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Manufacturers: SIFAVITOR SRL
Active ingredients
- Cromoglicic acid
Disease class
- Other diseases of the lacrimal gland
- Acute atopic conjunctivitis
- Keratitis
- Keratoconjunctivitis
- Vasomotor and allergic rhinitis
- Chronic rhinitis, nasopharyngitis and pharyngitis
- Asthma
- Allergy unspecified
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Membrane stabilizing
- Antiallergic
Pharmacological group
- Mast cell membrane stabilizers
Release form and composition
Dosage form of Cromoglycic acid - capsules: gelatin hard, size No. 2, with a white cap and body, filled inside with white or almost white powder; it is possible that there are compactions of the capsule mass in the form of a tablet or a column, which crumble when pressed with a glass rod (in a cardboard pack there is 1 polymer or polypropylene jar with first opening control, containing 100 capsules, or 1, 2, 3, 4, 5 or 10 packages of cellular contour , containing 10 capsules) and instructions for use of Cromoglycic acid.
Composition of 1 capsule:
- active substance: sodium cromoglycate – 100 mg;
- auxiliary components: titanium dioxide (E 171) – 2%, gelatin – up to 100%.
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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Sodium cromoglycate, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Sodium cromoglycate is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!
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Pharmacological properties
Pharmacodynamics
Cromoglicic acid is an antiallergic agent that has a membrane-stabilizing effect. The drug prevents the degranulation of mast cells and the release of leukotrienes, bradykinin, histamine and other biologically active substances from them. Its intake prevents the development, but does not eliminate the manifestations of immediate allergic reactions.
When administered orally in patients with mastocytosis, relief from skin symptoms (itching and urticaria) and gastrointestinal tract (abdominal pain, diarrhea) is observed after 14–42 days from the start of therapy and persists for 14–21 days.
Pharmacokinetics
Absorption of sodium cromoglycate from the gastrointestinal tract after oral administration is low (<1% of the dose), but its systemic clearance is high (plasma clearance is 7.9 ± 0.9 ml per 1 min per 1 kg). Thanks to this, the drug does not accumulate. Plasma protein binding is approximately 65%. Sodium cromoglycate is not metabolized. It is excreted unchanged through the kidneys and intestines in approximately equal proportions.
Powder substance Sodium cromoglicate
Instructions for medical use of the drug
Description of pharmacological action
Stabilizes the membranes of sensitized mast cells, inhibits the entry of calcium ions, degranulation and the release of histamine, bradykinin, leukotrienes (including the slow-reacting substance of anaphylaxis), prostaglandins and other biologically active substances.
Indications for use
Inhalation forms: bronchial asthma, incl. atopic, physical exertion and asthmatic triad, chronic bronchitis with broncho-obstructive syndrome. Capsules: food allergy (with proven presence of antigen, separately or in combination with a diet that limits the intake of allergen), as an aid: ulcerative colitis, proctitis, coloproctitis; mastocytosis. Nasal spray: year-round and seasonal allergic rhinitis, hay fever. Eye drops: acute and chronic allergic conjunctivitis, allergic keratitis, keratoconjunctivitis, dry eye syndrome, eye strain and fatigue, irritation of the mucous membrane of the eyes caused by allergic reactions (environmental factors, occupational hazards, household chemicals, cosmetics, ophthalmic drugs shapes, plants and pets).
Release form
powder substance;
Pharmacodynamics
Stabilizes the membranes of sensitized mast cells, inhibits the entry of calcium ions, degranulation and the release of histamine, bradykinin, leukotrienes (including the slow-reacting substance of anaphylaxis), prostaglandins and other biologically active substances. Prevents the development of allergic and inflammatory reactions, bronchospasm, inhibits the chemotaxis of eosinophils. It has the ability to block receptors specific for inflammatory mediators. Long-term use reduces the frequency of bronchial asthma attacks and facilitates their course, reduces the need for bronchodilators and glucocorticoids. In patients with mastocytosis, after 2–6 weeks from the start of treatment, a decrease in symptoms from the gastrointestinal tract (diarrhea, abdominal pain, nausea, vomiting) and skin (hyperemia, urticaria, itching) is observed, which persists for 2–3 weeks after its discontinuation. Reduction of symptoms in allergic eye diseases manifests itself in a period of several days to several weeks. With year-round allergic rhinitis, the effect appears within 1 week and reaches a maximum after 1–4 weeks.
Pharmacokinetics
After oral administration, no more than 1% is absorbed (0.45% is excreted in the urine within 24 hours), the rest is excreted in feces. When instilled into the eye, it is poorly absorbed into the systemic circulation (0.03%), trace amounts (less than 0.01%) penetrate into the aqueous humor and are completely eliminated within 1 day. After intranasal administration, less than 7% is absorbed into the systemic circulation. When administered by inhalation, up to 90% of the drug settles in the trachea and large bronchi. 5–15% of the dose is absorbed from the lungs (Cmax in the blood is created in 15–20 minutes), a small part enters the gastrointestinal tract, and the rest is exhaled. Absorption from the mucous membranes decreases as the amount of secretion increases. Binding to blood plasma proteins is 65–75%. It is not metabolized and is excreted from the body in equal quantities with urine and bile within 24 hours. T1/2 is 1–1.5 hours. It passes into breast milk in small quantities. The effect of a single dose lasts up to 5 hours.
Use during pregnancy
Contraindicated (especially in the first trimester of pregnancy). Breastfeeding should be stopped during treatment.
Contraindications for use
Hypersensitivity (including to benzalkonium hydrochloride), pregnancy, breastfeeding, children under 2 years of age (for a dosed aerosol - up to 5 years).
Side effects
For inhalation use: For the skin: exanthema, dermatitis; rarely - urticaria; in some cases - vascular edema, photodermatitis, exfoliative dermatitis. From the nervous system and sensory organs: in some cases - malaise, dizziness, irritability, insomnia, hallucinations, tremor, peripheral neuritis, tinnitus. From the gastrointestinal tract: nausea, gastroenteritis; in some cases - unpleasant taste in the mouth, stomatitis, glossitis, swelling of the parotid salivary gland, esophagospasm, dyspepsia, flatulence, abdominal pain, diarrhea, constipation, impaired liver function. From the genitourinary system: frequent urination, nephropathy. From the respiratory system: bronchial irritation during inhalation (cough, retching, short-term spasm; rarely - expressed with a decrease in external respiration, requiring discontinuation of the drug), pharyngitis; very rarely - hemoptysis, laryngeal edema, eosinophilic pneumonia. From the cardiovascular system: in some cases - chest pain, periarterial vasculitis, heart failure, pericarditis, hypotension, cardiac arrhythmia. From the musculoskeletal system: myositis, in some cases - muscle and joint pain, polymyositis, joint swelling. Other: rarely - serum sickness. When taken orally: From the gastrointestinal tract: nausea, vomiting, abdominal discomfort, diarrhea. Other: skin rash, joint pain. With intranasal administration: From the gastrointestinal tract: unpleasant taste in the mouth, swelling of the tongue. From the respiratory system: short-term irritation of the mucous membrane and increased secretion from the nose; very rarely - nosebleeds, ulceration of the nasal mucosa, cough, suffocation. Other: headache, arthralgia, anaphylactic reaction (cough, difficulty swallowing, itchy skin, swelling of the face, lips or eyelids, difficulty breathing), exanthema, urticaria. For eye drops - short-term burning and blurred vision, conjunctival hyperemia, lacrimation, conjunctival swelling, sensation of a foreign body in the eye, dryness around the eyes, stye.
Directions for use and doses
Inhalation: for bronchial asthma - adults and children over 5 years of age (metered-dose aerosol) at the beginning of treatment - 1-2 doses 4-6 (up to
once a day. To prevent asthma from physical exertion, an additional dose of the drug can be taken immediately before physical work. In severe cases, 2 doses 6–8 times a day, with clinical improvement - 1 dose 4 times a day. Orally, adults and children (over 12 years old) 2 capsules (200 mg) 4 times a day half an hour before food and sleep. Children from 2 to 12 years old - 1 capsule (100 mg) 4 times a day (up to 40 mg/kg/day). Intranasal - 1 aerosol dose in each nasal passage 3-4 times a day. Eye drops: conjunctivally, adults and children - 1-2 drops 4 times a day (up to 6-8 times) at equal intervals (when the effect is achieved, the intervals between uses are gradually lengthened).
Interactions with other drugs
Beta-agonists, glucocorticoids, antihistamines and theophylline potentiate the effect. You should not inhale bromhexine, ambroxol mixed with a solution of cromoglycic acid.
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
In a place protected from light, at a temperature not exceeding 25 °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
Cromoglicic acid, instructions for use: method and dosage
Capsules or a solution prepared from their contents are taken orally. To prepare the solution, pour the powder into a glass, pour 1 teaspoon of hot boiled water, and then dilute with 2 teaspoons of cold water.
In cases of food allergies, cromoglycic acid is taken 15–20 minutes before meals. The initial dose for children aged 2 to 14 years is 1 capsule (100 mg) 4 times a day; for children over 14 years of age and adults – 2 capsules 4 times a day. The maximum dose should not exceed 40 mg per 1 kg of body weight per day.
The dosage of the drug can be reduced to a minimum when a stable therapeutic effect is achieved, ensuring the absence of manifestations of pathology.
In cases where for some reason it is not possible to avoid eating food containing allergens, it is recommended to take 1 dose of the drug 15 minutes before meals. The optimal dose is selected by the doctor individually, but it should be no less than 1 and no more than 5 capsules.
If you accidentally miss the next dose of the drug, you should take it as soon as possible. If this coincides with the next dose, the missed dose is not taken.
special instructions
If there is a history of indications of anaphylactic shock or other life-threatening conditions that develop as a result of ingestion of food products, Cromoglycic acid is not used as an adjuvant.
The patient should be informed that the drug must be used regularly.
Impact on the ability to drive vehicles and complex mechanisms
No studies have been conducted on the effect of the drug on the ability to drive vehicles or operate complex machinery.
History[edit]
Cromolyn sodium was discovered in 1965 by Roger Altounian, who himself suffered from asthma all his life. This medication is considered a breakthrough in the treatment of asthma because in many cases patients can be steroid-free; however, it is primarily effective as a preventive measure for allergic and exercise-induced asthma rather than as a treatment for acute attacks. Altunyan studied some plants and herbs that have bronchodilator properties. One such plant was khella ( Ammi visnaga
), which has been used as a muscle relaxant since ancient times in Egypt. Altunyan deliberately inhaled derivatives of the active substance hellin to determine whether they could block his asthma attacks. After years of testing, he isolated an effective and safe asthma preventative called cromolyn sodium.
Use during pregnancy and lactation
During pregnancy, especially in the first trimester, the use of the drug is possible only under medical supervision. As with the prescription of other drugs, caution must be exercised.
The existing experience with the use of cromoglycic acid during pregnancy confirms the absence of adverse effects on fetal development. It is recommended to prescribe capsules only in cases where the need for their use is obvious.
There is no data confirming the entry of sodium cromoglycate into breast milk. Based on the physicochemical properties of the active substance, it can be considered unlikely that it will be excreted into breast milk. There have been no reports from nursing mothers who took the drug that would confirm any adverse effects of the drug on the child.
Reviews of Cromoglycic acid
According to reviews, Cromoglicic acid is a safe and effective drug used for food allergies. Among the advantages are the development of resistance to allergens, the ability to eat foods to which you were previously allergic, as well as the absence of side effects such as drowsiness or lethargy, which usually appear when taking similar medications.
Among the disadvantages, the most often mentioned is the need for long-term administration of capsules on a strict schedule, the high cost of the drug, and the impossibility of its use in children under 2 years of age.
