Cromoglycic acid - instructions for use, dose, side effects, contraindications

Description:Hard gelatin capsules No. 2, body and cap of white color.The contents of capsules are white or almost white powder. It is allowed to have capsule-shaped seals in the form of a column or a tablet, which, when pressed with a glass rod, crumble.

Pharmacotherapeutic group:Antiallergic agent - stabilizer of membranes of mast cells

ATX: & nbsp

S.01.G.X.01 Cromoglycic acid

R.03.B.C.01 Cromoglycic acid

Pharmacodynamics:

Antiallergic, has a membrane-stabilizing effect, prevents the degranulation of mast cells and the release of histamine, bradykinin, leukotrienes and other biologically active substances. Prevents development, but does not eliminate symptoms of allergic reactions of immediate type.

When administered orally in patients with mastocytosis, relief from gastrointestinal symptoms (diarrhea, abdominal pain) and skin (urticaria, pruritus) is observed on week 2-6 of the treatment and lasts 2-3 weeks.

Pharmacokinetics:After ingestion, the absorption of sodium cromoglycate from the gastrointestinal tract is low (less than 1% of the dose), but its system clearance is high (plasma clearance is 7.9 ± 0.9 ml / min / kg), so there is no accumulation of the drug.The connection with plasma proteins is approximately 65%. It is not metabolized. It stands out unchanged through the intestine and kidneys in approximately equal proportions.

Indications:

- Food allergy (with proved presence of an allergen) as a monotherapy or in combination with a diet that limits the intake of an allergen;

- Nonspecific ulcerative colitis (as an adjuvant in combination with glucocorticosteroids (GCS) or sulfasalazip, as well as a drug of choice in patients with hypersensitivity to sulfasalazine).

Contraindications:

- Hypersensitivity to sodium cromoglycate or any other component of the drug;

- Children under 2 years old.

Pregnancy and lactation:

During pregnancy (especially in the first trimester) with the appointment of the drug as well as with the appointment of other medicines, care should be taken. The accumulated experience in the use of the drug during pregnancy confirms the absence of adverse effects of the drug on fetal development. At pregnancy the preparation should be appointed or nominated only in those cases when the necessity of its or his reception is obvious.It is not established whether sodium cromoglycate enters the mother's milk, but on the basis of its physicochemical properties it can be considered as unlikely. There were no reports confirming that the use of sodium cromoglycate by nursing mothers had any adverse effect on the child.

Dosing and Administration:

The drug is taken orally in the form of capsules or a solution made from the contents of capsules (the capsule is opened, the contents are poured from a glass, poured into a glass 1 teaspoon of hot boiled water, the resulting solution is diluted with 2 teaspoons of cold water).

With food allergies, for 15-20 minutes before meals, adults and children over 14 years of age are prescribed in an initial dose of 200 mg 4 times a day; children aged 2 to 14 years - 100 mg 4 times a day. The maximum daily dose should not exceed 40 mg / kg.

At achievement of steady therapeutic effect the dosage can be reduced to a minimum, providing absence of symptoms of disease.

Patients who for some reason can not avoid eating food containing allergens should take 1 dose 15 minutes before meals.The optimum dose is selected individually, but in the range from 100 to 500 mg.

In case of an accidental admission pass, it should be taken as soon as possible. If this coincides with the reception of the next dose, then the missed dose is not taken.

Side effects:

Nausea, vomiting, diarrhea, abdominal discomfort, skin rash, joint pain. Allergic reactions are extremely rare.

Overdose:Since the drug Cromoglycic acid absorbed very slightly, an overdose is unlikely. In case of an overdose, medical supervision and, if necessary, symptomatic treatment are indicated.

Interaction:

The combined use of sodium cromoglycate and GCS can reduce the dose of the latter, and in some cases completely abolish them. During the dose reduction, the SCS patient must be under close medical supervision. The rate of reduction of the GCS dose should not exceed 10% per week.

Special instructions:

Patients who have a history of anaphylactic shock or other life-threatening conditions associated with food intake should not use cromoglycic acid as an adjuvant.

The patient should be warned about the need for regular use of the drug.

Effect on the ability to drive transp. cf. and fur:

Not studied.

Form release / dosage:

Capsules, 100 mg.

Packaging:

10 capsules in a planar cell package. For 1,2, 3, 4, 5 or 10 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

100 capsules per can of polymeric polypropylene for medicines with the control of the first opening, sealed with a cap with silica gel. On 1 bank together with the instruction on application place in a pack from a cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004298

Date of registration:18.05.2017

Expiration Date:18.05.2022

The owner of the registration certificate:Life Sainses OHCFLife Sainses OHCF Russia

Manufacturer: & nbsp

OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC Russia

Information update date: & nbsp20.06.2017

Illustrated instructions

Instructions

Cromoglycic acid (Cromoglicic acid)