Loperamide tablets

Loperamide

2 mg tablet

This medicine has been prescribed for your current condition. Therefore, do not use it in similar cases or recommend its use to others.

General instructions:

Before taking this medicine, consult your doctor in the following cases:

In case of allergy to this medicine or other medicines or any other substance such as food additives, preservatives, dyes, etc.
Patients with acute bloody diarrhea, acute ulcerative colitis, bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter and pseudomembranous colitis that occurs following the use of broad-spectrum antibiotics.
Use in pregnancy and lactation:

Loperamide should not be used during pregnancy and lactation unless under the advice of a specialist.

Warnings:
Loperamide is contraindicated in children under 2 years of age due to the risk of respiratory failure and serious cardiac side effects. Loperamide should also be used in children under 6 years of age only with a doctor’s prescription.
Loperamide is not recommended for use in patients taking medications that prolong the QT interval (such as antiarrhythmics, neuroleptics, antibiotics such as moxifloxacin) or in patients with congenital long QT syndrome.
Fluid and electrolyte depletion often occurs in patients with diarrhea. In such cases, adequate fluid and electrolyte replacement is important.
Loperamide is not recommended for patients with gastrointestinal disorders.
Loperamide should be discontinued immediately if constipation, abdominal pain without diarrhea, or abdominal distension occur.
AIDS patients treated with loperamide should discontinue the drug at the first sign of abdominal distension.
Loperamide is contraindicated in patients with acute bloody diarrhea, acute ulcerative colitis, bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter, and pseudomembranous colitis following the use of broad-spectrum antibiotics.
Loperamide is not recommended in patients with hepatic insufficiency due to reduced drug metabolism.
Loperamide is not recommended in elderly patients taking antiarrhythmic drugs or drugs that prolong the QT interval.
Concomitant use of loperamide with CYP3A4 inhibitors (e.g., itraconazole) or CYP2C8 inhibitors (e.g., gemfibrozil) or P-glycoprotein inhibitors (e.g., quinidine, ritonavir) may increase plasma concentrations of loperamide.
Dosage:

The dosage of the drug is determined by the attending physician for each patient. But the usual dosage of the drug is as follows:

Acute diarrhea:

Adults and children 13 years and older: 4 mg initially and then 2 mg after each watery stool. The maximum daily dose is 16 mg.

Children 6 to 12 years:

First day:

6 to 8 years (weighing 20 to 30 kg): 2 mg twice a day (4 mg total daily dose)

8 to 12 years (weighing more than 30 kg): 2 mg three times a day (6 mg total daily dose)

Next day:

After the first day of treatment, it is recommended that subsequent doses of loperamide be administered at 1 mg per 10 kg of body weight only after each stool. The total daily dose should not exceed the doses recommended for the first day.

Note: Clinical improvement is usually seen within 48 hours. If no improvement occurs within 48 hours, consult a doctor.

Chronic diarrhea:

Adults:

The recommended initial dose is 4 mg followed by 2 mg after each bowel movement until diarrhea is controlled. The dose of loperamide should then be reduced until the optimal daily dose is determined. This may be given as a single dose or in divided doses. The average daily maintenance dose in clinical trials was 4 to 8 mg. The maximum daily dose is 16 mg. If clinical improvement is not seen after treatment with 16 mg daily for at least 10 days, consult a doctor.

Recommendation: Avoid doses of loperamide higher than those recommended in adult patients or children 2 years of age and older due to the risk of serious cardiac side effects.

How to take the drug:

The drug can be taken with food or on an empty stomach and with fluids.

If you take more than the prescribed dose, see a doctor. Symptoms of low blood pressure, coordination disorders, numbness and cardiac arrest can be signs of drug poisoning.

If you forget, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and do not double the dose.

Avoid stopping the drug suddenly.

Side effects:

In addition to the desired therapeutic effects, any drug may have some unwanted side effects. If any of the following side effects occur, inform your doctor.

Important side effects that require doctor’s notice if they occur:

Sudden allergic reactions such as swelling of the face, tongue, shortness of breath, subcutaneous disorders and skin rash

Common or very common side effects: abdominal pain, bloating, nausea, vomiting, indigestion, constipation and headache

Uncommon side effects: dizziness, drowsiness, dry mouth, megacolon, ileus, skin reactions such as itching and hives

Rare or very rare side effects: angioedema, impaired consciousness, fatigue, severe skin adverse reactions, urinary retention, Stevens-Johnson syndrome, toxic epidermal necrolysis and anaphylactic shock, QT prolongation, ventricular tachycardia

Storage conditions:
Store the dry product at a temperature below 30°C, away from light and moisture.
Keep the medicine out of the reach of children.
Avoid using expired medicine.
Dosage Forms and Packaging:

This drug is produced and supplied in the form of tablets containing 2 mg of loperamide in boxes of 100 by Afashimi Pharmaceutical Company.