Alzolux DS

Approved Indications:

• Neurocysticercosis: For the treatment of active parenchymal neurocysticercosis caused by Taenia solium (pork tapeworm) larvae.
• Hydatid Disease (Cystic Echinococcosis): For the treatment of cystic hydatid disease of the liver, lung, and peritoneum caused by the larval form of Echinococcus granulosus.

Clinically Accepted Off-Label or Regionally Approved Uses:

• Ascariasis: Treatment of infections caused by Ascaris lumbricoides (roundworm).
• Enterobiasis: Treatment of pinworm infection caused by Enterobius vermicularis.
• Trichuriasis: Treatment of whipworm infection caused by Trichuris trichiura.
• Hookworm Infections: Treatment of infections due to Ancylostoma duodenale and Necator americanus.
• Strongyloidiasis: Treatment of Strongyloides stercoralis infection (regionally approved or off-label in some settings).
• Capillariasis: Treatment of Capillaria philippinensis infection (regionally accepted).
• Cutaneous Larva Migrans: Off-label use for creeping eruption caused by hookworm larvae migrating under the skin.
• Gnathostomiasis: Used off-label for Gnathostoma infections.

Prophylactic Use:

• Recommended in WHO mass drug administration campaigns for control of soil-transmitted helminths in endemic populations, usually as a single dose for deworming.

Recommended Dosages:

• Neurocysticercosis: 15 mg per kg of body weight per day, given in two divided doses. The maximum daily dose should not exceed 800 mg. Treatment duration ranges from 8 to 30 days, depending on the number, size, and location of cysts.
• Hydatid Disease: Same dosing — 15 mg per kg per day in two divided doses, up to a maximum of 800 mg daily. Treatment is given for 28 days and may be repeated for up to three cycles, with each cycle separated by a 14-day drug-free interval.
• Ascariasis, Trichuriasis, Hookworm, Enterobiasis (Pinworm): A single dose of 400 mg is sufficient. For pinworm infection, a second dose may be repeated after 2 to 3 weeks if reinfection is likely.
• Strongyloidiasis, Capillariasis: 400 mg once daily for 3 to 5 consecutive days.
• Cutaneous Larva Migrans: 400 mg daily for 3 days is typical.

Pediatric Use:
Children over 2 years of age generally receive the same dosing as adults, adjusted for body weight if needed. Some regions allow limited off-label use in younger children under medical supervision.

Elderly:
No specific dose adjustment is required, but liver function should be monitored.

Renal Impairment:
No dose adjustment has been established. Use caution due to limited clinical data.

Hepatic Impairment:
Use with caution. Baseline and periodic liver function tests are recommended if treatment is prolonged or repeated.

Albendazole is a broad-spectrum benzimidazole anthelmintic. It works by selectively binding to parasite β-tubulin and inhibiting microtubule polymerization within the intestinal and other cells of the parasite. This disruption impairs glucose uptake and depletes the parasite’s glycogen stores, leading to energy depletion, immobilization, and eventual death. Albendazole’s active metabolite, albendazole sulfoxide, is primarily responsible for its systemic antiparasitic effects, particularly for tissue parasites like cysticerci and hydatid cysts.

Albendazole is poorly absorbed when taken on an empty stomach, with about 5% bioavailability. When taken with a fatty meal, absorption increases significantly (up to fivefold). After absorption, albendazole undergoes extensive first-pass metabolism in the liver via CYP3A4, converting it to its active metabolite, albendazole sulfoxide. The active metabolite distributes widely throughout the body, including into cerebrospinal fluid and hydatid cyst fluid. The elimination half-life of albendazole sulfoxide is about 8 to 12 hours. Excretion is mainly through the urine as metabolites, with minimal amounts of unchanged drug found in the feces.

Pregnancy:
Albendazole is classified as Pregnancy Category C under the older FDA system. Animal studies have shown teratogenic effects. It should be avoided during pregnancy, especially during the first trimester, unless the potential benefits clearly outweigh the risks.

Lactation:
Small amounts of albendazole and its metabolites are excreted in breast milk. Single-dose or short-term use is generally considered acceptable while breastfeeding. If repeated or prolonged high-dose treatment is required, temporary interruption of breastfeeding may be advisable.

Albendazole is classified as an anthelmintic in the benzimidazole subclass.

• Known hypersensitivity to albendazole or other benzimidazole derivatives.
• Pregnancy, especially during the first trimester, unless treatment is clearly justified.
• Clinically significant, uncontrolled liver disease.

Albendazole may cause hepatotoxicity. Liver function tests should be done before starting therapy and periodically during prolonged or repeated courses. Rarely, albendazole can cause bone marrow suppression, including leukopenia and pancytopenia. Periodic complete blood counts are recommended for prolonged or high-dose regimens. When treating neurocysticercosis, inflammation due to dying cysts can raise intracranial pressure and worsen neurologic symptoms. Corticosteroids and anticonvulsants should be used as indicated. Patients should be screened for ocular cysticercosis before treatment because treatment may cause retinal damage if ocular cysts are present.

Common Side Effects:

• Abdominal pain, nausea, vomiting.
• Headache, dizziness.
• Transient elevation of liver enzymes.

Serious or Rare Side Effects:

• Hepatitis and, rarely, acute liver failure.
• Bone marrow suppression, including leukopenia and pancytopenia.
• Hypersensitivity reactions such as rash, itching, or very rarely, anaphylaxis.
• Worsening neurologic symptoms when treating neurocysticercosis due to inflammatory response.

Most side effects are mild and transient. Liver enzyme elevations usually resolve when treatment is stopped. Serious blood disorders are rare but require immediate medical attention.

Albendazole’s active metabolite levels may be increased by drugs such as cimetidine, dexamethasone, or praziquantel, which inhibit its metabolism. Grapefruit juice may also raise systemic levels and should be avoided in excess. Drugs that induce liver enzymes — such as carbamazepine, phenytoin, phenobarbital, or rifampin — can reduce albendazole’s effectiveness by speeding up its metabolism. Alcohol does not directly interact but may increase liver strain and should be limited during treatment.

According to recent WHO guidelines, albendazole remains a first-line medicine for mass deworming to control soil-transmitted helminths and is also used in combination therapies for lymphatic filariasis elimination programs. No major recent FDA label changes have occurred. Current best practices emphasize liver function monitoring and blood counts for prolonged or repeated treatment courses.

Store albendazole at controlled room temperature, ideally between 20°C and 25°C (68°F and 77°F). Short-term storage between 15°C and 30°C (59°F and 86°F) is acceptable. Keep the medication tightly closed in its original container and protect it from moisture and light. Do not freeze. No reconstitution is needed for tablets or chewable forms.