Asmanex Twisthaler


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mometasone (inhalation)

(moe-met-a-sone) ,

Asmanex Twisthaler

(trade name)

Classification

Therapeutic: antiasthmatics
Pharmacologic: corticosteroids
Pregnancy Category: C

Indications

Maintenance treatment of asthma as prophylactic therapy.May decrease the need for or eliminate use of systemic corticosteroids in patients with asthma.

Action

Potent, locally acting anti-inflammatory and immune modifier.

Therapeutic effects

Decreased frequency and severity of asthma attacks.
Improves asthma symptoms.

Pharmacokinetics

Absorption: <1%; action is primarily local after inhalation.
Distribution: 10–25% is deposited in airways if a spacer device is not used. All cross the placenta and enter breast milk in small amounts.
Metabolism and Excretion: Metabolized by the liver (primarily by CYP3A4) after absorption from lungs; 75% excreted in feces.
Half-life: 5 hr.

Time/action profile (improvement in symptoms)

ROUTEONSETPEAKDURATION
Inhalationwithin 24 hr1–4 wk†unknown
†Improvement in pulmonary function; ↓ airway responsiveness may take longer

Contraindications/Precautions

Contraindicated in: Hypersensitivity or intolerance to drug or milk proteins; Acute attack of asthma/status asthmaticus.
Use Cautiously in: Active untreated infections; Diabetes or glaucoma; Underlying immunosuppression (due to disease or concurrent therapy); Systemic corticosteroid therapy (should not be abruptly discontinued when inhalation therapy is started; additional corticosteroids needed in stress or trauma); Obstetric / Lactation: Safety not established; Pediatric: Children <4 yr (safety not established); prolonged or high-dose therapy in children may lead to complications.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • agitation
  • depression
  • dizziness
  • fatigue
  • insomnia
  • restlessness

Ear, Eye, Nose, Throat

  • dysphonia (most frequent)
  • hoarseness (most frequent)
  • cataracts
  • nasal congestion
  • pharyngitis
  • sinusitis

Respiratory

  • bronchospasm
  • cough
  • wheezing

Gastrointestinal

  • diarrhea
  • dry mouth
  • dyspepsia
  • esophageal candidiasis
  • taste disturbances
  • nausea

Endocrinologic

  • adrenal suppression (↑ dose, long-term therapy only), ↓ growth (children)
  • ↓ bone mineral density

Musculoskeletal

  • back pain

Miscellaneous

  • hypersensitivity reactions including anaphylaxis, laryngeal edema, urticaria, and bronchospasm (life-threatening)
  • churg-strauss syndrome (life-threatening)

Interactions

Drug-Drug interaction

Ketoconazole may ↑ levels.

Route/Dosage

Inhalation (Adults and Children >12 yr) Previously on bronchodilators or other inhaled corticosteroids—220 mcg (1 inhalation) once daily, up to 440 mcg/day as a single dose or 2 divided doses; Previously on oral corticosteroids—440 mcg (2 inhalations) twice daily (not to exceed 880 mcg/day).
Inhalation (Children 4–11 yr) 110 mcg once daily in evening (not to exceed 110 mcg/day).

Availability

Powder for inhalation: 110 mcg (delivers 100 mcg/metered inhalation; in packages of 7 and 30 inhalation units), 220 mcg (delivers 200 mcg/metered inhalation; in packages of 14, 30, 60, and 120 inhalation units)

Nursing implications

Nursing assessment

  • Monitor respiratory status and lung sounds. Assess pulmonary function tests periodically during and for several months after a transfer from systemic to inhalation corticosteroids.
  • Assess patients changing from systemic corticosteroids to inhalation corticosteroids for signs of adrenal insufficiency (anorexia, nausea, weakness, fatigue, hypotension, hypoglycemia) during initial therapy and periods of stress. If these signs appear, notify health care professional immediately; condition may be life-threatening.
  • Monitor for withdrawal symptoms (joint or muscular pain, lassitude, depression) during withdrawal from oral corticosteroids.
  • Monitor growth rate in children receiving chronic therapy; use lowest possible dose.
  • May cause decreased bone mineral density during prolonged therapy. Monitor patients with increased risk (prolonged immobilization, family history of osteoporosis, post-menopausal status, tobacco use, advanced age, poor nutrition, chronic use of drugs that can reduce bone mass [anticonvulsants, oral corticosteroids]) for fractures.
  • Monitor for signs and symptoms of hypersensitivity reactions (rash, pruritis, swelling of face and neck, dyspnea) periodically during therapy.
  • Lab Test Considerations: Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal (HPA) axis suppression in chronic therapy. Children and patients using higher than recommended doses are at highest risk for HPA suppression.
    • May cause ↑ serum and urine glucose concentrations if significant absorption occurs.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)
Risk for infection (Side Effects)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • After the desired clinical effect has been obtained, attempts should be made to decrease dose to lowest amount required to control symptoms. Gradually decrease dose every 2–4 wk as long as desired effect is maintained. If symptoms return, dose may briefly return to starting dose.
  • Inhalation: Allow at least 1 min between inhalations.

Patient/Family Teaching

  • Advise patient to take medication as directed. Take missed doses as soon as remembered unless almost time for next dose. Instruct patient to read the Patient Information and Instructions for Use before using and with each Rx refill, in case of new information. Advise patient not to discontinue medication without consulting health care professional; gradual decrease is required.
  • Advise patients using inhalation corticosteroids and bronchodilator to use bronchodilator first and to allow 5 min to elapse before administering the corticosteroid, unless otherwise directed by health care professional.
  • Advise patient that inhalation corticosteroids should not be used to treat an acute asthma attack but should be continued even if other inhalation agents are used.
  • Patients using inhalation corticosteroids to control asthma may require systemic corticosteroids for acute attacks. Advise patient to use regular peak flow monitoring to determine respiratory status.
  • Caution patient to avoid smoking, known allergens, and other respiratory irritants.
  • Advise patient to notify health care professional if sore throat or sore mouth occurs.
  • Advise patient to stop using medication and notify health care professional immediately if signs and symptoms of hypersensitivity reactions occur.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
  • Instruct patient whose systemic corticosteroids have been recently reduced or withdrawn to carry a warning card indicating the need for supplemental systemic corticosteroids in the event of stress or severe asthma attack unresponsive to bronchodilators.
  • Asmanex Twisthaler: Advise patient to remove cap while device is in upright position. To administer dose, exhale fully, then place mouthpiece between lips and inhale deeply and forcefully. Remove device from mouth and hold breath for 10 sec before exhaling (do not exhale into mouthpiece). Wipe the mouthpiece dry, if necessary, and replace the cap on the device. Rinse mouth with water. Advise patient to discard twisthaler 45 days from opening or when dose counter reads "00", whichever comes first.

Evaluation/Desired Outcomes

  • Management of the symptoms of chronic asthma.
  • Improvement in symptoms of asthma.

Asmanex Twisthaler

A breath-actuated inhaler containing the steroid drug MOMETASONE as a dry powder for the treatment of ASTHMA. The drug is poorly absorbed from the lungs but this preparation is not recommended for children.
References in periodicals archive ?
Although ASMANEX TWISTHALER may improve control of asthma symptoms during
5 mg on a weekly basis during treatment with ASMANEX TWISTHALER [see Dosage and Administration (2)].
ASMANEX TWISTHALER (mometasone furoate inhalation powder) is approved in the U.
Important Safety Information for ASMANEX TWISTHALER
We are pleased to announce the approval of the ASMANEX TWISTHALER in Japan," said Thomas P.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to potential market for ASMANEX TWISTHALER 110 mcg.
Inhaled steroids including ASMANEX TWISTHALER may cause a reduction in growth velocity when administered to pediatric patients.
The ASMANEX TWISTHALER employs an inhalation-driven device that was recognized with the DuPont Award for innovation in packaging.
11) The ASMANEX TWISTHALER employs an inhalation- driven device that does not use a propellant, thus eliminating the need for hand-breath coordination, and it provides patients with a numeric dose counter that provides a visual indication of the remaining doses.
Schering-Plough has launched ASMANEX TWISTHALER in the United Kingdom, Germany, Sweden and Ireland, and expects to launch the product in other European Union (EU) markets over the coming months.
Earlier this week we announced that Asmanex Twisthaler is being launched in the European Union as a treatment for asthma.
Gained FDA approval of ASMANEX TWISTHALER (mometasone furoate