mph Bangladesh


Albendazole

(al ben' da zole)

PCI  :Contraindicated in pregnancy

LCI  :Contraindicated in lactation

Molecule Info

|See TERMINOLOGY & ABBREVIATIONS |
Description

Albendazole is an orally administered broad-spectrum anthelmintic. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34.

Albendazole is a white to off-white powder. It is soluble in dimethylsulfoxide, strong acids, and strong bases. It is slightly soluble in methanol, chloroform, ethyl acetate, and acetonitrile. Albendazole is practically insoluble in water. Each white to off-white, film-coated tablet contains 200 mg of albendazole.

Inactive ingredients consist of: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium saccharin, sodium starch glycolate, and starch.

Indication(s) & Dosage

Albendazole is indicated for the treatment of the following infections:

Neurocysticercosis

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

Lesions considered responsive to albendazole therapy appear as nonenhancing cysts with no surrounding edema on contrast-enhanced computerized tomography. Clinical studies in patients with lesions of this type demonstrate a 74% to 88% reduction in number of cysts; 40% to 70% of albendazole-treated patients showed resolution of all active cysts.

Hydatid Disease

Albendazole 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.

This indication is based on combined clinical studies which demonstrated non-infectious cyst contents in approximately 80-90% of patients given Albendazole for 3 cycles of therapy of 28 days each. Clinical cure (disappearance of cysts) was seen in approximately 30% of these patients, and improvement (reduction in cyst diameter of >25%) was seen in an additional 40%. 

Echinococcosis
Adult: >60 kg: 400 mg bid for 28 days; <60 kg: 15 mg/kg daily in 2 divided doses. Max dose: 800 mg daily. For cystic echinococcosis, up to 3 treatment cycles of 28 days each may be given with 14 treatment-free days in between cycles. For alveolar echinococcosis, treatment cycles of 28 days each with 14 treatment-free days in between. Treatment cycles may need to be continued for mth or yr until complete eradication of parasites. 
Neurocysticercosis
Adult: >60 kg: 400 mg bid; <60 kg: 15 mg/kg daily in 2 divided doses for 8-30 days.
Max Dosage: Adult <60 kg: 800 mg daily.
Enterobiasis
Adult: 400 mg as a single dose.
Child: >2 yr: 400 mg as a single dose; 1-2 yr: 200 mg as a single dose for enterobiasis.
Ascariasis
Adult: 400 mg as a single dose.
Child: >2 yr: 400 mg as a single dose; 1-2 yr: 200 mg as a single dose for enterobiasis.
Hookworm infections
Adult: 400 mg as a single dose.
Child: >2 yr: 400 mg as a single dose; 1-2 yr: 200 mg as a single dose for enterobiasis.
Strongyloidiasis
Adult: 400 mg once daily or bid for 3 consecutive days, repeated after 3 wk if necessary.
Giardiasis
Adult: 400 mg daily for 5 days.
Child: 400 mg daily for 5 days.

Administration May be taken with or without food. May be taken with meals to minimise GI upset.
Overdosage Symptomatic and supportive measures are advised.
Contraindications Pregnancy and lactation. Neonates. Hypersensitivity, liver impairment.
Special Precautions
Special Populations

Patients with Impaired Renal Function

The pharmacokinetics of albendazole in patients with impaired renal function have not been studied. However, since renal elimination of albendazole and its primary metabolite, albendazole sulfoxide, is negligible, it is unlikely that clearance of these compounds would be altered in these patients.

Biliary Effects

In patients with evidence of extrahepatic obstruction (n = 5), the systemic availability of albendazole sulfoxide was increased, as indicated by a 2-fold increase in maximum serum concentration and a 7-fold increase in area under the curve. The rate of absorption/conversion and elimination of albendazole sulfoxide appeared to be prolonged with mean Tmax and serum elimination half-life values of 10 hours and 31.7 hours, respectively. Plasma concentrations of parent albendazole were measurable in only 1 of 5 patients.

Pediatrics

Following single-dose administration of 200 mg to 300 mg (approximately 10 mg/kg) albendazole to 3 fasted and 2 fed pediatric patients with hydatid cyst disease (age range 6 to 13 years), albendazole sulfoxide pharmacokinetics were similar to those observed in fed adults.

Elderly Patients

Although no studies have investigated the effect of age on albendazole sulfoxide pharmacokinetics, data in 26 hydatid cyst patients (up to 79 years) suggest pharmacokinetics similar to those in young healthy subjects.

Microbiology

The principal mode of action for albendazole is by its inhibitory effect on tubulin polymerization which results in the loss of cytoplasmic microtubules.

In the specified treatment indications albendazole appears to be active against the larval forms of the following organisms:

Echinococcus granulosus

Taenia solium

Adverse Drug Reaction(s) GI discomfort, headache, nausea, dizziness, allergic reactions, pruritus, raised liver enzymes, alopecia and dry mouth.
Potentially Fatal: Bone marrow depression.
Drug Interactions Cimetidine increases albendazole metabolism. Serum levels are increased if taken with dexamethasone and praziquantel agent.
Pregnancy Category (FDA) Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Storage Oral: Store at 20-25°C.
Pharmacology
CLINICAL PHARMACOLOGY
Pharmacokinetics

Absorption and Metabolism

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.

Maximal plasma concentrations of albendazole sulfoxide are typically achieved 2 to 5 hours after dosing and are on average 1.31 mcg/mL (range 0.46 to 1.58 mcg/mL) following oral doses of albendazole (400 mg) in 6 hydatid disease patients, when administered with a fatty meal. Plasma concentrations of albendazole sulfoxide increase in a dose-proportional manner over the therapeutic dose range following ingestion of a fatty meal (fat content 43.1 g). The mean apparent terminal elimination half-life of albendazole sulfoxide typically ranges from 8 to 12 hours in 25 normal subjects, as well as in 14 hydatid and 8 neurocysticercosis patients.

Following 4 weeks of treatment with albendazole (200 mg three times daily), 12 patients’ plasma concentrations of albendazole sulfoxide were approximately 20% lower than those observed during the first half of the treatment period, suggesting that albendazole may induce its own metabolism.

Distribution

Albendazole sulfoxide is 70% bound to plasma protein and is widely distributed throughout the body; it has been detected in urine, bile, liver, cyst wall, cyst fluid, and cerebral spinal fluid (CSF). Concentrations in plasma were 3- to 10-fold and 2- to 4-fold higher than those simultaneously determined in cyst fluid and CSF, respectively. Limited in vitro and clinical data suggest that albendazole sulfoxide may be eliminated from cysts at a slower rate than observed in plasma.

Metabolism and Excretion

Albendazole is rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which is further metabolized to albendazole sulfone and other primary oxidative metabolites that have been identified in human urine. Following oral administration, albendazole has not been detected in human urine. Urinary excretion of albendazole sulfoxide is a minor elimination pathway with less than 1% of the dose recovered in the urine. Biliary elimination presumably accounts for a portion of the elimination as evidenced by biliary concentrations of albendazole sulfoxide similar to those achieved in plasma.

ATC Classification P02CA03 - albendazole; Belongs to the class of benzimidazole derivative agents used as antinematodal.

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Brand/Product Info


Total Products : 81                                                                                 
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
ABENTEL Aristopharma Ltd. Albendazole 400mg Tablet 50's: 175.00 MRP
ADZE-400 Kemiko Pharmaceuticals Ltd Albendazole 400mg Tablet 50's: 200.00 MRP
AL Everest Pharmaceuticals Ltd. Albendazole 200mg/5ml Suspension 10ml: 15.00 MRP
AL 400 Everest Pharmaceuticals Ltd. Albendazole 400mg Tablet 30's: 114.00 MRP
AL-DS Globe Pharmaceuticals Ltd Albendazole 400mg Tablet 40's: 152.00 MRP
ALARM Decent Pharma Laboratories Ltd. Albendazole 400mg Tablet 30's: 120.00 MRP
ALBA Navana Pharmaceuticals Limited Albendazole 400mg Tablet 50's: 190.50 IP
ALBAMAX-DS Ziska Pharmaceuticals Ltd. Albendazole 400mg Tablet 100's: 456.00 MRP
ALBAZOLE-DS Central Pharmaceuticals Ltd Albendazole 400mg Tablet 50's: 200.00 MRP
ALBEN Eskayef Bangladesh Ltd Albendazole 200mg/5ml Suspension 10ml MRP: 15.00
ALBEN-DS Eskayef Bangladesh Ltd Albendazole 400mg Tablet 400mg x48's & 100's MRP: 192.00, 400.00
ALBENDA-DS Aexim Pharmaceutical Ltd. Albendazole 400mg Tablet 20's: 66.00 MRP
ALBENDOX Indo-Bangla Pharmaceuticals Works Ltd. Albendazole 400mg Tablet 50's: 200.00 MRP
ALBEZEN Zenith Pharmaceuticals Ltd. Albendazole 400mg Tablet 60's: 180.00 MRP
ALBEZOLE Apollo Pharmaceutical Laboratories Ltd. Albendazole 400mg Tablet 30's: 114.00 IP
ALBICON DS The White Horse Pharma Albendazole 400mg Tablet 100's: 400.00 MRP
ALBREX Medimet Pharmaceuticals Ltd Albendazole 400mg Tablet 50's: 175.00 MRP
ALDA Supreme Pharmaceuticals Ltd. Albendazole 200mg/5ml Suspension 10ml: 15.00 MRP
ALDA-DS Supreme Pharmaceuticals Ltd. Albendazole 400mg Tablet 25's: 80.00 MRP
ALDABEN Ad-din pharmaceuticals Ltd. Albendazole 200mg/5ml Suspension 10ml: 11.40 MRP
ALDABEN-DS Ad-din pharmaceuticals Ltd. Albendazole 400mg Tablet 25's: 96.00 MRP
ALDES Desh Pharmaceuticals (Pvt) Ltd Albendazole 200mg/5ml Suspension 10ml: 15.00 MRP
ALDES-DS Desh Pharmaceuticals (Pvt) Ltd Albendazole 400mg Tablet 50's & 100's: 200.00 & 400.00 MRP
ALDEX Gaco Pharmaceutical Ltd. Albendazole 200mg/5ml Suspension 10ml: 15.00 MRP
ALDEX-DS Gaco Pharmaceutical Ltd. Albendazole 400mg Tablet 20's: 66.00 MRP
ALDIN DS Techno Drugs Albendazole 400mg Tablet 60's: 180.00 MRP
ALENTIN-DS Renata Limited Albendazole 400mg Tablet 25's: 83.75 MRP
ALMEX Square Pharmaceuticals Ltd. Albendazole 400mg Tablet 12x4's: 240.96 MRP
ALMEX SUSP Square Pharmaceuticals Ltd. Albendazole 200mg/5 ml Suspension 6's: 120.00 MRP
ALMIN Kumudini Pharma Ltd Albendazole 400mg Tablet 50's: 180.00 MRP
ALMIN Suspension Kumudini Pharma Ltd Albendazole 200mg/5ml Suspension 10ml: 14.00 MRP
ALPHIN DS Beximco Pharmaceuticals Ltd Albendazole 400mg Tablet 50's: 250.00 MRP
ALPRO Pharmadesh Laboratories Limited Albendazole 400mg Tablet 30's: 120.00 MRP
ALZED General Pharmaceuticals Ltd Albendazole 400mg Tablet 20's: 66.20 MRP
ANTHEL Seema Pharmaceuticals Ltd. Albendazole 400mg Tablet 50's: 210.00 MRP
ASIBEN Asiatic Laboratories Ltd. Albendazole 200mg/5ml Suspension 10ml: 14.00 MRP
AZOLE Biopharma Laboratories Ltd Albendazole 400mg Tablet 20's: 80.40 MRP
AZOLE Suspension Biopharma Laboratories Ltd Albendazole 200mg/5ml Suspension 10ml: 15.06 MRP
BEN-A The Acme Laboratories Ltd. Albendazole 400mg Tablet 200mg x50's ; 400mg x25's: 134.00, 100.25 MRP
BEN-A Suspension The Acme Laboratories Ltd. Albendazole 200mg/5ml Suspension 10ml: 15.05 MRP
BENDA-DS Bristol Pharma Limited Albendazole 400mg Tablet 50's: 175.00 MRP
BENFAST Novo Healthcare and Pharma Ltd. Albendazole 400mg Tablet 50's: 187.50 MRP
BENZ-24 Belsen Pharmaceuticals Ltd. Albendazole 400mg Tablet 50's: 160.00 MRP
CHIR-DS Reliance Pharmaceuticals Ltd. Albendazole 400mg Tablet 10's: 51.00 MRP
CHUBEN Alco Pharma Ltd Albendazole 400mg Tablet 50's: 192.50 MRP
COLAZ Cosmic Chemical Industries Limited Albendazole 200mg/5ml Suspension 10ml: 15.00 MRP
COLAZ-400 Cosmic Chemical Industries Limited Albendazole 400mg Tablet 30's: 150.00 MRP
COSBEN 400 Cosmo Pharma Laboratories Ltd. Albendazole 400mg Tablet 50's: 150.00 MRP
DURAZOL Millat Pharmaceuticals Ltd Albendazole 200mg/5ml Suspension 10ml: 15.00 MRP
DURAZOL-400 Millat Pharmaceuticals Ltd Albendazole 400mg Tablet 50's: 200.00 MRP
EBEN Edruc Limited Albendazole 200mg/5ml Suspension 10ml: 15.00 IP
EBEN-DS Edruc Limited Albendazole 400mg Tablet 25's: 81.00 IP
ELMIN Jayson Pharmaceuticals Ltd. Albendazole 400mg Tablet 25's: 82.75 IP
ESTAZOL IBN SINA Pharmaceutical Industry Ltd. Albendazole 200mg/5ml Suspension 10ml: 20.00 IP
ESTAZOL-400 IBN SINA Pharmaceutical Industry Ltd. Albendazole 400mg Tablet 50's: 200.00 IP
G-ALBENDAZOLE Gonoshasthaya Pharmaceuticals Ltd Albendazole 200mg & 400mg Tablet 100's each: 224.00 & 326.00 MRP
H-BEN Hudson Pharmaceuticals Ltd Albendazole 400mg Tablet 40's: 144.00 MRP
HELBEN DS Modern Pharmaceuticals Ltd Albendazole 400mg Tablet 50's: 152.00 MRP
INFESEN Drug International Ltd Albendazole 400mg Tablet 60's: 210.00 MRP
INFESEN Suspension Drug International Ltd Albendazole 200mg/5ml Suspension 10ml: 15.00 MRP
KRIMIZOLE Mystic Pharmaceuticals Limited Albendazole 200mg/5ml Suspension 10ml: 15.00 MRP
KRIMIZOLE-DS Mystic Pharmaceuticals Limited Albendazole 400mg Tablet 25's: 81.25 MRP
MEBEL Medicon Laboratories Ltd Albendazole 200mg/5ml Suspension 10ml: 20.00 MRP
MEBEL DS Medicon Laboratories Ltd Albendazole 400mg Tablet 50's: 265.00 MRP
NEMATOX-DS Chemist Laboratories Ltd. Albendazole 400mg Tablet 50's: 177.00 MRP
NT-PAR Rangs Pharmaceuticals Ltd. Albendazole 400mg Tablet 50's: 187.50 MRP
NT-PAR Suspension Rangs Pharmaceuticals Ltd. Albendazole 200mg/5ml Suspension 10ml: 15.00 MRP
PAMIL DS Euro Pharma Ltd. Albendazole 400mg Tablet 50's: 190.00 MRP
R-ZOL Reman Drug Laboratories Ltd. Albendazole 400mg Tablet 25's: 100.00 MRP
SINTEL ACI Ltd. Albendazole 400mg Tablet 50's: 201.00 MRP
SINTEL Suspension ACI Ltd. Albendazole 200mg/5ml Suspension 10ml: 15.06 MRP
TRIBEN Ambee Pharmaceuticals Ltd. Albendazole 400mg Tablet 25's: 83.50 MRP
TRIBEN Suspension Ambee Pharmaceuticals Ltd. Albendazole 200mg/5ml Suspension 10ml: 13.91 MRP
VERMID Somatec Pharmaceuticals Ltd. Albendazole 400mg Tablet 25's: 82.50 IP
VERMIKIL NIPRO JMI Pharma Ltd. Albendazole 200mg/5ml Suspension 10ml: 15.06 MRP
VERMIKIL Chew NIPRO JMI Pharma Ltd. Albendazole 400mg Chewable Tablet 50's: 176.00 MRP
VERMIN-DS Nipa Pharmaceuticals Ltd. Albendazole 400mg Tablet 25's: 88.75 MRP
WORMEX Syntho Laboratories Ltd. Albendazole 400mg Tablet 26's: 91.00 MRP
WORMEX Suspension Syntho Laboratories Ltd. Albendazole 200mg/5ml Suspension 10ml: 14.00 MRP
ZOBEN Amico Laboratories Ltd. Albendazole 400mg Tablet 50's: 150.00 MRP
ZOBEN Suspension Amico Laboratories Ltd. Albendazole 200mg/5ml Suspension 10ml: 14.00 MRP

Gen. MedInfo

Why Albendazole is prescribed?

Albendazole is used to treat neurocysticercosis (infection caused by the pork tapeworm in the muscles, brain, and eyes that may cause seizures, brain swelling, and vision problems). Albendazole is also used along with surgery to treat cystic hydatid disease (infection caused by the dog tapeworm in the liver, lung, and lining of the abdomen that may damage these organs). Albendazole is in a class of medications called antihelmintics. It works by killing the worms.

How to use Albendazole?

Albendazole may come as a tablet/suspension to take by mouth. It is usually taken with food twice a day. When albendazole is used to treat neurocysticercosis, it is usually taken for 8 to 30 days. When albendazole is used to treat cystic hydatid disease, it is usually taken for 28 days, followed by a 14-day break, and repeated for a total of three cycles. Take albendazole at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take albendazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are giving the medication to a child or if you cannot swallow the tablets whole, you may crush or chew the tablets and swallow with a drink of water.

Take albendazole until you finish the prescription, even if you feel better. If you stop taking albendazole too soon or skip doses, your infection may not be completely treated.

Other uses

Albendazole is also sometimes used to treat infections caused by roundworms, hookworms, threadworm, whipworm, pinworm, flukes, and other parasites (a plant or animal that lives within another living organism to receive some benefit). Talk to your doctor about the risks of using Albendazole for your condition.

Albendazole may be prescribed for other uses; ask your doctor for more information.

What special precautions to follow?

  • inform your doctor if you are allergic to albendazole, mebendazole, any other medications, or any of the ingredients in albendazole tablets. Ask your pharmacist for a list of the ingredients.
  • inform your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention theophylline. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • inform your doctor if you have or have ever had liver disease.
  • inform your doctor if you are pregnant, could be pregnant, or plan to become pregnant. You should not begin your treatment with albendazole until you have taken a pregnancy test with negative results. You should not become pregnant while you are taking albendazole and for at least one month after finishing your treatment. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking albendazole, call your doctor immediately. Albendazole may harm the fetus.
  • inform your doctor if you are breast-feeding.
  • if you are having surgery, including dental surgery, inform the doctor or dentist that you are taking albendazole.
  • if you are taking albendazole to treat neurocysticercosis, your doctor will probably inform you to take certain medications to prevent damage to the nervous system during your treatment. Call your doctor right away if you have any of the following symptoms: seizures, headache, vomiting,extreme tiredness, or changes in behavior.

What special dietary instructions to follow?

Unless your doctor informs you otherwise, continue your normal diet.

What to do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects could appear?

Albendazole may cause side effects. inform your doctor if any of these symptoms are severe or do not go away:

  • stomach pain

  • nausea

  • vomiting

  • headache

  • dizziness

  • reversible hair loss

Some side effects can be serious and you may need to consult your doctor immediately:

  • sore throat, fever, chills and other signs of infection

  • unusual bleeding or bruising

  • weakness

  • fatigue

  • pale skin

  • shortness of breath

  • rash

  • hives

Albendazole may cause other side effects. Call your doctor if you have any unusual problems while taking Albendazole.

Ref: U.S. Natl. Library of Medicine

| See FDA approved Prescribing Information from Brand Manufacturer |    Manufacturer's 
     
| Latest mph edition: 19 Dec 2013 |
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*Trademark name & prescribing information are the property of their respective Manufacturers.

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