Mebeverine - Indications, Dosage, Side Effects, Warnings, and Precautions

Overview:

Mebeverine is an antispasmodic medicine used for managing irritable bowel syndrome and various other digestive disorders, such as spastic constipation (disorder causing stool to retain in the colon), mucus colitis (intestinal disorder causing inflammation and irritation in the colon), spastic colitis (spontaneous motility of the muscles of intestines), and colon inflammation. The drug is mainly used for spasms due to its antispasmodic effects, which help decrease irritability and discomfort and relax intestinal muscles.

The drug can be prescribed to adults mostly and children over the age of 18 years for treating gastrointestinal disorders related to bowel movement. The drug got its initial approval from the United States Food and Drug Administration (USFDA) on 28th January 1997 (also the date of revision - 23rd October 2020) for treating irritable bowel syndrome (IBS) and other associated conditions.

Drug Group:

The drug is an antispasmodic belonging to anticholinergic esters with tertiary amino groups.

• Class - Neuropsychiatric agent.

• Formula- C25H35NO5. HCl.

Indications:

Mebeverine is indicated for the treatment of irritable bowel syndrome (gastrointestinal disorder causing pain and cramps), abdominal spasms, and cramps.

Dose Form and Strength:

• Tablets - 135 mg (milligrams).

• Capsules (Modified-Release) - 200 milligrams.

• Suspension - 50mg/mL (milligram per milliliter).

• Granules (Sachets) - 135 mg Mebeverine along with ispaghula husk 3.5 grams.

For Patients

What Is Irritable Bowel Syndrome?

Irritable bowel syndrome (IBS) is a gastrointestinal disorder (stomach and intestines) that causes abdominal cramps, pain, diarrhea, gas, bloating, or constipation. It is a very chronic condition that needs to be treated immediately.

The condition causes changes in bowel movement and appearance, and a person may experience some serious symptoms, such as rectal bleeding, weight loss, iron deficiency anemia (a condition causing lack of enough red blood cells in the blood), diarrhea (a condition causing loose or watery stools) at night, and vomiting.

What Is Mebeverine Prescribed For?

• Irritable bowel syndrome (IBS).

• Abdominal and intestinal cramps and spasms.

• Constipation, gas, and bloating (fullness and tightness in the belly).

How Should Mebeverine Be Used?

• The drug should be taken at least 20 minutes before a meal.

• It should be taken at a fixed time daily and in a dosage prescribed by the doctor. Do not increase or decrease the drug dosage, frequency, or duration without consulting the doctor.

• One must not stop taking the drug without a doctor's consultation.

• The drug should not be chewed or dissolved. It must be taken as a whole with water or as the doctor prescribes.

What Precautions Should Be Followed Before Taking Mebeverine?

• One must inform the doctor about allergic (anaphylactic) reactions to Mebeverine, its ingredients, or any other drug.

• A person should also inform the doctor about any history of certain medical conditions, such as kidney disease, liver disease, abdominal problems, and stomach ulcers.

• The patients must also tell the doctor if they are taking prescription or non-prescription medications, including herbal products, vitamins, and nutritional supplements. As some of these medicines might react with Mebeverine, doctors can adjust the drug dosage or monitor the patient for any side effects.

• A person should inform the doctor if they are pregnant, planning to get pregnant, or breastfeeding before taking Mebeverine.

• If a person has any history of gut blockage or related conditions, they must inform the doctor beforehand.

• The drug causes dizziness; therefore, one must avoid driving and operating heavy machinery while taking this medication.

What Are the Side Effects of Mebeverine?

• Nausea.

• Rash.

• Itching.

• Vomiting.

• Breathing difficulties.

• Swelling in face, lips, eyes, and tongue.

• Headaches.

• Difficulty swallowing.

• Constipation.

• Heartburn.

• Dizziness.

• Indigestion.

Drug Dosage and Administration:

• Adults: The recommended drug dosage for Mebeverine hydrochloride is one tablet of 135 milligrams (mg) thrice a day before a meal (preferably 20 minutes before). The drug is recommended only for oral administration and to be swallowed directly with enough water.

• Overdose: In case of overdose with Mebeverine, one must contact the local poison control department, and if a person is feeling dizzy, has tremors, and collapses, the attendant should rush to the nearest healthcare facility. The treatment for overdose from Mebeverine is not yet established, and also there is no specific antidote available. Usually, the doctor stops the medication and provides supportive and systemic treatment by continuously monitoring the patient's vital functions.

• Missed Dose: If one misses out on the drug dose, they must take it as soon as they remember. In case it is already time for the next scheduled dose, a person should miss the missed dosage and continue taking the next dose.

Do not take double drug dosage to compensate for the missed one, as it can cause overdose. In case of any confusion, contact the healthcare provider.

Drug Storage and Disposal:

The drug should be kept away from the children and stored at room temperature (20 and 25 degrees Celsius or 68 and 77 degrees Fahrenheit) in a dry and cool place, away from sunlight.

The unused or expired medication should not be used and must be discarded safely. For this purpose, one can contact the nearest pharmacy to discard the drug through a take-back program. They can also reach out to the local garbage recycling authority to dispose of the drug safely.

Additionally, if one cannot access these, one can follow the FDA guidelines for safe drug disposal protocols.

For Doctors

Clinical Pharmacology:

Mechanism of Action

The drug has antispasmodic effects on the smooth muscles of the gastrointestinal tract (GI); however, the exact mechanism of action of Mebeverine hydrochloride is not known.

Pharmacodynamics:

The drug directly acts on the GI or gastrointestinal tract's smooth muscles without hampering the normal gut's motility. Although the exact mechanism of the drug is not known, the drug may affect muscarinic effects and calcium channels and have anesthetic effects as well. The drug mainly gets metabolized (almost completely) by esterases.

Pharmacokinetics:

• Absorption - Following oral ingestion of the tablet, the drug gets completely and rapidly absorbed into the system.

• Distribution - The drug gets significantly distributed and shows no accumulation in the body after multiple doses.

• Metabolism - Mebeverine is metabolized by esterase. The metabolites formed in plasma are demethylated carboxylic acid (DMAC).

• Elimination - The drug gets metabolized and excreted completely in the urine, partly as demethylated carboxylic acid and partly as carboxylic acid. The elimination half-life of the DMAC is 2.45 hours.

Ingredients:

• Active Ingredients - Mebeverine hydrochloride.

• Inactive Ingredients - Lactose monohydrate, microcrystalline cellulose, magnesium stearate, Opadry complete coating film coating system 03F58763 WHITE (hypromellose, polyethylene glycol, titanium dioxide, and talc), purified talc, Povidone, and sodium starch glycolate type A.

What Are the Contraindications for Mebeverine?

The drug is contraindicated in case of hypersensitivity to Mebeverine.

Drug Warnings and Precautions:

• The doctor must cautiously prescribe this medicine to a patient after taking proper medical history, such as any underlying medical condition or malignancy.

• The drug coating contains sucrose; therefore, while prescribing the drug, make sure that the patient does not have any rare hereditary problems, such as glucose-galactose malabsorption (inability to absorb simple sugars, such as galactose and glucose), fructose intolerance (inability to absorb fructose), or sucrose-isomaltose insufficiency (inability to digest sucrose and maltose).

• The drug also contains lactose; therefore, doctors must consider rare hereditary problems, such as Lapp lactase deficiency (or lactose intolerance) or galactose intolerance, before prescribing the drug.

• The drug should also be cautiously prescribed to patients with cardiac dysrhythmia, especially to those with severe ischemic heart diseases, angina, or atrioventricular heart block.

• Patients with advanced renal diseases and metabolic pathway disorders should be given this medicine carefully.

• The doctor also should prescribe Mebeverine cautiously to people having liver diseases, such as jaundice and liver cirrhosis.

Drug Interactions:

There is no data available related to Mebeverine’s interactions with other drugs. However, it may interact with certain drugs when given in combination, especially Buscopan, as they are both used to treat IBS symptoms, though both of them have different ingredients. Other drug interactions may include:

• Orlistat - The drug decreases Mebeverine’s serum concentration.

• Pregabalin - The drug decreases Mebeverine’s therapeutic efficacy.

• Mianserin - The drug decreases Mebeverine’s therapeutic efficacy.

• Mefloquine - The drug decreases Mebeverine’s therapeutic efficacy.

Use in Specific Populations:

• Pregnancy: The drug is usually not recommended during pregnancy; however, there are no known harmful effects caused by the drug. Since the efficacy and effectiveness of the drug in pregnancy are not clearly understood, the drug must be cautiously prescribed to this population category.

• Breastfeeding: It is unknown whether Mebeverine or its metabolites are excreted in human milk. Animal studies related to the excretion of Mebeverine in milk have also not been found. Therefore, the drug is not recommended during breastfeeding.

• Pediatric Use: The drug is recommended in this population only in children above 18 years of age. However, due to safety and efficacy, 135 milligrams (mg) is not recommended in the pediatric population.

• Geriatric Use: The drug is recommended for irritable bowel syndrome treatment in adults and elderly people. However, caution must be taken in patients suffering from liver or kidney-related disorders or some other underlying medical condition.

• Fertility: No clinical data shows any effects of the drug on female or male fertility. Also, no animal studies have been conducted on the harmful effects of Mebeverine on fertility.

• Preclinical Safety Data: Following oral and parenteral doses, the drug is known to cause central nervous system effects, such as convulsions, behavioral excitation, and tremors, due to repeated dosage.

The study on dogs revealed three times increased effects with oral dosage of a maximum recommended dose of 400 mg per day on body surface area.

The animal studies did not reveal any reproductive toxicity or teratogenic effects caused by the drug. However, the dose was twice the maximum recommended daily dose in rats and showed embryotoxicity effects, such as increased incidence of reabsorption and reduction in litter size. Although, no effects on female and male fertility were established at a dose equal to the maximum recommended dose.