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DRUG IMAGES
CROMOLYN 20 MG/2 ML NEB SOLN
The following indications for CROMOLYN SODIUM (cromolyn sodium) have been approved by the FDA:
Indications:
Maintenance therapy for asthma
Systemic mastocytosis
Professional Synonyms:
Systemic mast cell disease
Therapy to achieve long-term asthma control
Indications:
Maintenance therapy for asthma
Systemic mastocytosis
Professional Synonyms:
Systemic mast cell disease
Therapy to achieve long-term asthma control
The following dosing information is available for CROMOLYN SODIUM (cromolyn sodium):
The oral aerosol inhaler delivers 800 mcg of cromolyn sodium per metered spray from the mouthpiece. The commercially available aerosol containing 8.1 or 14.2
g of drug delivers at least 112 or 200 metered sprays, respectively; the canister should be discarded after the labeled number of actuations have been used since the correct drug dose per inhalation cannot be assured if used for additional doses.
Although cromolyn sodium is only minimally absorbed (up to 1%) following oral administration, the absorbed portion undergoes renal and biliary elimination. Severe anaphylactic reactions may occur rarely in patients receiving cromolyn sodium, and the manufacturer states that oral dosage of the drug should be reduced in patients with impaired renal or hepatic function. Dosage reduction of cromolyn sodium given via oral inhalation also should be considered in patients with renal or hepatic impairment.
g of drug delivers at least 112 or 200 metered sprays, respectively; the canister should be discarded after the labeled number of actuations have been used since the correct drug dose per inhalation cannot be assured if used for additional doses.
Although cromolyn sodium is only minimally absorbed (up to 1%) following oral administration, the absorbed portion undergoes renal and biliary elimination. Severe anaphylactic reactions may occur rarely in patients receiving cromolyn sodium, and the manufacturer states that oral dosage of the drug should be reduced in patients with impaired renal or hepatic function. Dosage reduction of cromolyn sodium given via oral inhalation also should be considered in patients with renal or hepatic impairment.
Cromolyn sodium is administered orally and via oral inhalation. The oral concentrate of the drug in ampuls should not be used for oral inhalation therapy nor injected. Proper administration of cromolyn sodium is necessary to obtain optimum results, and it is important that the patient receive careful instruction on the particular dosage form employed.
No dosing information available.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CROMOLYN 20 MG/2 ML NEB SOLN | Maintenance | Adults inhale 2 milliliters (20 mg) by nebulization route 4 times per day |
| CROMOLYN 100 MG/5 ML ORAL CONC | Maintenance | Adults take 200 mg (2 ampules) and squeeze contents into a glass of water and stir by oral route 4 times per day 30 min before meals and at bedtime |
The following drug interaction information is available for CROMOLYN SODIUM (cromolyn sodium):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for CROMOLYN SODIUM (cromolyn sodium):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Disease of liver |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Severe hepatic disease |
| Severe renal impairment |
The following adverse reaction information is available for CROMOLYN SODIUM (cromolyn sodium):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 22 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Pruritus of skin Skin rash Urticaria |
| Rare/Very Rare |
|---|
|
Allergic dermatitis Anaphylaxis Angioedema Arthralgia Arthritis Bronchospastic pulmonary disease Dizziness Dyspnea Dysuria Eosinophilic pneumonia Headache disorder Increased urinary frequency Laryngeal edema Muscle weakness Myalgia Pruritus of skin Severe headache disorder Skin rash Urticaria |
There are 16 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Cough Diarrhea Dry throat Dysgeusia Headache disorder Nasal congestion Nausea Sore throat Xerostomia |
Eye tearing Hoarseness |
| Rare/Very Rare |
|---|
|
Abdominal pain with cramps Insomnia Irritability Myalgia Nausea |
The following precautions are available for CROMOLYN SODIUM (cromolyn sodium):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
In animal studies, cromolyn has produced adverse effects on the fetus (e.g., increased resorption, decreased fetal weight) only in very high parenteral doses. Healthy infants have been born to women who received cromolyn throughout pregnancy; nevertheless, there is insufficient evidence to establish the safety of cromolyn in pregnancy. Cromolyn sodium should be used during pregnancy only when clearly needed.
Since it is not known if cromolyn is distributed into milk in humans, the drug should be used with caution in nursing women. Clinicians should weigh the potential benefits to the mother against the potential risks to the infant when considering cromolyn sodium therapy in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for CROMOLYN SODIUM (cromolyn sodium):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CROMOLYN SODIUM (cromolyn sodium)'s list of indications:
| Maintenance therapy for asthma | |
| J45 | Asthma |
| J45.2 | Mild intermittent asthma |
| J45.20 | Mild intermittent asthma, uncomplicated |
| J45.3 | Mild persistent asthma |
| J45.30 | Mild persistent asthma, uncomplicated |
| J45.4 | Moderate persistent asthma |
| J45.40 | Moderate persistent asthma, uncomplicated |
| J45.5 | Severe persistent asthma |
| J45.50 | Severe persistent asthma, uncomplicated |
| J45.9 | Other and unspecified asthma |
| J45.90 | Unspecified asthma |
| J45.909 | Unspecified asthma, uncomplicated |
| Systemic mastocytosis | |
| C96.21 | Aggressive systemic mastocytosis |
| D47.02 | Systemic mastocytosis |
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