Activated carbon

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Activated carbon FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Activated carbon in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Activated carbon in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Actidose® with Sorbitol is not recommended in children less than one year of age.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Activated carbon in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Activated carbon in pediatric patients.

Contraindications

There are no known absolute contraindications to the use of activated charcoal, however, it is not an equally effective adsorbent for all toxins. It should be used with caution, if at all, in patients who have ingested corrosive agents since the activated charcoal may obscure endoscopic visualization of esophageal and gastric lesions produced by the corrosive. The use of a cathartic with activated charcoal may not be advised if a patient has significant fluid or electrolyte abnormalities. Actidose® with Sorbitol should not be used in infants due to the possibility of excessive catharsis. Young children should not receive cathartic doses of sorbitol unless hospitalized and under the immediate care of a physician.

Warnings

If patient has been given ipecac syrup, DO NOT give ACTIDOSE® WITH SORBITOL or ACTIDOSE®-AQUA until after last vomiting episode. Do not use in persons who are not fully conscious. Do not use this product unless directed by a health professional, if turpentine, corrosives, such as alkalies (lye) and strong acids, or petroleum distillates, such as kerosene, gasoline, paint thinner, cleaning fluid or furniture polish, have been ingested. This product is not recommended for use in children weighing less than 32 kg, or during multiple dose activated charcoal therapy since excessive catharsis and significant fluid and electrolyte abnormalities may occur.

Keep this and all drugs out of the reach of children.

Do not use Actidose® with Sorbitol or Actidose®-Aqua in any person known to have a rare autosomal recessive genetic intolerance to fructose. Do not use Actidose® with Sorbitol in patients who are dehydrated. Actidose® with Sorbitol may cause excessive diarrhea.

Precautions

Actidose® with Sorbitol and Actidose®-Aqua should be used in a supervised medical facility or under the direction of a physician or poison control center.

Actidose® with Sorbitol and Actidose®-Aqua are adjuncts in the management of poisoning emergencies. Prior to the use of activated charcoal, proper basic life support measures must be implemented as well as the appropriate gastric emptying technique if indicated.

When Actidose® with Sorbitol or Actidose®-Aqua are used to treat a poisoning emergency, the patient and health care providers should be aware that activated charcoal will produce black stools. These stools may be diarrhetic and may persist for several hours.

Actidose® with Sorbitol may produce a profound cathartic effect and proper attention should be given to the patient’s fluid and electrolyte needs. Actidose® with Sorbitol should be used cautiously in patients receiving multiple dose activated charcoal. If Actidose® with Sorbitol is used at each dosage interval, profound catharsis may develop which could result in dehydration, hypotension and significant electrolyte and fluid abnormalities.

A study conducted in healthy adult human volunteers who ingested therapeutic amounts of activated charcoal and sorbitol resulted in severe prolonged diarrhea, but no significant changes were noted in serum electrolytes or osmolality, BUN, or the metabolic profile as compared to the control.8

Gastrointestinal obstruction from activated charcoal may occur as a consequence of toxin-induced antiperistaltic effects. Actidose® with Sorbitol and Actidose®-Aqua should be used cautiously in patients who have been exposed to toxins which interfere with gastrointestinal tract peristalsis (i.e., anticholinergics, opioids, etc.). Bowel sounds should be frequently monitored to assess peristaltic action, especially in patients undergoing multiple dose activated charcoal therapy.

Adverse Reactions

Clinical Trials Experience

Activated charcoal with sorbitol has produced severe hypernatremic dehydration when used in excessive amounts in pediatric patients.25, 27

Aspiration of activated charcoal has been reported to produce airway obstruction and a limited number of fatalities have occurred. 28,29,30,31 Bronchiolitis obliterans resulting in death has developed several weeks after the aspiration of activated charcoal.32

Gastrointestinal obstruction associated with the use of multiple dose activated charcoal therapy has been reported.33 An overdose of carbamazepine was responsible for the antiperistaltic effects which led to bowel obstruction.

Postmarketing Experience

There is limited information regarding Activated carbon Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Activated carbon Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Safe use during pregnancy and lactation has not been established. Actidose® with Sorbitol and Actidose®-Aqua should be used during pregnancy or lactation only if the potential benefit justifies the potential risk. No teratogenic effects have been noted in rabbits or rats.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Activated carbon in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Activated carbon during labor and delivery.

Nursing Mothers

Actidose® should be used during pregnancy or lactation only if the potential benefit justifies the potential risk.

Pediatric Use

Actidose® with Sorbitol is not recommended in children less than one year of age.

Geriatic Use

There is no FDA guidance on the use of Activated carbon in geriatric settings.

Gender

There is no FDA guidance on the use of Activated carbon with respect to specific gender populations.

Race

There is no FDA guidance on the use of Activated carbon with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Activated carbon in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Activated carbon in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Activated carbon in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Activated carbon in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral.

Monitoring

Monitor bowl sounds frequently to assess the

IV Compatibility

There is limited information regarding the compatibility of Activated carbon and IV administrations.

Overdosage

There is limited information regarding Activated carbon overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Activated carbon Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Activated carbon Mechanism of Action in the drug label.

Structure

There is limited information regarding Activated carbon Structure in the drug label.

Pharmacodynamics

There is limited information regarding Activated carbon Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Activated carbon Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Activated carbon Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Activated carbon Clinical Studies in the drug label.

How Supplied

There is limited information regarding Activated carbon How Supplied in the drug label.

Storage

There is limited information regarding Activated carbon Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Activated carbon Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Activated carbon interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Activated carbon Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Activated carbon Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.