Nalcrom instructions for use of the drug

Release form, packaging and composition of the drug Clinical-pharmacological group Pharmaco-therapeutic group Pharmacological action Indications for use Method of administration and doses Side effects Contraindications for use Use in children Special instructions Drug interactions

Registration Certificate Holder:

ITALCHIMICI, SpA (Italy)

ATX Code:

R03BC01

Active substance:

cromoglycic acid

Dosage form:

Nalkrom

The drug is available with a prescriptionNalkromCapsules
reg.
No.: P N011906/01 dated 11.26.07 - Valid

pharmachologic effect

Antiallergic agent, mast cell membrane stabilizer. Inhibits the release of histamine, leukotrienes and other biologically active substances from mast cells. It is believed that the delay in the release of mediators occurs as a result of an indirect blockade of the penetration of calcium ions into cells. It has been established that cromoglycic acid suppresses the migration of neutrophils, eosinophils, and monocytes.

Prevents immediate and delayed asthmatic reactions after inhalation of allergens and non-antigenic irritants.

Directions for use and doses

The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. The compliance of the dosage form of a particular drug with the indications for use and dosage regimen should be strictly observed.

Individual. For inhalations - 1-10 mg (depending on the dosage form used) 4 times a day.

Orally for adults - 200 mg 4 times a day, for children aged 2 to 14 years - 100 mg 4 times a day.

When used in ophthalmology and ENT practice, the dose is set depending on the indications and the dosage form used.

Rectally applied in the form of microenemas.

Similar drugs:

  • Dexamethasone Solution for intravenous and intramuscular administration
  • Calcium gluconate Chewable tablets
  • Pulmicort Suspension for inhalation
  • Cetrine Oral tablets
  • Sodium cromoglicate Substance-powder
  • Diprospan Solution for injection
  • Mometasone furoate Substance-powder
  • L-cet Oral tablets
  • Dexamethasone Solution for injection
  • Adrenaline (Adrenaline) Solution for injection

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Side effect

For inhalation administration:

possible irritation of the upper respiratory tract, cough, short-term bronchospasm; in some cases - severe bronchospasm with a decrease in external respiratory function.

For intranasal administration:

at the beginning of treatment, irritation of the nasal mucosa is possible; in isolated cases - nosebleeds, allergic reactions.

For local use in ophthalmology:

There may be a temporary disturbance in the clarity of visual perception, a feeling of heat in the eye.

Allergic reactions:

in isolated cases - skin rash, joint pain.

Other:

in isolated cases - nausea.

special instructions

Not used to relieve an acute attack of bronchial asthma. Use with caution in case of concomitant diseases of the liver and kidneys. In exceptional cases, when inhalation of cromoglycic acid develops bronchospasm with a decrease in external respiratory function, repeated use is not recommended. In the treatment of ulcerative colitis, proctitis or proctocolitis, cromoglicic acid acid is the drug of choice in patients with hypersensitivity to sulfasalazine. In the inhalation solution of cromoglicic acid, bromhexine and ambroxol should not be used simultaneously. For food allergies, it should be used in combination with a diet that limits the intake of antigen. In children under 2 years of age, the dose of cromoglicic acid has not been determined acids for inhalation use in the form of powder and solution. In children under 5 years of age, the dose of cromoglycic acid for inhalation use in the form of an aerosol and for intranasal use has not been determined. Impact on the ability to drive vehicles and operate machinery

For some time after instillation into the eyes, you should refrain from performing work that requires increased attention.

Nalcrom instructions for use

Indications for use

This medicine is prescribed for a number of serious health problems, in particular:

  1. Food allergies.
  2. Allergic keratoconjunctivitis and conjunctivitis (prevention and treatment).
  3. Allergic rhinitis (as a means of prevention).
  4. Mastocytosis (urticaria).
  5. Different types of bronchial asthma: atopic, asthmatic triad, as well as complications caused by this disease.
  6. Chronic bronchitis with broncho-obstructive syndrome.

pharmachologic effect

Sodium cromoglycate has a membrane-stabilizing property: it prevents the so-called mast cells from degranulating and prevents the formation of histamine (a mediator of instant allergic reactions), as well as a number of other substances (leukotrienes, bradykinin, etc.). As a result, it is possible to stop the development of an allergic reaction.

Note! The drug prevents an immediate allergic reaction, but does not relieve the symptoms!

When treating people with mastocytosis, the medicine gradually relieves abdominal pain, diarrhea, and skin rashes and itching over 2 to 6 weeks. And the achieved effect lasts for 2-3 weeks.

How to take, course of administration and dosage

This medicine is prescribed for a number of serious health problems, in particular:

  • the capsule is opened;
  • pour the powder into a small cup;
  • pour a teaspoon of hot water and stir;
  • add 4 teaspoons of cold water, stir;
  • drink.

It is advisable to take an aqueous solution if you are allergic to food - this way the product will work more effectively.

It is preferable that the dosage and duration of the course be prescribed by the attending physician. The manufacturer provides the following information in the instructions:

  • Adults. The initial dose is 2 capsules 4 times a day. Take before meals (15 minutes before). The maximum permissible daily dose is 40 mg per 1 kg of human weight.
  • Children from 2 to 14 years old. 1 capsule 4 times a day before meals. The maximum permissible daily dose is prescribed by the doctor.

When treating food allergies, Nalcrom may cause an increase in symptoms. In this case, the daily dose is reduced to 1 capsule per day, and then gradually increased to the required dose over 3-4 days.

During maintenance therapy, the dose is reduced to the minimum and no more is taken than is required to maintain the achieved effect.

Advice! If for any reason a person must eat food containing allergens, 15 minutes before meals should take 1 to 5 capsules (the dose is calculated individually).

Capsules or an aqueous solution can be used to treat allergic keratoconjunctivitis and conjunctivitis. For problems with the gastrointestinal tract, the drug can be used for microenemas, and for bronchial asthma - in the form of inhalations. In these cases, the dose should be prescribed by a specialist.

Contraindications

The medicine is strictly contraindicated for people allergic to sodium cromoglycate, as well as:

  1. Children under 2 years old.
  2. Children under 5 years old should not have inhalations (the permissible dose has not been established).
  3. Pregnant women in the first trimester.
  4. During an acute attack of bronchial asthma.

Pregnant women in the 2nd and 3rd trimester, as well as nursing mothers, are prescribed the drug only if the benefit from it is higher than the possible risk to the fetus or baby.

People with impaired liver and kidney function should use the product with caution. Ambroxol or bromhexine should not be added to the liquid for inhalation.

Side effects

When deciding to buy Nalkrom, keep in mind that taking the capsules may cause the following side effects:

  • nausea and vomiting;
  • intestinal disorder;
  • skin rashes;
  • nose bleed;
  • cough;
  • joint pain.

Very rarely, patients experienced an allergic reaction.

Storage conditions

Capsules are stored in a closed box in a dry place out of the reach of children. Temperature – up to +30C.

Drug interactions

When using cromoglycic acid with oral and inhaled forms of beta-agonists, oral and inhaled forms of corticosteroids, theophylline and other methylxanthine derivatives, antihistamines, a potentiation effect is possible. The combined administration of cromoglycic acid and corticosteroids allows you to reduce the dose of the latter, and in some cases, completely cancel it. During the dose reduction of GCS, the patient should be under close medical supervision; the rate of dose reduction should not exceed 10% per week. In the inhalation solution, it is pharmaceutically incompatible with bromhexine or ambroxol. Bronchodilators must be taken (inhaled) before inhalation of cromoglycic acid. When applied topically in ophthalmic practice, cromoglycic acid reduces the need for the use of ophthalmic drugs containing corticosteroids.

Nalcrom capsule

Instructions for medical use of the drug

Description of pharmacological action

An antiallergic agent that has a membrane-stabilizing effect, prevents the degranulation of mast cells and the release of histamine, bradykinin, leukotrienes and other biologically active substances from them, and prevents the development of bronchospasm. Prevents the development, but does not eliminate the symptoms of immediate allergic reactions. When taken orally in patients with mastocytosis, relief of symptoms from the gastrointestinal tract (diarrhea, abdominal pain) and skin (urticaria, itching) is observed after 2-6 weeks of treatment and lasts for 2-3 weeks.

Indications for use

Food allergy (if the presence of an allergen is proven, separately or in combination with a diet that limits the intake of the allergen). Ulcerative colitis, proctitis, coloproctitis (as an auxiliary drug in combination with GCS or sulfasalazine, as well as the drug of choice in patients with hypersensitivity to sulfasalazine). Mastocytosis (urticaria pigmentosa).

Release form

capsules 100 mg; polyethylene bottle (bottle) 100 cardboard pack 1;

Pharmacodynamics

An antiallergic agent that has a membrane-stabilizing effect, prevents the degranulation of mast cells and the release of histamine, bradykinin, leukotrienes and other biologically active substances from them, and prevents the development of bronchospasm. Prevents the development, but does not eliminate the symptoms of immediate allergic reactions. When taken orally in patients with mastocytosis, relief of symptoms from the gastrointestinal tract (diarrhea, abdominal pain) and skin (urticaria, itching) is observed after 2-6 weeks of treatment and lasts for 2-3 weeks.

Pharmacokinetics

A small amount is absorbed - 1% of the dose taken. Communication with blood proteins - 65-75%. Not metabolized. A small amount is excreted by the kidneys (about 0.45% of the administered dose is excreted within 24 hours). Enterohepatic circulation is of primary importance in drug elimination; Significant amounts are excreted in bile. T1/2 - about 80 min.

Use during pregnancy

Contraindicated (especially in the first trimester of pregnancy). Breastfeeding should be stopped during treatment.

Contraindications for use

Hypersensitivity, pregnancy, lactation, children (up to 2 years).

Side effects

From the gastrointestinal tract: nausea, vomiting, abdominal discomfort, diarrhea. Other: skin rash, joint pain.

Directions for use and doses

Orally, for food allergies, 15 minutes before meals, adults and children over 14 years old - 200 mg 4 times a day; children aged 2 to 14 years - 100 mg 4 times a day, from 2 months to 2 years - 20-40 mg/kg/day in several doses. Once a stable therapeutic effect is achieved, the dosage can be reduced to a minimum that ensures the absence of symptoms of the disease. Patients who for some reason cannot avoid eating food containing allergens can take 1 dose 15 minutes before meals. The optimal dose in this case is 100-500 mg. The capsules are swallowed whole or before taking their contents are dissolved in a small volume of very hot water, then diluted with cold water and taken orally. In the treatment of proctitis and coloproctitis, cromoglycic acid, in addition to oral administration, can be administered in the form of microenemas, dissolving the contents of the capsule in water.

Interactions with other drugs

Beta-agonists, corticosteroids, antihistamines and theophylline enhance the effect. The combined administration of cromoglycic acid and corticosteroids allows you to reduce the dose of the latter, and in some cases completely cancel it. While reducing the dose of GCS, the patient should be under close medical supervision; the rate of dose reduction should not exceed 10% per week.

Precautions for use

Use with caution in patients with impaired liver or kidney function. Treatment is continued as long as the allergenic factor is active. Discontinuation of the drug must be carried out by gradually reducing the dose over 1 week. The cough that occurs after inhalation can be stopped by drinking a glass of water. If the use of the drug causes repeated bronchospasm, preliminary inhalation of bronchodilators is recommended. When concomitant therapy with bronchodilators is used, they are used before inhalation of cromoglycic acid. If benzalkonium chloride (a preservative) is present in eye drops, you should not wear soft contact lenses during treatment. It is recommended to remove hard lenses 15 minutes before instillation. It should be taken into account that after instillation into the eye, a short-term visual impairment is observed (you should not immediately perform work that requires increased attention).

Special instructions for use

Not intended for relief of acute attacks of bronchial asthma and status asthmaticus. The patient should be warned about the need for regular use of the drug. Inhalation of the solution should be carried out using a compression, ultrasonic or piezoelectric inhaler through a face mask or mouthpiece. The aerosol can must be shaken before use and kept in an upright position during inhalation (the dosing valve must be at the bottom). Inhalation of the contents of the capsule is carried out using a special pocket turbo inhaler (“Spinhaler”), into which a capsule with the drug is placed. By pressing the cap of the inhaler, the capsule is pierced and with the patient’s active respiratory effort during inhalation, the powder enters the respiratory tract.

Storage conditions

List B.: In a dry place, at a temperature not exceeding 30 °C.

Best before date

60 months

ATX classification:

R Respiratory system

R03 Drugs for the treatment of bronchial asthma

R03B Other drugs for inhalation use for the treatment of bronchial asthma

R03BC Antiallergic drugs (excluding glucocorticoids)

R03BC01 Cromoglic acid

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