in Pregnancy & Breastfeeding
Boceprevir Drug Interactions
Boceprevir Support Group
0 Reviews for Boceprevir - Add your own review/rating

Boceprevir Professional Patient Advice (Wolters Kluwer)

boceprevir Advanced Consumer (Micromedex) - Includes Dosage Information

Victrelis Prescribing Information (FDA)

Victrelis Consumer Overview

Compare Boceprevir with other medications

Hepatitis C

Thursday, 12 August 2010

Memotropil

Memotropil may be available in the countries listed below.

Ingredient matches for Memotropil

Piracetam

Piracetam is reported as an ingredient of Memotropil in the following countries:

Latvia

Poland

Russian Federation

Vietnam

International Drug Name Search

Thursday, 5 August 2010

Barotrast oral and rectal

Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate)

Brand Names: Anatrast, Baricon, Baro-Cat, Barosperse, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, E-Z AC, E-Z Dose Kit with Polibar Plus, E-Z-Cat, E-Z-HD, E-Z-Paque, Eneset 2, Entero-H, Entrobar, Esopho-Cat, Liqui-Coat HD, Liquid Polibar, Medebar Plus, Medebar Super 250, Readi-Cat, Readi-Cat 2, Scan C, Smoothie Readi-Cat 2, Sol-O-Pake, Tonojug, Tonopaque, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen

What is barium sulfate?

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.

Barium sulfate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about barium sulfate?

You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.

Tell your doctor if you are pregnant or breast-feeding before your medical test.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Serious side effects of barium sulfate may include severe stomach pain, sweating, ringing in your ears, pale skin, weakness, or severe cramping, diarrhea, or constipation

What should I discuss with my health care provider before using barium sulfate?

You should not use barium sulfate if you are allergic to it. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

To make sure you can safely use barium sulfate, tell your doctor if you have any of these other conditions:

asthma, eczema, or allergies;

a blockage in your stomach or intestines;

cystic fibrosis;

a colostomy;

rectal cancer;

heart disease or high blood pressure;

Hirsch sprung's disease (a disorder of the intestines);

a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);

a recent history of surgery on your esophagus, stomach, or intestines;

a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;

if you have recently had a rectal biopsy;

if you have ever choked on food by accidentally inhaling it into your lungs;

if you are allergic to simethicone (Gas-X, Phazyme, and others); or

if you are allergic to latex rubber.

It is not known whether barium sulfate will harm an unborn baby, but the radiation used in x-rays and CT scans may be harmful. Before your medical test, tell your doctor if you are pregnant. Barium sulfate may pass into breast milk and could harm a nursing baby. Before your medical test, tell your doctor if you are breast-feeding a baby.

How should I use barium sulfate?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Barium sulfate comes in tablets, paste, cream, or liquid forms.

In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.

You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.

If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.

Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.

Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Store this medication at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

If you are using barium sulfate at home, call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe stomach pain, ongoing diarrhea, confusion, or weakness.

What should I avoid before or after using barium sulfate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Barium sulfate side effects

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 stomach pain;

severe cramping, diarrhea, or constipation;

sweating;

ringing in your ears;

confusion, fast heart rate; or

pale skin, weakness.

Less serious side effects may include:

mild stomach cramps;

nausea, vomiting;

loose stools or mild constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect barium sulfate?

There may be other drugs that can interact with barium sulfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Barotrast resources

Barotrast Side Effects (in more detail)
Barotrast Use in Pregnancy & Breastfeeding
Barotrast Support Group
0 Reviews for Barotrast - Add your own review/rating

Compare Barotrast with other medications

Computed Tomography

Where can I get more information?

Your doctor or pharmacist can provide more information about barium sulfate.

See also: Barotrast side effects (in more detail)

Tuesday, 3 August 2010

Acetadote

In the US, Acetadote (acetylcysteine systemic) is a member of the following drug classes: antidotes, mucolytics and is used to treat Acetaminophen Overdose.

US matches:

Acetadote

Ingredient matches for Acetadote

Acetylcysteine

Acetylcysteine is reported as an ingredient of Acetadote in the following countries:

United States

International Drug Name Search

Tuesday, 27 July 2010

Opium

Class: Opiate Agonists
VA Class: CN101
CAS Number: 8002-76-4
Brands: B & O

Introduction

Opiate agonist and antiperistaltic agent; naturally occurring phenanthrene derivative; contains several alkaloids, including anhydrous morphine, codeine, and papaverine.^a ^b ^c ^d ^g ^h

Uses for Opium

Pain Associated with Ureteral Spasm

Used rectally in combination with belladonna extract for the relief of moderate to severe pain associated with ureteral spasm unresponsive to nonopiate analgesics.^a ^d

Used when the analgesic, sedative, and antispasmodic effects of the combination may be useful (i.e., when pain and smooth-muscle spasm are present concurrently)^a and to space intervals between opiate injections.^d

Diarrhea

Paregoric or opium tincture are used principally for the treatment of diarrhea.^a ^b ^g ^h

Should not be used for treatment of diarrhea caused by poisoning until the toxic material is eliminated from the GI tract by gastric lavage or cathartics.^b ^g ^h (See Contraindications.)

Opiate Withdrawal

Used as a tincture (e.g., paregoric or diluted opium tincture) to treat opiate withdrawal† symptoms (e.g., generalized tremors, hypertonicity with any form of tactile stimuli, hyperalertness, sleeplessness, excessive crying, vomiting, diarrhea, yawning, fever) in neonates† born to women addicted to opiates.^a ^b ^c

Diluted opium tincture is preferred by some clinicians to paregoric tincture for the treatment of opiate withdrawal symptoms in neonates, since paregoric contains camphor and benzoic acid which may cause potential adverse effects.^b

Opium Dosage and Administration

Administration

Administer orally as a solution.^b ^g ^h

Administer rectally as a suppository.^a ^d

Oral Administration

Paregoric and opium tincture are administered orally as a solution.^b ^g ^h

Opium tincture contains 25 times more morphine than does paregoric and should never be confused with the latter preparation.^b ^f (See Concentrated Opium Solutions and also Possible Prescribing and Dispensing Errors, under Cautions.)

Dilution

For treatment of opiate withdrawal symptoms in neonates, opium tincture must be diluted and administered as a 1:25 dilution in water.^b

Rectal Administration

Opium is administered rectally as a suppository in combination with belladonna extract.^a ^d

Moisten finger and rectal suppository containing belladonna and opium with water prior to rectal insertion.^a ^d

Dosage

Tincture: Available as opium and paregoric; dosage is expressed in terms of anhydrous morphine alkaloid.^b ^f ^g ^h ⁱ

Opium tincture is an alcoholic solution containing 50 mg of anhydrous morphine (as granulated or sliced opium) per 5 mL.^b ^h

Paregoric contains 2 mg of anhydrous morphine (usually as opium), anise oil, benzoic acid, glycerin, and sufficient diluted alcohol to make 5 mL.^b ^g

Rectal suppository: Available as a fixed combination containing opium and belladonna; dosage expressed in terms of opium and belladonna.^d

Should be given in the smallest effective dose and as infrequently as possible to minimize the development of tolerance and physical dependence.^a ^c ^h

Pediatric Patients

Diarrhea

Paregoric

Oral

Usually, 0.25–0.5 mL/kg 1–4 times daily.^b ^g

Opiate Withdrawal†

Paregoric or 1:25 Dilution of Opium Tincture

Oral

To prevent potential overdose, opium tincture must be diluted and administered as a 1:25 dilution in water.^b (See Concentrated Opium Solutions and also Possible Prescribing and Dispensing Errors, under Cautions.)

Neonates†: Usually, 3–6 drops every 3–6 hours as needed; adjust dosage to control withdrawal symptoms.^b Alternatively, initially, 0.2 mL every 3 hours and increase, if necessary, by approximately 0.05 mL every 3 hours until withdrawal symptoms are controlled; rarely necessary to exceed 0.7 mL per dose.^b After withdrawal symptoms have stabilized for 3–5 days, gradually decrease dosage over a 2- to 4-week period.^b ^c

Adults

Pain Associated with Ureteral Spasm

Opium Combination Suppository

Rectal

Usually, 1 suppository once or twice daily, or as directed by a clinician.^a ^d

Diarrhea

Paregoric

Oral

Usually, 5–10 mL 1–4 times daily.^b ^g

Opium Tincture

Oral

Usually, 0.6 mL 4 times daily;^b ^h may range from 0.3–1 mL 4 times daily.^b

Prescribing Limits

Pediatric Patients

Opiate Withdrawal†

Paregoric or 1:25 Dilution of Opium Tincture

Oral

Neonates†: Rarely necessary to exceed 0.7 mL per dose.^b

Adults

Pain Associated with Ureteral Spasm

Opium Combination Suppository

Rectal

Maximum 1 suppository 4 times daily.^d

Diarrhea

Opium Tincture

Oral

Maximum 1 mL as a single dose or 6 mL daily.^b

Special Populations

Hepatic Impairment

Use with caution and reduce initial dosage in patients with hepatic cirrhosis or insufficiency.^b ^c ^g ^h

Renal Impairment

Use with caution and reduce initial dosage in patients with renal impairment.^c ^g

Geriatric and Debilitated Patients

Administer with caution and reduce dosage in geriatric or debilitated patients.^b ^c ^d ^g ^h

Cautions for Opium

Contraindications

Known hypersensitivity to opium or morphine.^c ^g

Convulsive states (e.g., status epilepticus, tetanus, strychnine poisoning).^d ^g

Undiluted opium tincture: Children.^h (See Pediatric Use under Cautions.)

Paregoric and opium tincture: Diarrhea caused by poisoning until the toxic material is eliminated from the GI tract.^g ^h

Opium and belladonna combination suppository: Glaucoma, severe renal or hepatic disease, bronchial asthma, respiratory depression, acute alcoholism, delirium tremens, premature labor.^d

Warnings/Precautions

Warnings

Dependence and Abuse

Abuse potential exists; use with caution.^d ^g ^h

Does not produce analgesia or euphoria in usual oral antidiarrheal doses; therefore, opium preparations may be used in the treatment of acute diarrhea with little risk of development of physical dependence in the patient.^b However, prolonged use of opium preparations (e.g., patients with ileitis or colitis) may produce physical dependence.^b ^g

Use with caution in patients with a history of opiate agonist dependence.^b

Mild withdrawal symptoms reported in patients receiving paregoric 10 mg every 4 hours for 1–2 weeks.^g Provide supportive care in a hospital setting for patients in opiate withdrawal.^g

Concentrated Opium Solutions

Serious adverse events and deaths have occurred when opium tincture was mistakenly interchanged for paregoric (also known as “camphorated tincture of opium” and “tincture of paregoric”).^f These medication errors resulted in fatal adverse events because opium tincture is 25 times more concentrated than paregoric.^f FDA recommends a poison label for all containers of opium tincture stating the strength of morphine per mL and a statement such as “WARNING! Do NOT confuse opium tincture with paregoric.”^f

Possible Prescribing and Dispensing Errors

Ensure accuracy of prescription spelling; similarity in acronyms for diluted tincture of opium and deodorized tincture of opium (e.g., DTO), which contains 25 times more opium.^e May result in fatal errors.^e

It is important that prescriptions for opium preparations be written clearly and filled with the proper concentration to prevent potential medication errors.^e

General Precautions

Head Injury and Increased Intracranial Pressure

Respiratory depressant effects (with CO₂ retention and secondary elevation of CSF pressure) may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure.^g ^h

May produce effects that obscure the clinical course in patients with head injuries.^g

Use with extreme caution, if at all, in patients with a head injury, brain tumor, or elevated CSF pressure.^c

Hypotensive Effects

Like all opiate analgesics, may cause severe hypotension in the postoperative patient or any individual whose ability to maintain their BP is compromised by a depleted blood volume or concomitant drugs (e.g., phenothiazines, general anesthetics).^c ^g

May produce orthostatic hypotension in ambulatory patients.^c Lightheadedness and dizziness appear to be more prominent in ambulatory patients; may be alleviated if the patient lies down.^g

Respiratory Effects

Respiratory depression requiring administration of naloxone or ventilatory support may result from toxic dosages.^d ^g

May decrease respiratory drive to the point of apnea while simultaneously increasing airway resistance, even at usual therapeutic doses.^g Use with extreme caution in patients with disorders characterized by hypoxia.^g

Use with caution in patients with asthma or emphysema.^b ^c

Acute Abdominal Conditions

Administration may complicate assessment of patients with acute abdominal conditions.^g

Reduce the initial dosage in patients who have undergone GI surgery.^c Use with caution in patients with GI hemorrhage.^h

CNS Effects

May impair mental and/or physical abilities needed to perform potentially hazardous activities such as driving or operating machinery.^c ^g Individuals who perform hazardous tasks requiring mental alertness or physical coordination should be warned about possible adverse CNS effects of opiate agonists.^c ^g

May aggravate preexisting seizures in patients with convulsive disorders.^c ^g Risk of seizures in patients without a history of seizure disorders at dosages above recommended levels.^g

Prostatic Hypertrophy or Urethral Stricture

Use with caution in patients with severe prostatic hypertrophy or urethral stricture.^b ^d ^g

Hypothyroidism and Myxedema

Use with caution and reduce the initial dosage in patients with hypothyroidism.^c ^g

Use with caution in patients with untreated myxedema.^c ^h

Addison’s Disease

Use with caution and reduce the initial dosage in patients with Addison’s disease.^c ^g

Cardiac Arrhythmia

May increase ventricular response rate through a vagolytic action; use with caution in patients with atrial flutter or other supraventricular tachycardias.^c ^g

Cerebral Arteriosclerosis.

Use with caution in patients with cerebral arteriosclerosis.^h

Fixed-Combination Preparations

Consider the cautions, precautions, and contraindications associated with other drug(s) in fixed-combination preparations.^a ^d ^h

Specific Populations

Pregnancy

Category C.^d ^g ^h

Lactation

Morphine is distributed into milk.^g Use with caution in nursing women.^d ^g ^h

Pediatric Use

Manufacturer does not recommend use of opium rectal suppositories in children ≤12 years of age.^d

Manufacturer does not recommend use of opium tincture in children;^h however, diluted opium tincture has been used to treat opiate withdrawal† symptoms in neonates† born to women addicted to opiates.^a ^c

Geriatric Use

Use with caution in geriatric patients.^d ^g

Hepatic Impairment

Use with caution in patients with severe hepatic impairment.^d ^g

Renal Impairment

Use with caution in patients with severe renal impairment.^d ^g

Common Adverse Effects

Opium tincture and fixed-combination suppositories: Constipation,^d ^h nausea,^d ^h vomiting.^d ^h

Paregoric: Lightheadedness,^g dizziness,^g sedation,^g nausea,^g vomiting.^g

Interactions for Opium

Specific Drugs

Drug	Interaction	Comments
CNS depressants (other opiates, general anesthetics, tranquilizers, sedatives, hypnotics, alcohol)	May potentiate the effects of other CNS depressants^c ^g	Use concomitantly with great caution and in reduced dosage^a ^c ^g ^h Some tranquilizers, especially phenothiazines, may antagonize opiate agonist analgesia^c
Diuretics	Opiate agonists may decrease the effects of diuretics in patients with CHF^c
Opiate partial agonists (butorphanol, nalbuphine, pentazocine)	Possible reduced analgesic effect and/or withdrawal symptoms	Avoid concomitant use
Skeletal muscle relaxants	May enhance the neuromuscular blocking action of skeletal muscle relaxants^c

Opium Pharmacokinetics

Absorption

Bioavailability

Following oral administration, morphine is variably absorbed from the GI tract.^a ^b ^h

Onset

Following rectal administration, analgesia occurs in 15–30 minutes.^a

Duration

Following rectal administration, analgesia is maintained for 3–5 hours.^a

Elimination

Metabolism

Metabolized principally in the liver and undergoes conjugation with glucuronic acid.^a ^b ^c ^h

Secondary conjugation may also occur to form 3,6-diglucuronide.^a ^b ^h

Elimination Route

Excreted principally in urine as metabolites and to a lesser extent as unchanged drug.^a ^b ^h

Approximately 75% of morphine excreted in the urine within 48 hours.^a ^b ^h

Stability

Storage

Oral

Solution

Paregoric: Tight, light-resistant containers at 15–30°C.^b ^g A sediment may form if exposed to low temperatures; filter if necessary.^g Avoid exposure to direct sunlight and to excessive heat.^b

Opium tincture: Tight, light-resistant containers at 15–30° C.^b ^h Avoid exposure to direct sunlight and to excessive heat.^b

Rectal

Suppositories

Room temperature.^d Do not refrigerate.^d Protect from moisture.^d

ActionsActions

Analgesic activity results primarily from the morphine content of opium preparations.^a ^d ^h

Increases smooth muscle tone in the longitudinal muscle of the GI tract, inhibits GI motility and propulsive contraction, and diminishes digestive secretions.^b ^h

Relatively small doses of opium are effective in controlling diarrhea, but do not produce substantial analgesia.^a ^b ^h

Papaverine content of the mixed alkaloids is too small to have demonstrable smooth muscle relaxant activity.^a ^b ^h

Advice to Patients

Importance of informing patients that drug may impair mental and/or physical ability required for performance of potentially hazardous tasks.^c ^g

Importance of informing patients that opium preparations should not be combined with alcohol or other CNS depressants (e.g., sleep medications, tranquilizers).^g ^h

Importance of informing patients that this is a drug of potential abuse.^d ^g ^h

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^g

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^g ^h

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Opium preparations are subject to control under the Federal Controlled Substances Act of 1970 as schedule II (C-II) drugs, but as schedule III (C-III) drugs when they contain ≤25 mg of opium per 5 mL, 5 g, or dosage unit in fixed combination with a therapeutic amount of one or more nonopiate drugs or as schedule V (C-V) drugs when they contain 1 mg or less of opium per mL or g in combination with one or more active nonopiate medicinal ingredients in sufficient proportion to confer on the preparation medicinal qualities not possessed by opium.^a ^b

Powdered Opium
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Powdered Opium Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Rectal	Suppositories	30 mg with Belladonna Extract 16.2 mg (equivalent to belladonna alkaloids 0.21 mg)*	B&O Supprettes No. 15A (C-II)	Amerifit
		60 mg with Belladonna Extract 16.2 mg (equivalent to belladonna alkaloids 0.21 mg)*	B&O Supprettes No. 16A (C-II)	Amerifit

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Opium Tincture (Deodorized Opium Tincture, Laudanum)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tincture	50 mg (of morphine anhydrous) per 5 mL*	Opium Tincture Deodorized (C-II)	Marathon

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Paregoric (Camphorated Opium Tincture)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tincture*	2 mg (of morphine anhydrous) per 5 mL*	Paregoric (C-III)

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

a. AHFS Drug Information 2007. McEvoy GK, ed. Opium. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2152.

b. AHFS Drug Information 2007. McEvoy GK, ed. Opium Preparations. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2917-8.

c. AHFS Drug Information 2007. McEvoy GK, ed. Opiate Agonists General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2123-28.

d. Paddock Laboratories. Belladonna & opium rectal suppositories prescribing information. Minneapolis, MN; Undated.

e. Food and Drug Administration. Drug Errors Caused by Abbreviations. FDA Patient Safety News: Show #15. FDA Patient Safety News May 2003. From FDA web site .

f. Food and Drug Administration. Dangerous Mixups Between Opium Tincture and Paregoric. FDA Patient Safety News: Show #27, May 2004. From FDA web site.

g. Actavis. Paregoric (camphorated opium tincture) [Morphine anhydrous (opium 2 mg)] prescribing information. Baltimore, MD; 2006 Feb.

h. Ranbaxy. Opium tincture (deodorized) prescribing information. Jacksonville, FL; 2004 Dec.

i. Code of federal regulations. Part 1304.31. Reports from manufacturers importing narcotic raw material. Revised as of April 1, 2006.

More Opium resources

Opium Side Effects (in more detail)
Opium Use in Pregnancy & Breastfeeding
Opium Drug Interactions
Opium Support Group
7 Reviews for Opium - Add your own review/rating

Opium Tincture MedFacts Consumer Leaflet (Wolters Kluwer)

opium Advanced Consumer (Micromedex) - Includes Dosage Information

Opium Deodorized Concise Consumer Information (Cerner Multum)

Paregoric MedFacts Consumer Leaflet (Wolters Kluwer)

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