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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 26.06.2023
Attention! Information on this page is intended only for medical professionals! Information is collected in open sources and may contain significant errors! Be careful and double-check all the information on this page!
Each gram of Audavate 0.1% (Audavate 0.1%*) Cream* contains: 640 mcg Audavate 0.1% dipropionate (equivalent to 500 mcg Audavate 0.1%).
Each gram of Audavate 0.1% (Audavate 0.1%*) Ointment* contains: 640 mcg Audavate 0.1% dipropionate (equivalent to 500 mcg Audavate 0.1%).
Audavate 0.1% (Audavate 0.1%*) Cream and Ointment contain Audavate 0.1% dipropionate, a synthetic corticosteroid with anti-inflammatory activity to be administered topically.
Audavate 0.1% dipropionate is a white to creamy white odorless crystalline powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol. It has a molecular weight of 504.16 and the empirical formula C28H37FO7; a chemical name of 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione,17,21-dipropionate.
WHAT IS BRONCHIAL AND WHAT IS IT USED FOR
Bronsal solution for injection contains the active substances Betamethasone, diprophylline and guaifenesin.
It is indicated in the acute phase of respiratory diseases that compromise adequate pulmonary ventilation.
This drug is designed for the symptomatic treatment of these acute processes that must be resolved in a short period of time (6-10 days). In chronic diseases, specific treatment should be continued.
HOW TO TAKE BRONSAL
Follow exactly the instructions for taking Bronsal as directed by your doctor. Consult your doctor or pharmacist if you have any doubts.
The recommended dose in adults is one injection every 12-24 hours intramuscularly.
If you use more bronchial solution for injection than you should
In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the toxicological Information Service, Phone 91 562 04 20, indicating the medicine and the amount ingested.
If you forgot to use Bronsal solution for injection
Do not use a double dose to make up for forgotten doses.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
See also:
What is the most important information I should know about Audavate 0.1%?
You should not use this medication if you are allergic to Audavate 0.1%, or if you have a fungal infection anywhere in your body.
Before taking Audavate 0.1%, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.
Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.
Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.
Do not receive a "live" vaccine while you are taking Audavate 0.1%. Vaccines may not work as well while you are taking a steroid.
Do not stop using Audavate 0.1% suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.
POSSIBLE SIDE EFFECTS
Like all medicines, bronchial can cause side effects, although not everyone gets them.
The severity of adverse effects associated with prolonged treatment increases with doses and duration of treatment. Short-term treatments usually do not produce adverse reactions.
Common (may affect between 1 and 10 in every 100 patients): gastrointestinal disorders (nausea, vomiting, abdominal pain, diarrhoea), headache, agitation, insomnia or drowsiness, osteoporosis, bone fragility, hyperglycemia, polyphagia (abnormal increase in the need to eat), delayed wound healing, susceptibility to infection (oropharyngeal candidiasis), signs of an overactive adrenal glands (Cushing"s Syndrome), hirsutism (excessive hair growth in women, in the face and in the body), hyperpigmentation of the skin, gastric ulcer.
Uncommon (may affect between 1 and 10 in every 1,000 patients): edema (swelling), hypertension, heart failure, hypokalemia (decreased potassium levels), amenorrhea (temporary or permanent absence of the menstrual flow), sweating, neurologic abnormalities, intracranial hypertension, acute pancreatitis (inflammation of the pancreas), thromboembolism, myasthenia (neuromuscular disease autoimmune and chronic characterized by varying degrees of weakness of the skeletal muscles (voluntary) of the body).
Unknown frequency: hiccups, blurred vision (See also Section 4.4).
If you experience any side effects, talk to your doctor or pharmacist, even if these are any side effects not listed in this leaflet.
BEFORE TAKING BRONSAL
Do not use Bronsal solution for injection
- If you are allergic to Betamethasone, diprophylline, guaifenesin or any of the other ingredients of this medicine (listed in Section 6).
- If you have a fungal infection.
- If you have been diagnosed with idiopathic thrombocytopenic purpura (a blood disease characterized by a lack of platelets).
- If you have severe hepatic or renal impairment.
- In children under 2 years.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Bronsal solution for injection if you are in any of the following situations:
- Uremic patients (uremia is the concentration in the blood of waste products that are usually removed by the kidney).
- Whenever there is or is suspected of the existence of an infectious process. Your doctor will prescribe antibiotics orally or parenterally.
- If the recommended treatment periods are exceeded, side effects from the use of systemic corticosteroids may occur.
- Elderly patients.
- Patients with a history of tuberculosis.
- Patients with severe myocardial or coronary lesions, or severe hypertension.
- Patients with hyperthyroidism.
- Patients with liver or kidney diseases.
- Patients with diabetes mellitus.
- With gastric ulcer.
- Patients with osteoporosis.
- Patients with epilepsy.
- Patients with myasthenia gravis (autoimmune and chronic neuromuscular disease characterized by varying degrees of weakness of the skeletal muscles (volunteers) of the Corps).
- Patients with glaucoma (eye disease in which the optic nerve is damaged).
- If you have blurred vision or other visual disturbances.
This drug contains Betamethasone which can produce a positive result in doping control tests.
Use of bronchial solution for injection with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicines, including those purchased without a prescription.
The following drugs may interact with Bronsal. Tell your doctor if you are taking any of them:
- Drugs of the xanthine type (for example, theophylline), as they can enhance the effect of Bronsal.
- Probenecid (medicine used to treat gout).
- Drugs that induce liver enzymes (barbiturates, phenytoin and rifampicin).
- Enzyme inhibitors (of the CYP3A4 enzyme) such as ketoconazole and Itraconazole (used for fungal infections) may increase the effect of corticosteroids. So your doctor will do thorough checks if you are taking these medicines (including some for HIV: ritonavir, cobicistat).
- Aspirin (salicylates). Caution should be exercised if it is used concomitantly bronchial with salicylates in patients with hypoprothrombinemia (deficiency of a substance (prothrombin) necessary for blood clotting).
- Diuretics that produce increased potassium removal.
- Isoproterenol (a medicine used to treat asthma).
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.
It is not recommended to use this medication during pregnancy and lactation, unless expressly indicated by a doctor.
Driving and using machines
They have not been described.
This medicinal product contains sodium, methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium metabisulfite.
It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of choking) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
It may cause severe allergic reactions or bronchospasm (sudden sensation of choking) because it contains sodium metabisulfite.
This medicinal product contains less than 23 mg (1 mmol) sodium per dose and is therefore considered essentially “sodium-free”.
See also:
What are the possible side effects of Audavate 0.1%?
Applies to Audavate 0.1% topical: topical application cream, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment
Other dosage forms:
- topical application cream, topical application lotion, topical application ointment, topical application spray
In addition to its needed effects, some unwanted effects may be caused by Audavate 0.1% topical (the active ingredient contained in Audavate 0.1%). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Audavate 0.1% topical:
More common:
- Burning, itching, or stinging at the application site
- Hair loss
- thinning of the hair
- Blistering, burning, crusting, dryness, or flaking of the skin
- irritation
- itching, scaling, severe redness, soreness, or swelling of the skin
- redness and scaling around the mouth
- thinning of the skin with easy bruising, especially when used on where the skin folds together (e.g. between the fingers)
Minor Side Effects
Some of the side effects that can occur with Audavate 0.1% topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Less common:
- Acne or pimples
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- Burning and itching of the skin with pinhead-sized red blisters
- burning, itching, and pain in hairy areas, or pus at the root of the hair
- increased hair growth on the forehead, back, arms, and legs
- lightening of normal skin color
- lightening of treated areas of dark skin
- reddish purple lines on the arms, face, legs, trunk, or groin
- softening of the skin
However, we will provide data for each active ingredient