Insta-Char

Charcoal is used to treat stomach pain caused by excess gas, diarrhea, or indigestion.

Charcoal also is used to relieve itching related to kidney dialysis treatment and to treat poisoning or drug overdose.

Charcoal may also be used for other purposes not listed in this medication guide.

You should not use this medication if you have ever had an allergic reaction to charcoal.

Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease, or any type of serious illness.

In a poisoning or overdose situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

If you are taking charcoal at home to treat diarrhea, stop taking it and call your doctor if your diarrhea lasts longer than 2 days or you also have a fever.

Do not take charcoal with any other medicine. Take your dose of charcoal at least 2 hours before or 1 hour after a dose of any other medicine. Charcoal binds to other drugs and can make them less effective, which could become dangerous.

You should not use this medication if you have ever had an allergic reaction to charcoal.

If possible, before you receive charcoal, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;

• kidney disease; or

• any type of serious illness.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

It is not known whether charcoal is harmful to an unborn baby. Before you take charcoal, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether charcoal passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

In a poisoning or overdose situation, it may not be possible to tell your caregivers that you are pregnant or breast-feeding before you are treated with charcoal. However, make sure any doctor caring for your pregnancy or your baby knows that you have received the medication.

Do not give this medication to a child younger than 1 year old without the advice of a doctor.

Since charcoal is often taken only when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Applies to charcoal: oral capsule

Other dosage forms:

• oral liquid

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dark stools.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to charcoal: compounding powder, oral capsule, oral delayed release tablet, oral granule for reconstitution, oral powder for reconstitution, oral suspension, oral tablet

Gastrointestinal

Gastrointestinal side effects have frequently included nausea and vomiting (13% to 30%) and constipation. Bowel obstruction, ileus, chalk like taste, perforation of the gastrointestinal tract and subsequent charcoal (the active ingredient contained in Insta-Char) peritoneum, and black colored stools have also been reported.[Ref]

A young woman developed a surgically acute abdomen following orogastric lavage and charcoal administration. Laparotomy revealed charcoal throughout the peritoneum. Complications included peritonitis, adhesions, abscess formation, persistent peritoneal charcoal deposits, oophorectomy, and small bowel resection.

A case report has described charcoal bezoar and small bowel obstruction following administration of 30 to 60 g of activated charcoal via nasogastric tube every 4 to 6 hours for 5 days.

In a study of 275 patients, 18 years old or younger, 20.4% (56/275) experienced vomiting within < 1 to 120 minutes (mean of 10 minutes) following enteral administration of 1 g/kg (no more than 50 g) of activated charcoal for acute poison ingestion. The following risk factors for vomiting were identified: nausea, a vomiting occurrence prior to charcoal ingestion, presence of signs or symptoms of poisoning (exclusive of nausea &/or vomiting), age greater than 12 years, administration by nasogastric or orogastric tube, and ingestion of emetogenic drug or chemical.

Bowel obstruction and ileus have occurred with multiple-dose administration.

Although charcoal is tasteless, it adheres to the surfaces of the mouth and tongue, producing a chalk like taste that can be unpalatable.[Ref]

Metabolic

Metabolic side effects have included hypernatremia, hypermagnesemia. electrolyte abnormalities, dehydration, and shock.[Ref]

Metabolic side effects occur primarily when sorbitol is combined with charcoal. Multiple-dose activated charcoal has been associated with hypernatremia and hypermagnesemia.[Ref]

Respiratory

Respiratory side effects have included bronchiolitis obliterans, empyema, and Adult Respiratory Distress Syndrome.[Ref]

Bronchiolitis obliterans and empyema have occurred due to charcoal aspiration following emesis.

Accidental administration of charcoal directly into the lungs has resulted in Adult Respiratory Distress Syndrome.[Ref]

Ocular

Ocular side effects have included corneal abrasions.[Ref]

Corneal abrasions may occur if charcoal comes in contact with eyes.[Ref]

Hematologic

Exacerbation of variegate porphyria may lead to increases in skin lesions, and urine and plasma porphyrins.[Ref]

Hematologic side effects have included exacerbation of variegate porphyria.[Ref]

Some side effects of Insta-Char may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.