Brand Names:

• Pantopon

Dosage Forms:

• Liquid
• Tincture

Uses of This Medicine:

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

Opium preparations are available only with your doctor's prescription.

Before Using This Medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Breathing problems may be especially likely to occur in children up to 2 years of age, who are usually more sensitive than adults to the effects of opium preparations.

Older adults

Breathing problems may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of opium preparations.

Pregnancy

Opium preparations have not been studied in pregnant women. However, morphine (contained in these medicines) has caused birth defects in animals when given in very large doses.

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

Breast-feeding

Opium preparations have not been reported to cause problems in nursing babies.

Other medicines

Using medicines in this class 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
• Codeine
• Fentanyl
• Hydrocodone
• Hydromorphone
• Levorphanol
• Meperidine
• Morphine
• Morphine Sulfate Liposome
• Opium
• Oxycodone
• Oxymorphone
• Propoxyphene
• Remifentanil
• Sufentanil

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 medicines in this class. Make sure you tell your doctor 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 effects of 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 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. This will cause the medicine to turn milky in color, but it will still work.

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

If this medicine upsets your stomach, your doctor may want you to take it 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 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.

Dosing

The dose medicines in this class 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 these medicines. 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 (drops):
  • For diarrhea:
    • Adults 5 to 16 drops of liquid, measured with the dropper in the bottle and mixed with a little water, four times a day until diarrhea is controlled.
    • Children Dose must be determined by your doctor.

• For oral dosage form (liquid):
  • For diarrhea:
    • Adults 1 or 2 teaspoonfuls one to four times a day until diarrhea is controlled. Use a measuring spoon to measure the dose. An ordinary household teaspoon 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 diarrhea is controlled. This amount of medicine must be measured with a dropper or a 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, check with your pharmacist.

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

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Keep the container for this medicine tightly closed to prevent the alcohol from evaporating and the medicine from becoming stronger.

Precautions While Using This Medicine:

Check with your doctor if your diarrhea does not stop after 1 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 for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are taking this 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 cause some 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 occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. If you feel very dizzy, lightheaded, or faint after 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 your doctor. Your doctor may want you to reduce gradually the amount you are using before stopping completely, to lessen the chance of withdrawal side effects.

If you think you or someone else may have taken an overdose, get emergency help at once. Taking an overdose of this medicine or taking alcohol or other CNS depressants with this medicine may lead to unconsciousness 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 may need medical attention.

Get emergency help immediately if 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 suddenly since 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

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Fast heartbeat

increased sweating

mental depression

redness or flushing of face

shortness of breath, wheezing, or troubled breathing

skin rash, hives, or itching

slow heartbeat

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:

More common with large doses

Difficult or painful urination

dizziness, lightheadedness, or feeling faint

drowsiness

frequent urge to urinate

nervousness or restlessness

unusual decrease in amount of urine

unusual tiredness or weakness

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends 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 the following side effects

Body aches

diarrhea

fever, runny nose, or sneezing

gooseflesh

increased sweating

increased yawning

nausea or 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 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.