Anthelmentics

Albendazole:

Echinococcus granulosus
Taenia solium

INDICATIONS AND USAGE:
ALBENZA is indicated for the treatment of the following infections:

Neurocysticercosis
ALBENZA 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
ALBENZA 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 to 90% of patients
given ALBENZA for 3 cycles of therapy of 28 days each (see DOSAGE AND
ADMINISTRATION). 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%.

NOTE: When medically feasible, surgery is considered the treatment of
choice for hydatid disease. When administering ALBENZA in the pre- or
post-surgical setting, optimal killing of cyst contents is achieved when
3 courses of therapy have been given.

NOTE: The efficacy of albendazole in the therapy of alveolar hydatid
disease caused by Echinococcus multilocularis has not been clearly
demonstrated in clinical studies.

WARNINGS
Rare fatalities associated with the use of ALBENZA have been reported
due to granulocytopenia or pancytopenia (see PRECAUTIONS). 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-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.

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-induced changes to the retinal
lesion.

DOSAGE AND ADMINISTRATION:
Dosing of ALBENZA 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.

Additional dosing (ADULT):
Source:  Lexi-Comp, Inc. (Lexi-Drugs).
Lexi-Comp, Inc.; April 30, 2014.
See reference for additional guidance.

---------------------------------------------
Neurocysticercosis:
---------------------------------------------
<60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day) for 8-30
days
≥60 kg: 800 mg/day in 2 divided doses for 8-30 days

---------------------------------------------
Ancylostoma caninum, Ascaris lumbricoides (roundworm), Ancylostoma
duodenale (hookworm), and Necator americanus (hookworm) (unlabeled use)
---------------------------------------------
Oral: 400 mg as a single dose

---------------------------------------------
Cutaneous larva migrans (unlabeled use):
---------------------------------------------
Oral: 400 mg once daily for 3
days

---------------------------------------------
Enterobius vermicularis (pinworm) (unlabeled use):
---------------------------------------------
Oral: 400 mg as a
single dose; repeat in 2 weeks

---------------------------------------------
Giardia duodenalis (giardiasis) (unlabeled use):
---------------------------------------------
Oral: 400 mg once daily
for 5 days

---------------------------------------------
Gnathostoma spinigerum (unlabeled use):
---------------------------------------------
Oral: 800 mg/day in 2 divided
doses for 21 days

---------------------------------------------
Disseminated microsporidiosis (unlabeled use):
---------------------------------------------
Oral: 800 mg/day in 2
divided doses

---------------------------------------------
Echinococcus granulosus (tapeworm) (unlabeled use):
---------------------------------------------
Oral: 800 mg/day in
2 divided doses for 1-6 months

SUPPLIED:
ALBENZA is supplied as 200 mg, white to off-white, circular, biconvex,
bevel-edged, film coated TILTAB tablet embossed "ap" and "550". They are
supplied as follows:

Bottles of 2 NDC 52054-550-22
Bottles of 28 NDC 52054-550-28

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room
Temperature].

ALBENZA and TILTAB are registered trademarks of GlaxoSmithKline, used
with permission.

SOURCE:
Package insert data:

Ivermectin (Stromectol®):

The selective activity of compounds of this class is attributable to the
facts that some mammals do not have glutamate-gated chloride channels
and that the avermectins have a low affinity for mammalian ligand-gated
chloride channels. In addition, ivermectin does not readily cross the
blood-brain barrier in humans.

Ivermectin is active against various life-cycle stages of many but not
all nematodes. It is active against the tissue microfilariae of
Onchocerca volvulus but not against the adult form. Its activity against
Strongyloides stercoralis is limited to the intestinal stages.

INDICATIONS AND USAGE:
STROMECTOL is indicated for the treatment of the following infections:

Strongyloidiasis of the intestinal tract. STROMECTOL is
indicated for the treatment of intestinal (i.e., nondisseminated)
strongyloidiasis due to the nematode parasite Strongyloides stercoralis.

This indication is based on clinical studies of both comparative and
open-label designs, in which 64-100% of infected patients were cured
following a single 200-mcg/kg dose of ivermectin.

Onchocerciasis. STROMECTOL is indicated for the
treatment of onchocerciasis due to the nematode parasite Onchocerca
volvulus.

This indication is based on randomized, double-blind, placebo-controlled
and comparative studies conducted in 1427 patients in onchocerciasis-endemic
areas of West Africa. The comparative studies used diethylcarbamazine
citrate (DEC-C).

NOTE: STROMECTOL has no activity against adult Onchocerca volvulus
parasites. The adult parasites reside in subcutaneous nodules which are
infrequently palpable. Surgical excision of these nodules (nodulectomy)
may be considered in the management of patients with onchocerciasis,
since this procedure will eliminate the microfilariae-producing adult
parasites.

CONTRAINDICATIONS
STROMECTOL is contraindicated in patients who are hypersensitive to any
component of this product.

WARNINGS
Historical data have shown that microfilaricidal drugs, such as
diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or
systemic reactions of varying severity (the Mazzotti reaction) and
ophthalmological reactions in patients with onchocerciasis. These
reactions are probably due to allergic and inflammatory responses to the
death of microfilariae. Patients treated with STROMECTOL for
onchocerciasis may experience these reactions in addition to clinical
adverse reactions possibly, probably, or definitely related to the drug
itself.

The treatment of severe Mazzotti reactions has not been subjected to
controlled clinical trials. Oral hydration, recumbency, intravenous
normal saline, and/or parenteral corticosteroids have been used to treat
postural hypotension. Antihistamines and/or aspirin have been used for
most mild to moderate cases.

DOSAGE AND ADMINISTRATION:
----------------------------------------
Strongyloidiasis
----------------------------------------
The recommended dosage of STROMECTOL for the treatment of
strongyloidiasis is a single oral dose designed to provide approximately
200 mcg of ivermectin per kg of body weight. See Table 1 for dosage
guidelines. Patients should take tablets on an empty stomach with water.
In general, additional doses are not necessary. However, follow-up stool
examinations should be performed to verify eradication of infection.

Table 1: Dosage Guidelines for STROMECTOL for Strongyloidiasis:

----------------------------------------
Onchocerciasis
----------------------------------------
The recommended dosage of STROMECTOL for the treatment of onchocerciasis
is a single oral dose designed to provide approximately 150 mcg of
ivermectin per kg of body weight. See Table 2 for dosage guidelines.
Patients should take tablets on an empty stomach with water.  In
mass distribution campaigns in international treatment programs, the
most commonly used dose interval is 12 months. For the treatment of
individual patients, retreatment may be considered at intervals as short
as 3 months.

Table 2: Dosage Guidelines for STROMECTOL for Onchocerciasis:

Additional dosing (ADULT):
Source:  Lexi-Comp, Inc. (Lexi-Drugs).
Lexi-Comp, Inc.; April 30, 2014.
See reference for additional guidance.

------------------------------------------------------------------------------------------
Ascariasis due to Ascaris lumbricoides (unlabeled use):
------------------------------------------------------------------------------------------
Oral: 200 mcg/kg as a single dose

------------------------------------------------------------------------------------------
Filariasis due to Mansonella ozzardi (unlabeled use):

------------------------------------------------------------------------------------------
Oral: 6 mg as a single dose

------------------------------------------------------------------------------------------
Lice due to Pediculus humanus capitis, Pediculus humanus corporis,
Phthirus pubis (unlabeled use):
------------------------------------------------------------------------------------------
Oral: 200 mcg/kg/dose; generally
requires >1 dose; number of doses and dosage intervals have not been
established

------------------------------------------------------------------------------------------
Pediculus humanus capitis:
------------------------------------------------------------------------------------------
Oral: 400 mcg/kg/dose every 7 days for 2 doses

------------------------------------------------------------------------------------------
Scabies due to Sarcoptes scabieiin immunocompromised patients (unlabeled
use):
------------------------------------------------------------------------------------------
Oral: 200 mcg/kg as a single dose; may repeat dose in 14 days

SUPPLIED:
No. 8495 -- Tablets STROMECTOL 3 mg are white, round, flat, bevel-edged
tablets coded MSD on one side and 32 on the other side. They are
supplied as follows:

NDC 0006-0032-20 unit dose packages of 20.

Storage

Store at temperatures below 30°C (86°F).
SOURCE: Package insert data

Mebendazole (Vermox®):

INDICATIONS AND USAGE:
Mebendazole tablets are indicated for the treatment of Enterobius
vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris
lumbricoides (common roundworm), Ancylostoma duodenale (common
hookworm), Necator americanus (American hookworm) in single or mixed
infections.

Efficacy varies as a function of such factors as preexisting diarrhea
and gastrointestinal transit time, degree of infection, and helminth
strains. Efficacy rates derived from various studies are shown in the
table below:

CONTRAINDICATIONS
Mebendazole is contraindicated in persons who have shown
hypersensitivity to the drug.

WARNINGS
There is no evidence that mebendazole, even at high doses, is effective
for hydatid disease. There have been rare reports of neutropenia and
agranulocytosis when mebendazole was taken for prolonged periods and at
dosages substantially above those recommended.

DOSAGE AND ADMINISTRATION:
The same dosage schedule applies to children and adults. The tablet may
be chewed, swallowed, or crushed and mixed with food.

If the patient is not cured three weeks after treatment, a second course
of treatment is advised. No special procedures, such as fasting or
purging, are required.

Additional dosing (ADULT):
Source:  Lexi-Comp, Inc. (Lexi-Drugs).
Lexi-Comp, Inc.; April 30, 2014.
See reference for additional guidance.

------------------------------------------------------------------------------------------
Ancylostoma duodenale (hookworm), Necator americanus (hookworm), Ascaris
lumbricoides (roundworm), Strongyloides stercoralis (roundworm), Taenia
solium (tapeworms), Trichuris trichiura (whipworm), mixed infection:

------------------------------------------------------------------------------------------
Oral: 100 mg twice daily for 3 days; repeat in 3 weeks if not cured with
initial treatment

------------------------------------------------------------------------------------------
Enterobius vermicularis (pinworm):
------------------------------------------------------------------------------------------
Oral: 100 mg as a single dose; repeat in 2 and 4 weeks

------------------------------------------------------------------------------------------
Ancylostoma duodenale (hookworm), Ascaris lumbricoides (roundworm),
Necator americanus (hookworm), Trichuris trichiura (whipworm):
------------------------------------------------------------------------------------------
500 mg as a single dose

------------------------------------------------------------------------------------------
Giardia duodenalis (giardiasis):
------------------------------------------------------------------------------------------
Oral: 200 mg 3 times daily for 5 days

SUPPLIED:
Mebendazole 100 mg, chewable, round, light peach-colored, unscored
tablets, debossed “93” and “107” on one side and plain on the other
side, supplied in boxes of twelve tablets, blister packaged.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room
Temperature].

SOURCE:
Package insert data:

 Praziquantel (Biltricide®):

CONTRAINDICATIONS
BILTRICIDE is contraindicated in patients who previously have shown
hypersensitivity to the drug or any of the excipients. Since parasite
destruction within the eye may cause irreversible lesions, ocular
cysticercosis must not be treated with this compound.

Concomitant administration with strong Cytochrome P450 (P450) inducers,
such as rifampin, is contraindicated since therapeutically effective
blood levels of praziquantel may not be achieved (see PRECAUTIONS/Drug
Interactions). In patients receiving rifampin who need immediate
treatment for schistosomiasis, alternative agents for schistosomiasis
should be considered. However, if treatment with praziquantel is
necessary, rifampin should be discontinued 4 weeks before administration
of praziquantel. Treatment with rifampin can then be restarted one day
after completion of praziquantel treatment (see PRECAUTIONS/Drug
Interactions).

WARNINGS
Therapeutically effective levels of BILTRICIDE may not be achieved when
administered concomitantly with strong P450 inducers, such as rifampin.

DOSAGE AND ADMINISTRATION:
The dosage recommended for the treatment of schistosomiasis is:

20 mg/kg bodyweight three times a day as a one day treatment, at
intervals of not less than 4 hours and not more than 6 hours.

The recommended dose for clonorchiasis and opisthorchiasis is:
25 mg/kg bodyweight three times a day as a one day treatment, at
intervals of not less than 4 hours and not more than 6 hours.

The tablets should be washed down unchewed with water during meals.
Keeping the tablets or segments thereof in the mouth can reveal a bitter
taste which can promote gagging or vomiting.

Additional dosing (ADULT):
Source:  Lexi-Comp, Inc. (Lexi-Drugs).
Lexi-Comp, Inc.; April 30, 2014.
See reference for additional guidance.

------------------------------------------------------------------------------------------
Tapeworms (unlabeled use):
------------------------------------------------------------------------------------------
Oral: 5-10 mg/kg as a single dose (25 mg/kg
for Hymenolepis nana)

SUPPLIED:
BILTRICIDE is supplied as a 600 mg white to orange tinged, film-coated,
oblong tablet with three scores. The tablet is coded with “BAYER” on one
side and “LG” on the reverse side. When broken, each of the four
segments contains 150 mg of active ingredient so that the dosage can be
easily adjusted to the patient’s bodyweight.

Segments are broken off by pressing the score (notch) with thumbnails.
If 1/4 of a tablet is required, this is best achieved by breaking the
segment from the outer end.

BILTRICIDE is available in bottles of 6 tablets.

SOURCE:
Package insert data:

Pyrantel pamoate:

Symptoms suggestive of pinworm infestation:
Pruritis Ani (itching in the anal area), insomnia, gastrointestinal
distress, irritability, enuresis (bed wetting) and secondary infection
due to localized scratching are symptoms of pinworms. However, you
should make a visual inspection and confirmation of the pinworms before
using this product.

How to find and identify the pinworm:
A pinworm is a small round worm that lives in the body of other animals.
They are 1/4 to 1/2 inch long and have white bodies and pointed tails.
There are several kinds of pinworms, however, only one kind, Enterobius
vermicularis, commonly infects human beings. The worms can usually be
detected during the hours of sleep when the worm migrates out of the
anus onto the surrounding skin.

The life cycle of the pinworm:
The young worms live in the upper part of the large intestine. When they
are ready to lay eggs, they crawl down the rectum and out the intestinal
opening called the anus, usually at night. They lay eggs on the
surrounding skin. This movement causes swelling and severe itching.

How pinworms are spread and how to avoid spreading:
The eggs fall off into the bedding or clothing and may be picked up
under the fingernails in scratching. If the eggs are swallowed, they
reach the intestine and become adult pinworms. Therefore, to avoid the
spreading of pinworms all areas should be as clean as possible.

INDICATIONS AND USAGE:
For the treatment of pinworms.

CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.

WARNINGS
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of
accidental overdose, seek professional assistance or contact a Poison
Control Center immediately.

Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness
sometimes occur after taking this drug. If any of these conditions
persist, consult a doctor. If you are pregnant or have liver disease, do
not take this product unless directed by a doctor.

DOSAGE AND ADMINISTRATION:
Information for Patients
Phenylketonurics
Pin-X® Chewable Tablets contain phenylalanine 11.8 mg per tablet.

DIRECTIONS FOR USE
Read package insert carefully before taking this medication. Take only
according to directions and do not exceed the recommended dosage unless
directed by a doctor. Medication should only be taken one time as a
single dose; do not repeat treatment unless directed by a doctor. When
one individual in a household has pinworms, the entire household should
be treated unless otherwise advised. See WARNINGS. If any worms other
than pinworms are present before or after treatment, consult a doctor.
If any symptoms or pinworms are still present after treatment, consult a
doctor. This product can be taken any time of day, with or without
meals. It may be taken alone or with milk or fruit juice. Use of a
laxative is not necessary prior to, during, or after medication.

Adults and children 2 years to under 12 years of age: oral dosage is a
single dose of 5 milligrams of pyrantel base per pound, or 11 milligrams
per kilogram, of body weight not to exceed 1 gram. Dosage information is
summarized on the following schedule:

Additional dosing (ADULT):
Source:  Lexi-Comp, Inc. (Lexi-Drugs).
Lexi-Comp, Inc.; April 30, 2014.
See reference for additional guidance.

------------------------------------------------------------------------------------------
Ancylostoma duodenale (hookworm), Ascariasis lumbricoides (roundworm),
Necator americanus (hookworm) (unlabeled use):
------------------------------------------------------------------------------------------
11 mg/kg (maximum: 1 g/dose) administered once daily for 3 days

------------------------------------------------------------------------------------------
Moniliformis (unlabeled use):
------------------------------------------------------------------------------------------
11 mg/kg administered as a single dose;
repeat twice 2 weeks apart

SUPPLIED:
Pin-X® Chewable Tablets are supplied as round, flat faced, orange color,
orange flavored chewable tablets with “Pin-X” debossed over a score line
on one side and plain on the reverse side, in bottles of 12.

Store at 15°-30°C (59°-86°F).

SOURCE:
Package insert data: