mannitol (inhalation)

REMS

Cystic fibrosis (as add-on maintenance therapy).

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.

Dry powder capsules for inhalation: 40 mg

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

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

Therapeutic effects:

Improvement in FEV₁.

Therapeutic Classification: cystic fibrosis therapy adjuncts, mucolytic

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

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.

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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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆