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Gastrointestinal System

Albendazol STADA® 400 mg

 

Pack size:

Box of 1 blister x  1 chewable tablet.

 

Composition:

Each chewable tablet contains albendazole 400 mg.

 

Shelf-life:

48 months from the date of manufacturing.

Store in a well-closed container, in a dry place, protect from light. Do not store above 30oC.

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Single or mixed infections caused by intestinal parasites, such as Ascaris lumbricoides, Enterobius vermicularis, Ancylostoma duodenale, Necator americanus, Trichuris trichiura, Strongyloides stercoralis, Hymenolepis nana, Taenia solium, Taenia saginata, Opisthorchis viverrini and Opisthorchis sinensis.
  • Albendazole may be effective against cutaneous larva migrans. Limited data indicate that albendazole is useful in neurocysticercosis. Albendazole seems to be the drug of choice for the treatment of inoperable hydatid cases, but its long-term benefit needs further assessment.

The tablets may be chewed and drunk with a glass of water, or crushed and mixed with food. No special procedures, e.g. fasting or purging are required.

  • Ascariasis, enterobiasis, ancylostomiasis or trichuriasis:
    Adults and children over 2 years: Same dose: a single dose of 400 mg. A further dose may be required after 3 weeks.
    Children up to 2 years: A single dose of 200 mg. A further dose may be required after 3 weeks.
  • Cutaneous larva migrans:
    Adults: 400 mg once daily, for 3 days.
    Children: 5 mg/kg daily, by mouth, for 3 days.
  • Hydatid disease:
    Adults: 800 mg daily in 2 divided doses by mouth with meals for 28 days. Doses may be repeated after 2-3 weeks, up to 2-3 courses, if needed. If hydatid cyst is inoperable, the 28-day course may be repeated after 2-3 weeks up to total of 5 treatment cycles.
    Children over 6 years: 10-15 mg/kg daily for 28 days. Doses may be repeated, if needed.
    Children up to 6 years: Dose not established.
  • Neurocysticercosis:
    Adults: 15 mg/kg daily for 30 days. Doses may be repeated after 3 weeks.
    Children: See doses for adults.
  • Taeniasis or H. nana infection, strongyloidiasis:
    Adults: 400 mg daily in a single dose by mouth for 3 days. Doses may be repeated after 3 weeks.
    Children over 2 years: Same dose as for adults.
    Children up to 2 years: 200 mg daily in a single dose by mouth for 3 days. Doses may be repeated after 3 weeks.

Or as advised by physicians.

 

 

  • Patients with a history of hypersensitivity to the compounds of benzimidazole class or any components of the drug.
  • Patient with a history of bone marrow toxicity.
  • Pregnant women.

     

In short-term treatment (≤ 3 days), a few cases of gastrointestinal discomfort (epigastric pain and diarrhea) and headache are reported.
During the treatment of hydatid disease or neurocysticercosis, where higher doses are used for longer time periods, side effects are more common and severe.
Usually adverse and side effects are mild and resolved without treatment. Treatment discontinuations are predominantly due to leukopenia or hepatic abnormalities.

Common:

  • Fever.
  • Headache, vertigo, meningeal signs, raised intracranial pressure.
  • Abnormal functions.
  • Abdominal pain, nausea, vomiting.
  • Alopecia (reversible).

Less common:

  • Allergic reactions.
  • Leukopenia.
  • Rash, urticaria.
  • Acute renal failure.

Rare:

  • Granulocytopenia, pancytopenia, agranulocytosis, thrombocytopenia.

     

  • Patients with abnormal liver function prior to commencing albendazole therapy, should be carefully evaluated, since the drug is metabolized by the liver and has been associated with hepatotoxicity in a few patients.
  • Patients with hematological diseases.
     
  • Albendazole should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Patients should not become pregnant for at least 1 months following cessation of albendazole therapy. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus and albendazole should be discontinued immediately.
  • The excretion of albendazole into breast milk is unknown, therefore, caution should be excreted when albendazole is administered to a nursing woman.
     
  • There are no known effects on ability to drive and use machines.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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