Gastrointestinal

Novo-Loperamide

Uses

Teva-Loperamide is an oral antidiarrheal agent used to relieve diarrhea symptoms.

Dosage/directions for use

Directions: Regular tablets should be taken with liquids.

Important: Loperamide tablets are not suitable for children under the age of 6 years old.

Adults and children 12 years of age and older with acute or chronic diarrhea: A starting dose of 4 mg, followed by a 2 mg dose after each loose bowel movement (or bout of diarrhea).

Important: Do not exceed 16 mg per day.

Stop taking the tablets if you have a solid or hard stool or if you go for 24 hours without a bowel movement.

For chronic diarrhea, once the optimal daily dose has been established, this dose can be given as a single daily dose or in divided doses.

Children 6 to 12 years of age (10 kg to 20 kg) can use this medication for acute or chronic diarrhea if recommended by a doctor.

Children 6 to 8 years old (or weighing 20 kg to 30 kg): On the first day, 2 mg twice daily.

Children 8 to 12 years of age who weigh over 30 kg: For the first day, 2 mg 3 times daily. If the diarrhea continues, then the medication is given only after a loose bowel movement, and the amount to be given depends on the weight of the child.

Contact your doctor or pharmacist for the recommended amount.

Children 2 to 5 years old (or weighing 10 kg to 20 kg): For the first day, 1 mg 3 times daily.


Ingredients

Each 2 mg tablet contains: 2 mg of loperamide hydrochloride.

Non-medicinal ingredients: D&C yellow #10, FD&C blue #1, FD&C yellow #6, magnesium stearate, lactose monohydrate, pregelatinized starch, sodium starch glycolate.


Storage

Store between 15°C and 30°C.

Boxes of unit-dose strips should be stored between 15°C and 25°C and protected from high humidity.

Protect from light.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.


Precautions

Acquired immune deficiency syndrome (AIDS): People with AIDS should stop taking loperamide and contact their doctor if they experience abdominal swelling or distention.

Constipation: If you develop constipation, stop taking this medication and contact your doctor.

Drowsiness or dizziness: Loperamide may cause drowsiness or dizziness. Do not drive or operate machinery until you know how loperamide affects you.

Fluids and electrolytes: The loss of fluids and electrolytes (e.g., chloride, sodium) can occur if you have diarrhea. Loperamide helps with the symptoms of diarrhea but will not correct any fluid or electrolyte problems caused by diarrhea. Talk to your doctor or pharmacist about whether you need fluid and electrolyte replacement, also referred to as oral rehydration therapy.

Improvement in diarrhea: If your diarrhea has not improved after 48 hours of treatment with loperamide, stop taking it and contact your doctor.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Medical conditions: Loperamide should not be used by people with intestinal infections such as dysentery, which is often associated with severe diarrhea, fever, and blood in the stool, and other infections of the gut. A more serious problem of the bowel may develop if loperamide is used by some people with acute ulcerative colitis or a serious form of diarrhea associated with antibiotic use.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking loperamide, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: This medication is not recommended for use in children under the age of 12 except on the advice of a physician. Loperamide should not be given to children under 6 years of age without medical prescription and supervision. Loperamide tablets are not suitable for children under 6 years of age. Loperamide should not be used for children under 2 years of age.