Zentel Albendazole Tablets and Suspension

ZENTEL™ Albendazole

 

QUALITATIVE AND QUANTITATIVE COMPOSITION

ZENTEL tablets 200mg

ZENTEL 100mg/5mL (2% liquid suspension)

 

PHARMACEUTICAL FORM

Tablet: Circular, off white film – coated with pyramid shaped structure on both sides.
Suspension: A white homogeneous liquid suspension with a characteristic odour and flavour.

 

CLINICAL PARTICULARS

Indications

ZENTEL is a benzimidazole carbamate with anthelmintic and anti-protozoal activity against the following intestinal and tissue parasites: Roundworm (Ascaris lumbricoides), pinworm (Enterobius vermicularis), hookworm (Necator americanus, Ancylostoma duodenale), whip-worm (Trichuris trichiura), threadworm (Strongyloides stercoralis), tapeworm (Taenia spp and Hymenolepis nana only in the case of associated parasitism), Chlonorchiasis (Chlonorchis sinensis), Opisthorchiasis (Opisthorchis viverrini) and cutaneous larva migrans; Giardiasis (G.lambIia, G.duodenalis, G.intestinalis, Lamblia intestinalis) in children.

 

DOSAGE AND ADMINISTRATION

Dosage

Indications Age Dose Period
– Roundworm

– Pinworm*

– Hookworms

– Whipworm

Adults and children over 2 years of age 400 mg (two 200 mg or 20 mL 2% suspension]# Single dose.
Children 1-2 years of age 200 mg (0ne 200 mg tablet or 10 mL 2% suspension) Single dose
– Strongyloidiasis

– Taeniasis

– Hymenolepiasis

Adults and children over 2 years of age 400 mg (#see above) Two doses per day for 3 days
– Chlonorchiasis
– Opisthorchiasis
Adults and children
over 2 years of age.
400 mg (#see above) Two doses per day for 3 days.
– Cutaneous larva migrans Adults and children
over 2 years of age.
400 mg (#see above) One dose per day for 1 to 3 days.
– Giardiasis Children 2 – 12 years of age only. 400 mg (#see above) One dose per day for 5 days.

*ln order to obtain a complete cure in the case of pinworm infestation, prescribe strict measures of hygiene, also treat the relatives and individuals sharing the same housing.
In cases of proven Hymenolepiasis, retreatment in 10 to 21 days is recommended.

 

Method of Administration

If the patient is not cured after three weeks, a second course of treatment is indicated.

No special procedures, such as fasting or purging, are required.

The tablets can be chewed or taken with water. Some people, particularly young children, may experience difficulties swallowing the tablets whole and should be encouraged to chew the tablets with a little water, alternatively the tablets may be crushed.

 

Special Patient Populations

• Elderly: Experience in patients 65 years of age or older is limited. Reports indicate that no dosage adjustment is required, however, ZENTEL should be used with caution in elderly patients with evidence of hepatic dysfunction (see Hepatic Impairment and Pharmacokinetics).

• Renal Impairment: Since renal elimination of albendazole and its primary metabolite, azole sulfoxide, is negligible, it is unlikely that clearance of these compounds would be altered in these patients. No dosage adjustment is required, however, patients with evidence of renal impairment should be carefully monitored.

• Hepatic impairment: Since albendazole is rapidly metabolised by the liver to the primary pharmacologically active metabolite, albendazole sulfoxide, hepatic impairment would be expected to have significant effects on the pharmacokinetics of albendazole sulfoxide. Patients with abnormal liver function test results (transaminases) prior to commencing albendazole therapy should be carefully monitored.

 

Contraindications

ZENTEL should not be administered during pregnancy, or in women thought to be pregnant.

ZENTEL is contraindicated in patients with a known history of hypersensitivity to the drug (albendazole or constituents).

 

Warnings and Precautions

In order to avoid administering ZENTEL during early pregnancy, women of childbearing age should initiate treatment during the first week of menstruation or after a negative pregnancy test.

Treatment with ZENTEL may uncover pre-existing neurocysticercosis, particularly in areas with high taenosis infection. Patients may experience 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. Symptoms may occur soon after treatment, appropriate steroid and anticonvulsant therapy should be started immediately.

ZENTEL suspension contains benzoic acid which is a mild irritant to the skin, eyes and mucous membrane. It may increase the risk of jaundice in newborn babies.

 

Interactions

Praziquantel has been reported to increase the plasma levels of the albendazole active metabolite.

Ritonavir, phenytoin, carbamazepine and phenobarbital may have the potential to reduce plasma concentrations of the active metabolite of albendazole; albendazole sulfoxide. The clinical relevance of this is unknown, but may result in decreased efficacy, especially in the treatment of systemic helminth infections. Patients should be monitored for efficacy and may require alternative dose regimens or therapies.

 

Pregnancy and Lactation

Pregnancy: ZENTEL should not be administered during pregnancy or in women thought to be pregnant (see Contraindications).

Lactation: It is not known whether albendazole or its metabolites are secreted in human breast milk. Thus ZENTEL should not be used during lactation unless the potential benefits are considered to outweigh the potential risks associated with treatment.

 

Effects on Ability to Drive and Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed.

 

Adverse Reactions

Data from large clinical studies were used to determine the frequency of very common to rare undesirable reactions. The frequencies assigned to all other undesirable reactions (i.e. those occurring at < 1/1000) were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency.

The following convention has been used for the classification of frequency:

Very common ≥1/10

Common ≥1/100 to <1/10

Uncommon ≥1/1000 to < 1/100

Rare ≥1/10,000 to < 1/1000

Very rare < 1/10,000

 

Immune system disorders

Rare: Hypersensitivity reactions including rash, pruritis and urticaria.

Nervous system disorders

Uncommon: Headache and dizziness.

Gastrointestinal disorders

Uncommon: Upper gastrointestinal symptoms (e.g. epigastric or abdominal pain, nausea, vomiting) and diarrhoea.

Hepatic disorders

Rare: Elevations of hepatic enzymes.

Skin and subcutaneous tissue disorders

Very rare: Erythema multiforme, Stevens-Johnson syndrome.

 

Overdose

Treatment: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

 

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

ATC code

P02CA03

 

Mechanism of Action

Albendazole exhibits larvicidal, ovicidal and vermicidal activity, and it is thought to exert its anthelmintic effect by inhibiting tubulin polymerisation. This causes the disruption of the helminth metabolism, incIuding energy depletion, which immobilises and then kills the susceptible helminth.

 

Pharmacokinetics

Absorption

In man, albendazole is poorly absorbed (less than 5%) following oral administration.

The-systemic pharmacological effect of albendazole is augmented if the dose is administered with a fatty meal, which enhances the absorption by approximately five fold.

 

Distribution

Following oral administration of a single dose of 400 mg albendazole, the pharmacoIogical active metabolite, albendazole sulfoxide, has been reported to achieve plasma concentrations from 1.6 to 6.0 micromol/L when taken with breakfast.

 

Metabolism

Albendazole rapidly undergoes extensive first-pass metabolism in the liver, and is generally not detected in plasma. Albendazole suIfoxide is the primary metabolite, which is thought to be the active moiety in effectiveness against systemic tissue infections.

 

Elimination

The plasma haIf-life of albendazole sulfoxide is 8.5 hours.

Albendazole suIfoxide and its metabolites appear to be principally eliminated in bile, with only a small proportion appearing in the urine.

 

Special Patient Populations

Elderly: 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. The number of elderly patients treated for either hydatid disease or neurocysticercosis is limited, but no problems associated with an older population have been observed.

Renal Impairment: The pharmacokinetics of albendazole in patients with impaired renal function has not been studied.

• Hepatic impairment: The pharmacokinetics of albendazole in patients with impaired hepatic function have not been studied.

 

PHARMACEUTICAL PARTICULARS

List of Excipients

Tablet

lactose, starch, povidone, sodium Iauryl sulphate, microcrystalline cellulose, sodium starch glycollate, trusil vanilla special, trusil orange special and magnesium
stearate.

Film coating: HPMC 15, HPMC 5, diehloromethane, isopropyl alcohol and propylene glycol.

 

Oral Suspension

Sodium Iauryl sulphate, glycerol, methyl hydroxybenzoate, carmellose sodium, sorbitol (70%), orange flavor, passion fruit flavour, vanilla extra strong and purified water.

 

Shelf Life

Use before the expiry date clearly indicated on the packaging.

 

Special Precautions for Storage

Tablets: Store below 30°C.

Suspensions: Store below 25°C and protect from direct sunlight.

 

Nature and Contents of Container

Albendazole tablets: 2’s in blister strips comprising a laminate of clear PVC and aluminium foil.

Albendazole suspension: Albendazole suspension 100mg/5mL packed in 28mL PVC resin bottle fitted with 22mm red colour PP cap.

 

Instructions for Use and Handling

Suspensions: Shake well before use.

 

Not all presentations are available in every country

KEEP OUT OF REACH OF CHILDREN

Further information is available on request.

 

Smithkline Beecham Pharmaceuticals

SmithKline Beecham SB House,

Brentford, TW8 9GS, U.K

 

ZENTEL is the trademark of GlaxoSmithKline Group of Companies

Pack insert Leaflet revised 23 April 2014. Version GA03

© 2014 GlaxoSmithKline

 

Manufactured by

MEDREICH LIMITED

Avalahalli, Bangalore – 560 062, INDIA.

Azen Albendazole USP Tablets

AZEN
Albendazole Tablets 200 mg

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory.

 

Composition

Each uncoated chewable tablet contains:

Albendazole USP 200 mg

Excipients: q.s.

Colour: Sunset Yellow Supra

Flavour: Orange Powder

 

PHARMACOLOGY

Animal and human studies have shown that Albendazole exhibits vermicidal, ovicidal and larvicidal activity. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the death of the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin.

Mechanism of action (If known)

As a vermicidal, albendazole causes degenerative alterations in the tegument and intestinal cells of the worm by binding to the colchicinesensitive site of tubulin, thus inhibiting its polymerizatIon or assembly into microtubules. The loss of the cytoplasmic microtubules leads to impaired uptake of glucose by the larval and adult stages of the susceptible parasites, and depletes their gIycogen stores. Degenerative changes in the endoplasmic reticulum, the mitochondria of the germinal layer, and the subsequent release of lysosomes result in decreased production of adenosine triphosphate (ATP), which is the energy required for the survival of the helminth. Due to diminished energy production, the parasite is immobilized and eventually dies.

Albendazole also has been shown to inhibit the enzyme fumarate reductase, which is helminth-specific. This action may be considered secondary to the effect on the microtubules due to the decreased absorption of glucose. This action occurs in the presence of reduced amounts of nicotinamide-adenine dinucleotide in reduced form (NADH), which is a coenzyme involved in many cellular oxidation-reduction reactions. Albendazole has larvicidal effects in necatoriasis and ovicidal effects in ascariasis, ancylostomiasis, and trichuriasis.

 

Relevant Pharmacokinetic Data

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 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 Neuro cysticercosis 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.

 

CLINICAL INFORMATION

Indications

Albendazole Tablet is indicated for the treatment of the following infections:

Neurocysticercosis

Albendazole Tablet is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia sollun. 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% of Albendazole treated patients showed resolution of all active cysts.

Hydatid Disease

Albendazole Tablet 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%.

 

Contra Indications

Albendazole is contraindicated in patients with known hypersensitivity to the Benzimidazole class of compounds or any components of Albendazole.

 

Precautions

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 anticysticeral therapy.

Pre-existing neurocysticercosis may also be uncovered in patients treated with Albendazole for other conditions. Patients may experience 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. Symptoms may occur soon after treatment; appropriate steroid and anticonvulsant therapy should be started immediately. Cysticercosis may, in rare cases, involve the retina. Before initiating therapy for neurocysticercosis, the patient should be examined for the presence of retinal lesions. If such 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.

 

Warnings

Rare fatalities associated with the use of Albendazole Tablet have been reported due to granulocytopenia or pancytopenia. Albendazole has been shown to cause bone marrow suppression, aplastic anemia, and granulocytosis in patients with and without underlying hepatic dysfunction. Blood counts should be monitored 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, including hepatic echinococcosis, appear to be more at risk for bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia attributable to Albendazole and warrant closer monitoring of blood counts. Albendazole should be discontinued in all patients if clinically significant decreases in blood cell counts occur.

Albendazole should not be used in pregnant women except in clinical circumstances – where no alternative management is appropriate. Patients should not become pregnant for at least 1 month following cessation of Albendazole therapy. If a patient becomes pregnant while taking this drug, Albendazole should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Adverse effects

The adverse event profile of Albendazole differs between hydatid disease and neurocysticercosis. Adverse events occurring with a frequency of > 1% in either disease are described in the table 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 events that were reported by investigators to be at least possibly or probably related to Albendazole.

Adverse Event Incidence ≥1 % in Hydatid Disease and Neurocysticercosis

Adverse Event Hydatid Disease Neurocysticercosis
Abnormal Liver Function Tests 15.6 <1.0
Abdominal Pain 6.0 0
Nausea/Vomiting 3.7 6.2
Headache 1.3 11.0
Dizziness/Vertigo 1.2 <1.0
Raised Intracranial Pressure 0 1.5
Meningeal Signs 0 1.0
Reversible Alopecia 1.6 <1.0
Fever 1.0 0

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

 

Blood and Lymphatic System Disorders

Leukopenia. There have been rare reports of granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia. Patients with liver disease, including hepatic echinococcosis, appear to be more at risk of bone marrow suppression.

 

Immune System Disorders

Hypersensitivity reactions, including rash and urticaria.

 

Drug Interaction

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 8 neurocysticercosis 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/kg/day) (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.

 

Dosage regimen

Average dose and dose range for adults and children
The usual recommended dose is a single dose of 400 mg of Albendazole in both adults and children above the age of 2 years.

Additional or more frequent dosage may be necessary in certain conditions.

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 5 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)
NOTE: When administering BENDAZIN in the pre- or post-surgical setting, optimal killing of cyst contents is achieved when 3 courses of therapy have been given
Neurocysticercosis 60 kg or greater 400 mg twice daily, with meals 8-30 days
less than
60 kg
15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)

 

Dosage interval

Dosing of Albendazole will vary, depending upon which of the following parasitic infections is being treated. In young children, the tablets should be crushed or chewed and swallowed with a drink of water.

 

Average duration of treatment

Not Applicable.

 

Dosage in special situations e.g. renal, hepatic and cardiac insufficiency

Not Applicable.

 

Over dosage

Brief clinical description of symptoms

Significant toxicity and mortality were shown in male and female mice at doses, exceeding 5,000 mg/kg; in rats, at estimated doses between 1,300 and 2,400 mg/kg; in hamsters, at doses exceeding 10,000 mg/kg; and in rabbits, at estimated doses between 500 and 1,250 mg/kg. In the animals, symptoms were demonstrated in a dose-response relationship and included diarrhea, vomiting, tachycardia, and respiratory distress.

Treatment of over dosage

No untoward effects were reported. In case of overdosage, symptomatic therapy and general supportive measures are recommended.

 

PHARMACEUTICAL INFORMATION

Dosage forms and strengths of different dosage forms

Each uncoated chewable tablet contains:

Albendazole USP 200 mg

Excipients: q.s.

Colour: Sunset Yellow Supra

Flavour: Orange Powder

 

Storage conditions and shelf life (expiration date)

Store below 30°C.

Protect from direct sunlight, heat and moisture.

Keep all medicines out of reach of children.

Shelf Life: 36 months

 

Package sizes

Blister pack of 2 tablets.

 

Description of the product e.g. tablet size, colour, markings etc

Orange coloured, round shape, uncoated chewable tablet.

 

Marketed by

Astranad Pharmaceuticals and Chemical Co. Ltd.

40, Oliyide Street Mushin,

Lagos. Nigeria.

 

Manufactured by

Fredun Pharmaceuticals Ltd.

14, 15, 16, Zorabian Industrial Complex,

Veoor, Palghar (E).

Dist. Thane – 401 404, INDIA.

Wormhooker Albendazole Tablets

WORMHOOKER TABLETS 400 mg
Albendazole Tablets

 

For the use of a Registered Medical Practitioner or Hospital or a Laboratory only.

 

Composition

Each chewable tablet contains:

Albendazole USP 400mg

Excipients q.s.

 

Description

Albendazole has advantage of single dose administration in many cases like ascariacis, hookworm (both species) and enterobasia.

Up to 75% patients are also cured of strongyloides tapeworms, H.nana is relatively insensitive. It expels Trichinella spiralis from intestines but efficacy in killing larvae that have migrated to muscle is uncertain.

Prolonged treatment has been shown to cause regression of hydatid cysts in liver, surgery may thus be avoided. It acts probably by blocking glucose uptake in parasite & depletion of its glycogen stores.

 

Clinical Pharmacology

Albendazole is a benzimidazole carbamate with anthelmintic and antiprotozoal activity against intestinal and tissue parasites. Animal studies have shown that albendazole exhibits vermicidal ovacidal and larvacidal activity and exerts its anthelmintic effect by inhibiting tubulin polymerization. This causes the disruption of the helminth metabolism, including energy depletion, which mobiIises and then kills the susceptible helminth.

 

Indications & Usage

Albendazole tablet is an oral drug designed to treat different kinds of worm infestations. The active ingredient Albendazole is an anthelmintic and works by killing sensitive parasites.

 

Usage

Albendazole is an anthelmintic exhibiting vermicidal, ovicidal and larvicidal activity, and is effective in the treatment of the following intestinal and tissue parasites: Roundworm (Ascaris lumbricoides), Whip worm (Trichuris trichuria), Pinworm/threadworm (Enterobious vermicularis). Hookworm (Ancylostoma duodenale and Necator americanus), Srongyloides stercoralis, Taenia solium, Taenia saginata, Opisthorchis viverrini, also hydatid cysts. It is thought to kill these worms by causing them to starve.

 

Contraindications

Contraindicated in pregnant and breastfeeding women, neonates, patients with known hypersensitivity, and liver impairment.

 

Drug Interaction

Antidiabetic agents potentiates their action. H2 antagonist increases the plasma concentration of Albendazole.

 

Warnings & Precautions

*Monitor blood counts and liver function.

*Administer within 7 days of start of normal menstruation in women of childbearing age.

*Adequate non-hormonal contraceptive measures must be taken during and for 1 month after therapy.

*Perform liver function tests and blood counts before and every 2 weeks during high dose therapy of hydatid disease.

*It may cause bone marrow depression.

*It may cause dizziness. Do not drive or perform other possibly unsafe tasks until you know how your react to it.

 

Pregnancy & Lactation

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

Pregnancy (Cat. C): obtain (-) pregnancy test first. Avoid pregnancy during or for at least 1 month after stopping; discontinue if pregnancy occurs.

Nursing mothers.

 

Adverse reaction

As specified below there are certain side effects aligned with Albendazole. In case you do observe any unwished effects, do consult your physician or pharmacist, because some of these side effects may need medical assistance.

Nausea, Vomiting, Dizziness, Headache, Insomnia, Infection, Stomach pain, Aggression, Temporary hair loss.

 

SYMPTOMS OF OVERDOSAGE AND ANTIDOTE

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

 

Dosage and administration

Adults & Children above 2yrs: 400mg as a single dose.

Strongyloidiasis, Taniasis, H.nana infections: 400 mg once daily for 3 consecutive days.

Hydatid disease: 400mg twice daily with meals for 28 days. Therapy may be repeated after 14 days intervals for a total of 3 cycles or as directed by Physician.

 

Storage

Store in a cool and dry place, away from light.

KEEP OUT OF REACH OF CHILDREN.

 

Presentation

Carton of 10 mono cartons with 1 blister of 1 tablet each.

 

Manufactured in India by

Maxheal Pharmaceuticals (India) Ltd.

H.O. Maxheal House, Bangur Nagar, Goregaon (W),

Mumbai-400 090

Factory: 95/6, M.I.D.C., Satpur, Nashik-422 007

http://www.maxheal.in