Aminophylline is a medication used to treat asthma, COPD, and other lung diseases. It is not recommended for use during pregnancy unless the potential benefits to the mother outweigh the risks to the unborn child. The FDA categorizes aminophylline as a Category C drug, indicating that animal studies have shown some babies born with problems, but no well-controlled studies have been conducted on humans. The manufacturer makes no recommendation regarding its use during pregnancy, and it is advised to consult a doctor for a recommended gestational management programme.
Characteristics | Values |
---|---|
FDA Pregnancy Category | C |
Animal Studies | Embryotoxicity without maternal toxicity was seen at 220 mg/kg |
Controlled Human Data | No |
Placenta Transfer | Yes |
Excretion in Breast Milk | Yes |
Use During Pregnancy | Only if the benefit outweighs the potential risk to the unborn baby |
What You'll Learn
- Aminophylline is not recommended for intravenous use during pregnancy
- Theophylline, an ingredient in aminophylline, is excreted in breast milk
- Animal studies show aminophylline caused embryotoxicity without maternal toxicity
- The FDA categorises aminophylline as a 'category C' medication
- Aminophylline may be used to treat breathing problems in premature infants
Aminophylline is not recommended for intravenous use during pregnancy
Aminophylline is a medication used to treat asthma, COPD, and other lung diseases. It is not recommended for intravenous use during pregnancy unless the patient requires hospitalisation.
The FDA categorises medications based on safety for use during pregnancy, and aminophylline falls into category C. This means that in animal studies, some babies were born with problems when the medication was administered. However, no well-controlled studies have been conducted on humans. Therefore, the potential benefits to the mother must outweigh the potential risks to the unborn child for this medication to be used during pregnancy.
Aminophylline pharmacokinetics may be altered by pregnancy, and the drug freely passes across the placenta. Embryotoxicity without maternal toxicity was observed in rodent studies at 220 mg/kg, but animal studies in non-rodent species have not been performed. There are no controlled data in human pregnancy.
Theophylline, a component of aminophylline, has been associated with cardiovascular anomalies in newborns when exposed prenatally. It is recommended to consult a doctor and obtain informed consent for the recommended gestational management programme before administering aminophylline intravenously to a pregnant patient.
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Theophylline, an ingredient in aminophylline, is excreted in breast milk
Aminophylline is a drug used to treat mild to severe asthma. It is a salt of theophylline, which is the active drug found in maternal serum and breast milk after aminophylline ingestion. Theophylline is excreted in breast milk and may cause irritability or other mild toxicities in nursing infants. Serious toxicity is only expected at toxic serum concentrations.
The concentration of theophylline is about the same in breast milk as in serum. Peak milk levels occur 1 to 3 hours after oral ingestion of immediate-release products and almost immediately after intravenous administration. Milk levels closely parallel serum levels and average about 70% of simultaneous maternal serum levels. Assuming a maternal weight-adjusted dosage of theophylline, an exclusively breastfed infant would receive about 21% of the dosage, or 17% of the maternal dosage of aminophylline.
Maternal theophylline use may occasionally cause stimulation, irritability, and fretful sleep in infants. Newborns and especially preterm infants are most likely to be affected because of their slow elimination and low serum protein binding of theophylline. There is no need to avoid theophylline products; however, it is recommended to keep maternal serum concentrations in the lower part of the therapeutic range and monitor the infant for signs of theophylline side effects. Infant serum theophylline concentrations can help determine if signs of agitation are due to theophylline.
To decrease the dose received by the breastfed infant, avoid breastfeeding for 2 hours after intravenous or 4 hours after an immediate-release oral aminophylline product. When theophylline is given as an oral sustained-release product, the timing of nursing with respect to the dose is of little or no benefit.
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Animal studies show aminophylline caused embryotoxicity without maternal toxicity
Animal studies have shown that aminophylline can cause embryotoxicity without maternal toxicity. In rodent studies, aminophylline was found to cause embryotoxicity at 220 mg/kg, although there was no maternal toxicity. These studies also showed no teratogenicity at doses up to three times the recommended human dose.
The effects of aminophylline on pregnancy have been studied in rodents, but similar studies have not been performed on non-rodent species. While these studies provide valuable information, it is important to note that animal studies may not always accurately predict the effects of a drug on human pregnancy.
Aminophylline is considered safe for use during pregnancy when the potential benefits outweigh the risks. However, there are no controlled data on the use of aminophylline in human pregnancy, and the manufacturer makes no recommendation regarding its use during pregnancy. It is important for pregnant women to consult with their healthcare providers before taking aminophylline or any other medication during pregnancy.
In terms of breastfeeding, aminophylline is excreted into human milk and may cause mild toxicities in nursing infants, such as irritability. Serious toxicity is only expected at toxic serum concentrations. Again, it is important for breastfeeding women to seek medical advice before taking aminophylline.
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The FDA categorises aminophylline as a 'category C' medication
Aminophylline is a bronchodilator used to treat the symptoms of asthma, bronchitis, and emphysema. It is also used to treat breathing problems in premature infants. The drug is FDA-approved to treat reversible airway obstruction due to asthma or other chronic lung diseases.
The FDA categorises aminophylline as a category C medication. This means that it is not known whether aminophylline will harm an unborn baby. The manufacturer makes no recommendation regarding its use during pregnancy. The drug passes freely across the placenta and is present in breast milk. Therefore, consistent monitoring and dose adjustment can help prevent adverse effects in this population.
Rodent studies did not show teratogenicity at doses up to three times the recommended human dose, but embryotoxicity without maternal toxicity was seen at 220 mg/kg. Animal studies in non-rodent species have not been performed. Theophylline, which is present in aminophylline, passes freely across the placenta and can cause irritability or other mild toxicities in nursing infants.
The US FDA has amended the pregnancy labelling rule for prescription drug products to require labelling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help healthcare 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.
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Aminophylline may be used to treat breathing problems in premature infants
Aminophylline is a drug that can be used to treat breathing problems in premature infants. It is often used to treat apnea of prematurity, which occurs when a baby stops breathing, causing a drop in heart rate and oxygen levels in the blood. This condition is common in babies born before 28 weeks of gestation and usually occurs a few days after birth.
Aminophylline is a medication that stimulates the baby's immature respiratory system, reducing the number of apnea episodes. It can be administered as a loading dose, followed by regular maintenance doses. Studies have shown that aminophylline is effective in reducing the incidence of apnea in premature infants, with a greater preventative effect in more extreme prematurity cases. However, it is not generally recommended for pregnant women unless hospitalisation is required.
While aminophylline can be beneficial for premature infants, it is important to carefully monitor and manage its use. In some cases, it may be necessary to use a ventilator or provide long-term therapy until the infant's nervous system matures.
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Frequently asked questions
The FDA categorizes medications based on safety for use during pregnancy. Aminophylline falls into category C, which means that in animal studies, some babies were born with problems. However, no well-controlled studies have been done on humans. Therefore, aminophylline may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
Aminophylline is used to treat wheezing, shortness of breath, and difficulty breathing caused by asthma, chronic bronchitis, emphysema, and other lung diseases. It relaxes and opens the airways in the lungs, making it easier to breathe.
You should tell your doctor immediately if you become pregnant while taking aminophylline.