cromolyn sodium, inhaled (Rx)

Brand and Other Names:
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

nebulization solution

  • 10mg/mL (2mL/vial)

Asthma

20 mg inhaled via nebulization QID; may decrease to BID/TID once stabilized

Bronchospasm Prophylaxis (Exercise Induced or Allergen)

Administer 20 mg as single dose 10-15 min prior to exercise or allergen exposure but no longer than 1 hr

Mastocytosis (Orphan)

Orphan designation for treatment of mastocytosis

Sponsor

  • Patara Pharma, LLC; 11455 El Camino Real, Suite 460; San Diego, California 92130

Dosage Forms & Strengths

nebulization solution

  • 10mg/mL (2mL/vial)

Asthma

<2 years: Safety and efficacy not established

≥2 years: 20 mg inhaled via nebulization QID; may decrease to BID/TID once stabilized

Bronchospasm Prophylaxis (Exercise Induced or Allergen)

<2 years: Safety and efficacy not established

&ge2 years: Administer 20 mg as single dose 10-15 min prior to exercise or allergen exposure but no longer than 1 hr

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Adverse Effects

Frequency Not Defined

Cough

Flushing

Palpitation

Chest pain

Nasal congestion

Nausea

Fatigue

Migraine

Sneezing

Wheezing

Psychosis

Pruritus

Dysphagia

Esophagospasm

Pancytopenia

Polycythemia

Tinnitus

Pharyngitis

Lupus erythematosus

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Warnings

Contraindications

Hypersensitivity; acute asthma attack

Cautions

Not for status asthmaticus

Use caution in patients with a history of cardiac arryhthmias

Use caution in renal or hepatic impairment; may require dose adjustment

Some reports of bronchospasm or cough after administration

Not useful in acute situations

Symptoms may reoccur while withdrawing or tapering the dose

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown whether distributed in breast milk; likely compatible

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

Absorption: 8%

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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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

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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