Combent Boehringer solution solution controls bronchodial spasm (1 blister x 10 tubes)

Dosage form Box of 1 blister x 10 tubes
Specifications Ipratropium, salbutamol
Ingredient Bronchodilator

Ingredient

Composition information	Content
Ipratropium	0.5mcg
Salbutamol	3010mcg

Uses

indications

Combent medicine is indicated in the following cases:

Hurry and bronchial controller is recovered from respiratory obstruction in patients who need more than one bronchodilator.

Pharmacy

The phenomenon of bronchospasm after using ipratropium bromide is mainly local and specific effects in the lungs and the nature has no systemic effect.

Salbutamol Sulfate is a beta-2-adrenergic stimulant with a muscle effect on the respiratory tract causing muscle dilatation. Salbutamol causes all smooth muscle relaxation from the trachea to the bronchi and against the stimulus causing bronchospasm.

Combent provides simultaneous release of ipratropium bromide and salbutamol sulfate for the combination effect on both Muscarinic and Beta-2-adrenergic receptors in the lungs that cause bronchodilator superior to the drug containing single ingredients.

The control studies in patients with a recovery of bronchodial spasms show that Combent has a stronger bronchodilator effect than every single active active ingredient of the drug and does not increase the adverse effect.

pharmacokinetics

The total amount of ipratropium (original active ingredient) eliminates the kidneys (0 - 24 hours) about 46% of the intravenous dosage, less than 1% of oral doses and about 3-4% of the dosage. The full bioavailability of ipratropium bromide orally and the estimated aerosol is 2% and 7 - 9% respectively. Considering this factor, the amount of ipratropium bromide swallowing does not contribute significantly to the whole body distribution.

Dynamic parameters describe the distribution of ipratropium calculated from plasma concentrations after intravenous injection. The concentration of drugs in plasma has decreased rapidly through 2 stages. The apparent distribution volume in a stable state (VDSS) is about 176L (~ 2.4L/kg). The drug is very small with plasma proteins (less than 20%). Pre -clinical studies conducted on mice and dogs show that ipratropium amine level 4 does not pass the bloodstream barrier.

Selling time is approximately 1.6 hours. The total clearance of ipratropium is 2.3L/min and the renal clearance is 0.9L/min. After intravenous injection, about 60% of the drug is likely to be metabolized mainly in the liver through the oxidation path.

In a study of elimination balance, the total amount of radioactive related to the drug (including the initial active ingredient and all the metabolites) excreted through the kidney (6 days) is 72.1% of intravenous injection dose, 9.3% oral doses and 3.2% dosage. The total amount of radioactivity excreted through feces accounts for 6.3% of intravenous infusion dose, 88.5% oral dosage and 69.4% of the dose of gas. Calculated by the amount of radioactive associated with drugs excreted after intravenous use, the drug is excreted mainly through the kidneys. The selling time of radioactive is related to drugs (initial active ingredients and metabolites) is 3.6 hours. The main metabolites excreted via urinary lines are weak with Muscarinic receptors and is thought to be inactive.

salbutamol

Salbutamol is absorbed quickly and completely after oral use due to swallowing when spraying aerosol or drinking through the digestive tract and having oral bioavailability is about 50%. The average peak concentration of Salbutamol in plasma is 49pg/ml achieved within 3 hours after the aerosol with Combent. After inhaling the single dose, about 27% of the dose through the suck tube is eliminated in the form of unchanged urine for 24 hours. The dynamic parameters are calculated from the drug concentration in plasma after intravenous injection. Expression distribution (VZ) is about 156L (~ 2.5L/kg). About 8% of the drug is attached to plasma proteins. Salbutamol passed the brain barrier and achieved concentrations of about 5% of the drug concentration in plasma. The average selling time is about 4 hours with the average total clearance of 480ml/min and the average renal clearance is 291ml/min.

Salbutamol is converted into a Salbutamol 4'-O-Sulfate Complex. Salbutamol's opposite isomer (levosalbutamol) metabolizes stronger, so excreting from the body is faster than the isomer S (+). After intravenous injection, the drug is completely eliminated through the urinary tract after about 24 hours. The drug is excreted mainly in the form of original active ingredients (64.2%) and 12% in the form of sulfate complex. After oral medication, the urinary excretion rate of the drug is 31.8% of the original active ingredient and 48.2% of the sulfate combined form.

Simultaneous use of ipratropium bromide and Salbutamol Sulfate does not affect the absorption of each component in the body and thus the combined effect of Combent is a combination effect on the lungs after the temperament.

Before taking Combent Boehringer solution solution controls bronchodial spasm (1 blister x 10 tubes)

How to use Combent Air

Inhalation drugs.

Single -dose vials are only used for inhalation with appropriate tools, not to be taken or injected. It is not necessary to dilute the solution in a single dose jar to use.

Instructions for use

Prepare aerosol device to recharge according to the instructions of the manufacturer or doctor.

Open the medicine bag and separate a single -dose vial from the blister.

Open single -dose vials by strongly twisting the top of the vial.

Strongly press the body to flow into the atmosphere.

Install the instructions and use instructions.

After use, remove the remaining medication in the aerosol and clean the aerosol device according to the manufacturer's instructions.

Because the single -dose vial has no preservatives, it is important to immediately use the drug solution after opening and the vial is only used once to avoid bacterial infections. Should remove the vials used in part, opened or damaged.

Absolutely not mix Combent solution with other drugs in the same aerosol device.

Patients should see a doctor or go to the nearest hospital immediately in case of acute shortness of breath or severe shortness of breath if using additional dosage of Combent gas does not bring satisfactory improvement.

In asthma treatment, should consider using anti -inflammatory drugs.

Combent solution for aerosol in single -dose vials can be used with a suitable air machine or by interrupted positive pressure machine.

Dosage

Due to the lack of information on children's use, Combent is not specified for children.

Combent has not been studied used in patients with liver failure or renal failure. Should be cautious when using the drug for these patients.

The following dose of Combent is recommended for adults (including elderly patients).

Acute attack treatment

1 single -dose bottle is enough to cut the attack quickly in many cases.

In severe cases, if you cannot cut a single -dose jar, you may need a second -dose single jar. In these cases, patients should see a doctor or immediately go to the nearest hospital.

Maintain treatment

1 single -dose bottle x 3-4 times/day.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Suitable antagonistic drugs are beta receptor inhibitors, more suitable than selection on beta; However, it is necessary to take into account the possibility of increasing bronchial obstruction and should be carefully adjusted in patients with bronchial asthma.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Combent medicine, you may experience unwanted effects (ADR).

The most frequent side effects in clinical trials are headache, throat irritation, cough, dry mouth, stomach peristaltic disorders (including constipation, diarrhea and vomiting), nausea and dizziness.

Rare:

immune system disorders: Anaphylaxis, hypersensitivity.

Metabolism and nutrition: Hypotension.

Mental disorders: Mental disorders.

visual disorders: regulating disorders, cornea edema, glaucoma, increased internal pressure, dilated pupils, blurred vision, eye pain, conjunctival congestion, vision.

Cardiovascular disorders: arrhythmia, atrial fibrillation, ventricular tachycardia, myocardial ischemia.

Respiratory disorders, chest and mediastinum: dry throat, bronchospasm, paradoxical bronchospasm (caused by bronchodilators), larynx spasm, throat edema.

Gastric - intestinal disorders: Stomach - intestinal peristalsis (diarrhea, constipation, vomiting), mouth edema, stomatitis.

Skin and subcutaneous disorders: sweat, rash, urticaria, itching.

muscle and bink tissue disorders: muscle spasm, muscle weakness, muscle pain.

kidney and urinary disorders: urination.

Systemic disorders and at the position of use: weakness.

Review method: Reduce diastolic blood pressure.

Not popular

Mental disorders: Anxiety.

Nervous disorders: dizziness, headache, tremor.

Vascular injection disorders: Brushing chest drums, nervousness.

Chest respiratory disorders and mediastinum: cough, difficult to pronounce, stimulate the throat.

Stomach - intestines: dry mouth, nausea.

Skin and tissue disorders: Skin reaction.

Testing: systolic hypertension.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Combent medicine is contraindicated in the following cases:

Patients with hypertrophic congestion or tachycardia.

Hypersensitivity patients with Atropine or Atropine derivatives or any ingredients of the drug.

Precautions when using

may appear hypersensitivity reactions immediately after using Combent, manifested by rare cases of urticaria, angio, rash, bronchospasm and pharyngeal edema.

There have been individual reports on eye complications (such as pupils, increased intraocular pressure, narrow-angle glaucoma, eye pain) when ipratropium bromide is used alone or in combination with a beta-2-adrenergic owner sticking to the eyes.

eye pain or discomfort in the eyes, blurred vision, glory or visual images that are tinted with red eyes due to conjunctival conjunctiva or corneal edema can be signs of the narrow -angle glaucoma. If there is any combination of the above symptoms, immediately treatment is with eye drops that cause pupils and consult a doctor.

Patients must be instructed properly Combent. Be careful not to put Combent's solution or aerosol. Patients who are likely to have Glaucoma need special warning to protect the eyes.

Recommended the use of Combent solution for aerosol (UDV) through the suck tube. If there is no suck tube but using a gas mask, it must be used appropriately.

In the following cases, Combent should be considered after careful evaluation between benefits/risks, especially when taking the dose higher than the recommended dose: Patients with diabetes are not fully controlled, new myocardial infarction, severe physical disorders, hyperthyroidism, adrenal marrow, narrow -angle glaucoma risk, prostate hypertrophy or bladder obstruction.

Cardiovascular effects have been observed when using sympathetic medications, including Combent.

There has been evidence from after -sales data and in literature on rare cases of local myocardial ischemia related to Salbutamol. Patients with severe heart disease (such as heart disease due to ischemia, tachycardia or severe heart failure) use Salbutamol to treat respiratory diseases should be careful to consult a doctor if chest pain or other symptoms of severe heart disease. It should be noted to assess the symptoms of shortness of breath and chest pain due to these symptoms that can come from respiratory or cardiovascular causes.

Beta-2-blood medication treatment may cause severe hypotension. In addition, oxygen reduction can worsen the effects of hypokalemia on the heart rate.

Patients with fibrosis can be prone to gastric peristalt dysfunction.

In case of shortness of breath progressing quickly and acute, see a doctor immediately.

Doctors should review the patient treatment regimen if the dose is needed higher than the new recommendation to control symptoms.

The use of Combent can lead to a positive result with Salbutamol when working for subclinical tests to assess the abuse of the active ingredient Salbutamol, for example in the case of using stimulants to improve sports achievements.

The ability to drive and operate machinery

No studies have been conducted on the effects of the drug on driving and operating machinery. However, patients should be notified of unwanted effects that may occur during the use of drugs such as dizziness, regulatory disorders, pupils, blurred vision. So be cautious when driving or operating machinery. If you encounter unwanted effects mentioned above, patients should avoid dangerous activities such as driving or operating machinery.

Pregnancy

has not established Combent's safety in the period of pregnancy in humans. Pay attention to the effect of inhibiting Combent's uterus. The benefits of using drugs in women suspected or have been determined to be pregnant must be considered compared to the risk to the fetus. It is recommended to apply common cautious measures when using the drug during pregnancy, especially in the first 3 months of pregnancy.

For ipratropium bromide, preclinical studies do not show that the toxicity on the embryo or the teratogenic effect of the drug after using the aerosol or sugar in the nose is significantly higher than the recommended doses in humans. For Salbutamol Sulfate, preclinical studies have not shown a direct or indirect harmful effect unless the maximum daily overdose is recommended for humans (Maximum recommended Human Daily Dose - MRHDD).

Breastfeeding period

is still unclear whether ipratropium bromide and salbutamol sulfate are excreted into breast milk or not. Although the quadratic cations insoluble lipids into breast milk, it is difficult to be able to ipratropium bromide to get breastfed babies in large amounts when using inhaled form. However, like many drugs excreted on breast milk, should be cautious when using Combent in women who are breastfeeding.

Medicinal interaction

Simultaneous use of Xanthine's derivatives as well as other beta-adrenergic drugs and anti-cholinergic drugs that can increase side effects.

Hemotentic reduction due to beta -contrary substances may be worse when treated simultaneously with xanthine derivatives, glucocorticoids and diuretics. This ability should be considered especially in patients with severe respiratory obstruction.

Hemoto reduction can make patients using digoxin prone to arrhythmia. Must monitor plasma potassium concentration in these cases.

Bronchodilator effects can be severely reduced when used simultaneously with beta inhibitors.

Be careful to use the beta-adrenergic beneficiaries in patients who are being treated with monoamine oxidase inhibitors or three-round antidepressants, due to the effects of beta-adrenergic beneficiaries that may be stronger.

Inhaling Halogen Halogen Hydrocarbon anesthesia such as Halothane, Trichloroethylene and Enflurane can increase the sensitivity to the cardiovascular effects of the Beta Agency.

Storage

Store less than 30 ° C, avoid light.

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