8 Interactions found for:

The following applies to the ingredients: Albuterol

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned

Comments:
-There are no randomized clinical studies of albuterol use during pregnancy, but available information on pregnancy exposure by inhalation do not consistently show miscarriage or major birth defects.
-This drug is known to cross the placental barrier, as evidenced by increases in fetal heart rate.
-Beta-agonists, including this drug, may potentially interfere with uterine contractility.
-In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and the dose adjusted as necessary to maintain optimal control.
-In some countries, intravenous injection presentations of this drug have been approved for delay pre-term labor (tocolytic agent) and should not be used in the management of uncomplicated premature labor.

Epidemiological studies and postmarketing case reports following inhaled administration of this drug do not consistently demonstrate a risk of major birth defects or miscarriage. In animal reproduction studies, subcutaneous administration to pregnant mice evidence of cleft palate at less than and up to 9 times the maximum recommended human daily inhalation dose (MRHDID). A study in pregnant rats demonstrated that drug-related material was transferred from the maternal circulation to the fetus. There are no controlled data in human pregnancy.
During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with this drug. Some of the mothers were taking multiple medications during their pregnancies. A relationship between the use of this drug and congenital anomalies has not been established. Profuse uterine bleeding following spontaneous abortion has been reported after the use of this drug. Special care is required in pregnant diabetic women. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

A pregnancy exposure registry monitors outcomes after exposure to asthma medications during pregnancy. For more information, contact the Mothers To Baby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at http://mothertobaby.org/pregnancystudies/.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Fluticasone (found in Advair Diskus)

Use is not recommended unless the benefit outweighs the risk to the fetus

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-Pregnant women with asthma should be closely monitored to maintain optimal asthma control.
-Hypoadrenalism may occur in neonates exposed to glucocorticosteroids in utero; carefully observe neonates for signs and symptoms of hypoadrenalism.
-There is insufficient data on use in pregnancy.

Animal studies have shown teratogenicity typical of corticosteroids (decreased fetal body weight and/or skeletal variations) with subcutaneously administered doses of this drug. Rats dosed via inhalation have shown decreased fetal body weight, but teratogenicity was not observed. Epidemiologic data of other inhaled corticosteroids have not demonstrated these effects in animals to occur in humans. Women with poorly or moderately controlled asthma have shown an increased risk of pre-eclampsia, and there has been an increased incidence of prematurity, low birth weight, and small for gestational age events observed in their babies. There are no adequate and well controlled studies in pregnant women. Fluticasone was detected in neonatal cord blood after drug inhalation by the parent.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Salmeterol (found in Advair Diskus)

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-Available data from studies and case reports have not found a drug-associated increase in major birth defects, miscarriage, or adverse fetal or maternal outcomes.
-There are clinical considerations for asthma during pregnancy; poorly or moderately controlled asthma is associated with pre-eclampsia, prematurity, low birth weight, and small for gestational age infants.
-Severe asthma is associated with maternal mortality, fetal mortality, or both.
-Closely monitor pregnant patients and adjust medications to optimize asthma control.
-Beta-agonists, including this drug, may potentially interfere with uterine contractility due to a relaxant effect on uterine smooth muscle; use this drug during labor only if benefits clearly outweigh the risks.

Animal studies of oral doses approximately 50 times the maximum recommended human daily inhalation dose (MRHDID) caused teratogenicity characteristic of beta-adrenoreceptor stimulation, including precocious eyelid openings, cleft palate, sternebral fusion, limb and paw flexures, and delayed ossification of frontal cranial bones; no such effects occurred at oral doses 20 times the MRHDID. Doses 973 times the MRHDID was fetotoxic and decreased fertility in survivors. This drug crossed the placenta following oral administration to rodents. Published data in humans do not definitively establish absence of risk, but have not established an association with major birth defects, miscarriage, or adverse fetal or maternal outcomes. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Fluticasone-Salmeterol (found in Advair Diskus)

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk Summary:
-There are no randomized clinical studies of this combination drug or individual monoproducts in pregnant women.
-Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control.

Comments:
-Patients should contact their physician if pregnancy occurs while taking this drug.
-If needed, the lowest effective dose of this drug should be used.
-Closely monitor pregnant patients and adjust medications to optimize asthma control.
-There are no human studies of the effects of this drug on labor and delivery.
-Beta-agonists may interfere with uterine contractility.

Corticosteroids and beta2-agonists have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. In mouse reproduction assays, fluticasone propionate by the subcutaneous route at a dose approximately 3/5 the maximum recommended human daily inhalation dose (MRHDID) combined with oral salmeterol at a dose approximately 410 times the MRHDID produced cleft palate, fetal death, increased implantation loss, and delayed ossification. These observations are characteristic of glucocorticoids. No developmental toxicity was observed at combination doses of fluticasone propionate subcutaneously up to approximately 1/6 the MRHDID and doses of salmeterol up to approximately 55 times the MRHDID. In rats, combining fluticasone propionate subcutaneously at a dose equivalent to the MRHDID and a dose of salmeterol at approximately 810 times the MRHDID produced decreased fetal weight, umbilical hernia, delayed ossification, and changes in the occipital bone. These effects were not seen when combining fluticasone propionate subcutaneously at a dose less than the MRHDID and an oral dose of salmeterol at approximately 80 times the MRHDID. There are no controlled data in human pregnancy.

Fluticasone Propionate and Salmeterol:
The combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol during the period of organogenesis, in rats and mice were generally consistent with the individual monoproducts and there was no exacerbation of expected fetal effects. Omphalocele, increased embryofetal deaths, decreased body weight, and skeletal variations were observed in rat fetuses in the presence of maternal toxicity when combining fluticasone propionate at a dose approximately equivalent to the MRHDID and salmeterol at a dose approximately 970 times the MRHDID. Cleft palate, fetal death, increased implantation loss, and delayed ossification were observed in mouse fetuses when combining fluticasone propionate at a dose approximately 0.7 times the MRHDID and salmeterol at a dose approximately 490 times the MRHDID.

Salmeterol xinafoate crossed the placenta following oral administration to mice and rats.

Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. It was not associated with decreases in pup body weight, and had no effects on developmental landmarks, learning, memory, reflexes, or fertility at doses up to 0.5 times the MRHDID.

Data Human Data:
Fluticasone Propionate: Following inhaled administration, fluticasone propionate was detected in the neonatal cord blood after delivery.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Albuterol

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

The following applies to the ingredients: Fluticasone-Salmeterol (found in Advair Diskus)

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and any potential adverse effects on the breastfed child.

Excreted into human milk: Unknown (fluticasone-salmeterol)
Excreted into animal milk: Yes (fluticasone-salmeterol)

Comments: The effects in the nursing infant are unknown.

Fluticasone-salmeterol:
After inhaled therapeutic doses, plasma levels are low and therefore concentrations in human breast milk are likely to be correspondingly low.

Salmeterol:
Oral administration of salmeterol in lactating rats at 10,000 mcg/kg/day (approximately 973 times the MRHDID for adults) resulted in measurable levels in milk.

Fluticasone:
Subcutaneous administration of 10 mcg/kg/day to lactating rats of tritiated fluticasone propionate resulted in measurable radioactivity in the milk.

There are no controlled data on the use of this drug by nursing mothers.

The following applies to the ingredients: Fluticasone (found in Advair Diskus)

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comment: Inhaled corticosteroids are generally considered acceptable to use during breastfeeding as the amount, if excreted into breastmilk, would probably be too small to affect a breastfed infant.

Measurable milk levels were seen after subcutaneous administration of 10 mcg/kg/day of titrated fluticasone propionate to lactating rats.

The following applies to the ingredients: Salmeterol (found in Advair Diskus)

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Drug concentrations in human plasma after inhalation are low; concentrations in breast milk are expected to be low.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

Animal studies of oral doses of 10,000 mg/kg/day salmeterol showed measurable levels in the milk.