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Cromolyn (Systemic)

Medically reviewed on September 10, 2018

Pronunciation

(KROE moe lin)

Index Terms

  • Cromoglicate
  • Cromoglycic Acid
  • Cromolyn Sodium
  • Disodium Cromoglycate
  • DSCG
  • Sodium Cromoglicate
  • Sodium Cromoglycate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Concentrate, Oral, as sodium:

Gastrocrom: 100 mg/5 mL (5 mL)

Generic: 100 mg/5 mL (5 mL)

Concentrate, Oral, as sodium [preservative free]:

Generic: 100 mg/5 mL (5 mL)

Brand Names: U.S.

  • Gastrocrom

Pharmacologic Category

  • Mast Cell Stabilizer

Pharmacology

Prevents the mast cell release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis by inhibiting degranulation after contact with antigens

Absorption

Oral: <1% of dose absorbed

Excretion

Urine and feces (equal amounts as unchanged drug)

Onset of Action

Response to treatment: Oral: May occur within 2 to 6 weeks

Half-Life Elimination

80 to 90 minutes

Use: Labeled Indications

Food allergy: Nalcrom [Canadian product]: Treatment of food allergy in conjunction with restriction of main causative allergens

Systemic mastocytosis: Management of systemic mastocytosis

Contraindications

Hypersensitivity to cromolyn or any component of the formulation

Dosing: Adult

Food allergy: Nalcrom [Canadian product]: Oral: Initial: 200 mg 4 times daily; dose may be increased after 2 to 3 weeks if response not adequate to a maximum of 40 mg/kg/day. Once the desired effect is achieved, taper to lowest effective dose.

Systemic mastocytosis: Oral: 200 mg 4 times daily; dose may be increased after 2 to 3 weeks if response not adequate to a maximum of 40 mg/kg/day. Once the desired effect is achieved, taper to lowest effective dose.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Food allergy: Nalcrom [Canadian product]: Oral: Initial:

Children ≥2 years of age and Adolescents to ≤14 years of age: 100 mg 4 times daily; dose may be increased after 2 to 3 weeks if response not adequate to a maximum of 40 mg/kg/day. Once the desired effect is achieved, taper to lowest effective dose.

Adolescents >14 years of age: Refer to adult dosing.

Systemic mastocytosis: Oral:

Infants <6 months of age: Initial: 20 mg/kg/day in 4 divided doses; maximum daily dose: 20 mg/kg/day. Once desired effect is achieved, taper to lowest effective dose. Note: Routine use not recommended; reserve for patients with severe disease in whom potential benefits outweigh risks.

Infants ≥6 months of age and Children <2 years of age: Initial: 20 mg/kg/day in 4 divided doses; maximum dose: 100 mg/dose; if control of symptoms is not observed within 2 to 3 weeks, may increase dose; maximum daily dose: 40 mg/kg/day. Once desired effect is achieved, dose may be tapered to lowest effective maintenance dose. Note: Routine use not recommended; reserve for patients with severe disease in whom potential benefits outweigh risks.

Children 2 to 12 years of age: Initial: 100 mg 4 times daily; dose may be increased after 2 to 3 weeks if response not adequate to a maximum of 40 mg/kg/day. Once the desired effect is achieved, taper to lowest effective dose.

Children >12 years of age and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

Decrease dose in patients with renal impairment.

Dosing: Hepatic Impairment

Decrease dose in patients with hepatic impairment.

Administration

Oral capsule: Nalcrom [Canadian product]: Administer as a solution (preferred) by adding 5 mL of very hot water to the capsule contents in a cup and further diluting with 20 mL of cold water. May also swallow capsule whole. Administer 15 to 20 minutes before meals.

Oral solution: Open ampule and squeeze contents into glass of water; stir well; administer entire contents of glass at least 30 minutes before meals and at bedtime.

Storage

Store at 15°C to 30°C (59°F to 86°F). Protect from light. Do not use oral solution if solution becomes discolored or forms a precipitate.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Cardiovascular: Chest pain, edema, flushing, palpitations, tachycardia, ventricular premature contractions

Central nervous system: Headache (5%), irritability (2%), malaise (1%), anxiety, behavioral changes, burning sensation, convulsions, depression, dizziness, dizziness (postprandial), fatigue, hallucination, hypoesthesia, insomnia, lethargy, migraine, nervousness, paresthesia, psychosis

Dermatologic: Pruritus (3%), skin rash (2%), erythema, skin photosensitivity, urticaria

Gastrointestinal: Diarrhea (5%), nausea (3%), abdominal pain (2%), constipation, dyspepsia, dysphagia, esophageal spasm, flatulence, glossitis, stomatitis, unpleasant taste, vomiting

Genitourinary: Dysuria, urinary frequency

Hematologic & oncologic: Neutropenia, pancytopenia, polycythemia, purpura

Hepatic: Abnormal hepatic function tests

Hypersensitivity: Anaphylaxis, angioedema

Neuromuscular & skeletal: Myalgia (3%), arthralgia, lower extremity weakness, lupus erythematosus, stiffness of legs

Otic: Tinnitus

Respiratory: Dyspnea, pharyngitis

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis: Severe anaphylactic reactions may occur rarely

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment recommended.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment recommended.

Other warnings/precautions:

• Appropriate use: Prophylactic drug with no benefit for acute situations.

• Withdrawal: Do not abruptly discontinue therapy; use caution when withdrawing the drug or tapering the dose as symptoms may reoccur.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Systemic absorption following oral administration is <1%.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, nausea, vomiting, insomnia, sneezing, bad taste, joint pain, or headache. Have patient report immediately to prescriber wheezing, cough, muscle pain, muscle weakness, shortness of breath, excessive weight gain, or swelling of arms or legs (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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