cromolyn

Therapeutic Classification: antiasthmatics, allergy, cold and cough remedies

Pharmacologic Classification: mast cell stabilizers

REMS

Inhaln: Prophylaxis (long-term control) of bronchial asthma.
Prevention of exercise-induced bronchospasm.
Prevention and treatment of seasonal and perennial allergic rhinitis.
PO: Mastocytosis.
Treatment of food allergy.
Treatment of inflammatory bowel disease (IBD).

Prevents the release of histamine and slow-reacting substance of anaphylaxis (SRS-A) from sensitized mast cells.

Therapeutic effects:

Decreased frequency and intensity of asthmatic episodes or allergic reactions.

Absorption: Oral: 0.5—2 %; Inhalation: Poorly absorbed systemically (total bioavailability is 8%); action is local. Small amounts may reach systemic circulation after inhalation.

Distribution: Because only small amounts are absorbed, distribution is not known.

Metabolism/Excretion: Small amounts absorbed are excreted unchanged in bile and urine.

Half-Life: 80–90 min.

ROUTE	ONSET	PEAK	DURATION
Cromolyn-inhalation	1–2 wk	2–4 wk	unknown
Cromolyn-nasal	1–2 wk	2–4 wk	unknown

Contraindicated in:

Hypersensitivity;
Acute attacks of asthma (inhalation).

Use Cautiously in:

Renal or hepatic dysfunction;
Bronchospasm—Will not relieve and may worsen acute attacks (inhalation);
OB: Safety not established;
Pedi: Safety not established in children <2 yr.

Derm: rash, urticaria, angioedema

EENT: intranasalnasal irritation, nasal congestion, sneezing

Neuro: dizziness, headache

Resp: inhalationirritation of the throat and trachea, cough, wheezing, bronchospasm

GI: nausea, unpleasant taste

Misc: ANAPHYLAXIS OR WORSENING OF CONDITIONS BEING TREATEDALLERGIC REACTIONS INCLUDING

Drug-drug:

Not known.

Inhaln (Adults and Children ≥2 yr): Nebulized solution:One ampule (20-mg) of the nebulizer solution 4 times daily. For prevention of bronchospasm, use one nebulized ampule (20 mg) 10–15 min before exposure to known precipitating situation.
(Adults and Children ≥2 yr): 1 spray (5.2 mg/spray) into each nostril 3–4 times daily (up to 6 times daily).
PO (Adults and Children >12 yr): 200 mg 4 times a day.
PO (Children 2–12 yr): 100 mg 4 times a day; not to exceed 40 mg/kg/day.

(Generic available)

Solution for nebulization: 10 mg/mL
Nasal solution: 40 mg/mL (5.2 mg/spray) in 13-mL (≥100 sprays) or 26-mL (≥200 sprays) containers^OTC
Oral solution: 100 mg/5 mL

Inhaln: Evaluate pulmonary function testing before initiating therapy in asthmatics.
- Assess lung sounds and respiratory function before and periodically during therapy.
Assess for symptoms of rhinitis (stuffiness, rhinorrhea).

Reduction in dose of other asthma medications may be possible after 2–4 wk of therapy.
PO: Break open and squeeze contents of ampule into a glass of water. Stir solution. Drink all of liquid. Administer 30 min before meals and at bedtime.
Inhaln: Medication should be used prophylactically, not during acute asthma attacks or status asthmaticus.
- Pretreatment with bronchodilator may be required to increase delivery of inhalation product.
- Do not use nebulizer solution that is cloudy or contains a precipitate. Compatible with acetylcysteine, epinephrine, isoetharine, isoproterenol, and terbutaline solutions for up to 60 min.

Instruct patient on correct use of medication. Medication must be used routinely and not more frequently than prescribed. Take missed doses as soon as remembered and space other doses at regular intervals. Do not double doses. Do not discontinue therapy without consulting health care professional, or exacerbation of symptoms may occur.
Instruct patient not to discontinue concurrent corticosteroid or bronchodilator therapy without consulting health care professional.
If cromolyn is prescribed before contact with known allergen or exercise, explain that it should be administered 10–15 min, and no earlier than 60 min, in advance.
Inhaln: Caution patient to notify health care professional if asthmatic symptoms do not improve within 4 wk, worsen, or recur.
Instruct patient to clear nasal passages before administration and to inhale through nose during administration.
- Instruct patient to start using product up to 1 wk before coming into contact with allergen and to use every day while in contact with allergen.

Therapeutic effects, observable within 2–4 wk after beginning therapy, are demonstrated by:.
Reduction in symptoms of asthma.
Prevention of exercise-induced bronchospasm.
Decrease in the symptoms of allergic rhinitis.

Gastrocrom, NasalCrom

Ineffective airway clearance(Indications)

NDC Code

0037- Meda Pharmaceuticals Inc.
- 0037-0678- Gastrocrom
  - 0037-0678-96- 12 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE

0172- Teva Pharmaceuticals USA, Inc.
- 0172-6406- Cromolyn Sodium
  - 0172-6406-49- 12 POUCH in 1 CARTON (0172-6406-49) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0172-6406-05) / 2 mL in 1 VIAL, SINGLE-DOSE

12780- Fermion Oy
- 12780-4960-
  - 12780-4960-0- 1 BAG in 1 DRUM (12780-4960-0) / 25 kg in 1 BAG

12828- Cambrex Profarmaco Milano Srl
- 12828-0062-
  - 12828-0062-1- 25 kg in 1 DRUM (12828-0062-1)

16571- Rising Pharma Holdings, Inc.
- 16571-600- CROMOLYN SODIUM
  - 16571-600-96- 12 POUCH in 1 CARTON (16571-600-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

17337- Olon SpA
- 17337-0511-
  - 17337-0511-0- 1 BAG in 1 DRUM (17337-0511-0) / 1 BAG in 1 BAG / 25 kg in 1 BAG

38779- Medisca Inc.
- 38779-0301-
  38779-0301-3- 5 g in 1 BOTTLE, GLASS (38779-0301-3)

38779- Medisca Inc.
- 38779-0301-
  38779-0301-4- 25 g in 1 JAR (38779-0301-4)

38779- Medisca Inc.
- 38779-0301-
  38779-0301-5- 100 g in 1 JAR (38779-0301-5)

38779- Medisca Inc.
- 38779-0301-
  38779-0301-8- 500 g in 1 JAR (38779-0301-8)

42571- Micro Labs Limited
- 42571-132- CROMOLYN SODIUM
  42571-132-52- 96 CARTON in 1 CARTON (42571-132-52) / 1 TRAY in 1 CARTON / 8 AMPULE in 1 TRAY / 5 mL in 1 AMPULE (42571-132-21)

42571- Micro Labs Limited
- 42571-350- Cromolyn Sodium
  - 42571-350-09- 5 CARTON in 1 CARTON (42571-350-09) / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08)

42571- Micro Labs Limited
- 42571-350- Cromolyn Sodium
  - 42571-350-50- 10 CARTON in 1 CARTON (42571-350-50) / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08)

42571- Micro Labs Limited
- 42571-445-
  - 42571-445-38- 10 kg in 1 DRUM (42571-445-38)

49452- Spectrum Laboratory Products, Inc.
- 49452-0006-
  49452-0006-1- 1 g in 1 BOTTLE (49452-0006-1)

49452- Spectrum Laboratory Products, Inc.
- 49452-0006-
  49452-0006-2- 5 g in 1 BOTTLE (49452-0006-2)

49452- Spectrum Laboratory Products, Inc.
- 49452-0006-
  49452-0006-3- 25 g in 1 BOTTLE (49452-0006-3)

49452- Spectrum Laboratory Products, Inc.
- 49452-0006-
  49452-0006-4- 100 g in 1 BOTTLE (49452-0006-4)

49452- Spectrum Laboratory Products, Inc.
- 49452-0006-
  49452-0006-6- 500 g in 1 BOTTLE (49452-0006-6)

49452- Spectrum Laboratory Products, Inc.
- 49452-0006-
  49452-0006-7- 25000 g in 1 DRUM (49452-0006-7)

50090- A-S Medication Solutions
- 50090-1202- Cromolyn Sodium
  50090-1202-0- 10 mL in 1 BOTTLE, PLASTIC (50090-1202-0)

51525- Wallace Pharmaceuticals Inc.
- 51525-0470- cromolyn sodium
  - 51525-0470-9- 12 POUCH in 1 CARTON (51525-0470-9) / 8 AMPULE in 1 POUCH (51525-0470-8) / 5 mL in 1 AMPULE

51552- Fagron Inc
- 51552-0423-
  - 51552-0423-4- 25 g in 1 CONTAINER (51552-0423-4)

51552- Fagron Inc
- 51552-0423-
  51552-0423-5- 100 g in 1 CONTAINER (51552-0423-5)

51927- Professional Compounding Centers of America
- 51927-5178-
  51927-5178-0- 1 kg in 1 BOTTLE (51927-5178-0)

52183- Prestige Brands Holdings, Inc.
- 52183-199- NasalCrom
  52183-199-13- 1 BOTTLE, PUMP in 1 CARTON (52183-199-13) / 200 SPRAY, METERED in 1 BOTTLE, PUMP

52183- Prestige Brands Holdings, Inc.
- 52183-199- NasalCrom
  - 52183-199-14- 1 BOTTLE, PUMP in 1 CARTON (52183-199-14) / 100 SPRAY, METERED in 1 BOTTLE, PUMP

57782- Bausch & Lomb Incorporated
- 57782-397- Cromolyn Sodium
  - 57782-397-26- 1 BOTTLE in 1 CARTON (57782-397-26) / 200 SPRAY, METERED in 1 BOTTLE

61314- Sandoz Inc
- 61314-237- Cromolyn Sodium
  - 61314-237-10- 10 mL in 1 BOTTLE, PLASTIC (61314-237-10)

62991- LETCO MEDICAL, LLC
- 62991-1038-
  - 62991-1038-1- 25 g in 1 JAR (62991-1038-1)

62991- LETCO MEDICAL, LLC
- 62991-1038-
  62991-1038-2- 100 g in 1 JAR (62991-1038-2)

62991- LETCO MEDICAL, LLC
- 62991-1038-
  62991-1038-3- 500 g in 1 JAR (62991-1038-3)

63629- Bryant Ranch Prepack
- 63629-2483- CROMOLYN SODIUM
  63629-2483-1- 12 POUCH in 1 CARTON (63629-2483-1) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

63629- Bryant Ranch Prepack
- 63629-2485- CROMOLYN SODIUM
  - 63629-2485-1- 12 POUCH in 1 CARTON (63629-2485-1) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

68788- Preferred Pharmaceuticals Inc.
- 68788-8490- Cromolyn Sodium
  - 68788-8490-1- 10 mL in 1 BOTTLE, PLASTIC (68788-8490-1)

69784- Woodward Pharma Services LLC
- 69784-200- CROMOLYN SODIUM
  - 69784-200-96- 12 POUCH in 1 CARTON (69784-200-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

71052- DARMERICA, LLC
- 71052-686-
  - 71052-686-01- 1000 g in 1 CONTAINER (71052-686-01)

71052- DARMERICA, LLC
- 71052-686-
  71052-686-10- 100 g in 1 CONTAINER (71052-686-10)

71052- DARMERICA, LLC
- 71052-686-
  71052-686-40- 400 g in 1 CONTAINER (71052-686-40)

71052- DARMERICA, LLC
- 71052-686-
  71052-686-50- 500 g in 1 CONTAINER (71052-686-50)

71205- Proficient Rx LP
- 71205-085- Cromolyn Sodium
  71205-085-10- 1 BOTTLE, DROPPER in 1 CARTON (71205-085-10) / 10 mL in 1 BOTTLE, DROPPER

71205- Proficient Rx LP
- 71205-230- Cromolyn Sodium
  - 71205-230-10- 10 mL in 1 BOTTLE, PLASTIC (71205-230-10)

72162- Bryant Ranch Prepack
- 72162-1934- CROMOLYN SODIUM
  - 72162-1934-2- 12 POUCH in 1 CARTON (72162-1934-2) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

73377- AX Pharmaceutical Corp
- 73377-119-
  - 73377-119-01- 1000 g in 1 JAR (73377-119-01)

73377- AX Pharmaceutical Corp
- 73377-119-
  73377-119-02- 100 g in 1 JAR (73377-119-02)

76003- Fagron Services B.V.
- 76003-0773-
  76003-0773-5- 5000 g in 1 CONTAINER (76003-0773-5)

81665- Omnivium Pharmaceuticals LLC
- 81665-104- CROMOLYN SODIUM
  81665-104-96- 12 POUCH in 1 CARTON (81665-104-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

82298- EUROAPI FRANCE
- 82298-910-
  - 82298-910-00- 20 kg in 1 DRUM (82298-910-00)

84317- Yumen Qianhua Pharmaceutical Co., Ltd.
- 84317-101-
  84317-101-25- 25 kg in 1 DRUM (84317-101-25)

85270- Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd.
- 85270-001-
  85270-001-01- 10 kg in 1 DRUM (85270-001-01)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Pot. Nursing Diagnoses ⬆ ⬇

Code ⬆