OPIUMPREPARATIONS (Systemic)

Other commonly used names are camphoratedopium tincture and laudanum.

Category

• Antidiarrheal
• Suppressant,narcotic abstinence syndrome

Description

Opium preparations are used along with othermeasures to treat severe diarrhea. These medicines belong to the group ofmedicines called narcotics. If too much of a narcotic is taken, it may becomehabit-forming, causing mental or physical dependence. Physical dependencemay lead to withdrawal side effects when you stop taking the medicine.

Opium preparations are available only with your doctor's prescription,in the following dosage forms:

Oral
• Opium Tincture
  • Oral liquid (U.S. and Canada)
• Paregoric
  • Oral liquid (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For opium preparations,the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to morphine, codeine, or papaverine. Also tell your healthcare professional if you are allergic to any other substances, such as foods,preservatives, or dyes.

Pregnancy?Opium preparations have not been studied in pregnantwomen. However, morphine (contained in these medicines) has caused birth defectsin animals when given in very large doses.

Regular use of opium preparations during pregnancy may cause the fetusto become dependent on the medicine. This may lead to withdrawal side effectsin the newborn baby. Also, these medicines may cause breathing problems inthe newborn baby, especially if they are taken just before delivery.

Breast-feeding?Opium preparations have not been reported to causeproblems in nursing babies.

Children?Breathing problems may be especially likely to occurin children up to 2 years of age, who are usually more sensitive than adultsto the effects of opium preparations.

Older adults?Breathing problems may be especially likely to occurin elderly patients, who are usually more sensitive than younger adults tothe effects of opium preparations.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingan opium preparation, it is especially important that your health care professionalknow if you are taking any of the following:

• Anticholinergics (medicine for abdominal or stomach spasms or cramps)or
• Central nervous system (CNS) depressants, especially other narcotics,or
• Other diarrhea medicine or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine[e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane],doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g.,Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])?Thechance of side effects is increased

• Naltrexone (e.g., Trexan)?Naltrexone blocks the effects ofopium preparations and makes them less effective in treating diarrhea

Other medical problems?The presence of other medicalproblems may affect the use of opium preparations. Make sure you tell yourdoctor if you have any other medical problems, especially:

• Alcohol or other drug abuse (or history of) or
• Colitis or
• Heart disease or
• Kidney disease or
• Liver disease or
• Underactive thyroid?The chance of side effects may be increased

• Brain disease or head injury or
• Emphysema, asthma, bronchitis, or other chronic lung disease or
• Enlarged prostate or problems with urination or
• Gallbladder disease or gallstones?Some of the side effectsof opium preparations can be dangerous if these conditions are present

• Convulsions (seizures), history of?Opium can rarely cause convulsions

Proper Use of This Medicine

This medicineis to be taken by mouth even if it comes in a dropper bottle. The amount youshould take is to be measured with the special dropper provided with yourprescription and diluted with water just before you take each dose. This willcause the medicine to turn milky in color, but it will still work.

If your prescription does not come in a dropper bottle and the directionson the bottle say to take it by the teaspoonful, it is not necessary to diluteit before using.

If this medicine upsets your stomach, your doctor may want you to takeit with food.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not takeit for a longer time than your doctor ordered. This is especially importantfor young children and for elderly patients, who are especially sensitiveto the effects of opium preparations. If too much is taken, this medicinemay become habit-forming (causing mental or physical dependence) or lead toproblems because of an overdose.

Dosing?The dose of these medicines will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of these medicines. If your dose isdifferent, do not change it unless your doctor tells you to do so.

For opium tincture (laudanum)
• For oral liquid dosage form (drops):
  • For diarrhea:
    • Adults?5 to 16 drops of liquid, measured with the dropper inthe bottle and mixed with a little water, four times a day until diarrheais controlled.
    • Children?Dose must be determined by your doctor.

For paregoric
• For oral liquid dosage form:
  • For diarrhea:
    • Adults?1 or 2 teaspoonfuls one to four times a day until diarrheais controlled. Use a measuring spoon to measure the dose. An ordinary householdteaspoon that is used at the table may not hold the right amount of medicine.
    • Children 2 years of age and older?0.25 to 0.5 milliliters (mL)(4 to 8 drops), mixed with a little water, one to four times a day until diarrheais controlled. This amount of medicine must be measured with a dropper ora special measuring device that can be used for very small amounts of liquid.If you did not receive a dropper or measuring device with the medicine, checkwith your pharmacist.

Missed dose?If you miss a dose of this medicine, take it assoon as you remember. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children. Overdose is very dangerous inyoung children.
• Store away from heat and direct light.
• Keep the container for this medicine tightly closed to prevent thealcohol from evaporating and the medicine from becoming stronger.
• Do not store this medicine in the refrigerator or allow the medicineto freeze. If it does get cold and you notice any solid particles in it, throwit away.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your doctor if your diarrhea does not stop after1 or 2 days or if you develop a fever.

This medicine will add to the effects of alcohol and other CNS depressants(medicines that slow down the nervous system, possibly causing drowsiness).Some examples of CNS depressants are antihistamines or medicine for hay fever,other allergies, or colds; sedatives, tranquilizers, or sleeping medicine;prescription pain medicine or other narcotics; barbiturates; medicine forseizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with yourdoctor before taking any of the medicines listed above, while you are takingthis medicine.

This medicine may cause some people to become drowsy, dizzy, lightheaded,or less alert than they are normally. Even if taken at bedtime, it may causesome people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines,or do anything else that could be dangerous if you are dizzy or are not alert.

Dizziness, lightheadedness, or fainting may be especially likely to occurwhen you get up suddenly from a lying or sitting position. Getting up slowlymay help lessen this problem. If you feel very dizzy, lightheaded, or faintafter taking this medicine, lying down for a while may help.

If you have been taking this medicine regularly for several weeks or more, do not stop using it without first checking with yourdoctor. Your doctor may want you to reduce gradually the amount youare using before stopping completely, to lessen the chance of withdrawal sideeffects.

If you think you or someone else may have taken anoverdose, get emergency help at once. Taking an overdose of this medicineor taking alcohol or other CNS depressants with this medicine may lead tounconsciousness and possibly death. Signs of overdose include convulsions(seizures), confusion, severe nervousness or restlessness, severe dizziness,severe drowsiness, slow or irregular breathing, and severe weakness.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Get emergency help immediatelyif any of the following symptoms of overdose occur:

Cold, clammy skin; confusion; convulsions (seizures); dizziness (severe); drowsiness (severe); low blood pressure; nervousness or restlessness (severe); pinpoint pupils of eyes; slow heartbeat; slow or irregular breathing; weakness (severe)

Also, check with your doctor immediately if any of the following side effects are severe and occur suddenlysince they may indicate a more severe and dangerous problem with your bowels:

Rare

Bloating; constipation; loss of appetite; nausea or vomiting; stomach cramps or pain

In addition, check with yourdoctor as soon as possible if any of the following side effects occur:

Rare

Fast heartbeat; increased sweating; mental depression; redness or flushingof face; shortness of breath, wheezing, or troubledbreathing; skin rash, hives, or itching; slow heartbeat

Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. However, check withyour doctor if any of the following side effects continue or are bothersome:

More common with large doses

Difficult or painful urination; dizziness,lightheadedness, or feeling faint; drowsiness; frequent urge to urinate; nervousnessor restlessness; unusual decrease in amount of urine; unusual tiredness or weakness

After you stop using thismedicine, your body may need time to adjust. The length of time this takesdepends on the amount of medicine you were using and how long you used it.During this period of time check with your doctor if you notice any of thefollowing side effects:

Body aches; diarrhea; fever, runny nose, or sneezing; gooseflesh; increased sweating; increased yawning; loss of appetite; nauseaor vomiting; nervousness, restlessness, or irritability; shivering or trembling; stomach cramps; trouble in sleeping; unusually large pupils of eyes; weakness(severe)

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.