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Acticlose Prescribing Information

Generical name: Activated charcoal
Dosage form: Oral suspension
Drug classes: Antidotes, miscellaneous GI agents

What is Acticlose?

Acticlose(r) using sorbitol Acticlose(r) with sorbitol is a ready-to-use activated carbonate suspension that contains sorbitol. It contains 25 grams or 50 grams of activated charcoal and 48 grams or 96 grams of sorbitol as an aqueous solution with the most unique preservative mechanism. Each millilitre has the equivalent of 208 mg (0.208 grammes) of activated carbon and 400 mg (0.400 grams) of sorbitol. Sorbitol eases the gritty feeling that activated charcoal causes, gives a pleasant taste that improves the compliance of patients, and typically results in a cathartic experience.

Acticlose(r)-Aqua is a ready-to-use activated charcoal suspension. It has 15 grams, 25 grams, or 50 grams of activated charcoal in an aqueous suspension that has an exclusive preservative method. Every milliliter contains 208 mg (0.208 grams) of activated carbon.

Warnings

If a patient has received ipecac syrup, do not use Acticlose(r) with sorbitol or Acticlose(r)-aqua until after the vomiting event. Don't use it on people who aren't completely conscious. Thinner, avoid using this product unless supervised by an experienced health care professional. Do not use if you are exposed to the presence of turpentine or corrosives such as alkalies (lye), as well as powerful acids or distillates of petroleum, including gasoline, kerosene cleaner fluid, paint thinner, or furniture polish. The product should not be used for children with a weight of fewer than 32 kilograms or during multidose-activated charcoal therapy because of the risk of excess catharsis and significant electrolyte and fluid abnormalities that could be observed.

Make sure that this drug and other drugs are kept out of the reach of young children.

Don't use Acticlose(r) together with sorbitol or Acticlose(r)-aqua in anyone who is known to suffer from a rare autosomal recessive genetic disorder that causes intolerance to fructose. Avoid using Acticlose (r) together with sorbitol when patients suffer from dehydration. Acticlose (r) together with sorbitol can create excessive diarrhoea.

Simethicone, aluminum hydroxide/magnesium oxide

dimethicone, Mylanta, politely, gas-x, gavilyte-g, and activated charcoal

The process of making activated charcoal involves the pyrolysis of organic matter like wood as well as an activation procedure that removes and breaks down the charcoal after exposure to the oxidizing gas compounds made up of oxygen, steam, and acids at extremely high temperatures, resulting in an increase in surface area due to the formation of numerous internal and external pores. The pores function as reservoirs for adsorbing compounds that are admixed with activated charcoal, which makes it an effective adsorbent of certain toxic substances.

It is chemically inert and does not absorb into the digestive tract. It is able to adsorb many organic and inorganic compounds and is most efficient in the adsorption of compounds that have a molecular weight between 100 and 1,000 daltons (amus). 1 A variety of other physiological and physicochemical variables affect the capacity to absorb substances from activated charcoal, including pH, the charcoal-to-drug percentage, the contents of the stomach, and the adsorption kinetics.

The majority of research that investigated the capacity for adsorptive activity in activated charcoal was done in vitro. The majority of studies could be in error since the physiologic effects on pH weren't considered or maintained at a constant level. In research models used to mimic the gastric environment, certain toxins weren't absorbed by activated carbon. The results were interpreted to imply that activated carbon was unable to adsorb the toxins, thus proving useless for treating this sort of incident. The study failed to recognize that the elevated pH in the small intestine is an environment that is receptive to the absorption of the poison through activated charcoal. The use of activated charcoal can effectively absorb neutral, acidic, and alkaline compounds (not suggesting the use of activated charcoal for poisonings triggered by corrosive agents). The degree of adsorption will depend on the solubility of the substance at the pH that is specified.

The most effective dosage ratio of activated charcoal to toxin. There are many factors that contribute to and inhibit the ability of an adsorptive agent. Therefore, this ratio might not be appropriate in a medical setting. In addition, a major use of activated carbon is in adults who've deliberately consumed a toxin in order to achieve the purpose of suicide or substance abuse. They may not be able to divulge information about the substance or quantity consumed and may also have a diminished degree of awareness. In these circumstances, it can be difficult to identify the exact amount of time consumed, which makes it difficult to employ the ratio 10:1. It is also not practical when huge doses of toxin are taken in (i.e., in the case of an overdose of 50 grams of aspirin, you could need 500 grams.

The gastric contents can also interfere with the toxins ingested and hinder their absorption into activated charcoal. In the event that activated charcoal needs to be given to patients who are known to have consumed the equivalent of a substantial meal in close proximity to the time the treatment is scheduled, then a greater dose of activated carbon may be recommended.

In the right physiologic environment, activated charcoal absorbs toxic substances instantly. The process of adsorptive absorption is reversible, and the equilibrium between bound and free toxins can be observed. Based on the laws of mass effect, the quantity of free toxins diminishes when the amount of activated carbon increases. Thus, high doses of activated carbon may help to improve an equilibrium that favors increased toxin adsorption as well as efficiency. It is not clear whether the desorption of a toxic substance from activated charcoal might occur. Thus, there's an opportunity for readsorption of the toxin as well as increased toxicity. The standard treatment is administering a cathartic using only a single dose of activated carbon to speed up the removal of the complex toxin or activated charcoal out of the digestive tract. cathartics are to be utilized cautiously during activated charcoal therapy, which involves multiple doses, and it is not suggested to use a cathartic for every amount of activated charcoal. 

Before taking this drug

Adsorption of a toxin through activated charcoal is possible anywhere within the digestive tract. But, in order to utilize Acticlose(r) together with sorbitol or Acticlose(r)-aqua to the maximum extent, it's essential to give it as quickly as you can to the sufferer of an exposure. The longer it takes between the ingestion of the toxin and the administration of activated charcoal, the more ineffective it is. When syrup of ipecac is employed to induce emesis, administering Acticlose(r) using sorbitol or Acticlose(r)-aqua will usually be delayed by 30–60 minutes after the end of an emesis. In a study that used ipecac syrup, 60 ml of activated charcoal was not able to hinder the effect of the emesis of the syrup ipecac.23

When gastric lavage is employed to assist in the stomach's evacuation, one dose of activated charcoal may be administered during the initial stage of gastric drainage. If this is the case, Acticlose (r)-aqua, which does include sorbitol, should not be utilized. Following the completion of gastric lavage, Acticlose (r) is infused with sorbitol and is able to be administered via the tube for lavage. The one drawback with the activation of charcoal in this manner is that gastric lavage's returns will turn dark, making it difficult to assess the amount of food consumed via visual examination. One of the main advantages of this method is that activated charcoal may be given early to patients. Its convenient packaging includes Acticlose(r) together with sorbitol as well as Acticlose(r)-aqua (except for the size of 15 g/72 ml) inside the form of a squeeze bottle fitted with the nozzle tapered to speed up emergencies, with the ability to attach to a tube for gastric drainage as well as administration of the contents.

The most frequent use of activated charcoal occurs in the context of acute exposure to toxic substances. Acticlose(r) together with sorbitol as well as Acticlose(r)-aqua may adsorb harmful substances, thus stopping the absorption. Activated charcoal may also be employed in certain hazardous situations when absorption is total or exposure takes place by the parenteral method. The procedure typically involves repeated or several doses of activated carbon.

Numerous doses of activated carbon can be effective in adsorbing toxic substances that go through the enterohepatic circulation. 13 substances that undergo biliary production, like digitoxin, for instance, are continuously secreted into the gastrointestinal tract and then reabsorbed, resulting in a prolonged toxic effect. Regular doses of activated carbon could help adsorb these toxins, which prevents their absorption, thereby improving their removal via the digestive tract.

The charcoal that is activated in multiple doses can also be employed in the process of gastrointestinal dialysis. There are some toxins that could be eliminated using this technique. Numerous doses of activated carbon adsorb the toxin, thereby stopping its absorption and increasing the gradient of concentration that allows the diffusion of more toxin in the stomach lumen. The compounds that are most effectively transferred through this process are lipophilic. They are non-charged and do not bind to proteins. Phenobarbital and theophylline are a couple of examples of toxins that are cleared more efficiently using this method.

How to take Acticlose?

Acticlose(r), together with sorbitol and Acticlose(r)-aqua, must be administered in a controlled medical setting or under the supervision of a poison control center.

Acticlose(r), together with sorbitol and Acticlose(r)-aqua, is recommended in the treatment of a variety of poisoning situations after the toxin is consumed or is indicated to treat only a few symptoms of systemic poisoning that result from parental excess doses or when the toxic substance is completely absorbed. When the physiologic condition is optimal, activated charcoal is most effective. It is able to absorb toxins that have a molecular mass of between 100 and 1000 daltons (amus). It is possible that activated charcoal will not be as efficient in the absorption of low molecular weight compounds like aliphatic alcohols (methanol, isopropanol, ethanol, etc.), metals (iron, lead, mercury, etc.), and other elements like lithium. 2. Two studies on animals have shown that extremely harmful and low-molecular-weight compounds of cyanide are absorbed by activated charcoal. It is recommended to use activated charcoal during emergency situations involving toxic substances; it isn't contraindicated. A lot of poisonings are caused by multiple substances, so Acticlose (r) is a good choice. Sorbitol as well as Acticlose(r)-aqua could be efficient in adsorbing a portion or all of the ingestion poisons.

 Usage in children

Acticlose (r) together with sorbitol is not recommended for babies younger than one year old.

Details on dosage

Before administering Acticlose (r) by sorbitol or Acticlose (r)-aqua, shake the bottle extensively for at least 30 minutes. Following the administration of Acticlose(r) using sorbitol or Acticlose(r)-aqua, the bottle should be washed thoroughly with water. The remaining leftovers must be given to the patient in order for them to be sure the complete dosage has been administered.

Use during pregnancy or lactation

Use during lactation or pregnancy hasn't been confirmed. Acticlose(r), together with sorbitol and Acticlose(r)-aqua, can be utilized in lactation or during pregnancy only when the benefits outweigh the risks. There have been no teratogenic side effects discovered in rodents or rabbits.

What should be avoided?

Acticlose (r) together with sorbitol shouldn't be utilized at every dose of the activated charcoal regime in the event that it is required to cause catharsis. Acticlose(r) is a combination of sorbitol, a source of sorbitol that could cause excessive catharsis and consequent electrolyte and fluid problems when employed at all times during the dosing period (see precautions). 9,25 Acticlose (r)-Aqua is best employed at dose intervals at times when Acticlose (r) contains sorbitol and is not in use. 

If activated charcoal catharsis is not observed following the administration of Acticlose(r) together with sorbitol within 4 to 8 hours, a second dose of sorbitol, 1.5 mg/kg, can be administered. If desired, a saline cathartic drug like magnesium citrate can be utilized if kidney function isn't impaired. Acticlose(r) is formulated with sorbitol, and Acticlose(r)-aqua is made in digestible containers that eliminate the requirement to include any flavor or consistency enhancers. It is recommended to avoid the addition of any additional ingredients; syrups or dairy products must be avoided because their inclusion can reduce the capacity of absorption of Acticlose(r) using sorbitol as well as Acticlose(r)-aqua.

Side effects

The sorbitol-activated charcoal has caused severe hypernatremic dehydration and is used in large quantities in children's patients. 

The aspiration of activated carbon has been known to cause airway obstruction and a small number of fatalities have been recorded. The condition that causes death has occurred several weeks after aspiration of activated charcoal.

Gastrointestinal obstruction that is a result of the treatment with multiple doses of activated charcoal therapy was reported.  A high dose of carbamazepine caused the antiperistaltic effects that caused bowel obstruction.

Interaction with other drugs

There aren't any known specific contraindications to the use of activated charcoal. However, it's not the same absorber for all toxic substances. At any point, the use of activated charcoal should be done cautiously when patients are consuming corrosive chemicals, as the activated carbon may block the view through endoscopy of esophageal as well as gastric lesions caused by acid. Cathartic therapy that contains activated charcoal should not be recommended if patients have an electrolyte imbalance or a significant change in the fluid. Acticlose(r) with sorbitol must not be administered to infants because of the risk of overly catharsis. Little ones should not take dosages that trigger catharsis if they are hospitalized and receiving the immediate attention of a medical professional.

Acticlose(r) is a combination of sorbitol and Acticlose(r)-aqua and must be administered in a controlled medical setting or under the supervision of a doctor or poison control center.

Acticlose(r), along with sorbitol and Acticlose(r)-aqua, can be used as an adjunct for the treatment of emergency poisoning. Before using activated charcoal, the appropriate basic precautions for life should be taken in conjunction with the correct procedure for emptying gastric contents if required.

If Acticlose(r) together with sorbitol or Acticlose(r)-aqua can be used for treating an emergency poisoning, the patient as well as health professionals must be aware that activated charcoal may create black stool. The stools can be diarrheal and can last for up to hours.

Acticlose(r) combined with sorbitol can cause a powerful cathartic reaction, and care is required to consider the patient's electrolyte, fluid, and demands. Acticlose (r) combined with sorbitol should not be administered to patients who are receiving multiple doses of activated charcoal. When Acticlose(r) with sorbitol is utilized at every dose interval, there is a risk of forming a profound catharsis that could lead to hypotension, dehydration, and changes in fluid and electrolyte levels.

The study was conducted with healthy human volunteers over the age of 18 who consumed therapeutic doses of activated charcoal as well as sorbitol, which caused severe and long-lasting diarrhea. However, no notable changes were found in serum electrolytes, the osmolality of bun, or the metabolic profile in comparison to the control. 

Gastrointestinal obstruction due to activated charcoal can occur as the result of toxins' antiperistaltic actions. Acticlose(r) is a combination of sorbitol and Acticlose(r)-aqua and is recommended to be utilized with caution when patients have been exposed to poisons that can affect the peristalsis of the gastrointestinal tract (i.e., anticholinergics, opioids such as opioids, anticholinergics, etc.). Bowel sounds must be regularly examined to evaluate peristaltic activity, particularly in patients who are undergoing the therapy of activated charcoal in multiple doses.