mannitol (inhalation)

MAN-i-tol

Therapeutic Classification: cystic fibrosis therapy adjuncts, mucolytic

REMS

Cystic fibrosis (as add-on maintenance therapy).

Mechanism in improving pulmonary function in patients with cystic fibrosis is unknown.

Therapeutic effects:

Improvement in FEV₁.

Absorption: Extent of absorption following oral inhalation unknown.

Distribution: Unknown.

Metabolism/Excretion: Excreted by the kidneys; minimal liver metabolism.

Half-Life: 4.7 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
Inhalation	unknown	1.5 hr	Unknown

Contraindicated in:

Hypersensitivity;
Failure to pass the Bronchitol Tolerance Test.

Use Cautiously in:

OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

EENT: oropharyngeal pain

GI: vomiting

MS: arthralgia

Resp: cough, hemoptysis, bronchospasm

Misc: fever

Drug-drug:

None reported.

Inhaln (Adults ): 400 mg (contents of 10 capsules) twice daily (with evening dose taken 2–3 hr before bedtime).

Dry powder capsules for inhalation: 40 mg

Monitor for bronchial hyperreactivity during therapy. If bronchospasm occurs, immediately discontinue mannitol and treat with inhaled short-acting bronchodilator and as clinically appropriate.

Prior to initiation of inhaled mannitol, the Bronchitol Tolerance Test must be performed to identify suitable candidates for maintenance therapy. Do not perform test if clinically unstable. If ↓ in oxygen saturation or FEV₁ occurs, do not initiate inhaled mannitol. Ensure rescue medication and resuscitation equipment are readily available to treat bronchospasm.
- Administer an inhaled short-acting bronchodilator 5–15 min before every dose of inhaled mannitol.
Inhaln: Using provided device, inhale the powder of 10 capsules (400 mg) twice daily. Store capsules at room temperature. Do not refrigerate or freeze. Allow inhaler device to thoroughly air-dry in between uses. Discard and replace device after 7 days of use.

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Instruct patient on safe hygiene practices and correct inhaler use, including loading of capsules and proper inhalation technique.
Instruct patient that an inhaled short-acting bronchodilator must always be used 5–15 min prior to every dose of inhaled mannitol.
Advise patient to immediately discontinue inhaled mannitol and inform health care professional if hemoptysis (coughing blood) or bronchospasm (wheezing, coughing, difficulty breathing) occurs.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Improvement in FEV₁ in adults with cystic fibrosis.

Bronchitol

NDC Code

0264- B. Braun Medical Inc.
- 0264-7578- Mannitol
  - 0264-7578-10- 24 CONTAINER in 1 CASE (0264-7578-10) / 500 mL in 1 CONTAINER

0264- B. Braun Medical Inc.
- 0264-7578- Mannitol
  - 0264-7578-20- 24 CONTAINER in 1 CASE (0264-7578-20) / 250 mL in 1 CONTAINER

0338- Baxter Healthcare Company
- 0338-0353- Osmitrol
  - 0338-0353-03- 500 mL in 1 BAG (0338-0353-03)

0338- Baxter Healthcare Company
- 0338-0357- Osmitrol
  - 0338-0357-02- 250 mL in 1 BAG (0338-0357-02)

0338- Baxter Healthcare Company
- 0338-0357- Osmitrol
  - 0338-0357-03- 500 mL in 1 BAG (0338-0357-03)

0404- Henry Schein, Inc.
- 0404-9905- Mannitol
  - 0404-9905-50- 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSE

0409- Hospira, Inc.
- 0409-4031- Mannitol
  - 0409-4031-01- 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16)

0990- ICU Medical Inc.
- 0990-7715- Mannitol
  - 0990-7715-02- 24 POUCH in 1 CASE (0990-7715-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0990-7715-12)

0990- ICU Medical Inc.
- 0990-7715- Mannitol
  - 0990-7715-03- 12 POUCH in 1 CASE (0990-7715-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0990-7715-13)

49574- Hunan Jiudian Pharmaceutical Co.,Ltd.
- 49574-527-
  - 49574-527-01- 25 kg in 1 DRUM (49574-527-01)

50516- Roquette Freres SA
- 50516-002-
  - 50516-002-00- 25 kg in 1 BAG (50516-002-00)

51662- HF Acquisition Co LLC, DBA HealthFirst
- 51662-1468- MANNITOL
  - 51662-1468-1- 50 mL in 1 VIAL, SINGLE-DOSE (51662-1468-1)

51662- HF Acquisition Co LLC, DBA HealthFirst
- 51662-1468- MANNITOL
  - 51662-1468-3- 25 POUCH in 1 CASE (51662-1468-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1468-2) / 50 mL in 1 VIAL, SINGLE-DOSE

57821- Agno Pharma Jiangsu
- 57821-013-
  - 57821-013-01- 300 g in 1 CANISTER (57821-013-01)

63323- Fresenius Kabi USA, LLC
- 63323-024- Mannitol
  63323-024-25- 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-024-01)

67850- Methapharm, Inc.
- 67850-552- Aridol Bronchial Challenge Test Kit
  - 67850-552-01- 1 KIT in 1 KIT (67850-552-01) * 1 POWDER in 1 KIT * 1 POWDER in 1 KIT * 1 POWDER in 1 CAPSULE * 1 POWDER in 1 KIT

84639- Arna Pharma Pty Ltd
- 84639-212- BRONCHITOL
  - 84639-212-04- 1 BLISTER PACK in 1 CARTON (84639-212-04) / 10 CAPSULE in 1 BLISTER PACK (84639-212-01)

84639- Arna Pharma Pty Ltd
- 84639-212- BRONCHITOL
  - 84639-212-14- 14 BLISTER PACK in 1 CARTON (84639-212-14) / 10 CAPSULE in 1 BLISTER PACK (84639-212-01)

84639- Arna Pharma Pty Ltd
- 84639-212- BRONCHITOL
  - 84639-212-56- 4 CARTON in 1 BOX (84639-212-56) / 14 BLISTER PACK in 1 CARTON (84639-212-14) / 10 CAPSULE in 1 BLISTER PACK (84639-212-01)

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Assessment ⬆ ⬇

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