Albendazole

Name: Albendazole

Indications

Neurocysticercosis

ALBENZA is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.

Hydatid Disease

ALBENZA is indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.

Side effects

Clinical Trials Experience

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 adverse reaction profile of ALBENZA differs between hydatid disease and neurocysticercosis. Adverse reactions occurring with a frequency of 1% or greater in either disease are described in Table 2 below.

These symptoms were usually mild and resolved without treatment. Treatment discontinuations were predominantly due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease). The following incidence reflects adverse reactions that were reported to be at least possibly or probably related to ALBENZA.

Table 2: Adverse Reaction Incidence 1% or Greater in Hydatid Disease and Neurocysticercosis

Adverse Reaction Hydatid Disease Neurocysticercosis
Gastrointestinal
Abdominal Pain 6 0
Nausea 4 6
Vomiting 4 6
General disorders and administration site conditions
Fever 1 0
Investigations
Elevated Hepatic Enzymes 16 less than 1
Nervous system disorders
Dizziness 1 less than 1
Headache 1 11
Meningeal Signs 0 1
Raised Intracranial Pressure 0 2
Vertigo 1 less than 1
Skin and subcutaneous tissue disorders
Reversible Alopecia 2 less than 1

The following adverse events were observed at an incidence of less than 1%:

Blood and Lymphatic System Disorders: There have been reports of leukopenia, granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia [see WARNINGS AND PRECAUTIONS].

Immune System Disorders: Hypersensitivity reactions, including rash and urticaria.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ALBENZA. 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.

Blood and Lymphatic System Disorders: Aplastic anemia, bone marrow suppression, neutropenia.

Eye Disorders: Vision blurred.

Gastrointestinal Disorders: Diarrhea.

General System Disorders: Asthenia.

Hepatobiliary Disorders: Elevations of hepatic enzymes, hepatitis, acute liver failure.

Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis.

Nervous System Disorders: Somnolence, convulsion.

Renal and Urinary Disorders: Acute renal failure.

Skin and Subcutaneous Tissue Disorders: Erythema multiforme, Stevens-Johnson syndrome.

Albendazole Overview

Albendazole is a prescription medication used to treat neurocysticercosis (infection caused by pork tapeworm) and cystic hydatid disease (infection caused by dog tapeworm). Albendazole belongs to a group of drugs called antihelmintics. It works by preventing worms from growing and multiplying in the body.

This medication comes in tablet form. It is taken twice daily, with food. For young children, the tablets should be crushed or chewed and swallowed with a drink of water.

Common side effects include stomach pain, nausea, vomiting and headache. Albendazole may also cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

What should I discuss with my healthcare provider before taking albendazole?

You should not use this medicine if you are allergic to albendazole, or to similar drugs such as mebendazole (Vermox).

To make sure albendazole is safe for you, tell your doctor if you have:

  • liver disease; or

  • bone marrow suppression.

It is not known whether this medicine will harm an unborn baby. Albendazole should not be used during pregnancy, unless there is no alternate treatment. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. Use effective birth control to prevent pregnancy while taking this medicine and for at least 1 month after your treatment ends.

You may need to have a negative pregnancy test before starting this treatment.

It is not known whether albendazole passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

What should I avoid while taking albendazole?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Interactions for Albendazole

Induces CYP1A isoenzyme.1

Specific Drugs

Drug

Interaction

Comments

Cimetidine

Increased albendazole sulfoxide concentrations in bile and cystic fluid in hydatid cyst patients receiving cimetidine; plasma concentrations of albendazole sulfoxide unchanged1

Dexamethasone

Increased albendazole trough concentrations1

Praziquantel

Increased plasma concentrations and AUC of albendazole sulfoxide; time to peak concentrations and plasma elimination half-life of albendazole sulfoxide unchanged1

Theophylline

Single albendazole dose does not affect theophylline metabolism; potential for interaction exists since albendazole induces CYP1A1

Monitor theophylline concentrations during and after albendazole therapy1

Actions and Spectrum

  • Broad-spectrum anthelmintic agent.1

  • Benzimidazole derivative1 4 structurally related to thiabendazole and mebendazole.4

  • Principal anthelmintic effect of benzimidazoles appears to be specific, high-affinity binding to free β-tubulin in parasite cells,1 3 4 resulting in selective inhibition of parasite microtubule polymerization,1 3 4 and inhibition of microtubule-dependent uptake of glucose.2 3 6

  • Benzimidazole derivatives bind to the β-tubulin of parasites at much lower concentrations than to mammalian β-tubulin protein;4 the drugs do not inhibit glucose uptake in mammals, and do not appear to have any effect on blood glucose concentrations in humans.2 6

  • Active against the larval forms of Echinococcus granulosus and Taenia solium.1

Before Using albendazole

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 albendazole, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albendazole to treat neurocysticercosis in children. However, hydatid disease is uncommon in children.

Geriatric

Although appropriate studies on the relationship of age to the effects of albendazole have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using albendazole with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use albendazole, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of albendazole. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone marrow problems (eg, agranulocytosis, aplastic anemia, granulocytopenia, pancytopenia)—Use with caution. May make these conditions worse.
  • Cysticercosis involving the eye—Patients who are being treated with albendazole for neurocysticercosis should be examined for lesions in the eye. Using albendazole may increase your risk of side effects involving the eye.
  • Liver disease or
  • Liver enzymes, elevated—Use with caution. May increase risk for more serious side effects.

Proper Use of albendazole

Use albendazole exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

No special preparations (fasting, laxatives, or enemas) or other steps are necessary before, during, or immediately after treatment with albendazole.

Take albendazole with meals, especially with food containing fat, to help your body absorb the medicine better.

You may crush or chew the tablet and swallow it with water. If you have difficulty with swallowing, you may take the chewable tablet.

If you are taking albendazole for neurocysticercosis, your doctor will give you additional medicines (such as medicines for seizures or steroids) while you are taking albendazole.

To help clear up your infection completely, take albendazole exactly as directed by your doctor for the full time of treatment. In some infections, additional treatments with albendazole may be needed at 2-week intervals to clear up the infection completely. Do not miss any doses.

Dosing

The dose of albendazole 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 albendazole. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (chewable tablets or tablets):
    • For hydatid disease of the liver, lung, and peritoneum:
      • Adults weighing 60 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is usually 400 milligrams (mg) two times a day, taken with meals for 28 days (1 cycle). This is followed by not taking albendazole for 14 days, for a total of 3 cycles.
      • Adults weighing less than 60 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 mg per kg of body weight per day, divided into two doses, taken with meals for 28 days. This is followed by not taking albendazole for 14 days, for a total of 3 cycles. The dose is usually not more than 800 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For neurocysticercosis:
      • Adults and children weighing 60 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is usually 400 milligrams (mg) two times a day, taken with meals, for 8 to 30 days.
      • For adults and children weighing less than 60 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 mg per kg of body weight per day, divided into two doses, taken with meals, for 8 to 30 days.

Missed Dose

If you miss a dose of albendazole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Dosing Hepatic Impairment

There are no dosage adjustments provided in manufacturer's labeling. However, patients with underlying liver disease may be more at risk for adverse effects.

What is the most important information i should know about albendazole (albenza)?

You should not use this medication if you are allergic to albendazole, or to similar medications such as mebendazole (Vermox).

Before using albendazole, tell your doctor if you are allergic to any drugs, or if you have liver disease or have ever had abnormal liver function tests.

You should not use albendazole if you are pregnant or planning to become pregnant during treatment. Use an effective form of birth control while you are using albendazole, and for at least 1 month after your treatment ends.

Take albendazole with food to lessen stomach upset.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Albendazole will not treat a viral infection such as the common cold or flu.

Albendazole can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

What happens if i miss a dose (albenza)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

For the Consumer

Applies to albendazole: oral tablet, oral tablet chewable

Along with its needed effects, albendazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking albendazole:

Less common
  • Fever
Rare
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest pain
  • chills
  • cough
  • painful or difficult urination
  • pinpoint red spots on the skin
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • Blistering, peeling, loosening of the skin
  • blurred vision
  • dark-colored urine
  • diarrhea
  • general feeling of tiredness or weakness
  • headache
  • itching
  • joint or muscle pain
  • light-colored stools
  • red, irritated eyes
  • seizures
  • stomach pain, continuing
  • tightness in the chest
  • vomiting
  • yellow eyes or skin

Some side effects of albendazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain
Less common
  • Nausea
Less common or rare
  • Dizziness
  • thinning or loss of the hair
Incidence not known
  • Lack or loss of strength

Usual Adult Dose for Hydatid Disease

Less than 60 kg: 15 mg/kg/day orally in divided doses twice a day with meals
Maximum dose: 800 mg/day

60 kg or more: 400 mg orally twice a day with meals

Duration of therapy: 28-day cycle followed by a 14-day drug-free interval, for a total of 3 cycles

Use: For the treatment of cystic hydatid disease of the liver, lung, and peritoneum due to the larval form of Echinococcus granulosus

Usual Adult Dose for Cutaneous Larva Migrans

US CDC recommendations: 400 mg orally once a day for 3 to 7 days

Case Report (4)
400 mg orally twice a day for 3 to 5 days

Usual Adult Dose for Gnathostomiasis

US CDC recommendations: 400 mg orally twice a day for 21 days

Comments: Recommended for cutaneous symptoms

Usual Pediatric Dose for Hydatid Disease

Less than 60 kg: 15 mg/kg/day orally in divided doses twice a day with meals
Maximum dose: 800 mg/day

60 kg or more: 400 mg orally twice a day with meals

Duration of therapy: 28-day cycle followed by a 14-day drug-free interval, for a total of 3 cycles

Comments: Hydatid disease is uncommon in infants and young children.

Use: For the treatment of cystic hydatid disease of the liver, lung, and peritoneum due to the larval form of E granulosus

Usual Pediatric Dose for Cysticercus cellulosae (Cysticercosis)

Some experts recommend: 15 mg/kg/day orally in divided doses twice a day
Maximum dose: 800 mg/day
Duration of therapy: 8 to 30 days

Comments:
-May repeat as necessary
-Therapy for at least 30 days recommended in patients with subarachnoid cysts or giant cysts in the fissures.
-Surgical intervention (especially neuroendoscopic removal) or CSF diversion followed by treatment with this drug and steroids recommended for obstructive hydrocephalus.
-With prednisone or dexamethasone, recommended for arachnoiditis, vasculitis, or cerebral edema

Usual Pediatric Dose for Ascariasis

US CDC and AAP recommendations: 400 mg orally as a single dose

Usual Pediatric Dose for Whipworm Infection (Trichuris trichiura)

US CDC and AAP recommendations: 400 mg orally once a day for 3 days

Usual Pediatric Dose for Microsporidiosis

Some experts recommend: 15 mg/kg/day orally in divided doses twice a day
Maximum dose: 800 mg/day

Comments:
-Recommended for disseminated infection due to E hellem, E cuniculi, E intestinalis, Pleistophora species, Trachipleistophora species, or A vesicularum
-Recommended for intestinal infection due to E intestinalis
-With fumagillin, recommended for ocular infection due to E hellem, E cuniculi, or V corneae

US CDC, NIH, HIVMA/IDSA, Pediatric Infectious Diseases Society, and AAP recommendations for HIV-exposed and HIV-infected children: 15 mg/kg/day orally in divided doses twice a day
Maximum dose: 800 mg/day

US CDC, NIH, and HIVMA/IDSA recommendations for HIV-infected adolescents: 400 mg orally twice a day

Comments:
-Recommended as preferred therapy (including treatment and secondary prophylaxis)
-Recommended for intestinal and disseminated (not ocular) infection due to Microsporidia other than E bieneusi and V corneae
-With fumagillin, recommended for ocular infection for management of systemic infection

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