Nalkrome - instructions for use, doses, side effects, contraindications

Description:Hard gelatin capsules number 2, consisting of a transparent, colorless body and a transparent colorless lid. The capsule shows the inscription "SODIUM CROMOGLICATE 100 mg".The capsule contains a white granular powder.

Pharmacotherapeutic group:Antiallergic agent, stabilizer of mast cell membranes

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 symptoms from the gastrointestinal tract (GIT) - (diarrhea, abdominal pain) and skin (hives, itching) is observed at 2-6 weeks of treatment and persists for 2-3 weeks.

Pharmacokinetics:

After ingestion, absorption of sodium cromoglycate from the gastrointestinal tract is low (less than 1% of the dose), however, its system clearance is high (plasma clearance is 7.9 + 0.9 ml.min kg, therefore no cumulation of the drug occurs.

The connection with plasma proteins is approximately 65%. It is not metabolized. It is allocated in an unchanged form with bile and urine approximately in 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 sulfasalazine, and as a drug of choice in patients with hypersensitivity to sulfasalazine.

Mastocytosis (pigmentary urticaria).

Contraindications:

Hypersensitivity.

Children up to 2 years.

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 cromoglycate of sodium 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:

Inside. Capsules should be swallowed whole or dissolve their contents in a small amount (1 teaspoon) of very hot water, and then dilute with cold water (4 teaspoons) and drink. With food allergies, it is more preferable to take the drug as an aqueous solution.

Adults (including elderly people):

Initial dose: 2 capsules (200 mg) 4 times a day for about 15 minutes before meals. The maximum daily dose should not exceed 40 mg / kg.

Children (2-14 years):

The initial dose of 1 capsule (100 mg) 4 times a day about 15 minutes before eating. The maximum daily dose should not exceed 40 mg / kg.

In patients with food allergies, it is possible to increase symptoms of the disease with the onset of therapy. In this case, it is necessary to start taking Nalcomrom at a dose of not more than 100 mg per day, gradually increasing it after 3-4 days until the necessary therapeutic effect is achieved.

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

Overdose:Since Nalcrom is absorbed very slightly, an overdose of the drug is unlikely.

Interaction:The combined use of sodium cromoglycate and GCS can reduce the dose of the latter, and in some cases completely eliminate 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 with a history of anaphylactic shock or other life-threatening allergic reactions in response to taking any food products should not use Nalcrom as a prophylactic drug.

Effect on the ability to drive transp. cf. and fur:It is not known.

Form release / dosage:Capsules of 100 mg.

Packaging:

For 100 capsules in a polyethylene bottle with a screw cap. 1 bottle with instructions for use in a cardboard box.

Storage conditions:

List B. At temperatures below + 30 ° C in a dry place.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011906 / 01

Date of registration:26.11.2007

Expiration Date:Unlimited

The owner of the registration certificate:Italkhimichi SpAItalkhimichi SpA Italy

Manufacturer: & nbsp

ITC FARMA, S.r.L Italy

Information update date: & nbsp23.05.2018

Illustrated instructions

Instructions

Nalkrome® (Nalcrom®)