ALBENDAZOLE

Drugs in Pregnancy and Lactation.

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Name: ALBENDAZOLE
Class: Anthelmintic
Risk Factor:    CM
Fetal Risk Summary Albendazole is an orally administered, benzimidazole class, broad-spectrum anthelmintic used in the treatment of parenchymal neurocysticerosis caused by larval forms of the pork tapeworm, Taenia solium. It is also active against the larval forms of Echinococcus granulosus. Plasma concentrations of albendazole are negligible or undetectable because of poor systemic absorption attributable to low water solubility and its rapid hepatic metabolism to the active metabolite, albendazole sulfoxide (1). However, administration of albendazole with a fatty meal will markedly increase the levels of the metabolite in human plasma (up to 5-fold on average) (1).

Reproduction studies have been conducted in mice, rats, and rabbits (1). In rats, albendazole did not adversely affect male or female fertility at oral doses 0.32 times the recommended human dose (RHD) based on body surface area. The drug was embyrotoxic and teratogenic (skeletal malformations) in pregnant rats at oral doses of 10 mg/kg/day and 30 mg/kg/day (0.10 and 0.32 times the RHD, respectively) administered during organogenesis. Similar toxicity was observed in pregnant rabbits at 30 mg/kg/day (0.60 times the RHD) during organogenesis. However, the dose in rabbits was maternally toxic (33% mortality). No teratogenicity was observed in mice given oral doses up to 0.16 times the RHD (30 mg/kg/day) during organogenesis (1).

A reproductive study in rats examined the effect of oral albendazole (0, 10, or 20 mg/kg/day) administered on gestational days 9 to 11 (2). Compared to controls, the 10 mg/kg dose resulted in a decrease in crown-rump length, a small increase in resorptions, but no teratogenicity. The high dose, however, caused marked fetal growth retardation, an increase in the number of resorptions, and craniofacial and skeletal malformations. Because the severity of the toxic effects differed significantly among the litters, the results suggested that differences in maternal metabolism of albendazole might be involved (2).

In another report by the above researchers, pregnant rats were administered albendazole 0, 10, 20, or 30 mg/kg/day on gestational days 10 to 12 (3). Dose-related resorptions and growth retardation were observed in the three groups receiving albendazole. At 10 mg/kg/day, increased development delay of limb buds was observed, but less than 5% of the embryos had abnormal heads or shapes. At the two higher doses, however, more than 20% of the embryos had morphologic alterations in head shapes and in the development of forelimb buds, branchial bars, eyes, and telencephalon (3). As in their initial communication, the researchers concluded that differences in maternal metabolism may have accounted for the observed interlitter differences in adverse fetal outcomes (3).

It is not known if albendazole or its active metabolite, albendazole sulfoxide, crosses the placenta. The molecular weight of the parent compound (about 265) is low enough for transfer, but the poor oral bioavailability suggests that little, if any, of this agent reaches the plasma. No information is available on the metabolite other than that portions of it undergo further oxidative metabolism before elimination (1).

A brief 1993 publication reported the “accidental” exposure to “high doses” (specific doses not given) of albendazole for systemic infections during the 1st trimester in 10 women (4). The women were followed to term, and all delivered normal infants. Moreover, some of the offspring have been followed for up to 1 year without noting any adverse effects from the exposure (4).

In a randomized, placebo-controlled field trial in western Sierra Leone, anthelmintic treatment was studied as part of a strategy to control maternal anemia caused by parasitic infections (5). A single oral dose of albendazole (400 mg) was given to 61 pregnant women in the 2nd trimester. No adverse pregnancy outcomes attributable to the drug were observed.

In summary, albendazole is a broad-spectrum anthelmintic that is used both in humans and in mass treatments of farm animals (3,6). Although the human use of albendazole is apparently widespread (3), the published human pregnancy data are too limited to assess its fetal risk. The drug is embryo toxic and teratogenic in rats and rabbits, but not in mice at the dose tested. One source stated that the developmental toxicity of albendazole observed in animals was attributable to the active metabolite, albendazole sulfoxide (3). At least in rats, the oral bioavailability of albendazole is much higher than in humans: 1% in humans vs. 20% to 30% in rats (3). Because of the limb reduction defects observed at all doses in one animal study, the potential for much higher plasma concentrations of the metabolite if the drug is consumed with a fatty meal, and the very limited human pregnancy data, the use of albendazole during pregnancy is not recommended. If albendazole is required during pregnancy, avoiding the 1st trimester is strongly advised. A 1997 review also concluded that 1st trimester exposure to albendazole should be avoided (6).

Breast Feeding Summary

No reports describing the use of albendazole during human lactation have been located. The anthelmintic is excreted in animal milk (1,7). Although the relatively low molecular weight (about 265) is low enough for excretion into human breast milk, the negligible bioavailability of the parent drug suggests that excretion of clinically significant amounts of this compound do not occur. However, excretion of the active metabolite (albendazole sulfoxide) into breast milk may occur. Moreover, administration of albendazole with a fatty meal will markedly increase the plasma concentration of the metabolite (1) and, thus, may increase the amounts in milk. The effects of this exposure on a nursing infant are unknown.

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References

  1. Product information. Albenza. SmithKline Beecham Pharmaceuticals, 2001.
  2. Mantovani A, Macri C, Stazi AV, Ricciardi C. Effects of albendazole on the early phases of rat organogenesis in vivo: preliminary results (abstract). Teratology 1992;46:25A.
  3. Mantovani A, Ricciardi C, Stazi AV, Macri C. Effects observed on gestational day 13 in rat embryos exposed to albendazole. Reprod Toxicol 1995;9:265–73.
  4. Horton J. The use of antiprotozoan and anthelmintic drugs during pregnancy and contraindications. J Infect 1993;26:104–5.
  5. Torlesse H, Hodges M. Anthelminthic treatment and haemoglobin concentrations during pregnancy. Lancet 2000;356:1083.
  6. de Silva N, Guyatt H, Bundy D. Anthelmintics. A comparative review of their clinical pharmacology. Drugs 1997;53:769–88.
  7. Fletouris DJ, Botsoglou NA, Psomas IE, Mantis AI. Trace analysis of albendazole and its sulphoxide and sulphone metabolites in milk by liquid chromatography. J Chromatogr B Biomed Appl 1996;687:427–35.

Index

Q&A about Albendazole

kathir.m...
which one is the best drug to treat the tape worm Taenia (albendazole resistant) infection in India?
I have suffered with tape worm (Taenia) infection for the past 3 years, I took heavy dose of albendazole treatment so many times but it no use.

so which one is the best drug to treat the tape worm infection? in India cant get nicolasamide tablets.
abagail
I am SO sorry to hear about your tapeworm. I don't have an answer for you but I sympathize with you. I had a tapeworm for 12 years and it's HORRIBLE! I took everything they gave me. I was a baby when my mother noticed it and 12 years old when it finally passed 40 feet. Nobody knows why but I never saw it again. I'm 66 yrs now. I still remember the screaming everytime I saw it coming out. I hope you find good answers here. I'll ask around and see if I can find out anything. Abby
Sunshine
How often is de-worming done for kids & adults? Is Albendazole tablet safe ? Is it taken after dinner ?
Can the tablet be taken on an empty stomach? Can it be given to a 5 yr old in suspension form ? My friends get it from the medical shops without Dr's prescription, is that fine ? Will the tablet disintegrate the worms? Are there any homeopathic remedies for deworming ? Will it be effective ? Is anal itching caused due to worms?
Dreamlan...
I purchase at herbal store an herb called Virastop. It is an enzyme and cleans the body from parasites. I give the children one when they complain of anal itching. The schools now a days do not clean the playgrounds therefore transferring ringworm's, tapeworms and pin worms in school aged children. You can tell when the child is itchy and they complain, especially at night.

I give them one when they complain and they rid of them quickly. It is very safe for a 5 year old and anyone in the household or that uses the toilet must be treated also.

* If your child cannot swallow the tablet. Place it in an 8 oz cup of orange juiceand have the drink it all.

best if taken at night 1 hour before meals as it helps to have an empty stomach and does not cause irritation.
VampireS...
Is albendazole dangerous to take?
hi i am about to take albendazole in the morning i am wandering whether its dangerous to take i have been told that i have worms by a ama doc right here on yahoo answers and my stool conditions have not changed. I would like to know if the medicine is safe to take even if i dont have worms?Is it safe to take?
lportil
first rule of medicine: DO NO HARM

this yahoo doctor may not a an MD after all (I am an astronaut physicist -NOT)

a real MD would never reccomend a medicine that has potential side effects for an illness that has not been diagnosed or at least other illness have been entertained and ruled out (discarded)

even if albendazole is not dangerous I would not take it unless I really had worms as the potential side effects may outweight the potential benefits (no diagnosis means is there a real need and hence a real benefit from taking the medicine - in this case I see no benefit since there is no diagnosis)

hope this helps
sunny
Is it dangerous to take zentel (albendazole) every week?
to treat pinworms
Mir A
No chemical is without side effects. Taking Albendazole in excess may be seriously injurious to your heath, so, please, consult a physician.

As far as I know, you may take a doge every six months or so, to keep yourself dis-infested. One tablet this week and after two weeks take the second to ensure proper cleansing.
pulakurthy r
how good is albendazole as chewable tablet when compared to other dosage ?form?
elitedud...
Chewables are usually for children who have a small esophagus and can't swallow pills. If it comes in a pill then the pill is better because it releases the medicine when it is in your stomach where is can be absorbed the most.
sehling9...
What is an effective cure against intestinal tapeworms?
I have a cousin in Europe who has been struggling with a parazite in her intestine (Taenia solium, a flatworm from pigs) for several years. Her condition is deteriorating rapidly with no hope for cure. She has been treated with Albendazole, Niclosamide, Parazitin

(Vaxa) and several homeopathic products (male fern extract, pumpkin seed extract, black walnut extract) without any success. If anybody knows any cure, I will greatly appreciate their sharing of the information.
quijibor...
This disease is highly curable with good medical treatment and fatal without. Quit the homeopathic stuff as this is wasting time when the disease is progressing and causing brain damage. The article linked below describes treatment. If you need to sign in to access it, don't worry as access if free. Print out the article and have your cousin take it with her to a hospital for treatment. The various curative drug options are listed towards the bottom of the web page as are additional treatments for the damage being done by the flatworm. good luck as this ailment sounds horrible.

http://www.emedicine.com/med/topic494.ht...
dulci
The pharmacology of Albendazole?
cinnomone queen
It's a part of pharmacology.Albendazole is poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Albendazole concentrations are negligible or undetectable in plasma as it is rapidly converted to the sulfoxide metabolite prior to reaching the systemic circulation. The systemic anthelmintic activity has been attributed to the primary metabolite, albendazole sulfoxide. Oral bioavailability appears to be enhanced when albendazole is coadministered with a fatty meal (estimated fat content 40 g) as evidenced by higher (up to 5-fold on average) plasma concentrations of albendazole sulfoxide as compared to the fasted state.
Sathish
Why to take Albendazole or Mebendazole?As v people consume ltrs of Pepsis @ Colas?
Jacuti
These are azole derivatives of fungi... These are anti - fungal agents... what these have to do with aerated drinks....

Are you trying to say that aerated drinks containing all the pesticides and insecticides are good enough to treat your physical illness and there is no requirement for those antifungal agents....?

Well if that is your question? Then what will be the state of those who don't want to or cannot consume the so called PEPSI AND COLA jus because they have diabetes or ulcer ....

Look doctors and physicians are not idiots to prescribe the medicines ....

Jus because U see those aerated drinks as medical ailment you cannot expect everyboby to see in your way... You have chose to live a life with a slow poison ... But we seldom think of that poison ....

Do you know the process involved in making an Antibiotic .... But am sure you must be knowing the ingridients of PEPSI AND COLA ....

THESE PEPSI AND COLA CONTAINS:

AERATED CARBON

INSECTICIDES

PESTICIDES

COLOURING AGENT

PRESERVATIVE --- Do you think that any of these ingridient or on the whole will ne an alternative ... No... NEVER ....

stop asking questions like this ... stop spreading stupid questions like this