Imodium 2mg Janssen medicine for acute diarrhea (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Loperamid hydrochloride

Ingredient

Composition information	Content
Loperamid hydrochloride	2mg

Uses

indications

IMODIUM drug indicated in the following cases:

Treatment of symptoms of acute diarrhea in adults and children aged 12 and older.

ATC code: A07DA03

Loperamid is associated with the Opiat receptor in the gastrointestinal wall, reducing the peristalsis push, extending the circulation time in the intestine and increasing the reabsorption of water and electrolytes. Loperamid increases the tone of anal spasms that help reduce the urgent and uncontrolled bowel movement.

In a double blind clinical trial, randomly over 56 patients with acute diarrhea treated with loopamid, observed the onset of anti -diarrhea within 1 hour after taking a single dose of 4mg. Clinical comparisons with other diarrhea medications have confirmed this special rapid trigger of loopamid.

Dynamic pharmacokinetics

absorption

Most of the loyalamids will be absorbed from the intestine, but due to the result of significant initial metabolism, bioavailability is only about 0.3%.

distribution

Studies on drug distribution in rats shows high affinity in the intestinal wall with the likelihood associated with receptors in vertical muscle layers. Loperamid's plasma protein binding ratio is 95%, mainly albumin. Pre-clinical data has shown that looperamid is a substrate of p-glycoprotein.

transformation

Loperamid is almost completely metabolized in the liver, largely in the combination form and is excreted through bile. The main metabolic path of Loperamid through methyl oxidation is at N position and through mainly CYP3A4 and CYP2C8 enzymes. Due to this very strong initial metabolism, the plasma concentration of the drug in the form of unchanged is extremely low.

Elimination

The half -life of loopamid in humans is about 11 hours, changing for about 9-14 hours. The excretion of Loperamid is in a constant form and of the metabolites mainly through the stool.

Before taking Imodium 2mg Janssen medicine for acute diarrhea (10 blisters x 10 tablets)

How to use

IMODIUM drug used by oral, should take capsules with water.

Dosage

acute diarrhea

Adults and children 12 years of age:

The starting dose is 2 capsules (4 mg), then 1 capsule (2 mg) after each liquid stool. The usual dose is 3-4 capsules (6 mg - 8 mg) a day. Total daily dose should not exceed 6 capsules (12 mg).

Symptomatic treatment of acute diarrhea related to irritable bowel syndrome in adults aged 18 and over

The starting dose is 2 capsules (4 mg), then 1 capsule (2 mg) after each liquid feces, or when the doctor is indicated. The maximum daily dose should not exceed 6 capsules (12 mg).

Children

IMODIUM is contraindicated in children under 12 years old.

Elderly

No dose adjustment in the elderly.

body failure

No dose adjustment in patients with renal failure.

Hepatic failure

Although there is no pharmacokinetic data in patients with hepatic impairment, should be cautious when using imodium in these patients because of reducing the initial flower transfer through the liver.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? The effects on central nervous systems in children and patients with impaired liver function may be more sensitive.

If the symptoms of an overdose occur, Naloxon can be used as antagonists. Because the effect of the loopamid is longer than Naxolon (1 to 3 hours), it may be necessary to repeat the dose of Naxolon. Therefore, it is necessary to closely monitor patients at least 48 hours to detect signs of central neurological inhibition.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using imodium medicine you may experience unwanted effects (ADR):

adults and children ≥ 12 years old

The safety of Loperamide HCI has been evaluated in 2755 adult patients and children ≥ 12 years old participating in 26 clinical trials with control and non -control of Loperamide HCI in acute diarrhea treatment.

The most common adverse drug reactions are reported (frequency ≥ 1%) in clinical trials for treatment of acute diacolic diacolic diacolic diagon diarrhea are constipation (2.7%), flatulence (1.2%), headache (1.2%) and nausea (1.1%).

Table 1 lists the adverse drug reactions that have been reported when using Loperamide HCI from clinical trials (acute diarrhea) or in after -sales experience.

Classification of frequency according to the following convention: Very common (≥ 1/10); Common (≥ 1/100 to

immune system disorders:

Rare: Stery reaction, anaphylactic reaction (including anaphylaxis) a, anaphylactic reaction.

Nervous system disorders:

Common: headache

Rare: Co Dong.

Digestive disorders:

Common: constipation, nausea, flatulence. Skin:

Uncommon: Red rash.

Rare: Secret.

Rare: tired. The process of determining the adverse reaction of the drug after bringing the drug to the market is not distinguished for acute or chronic or adult or children, the frequency is estimated from all clinical trials with Loperamide HCI (acute and chronic), including tests in children ≤ 12 years old (n = 3683).

b: See warning and prudent especially when taking the drug.

Report harmful reactions

Reporting suspicious harmful reactions after the drug licensed for circulation is very important. It allows to continue monitoring the benefits/risks of the drug.

Health workers are required to report any suspicious reactions through the drug information center and monitor the harmful reactions of the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

IMODIUM drug contraindicated in the following cases:

Hypersensitivity to the medicinal substance or any excipients of the drug.

Children under 12 years old. Human with fake colitis is related to the use of broad spectrum antibiotics.

Do not use imodium when it is necessary to avoid inhibition of intestinal peristalsis due to the risks of severe complications including intestinal obstruction, enlarged colon and enlarged colon. Must stop using imodium as soon as the intestinal obstruction, constipation or bloating.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Treatment of diarrhea with imodium is only symptomatic treatment. Private treatment should be taken when it is possible to determine the cause of diarrhea. The priority in acute diarrhea treatment is to prevent or restore dehydration and electrolytes. This is especially important in young children and sick patients and elderly people with acute diarrhea. Using this drug does not interfere with the use of complementary and electric therapies.

In acute diarrhea, if clinical does not improve within 48 hours, do not use Imodium and patients should consult a doctor's advice. A few cases of constipation are at risk of increasing aneurysms that cause enlarged colon in AIDS patients with viral and bacterial infections treated with Loperamide Hydrochloride. Mat. Loperamide HCI and consult a doctor. Patients should re -examine if their symptom type changes or if the diarrhea is repeated for more than 2 weeks. Some cases have led to death. Patients should not use exceeding the recommended dose and/or recommended treatment period.

Special warning:

Only use imodium to treat acute diarrhea related to irritating bowel syndrome (IBS) if previously diagnosed by the doctor IBS.

If there are any of the following signs, do not use the drug without the guidance of a doctor, even if you know you have irritable bowel syndrome:

from 40 years of age and older and have not been stimulated by bowel syndrome. Difficult or painful.

When fever.

Consult your doctor if new symptoms appear, or when the symptoms are severe or not improve after 2 weeks.

The effect of the drug on the ability to drive and operate machinery

loss of consciousness, reducing awareness, fatigue, dizziness or drowsiness may occur when treating diarrhea with this drug. Therefore, should be careful to use this medication when driving or operating machinery.

Use drugs for women during pregnancy and lactation

Pregnant women

Safety in pregnant women has not been established, although animal studies do not show that Loperamide HCI causes teratogenic or embryo toxicity.

As other drugs, this drug should not be used for pregnant women, especially in the first 3 months of pregnancy.

breastfeeding women

Small amount of loopamide can be seen in breast milk, so it is not recommended to use this medication while breastfeeding.

Therefore, pregnant or lactating women should consult a doctor for appropriate treatment.

fertility

affect fertility in humans has not been evaluated.

Drug interactions

Pre-clinical data shows that Loperamide is a p-glycoprotein substrate. Simultaneous use of Loperamide (single dose of 16 mg) with quinidine, or ritonavir, both are p-glycoprotein inhibitors resulting in an increase of 2 to 3 times loopamide concentration in plasma. It is unknown the clinical association of this pharmacokinetic interaction with p-glycoprotein inhibitors when loopamide is used in recommended doses.

Simultaneous use of Loperamide (single dose of 4 mg) and iTraconazole, a CYP3A4 and P-Glycoprotein inhibitors, leads to 3-4 times of loopamide concentration in plasma. In the same study with Gemfibrozil, a CYP2C8 inhibitor, Loperamide concentration increased by about twice. Using ITRAConazole and Gemfibrozil combine increases 4 times the peak concentration in Loperamide's plasma and increases 13 times the total drug concentration in plasma. Cases that increase the concentration of this drug do not accompany the central nervous effects (CNS) when being explored by mental mental assessments (ie evaluating inspection of drowsiness and evaluating cognitive function by digital symbol substitation test).

Simultaneous use of Loperamide (single dose of 16 mg) and ketoconazole, a CYP3A4 and P-Glycoprotein inhibitors, leading to an increase of Loperamide concentration in plasma. The increase in this drug concentration does not increase the effect of pharmacological force when measuring by the pupils.

Simultaneously used with oral desmopressin increases 3 times the plasma desmopressin concentration, probably due to slower gastrointestinal movement. Medicines with similar pharmacological properties can affect the effects of loopamide and drugs that increase the movement of the gastrointestinal tract can reduce the effect of the drug.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children, read the user manual carefully before use.

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