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|Donnagel-PG

KAOLIN, PECTIN, AND PAREGORIC (Systemic)*

Some commonly used brand names are:

In Canada—

• Donnagel-PG

* Not commercially available in the U.S.

Category

• Antidiarrheal, adsorbent

Description

Kaolin, pectin, and paregoric (KAY-oh-lin, PEK-tin, and par-e-GOR-ik) combination medicine is used to treat diarrhea. However, it has generally been replaced by safer medicines for the treatment of diarrhea.

Kaolin, pectin, and paregoric combination medicine is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Oral suspension (Canada)

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 kaolin, pectin, and paregoric combination medicine, the following should be considered:

Allergies—Tell your doctor if you have ever had an unusual or allergic reaction to paregoric or any other narcotic medicine. Also, tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—This medicine has not been shown to cause birth defects or other problems in humans. However, too much use of opium preparations such as paregoric (contained in this combination medicine) late in pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth.

Breast-feeding—Although the paregoric in this medicine passes into breast milk, it has not been reported to cause problems in nursing babies.

Children—Children are especially sensitive to the effects of paregoric (contained in this combination medicine). This may increase the chance of side effects during treatment. Also, the fluid loss caused by the diarrhea may result in a severe condition (dehydration), which may be hidden by this medicine. For this reason, antidiarrheals must not be given to young children without first checking with their doctor. In older children with diarrhea, antidiarrheals may be used, but it is also very important that a sufficient amount of liquids be given to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Older adults—Elderly people are especially sensitive to the effects of paregoric (contained in this combination medicine). This may increase the chance of side effects during treatment. Also, the fluid loss caused by the diarrhea may result in a severe condition (dehydration), which may be hidden by this medicine. For this reason, elderly persons should not take this medicine without first checking with their doctor. It is also very important that a sufficient amount of liquids be taken to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

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 health care professional know if you are taking any of the following:

• Central nervous system (CNS) depressants—Effects of CNS depressants or of paregoric, such as drowsiness, may become greater

• Naloxone (e.g., Narcan) or
• Naltrexone (e.g., ReVia)—These medicines block the effect of paregoric and make it less effective in treating diarrhea

• Other diarrhea medicine—The chance of severe constipation may be increased

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 or drug abuse or dependence (history of)—There is a greater chance that this medicine may become habit-forming

• 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 or
• Heart disease or
• Irregular heartbeat or
• Overflow incontinence or
• Seizures (convulsions) (history of)—The paregoric contained in this medicine may make these conditions worse

• Colitis or other intestinal disease—A more serious condition may develop with the use of this medicine

• Diarrhea caused by antibiotics—This medicine may make the diarrhea caused by antibiotics worse or make it last longer

• Dysentery—This condition may get worse; a different kind of treatment may be needed

• Kidney disease or
• Liver disease—In patients with kidney or liver disease, paregoric may build up in the body; smaller doses of this medicine may be needed

• Underactive thyroid—This medicine may cause central nervous system (CNS) depression and breathing problems in patients with this condition

Proper Use of This Medicine

If this medicine upsets your stomach, you may take it with food.

Take this medicine only as directed on the label or as ordered by your doctor . Do not take more of it, do not take it more often, and do not take it for a long time. If too much is taken, it may become habit-forming.

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Importance of diet and fluid intake while treating diarrhea :

• In addition to using medicine for diarrhea, it is very important that you replace the fluid lost by the body and follow a proper diet . For the first 24 hours you should eat gelatin and drink plenty of clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, and broth. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, and caffeine and alcoholic beverages may make the condition worse.
• If too much fluid has been lost by the body due to the diarrhea a serious condition (dehydration) may develop. This condition may be hidden by use of this medicine. Check with your doctor as soon as possible if any of the following signs of too much fluid loss occur:
  • Decreased urination
  • Dizziness and lightheadedness
  • Dryness of mouth
  • Increased thirst
  • Wrinkled skin

Dosing—The dose of kaolin, pectin, and paregoric combination 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 kaolin, pectin, and paregoric combination medicine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (suspension):
  • For diarrhea:
    • Adults and teenagers—The usual dose is 2 tablespoonfuls (30 milliliters [mL]) after each loose bowel movement. No more than 4 doses should be taken in twelve hours.
    • Children 2 years of age and over weighing 13.5 kilograms (kg) (29.7 pounds) or more—The usual dose is 1 to 2 teaspoonfuls (5 to 10 mL) after each loose bowel movement. No more than 4 doses should be taken in twelve hours.
    • Children 2 years of age and over weighing 9 to 13.5 kg (19.8 to 29.7 pounds)—The usual dose is 1 teaspoonful (5 mL) after each loose bowel movement. No more than 4 doses should be taken in twelve hours.
    • Children 2 years of age and over weighing 4.5 to 9 kg (9.9 to 19.8 pounds)—The usual dose is 1/2 teaspoonful (2.5 mL) after each loose bowel movement. No more than 4 doses should be taken in twelve hours.
    • Children 2 years of age and over weighing less than 4.5 kg (9.9 pounds)—Dose must be determined by your doctor.
    • Children up to 2 years of age—Use is not recommended.

Storage—To store this medicine:

• Keep out of the reach of children since overdose is especially dangerous in children.
• Store away from heat and direct light.
• Do not store this medicine in the refrigerator. If it does get cold and you notice any solid particles in it, throw it away.
• Keep this medicine from freezing.
• Keep the container for this medicine tightly closed to prevent the alcohol from evaporating and the medicine from becoming stronger.
• Do not keep outdated medicine or medicine no longer needed. Be sure that 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 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 make you drowsy or less alert). 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 narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine .

This medicine may cause some people to become dizzy, drowsy, 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 .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects appear very often, when they do occur they may require medical attention.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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

Revised: 04/26/1995

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