Albenza

Name: Albenza

Albenza Drug Class

Albenza is part of the drug class:

  • Benzimidazole derivatives

What should I avoid while taking Albenza (albendazole)?

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

Precautions While Using Albenza

It is important that your doctor check your progress after treatment. This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects. Blood tests may be needed to check for unwanted effects.

If your symptoms do not improve after you have taken this medicine for the full course of treatment, or if they become worse, check with your doctor.

For women of childbearing age, it is important that you use an effective form of birth control while using this medicine and for at least 1 month after your last dose. Also, your doctor should give you a pregnancy test before you start the medicine to make sure you are not pregnant.

Albendazole can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

For patients treated for neurocysticercosis, this medicine may increase your risk for increased pressure in the head or seizures. Tell your doctor right away if you have these symptoms.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Albenza Side Effects

Along with its needed effects, a medicine 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:

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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Albenza Dosage and Administration

Dosage

Dosing of Albenza will vary depending upon the indication. Albenza tablets may be crushed or chewed and swallowed with a drink of water. Albenza chewable tablets are also available for children and patients who may experience swallowing difficulties. Albenza tablets and Albenza chewable tablets should be taken with food [see Clinical Pharmacology (12.3)].

Table 1: Albenza Dosage
 Indication  Patient Weight  Dose  Duration
 Hydatid Disease  60 kg or greater  400 mg twice daily, with meals  28-day cycle followed by a 14-day albendazole-free interval, for a total of 3 cycles
 Less than 60 kg  15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)
 Neurocysticercosis  60 kg or greater  400 mg twice daily, with meals  8 to 30 days
 Less than 60 kg  15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)

Concomitant Medication to Avoid Adverse Reactions

Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment [see Warnings and Precautions (5.3)].

Monitoring for Safety Before and During Treatment

  • Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with Albenza in all patients [see Warnings and Precautions (5.1)].
  • Monitor liver enzymes (transaminases) at the beginning of each 28-day cycle of therapy, and at least every 2 weeks during treatment with Albenza in all patients [see Warnings and Precautions (5.5)].
  • Obtain a pregnancy test in women of reproductive potential prior to therapy [see Warnings and Precautions (5.2)].

Contraindications

Albenza is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of Albenza.

Adverse Reactions

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 (5.1)].

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.

Overdosage

In case of overdosage, symptomatic therapy and general supportive measures are recommended.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies were conducted in mice and rats.

No evidence of increased incidence of tumors was found in the mice or rats at up to 400 mg/kg/day or 20 mg/kg/day respectively (2 times and 0.2 times the recommended human dose on a body surface area basis).

In genotoxicity tests, albendazole was found negative in an Ames Salmonella/Microsome Plate mutation assay, Chinese Hamster Ovary chromosomal aberration test, and in vivo mouse micronucleus test. In the in vitro BALB/3T3 cells transformation assay, albendazole produced weak activity in the presence of metabolic activation while no activity was found in the absence of metabolic activation.

Albendazole did not adversely affect male or female fertility in the rat at an oral dose of 30 mg/kg/day (0.32 times the recommended human dose based on body surface area in mg/m2).

How Supplied/Storage and Handling

How Supplied

Tablets

Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with “ap” and “550” and contains 200 mg of albendazole.

Bottles of 2 Tablets       NDC 52054-550-22

Bottles of 28 Tablets     NDC 52054-550-28

Chewable Tablets

Each round, mottled pink, concave chewable tablet is debossed with “ap” above “551” and contains 200 mg of albendazole.

2 Tablets in 1 Blister Pack (configured as a Wallet Card)   NDC 52054-551-22

6 Tablets in 1 Blister Pack; 2 Blister Packs in 1 Carton      NDC 52054-551-12

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

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