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Opium (Oral route)

Pronunciation:

OH-pee-um

Brand Names:

  • Pantopon

Dosage Forms:

  • Tincture

Classifications:

Therapeutic—

Analgesic

Chemical—

Opium (class)

Uses of This Medicine:

Opium tincture is used to treat diarrhea. This medicine belongs to the group of medicines called narcotics.

When a narcotic is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of opium tincture in the pediatric population. Use in children is not recommended.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of opium tincture in the elderly. However, elderly patients are more likely to have age-related liver, lung, or breathing problems which may require caution for patients receiving opium tincture.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Anileridine
  • Carbinoxamine
  • Codeine
  • Fentanyl
  • Hydrocodone
  • Hydromorphone
  • Levorphanol
  • Meclizine
  • Meperidine
  • Morphine
  • Morphine Sulfate Liposome
  • Opium
  • Oxycodone
  • Oxymorphone
  • Propoxyphene
  • Remifentanil
  • Sufentanil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Perampanel

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, history of or
  • Brain disease (e.g., cerebral arteriosclerosis) or
  • Breathing problems (e.g., asthma, emphysema) or
  • Drug dependence, especially narcotic abuse or dependence, or history of or
  • Head injuries or
  • Increased pressure in your head or
  • Liver disease (e.g., cirrhosis) or
  • Stomach or bowel bleeding or
  • Underactive thyroid—Use with caution. May increase risk for more serious side effects.
  • Diarrhea caused by poisoning—Should not be used in patients with this condition.

Proper Use of This Medicine:

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

This medicine is to be taken by mouth even if it comes in a dropper bottle. The amount you should take is to be measured with the special dropper provided with your prescription and diluted with water just before you take each dose.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tincture):
    • For diarrhea:
      • Adults—0.6 milliliters (mL) four times a day.
      • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the bottle tightly closed after use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

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 may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
Difficulty having a bowel movement (stool)
hives or welts
nausea
vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
Anxiety
blurred vision
blue lips and fingernails
chest pain or discomfort
chills
cold sweats
coma
confusion
constricted, pinpoint, or small pupils (black part of eye)
cool, clammy skin
coughing that sometimes produces a pink frothy sputum
depression
difficult, fast, or noisy breathing, sometimes with wheezing
difficult or troubled breathing
difficulty sleeping
disorientation
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
drowsiness to profound coma
fast heartbeat
hallucination
headache
increased hunger
increased sweating
irregular, fast or slow, or shallow breathing
lethargy
lightheadedness
mood or other mental changes
nervousness
nightmares
no blood pressure or pulse
no muscle tone or movement
not breathing
pale or blue lips, fingernails, or skin
seizures
shakiness
shortness of breath
slow or irregular heartbeat
slurred speech
stopping of heart
swelling in legs and ankles
unconsciousness
unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
Itching skin
redness of skin
skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 4/4/2014

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