What Is Ipratropium Bromide Nasal Spray?

Ipratropium bromide aerosol with indications suitable for the prevention and treatment of dyspnea associated with chronic obstructive airway disease: chronic obstructive bronchitis with or without emphysema; mild to moderate bronchi asthma.

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Drug Name: Ipratropium bromide aerosol

Drug type: Prescription drugs, topical drugs, essential drugs
Use classification: M receptor blocker

Ipratropium bromide aerosol ingredients

Main ingredients: Each spray contains (8) -3-hydroxy-8-isopropyl-1H.
Chemical name: (8r) -3-hydroxy-8-isopropyl-1H, 5H-bromotropine (±) tropine acid (= isotropium bromide) -hydrate.
Chemical Structure:

Molecular formula: C ₂₀ H ₃₀ BrNO ₃ · H ₂ O
Molecular weight: 430.4

Properties of Ipratropium Bromide Aerosol

The liquid medicine of this product in a pressure-resistant container is a clear and colorless liquid. When the valve is pressed, the liquid medicine is sprayed out as mist.

Ipratropium bromide aerosol indications

This product is suitable for the prevention and treatment of dyspnea associated with chronic obstructive airway disease:
Chronic obstructive bronchitis with or without emphysema;
Mild to moderate bronchial asthma.

Ipratropium bromide aerosol specifications

139: 4.86mg (based on ipratropium bromide monohydrate), 20g per (based on ipratropium bromide)

Ipratropium bromide aerosol usage dosage

Dosages Unless specifically prescribed by your doctor, the following dosages are generally recommended for adults and children over 6 years: prevention and long-term treatment:
1-2 , several times a day;
The average daily dose is 1-2 , 3-4 times a day.
The same applies to children under 6 years of age. However, there is no sufficient medication experience for people of this age, so only use Aquale quantitative aerosol under the supervision of a doctor. If the patient needs to increase the dose gradually, it should be confirmed whether other combined treatment is needed, and the total daily dose should not exceed 12%.
Important note: If medication does not produce significant improvement or worsen the patient's condition, you should see a doctor to change your treatment plan. Seek immediate medical attention if acute or rapidly worsening dyspnea occurs. Additional treatment with adrenocortical hormones, beta-sympathomimetics, or theophylline may be needed. For acute or rapidly worsening dyspnea, seek medical attention immediately.
In such cases, treatment with AQTROL 250 g / 2ml inhalation solution or AQTROL 500 g / 2ml inhalation solution should be considered.
The usage must use the quantitative aerosolizer correctly to achieve a good therapeutic effect.
Alcatel Quantitative Aerosols can only be used for inhalation.
Patients are advised to sit or stand while inhaling.
The valve of the aerosolizer should be moved twice before using the quantitative aerosolizer for the first time.
Each use must follow the following rules:
1. Remove the dust cover (see Figure 1);
2. Exhale deeply
3 Hold the dosing aerosol dispenser as shown in Figure 2 and close the lips to bite the nozzle. The arrow at the base of the container should point upwards and the nozzle should point downwards;
4 Inhale as deeply as possible and press the base of the aerosolizer at the same time to release a certain amount. Hold your breath for a few seconds, then remove the nozzle from your mouth and exhale slowly;
5. Replace the dust cap after use.

Care needs to be taken to ensure that inhalants are not sprayed into the eyes. Children need to use this product under adult supervision.
Other information If the pressure dosing aerosolizer is not used for more than 3 days, the valve should be moved once before use.
The nozzle should be kept clean to ensure its normal operation, and it should be cleaned regularly according to the following method: Remove the nozzle from the spray and wash it with warm water. If using soap or detergent, the nozzle should be rinsed thoroughly with clean hot water.
Dry the nozzle thoroughly by shaking, and do not use any heating method to dry.
It is easy to keep the nozzle clean without taking a deep breath into the inside of the nozzle.
Sprays should not be opened with force or exposed to temperatures above 50 ° C.
important hint:
Nozzles were developed specifically for AQLORA metered aerosols to ensure that the correct dose is released each time and therefore cannot be used for any other metered dose inhaler. Similarly, other than the nozzles provided, other nozzles cannot be used for the AQLORA metered aerosol.
Residual dose in aerosol can be checked by removing the spray nozzle and placing the spray in a container filled with water. The position of the spray indicates the amount of residual dose.

Adverse reactions of ipratropium bromide

Like all medicines, Ai Quanle quantitative aerosol can also cause adverse reactions. The adverse reactions are listed below according to the system classification and frequency.
Adverse reactions were assessed by using the following rates:
Very common: more than 1 in 10 patients treated;
Common: Less than 1 in 10 patients treated, but more than 1 in 100 patients treated;
Uncommon: less than 1 in 100 patients treated, but more than 1 in 1000 patients treated;
Rare: less than 1 in 1000 patients treated, but more than 1 in 10,000 patients treated;
Very rare: less than 1 in 10,000 patients treated, or individual cases.
Adverse reactions to immune system disorders:
Uncommon: Urticaria Rare: Allergic reactions such as angioedema of the tongue, lips and face Nervous system disorders:
Common: headaches, dizziness, and functional abnormalities:
Uncommon: Adjustment disorders, angle-closure glaucoma are rare: increased intraocular pressure, eye pain, and dilated pupils. If the drug is accidentally entered into the eye due to improper use, it may cause mild, reversible eye complications, and Acute attacks of glaucoma are caused in some susceptible individuals. For patients with diagnosed angle-closure glaucoma, the simultaneous use of ipratropium bromide spray and 2-agonist may increase the risk of acute glaucoma attack. Eye pain or discomfort associated with conjunctival hyperemia and corneal edema, blurred vision, iridescence, or colored imaging may be signs of an acute glaucoma attack. If necessary, pupil contraction agents can be used to treat dilated pupils or mild dysregulation. However, if serious eye complications have occurred, the patient should consult an ophthalmologist.
Functional abnormalities of the heart:
Uncommon: Increased heart rate Rare: Palpitations, supraventricular tachycardia, atrial fibrillation and functional abnormalities in the respiratory system:
Common: Cough, local irritation, inhalation-related bronchospasm Rare: Laryngeal spasm Gastrointestinal disorders:
Common: Dry mouth, gastrointestinal disturbances (eg constipation, diarrhea, abdominal pain, vomiting)
Rare: Nausea and gastrointestinal disturbances are particularly common in patients with cystic fibrosis. Usually after treatment is interrupted,
The peristalsis returned to normal.
Skin and skin attachment discomfort:
Uncommon: rash, pruritus, kidney and genitourinary disorders:
Rare: The effect of urinary retention on the ability to drive and operate machines is not particularly limited if the drug is used as directed.

Ipratropium bromide aerosol contraindications

Ai Quanle quantitative aerosol is contraindicated for those allergic to ipratropium bromide, or any of the other components, and atropine or its derivatives.
Love full fun. Quantitative aerosols are used with caution in patients with angle-closure glaucoma, and special care should be taken to ensure that the drug cannot reach the eyes (see [Adverse Reactions] and [Dosage and Administration]). For patients with dysuria such as benign prostatic hyperplasia, the potential benefits of ipratropium bromide should be weighed, and only used when the benefits far outweigh the risk of increased urinary retention.
Pregnancy and lactation Although there is no evidence to date that the drug has any harmful effects on the fetus, AQLORA quantitative aerosols cannot be used during pregnancy, especially during early pregnancy, or during lactation, unless the expected benefits are greater than Anything that could be harmful to the fetus is more important.
The risks associated with inadequate treatment should also be considered. There is no experience using it during pregnancy and lactation in women.

Precautions for ipratropium bromide

If dyspnea suddenly worsens (paroxysmal bronchospasm) while inhaling the drug, you should immediately stop treatment, seek medical attention, and re-evaluate the treatment plan.
This product contains alcohol (less than 100mg per dose).

Ipratropium bromide aerosol medication for pregnant and lactating women

The safety of medications during pregnancy has not been confirmed.
The use of this product in women who have been determined to be pregnant or suspected to be pregnant must be carefully weighed against the benefits of the medication and the harm to the fetus. Preclinical studies have shown that when inhaled or nasally administered doses are higher than human recommended doses, no fetal toxicity or teratogenicity is shown.
It is unclear whether this product will enter milk. Although non-fat-soluble tetravalent ammonium can enter milk when inhaled, the amount of drug that enters the baby's body will not be large. However, because many drugs can enter the milk, lactating women should also pay special attention to this product.

Ipratropium bromide aerosol for children

See Dosage and Administration.

Ipratropium bromide aerosol

No special notice.

Ipratropium bromide aerosol drug interactions

Use of -adrenergic stimulants or xanthine preparations (such as theophylline) can enhance the effect of this product.
If other anticholinergic drugs are used at the same time, such as pirenzepine-containing preparations, the therapeutic effects and adverse reactions of Ai Quanle quantitative aerosol will be more significant.

Ipratropium bromide aerosol overdose

So far there are no specific symptoms of overdose.
If the drug is overdose, the degree of adverse reactions described above may be exacerbated.
However, taking into account the large therapeutic dose range of Aiquanle aerosols and the local route of administration, the possibility of severe anticholinergic symptoms is low.

Pharmacology and Toxicology of Ipratropium Bromide Aerosol

Pharmacological effects Ipratropium bromide can inhibit vagus-induced bronchoconstriction reflex. Ipratropium bromide inhibits the release of mediators that mediate bronchospasm by reducing cyclic guanosine phosphate (mast cell stabilization) in mast cells.
The bronchodilator effect of inhalation of this product is caused by the anticholinergic effect of local drugs on bronchial smooth muscle, and it is a non-systemic effect.
Patients with bronchospasm associated with chronic obstructive pulmonary disease (chronic bronchitis and emphysema) conducted a 90-day observational study and produced significant improvements in lung function 15 minutes after treatment (FEV1 and FEF25-75% increase 15 % Or 15%), peaked after 1-2 hours, and its sustained effect can reach 6 hours for most patients.
Toxicological studies Toxicological studies have shown that after repeated administration of Aiquan, the toxicity of Freon-free Aiquan and the traditional CFC Aiquan are comparable.
Long-term toxicity was performed in rats, dogs and rhesus monkeys for up to 6 months. The doses without adverse reactions (NOAEL) were 0.38 mg / kg / day, 0.18 mg / kg / day and 0.8 mg, respectively. / kg / day.
Histopathological examination revealed no pathological damage associated with the product in the broncho-pulmonary system. The dose at which no adverse reaction (NOAEL) was observed in rats after 18 months of administration was 0.5 mg / kg / day.
The newly developed dosage form (this hydroflurane dosage form and lactose powder inhalation dosage form) has been studied in rats and dogs for up to 3 months of long-term inhalation toxicity studies. The results obtained are consistent with the overall toxicity of ipratropium bromide. . The changes are mainly seen in pharmacological adverse reactions after known anticholinergic overdose.
Genotoxicity in vitro bacterial mutagenicity test (Ames test) No mutagenicity was found. The results of in vivo tests (micronucleus test, mouse dominant lethal test, cytoplasmic gene test of Chinese hamster bone marrow cells) did not show an increase in the rate of chromosome aberration after administration.
Carcinogenicity has not been found in long-term studies in mice and rats.
Reproductive toxicity tests on mice, rats and rabbits have shown that the drug has no teratogenic effects. In the rat test, the dose (50 mg / kg body weight) that caused maternal toxicity was seen to increase stillbirth and embryo toxicity.
When the rats were inhaled at 1.5 mg / kg body weight / day and rabbits at 1.8 mg / kg body weight / day during organogenesis, no embryo toxicity was observed.
During perinatal and lactation periods in rats, oral doses that cause maternal toxicity (50,500 mg / kg body weight / day) can result in increased stillbirth, reduced offspring weight, and increased postnatal mortality.
Oral doses up to 90 mg / kg body weight / day had no effect on fertility in male and female rats. Experience in human pregnancy and lactation.

Pharmacokinetics of ipratropium bromide aerosol

Studies using radiolabeled preparations show that depending on the inhalation technique, the proportion of drugs that reach the bronchi after inhaling the drug in the human body is between about 20 and 35%, while 65 to 80% of the drug is swallowed.
About 10-30% of the swallowed drug will be absorbed through the gastrointestinal tract.
After inhalation, the blood concentration of the drug has nothing to do with the pharmacodynamic time response curve. After intravenous injection, the plasma half-life is only a few minutes in the first elimination phase, and the end-elimination phase half-life is 2 to 4 hours; up to 20% of the drug binds to plasma proteins. The drug is completely cleared through the bile and kidneys within 24 hours.
After intravenous injection in rats by 14C-labeled active ingredient autoradiography, it was found that the drug did not pass through the placenta.

Ipratropium bromide aerosol storage

Store below 30 ° C.
Sprays should not be opened with force, or exposed directly to sunlight, or temperatures above 50 ° C, or frozen.

Ipratropium bromide aerosol packaging

Canned in stainless steel, 10 ml / piece.

Ipratropium bromide aerosol expiration date

36 months.

Ipratropium Bromide Aerosol Standard

Import drug registration standard JX20030025 ^[1]