Bronchorus 3mg/ml 100ml syrup
Clinical and pharmacological group
Pulmonology
Description
syrup 3 mg/ml
Pharmacotherapeutic group
mucolytic expectorant
Tradename
Bronchorus®
International nonproprietary name
ambroxol
Dosage form
syrup
Compound
Composition per 100 ml:
Active ingredient: butamirate citrate – 0.15 g.
Excipients: sorbitol, glycerol (glycerol), sodium saccharinate dihydrate, benzoic acid, vanillin, ethanol (rectified ethyl alcohol), sodium hydroxide solution 30%, purified water.
ATX code
[R05CB06]
Pharmacological properties
Pharmacodynamics Butamirate, the active ingredient of the drug, is a centrally acting antitussive. It does not relate to alkaloidamopia either chemically or pharmacologically. It does not form dependence or addiction. Suppresses cough, having a direct effect on the cough center. It has a bronchodilating effect (expands the bronchi). Promotes easier breathing, improving spirometry (reduces airway resistance) and blood oxygenation (saturates the blood with oxygen). Pharmacokinetics Absorption Based on available data, it is assumed that butamirate ester is rapidly and completely absorbed and hydrolyzed in plasma, turning into 2-phenylbutyric acid and diethylaminoethoxyethanol. The effect of food on absorption has not been studied. The change in the concentration of 2-phenylbutyric acid and diethylaminoethoxyethanol occurs in proportion to the dose taken in the range of 22.5 mg - 90 mg. Butamirate is rapidly and completely absorbed when taken orally, measured concentrations are found in the blood 5-10 minutes after taking doses of 22.5 mg, 45 mg, 67.5 mg and 90 mg. Maximum concentrations (Cmax) in blood plasma are achieved within 1 hour when taking dosages at all 4 levels, the average is 16.1 ng/ml when taking a dose of 90 mg orally. Average plasma concentrations of 2-phenylbutyric acid are achieved within 1.5 hours; the maximum concentration was observed after a dose of 90 mg (3052 ng/ml); average plasma concentrations of diethylaminoethoxyethanol are reached within 0.67 hours; Cmax is observed after taking a dose of 90 mg (160 ng/ml). Distribution Butamira has a large volume of distribution in the range of 81-112 l (adjusted for body weight in kg), as well as a high degree of binding to plasma proteins. 2-phenylbutyric acid has a high degree of binding to plasma proteins at all dosage levels (22.5 - 90 mg), and averages 89.3% - 91.6%. The ability of diethylaminoethoxyethanolac to bind to plasma proteins is also detected; average values vary between 28.8% and 45.7%. It is unknown whether butamirate crosses the placenta or is excreted in mother's milk. The metabolism of hydrolysis of butamirate, which results in the formation of 2-phenylbutyric acid and diethylaminoethoxyethanol, which have an antitussive effect, occurs very quickly. 2-phenylbutyric acid undergoes further partial metabolism by hydroxylation in the para position. Excretion Excretion of the three metabolites occurs primarily through the kidneys; After conjugation in the liver, acidic metabolites are largely bound to glucuronic acid. Conjugates of 2-phenylbutyric acid are detected in urine in significantly higher concentrations than in blood plasma. Butamirate is detectable in urine within 48 hours, and the proportion of butamirate excreted in urine during the 96-hour sampling period accounts for approximately 0.02, 0.02, 0.03 and 0.03% of administered doses 22.5 mg, 45 mg, 67 .5 mg and 90 mg, respectively. As a percentage, butamirate is excreted in the urine in greater quantities in the form of diethylaminoethoxyethanol than butamirate in unchanged form or in the form of unconjugated 2-phenylbutyric acid. The measured half-lives (T1/2) of 2-phenylbutyric acid, butamirate and diethylaminoethoxyethanol were 23.26-24.42 hours, 1.48-1.93 hours and 2.27-2.90 hours, respectively.
Indications for use
Treatment of dry cough of various etiologies: to suppress cough in the preoperative and postoperative period, during surgical interventions, bronchoscopy, and whooping cough.
Carefully
Pregnancy (II and III trimesters).
Due to the presence of ethyl alcohol in the drug, use with caution in patients with a tendency to develop drug dependence, with liver diseases, alcoholism, epilepsy, brain diseases, pregnant women and children.
Contraindications
– Hypersensitivity to the components of the drug;
– Children under 3 years of age;
– Pregnancy (I trimester);
– Breastfeeding period;
– Fructose intolerance (the drug contains sorbitol).
Use during pregnancy
There is no data on the safety of the drug during pregnancy and its passage through the placental barrier. The drug is not recommended for use in the first trimester of pregnancy. In the second and third trimesters of pregnancy, use of the drug is possible only after consultation with a doctor.
Given the lack of data on the excretion of butamirate in breast milk, the use of the drug during breastfeeding is not recommended.
Impact on the ability to drive vehicles and machinery
The drug may cause dizziness and drowsiness, so it is recommended to refrain from driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
Directions for use and doses
Inside, before meals.
Children from 3 to 6 years old – 5 ml (1 teaspoon or dosage spoon) 3 times a day.
Children from 6 to 12 years old – 10 ml (2 teaspoons or dosage spoons) 3 times a day.
Children aged 12 years and older – 15 ml (3 teaspoons or dosage spoons) 3 times a day.
Adults – 15 ml (3 teaspoons or dosage spoons) 4 times a day.
Use the included dosing spoon.
If the cough persists for more than 7 days, you should consult a doctor.
Side effect
Classification of the frequency of side effects: very often (≥1/10), often (≥1/100,
From the nervous system: rarely - drowsiness, dizziness, which goes away when the drug is discontinued or the dose is reduced.
From the digestive system: rarely – nausea, diarrhea.
From the skin and subcutaneous tissues: rarely – urticaria.
Other: allergic reactions may develop.
Overdose
Symptoms: drowsiness, dizziness, nausea, vomiting, abdominal pain, diarrhea, irritability, impaired coordination of movements, decreased blood pressure.
Treatment: rinse the stomach, prescribe activated charcoal, laxatives, and take measures to maintain the function of the cardiovascular and respiratory systems. There is no antidote. Treatment is symptomatic.
Use with other medications
No drug interactions have been reported for butamirate. During treatment with the drug, it is not recommended to drink alcoholic beverages, as well as drugs that depress the central nervous system (hypnotics, antipsychotics, tranquilizers and other drugs).
Due to the fact that butamirate suppresses the cough reflex, the simultaneous use of expectorants should be avoided to avoid the accumulation of sputum in the respiratory tract with the risk of developing bronchospasm and respiratory tract infection.
special instructions
The syrup contains sodium saccharinate and sorbitol as sweeteners, so it can be prescribed to patients with diabetes.
Due to the presence of ethyl alcohol in the composition of the drug, the drug should be used with caution in patients with a tendency to develop drug addiction, with liver disease, alcoholism, epilepsy, brain diseases, and pregnant children.
The drug is not used in patients with fructose intolerance.
If after 5-7 days of using the drug the cough does not stop, you should consult a doctor.
Release form
Suspensions, syrups
Release form
Syrup 1.5 mg/ml.
100 ml in orange glass bottles with a screw neck, sealed with aluminum caps with perforations or screw-on caps with tamper evident or tamper evident and child resistant caps or tamper evident caps or child resistant caps.
Each bottle with instructions for use and a polymer double-sided dosing spoon for medicines or a polymer double-sided dosing spoon for medicines or a dosing spoon, or without a spoon, is placed in a cardboard pack.
Storage conditions
In a place protected from light at a temperature not higher than 25°C. Keep out of the reach of children.
Best before date
3 years. Do not use after the expiration date.
Conditions for dispensing from pharmacies
over the counter
Fenofibrate Canon tablet film 145 mg x30
Fenofibrate Canon tablet film 145 mg x30
ATX Code: C10AB05 (Fenofibrate)
Active substance: fenofibrate (fenofibrate) Rec.INN registered by WHO
Dosage form
FENOFIBRATE CANON
film-coated tablets, 145 mg: 10, 20, 28, 30, 50, 60, 84, 90, 98 or 100 pcs.reg. No.: LP-002740 dated 12/02/14 - Valid
Release form, composition and packaging
Film-coated tablets are white or almost white, oval, biconvex, almost white in cross section.
1 tab.
fenofibrate 145 mg
Excipients: corn starch - 137 mg, colloidal silicon dioxide - 10 mg, croscarmellose sodium - 33 mg, mannitol - 170 mg, magnesium stearate - 6 mg, povidone K-30 - 44 mg, microcrystalline cellulose - 105 mg.
Composition of the film shell: Opadry II white - 20 mg, incl. polyvinyl alcohol - 9.38 mg, macrogol (polyethylene glycol 4000) - 4.72 mg, talc - 3.48 mg, titanium dioxide - 2.42 mg.
Clinical and pharmacological group: Lipid-lowering drug Pharmaco-therapeutic group: Lipid-lowering drug - fibrate
pharmachologic effect
Pharmacokinetics,
Indications
Used in combination with diet:
- simultaneously with HMG-CoA reductase inhibitors (statins) as part of combination therapy for mixed dyslipidemia (type lla, llb according to Fredrickson), in order to reduce triglycerides and increase HDL concentrations in patients with coronary artery disease or at high risk of developing coronary artery disease (other clinical forms of atherosclerotic diseases: atherosclerosis of peripheral arteries, abdominal aortic aneurysm and symptomatic atherosclerosis of the carotid artery, diabetes mellitus, multiple risk factors that correspond to a 10-year risk of developing coronary complications >.20%),
- to reduce the concentration of triglycerides in patients with severe hyperglyceridemia (dyslipidemia IV, V type according to Fredrickson),
- in order to reduce the elevated concentrations of LDL, total cholesterol, triglycerides and apoB and increase the concentration of HDL in patients with primary hyperlipidemia or mixed dyslipidemia (type lla, llb, III, IV according to Fredrickson).
ICD-10 codes
ICD-10 code Indication
E78.0 Pure hypercholesterolemia
E78.1 Pure hyperglyceridemia
E78.2 Mixed hyperlipidemia
E78.3 Hyperchylomicronemia, dosage regimen
The drug is taken orally with meals. The tablets should be swallowed whole without chewing.
The drug should be taken for a long time, while continuing to follow the diet that the patient followed before starting treatment with Fenofibrate Canon.
Adults are prescribed 1 tablet. 1 time/day
Patients taking 1 caps. fenofibrate 200 mg, can switch to taking Fenofibrate Canon 145 mg without additional dose adjustment.
The maximum daily dose is 145 mg.
Elderly patients are recommended to take 1 tablet. (145 mg) 1 time/day.
The use of the drug in patients with liver diseases has not been studied.
Side effect
Side effects when using the drug in therapeutic doses are given with a distribution by frequency and system-organ classes according to the WHO classification: very often - ≥1/10 prescriptions (>.10%), often - from ≥1/100 to <.1/10 prescriptions (>.1% and <.10%), infrequently - from ≥1/1000 to <.1/100 prescriptions (>.0.1% and <.1%), rarely - from ≥1/10,000 to <. 1/1000 prescriptions (>.0.01% and <.0.1%), very rare - <.1/10,000 prescriptions (<.0.01%).
From the digestive system: often - abdominal pain, nausea, vomiting, diarrhea and moderate flatulence, moderate increase in the activity of serum transaminases, infrequently - cases of pancreatitis, formation of gallstones, very rarely - hepatitis. If symptoms of hepatitis appear (jaundice, itching), laboratory tests should be performed and, if hepatitis is confirmed, fenofibrate should be discontinued.
From the musculoskeletal system: rarely - diffuse myalgia, myositis, muscle spasm and weakness, very rarely - rhabdomyolysis, increased CPK activity.
From the cardiovascular system: infrequently - venous thromboembolism (pulmonary embolism, deep vein thrombosis).
From the hematopoietic system: rarely - increased hemoglobin and leukocytes.
From the nervous system: rarely - headache.
From the respiratory system: very rarely - interstitial pneumopathy.
From the reproductive system: rarely - sexual dysfunction.
From the skin and subcutaneous tissues: uncommon - rash, itching, urticaria or photosensitivity reactions, rare - alopecia, very rare - photosensitivity accompanied by erythema, blistering or nodules on areas of the skin exposed to sunlight or artificial UV radiation (for example , quartz lamp) in some cases (even after many months of use without any complications).
From laboratory parameters: infrequently - increased concentrations of creatinine and urea in the blood serum.
Contraindications for use
- liver failure (including biliary cirrhosis and persistent liver dysfunction of unknown etiology),
— severe renal failure (creatinine clearance <.20 ml/min),
- chronic or acute pancreatitis, with the exception of cases of acute pancreatitis caused by severe hypertriglyceridemia,
- history of gallbladder disease,
- a history of photosensitivity or phototoxicity during treatment with fibrates or ketoprofen,
- lactation period (breastfeeding),
- age under 18 years (efficacy and safety have not been established),
- hypersensitivity to fenofibrate or other components of the drug.
The drug should be used with caution in hypothyroidism, in patients who abuse alcohol, in patients with impaired renal function (creatinine clearance more than 20 ml/min), in elderly patients, with a history of hereditary muscle diseases, while using oral anticoagulants, HMG-inhibitors CoA reductases.
Use during pregnancy and breastfeeding
There are limited data on the use of fenofibrate in pregnant women. In experimental animal studies, a teratogenic effect of fenofibrate was not observed. Embryotoxicity was observed when the drug was used during preclinical trials in doses toxic to the maternal body. The potential risk to humans is unknown, therefore, during pregnancy, Fenofibrate Canon should only be used after a careful assessment of the risk-benefit ratio.
The drug Fenofibrate Canon is contraindicated for use during breastfeeding (there is insufficient data on the use of the drug during this period).
Use for liver dysfunction
The use of the drug in patients with liver diseases has not been studied.
The use of the drug is contraindicated in case of liver failure (including biliary cirrhosis and persistent liver dysfunction of unknown etiology).
Use for renal impairment
The use of the drug is contraindicated in severe renal failure (creatinine clearance <20 ml/min).
The drug should be prescribed with caution to patients with impaired renal function (creatinine clearance > 20 ml/min).
Use in children The use of the drug is contraindicated in people under 18 years of age (efficacy and safety have not been established).
Use in elderly patients
The drug should be used with caution in elderly patients.
Recommended dose: 1 tablet. (145 mg) 1 time/day.
special instructions
Before starting treatment with Fenofibrate Canon, appropriate treatment should be carried out to eliminate the cause of secondary hypercholesterolemia, for example, in diseases such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, the effects of drug therapy, alcoholism.
The effectiveness of therapy should be assessed by the content of lipids (total cholesterol, LDL, triglycerides) in the blood serum. If there is no therapeutic effect after several months of therapy (usually after 3 months), the advisability of prescribing concomitant or alternative therapy should be considered.
In patients with hyperlipidemia taking estrogens or hormonal contraceptives containing estrogens, it is necessary to determine whether the hyperlipidemia is of a primary or secondary nature. In such cases, the increase in lipid levels may be caused by estrogen intake.
When using fenofibrate and other drugs that lower lipid concentrations, an increase in the activity of hepatic transaminases has been described in some patients. In most cases, this increase was temporary, minor and asymptomatic. During the first 12 months of treatment, it is recommended to monitor transaminase activity (ALT, AST) every 3 months. Patients whose transaminase concentrations have increased during treatment require attention, and if the activity of ALT and AST increases by more than 3 times compared to ULN, the drug should be discontinued.
Cases of pancreatitis have been described during treatment with fenofibrate. Possible causes of pancreatitis in these cases were: insufficient effectiveness of the drug in patients with severe hypertriglyceridemia, direct effects of the drug, as well as secondary phenomena associated with the presence of stones or sediment formation in the gallbladder, accompanied by obstruction of the common bile duct.
When using fenofibrate and other drugs that lower lipid concentrations, cases of toxic effects on muscle tissue, including very rare cases of rhabdomyolysis, have been described. The incidence of this disorder increases in the case of hypoalbuminemia and a history of renal failure. The possibility of this complication increases with hypoalbuminemia and renal failure.
A toxic effect on muscle tissue can be suspected based on patient complaints of weakness, diffuse myalgia, myositis, muscle spasms and cramps and/or a marked increase in CPK activity (more than 5 times compared to ULN). In these cases, treatment with fenofibrate should be discontinued.
The risk of developing rhabdomyolysis may increase in patients with a predisposition to myopathy and/or rhabdomyolysis, including age over 70 years, a family history of hereditary muscle diseases, impaired renal function, hypothyroidism, and alcohol abuse. Such patients should be prescribed the drug only if the expected benefit outweighs the possible risk of developing rhabdomyolysis. When Fenofibrate Canon is taken concomitantly with HMG-CoA reductase inhibitors or other fibrates, the risk of serious toxic effects on muscle fibers increases, especially if the patient had a muscle disease prior to treatment. In this regard, the joint prescription of the drug Fenofibrate Canon and a statin is permissible only if the patient has severe mixed dyslipidemia and high cardiovascular risk, in the absence of a history of muscle disease and under conditions of close monitoring aimed at identifying signs of the development of toxic effects on muscle tissue .
When using the drug Fenofibrate Canon as monotherapy or in combination with statins, patients experienced a reversible increase in serum creatinine concentrations. The increase in creatinine concentrations was generally stable over time, with no evidence of further increases in serum creatinine concentrations with long-term therapy, with a tendency to return to baseline values after discontinuation of treatment. The clinical significance of these observations has not been established. In patients with renal failure, when using the drug Fenofibrate Canon, it is recommended to monitor renal function. Monitoring renal function is also necessary in patients at risk of developing renal failure, namely in elderly patients and patients with diabetes mellitus. Treatment should be discontinued if creatinine concentration increases >.50% of ULN. It is recommended to determine creatinine concentrations during the first 3 months after the start of treatment, as well as periodically after its completion.
Impact on the ability to drive vehicles and operate machinery
When using the drug, there was no effect on the ability to drive a car or use other mechanisms.
Overdose
Cases of overdose have not been described.
Treatment: if overdose is suspected, symptomatic and, if necessary, supportive treatment should be prescribed. A specific antidote is unknown. Hemodialysis is ineffective.
Drug interactions
Fenofibrate enhances the effect of oral anticoagulants and may increase the risk of bleeding, which is associated with the displacement of the anticoagulant from binding sites with blood plasma proteins. At the beginning of treatment with fenofibrate, it is recommended to reduce the dose of anticoagulants by approximately one third, followed by gradual titration of the dose. Dose selection is recommended under the control of INR.
Several severe cases of reversible renal dysfunction have been described during concomitant treatment with fenofibrate and cyclosporine. Therefore, it is necessary to monitor the status of renal function in such patients and discontinue fenofibrate in case of serious changes in laboratory values.
When fenofibrate is used concomitantly with HMG-CoA reductase inhibitors or other fibrates, the risk of serious muscle toxicity increases.
In vitro studies of human liver microsomes have shown that fenofibrate and fenofibric acid are not inhibitors of the following cytochrome P450 isoenzymes (CYP3A4, CYP2D6, CYP2E1 or CYP1A2). At therapeutic concentrations, these compounds are weak inhibitors of CYP2C19 and CYP2A6 isoenzymes and weak to moderate inhibitors of CYP2C9.
Storage conditions and periods
The drug should be stored out of the reach of children, in a dry place, protected from light, at a temperature not exceeding 25°C. Shelf life: 2 years.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
