Mometasone Inhaled

Mometasone Inhaled is a prescription medication used to treat the symptoms of Asthma.

• Mometasone Inhaled is available under the following different brand names: Asmanex Twisthaler, Asmanex HFA 

Common side effects of Mometasone Inhaled include:

• increased sinus allergy (runny nose, stuffy nose, sinus pain),
• sore throat,
• nosebleed,
• headache,
• muscle or bone pain,
• back pain,
• flu symptoms,
• upset stomach,
• menstrual pain,
• hoarseness, and
• deepened voice

Serious side effects of Mometasone Inhaled include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• wheezing,
• choking,
• other breathing problems after using the medication,
• blurred vision,
• tunnel vision,
• eye pain,
• seeing halos around lights,
• changes in the shape or location of body fat (especially in the arms, legs, face, neck, breast, and waist),
• worsening asthma symptoms,
• sores or white patches in the mouth or throat,
• trouble swallowing,
• extreme tiredness or weakness,
• nausea,
• vomiting, and
• lightheadedness 

Rare side effects of Mometasone Inhaled include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Powder for inhalation (Asmanex Twisthaler)

• 110 mcg/actuation
• 220 mcg/actuation

Metered dose inhaler (Asmanex HFA)

• 50 mcg/actuation
• 100 mcg/actuation
• 200 mcg/actuation

Asthma

Adult dosage

Asmanex Twisthaler

• Received bronchodilators alone or Inhaled corticosteroids: 220 mcg orally Inhaled once daily in the evening; may increase to 220 mcg every 12 hours if needed
• Received orally corticosteroids: 440 mcg orally Inhaled every 12 hours; not to exceed 880 mcg/day

Asmanex HFA

• 2 inhalations orally every12hours (. e. 200-400 mcg every 12 hours); starting dose based on prior asthma therapy
• Patients who are not on an Inhaled corticosteroid: 200 mcg Inhaled orally every 12 hours (as 2 actuation of 100 mcg/actuation)
• Currently taking oral corticosteroids: 400 mcg Inhaled orally every 12 hours (as 2 actuation of 200 mcg/actuation)
• Failure to respond to initial dose after 2 weeks: Increasing dose may provide additional asthma control; maximum daily recommended dose is 200 mcg Inhaled every 12 hours (as 2 actuation of 200 mcg/actuation); not to exceed 800 mcg/day
• Maximum benefit may not be achieved for above 1 week after beginning treatment; patients may experience a variable time to onset and degree of symptom relief

Pediatric dosage

Asmanex Twisthaler

• Children below 4 years: Safety and efficacy not established
• Children between 4-11 years: 110 mcg orally Inhaled once daily in the evening; not to exceed 110 mcg/day
• Children above 12 years
  • Received bronchodilators alone or Inhaled corticosteroids): 220 mcg orally Inhaled once daily in the evening; may increase to 220 mcg every 12 hours if needed
  • Received orally corticosteroids: 440 mcg orally Inhaled every 12 hours; not to exceed 880 mcg/day

Asmanex HFA

• Children below 5 years: Safety and efficacy not established
• Children 5 to below 12 years: 100 mcg Inhaled orally every 12 hours (as 2 actuation of 50 mcg/inhalation); not to exceed 200 mcg/day
• Children above12 years
  • 2 inhalations orally every 12 hours (. e. 200-400 mcg every 12 hours); starting dose based on prior asthma therapy
  • Patients who are not on an Inhaled corticosteroid: 200 mcg Inhaled orally every12hours (as 2 actuation of 100 mcg/actuation)
  • Currently taking oral corticosteroids: 400 mcg Inhaled orally every 12 hours (as 2 actuation of 200 mcg/actuation)
  • Failure to respond to initial dose after 2 weeks: Increasing dose may provide additional asthma control; maximum daily recommended dose is 200 mcg Inhaled every12hours (as 2 actuation of 200 mcg/actuation); not to exceed 800 mcg/day
  • Maximum benefit may not be achieved for above 1 week after beginning treatment; patients may experience a variable time to onset and degree of symptom relief

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Mometasone Inhaled has severe interactions with no other drugs.
• Mometasone Inhaled has serious interactions with the following drugs:
  • aldesleukin
  • desmopressin
  • loxapine Inhaled
• Mometasone Inhaled has moderate interactions with at least 36 other drugs.
• Mometasone Inhaled has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Immunosuppressed patients
• Tuberculosis
• Status asthmaticus or other acute asthma episode necessitating intensive measures
• Known hypersensitivity to milk proteins or any other ingredients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Mometasone Inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Mometasone Inhaled?”

Cautions

• Respiratory tract tuberculosis, untreated fungal or bacterial infections, viral or parasitic infections, ocular herpes simplex
• Nasal septum perforation, epistaxis, wheezing
• Cataracts, glaucoma, and increased intraocular pressure were reported; consider referral to an ophthalmologist in patients who develop ocular symptoms or long-term therapy
• Risk of more serious or fatal course of chickenpox and measles in susceptible individuals; avoid use in unvaccinated or immunologically unexposed children or adults
• Deaths from adrenal insufficiency have occurred after abrupt withdrawal of oral steroids, taper withdrawal gradually
• May retard growth in children
• Immunocompromised patients
  • Excessive use may suppress the hypothalamic-pituitary-adrenal function
  • During periods of stress or severe status asthmaticus, the patient may require supplementary systemic corticosteroids immediately; carry a warning card to that effect
  • Long-term administration reduces the bone mineral density
• Fungal infections
  • Localized infections of the mouth and pharynx with Candida albicans were reported; if oropharyngeal candidiasis develops, treat with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment; at times therapy may need to be interrupted
  • To reduce the risk of oropharyngeal candidiasis, after dosing, advise patients to rinse their mouth with water and spit out the contents without swallowing
• Drug interaction overview
  • Strong CYP3A4 inhibitors (. g, ritonavir): Use with caution; may cause increased systemic corticosteroid effects 

Pregnancy and Lactation

• There are no randomized clinical studies on pregnant women
• Clinical considerations
  • In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small gestational age in the neonate
  • Closely monitor pregnant women with asthma and adjust medication as necessary to maintain optimal asthma control
• Lactation
  • There are no available data on the presence of human milk, the effects on the breastfed child, or the effects on milk production
  • Other Inhaled corticosteroids, similar to mometasone furoate, are present in human milk
  • Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant from mometasone Inhaled or from the underlying maternal condition