Arformoterol 15mcg/2ml Inh 60 X 2ml

Arformoterol is a long-acting beta2-adrenergic agonist (LABA). It selectively stimulates beta2-adrenergic receptors in the lungs, leading to relaxation of bronchial smooth muscle and bronchodilation. This action is mediated by the activation of adenyl cyclase, which catalyzes the conversion of ATP to cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels lead to activation of protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in smooth muscle relaxation.

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ An abnormal heartbeat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ An abnormal heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Feeling very sleepy
+ Shortness of breath
+ Feeling very tired or weak
Chest pain or pressure
Fast heartbeat or abnormal heartbeat
Swelling in the legs or feet

Respiratory Problems: A Life-Threatening Condition

This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Back pain
Diarrhea
Stuffy nose
Flu-like symptoms
Dry mouth
Headache
Shakiness
Feeling nervous and excitable
Upset stomach
Feeling dizzy, tired, or weak
* Trouble sleeping

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have asthma, as this medication is not intended to treat this condition.
If you are currently using a similar medication. If you are unsure, consult your doctor or pharmacist to determine if the medications are similar.

This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your overall health and any existing medical conditions

To ensure your safety, carefully review all your medications and health conditions with your doctor before taking this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have diabetes (high blood sugar), be aware that this drug may occasionally increase your blood sugar levels. Consult with your doctor to discuss strategies for maintaining control over your blood sugar.

If you experience worsening breathing problems, a decrease in the effectiveness of your rescue inhaler, or an increased need to use your rescue inhaler, contact your doctor immediately. Do not exceed the prescribed dose or frequency of this medication, as overdoses of this type of drug have been fatal. Consult with your doctor if you have any concerns.

Medications like this one may increase the risk of asthma-related deaths in individuals with asthma who are not also using an inhaled steroid. However, this risk does not appear to apply to people with Chronic Obstructive Pulmonary Disease (COPD). If you have questions or concerns, discuss them with your doctor.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.

• Other long-acting beta2-adrenergic agonists (LABAs)
• Beta-blockers (non-selective, e.g., propranolol, carvedilol)

• Monoamine oxidase inhibitors (MAOIs) (e.g., phenelzine, selegiline)
• Tricyclic antidepressants (TCAs) (e.g., amitriptyline, imipramine)
• QTc-prolonging drugs (e.g., quinidine, sotalol, macrolide antibiotics, antipsychotics)
• Diuretics (non-potassium sparing, e.g., furosemide, hydrochlorothiazide)

• Sympathomimetics (e.g., pseudoephedrine, epinephrine)
• Xanthine derivatives (e.g., theophylline)
• Corticosteroids (systemic)
• Non-potassium sparing diuretics

• Not available

• Worsening shortness of breath
• Increased cough
• Increased sputum production
• Increased use of rescue inhaler
• Chest pain or discomfort
• Palpitations
• Tremor
• Nervousness
• Muscle cramps

Category C. There are no adequate and well-controlled studies of arformoterol in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beta2-agonists may interfere with uterine contractility.

It is not known whether arformoterol is excreted in human milk. Caution should be exercised when arformoterol is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for arformoterol and any potential adverse effects on the breastfed infant from arformoterol or from the underlying maternal condition.

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Arformoterol is not indicated for use in children.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, caution should be exercised in elderly patients due to the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

• Arformoterol is a maintenance bronchodilator for COPD; it is NOT a rescue medication for acute bronchospasm.
• Patients should always have a short-acting beta2-agonist (SABA) available for acute symptoms.
• The black box warning for LABAs regarding asthma-related death applies to the class, even though arformoterol is indicated only for COPD.
• Administer twice daily, approximately 12 hours apart, using a nebulizer.
• Monitor for cardiovascular adverse effects (tachycardia, palpitations, hypertension) and metabolic effects (hypokalemia, hyperglycemia), especially in susceptible patients.
• Avoid concomitant use with other LABAs or non-selective beta-blockers.

• Other LABAs (e.g., formoterol, salmeterol, indacaterol, olodaterol, vilanterol)
• Long-acting muscarinic antagonists (LAMAs) (e.g., tiotropium, aclidinium, glycopyrronium, umeclidinium)
• Short-acting beta2-agonists (SABAs) for rescue (e.g., albuterol, levalbuterol)
• Short-acting muscarinic antagonists (SAMAs) for rescue (e.g., ipratropium)
• Methylxanthines (e.g., theophylline) - less commonly used due to narrow therapeutic index.

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.