Ipratropium Steri-Neb (Solution) Instructions for Use

Marketing Authorization Holder

NORTON HEALTHCARE, Limited (United Kingdom)

Manufactured By

IVAX Pharmaceuticals UK, Limited (United Kingdom)

ATC Code

R03BB01 (Ipratropium bromide)

Active Substance

Ipratropium bromide (Rec.INN registered by WHO)

Dosage Form

Ipratropium Steri-Neb

Solution for inhalation 250 mcg/1 ml: amp. 1 ml or 2 ml 20, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

Solution for inhalation colorless or almost colorless, transparent.

Excipients: sodium chloride – 8.5 mg, hydrochloric acid – to pH 3.4, water for injections – to 1 ml.

1 ml – polyethylene ampoules, welded together in the form of a block (5) – blocks (4) – cardboard packs.
1 ml – polyethylene ampoules, welded together in the form of a block (5) – blocks (6) – cardboard packs.
1 ml – polyethylene ampoules, welded together in the form of a block (5) – blocks (6) – cardboard packs (2) – cardboard boxes.
2 ml – polyethylene ampoules, welded together in the form of a block (5) – blocks (4) – cardboard packs.
2 ml – polyethylene ampoules, welded together in the form of a block (5) – blocks (6) – cardboard packs.
2 ml – polyethylene ampoules, welded together in the form of a block (5) – blocks (6) – cardboard packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Bronchodilator drug – m-cholinergic receptor blocker

Pharmacotherapeutic Group

M-cholinoblocker

Pharmacological Action

Bronchodilator agent, blocks m-cholinergic receptors of the smooth muscles of the tracheobronchial tree (mainly at the level of large and medium bronchi) and suppresses reflex bronchoconstriction. Having a structural similarity to the acetylcholine molecule, it is its competitive antagonist. It effectively prevents bronchoconstriction resulting from the action of various bronchospastic agents and also relieves bronchospasm associated with the influence of the vagus nerve. When used by inhalation, it has practically no resorptive effect.

The bronchodilator effect develops within 5-15 minutes, reaches its maximum in 1-2 hours and lasts up to 6 hours (sometimes up to 8 hours).

Pharmacokinetics

Absorption is extremely low. Up to 90% of the inhaled dose is swallowed, is practically not absorbed in the gastrointestinal tract and is excreted mainly with feces (25% unchanged, the rest in the form of metabolites). The absorbed part (small) is metabolized in the liver into 8 inactive or weakly active anticholinergic metabolites, which are excreted by the kidneys. Being a quaternary ammonium derivative, it is poorly soluble in fats and weakly penetrates biological membranes. Does not accumulate. The half-life of the drug that has entered the bronchial tree is 3.6 hours; 70% of this dose is excreted in the urine. Changes in pharmacokinetic parameters in patients with impaired renal or liver function and in elderly patients are not of clinical significance and do not require dose adjustment.

Indications

• Reversible airway obstruction;
• Chronic obstructive pulmonary disease;
• Bronchial asthma;
• Chronic obstructive bronchitis;
• Pulmonary emphysema.

ICD codes

Dosage Regimen

The drug Ipratropium Steri-Neb is used by inhalation using inhalers – nebulizers.

Adults and children over 12 years

2.0 ml of solution (40 drops=500 mcg) 3-4 times a day. The maximum daily dose is 8 ml.

Children from 6 to 12 years

1.0 ml of solution (20 drops=250 mcg) 3-4 times a day. The maximum daily dose is 4 ml.

Children under 6 years

0.4-1.0 ml of solution (8-20 drops=100-250 mcg) 3-4 times a day. The maximum daily dose is 4 ml. Treatment of children should be carried out under medical supervision. If necessary, the drug can be diluted with 0.9% sodium chloride solution.

Technique for using the drug

Before using the drug, it is necessary to read the manufacturer’s instructions for the nebulizer.

Prepare the nebulizer according to the manufacturer’s instructions.

Separate the Steri-Neb (ampoule with sterile solution) from the block by twisting and pulling it as shown in Fig. 1.

Holding the ampoule vertically with the cap up, break off the cap. Squeeze the solution into the reservoir of your nebulizer. Use the nebulizer according to the manufacturer’s instructions. The solution remaining unused in the nebulizer chamber should be discarded. Wash the nebulizer thoroughly. When using the drug, avoid getting the solution into the eyes.

Adverse Reactions

Dry mouth, headache, nausea, increased sputum viscosity.

Rarely constipation, decreased gastrointestinal motility, urinary retention, paradoxical bronchospasm, cough, tachycardia (including supraventricular), atrial fibrillation, palpitations, accommodation paresis.

Allergic reactions – skin rash (including urticaria and multiforme erythema), swelling of the tongue, lips and face, laryngospasm and other manifestations of anaphylaxis.

When used in therapeutic doses, no adverse effects on bronchial secretion were noted.

Contraindications

• Hypersensitivity to atropine and its derivatives;
• Hypersensitivity to ipratropium bromide and other components of the drug;
• Pregnancy (I trimester).

With caution: angle-closure glaucoma, urinary tract obstruction (prostatic hyperplasia), children under 6 years of age.

Use in Pregnancy and Lactation

The drug is contraindicated in the first trimester of pregnancy. Prescribing the drug in the II and III trimesters of pregnancy and during lactation is possible only if the intended therapeutic benefit for the mother outweighs the possible risk to the fetus or infant.

Pediatric Use

Use is possible according to the dosage regimen.

Use of the drug with caution in children under 6 years of age.

Special Precautions

Caution should be exercised during the first uses of the drug via a nebulizer. There are reports of rare cases of paradoxical bronchospasm. If the effectiveness of the drug decreases, you should consult a doctor. Not recommended for emergency relief of an asthma attack (bronchodilator effect develops later than with beta-adrenergic agonists).

Patients should be able to use the drug Ipratropium Steri-Neb correctly. Avoid getting the solution into the eyes. Patients predisposed to developing glaucoma should be specifically warned about the need to protect their eyes from getting the drug.

Overdose

Inhalation of a dose of 5 mg causes tachycardia, but single doses of 2 mg in adults and 1 mg in children did not cause adverse effects. A single oral dose of ipratropium bromide equal to 30 mg causes minor manifestations of systemic anticholinergic action, such as dry mouth, accommodation paresis, and increased heart rate.

Treatment is symptomatic.

Drug Interactions

Enhances the bronchodilator effect of beta-adrenergic agonists and xanthine derivatives. The anticholinergic effect is enhanced by antiparkinsonian drugs, quinidine, and tricyclic antidepressants.

When used simultaneously, it enhances the effect of other anticholinergic drugs – additive effect.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F) in a place protected from light. Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

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.