Pricing
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All price changes →Indications & Uses
Loperamide + Simethicone is used to treat the symptoms of acute diarrhea in adults and adolescents over 12 years, when the diarrhea comes with gas-related discomfort in the abdomen such as bloating, cramping or flatulence.
Pharmacology
Loperamide binds to the opiate receptor in the gut wall. This reduces propulsive peristalsis, so food and fluid move through the intestine more slowly, and more water and electrolytes are taken back into the body. Loperamide also increases the tone of the anal sphincter. Simethicone is a surface-active agent with anti-foaming properties, so it may relieve gas-related symptoms that come with diarrhea.
Most of the Loperamide that is swallowed is absorbed from the gut. But because of significant first pass metabolism, systemic bioavailability is approximately 0.3%. Simethicone is not absorbed.
Plasma protein binding of Loperamide is 95%. The liver extracts almost all of it, where it is mainly metabolized, conjugated and excreted through the bile. Loperamide has a half-life of about 11 hours. Unchanged Loperamide and its metabolites leave the body mainly in the faeces.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
For adults and children 12 years of age and older, the dose of Loperamide + Simethicone is 2 tablets after the first loose bowel movement, then one tablet or caplet after each loose bowel movement that follows. The maximum is 4 tablets or caplets a day, for no more than 2 days.
Children 6 to 11 years of age: this medicine is not recommended for children under 12 years except on the advice of a physician. The proposed dose is 1 tablet after the first loose bowel movement and 1/2 tablet or caplet after each one after that. The daily maximum is 3 tablets or caplets for ages 9 to 11 years, or 2 tablets or caplets for ages 6 to 8 years, and it should not be used for longer than 2 days.
Children under 12 years of age: the tablet should be used with special caution, because response varies more in children and swallowing may be difficult.
Geriatrics (over 65 years of age): no dose adjustment is needed for the elderly.
Renal impairment: no dosage adjustment is needed.
Hepatic impairment: no pharmacokinetic data are available for patients with hepatic impairment. The tablet should still be used with caution in these patients because first pass metabolism is reduced.
Administration: take the tablet by mouth. It can be taken at any time of day. Caplets should be taken with a full glass of water (250 mL). Chewable tablets should be chewed fully and then swallowed. Drink plenty of clear fluids, which helps prevent the dehydration that may come with diarrhea. Take it only on an empty stomach, which means 1 hour before or 2 hours after a meal.
Side Effects
Loperamide-Simethicone was checked for safety in 2040 patients across five clinical trials. The most commonly reported ADRs (adverse drug reactions, with an incidence of 21%) were dysgeusia (2.6%) and nausea (1.6%).
Cautions & Contraindications
Warnings & Precautions
Treatment of diarrhea with Loperamide-Simethicone is only symptomatic. Whenever an underlying cause can be found, specific treatment should be given for it. If there is no clinical improvement within 48 hours, Loperamide-Simethicone must be stopped. Use this medicine with caution in patients with hepatic impairment, because it may cause a relative overdose, which can lead to central nervous system (CNS) toxicity. In patients with severe hepatic dysfunction, it should be used under medical supervision. Cardiac events, including OT interval and QRS complex prolongation, have been reported in association with overdose.
Contraindications
Loperamide hydrochloride/Simethicone is contraindicated in patients who are hypersensitive to this drug, to any ingredient in the formulation or to any component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. It is also contraindicated in children under 2 years of age, and in anyone in whom constipation must be avoided. This medicine should not be used in acute dysentery, which shows up as blood in the stools and a raised temperature. Fluid and electrolyte depletion may occur in patients who have diarrhea, and using the medicine does not rule out giving appropriate fluid and electrolyte therapy. It should also not be used in patients with bacterial enterocolitis caused by invasive organisms, including Salmonella, Shigella and Campylobacter. It must not be used in patients with acute ulcerative colitis, or with pseudomembranous colitis associated with broad-spectrum antibiotics. In these patients, agents that inhibit intestinal motility or delay intestinal transit time have increased the possible risk of significant sequelae, including ileus, megacolon and toxic megacolon. Stop Loperamide hydrochloride/Simethicone promptly if abdominal distention occurs or if untoward symptoms develop. In general, don't use it when the inhibition of peristalsis is to be avoided.
Pregnancy & Breastfeeding
Nobody has established that Loperamide with Simethicone is safe in human pregnancy. Animal studies show no signs of teratogenic or embryotoxic effects. Even so, it shouldn't be given during pregnancy, especially in the first trimester, unless there is a clinical reason for it.
Small amounts of Loperamide may pass into human breast milk. For that reason, this medicine is not recommended during breast feeding.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Store Loperamide + Simethicone below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Lopesim 2 mg+125 mg
What is Lopesim 2 mg+125 mg Tablet?
Lopesim 2 mg+125 mg Tablet is a medicine that contains Loperamide + Simethicone. It is made by Navana Pharmaceuticals Ltd.
What is Lopesim used for?
Loperamide + Simethicone is used to treat the symptoms of acute diarrhea in adults and adolescents over 12 years, when the diarrhea comes with gas-related discomfort in the abdomen such as bloating, cramping or flatulence.
What are the side effects of Lopesim?
Loperamide-Simethicone was checked for safety in 2040 patients across five clinical trials. The most commonly reported ADRs (adverse drug reactions, with an incidence of 21%) were dysgeusia (2.6%) and nausea (1.6%).
Can I take Lopesim during pregnancy or while breastfeeding?
Nobody has established that Loperamide with Simethicone is safe in human pregnancy. Animal studies show no signs of teratogenic or embryotoxic effects. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Lopesim?
Store Loperamide + Simethicone below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Lopesim?
Some medicines can interact with Loperamide + Simethicone, for example: Itraconazole, Gemfibrozil, Ritonavir, Desmopressin Acetate, Ketoconazole. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Lopesim is already among the lowest-priced brands of Loperamide + Simethicone at this strength.
Do I need a prescription for Lopesim?
Lopesim is a prescription (Rx) medicine. Take it as your doctor advises.