Vermox Mebendazole Tablets

Vermox®

PRODUCT NAME

VERMOX® (mebendazole) tablets.

 

DOSAGE FORMS AND STRENGTHS

VERMOX® 500 mg tablet: white to faintly cream- colored, circular, flat, bevel-edged tablet.

Each tablet contains 500 mg mebendazole

For excipients, see List of Excipients.

 

CLINICAL INFORMATION

Indications

VERMOX® 500 mg is indicated for the mass treatment of single or mixed gastrointestinal infestations by Enterobius vermicularis (pinworm); Trichuris trichiura (whipworm); Ascaris lumbricoides (large roundworm); Ancylostoma duodenale, Necator americanus (hookworm).

In patients living in heavily endemic areas, regular treatment with VERMOX® 500 mg (3-4 times a year) will substantially reduce the overall wormload and keep it well below the level of clinical significance.

 

Dosage and Administration

Dosage

1 single tablet of VERMOX® 500 mg.

 

Special populations

Pediatrics

VERMOX® 500 mg given as a single dose.

Pediatrics <2 years of age

Because of the risk of convulsions, VERMOX® is contraindicated in children below the age of 1 year for the mass treatment of single or mixed gastrointestinal infestations (see Contraindications, Warnings and Precautions).

VERMOX® has not been extensively studied in children below the age of 2 years.

Therefore, VERMOX® should be used in children aged 1-2 years only if the potential benefit justifies the potential risk (see Warnings and Precautions).

 

Administration

No special procedures, such as diet or use of laxatives, are required.

 

Contraindications

VERMOX® is contraindicated in children below the age of 1 year for the mass treatment of single or mixed gastrointestinal infestations. In addition, VERMOX® is contraindicated in persons with a known hypersensitivity to the drug or its excipients.

 

Warnings and Precautions

Convulsions in children, including in infants below one year of age, have been reported very rarely during post-marketing experience with VERMOX® (see Adverse Reactions). VERMOX® has not been extensively studied in children below the age of 2 years.

Therefore VERMOX® should be used in children aged 1-2 years only if the potential benefit justifies the potential risk (e.g. if their worm infestation interferes significantly with their nutritional status and physical development).

To reduce the risk of choking, VERMOX® oral suspension should be considered for patients such as young children who are unable to swallow the tablet. There have been rare reports of reversible liver function disturbances, hepatitis, and neutropenia described in patients who were treated with mebendazole at standard dosages for indicated conditions (see Adverse Reactions — Post-marketing data). These events, along with glomerulonephritis, have also been reported with dosages substantially above those recommended and with treatment for prolonged periods of time.

Results from a case-control study investigating an outbreak of Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) suggested a possible relationship between SJS/TEN and the concomitant use of mebendazole and metronidazole. Further data suggesting such a drug-drug interaction are not available. Therefore, concomitant use of mebendazole and metronidazole should be avoided.

 

Interactions

Concomitant treatment with cimetidine may inhibit the increased plasma concentrations of the drug especially during prolonged treatment.

Concomitant use of mebendazole and metronidazole should be avoided (see Warnings and Precautions).

 

Pregnancy, Breast-feeding and Fertility

Pregnancy

Mebendazole has shown embryotoxic and teratogenic activity in rats and in mice. No harmful effects on reproduction were noted in other animal species tested (see Non-clinical Information).

The possible risks associated with prescribing VERMOX® 500 mg during pregnancy, particularly during the first trimester, should be weighed against the expected therapeutic benefits.

 

Breast-feeding

It is not known whether mebendazole is excreted in human breast milk. Therefore, caution should be exercised when VERMOX® 500 mg is administered to breast-feeding women.

 

Fertility

Results of mebendazole reproduction studies showed no effects on fertility up to and including doses of 10 mg/kg/day (60 mg/m2) (see Non-clinical information).

 

Effects on Ability to Drive and Use Machines

VERMOX® 500 mg does not affect the mental alertness or driving ability.

 

Adverse Reactions

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of mebendazole based on the comprehensive assessment of the available adverse event information. A causal relationship with mebendazole cannot be reliably established in individual cases.

Further, 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 clinical practice.

 

Clinical trial data

The safety of VERMOX® was evaluated in 6276 subjects who participated in 39 clinical trials for the treatment of single or mixed parasitic infestations of the gastrointestinal tract. In these 39 clinical trials, no adverse reactions occurred in ≥1 % of VERMOX® treated subjects. Adverse reactions occurring in <1% of VERMOX® treated subjects are shown in Table 1.

 

Table 1. Adverse Reactions Reported by <1% of VERMOX®-Treated Subjects in 39 Clinical Trials

System/Organ Class

Adverse Reaction

 

Gastrointestinal Disorders

Abdominal Discomfort

Diarrhea

Flatulence

 

Skin and Subcutaneous Tissue Disorders

Rash

 

Post-marketing data

Adverse reactions first identified during post- marketing experience with VERMOX® (mebendazole) are included in Table 2. In this table, adverse reactions are based on spontaneous reporting rates, and presented by frequency category according to the following convention:

Very common ≥1/10

Common ≥1/100 and <1/10

Uncommon ≥1/1000 and <1/100

Rare ≥1/10000 and <1/1000

Very rare <1/10000, including isolated reports.

 

Table 2. Adverse Reactions Identified During Postmarketing Experience with VERMOX® by Frequency Category Estimated from Spontaneous Reporting Rates

System Organ Class

Frequency Adverse Reaction

Category

Blood and Lymphatic System Disorders

Very Rare Neutropenia

 

Immune System Disorders

Very Rare Hypersensitivity including anaphylactic reaction and anaphylactoid reaction.

 

Nervous System Disorders

Very Rare Convulsions, Dizziness

 

Gastrointestinal Disorders

Very Rare Abdominal pain

 

Hepatobiliary Disorders

Very Rare Hepatitis, Abnormal liver function tests

 

Skin and Subcutaneous Tissue Disorders

Very Rare Toxic epidermal necrolysis, Stevens- Johnson syndrome, Exanthema, Angioedema, Urticaria, Alopecia

 

Overdose

In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported rarely: alopecia, reversible liver function disturbances, hepatitis, agranulocytosis, neutropenia, and glomerulonephritis. With the exception of agranulocytosis and glomerulonephritis, these also have been reported in patients who were treated with mebendazole at standard dosages (see Adverse Reactions — Post- marketing data).

 

Signs and symptoms

In the event of accidental overdose, abdominal cramps, nausea, vomiting and diarrhea may occur.

 

Treatment

There is no specific antidote. Activated charcoal may be given if considered appropriate.

 

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic Properties

Pharmacotherapeutic group: Anthelmintic for oral administration, benzimidazole derivatives, ATC code: PO2CA01

 

Mechanism of action

In therapeutic indications mebendazole acts locally in the lumen of the gut by interfering with cellular tubulin formation in the intestines of worms. Mebendazole binds specifically to tubulin and causes ultrastructural degenerative changes in the intestine.

As a result, the glucose uptake and the digestive functions of the worm are disrupted to such an extent that an autolytic process occurs.

 

Pharmacokinetic Properties

Absorption

Following oral administration, <10% of the dose reaches the systemic circulation, due to incomplete absorption and to extensive pre-systemic metabolism (first-pass effect).

Maximum plasma concentrations are generally seen 2 to 4 hours after administration. Dosing with a high fat meal leads to a modest increase in the bioavailability of mebendazole.

 

Distribution

The plasma protein binding of mebendazole is 90 to 95%. The volume of distribution is 1 to 2 L/kg, indicating that mebendazole penetrates areas outside the vascular space. This is supported by data in patients on chronic mebendazole therapy (e.g., 40 mg/kg/day for 3-21 months) that show drug levels in tissue.

 

Metabolism

Orally administered mebendazole is extensively metabolized primarily by the liver. Plasma concentrations of its major metabolites (amino and hydroxylated amino forms of mebendazole) are substantially higher than those of mebendazole. Impaired hepatic function, impaired metabolism, or impaired biliary elimination may lead to higher plasma levels of mebendazole.

 

Elimination

Mebendazole, the conjugated forms of mebendazole, and its metabolites likely undergo some degree of enterohepatic recirculation and are excreted in the urine and bile. The apparent elimination half-life after an oral dose ranges from 3 to 6 hours in most patients.

 

Steady-state pharmacokinetics

During chronic dosing (e.g., 40 mg/kg/day for 3-21 months), plasma concentrations of mebendazole and its major metabolites increase, resulting in approximately 3-fold higher exposure at steady-state compared to single dosing.

 

NON-CLINICAL INFORMATION

The single-dose toxicity evaluations in multiple species revealed that mebendazole was well tolerated and has a large margin of safety. Repeated-dose, oral, chronic toxicity results in rats, at toxic dose levels of 40 mg/kg (240 mg/m2) and above, showed altered liver weights with some slight centrilobular swelling and hepatocellular vacuolation, and altered testicular weights with some tubular degeneration, desquamation and marked inhibition of spermatogenic activity.

 

Carcinogenicity and Mutagenicity

No carcinogenic effects were observed in the mouse or rat. No mutagenic activity was shown in in vitro gene-mutagenicity studies.

In vivo tests revealed no structural chromosome damaging activity. Micronucleus test results have shown aneugenic effects in mammalian somatic cells above a threshold plasma concentration of 115 ng/mL.

 

Reproductive Toxicology

At maternal toxic doses, embryo toxic and teratogenic activity has been shown in pregnant rats at a single dose of 10 mg/kg (60 mg/m2) and above. Teratogenic and fetotoxic effects have also been observed in mice at maternally toxic doses of 10 mg/kg (60 mg/m2) and higher. No harmful effects on reproduction were noted in other animal species tested.

 

Fertility

Male rat fertility was not affected with doses up to 40 mg/kg (240 mg/m2) for 60 days.

When female rats were dosed at up to 10 mg/kg body weight for 14 days before gestation and during pregnancy, no significant effect upon fetuses and offspring were observed.

However, when female rats were dosed at 40 mg/kg (240 mg/m2) a reduction in the pregnancy rate was observed.

 

PHARMACEUTICAL INFORMATION

List of Excipients

Colloidal anhydrous silica, lactose monohydrate, magnesium stearate, maize starch, methylcellulose, microcrystalline cellulose, sodium starch glycolate.

 

Incompatibilities

None known.

 

Shelf Life

See expiry date on the outer pack.

 

Storage Conditions

See storage conditions on the outer pack.

Keep out of the sight and reach of children.

 

Nature and Contents of Container

VERMOX® 500 mg is supplied in packs containing one tablet or in bottles containing 150 tablets.

Not all pack sizes may be available.

 

Instructions for Use and Handling

Not applicable.

 

Instructions for Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

 

MANUFACTURED BY

See outer carton.

 

Manufactured for

Janssen Pharmaceutica NV,

Turnhoutseweg 30,

B-2340 Beerse, Belgium

 

DATE OF REVISION OF THE TEXT

5 July 2015 based on CCDS 13 June 2014

© Janssen-Cilag 2015

Tanzol Albendazole Chewable Tablet and Oral Suspension

Tanzol™

(Albendazole Chewable Tablet /Albendazole Oral Suspension USP)

 

Composition

Tanzol tablet

Each uncoated chewable tablet contains:

Albendazole USP 400mg.

Colour: Sunset Yellow.

Flavour: Orange.

Excipients: Calcium Hydrogen Phosphate BP, Maize Starch BP, Gelatin BP, Sodium Benzoate BP, Saccharin Sodium BP, Magnesium Stearate BP and Purified Talc BP.

Tanzol suspension

Each 10ml contains:

Albendazole USP 400mg.

Colour: Sunset Yellow FCF.

Flavour: Banana.

Excipients: Citric Acid Monohydrate BP, Glycerol BP, Sodium Methyl Hydroxy Benzoate BP, Sodium Propyl Hydroxy Benzoate BP, Carmellose Sodium BP, Liquid Sorbitol (70%) BP, Sucrose, Polysorbate-80 BP, Purified Water BP.

 

Pharmacological Category

Tanzol is a benzimidazole anthelmintic drug.

 

Pharmacological Action

Tanzol selectively blocks me glucose uptake by adult helminthes in the intestine and their tissue dwelling larvae. Inhibition of glucose uptake leads to endogenous depletion of glycogen stored within the parasite. This in turn causes a decrease in the formation of adenosine triphosphate. By this mechanism, the drug slowly depletes the energy levels of the susceptible parasites.

 

Therapeutic Indications

Tanzol is indicated for the treatment of parasitic worm infestations (single or mixed) due to: Enterobius vermicularis (Pin worms), Trichuris trichuira (Whipworms), Ascaris lumbricoides (Large Roundworms), Ancylostoma duodenale (Hookworms), Necator americanus (Hookworms), Strongyloides stercoralis (Threadworms), Taenia spp (Tapeworms), Hymenolepis nana (Dwarf tapeworms), Taenia solium (Neurocysticercosis), Echinococcus granulosus (Hydatid cysts).

 

Contraindication

Tanzol is contraindicated in pregnancy and in patients with known hypersensitivity to albendazole.

 

Dosage and method of administration

The dose of Tanzol for adults and children above 2 years is one tablet or 10ml of suspension (400mg albendazole) as a single dose in suspected or confirmed infestations with Pin worms, Whipworms, Large Roundworms, Hookworms. In case of suspected or confirmed cases of Threadworms, Tapeworms, or Dwarf tapeworms, Tanzol should be used at a dose of one tablet or 10ml suspension once daily for 3 consecutive days. In cases of Dwarf Tapeworms, retreatment in 10-21 days is recommended. Tanzol 400mg twice daily for 3 consecutive days is effective in the treatment of patients with mixed worm infestation including infestation with Opisthorchis viverrini and Opisthorchis sinensis. For hydatid cysts: 10mg/kg of body weight/day for4-8weeks. For neurocysticercosis: 400mg twice a day for 30 days.

 

Pharmacokinetic Properties

Absorption: Oral absorption is low

Plasma half life: 8.5hrs

Mean plasma peak concentration: 0.46 to 1.58mcg/ml

Elimination: Via bile

 

Side effects of Tanzol

Include transient abdominal pain and diarrhea, dizziness, nausea, constipation, dry mouth etc.

 

Adverse Reaction

Use of large doses of Tanzol can cause adverse effects like allergic reactions, raised liver enzyme values, alopecia, bone marrow depression etc.

 

Warnings and Precautions

General

It has been noted that leucopaenia has occurred when used for periods longer than recommended. Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Cysticercosis may, in rare cases, involve the retina. If retinal lesions are visualized, the need for anticysticeral therapy should be weighed against the possibility of retinal damage caused by albendazole induced changes to the retinal lesion.

 

For use in special populations

Paediatrics

During albendazole therapy, because of the possibility of harm to the liver or bone marrow, routine (every 2 weeks) monitoring of blood counts and liver function tests should take place. Albendazole should be taken with food.

Pregnancy

Refer to contra-indication.

Lactation

Because of inadequate data breast feeding should be discontinued during and minimum 5 days after the treatment.

 

Effects on ability to drive and operate machinery

Not applicable.

 

Drugs interactions

Praziquantel, Cimetidine and Dexamethasone increases the drug level of Tanzol.

Theoretical risk of interaction with the theophylline, anticonvulsants, oral contraceptives and oral hypoglycaemics increases.

 

Symptoms of over dosage and its treatment

If poisoning or excessive overdosage is suspected it is recommended, on general principles, that vomiting be induced or gastric lavage be performed, and symptomatic supportive therapy be administered as appears indicated.

 

Storage condition

Do not store above 30°C.

Protect from sunlight.

Keep out of reach of children.

 

Presentation

Tanzol tablets: Pack of 1 tablet.

NAFDAC Reg. No.: 04-2927

Zambia Lic. No.: 075/046

Method of sale in Zambia: P

PPB Reg. No.: H2011/CTD1901357

Publication Date: 13/04/2016

 

Tanzol suspension: Pack of 10ml bottle.

NAFDAC Reg. No.: 04-8748

Zambia Lic. No.: 075/077

Method of sale in Zambia: P

PPB Reg. No.: H2013/CTD6381388

Axeitol Albendazole Chewable Tablets

AXEITOL

ALBENDAZOLE TABLETS

 

Composition

Each uncoated chewable tablet contains:

Albendazole USP 400mg

 

Indications

Albendazole is indicated for the treatment of the following infections:

Neurocystiscercosis: 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 non-enhancing 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% 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.

 

Pharmacology

Albendazole is a synthetic, benzimidazole-derivative, anthelmintic agent. The drug is structurally related to thiabendazole and mebendazole, and like mebendazole, it is a benzimidazole carbamate derivative. Albendazole is metabolized in the liver to an active metabolite, albendazole sulfoxide which accounts for detectable plasma concentrations of the drug systemic anthelmintic activity of the drug has been attributed to this metabolite. Although the exact mechanism of action of albendazole has not been fully elucidated, the principal anthelmintic effect of benzimidazoles, including albendazole, appears to be the specific, high affinity binding of the drug to free beta-tubulin in parasite cells resulting in selective inhibition of parasite microtubule polymerization and inhibition of microtubule dependent uptake of glucose. Benzimidazole drugs bind to the beta-tubulin of parasites at much lower concentrations than to mammalian beta-tubulin protein; drugs do not inhibit glucose uptake in mammals, and do not appear to have any effect on blood glucose concentrations in humans.

 

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 co-administered 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 an average 1.31 mcg/ml (range 0.46 to 1.58 mcg/mL), following oral doses of albendazole (400 mg) in six 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. The mean apparent terminal half-life of albendazole sulfoxide typically ranges from 8 to 12 hours in twenty-five normal subjects, as well as in fourteen hydatid and eight neurocysticerosis patients. Following four weeks of treatment with albendazole (200 mg three times daily), twelve 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.

 

DOSAGE AND ADMINISTRATION

Dosing of Albendazole will vary, depending upon which of the following parasitic infections is being treated.

Indication Patient Weight Dose Duration
Neurocysticercosis 60 kg or greater 400 mg b.i.d., with meals 8-30 days
less than 60 kg 15 mg/kg/day given in divided doses b.i.d. with meals (maximum total daily dose 800 mg)
Hydatid Disease 60 kg or greater 400 mg b.i.d., with meals 28-day cycle followed by a
14-day albendazole-free interval, for a total of 3 cycles
less than 60kg 15mg/kg/day given in divided doses b.i.d. with meals (maximum total daily dose 800 mg)
[NOTE: When administering albendazole in the pre- or post-surgical setting, optimal killing of cyst contents is achieved when three courses of therapy have been given].

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.

Albendazole is administered orally with food. Oral bioavailability of albendazole appears to be increased when the drug is administered with a fatty meal; when the drug is administered with meals containing about 40g of fat, plasma concentrations of albendazole sulfoxide are up to 5 times higher than those observed when the drug is administered to fasting patients. Albendazole may cause harm to the fetus. Therefore, women of childbearing age should begin treatment only after a negative pregnancy test, and should be cautioned against becoming pregnant while receiving albendazole or within 1 month of completing treatment with the drug. Because albendazole has been associated with mild to moderate increases of hepatic enzymes in about 16% of patients receiving the drug in clinical trials, and may cause hepatotoxicity, liver function tests should be performed prior to each course of albendazole therapy and at least every 2 weeks during treatment with the drug. If clinically important increases in liver function test results occur, albendazole should be discontinued. Leukopenia has occurred in less than 1% of patients receiving albendazole, and rarely, granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia have been reported. Blood counts should be performed at the start of, and every 2 weeks during, each 28-day treatment cycle.

Manufacturer states that if decreases in the total leukocyte count occur, treatment with albendazole may be continued if the decreases are modest and do not progress.

 

Contra-Indications

Albendazole is contra-indicated in patients with known hypersensitivity to the benzimidazole class of compounds.

 

Adverse Reactions

The adverse event profile of Albendazole differs between hydatid disease and neurocysticercosis. Adverse events occurring with a frequency of ≥1% in either disease.

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 adverse events were observed at an incidence of <1%:

Hematologic: Leukopenia. There have been rare reports of granulocytopenia, pancytopenia, agranulocytosis, orthrombocytopenia.

Dermatologic: Rash, urticaria.

Hypersensitivity: Allergic reactions.

Renal: Acute renal failure related to albendazole therapy has been observed.

 

Precautions

Patients being treated for neurocysticerosis 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 anticysticeral therapy.

Cysticercosis may, in rare cases, involve the retina. Before initiating therapy for neurocysticercosis, the patients should be examined for the presence of retinal lesions. If lesions are visualized, the need for anticysticeral therapy should be weighed against the possibility of retinal damage caused by albendazole-induced changes to the retinal lesion.

 

Pregnancy and Lactation

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 recommended human dose based on body surface area in mg/m2, respectively) during gestation days 6 to 15 and in pregnant rabbits at oral doses of 30mg/kg/day (0.60 times the recommended human dose based on body surface area in mg/m2) administered during 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/m2), administered during gestation days 6 to 15.

There are no adequate and well-controlled studies of albendazole administration in pregnant women. Albendazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Albendazole is excreted in animal milk. It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when albendazole is administered to a nursing woman.

 

Pediatric Use

Experience in children under the age of 6 years is limited. In hydatid disease, infection in infants and young children is uncommon, but no problems have been encountered in those who have been treated. In neurocysticercosis, infection is more frequently encountered. In five published studies involving pediatric patients as young as 1 year, no significant problems were encountered, and the efficacy appeared similar to the adult population.

 

Geriatric Use

Experience in patients 65 years of age or older is limited. The number of patients treated for either hydatid disease or neurocysticercosis is limited, but no problems associated with an older population have been observed.

 

Treatment of Overdosage

In case of overdosage, symptomatic therapy (e.g. Gastric lavage and activated charcoal) and general supportive measures are recommended.

 

Drug Interactions

Dexamethasone: 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 eight neurocysticerosis patients.

Praziquantel: 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 Tmax and mean plasma elimination half-life of albendazole sulfoxide were unchanged. The pharmacokinetics of praziquantel were unchanged following co-administration with albendazole (400 mg).

Cimetidine: Albendazole sulfoxide concentrations in bile and cystic fluid were increased (about 2-fold) in hydatid cyst patients treated with cimetidine (10 mg/day/kg) (n=7) compared with albendazole (20 mg/kg/day) alone (n=12). Albendazole sulfoxide plasma concentrations were unchanged 4 hours after dosing.

Theophylline: The pharmacokinetics of theophylline (aminophylline 5.8 mg/kg infused over 20 minutes) were unchanged following a single oral dose of albendazole (400 mg) in 6 healthy subjects.

 

Storage

Store in a cool dry place. Keep out of reach of children.

 

Presentation

Pack of 20 x 1’s & 10 x l’s

Bulk pack of 100’s & 1000’s.

 

NAFDAC Reg. No: 04-8123 ()

 

Manufactured in India by

Khandelwal Laboratories Pvt. Ltd.

Survey NO.277/3/6, Demni Road, Dadra U.T. 396 191.

Regd. Office: 79/87, D. Lad Path, Mumbai -400 033.

 

Marketed by

EDEN U-K PHARMACEUTICAL LTD.

J116 Daminja Avenue Housing Estate

Fegge Onitsha, Anambra State, Nigeria.