Exbenzol

Exbenzol is an organic compound that consists of a six-membered ring containing two opposing nitrogen atoms. Exbenzol exists as small alkaline deliquescent crystals with a saline tasteraverm was introduced to medicine as a solvent for uric acid. When taken into the body the drug is partly oxidized and partly eliminated unchanged. Outside the body, piperazine has a remarkable power to dissolve uric acid and producing a soluble urate, but in clinical experience it has not proved equally successfulraverm was first introduced as an anthelmintic in 1953. A large number of piperazine compounds have anthelmintic action. Their mode of action is generally by paralysing parasites, which allows the host body to easily remove or expel the invading organism.

Exbenzol belongs to the family of medicines called anthelmintics. Anthelmintics are medicines used in the treatment of worm infections.

Exbenzol is used to treat:

Common roundworms (ascariasis);

Hookworm infections (uncinariasis);

Pinworms (enterobiasis; oxyuriasis);

Whipworms (trichuriasis); and

More than one worm infection at a time.

Exbenzol may also be used for other worm infections as determined by your doctor.

Exbenzol works by keeping the worm from absorbing sugar (glucose). This gradually causes loss of energy and death of the worm.

Exbenzol belongs to the family of medicines called anthelmintics. Anthelmintics are medicines used in the treatment of worm infections.

Exbenzol is used to treat:

• Common roundworms (ascariasis);
• Hookworm infections (uncinariasis);
• Pinworms (enterobiasis; oxyuriasis);
• Whipworms (trichuriasis); and
• More than one worm infection at a time.

Exbenzol may also be used for other worm infections as determined by your doctor.

Exbenzol works by keeping the worm from absorbing sugar (glucose). This gradually causes loss of energy and death of the worm.

Exbenzol is available only with your doctor's prescription.

The recommended dosage in patients one year of age and older is one Exbenzol™ CHEWABLE 500 mg tablet taken as a single dose.

Chew Exbenzol™ CHEWABLE 500 mg tablet completely before swallowing. Do not swallow the tablet whole.

For patients who have difficulty chewing the tablet, Exbenzol™ CHEWABLE 500 mg tablet can be placed in a spoon and approximately 2 mL to 3 mL of drinking water added onto the tablet using a dosing syringe. Within 2 minutes, the tablet absorbs the water and turns into a soft mass with semi-solid consistency, which can then be swallowed.

Exbenzol™ CHEWABLE 500 mg tablet can be taken without regard to food intake.

How supplied

Dosage Forms And Strengths

Chewable Tablet: 500 mg round, flat radius-edged white to yellowish chewable tablet that is debossed with “M/500” on one side and “J” on the other side.

Storage And Handling

Exbenzol™ CHEWABLE tablets are supplied as 500 mg, round, flat radius-edged white to yellowish chewable tablets that are debossed with “M/500” on one side and “J” on the other side. They are supplied as follows:

Bottles of 200 tablets NDC 50458-675-20

Store below 30°C. Keep container tightly closed. Unused tablets should be discarded 1 month after the bottle is first opened. When the bottle is first opened this Discard After date should be written on the bottle label in the place provided.

Manufactured by: Lusomedicamenta Lisbon, Portugal. Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560. Revised: Oct 2016

See also:
What is the most important information I should know about Exbenzol?

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 Exbenzol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Exbenzol 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.

Use Exbenzol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Exbenzol. Talk to your pharmacist if you have questions about this information.
• Take Exbenzol by mouth with or without food.
• Chew thoroughly before swallowing. Exbenzol may also be crushed and mixed with food.
• Wear tight underwear both day and night while taking Exbenzol.
• If you miss a dose of Exbenzol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Exbenzol.

Use: Labeled Indications

Intestinal nematode infection: Treatment of patients ≥2 years of age with GI infections caused by Ancylostoma duodenale or Necator americanus (hookworms), Ascaris lumbricoides (roundworms), Enterobius vermicularis (pinworms), and Trichuris trichiura (whipworms).

Off Label Uses

Capillariasis

Data from case reports suggest that Exbenzol may be beneficial for the treatment of capillariasis.

See also:
What other drugs will affect Exbenzol?

CarBAMazepine: May decrease the serum concentration of Exbenzol. Monitor therapy

Cimetidine: May increase the serum concentration of Exbenzol. Monitor therapy

Fosphenytoin: May decrease the serum concentration of Exbenzol. Monitor therapy

MetroNIDAZOLE (Systemic): Exbenzol may enhance the adverse/toxic effect of MetroNIDAZOLE (Systemic). Particularly the risk for Stevens-Johnson syndrome or toxic epidermal necrolysis may be increased. Avoid combination

Phenytoin: May decrease the serum concentration of Exbenzol. Monitor therapy

Ritonavir: May decrease the serum concentration of Exbenzol. Monitor therapy

See also:
What are the possible side effects of Exbenzol?

Clinical Studies

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Exbenzol was evaluated in 6276 adult and pediatric subjects one year of age and older who participated in 39 clinical trials for treatment of single or mixed parasitic infections of the gastrointestinal tract. In these trials, the formulations, dosages and duration of Exbenzol treatment varied. Adverse reactions reported in Exbenzol-treated subjects from the 39 clinical trials are shown in Table 1 below.

Table 1: Adverse Reactions Reported in Exbenzol-Treated Subjects from 39 Clinical Trials*

Clinical Studies With Exbenzol Chewable 500 mg Tablet

The safety profile of Exbenzol chewable 500 mg tablets administered as a single dose was evaluated in 677 pediatric subjects aged 1 to 16 years and in 34 adults. The safety profile was consistent with the known safety profile of Exbenzol.

Postmarketing Experience

The following adverse reactions have been identified in adult and pediatric patients postmarketing with Exbenzol formulations and dosages other than the Exbenzol™ CHEWABLE 500 mg tablet. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Table 2: Adverse Reactions Identified During Postmarketing Experience with Exbenzol*