Albendazole 200 mg Tablet, 2-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Anthelmintic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Yes, albendazole is used for two serious tapeworm-related infections. Neurocysticercosis happens when the larval stage of the pork tapeworm ends up forming cysts in brain tissue —...
- What exactly is albendazole treating — is it really a tapeworm in my brain?
- It really does matter with this one. Taking albendazole with a fatty meal can increase the amount of active drug that gets into your bloodstream by up to five times compared with t...
- Does it matter if I take it with food? I usually take my pills on an empty stomach.
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $4.192 | $8.38 / 2 tablets |
| Medicaid paysCMS SDUD · 12 mo | $13.16 | $26.31 / 2 tablets |
| Medicare drug plans payPart D · Q2 2026 | $13.97 | $27.94 / 2 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Albendazole 200 mg 00591-2712-02 | Actavis | 2 tablets | $4.192 | — | Availability likely | — |
| Albendazole 200 mg 42799-0110-02 | Edenbridge | 2 tablets | $4.192 | AB | Availability likely | — |
| Albendazole 200 mg 43598-0452-02 | Dr.Reddys | 2 tablets | $4.192 | AB | Availability likely | — |
| Albendazole 200 mgthis 72205-0051-08 | Novadoz | 2 tablets | $4.192 | AB | Availability likely | — |
| Albendazole 200 mg 00115-1701-49 | Amneal | 2 tablets | $12.609 | — | FDA listed | +201% |
| Albendazole 200 mg 46708-0681-02 | Alembic | 2 tablets | — | AB | FDA listed | — |
| Albendazole 200 mg 51407-0258-02 | Golden | 2 tablets | — | AB | FDA listed | — |
| Albendazole 200 mg 62332-0681-02 | Alembic | 2 tablets | — | AB | FDA listed | — |
| Albenza 200 mg 64896-0693-49 | Amneal | 2 tablets | — | — | FDA listed | — |
| Albendazole 200 mg 72162-2359-02 | Bryant | 2 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 72205-0051-08 You're viewing this | 2 TABLET in 1 BOTTLE (72205-051-08) | $4.19 / ea | $8.38 | 2021-02-24 | Active |
| 72205-0051-28 | 28 TABLET in 1 BOTTLE (72205-051-28) | — | — | 2021-02-24 | Active |
You're viewing the smallest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 72205-0051-08?
What is the difference between NDC 72205-0051-08 and NDC 72205-0051-28?
What NDC number is used to bill for this package of Albendazole 200 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Albendazole tablet is an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . ( 1.1 ) Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . ( 1.2 )
1.1Neurocysticercosis Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium .
1.2Hydatid Disease Albendazole tablets are 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 .
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg,15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole tablets should be taken with food. ( 2 ) Hydatid disease: 28-day cycle followed by 14-day albendazole-free interval for a total of 3 cycles. ( 2 ) Neurocysticercosis: 8 to 30 days. ( 2 ) See additional important information in the Full Prescribing Information. ( 2 )
2.1Dosage Dosing of albendazole tablets will vary depending upon the indication. Albendazole tablets may be crushed or chewed and swallowed with a drink of water. Albendazole tablets should be taken with food [ see Clinical Pharmacology (12.3)].
Table 1: Albendazole Tablets 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)
2.2Concomitant 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)].
2.3Monitoring 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 albendazole tablets 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 albendazole tablets in all patients [ see Warnings and Precautions (5.5)]. Obtain a pregnancy test in females of reproductive potential prior to therapy [ see Warnings and Precautions (5.2)].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablet: 200 mg Tablet: 200 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Albendazole is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole. Patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Bone Marrow Suppression: Fatalities have been reported due to bone marrow suppression; monitor blood counts in all patients at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy. Discontinue albendazole if clinically significant changes in blood counts occur. ( 5.1 , 5.4 ) Embryo-Fetal Toxicity: May cause fetal harm.
Pregnancy testing is recommended for females of reproductive potential prior to therapy. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception. ( 2.3 , 5.2 , 8.1 , 8.3 ) Risk of Neurologic Symptoms: Neurocysticercosis patients may experience cerebral hypertensive episodes, seizures or focal neurologic deficits after initiation of therapy; begin appropriate steroid and anticonvulsant therapy.
( 5.3 ) Risk of Retinal Damage in Retinal Cysticercosis: Cases of retinal involvement have been reported; examine the patient for the presence of retinal lesions before initiating therapy for neurocysticercosis. ( 5.4 ) Hepatic Effects. Elevations of liver enzymes may occur.
Monitor liver enzymes before the start of each treatment cycle and at least every 2 weeks while on albendazole therapy and discontinue if clinically significant elevations occur. ( 5.5 )
5.1Bone Marrow Suppression Fatalities associated with the use of albendazole have been reported due to granulocytopenia or pancytopenia. Albendazole may cause bone marrow suppression, aplastic anemia, and agranulocytosis. Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with albendazole in all patients.
Patients with liver disease and patients with hepatic echinococcosis are at increased risk for bone marrow suppression and warrant more frequent monitoring of blood counts. Discontinue albendazole if clinically significant decreases in blood cell counts occur.
5.2Embryo-Fetal Toxicity Based on findings from animal reproduction studies, albendazole may cause fetal harm when administered to a pregnant woman. Embryotoxicity and skeletal malformations were reported in rats and rabbits when treated during the period of organogenesis (at oral doses approximately 0.1 to 0.6 times the recommended human dose normalized for total body surface area). Advise pregnant women of the potential risk to a fetus.
Pregnancy testing is recommended for females of reproductive potential prior to initiating albendazole [ see Dosage and Administration (2.3) ]. Advise females of reproductive potential to use an effective method of contraception during treatment with albendazole and for 3 days after the final dose [ see Use in Specific Populations (8.1, 8.3) and Clinical Pharmacology (12.3) ].
5.3Risk of Neurologic Symptoms in Neurocysticercosis Patients being treated for neurocysticercosis should receive steroid and anticonvulsant therapy to prevent neurological symptoms (e.g. seizures, increased intracranial pressure and focal signs) as a result of an inflammatory reaction caused by death of the parasite within the brain.
5.4Risk of Retinal Damage in Patients with Retinal Neurocysticercosis Cysticercosis may involve the retina. Before initiating therapy for neurocysticercosis, examine the patient for the presence of retinal lesions. If such lesions are visualized, weigh the need for anticysticeral therapy against the possibility of retinal damage resulting from inflammatory damage caused by albendazole-induced death of the parasite.
5.5Hepatic Effects In clinical trials, treatment with albendazole has been associated with mild to moderate elevations of hepatic enzymes in approximately 16% of patients. These elevations have generally returned to normal upon discontinuation of therapy. There have also been case reports of acute liver failure of uncertain causality and hepatitis [ see Adverse Reactions (6)].
Monitor liver enzymes (transaminases) before the start of each treatment cycle and at least every 2 weeks duri…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Adverse reactions 1% or greater in hydatid disease: abnormal liver function tests, abdominal pain, nausea/vomiting, reversible alopecia, headache, dizziness/vertigo, fever. ( 6.1 ) Adverse reactions 1% or greater in neurocysticercosis: headache, nausea/vomiting, raised intracranial pressure, meningeal signs. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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 albendazole 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 albendazole.
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.
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of albendazole. 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.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Dexamethasone: Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when dexamethasone was coadministered with each dose of albendazole. ( 7.1 ) Praziquantel: In the fed state increased mean maximum plasma concentration and area under the curve of albendazole sulfoxide by about 50% in healthy subjects. ( 7.2 ) Cimetidine: Increased albendazole sulfoxide concentrations in bile and cystic fluid by about 2-fold in hydatid cyst patients.
( 7.3 ) Theophylline: Albendazole induces cytochrome P450 1A in human hepatoma cells; therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment. ( 5.5 , 7.4 )
7.1Dexamethasone Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when 8 mg dexamethasone was co-administered with each dose of albendazole (15 mg/kg/day) in 8 neurocysticercosis patients.
7.2Praziquantel In the fed state, praziquantel (40 mg/kg) increased mean maximum plasma concentration and area under the curve of albendazole sulfoxide by about 50% in healthy subjects (n = 10) compared with a separate group of subjects (n = 6) given albendazole alone. Mean T max and mean plasma elimination half-life of albendazole sulfoxide were unchanged. The pharmacokinetics of praziquantel were unchanged following co-administration with albendazole (400 mg).
7.3Cimetidine Albendazole sulfoxide concentrations in bile and cystic fluid were increased (about 2-fold) in hydatid cyst patients treated with cimetidine (10 mg/kg/day) (n = 7) compared with albendazole (20 mg/kg/day) alone (n = 12). Albendazole sulfoxide plasma concentrations were unchanged 4 hours after dosing.
7.4Theophylline Following a single dose of albendazole (400 mg), the pharmacokinetics of theophylline (aminophylline 5.8 mg/kg infused over 20 minutes) were unchanged. Albendazole induces cytochrome P450 1A in human hepatoma cells; therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Based on findings from animal reproduction studies, albendazole may cause fetal harm when administered to a pregnant woman. However, available human data from a small number of published case series and reports on the use of multiple-dose albendazole in the 1st trimester of pregnancy, and several published studies on single-dose albendazole use later in pregnancy, have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive studies, oral administration of albendazole during the period of organogenesis caused embryotoxicity and skeletal malformations in pregnant rats (at doses of 0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m 2 ) and pregnant rabbits (at doses of 0.60 times the maximum recommended human dose based on body surface area in mg/m 2 ).
Albendazole was also associated with maternal toxicity in rabbits (at doses of 0.60 times the recommended human dose based on body surface area in mg/m 2 ) ( see Data ). Advise a pregnant woman of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Albendazole has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits.
The teratogenic response in the rat was shown at oral doses of 10 and 30 mg/kg/day (0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m 2 , respectively) during organogenesis (gestation days 6 to 15) and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the maximum recommended human dose based on body surface area in mg/m 2 ) administered during organogenesis (gestation days 7 to 19). In the rabbit study, maternal toxicity (33% mortality) was noted at 30 mg/kg/day.
In mice, no teratogenic effects were observed at oral doses up to 30 mg/kg/day (0.16 times the recommended human dose based on body surface area in mg/m 2 ), administered during gestation days 6 to 15.
8.2Lactation Risk Summary Concentrations of albendazole and the active metabolite, albendazole sulfoxide, have been reported to be low in human breast milk. There are no reports of adverse effects on the breastfed infant and no information on the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for albendazole and any potential adverse effects on the breastfed infant from albendazole or from the underlying maternal condition.
8.3Females and Males of Reproductive Potential Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating albendazole. Contraception Females Albendazole may cause fetal harm when administered to a pregnant woman [ see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with albendazole and for 3 days after the final dose.
8.4Pediatric Use Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of albendazole in children appears to be similar to that in adults.
8.5Geriatric Use In patients aged 65 and older with either hydatid disease or neurocysticercosis, there was insufficient data to determine whether the safety and effectiveness of albendazole is different from that of younger patients.
8.6Patients with Impaired Renal Function The pharmacokinetics of albendazole in patients with impaired renal function has not been studied.
8.7 Patients with Extra-Hepatic Obstructi…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings from animal reproduction studies, albendazole may cause fetal harm when administered to a pregnant woman. However, available human data from a small number of published case series and reports on the use of multiple-dose albendazole in the 1st trimester of pregnancy, and several published studies on single-dose albendazole use later in pregnancy, have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive studies, oral administration of albendazole during the period of organogenesis caused embryotoxicity and skeletal malformations in pregnant rats (at doses of 0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m 2 ) and pregnant rabbits (at doses of 0.60 times the maximum recommended human dose based on body surface area in mg/m 2 ).
Albendazole was also associated with maternal toxicity in rabbits (at doses of 0.60 times the recommended human dose based on body surface area in mg/m 2 ) ( see Data ). Advise a pregnant woman of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Albendazole has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits.
The teratogenic response in the rat was shown at oral doses of 10 and 30 mg/kg/day (0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m 2 , respectively) during organogenesis (gestation days 6 to 15) and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the maximum recommended human dose based on body surface area in mg/m 2 ) administered during organogenesis (gestation days 7 to 19). In the rabbit study, maternal toxicity (33% mortality) was noted at 30 mg/kg/day.
In mice, no teratogenic effects were observed at oral doses up to 30 mg/kg/day (0.16 times the recommended human dose based on body surface area in mg/m 2 ), administered during gestation days 6 to 15.
🧒 Pediatric Use ▾
8.4Pediatric Use Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of albendazole in children appears to be similar to that in adults.
🧓 Geriatric Use ▾
8.5Geriatric Use In patients aged 65 and older with either hydatid disease or neurocysticercosis, there was insufficient data to determine whether the safety and effectiveness of albendazole is different from that of younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE In case of overdosage, symptomatic therapy and general supportive measures are recommended.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Albendazole is a synthetic, anthelmintic drug of the class benzimidazole [ see Clinical Pharmacology (12.4)].
12.3Pharmacokinetics Absorption 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 grams) 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 were achieved 2 hours to 5 hours after dosing and were on average 1310 ng/mL (range 460 ng/mL to 1580 ng/mL) following oral doses of albendazole (400 mg) in 6 hydatid disease patients, when administered with a fatty meal.
Plasma concentrations of albendazole sulfoxide increased in a dose-proportional manner over the therapeutic dose range following ingestion of a high-fat meal (fat content 43.1 grams). The mean apparent terminal elimination half-life of albendazole sulfoxide ranged from 8 hours to 12 hours in 25 healthy 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 cerebrospinal fluid (CSF). Concentrations in plasma were 3-fold to 10-fold and 2-fold to 4-fold higher than those simultaneously determined in cyst fluid and CSF, respectively. 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.
Specific Populations 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. Geriatrics 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.
12.4Microbiology Mechanism of Action Albendazole binds to the colchicine-sensitive site of β-tubulin inhibiting their polymerization into microtubules. The decrease in microtubules in the intestinal cells of the parasites decreases their absorptive function, especially the uptake of glucose by the adult and larval forms of the parasites, and also depletes glycogen storage. Insufficient glucose results in insufficient energy for the production of adenosine trisphosphate (ATP) and the parasite eventually dies.
Mechanism of Resistance Parasitic resistance to albendazole is caused by changes in amino acids that result in changes in the β-tubulin protein. This causes reduced binding of the drug to β…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Albendazole is a synthetic, anthelmintic drug of the class benzimidazole [ see Clinical Pharmacology (12.4)].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Albendazole tablets USP, 200 mg are white colored, round shaped, biconvex, film coated tablets debossed with "MA 7" on one side and plain on other side and contains 200 mg of albendazole. They are supplied as follows: Bottles of 2 Tablets NDC 72205-051-08 Bottles of 28 Tablets NDC 72205-051-28
16.2Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Albendazole tablets, USP are an orally administered anthelmintic drug. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C 12 H 15 N 3 O 2 S.
Its molecular weight is 265.34. It has the following chemical structure: Albendazole, USP is a white to faintly yellowish powder, Sometimes with pinkish hue. It is freely soluble in anhydrous formic acid, very slightly soluble in ether and in methylene chloride.
Albendazole, USP is practically insoluble in alcohol and in water. Each white colored, round shaped, biconvex, film coated tablets debossed with "MA 7" on one side and plain on other side. Inactive ingredients consist of: corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K 30, sodium lauryl sulfate, sodium starch glycolate, hypromellose, titanium dioxide, polyethylene glycol. struct
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Patients should be advised that: Some people, particularly children, may experience difficulties swallowing the albendazole tablets whole. Take albendazole tablets with food. Advise pregnant women and females of reproductive potential of the potential risk to the fetus.
Advise females to inform their prescriber of a known or suspected pregnancy [ see Warnings and Precautions (5.2), Use in Specific Populations (8.1) ]. Advise females of reproductive potential to use effective contraception during treatment with albendazole tablets and for 3 days after the final dose [ see Use in Specific Populations (8.3 )]. During albendazole tablets therapy, monitor blood counts and liver enzymes every 2 weeks because of the possibility of harm to the liver or bone marrow [ see Warnings and Precautions (5.5) ].
Manufactured by: MSN Laboratories Private Limited Telangana – 509 228, INDIA Distributed by: Novadoz Pharmaceuticals LLC Piscataway, NJ 08854-3714 Issued on: 02/2020