Nalcrom (Capsules) Instructions for Use

Marketing Authorization Holder

Italchimici, S.p.A. (Italy)

Manufactured By

ITC Farma, S.r.L (Italy)

ATC Code

A07EB01 (Cromoglicic acid)

Active Substance

Cromoglicic acid (Rec.INN registered by WHO)

Dosage Form

Nalcrom

Capsules 100 mg: 30 pcs.

Dosage Form, Packaging, and Composition

100 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Mast cell membrane stabilizer. Anti-allergic drug

Pharmacotherapeutic Group

Antiallergic agent – mast cell membrane stabilizer

Pharmacological Action

An antiallergic agent that has a membrane-stabilizing effect, prevents mast cell degranulation and the release of histamine, bradykinin, leukotrienes, and other biologically active substances from them. It prevents the development, but does not eliminate the symptoms of immediate-type allergic reactions.

When taken orally in patients with mastocytosis, relief of gastrointestinal symptoms (diarrhea, abdominal pain) and skin symptoms (urticaria, itching) is observed at 2-6 weeks of treatment and persists for 2-3 weeks.

Pharmacokinetics

After oral administration, absorption from the gastrointestinal tract is low (less than 1% of the dose), however, plasma clearance is high and amounts to 7.9±0.9 ml/min/kg), so accumulation does not occur. Plasma protein binding is approximately 65%. It is not metabolized. It is excreted unchanged through the intestines and kidneys in approximately equal proportions.

Indications

Food allergy (with proven presence of an allergen) as monotherapy or in combination with a diet that limits allergen intake.

Ulcerative colitis (as an adjuvant in combination with glucocorticosteroids or sulfasalazine, as well as the drug of choice in patients with hypersensitivity to sulfasalazine).

ICD codes

Dosage Regimen

Administer orally. The standard adult and pediatric dose for food allergy is 200 mg four times daily.

For ulcerative colitis, use 200 mg four times daily as an adjunctive therapy.

For children aged 2 to 12 years, initiate therapy with 100 mg four times daily.

Increase the dose to the adult level of 200 mg four times daily if the clinical response is inadequate after two weeks.

Take capsules 15-20 minutes before meals.

Open the capsule and dissolve the powder in hot water. Add cold water to cool the solution before ingestion for improved palatability.

Do not exceed the maximum daily dose of 40 mg per kg of body weight.

After a stable therapeutic effect is achieved, typically within 2-3 weeks, reduce the dosage to the minimum effective level that maintains symptom control.

For maintenance therapy, a reduced frequency of administration, such as twice daily, may be sufficient.

Abrupt discontinuation may lead to symptom recurrence; taper the dose gradually under medical supervision.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea, abdominal discomfort, skin rash.

Other: joint pain; extremely rarely – allergic reactions.

Contraindications

Hypersensitivity to cromoglicic acid; children under 2 years of age.

Use in Pregnancy and Lactation

Use with caution in the first trimester of pregnancy. The accumulated experience with the use of cromoglicic acid during pregnancy confirms the absence of adverse effects on fetal development. Use during pregnancy only in cases where the need for its use is obvious.

It is not known whether cromoglicic acid is excreted in human breast milk, but based on the physicochemical properties of ambroxol, this can be considered unlikely. There have been no reports confirming that the use of cromoglicic acid has any adverse effect on the child.

Use in Hepatic Impairment

Use with caution in concomitant liver diseases.

Use in Renal Impairment

Use with caution in concomitant kidney diseases.

Pediatric Use

Contraindicated for use in children under 2 years of age.

Geriatric Use

There are no special instructions for limiting use in elderly patients.

Special Precautions

Patients with a history of anaphylactic shock or other life-threatening conditions caused by food intake should not use cromoglicic acid as an auxiliary drug.

Drug Interactions

Concomitant use with glucocorticosteroids allows reducing the dose of the latter, and in some cases, completely discontinuing them. During the reduction of the glucocorticosteroid dose, the patient should be under careful medical supervision. The rate of glucocorticosteroid dose reduction should not exceed 10% per week.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.