PINWORM TREATMENT

DESCRIPTION

Each chewable tablet for oral administration contains:

Pyrantel pamoate ..................................720.5 mg
(equivalent to 250 mg pyrantel base)

Also contains aspartame, citric acid, colloidal silicon dioxide, croscarmellose sodium, dextrose, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, sorbitol and stearic acid.

CLINICAL PHARMACOLOGY

Pin-X® has demonstrated anthelmintic activity against Enterobius vermicularis (pinworm) and Ascaris lumbricoides (common roundworm). The anthelmintic action is probably due to the neuromuscular blocking property of the drug. Pin-X® is partially absorbed after an oral dose. Plasma levels of unchanged drug are low. Peak levels (0.05 - 0.13 micrograms per milliliter) are reached in 1-3 hours. Quantities greater than 50% of administered drug are excreted in feces as the unchanged form, whereas only 7% or less of the dose is found in urine as the unchanged form of the drug and its metabolites.

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

PRECAUTION

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:

HOW 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.

Distributed by:
QUARTZ SPECIALTY PHARMACEUTICALS, LLC
130 Vintage Drive
Huntsville, Alabama 35811

8182505
Rev 12/10
R2

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL