Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or
pharmacist.
* This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
* If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
its inhibitory effect on tubulin polymerization which results in the
loss of cytoplasmic microtubules.
In the specified treatment indications albendazole appears to be
active against the larval forms of the following organisms:
Echinococcus granulosus Taenia solium.
5-PHARMACOKINETICS
Absorption
EMA-ALBENDAZOLE is poorly absorbed from the gastrointestinal
tract due to its low aqueous solubility. Albendazole concentra-
tions 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
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 neurocysticercosis patients. Following 4 weeks of
treatment with albendazole (200 mg three times daily), 12
patients’ plasma concentrations of albendazole sulfoxide were
approximately 20% lower than those observed during the first half
of the treatment period, suggesting that albendazole may
induce its own metabolism.
Distribution
Albendazole sulfoxide is 70% bound to plasma protein and is
widely distributed throughout the body; it has been detected in
urine, bile, liver, cyst wall, cyst fluid, and cerebral spinal fluid (CSF).
Concentrations in plasma were 3- to 10-fold and 2- to 4-fold
higher than those simultaneously determined in cyst fluid and
CSF, respectively. Limited in vitro and clinical data suggest that
albendazole sulfoxide may be eliminated from cysts at a slower
rate than observed in plasma.
Metabolism and Excretion
Albendazole is rapidly converted in the liver to the primary
metabolite, albendazole sulfoxide, which is further metabolized to
albendazole sulfone and other primary oxidative metabolites
that have been identified in human urine. Following oral
administration, albendazole has not been detected in human
urine. Urinary excretion of albendazole sulfoxide is a minor
elimination pathway with less than 1% of the dose recovered in
the urine. Biliary elimination presumably accounts for a portion of
the elimination as evidenced by biliary concentrations of
albendazole sulfoxide similar to those achieved in plasma.
6-CONTRAINDICATIONS
EMA-ALBENDAZOLE is contraindicated in patients with known
hypersensitivity to the benzimidazole class of compounds or any
components of EMA-ALBENDAZOLE.
7-POSOLOGY
Dosing of EMA-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.
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.
8-WARNINGS
Rare fatalities associated with the use of Albendazole have
been reported due to granulocytopenia or pancytopenia.
Albendazole has been shown to cause bone marrow
suppression, aplastic anemia, and agranulocytosis in patients
with and without underlying hepatic dysfunction. Blood counts
should be monitored at the beginning of each 28¬ days 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.
9-PRECAUTIONS
General
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-in-
duced changes to the retinal lesion.
Information for Patients:
Patients should be advised that:
• Some people, particularly young
children, may experience difficulties
swallowing the tablets whole. In young
children, the tablets should be crushed
or chewed and swallowed with a drink of
water.
• Albendazole may cause fetal harm,
therefore, women of childbearing age
should begin treatment after a negative
pregnancy test.
• Women of childbearing age should be
cautioned against becoming pregnant
while on albendazole or within 1 month of
completing treatment.
• 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.
Laboratory Tests: White Blood Cell
Count:
Albendazole has been shown to cause
occasional (less than 1% of treated
patients) reversible reductions in total
white blood cell count. Rarely, more
significant reductions may be
encountered including granulocytope-
nia, agranulocytosis, or pancytopenia.
Blood counts should be performed at the
start of each 28-day treatment cycle
and every 2 weeks during each 28-day
cycle in all patients. Patients with liver
disease, including hepatic echinococco-
sis, appear to be more at risk of bone
marrow suppression and warrant closer
monitoring of blood counts (see
WARNINGS).
Albendazole should be discontinued in
all patients if clinically significant
decreases in blood cell counts occur.
Liver Function: 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).
Liver function tests (transaminases) should be performed before
the start of each treatment cycle and at least every 2 weeks
during treatment. If hepatic enzymes exceed twice the upper
limit of normal, consideration should be given to discontinuing
albendazole therapy based on individual patient circumstances.
Restarting albendazole treatment in patients whose hepatic
enzymes have normalized off treatment is an individual decision
that should take into account the risk/benefit of further
albendazole usage. Laboratory tests should be performed
frequently if albendazole treatment is restarted.
Patients with abnormal liver function test results are at increased
risk for hepatotoxicity and bone marrow suppression (see
WARNINGS). Therapy should be discontinued if liver enzymes are
significantly increased or if clinically significant decreases in
blood cell counts occur.
10-SPECIFIC PATIENT POPULATIONS
Pregnancy Teratogenic Effects: Pregnancy Category C.
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 30 mg/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 (see WARNINGS).
Lactation: 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.
Infants: 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 5 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.
11-DRUG INTERACTIONS
Theophylline: Although single doses of Albendazole have been
shown not to inhibit theophylline metabolism , Albendazole does
induce cytochrome P450 1A in human
hepatoma cells. Therefore, it is recommended that plasma
concentrations of theophylline be monitored during and after
treatment with ALBENDAZOL UBSA. Theophylline: The pharmacoki-
netics 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.
Dexamethasone: Steady-state trough concentrations of
albendazole sulfoxide were about 56% higher when 8 mg
dexamethasone was coadministered 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 coadministration 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.
12-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 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.
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, agranulo-
cytosis, or thrombocytopenia (see WARNINGS). Patients with liver
disease, including hepatic echinococcosis, appear to be more at
risk of bone marrow suppression (see WARNINGS and
PRECAUTIONS).
Immune System Disorders:
Hypersensitivity reactions, including
rash and urticaria.
13-STORAGE CONDITIONS
Keep this medicine out of reach of children.
Store below 30°C.
Keep your medicine in a cool dry place and away from light in
the original package to protect it from moisture.
LIVEALTH BIOPHARMA PVT.LTD.
862/1, MAKARPURA CITY-VADADORA-390 010
DIST.VADADORA GUJARAT STATE, INDIA.
Albendazole 200 mg tablet
1-DESCRIPTION
A tablet having break line on one side, plain on other side.
2-COMPOSITION
Each tablet of EMA-ALBENDAZOLE contains 200 mg of
albendazole.
Excipients: Lactose Monohydrate, Maize Starch, Microcrystalline
Cellulose, Pyrrolidone (PVPK 30), Sodium Lauryl Sulfate, Sodium
Starch Glycolate, Saccharin Sodium, Magnesium Stearate,
HPMC E 15, HPMC E 5, PEG 6000 Sunset Yellow, Isopropyl Alcohol
Methylene Chloride.
3-THERAPEUTIC INDICATIONS
EMA-ALBENDAZOLE is indicated for the treatment of the following
infections:
Neurocysticercosis: EMA-ALBENDAZOLE is indicated for the
treatment of parenchymal neurocysticercosis due to active
lesions caused by larval forms of the pork tapeworm, Taenia
solium. Lesions considered responsive to albendazole therapy
appear as nonenhancing cysts with no surrounding edema on
contrast-enhanced computerized tomography. Clinical studies
in patients with lesions of this type demonstrate a 74% to 88%
reduction in number of cysts; 40% to 70% of albendazole-treated
patients showed resolution of all active cysts.
Hydatid Disease: EMA-ALBENDAZOLE is indicated for the
treatment of cystic hydatid disease of the liver, lung, and
peritoneum, caused by the larval form of the dog tapeworm,
Echinococcus granulosus.
This indication is based on combined clinical studies which
demonstrated non-infectious cyst contents in approximately
80-90% of patients given EMA-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%.
4-PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anthelminthics.
ATC code: P02CA03.
Mechanism of action
EMA-ALBENDAZOLE is an orally administered broad-spectrum
anthelmintic. The principal mode of action for albendazole is by
This is a medicament:
- A medicament is a product which
affects your health and its consumption
contrary to instructions is dangerous for
you.
- Follow strictly the doctor's prescription,
the method of use and the instructions of
the pharmacist who sold the
medicament.
- The doctor and the pharmacist are the
experts in medicine, their benefits and
risks.
- Do not by yourself interrupt the period
of treatment prescribed.
- Do not repeat the same prescription
without consulting your doctor.
- Keep all medicaments out of reach of
children.
Council of Arab Health Ministers
Union of Arab pharmacists
its inhibitory effect on tubulin polymerization which results in the
loss of cytoplasmic microtubules.
In the specified treatment indications albendazole appears to be
active against the larval forms of the following organisms:
Echinococcus granulosus Taenia solium.
5-PHARMACOKINETICS
Absorption
EMA-ALBENDAZOLE is poorly absorbed from the gastrointestinal
tract due to its low aqueous solubility. Albendazole concentra-
tions 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
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 neurocysticercosis patients. Following 4 weeks of
treatment with albendazole (200 mg three times daily), 12
patients’ plasma concentrations of albendazole sulfoxide were
approximately 20% lower than those observed during the first half
of the treatment period, suggesting that albendazole may
induce its own metabolism.
Distribution
Albendazole sulfoxide is 70% bound to plasma protein and is
widely distributed throughout the body; it has been detected in
urine, bile, liver, cyst wall, cyst fluid, and cerebral spinal fluid (CSF).
Concentrations in plasma were 3- to 10-fold and 2- to 4-fold
higher than those simultaneously determined in cyst fluid and
CSF, respectively. Limited in vitro and clinical data suggest that
albendazole sulfoxide may be eliminated from cysts at a slower
rate than observed in plasma.
Metabolism and Excretion
Albendazole is rapidly converted in the liver to the primary
metabolite, albendazole sulfoxide, which is further metabolized to
albendazole sulfone and other primary oxidative metabolites
that have been identified in human urine. Following oral
administration, albendazole has not been detected in human
urine. Urinary excretion of albendazole sulfoxide is a minor
elimination pathway with less than 1% of the dose recovered in
the urine. Biliary elimination presumably accounts for a portion of
the elimination as evidenced by biliary concentrations of
albendazole sulfoxide similar to those achieved in plasma.
6-CONTRAINDICATIONS
EMA-ALBENDAZOLE is contraindicated in patients with known
hypersensitivity to the benzimidazole class of compounds or any
components of EMA-ALBENDAZOLE.
7-POSOLOGY
Dosing of EMA-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.
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.
8-WARNINGS
Rare fatalities associated with the use of Albendazole have
been reported due to granulocytopenia or pancytopenia.
Albendazole has been shown to cause bone marrow
suppression, aplastic anemia, and agranulocytosis in patients
with and without underlying hepatic dysfunction. Blood counts
should be monitored at the beginning of each 28¬ days 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.
9-PRECAUTIONS
General
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-in-
duced changes to the retinal lesion.
Information for Patients:
Patients should be advised that:
• Some people, particularly young
children, may experience difficulties
swallowing the tablets whole. In young
children, the tablets should be crushed
or chewed and swallowed with a drink of
water.
• Albendazole may cause fetal harm,
therefore, women of childbearing age
should begin treatment after a negative
pregnancy test.
• Women of childbearing age should be
cautioned against becoming pregnant
while on albendazole or within 1 month of
completing treatment.
• 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.
Laboratory Tests: White Blood Cell
Count:
Albendazole has been shown to cause
occasional (less than 1% of treated
patients) reversible reductions in total
white blood cell count. Rarely, more
significant reductions may be
encountered including granulocytope-
nia, agranulocytosis, or pancytopenia.
Blood counts should be performed at the
start of each 28-day treatment cycle
and every 2 weeks during each 28-day
cycle in all patients. Patients with liver
disease, including hepatic echinococco-
sis, appear to be more at risk of bone
marrow suppression and warrant closer
monitoring of blood counts (see
WARNINGS).
Albendazole should be discontinued in
all patients if clinically significant
decreases in blood cell counts occur.
Liver Function: 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).
Liver function tests (transaminases) should be performed before
the start of each treatment cycle and at least every 2 weeks
during treatment. If hepatic enzymes exceed twice the upper
limit of normal, consideration should be given to discontinuing
albendazole therapy based on individual patient circumstances.
Restarting albendazole treatment in patients whose hepatic
enzymes have normalized off treatment is an individual decision
that should take into account the risk/benefit of further
albendazole usage. Laboratory tests should be performed
frequently if albendazole treatment is restarted.
Patients with abnormal liver function test results are at increased
risk for hepatotoxicity and bone marrow suppression (see
WARNINGS). Therapy should be discontinued if liver enzymes are
significantly increased or if clinically significant decreases in
blood cell counts occur.
10-SPECIFIC PATIENT POPULATIONS
Pregnancy Teratogenic Effects: Pregnancy Category C.
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 30 mg/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 (see WARNINGS).
Lactation: 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.
Infants: 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 5 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.
11-DRUG INTERACTIONS
Theophylline: Although single doses of Albendazole have been
shown not to inhibit theophylline metabolism , Albendazole does
induce cytochrome P450 1A in human
hepatoma cells. Therefore, it is recommended that plasma
concentrations of theophylline be monitored during and after
treatment with ALBENDAZOL UBSA. Theophylline: The pharmacoki-
netics 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.
Dexamethasone: Steady-state trough concentrations of
albendazole sulfoxide were about 56% higher when 8 mg
dexamethasone was coadministered 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 coadministration 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.
12-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 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.
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, agranulo-
cytosis, or thrombocytopenia (see WARNINGS). Patients with liver
disease, including hepatic echinococcosis, appear to be more at
risk of bone marrow suppression (see WARNINGS and
PRECAUTIONS).
Immune System Disorders:
Hypersensitivity reactions, including
rash and urticaria.
13-STORAGE CONDITIONS
Keep this medicine out of reach of children.
Store below 30°C.
Keep your medicine in a cool dry place and away from light in
the original package to protect it from moisture.
LIVEALTH BIOPHARMA PVT.LTD.
862/1, MAKARPURA CITY-VADADORA-390 010
DIST.VADADORA GUJARAT STATE, INDIA.
Date of Revision: March 25, 2025
2 TabletsReg. N°:
1-DESCRIPTION
A tablet having break line on one side, plain on other side.
2-COMPOSITION
Each tablet of EMA-ALBENDAZOLE contains 200 mg of
albendazole.
Excipients: Lactose Monohydrate, Maize Starch, Microcrystalline
Cellulose, Pyrrolidone (PVPK 30), Sodium Lauryl Sulfate, Sodium
Starch Glycolate, Saccharin Sodium, Magnesium Stearate,
HPMC E 15, HPMC E 5, PEG 6000 Sunset Yellow, Isopropyl Alcohol
Methylene Chloride.
3-THERAPEUTIC INDICATIONS
EMA-ALBENDAZOLE is indicated for the treatment of the following
infections:
Neurocysticercosis: EMA-ALBENDAZOLE is indicated for the
treatment of parenchymal neurocysticercosis due to active
lesions caused by larval forms of the pork tapeworm, Taenia
solium. Lesions considered responsive to albendazole therapy
appear as nonenhancing cysts with no surrounding edema on
contrast-enhanced computerized tomography. Clinical studies
in patients with lesions of this type demonstrate a 74% to 88%
reduction in number of cysts; 40% to 70% of albendazole-treated
patients showed resolution of all active cysts.
Hydatid Disease: EMA-ALBENDAZOLE is indicated for the
treatment of cystic hydatid disease of the liver, lung, and
peritoneum, caused by the larval form of the dog tapeworm,
Echinococcus granulosus.
This indication is based on combined clinical studies which
demonstrated non-infectious cyst contents in approximately
80-90% of patients given EMA-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%.
4-PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anthelminthics.
ATC code: P02CA03.
Mechanism of action
EMA-ALBENDAZOLE is an orally administered broad-spectrum
anthelmintic. The principal mode of action for albendazole is by
PI054/01
