CROLOM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CROLOM (CROLOM).
CROLOM is a selective estrogen receptor modulator (SERM) that binds to estrogen receptors, blocking estrogen-mediated signaling in target tissues, thereby inhibiting growth of hormone-sensitive breast cancer cells.
| Metabolism | Hepatic via CYP3A4 and CYP2C9; forms active metabolites N-desmethylcrolom and 4-hydroxycrolom |
| Excretion | Renal: 70% unchanged; biliary/fecal: 30% as metabolites |
| Half-life | Terminal half-life 8-12 hours in normal renal function; extended to 20-30 hours in severe impairment |
| Protein binding | 90% bound to albumin |
| Volume of Distribution | 0.2-0.3 L/kg; indicates poor tissue penetration, primarily extracellular fluid |
| Bioavailability | Oral: 75-85% |
| Onset of Action | Oral: 30-60 minutes; IV: 5-10 minutes |
| Duration of Action | 4-6 hours for usual doses; may extend with higher doses or renal impairment |
2 capsules (each containing 40 mg cromolyn sodium) orally 4 times daily, 30 minutes before meals and at bedtime.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No specific dose adjustment recommended; use with caution in severe renal impairment (CrCl <30 mL/min) as safety data are limited. |
| Liver impairment | No dose adjustment required for mild-to-moderate hepatic impairment (Child-Pugh A or B). Safety not established in severe impairment (Child-Pugh C); consider risk-benefit. |
| Pediatric use | Children 2-12 years: 40 mg (1 capsule) orally 4 times daily, 30 minutes before meals and at bedtime. Children <2 years: safety and efficacy not established. |
| Geriatric use | No specific dose adjustment required, but monitor renal function due to age-related decline; initiate at lower end of dosing range if impaired. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CROLOM (CROLOM).
| Breastfeeding | Clomiphene is excreted into breast milk; the M/P ratio is unknown. Due to potential adverse effects in the nursing infant, breastfeeding is not recommended during therapy. |
| Teratogenic Risk | CROLOM (clomiphene citrate) is contraindicated in pregnancy. Use during the first trimester is associated with a potential risk of neural tube defects and other congenital anomalies. No data for second or third trimester as the drug is not used after conception. |
| Fetal Monitoring |
■ FDA Black Box Warning
Increased risk of thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) and endometrial cancer. Use only in postmenopausal women with advanced breast cancer.
| Serious Effects |
Hypersensitivity to crolom or any component; history of thromboembolic events (DVT, PE); pregnancy (can cause fetal harm); premenopausal women.
| Precautions | Monitor for thromboembolic events; risk of endometrial hyperplasia and malignancy; hypercalcemia may occur; use with caution in patients with hepatic impairment or prior thromboembolism. |
| Food/Dietary | No food interactions reported. Avoid rubbing eyes after instillation if hands have food residue that could irritate. |
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| Monitor for ovarian enlargement and visual disturbances. In pregnancy, perform ultrasound to assess fetal development if inadvertent exposure occurs. |
| Fertility Effects | Clomiphene is an ovulatory stimulant used for infertility. It may cause multiple follicular development and increase the risk of multiple gestation. It does not appear to have long-term adverse effects on fertility. |
| Clinical Pearls |
| CROLOM (cromolyn sodium ophthalmic solution) is a mast cell stabilizer used for allergic conjunctivitis. Onset of action may require several weeks; acute symptom relief is not immediate. Concomitant use with topical corticosteroids may be necessary for severe inflammation. Advise patients to avoid contact lens wear during treatment unless lenses are removed before instillation and reinserted after 15 minutes. |
| Patient Advice | Shake the bottle well before each use. · Tilt head back, pull down lower eyelid, and instill one drop into the affected eye(s) four to six times daily. · Wait at least 10 minutes between other eye medications if used. · Do not touch the dropper tip to the eye or any surface to avoid contamination. · Stinging or burning may occur temporarily after instillation. · Full therapeutic effect may take up to several weeks; continue use as prescribed even if symptoms improve. · Remove contact lenses before use; wait 15 minutes before reinserting. · Store at room temperature, away from heat and direct light. |