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cromolyn sodium (Rx)Brand and Other Names:Gastrocrom

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral concentrate

  • 100mg/5mL
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Mastocytosis

200 mg PO four times daily; 30 minutes prior to meals; may increase to 40 mg/kg/day if control of symptoms not seen within 2-3 weeks 

Food Allergy & Inflammatory Bowel Disease (Off-label)

200 mg PO four times daily; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 400 mg PO four times daily

Administration

Dilute contents of ampule with glass of water; stir well

For systemic mastocytosis administer 30 minutes before meals and bedtime

For food allergy and inflammatory bowel disease administer 15-20 minutes before meals

Dosage Forms & Strengths

oral concentrate

  • 100mg/5mL
more...

Mastocytosis

<2 years: Safety and efficacy not established

2-12 years: 100 mg PO four times daily; not to exceed 40 mg/kg/day; give 30 minutes AC and HS 

>12 years: As in adults; 200 mg PO four times daily; 30 minutes prior to meals; may increase to <40 mg/kg/day if control of symptoms not seen within 2-3 weeks

Food Allergy & Inflammatory Bowel Disease (Off-label)

<2 years old: Not recommended

2-12 years: 100 mg four times daily initially; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 40 mg/kg/day 

>12 years: 200 mg PO four times daily; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 400 mg PO four times daily

Administration

Dilute the contents of ampule with glass of water

For systemic mastocytosis administer 30 minutes before meals and bedtime

For food allergy and inflammatory bowel disease administer 15-20 minutes before meals

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Adverse Effects

Frequency Not Defined

Diarrhea

Headache

Angioedema

Premature ventricular contractions

Hypoesthesia

Lightheadedness

Flushing

Palpitation

Erythema

Postprandial

Photosensitivity

Behavior changes

Psychosis

Esophagospasm

Nausea

Abdominal pain

Pancytopenia

Polycythemia

Stomatitis

Neutropenia

Rash

Pruritus

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Warnings

Contraindications

Hypersensitivity

Acute asthma attack

Cautions

Severe anaphylactic reactions may occur (rare)

Monitor closely patients with hepatic/renal insufficiency

Use caution in patients with history of cardiac arrhythmia and hepatic or renal impairment

Oral concentrated solution should not be used for inhalation or injection

Not beneficial in the acute setting

Symptomes may reoccur when tapering or withdrawing the drug; use caution

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown if excreted in breast milk, use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Mast cell stabilizer; inhibits release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis from mast cell by inhibiting degranulation following exposure to reactive antigens

Pharmacokinetics

Bioavailability: 0.5-2%

Peak plasma time: 15 min

Peak plasma concentration: 9 ng/mL

Half-life: 80-90 min

Onset: 2-6 weeks (PO)

Duration: 6 hr

Excretion: Feces (98%, unabsorbed drugs); urine (<0.5%)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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