Duspatalin, capsules 200 mg 30 pcs

Pharmacodynamics

A myotropic antispasmodic. It has a direct effect on the smooth muscles of the gastrointestinal tract. It relieves spasm without affecting normal intestinal peristalsis.

It has no anticholinergic effect.

Pharmacokinetics

Intake

Mebeverin is quickly and completely absorbed after oral administration. The modified-release dosage form allows a dosing regimen of 2 times/day.

Distribution

There is no significant cumulation when the drug is taken repeatedly.

Metabolism

Meberine hydrochloride is primarily metabolized by esterases, which first break down the ester into veric acid and meberine alcohol. The main metabolite circulating in plasma is demethylated carboxylic acid. The T_1/2 in equilibrium of demethylated carboxylic acid is approximately 5.77 h. When repeatedly taken at a dose of 200 mg 2 times/day, the C_max of demethylated carboxylic acid in the blood is 804 ng/ml, T_max is about 3 h.

The average relative bioavailability of the drug in a modified-release capsule is 97%.

Elimination

Meberine is not excreted unchanged, it is completely metabolized; its metabolites are almost completely eliminated from the body. Veratroic acid is excreted by the kidneys. Alcohol of meberine is also excreted by the kidneys, partly as carboxylic acid and partly as demethylated carboxylic acid.

Indications

In adults:

In children over 12 years of age:

Active ingredient

Composition

Active substances:

Meberine hydrochloride 200 mg.

Auxiliary substances:

Magnesium stearate – 13.1 mg,

Methyl methacrylate and ethyl acrylate copolymer (1:2) – 10.4 mg,

talc – 4.9 mg,

hypromellose – 0.1 mg,

methacrylic acid and ethyl acrylate copolymer (1:1) – 15.2 mg,

triacetin – 2.9 mg.

Capsule shell composition:

gelatin – 75.9 mg,

titanium dioxide (E171) – 1.5 mg.

Composition of the ink:

shellac (E904),

propylene glycol,

ammonia aqueous,

Potassium hydroxide,

Iron oxide black dye (E172).

How to take, the dosage

The drug is taken orally.

The capsules should be swallowed with enough water (at least 100 ml). The capsules should not be chewed because their coating allows prolonged release of the drug.

Prescribe 200 mg (1 capsule) 2 times a day 20 min before meals (morning and evening).

The duration of the drug is not limited.

If a patient forgets to take one or more capsules, the medication should be continued with the next dose.

Do not take one or more missed doses in addition to the usual dose.

Interaction

There have only been studies to study the interaction of this drug with alcohol.

The animal studies have shown no interaction between Duspatolin® and ethanol.

Special Instructions

Impact on the ability to drive vehicles and other mechanisms requiring high concentration

There have been no studies of the effect of the drug on the ability to drive vehicles and other mechanisms.

Pharmacological properties of the drug as well as experience of its use do not indicate any adverse effect of mebeverine on driving and other mechanisms.

Synopsis

Contraindications

Side effects

Overdose

Symptoms: theoretically, in case of overdose, increased CNS excitability is possible.

In cases of mebeverine overdose, symptoms were either absent or mild and usually quickly reversible. Reported overdose symptoms were neurological and cardiovascular in nature.

Treatment: no specific antidote is known.

Symptomatic treatment is recommended.

Gastric lavage is only necessary if intoxication is detected within approximately one hour of taking several doses of the drug.

Accommodation to reduce absorption is not necessary.

Pregnancy use

Due to insufficient data on efficacy and safety, it is not recommended for children under 18 years of age.

There are insufficient data on the use of meberine in pregnant women. It is not recommended to use Duspatlin® during pregnancy.

There is insufficient information on the excretion of mebiverine or its metabolites with breast milk. Duspataline® should not be taken while breastfeeding.

There are no clinical data on the effect of the drug on fertility in men or women; however, animal studies have not demonstrated adverse effects of Duspataline.

Similarities