Index
It is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) (post-bronchodilator FEV1 less than 50% predicted).
It is associated with chronic bronchitis in adult patients with frequent exacerbations adjunct to bronchodilator treatment.
What is Texas?
Roflumilast (trade names Daxas, Daliresp) is a drug that acts as a selective long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE-4).
It has anti-inflammatory effects and is used as an orally administered drug to treat inflammatory conditions of the lungs, such as chronic obstructive pulmonary disease (COPD).
In June 2010, it was approved in the European Union (EU) for severe chronic obstructive pulmonary disease associated with chronic bronchitis. In March 2011, he obtained approval from the US Food and Drug Administration. UU To reduce exacerbations of chronic obstructive pulmonary disease.
It is available as tablets (500 micrograms).
Each yellow D-shaped tablet is film-coated, with “D” engraved on one side. Non-medicinal ingredients: lactose monohydrate, corn starch, povidone, and magnesium stearate; film-coating: hypromellose, macrogol 4000, titanium dioxide, and yellow iron oxide.
For what do you use it?
It belongs to the class of drugs called phosphodiesterase 4 (PDE4) inhibitors. It is used together with a bronchodilator (e.g., Salbutamol) to treat severe chronic obstructive pulmonary disease (COPD) with chronic cough and sputum (mucosa) in adults who have frequent outbreaks.
It works by reducing inflammation in the lungs.
Texas is used to treat severe chronic obstructive pulmonary disease (COPD) in adults who suffer from chronic bronchitis (long-term inflammation of the airways) and whose obstructive pulmonary disease is frequently inflamed.
Obstructive pulmonary disease is a long-term disease in which the airways and alveoli within the lungs become damaged or blocked, causing difficulty in inhaling and extracting air from the lungs.
Texas is not used alone but as an “addition” to bronchodilator treatment (drugs that dilate the airways in the lungs).
The medication can only be dispensed with a prescription.
The recommended dose of Texas is one tablet once a day. The tablets should be swallowed with water at the same time every day. Patients may need to take Texas for several weeks before it affects.
Mechanism of action
The active substance in Texas, roflumilast, belongs to a group of medicines called phosphodiesterase type 4 (PDE4) inhibitors. It blocks the action of the enzyme inhibitor phosphodiesterase type 4, which is involved in the inflammation process that leads to obstructive lung disease.
By blocking the action of the phosphodiesterase type 4 inhibitor, Texas reduces inflammation in the lungs, helping to reduce the patient’s symptoms or to prevent them from getting worse.
Administration
The recommended dose of Texas is a 500xg Texas tablet taken orally once a day, at the same time every day.
If you forget to take a dose at the usual time, take it as soon as possible or take it as soon as you remember that day and continue with your regular schedule.
However, if you forget to take your tablet for an entire day, skip the missed dose and take your following scheduled amount. Store this medicine at room temperature and keep it out of the reach of children.
How has Texas been studied?
Texas has been compared to a placebo (a dummy treatment) in two central studies that included more than 3,000 adults with severe obstructive pulmonary disease who had had at least one illness outbreak last year.
The primary measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in moderate or severe outbreaks of obstructive pulmonary disease during one year of treatment.
Forced expiratory volumes (FEV1) are the most significant amount of air that a person can exhale in a second.
Texas proved to be more effective than a placebo in treating obstructive pulmonary disease.
After one year, patients who took Texas had an average increase of 40ml, while those who received a placebo had an average decrease of 9ml.
What is the risk associated with Texas?
The most common side effects with Texas (observed between 1 and 10 patients in 100) are weight loss, decreased appetite, insomnia (difficulty sleeping), headache, diarrhea, nausea (feeling sick), and abdominal pain ( stomach ache).
Texas should not be used in patients who have moderate or severe problems with their liver.
The Committee for Medicinal Products for Human Use noted a need for new treatments for obstructive pulmonary disease. The primary studies showed a modest benefit of Texas in patients with severe obstructive pulmonary disease.
This benefit was observed, and the patients’ treatments were already receiving were effects. After considering all available data on the impact of the medication, the committee decided that the benefits of Texas are more significant than its risks and recommended that a marketing authorization be granted.
The safety information has been included in the summary of product characteristics and in the Texas package leaflet, including the appropriate precautions to be followed by health professionals and patients.
In addition, the company that makes Texas will ensure that health professionals who prescribe the drug in all EU Member States receive educational material that contains information about the side effects of the drug and how it should be used.
The company will also provide cards for patients, telling them what information they need to inform their doctor about their symptoms and past illnesses to help the doctor know if Texas is appropriate for them. The card will include an area where patients can register their weight.
What side effects are possible from Texas?
You may experience diarrhea, nausea, abdominal pain, or headache during the first weeks of taking this medication. These side effects usually improve with continuous treatment.
Talk to your doctor if they do not improve within the first weeks of treatment. The fact that a side effect is indicated here does not mean that all people who use this drug experience that or any side effect:
Common (affects between 1 in 10 and 1 in 100 people):
- Decreased appetite and weight loss.
- Difficulty sleeping (insomnia).
- Headache.
- Diarrhea.
- Feeling sick.
- Abdominal pain.
Uncommon (affect between 1 in 100 and 1 in 1000 people):
- Tremor, usually from the hands.
- Anxiety.
- Dizziness.
- Awareness of the beating of your heart (palpitations).
- Bowel disorders such as vomiting, indigestion, and acid reflux.
- Inflammation of the stomach ( gastritis ).
- Acne.
- Muscle spasms, weakness, and pain.
- Back pain.
- Feeling weak, tired, or generally misbehaving.
- Hypersensitivity reactions include rash, itching, hives, or swelling of the lips and face.
Rare (affect between 1 in 1000 and 1 in 10,000 people):
- Abnormal results in liver function tests.
- Increase in creatinine levels in the blood.
- Constipation .
- Respiratory tract infections.
- Changes in taste.
- Depression .
- Nervousness.
- Abnormal enlargement of the breasts in men ( gynecomastia ).
- Blood in the stool.
Do not take this medication (Texas) if you:
- You are allergic to roflumilast or any other ingredient in this medicine (Texas).
- You have moderate or severe liver disease.
Texas tablets contain lactose and should not be taken by people with hereditary galactose intolerance, Lapp lactase deficiency, or glucose or galactose malabsorption.
Behavioral changes and suicidal thoughts: people who take Texas tablets have experienced an increased risk of psychiatric problems, such as anxiety, nervousness, trouble sleeping (insomnia), depression, and, rarely, thoughts about suicide.
Suppose you experience behavioral changes or symptoms such as sadness, anxiety, helplessness, feeling guilty, loss of pleasure or interest in activities, changes in sleep patterns, or restlessness while taking this medication (Texas). In that case, you must talk to your doctor or contact your doctor immediately.
Family members or caregivers of people taking Texas should contact the person’s doctor immediately if they notice unusual behavioral changes.
If you have a history of depression with thoughts of self-harm or suicide, you should avoid this medication.
Continue taking bronchodilators: this medication (Texas) does not replace your bronchodilator medications (such as Salbutamol), so you should take Texas and your bronchodilator medication (such as Salbutamol) daily.
Heart disease: This medicine (Texas) can cause abnormal heart rhythms.
Infections: Stop using Texas and get immediate medical attention if symptoms of the severe acute disease occur (e.g., fever, chills or tremors, rapid heartbeat, rapid breathing, confusion, and rash).
Severe diseases of the immune system: If you have a painful condition of the immune system, such as HIV infection, multiple sclerosis, lupus erythematosus, and progressive multifocal leukoencephalopathy, you should not take Texas.
Sudden attacks of shortness of breath: This medication (Texas) does not treat sudden attacks of difficulty breathing. You should always have a bronchodilator medication (such as Salbutamol) to treat a sudden attack of dyspnea.
Weight loss: people who take Texas have experienced weight loss. You should weigh yourself regularly and consult your doctor if you notice that your weight drops unintentionally (not due to a diet or increased exercise).
While taking Texas, you or your health care supervisors should control your weight regularly. You or your health care supervisor should contact your doctor if an unexpected weight loss has occurred.
Children: the safety and efficacy of using this medicine (Texas) have not been established for children.
What other drugs may interact with this medicine?
The following medications may increase the amount of roflumilast in your blood, and this may increase the risk of side effects:
- Cimetidine
- Enoxacin.
- Erythromycin .
- Fluvoxamine.
- Ketoconazole
- Oral contraceptives containing gestodene and ethinylestradiol.
- Theophylline (not recommended in combination with data tablets).
The following medications may decrease the amount of Texas in your blood and, therefore, may make it less effective. For this reason, Texas is not recommended for people who take any of these medications:
- Carbamazepine.
- Phenobarbital.
- Phenytoin
- Rifampin .
There may be an interaction between this medicine (Texas) and any of the following medications:
- Anticancer drugs (e.g., carboplatin, cyclophosphamide, doxorubicin, ifosfamide, vincristine).
- Anakinra.
- Azathioprine.
- Belimumab.
- Bosentan.
- Ciprofloxacin.
- Corticosteroids (such as dexamethasone and prednisone )
- Cyclosporine.
- Dabrafenib.
- Deferasirox.
- Dexamethasone.
- Efavirenz.
- Enzalutamide.
- Eslicarbazepine.
- Etravirine.
- Fingolimod.
- Infliximab.
- Loxapine.
- Leflunomide .
- Lenalidomide.
- Drugs that suppress the immune system (such as drugs for cancer or organ transplants).
- Modafinil.
- Mycophenolate .
- Nevirapine.
- Primidone.
- Rifabutin.
- Rifampin.
- Riociguat.
- Grass of San Juan.
- Tacrolimus.
- Teriflunomide.
- Theophylline .
- Tretinoin.
