Mebeverine/Sulpiride

Irritable bowel syndrome & allied conditions eg, chronic irritable colon, spastic constipation, mucous colitis and spastic colitis. Symptomatic treatment of abdominal pain, cramps, nonspecific diarrhoea & flatulence. GI spasm secondary to organic diseases eg, diverticulitis, gastritis, duodenitis, oesophagitis, cholecystitis, Crohn's disease, ulcerative colitis, peptic ulcer, gallbladder disease, hiatus hernia, GIT inflammation.

Sulpiride is indicated for the treatment of schizophrenia.

Adults: 1 capsule twice daily (1 in the morning and 1 in the evening).

Special Populations: Elderly, Renal and Hepatic Impairment: No posology studies in elderly, renal and/or hepatically impaired patients have been performed. However, no specific risk for elderly, renal and/or hepatically impaired patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in these patients.

Missed Dose: In case of ≥1 doses missed, continue with the next dose as prescribed; the missed doses are not to be taken in addition to the regular dose.

Administration: The capsules should be swallowed with a sufficient amount of water (at least 100 mL of water).

It should not be chewed because the coating is intended to ensure a prolonged release mechanism.

The dosing regimen of Sulpiride East West Pharma is individual. For oral administration the starting dose is 20 mg, the single dose is 40-80 mg, the frequency of reception is 2-3 times / day.

For IV jet slowly injection the initial dose is 1 mg; after 2 minutes is administered the same dose again. In the absence of the effect of it is possible repeated injections.

Maximum doses: for oral administration - 320 mg / day; the repeated IV total dose is 10 mg (under the control of blood pressure and ECG).

Hypersensitivity to mebeverine HCl or to any of the excipients of Mebeverine.

AV-block II and III degree, sinoatrial block, bradycardia (heart rate is less than 55 beats / min), SSS, hypotension (systolic blood pressure is less than 90 mm Hg, especially in myocardial infarction), chronic heart failure IIB-III stages, acute heart failure, cardiogenic shock, hypersensitivity to propranolol.

Mebeverine is used to treat irritable bowel syndrome (disorder of the intestines that leads to cramps in the abdomen, gas, bloating and changes in bowel habits). It is also used to treat other conditions that involve spasm and pain related to small and large bowel.

No interaction studies have been performed except with alcohol. In vitro and in vivo studies in animals have demonstrated the absence of any interaction between Mebeverine and ethanol.

Incompatibilities: Not applicable.

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic action of paracetamol.

With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.

With the simultaneous use of anticholinergics may decrease absorption of paracetamol.

With the simultaneous use of oral contraceptives accelerated excretion of paracetamol from the body and may reduce its analgesic action.

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of paracetamol.

When Sulpiride Durbin applied simultaneously with diazepam may decrease excretion of diazepam.

There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with paracetamol. A case of severe toxic liver injury.

Described cases of toxic effects of paracetamol, while the use of isoniazid.

When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of paracetamol, which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of paracetamol and phenobarbital.

In applying cholestyramine a period of less than 1 h after administration of paracetamol may decrease of its absorption.

At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.

With the simultaneous use of metoclopramide may increase absorption of paracetamol and its increased concentration in blood plasma.

When applied simultaneously with probenecid may decrease clearance of paracetamol, with rifampicin, sulfinpyrazone - may increase clearance of paracetamol due to increasing its metabolism in the liver.

At simultaneous application of Sulpiride Durbin with ethinylestradiol increases absorption of paracetamol from the gut.

Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of caffeine increases, reduce - rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).

Although adverse effects appear rare, gastrointestinal disturbances, dizziness, headache, insomnia, anorexia and tachycardia have been reported in patients receiving Mebeverine.

Applies to acetaminophen: capsule, capsule liquid filled, elixir, liquid, powder, powder for solution, solution, suppository, suspension, syrup, tablet, tablet chewable, tablet disintegrating, tablet effervescent, tablet extended release

Other dosage forms:

• intravenous solution

In addition to its needed effects, some unwanted effects may be caused by acetaminophen (the active ingredient contained in Sulpiride). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking acetaminophen:

Rare

• Bloody or black, tarry stools
• bloody or cloudy urine
• fever with or without chills (not present before treatment and not caused by the condition being treated)
• pain in the lower back and/or side (severe and/or sharp)
• pinpoint red spots on the skin
• skin rash, hives, or itching
• sore throat (not present before treatment and not caused by the condition being treated)
• sores, ulcers, or white spots on the lips or in the mouth
• sudden decrease in the amount of urine
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

If any of the following symptoms of overdose occur while taking acetaminophen, get emergency help immediately:

Symptoms of overdose:

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling, pain, or tenderness in the upper abdomen or stomach area

Each capsule contains mebeverine HCl 200 mg.

Mebeverine also contains the following excipients: Capsule Content (Granules): Magnesium stearate, polyacrylate dispersion 30%, talc, hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% and glycerol triacetate. Capsule Shell: Gelatin, titanium dioxide (E171). Printing Ink: Shellac (E904), black iron oxide (E172), propylene glycol, concentrated ammonia solution, potassium hydroxide.

An analgesic and antipyretic that has been given by mouth and as ear drops. Sulpiride is often used in testing the effects of other drugs or diseases on drug-metabolizing enzymes in the liver. (From Martindale, The Extra Pharmacopoeia, 30th ed, p29)