Forair 125/Forair 250

Forair 125/Forair 250 Use In Pregnancy & Lactation

salmeterol + fluticasone

Manufacturer:

Cadila Healthcare

Distributor:

Metro Drug

Marketer:

Zydus Healthcare Phils
Full Prescribing Info
Use In Pregnancy & Lactation
Use in Pregnancy: Fertility: Fluticasone: No evidence of impairment of fertility was seen in studies done on male and female rats at subcutaneous doses up to 50 mcg/kg (less than the maximum recommended daily inhalation dose in adults on a mcg/m2 basis). Prostate weight was significantly reduced at a subcutaneous dose of 50 mcg/kg.
Salmeterol: No effects on fertility were found in male and female rats treated with Salmeterol at oral doses up to 2 mg/kg (approximately 180 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis).
Fluticasone and Salmeterol combination: No evidence of enhanced toxicity was seen in studies done using the combination of Fluticasone and Salmeterol as compared to the use of the drugs individually. In mice, the combination of 150 mcg/kg subcutaneously of Fluticasone (less than the maximum recommended daily inhalation dose in adults on a mg per m2 basis) with 10 mg/kg orally of Salmeterol (approximately 450 times the maximum recommended daily inhalation dose in adults on a mg per m2 basis) was teratogenic. Cleft palate, fetal death, increased implantation loss and delayed ossification were seen. These observations are characteristic of glucocorticoids. No developmental toxicity was observed at combination doses up to 40 mcg/kg subcutaneously of Fluticasone (less than the maximum recommended daily inhalation dose in adults on a mg per m2 basis) and up to 1.4 mg/kg orally of Salmeterol (approximately 65 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis).
In rats, there was no teratogenicity observed at combination doses up to 30 mcg/kg subcutaneously of Fluticasone (less than the maximum recommended daily inhalation dose in adults on a mg per m2 basis) and up to 1 mg/kg of Salmeterol (approximately 90 times the MRD inhalation dose in adults on a mcg/m2 basis). Combining 100 mcg/kg subcutaneously of Fluticasone (less than the maximum recommended daily inhalation dose in adults on a mg/m2 basis) with 10 mg/kg orally of Salmeterol (approximately 900 times the MRD inhalation dose in adults on a mcg/m2 basis) produced maternal toxicity, decreased placental weight, decreased fetal weight, umbilical hernia, delayed ossification, and changes in the occipital bone.
There are no adequate and well controlled studies of the combination of Fluticasone and Salmeterol in pregnant women. It should be used during pregnancy only when the potential benefit justifies the potential risk to the fetus.
Pregnancy Category C: Fluticasone: Studies in mice and rats at subcutaneous doses of Fluticasone at 45 and 100 mcg/kg, respectively (less than or equivalent to the MRD inhalation dose in adults on a mcg/m2 basis) found fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification. Studies in rabbits at subcutaneous doses of 4 mcg/kg (less than the MRD inhalation dose in adults on a mcg/m2 basis) found fetal weight reduction and cleft palate. However, no teratogenic effects were reported at oral doses of up to 300 mcg/kg (approximately 5 times the MRD inhalation dose in adults on a mcg/m2 basis); in addition, no Fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration.
Fluticasone propionate crosses the placenta following a subcutaneous dose of 100 mcg /kg to mice (less than the MRD inhalation dose in adults on a mcg/m2 basis); subcutaneous or oral administration of 100 mcg/kg to rats (approximately equivalent to the MRD in adults on a mcg/m2 basis) or 300 mcg/kg to rabbits (approximately 5 times the MRD inhalation dose in adults on a mcg/m2 basis).
Experience suggests that rodents are more susceptible to the teratogenic effects of pharmacologic doses of oral glucocorticoids than are humans. Additionally, because production of glucocorticoids increases naturally during pregnancy, most women will require a lower
exogenous glucocorticoids dose and many may not need glucocorticoids treatment during pregnancy.
Pregnancy Category C: Salmeterol: Rats given oral doses of 2 mg/kg of Salmeterol (approximately 180 times the maximum recommended daily inhalation dose (MRD) in adults on a mg/m2 basis) experienced no teratogenic effects. In pregnant Dutch rabbits given oral doses of 1 mg per kg and above (approximately 50 times the MRD based on the comparison of the AUCs) toxic effects were shown in the fetus. The developed effects were considered to be characteristic of beta-adrenergic stimulation (i.e., precocious eyelid openings, cleft palate, sternebral fusion, limb and paw flexures, and delayed ossification of the frontal cranial bones). No significant effects occurred at 20 times the recommended human clinical dose based on AUC comparisons. New Zealand white rabbits were less sensitive, and the exposure to oral doses of 10 mg/kg (approximately 1800 times the recommended human clinical dose based on mg/m2 basis) produced only delayed ossification of frontal bones.
Salmeterol crossed the placenta following oral administration of 10 mg/kg to mice and rats (approximately 450 and 900 times, respectively, the recommended human clinical dose based on mg/m2 basis).
Use in Lactation: Labor and delivery: There are no well controlled human studies that have investigated the effects of the combination of Fluticasone and Salmeterol on pre-term labor or labor at term. Because of the potential for beta-agonist interference with uterine contractility, the use of the drug for management of asthma during labor should be restricted to those patients in whom the benefit clearly outweighs the risk.
Breast-feeding: It is not known whether the combination of Fluticasone and Salmeterol is distributed into breast milk. Caution should be used when administering to nursing women.
Fluticasone: It is not known whether Fluticasone is distributed into breast milk, however other corticosteroids have been detected in human milk. After subcutaneous administration of triturated Fluticasone at a 10 mcg per kg dose (less than the maximum recommended daily inhalation dose in adults on a mg per m2 basis) to lactating rats resulted in measurable radioactivity in milk.
Salmeterol: It is not known whether Salmeterol is distributed into breast milk, however Salmeterol Xinafoate is distributed in rat's milk.
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