Arformoterol 15mcg/2ml Inh 30 X 2ml

Arformoterol is a long-acting selective beta2-adrenergic agonist (LABA). It acts locally in the lung as a bronchodilator by stimulating beta2-adrenergic receptors on airway smooth muscle. This stimulation leads to activation of adenyl cyclase, which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels lead to relaxation of bronchial smooth muscle and inhibition of mediator release from mast cells in the airway.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience 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 Emergency

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 Possible 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 experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

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

If you have questions about side effects or experience any side effects not listed here, contact your doctor for medical advice. 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have asthma, as this medication is not intended to treat asthma.
* 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 list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you verify that it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not initiate, discontinue, or modify 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, be aware that this drug may occasionally increase your blood sugar levels. Discuss with your doctor strategies for maintaining control over your blood sugar.

Immediately contact your doctor if you experience worsening breathing problems, if your rescue inhaler becomes less effective, or if you find yourself needing to use your rescue inhaler more frequently. Do not exceed the prescribed dose or use this medication more often than directed, as overdoses of this type of drug have been fatal. Consult with your doctor if you have any concerns.

Be aware that 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 drug, as you may be more susceptible to side effects. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.

• Other long-acting beta2-adrenergic agonists (LABAs)
• Acute bronchospasm (as monotherapy)

• Beta-blockers (especially non-selective): May block the bronchodilatory effect of arformoterol and produce severe bronchospasm.
• QTc-prolonging drugs (e.g., Class IA and III antiarrhythmics, macrolides, tricyclic antidepressants): Increased risk of ventricular arrhythmias.
• Diuretics (non-potassium sparing): May worsen ECG changes and/or hypokalemia.

• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the cardiovascular effects of arformoterol.
• Sympathomimetics: May potentiate adverse cardiovascular effects.

• Xanthine derivatives (e.g., theophylline): May potentiate hypokalemia.

• Worsening shortness of breath
• Increased wheezing
• Increased cough
• Chest tightness
• Increased need for rescue inhaler (short-acting beta-agonist)
• Paradoxical bronchospasm (immediate worsening of breathing after dose)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Arformoterol is Pregnancy Category C.

It is not known whether arformoterol is excreted in human milk. Consider the developmental and health benefits of breastfeeding 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. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients. Arformoterol is not indicated for use in children.

No dosage adjustment is required based on age. Clinical studies did not reveal differences in safety or effectiveness between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution in elderly patients with cardiovascular disease or other comorbidities.

• Arformoterol is a maintenance medication for COPD; it is NOT a rescue inhaler for acute bronchospasm.
• Patients should always have a short-acting beta-agonist (SABA) available for acute symptoms.
• Emphasize the importance of twice-daily dosing, 12 hours apart, for consistent bronchodilation.
• Educate patients on the black box warning regarding increased risk of asthma-related death with LABAs, and clarify that arformoterol is for COPD, not asthma.
• Monitor for paradoxical bronchospasm, which requires immediate discontinuation and alternative therapy.
• Caution with concomitant use of beta-blockers, especially non-selective ones, as they can antagonize the bronchodilatory effect and cause severe bronchospasm.

• Other LABAs (e.g., Salmeterol, Indacaterol, Olodaterol, Formoterol)
• Long-acting muscarinic antagonists (LAMAs) (e.g., Tiotropium, Aclidinium, Glycopyrronium, Umeclidinium)
• Inhaled corticosteroids (ICS) (often in combination with LABAs for COPD)
• Phosphodiesterase-4 (PDE4) inhibitors (e.g., Roflumilast) for severe COPD with chronic bronchitis and frequent exacerbations.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.