Duspatalin sustained release capsules 200mg, 30pcs

Composition

Active ingredients:

Mebeverinee 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 (E 171) – 1.5 mg.

Ink composition:

shellac (E 904),

propylene glycol,

water ammonia,

potassium hydroxide,

iron oxide black dye (E 172).

Pharmacological action

Pharmacodynamics

Antispasmodic of myotropic action. It has a direct effect on the smooth muscles of the gastrointestinal tract. Eliminates spasm without affecting normal intestinal motility.

It does not have an anticholinergic effect.

Pharmacokinetics

Suction

Mebeverine is rapidly and completely absorbed after oral use. The modified release dosage form allows you to use the dosage regimen 2 times / day.

Distribution

With repeated use of the drug, significant accumulation does not occur.

Metabolism

Mebeverinee hydrochloride is primarily metabolized by esterases, which first cleave the ester into veratric acid and Mebeverinee alcohol. The main metabolite circulating in plasma is demethylated carboxylic acid. T_1/2 in the equilibrium state of demethylated carboxylic acid is approximately 5.77 hours. With repeated use at a dose of 200 mg 2 times / day, the_cmax of demethylated carboxylic acid in the blood is 804 ng / ml, the tmax is about 3 hours.

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

Deduction

Mebeverinee in unchanged form is not excreted from the body, it is completely metabolized; its metabolites are almost completely eliminated from the body. Veratric acid is excreted by the kidneys. Mebeverine alcohol is also excreted by the kidneys, partly as carboxylic acid and partly as demethylated carboxylic acid.

Indications

For adults:

• spasm of the gastrointestinal tract (including due to organic disease);
• biliary colic, cholecystitis, renal colic;
• irritable bowel syndrome.

For children over 12 years of age:

• functional disorders of the gastrointestinal tract, accompanied by abdominal pain.

Use during pregnancy and lactation

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

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

There is insufficient information on the excretion of Mebeverine or its metabolites in breast milk. Do not take Duspatalin® during breast-feeding.

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 the drug Duspatalin.

Contraindications

• hypersensitivity to any component of the drug;
• age under 18 years (due to insufficient data on efficacy and safety);
• pregnancy (due to insufficient data).

Side effects

Skin disorders: urticaria, angioedema, including facial edema, exanthema. Immune system disorders: hypersensitivity reactions (anaphylactic reactions).

Interaction

Only studies on the interaction of this drug with alcohol were conducted.

Animal studies have shown that there is no interaction between Duspatalin and ethyl alcohol.

How to take, course of use and dosage

The drug is taken orally.

Capsules should be swallowed with a sufficient amount of water (at least 100 ml). Capsules should not be chewed, because their shell provides a long-term release of the drug.

Assign 200 mg (1 capsule) 2 times / day for 20 minutes before meals (morning and evening).

The duration of taking the drug is not limited.

If the patient has forgotten to take one or more capsules, the drug should be continued with the next dose.

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

Overdose

Symptoms: theoretically, in case of overdose, an increase in the excitability of the central nervous system is possible.

In cases of overdose of Mebeverinee, the symptoms were either absent or minor and usually quickly reversible. The reported overdose symptoms were neurological and cardiovascular in nature.

Treatment: No specific antidote is known.

Symptomatic treatment is recommended.

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

Measures to reduce absorption are not required.

Description

Extended-release capsules, solid gelatin, size # 1, opaque, white in color, marked “245” on the capsule body; the contents of the capsules are white or almost white granules.

Special instructions

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Studies of the effect of the drug on the ability to drive a car and other mechanisms have not been conducted.

The pharmacological properties of the drug, as well as the experience of its use, do not indicate any adverse effect of Mebeverinee on the ability to drive a car and other mechanisms.

Form of production

Capsules

Storage conditions

In a dry place, at a temperature not exceeding 25 °C

Shelf life

1 year

Active ingredient

Mebeverine

Conditions of release from pharmacies

By prescription

Dosage form

long-acting capsules

Description

For adults as directed by your doctor

Indications

Flatulence, Constipation, Diarrhea, Gastrointestinal Spasm, Biliary Dyskinesia