Drug Information
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Buprenorphine (Subutex ), has been available in Australia since 2000 as an alternative drug therapy to methadone for the treatment of opiate dependence.
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The safety of buprenorphine during pregnancy and breastfeeding remains uncertain at this stage. This is because there is currently a lack of research to demonstrate the safety of this medication in pregnancy. Research, however, is continuing. Methadone maintenance remains the treatment of choice for pregnant and breastfeeding women because it is considered the safest option.
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Women who conceive whilst on buprenorphine treatment are currently advised to transfer to methadone maintenance.
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Effects on pregnancy
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Safety in human pregnancy has not been established.
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If you are pregnant and using buprenorphine, you need to discuss the options for ongoing treatment with your doctor. Your doctor will generally advise you to transfer to methadone treatment.
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If, after a full explanation and consideration of the risks of ongoing treatment with buprenorphine, you and your doctor decide that you will continue this treatment, you are required to provide informed consent.
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Buprenorphine does not appear to be associated with birth abnormalities.
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Counselling in pregnancy
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Counselling and support can assist you in making an informed decision about your treatment options as well as exploring your illicit drug use, lifestyle issues and parental responsibilities.
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Pregnancy Care
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Pregnancy care is important to ensure you are healthy and your baby is growing well. This will involve regular visits to your midwife or doctor to meet your individual requirements which will vary during the different stages of your pregnancy. Routine investigations such as blood tests, ultrasounds and a sexual health screen will be included in your care.
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Your dose of buprenorphine may need to be increased during your pregnancy, especially in the later months. This is due to several factors including:
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- increased volume of fluid in your body
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- increased metabolism by the placenta and fetus
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- increased excretion by your kidneys.
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It is important that you do not miss a dose of buprenorphine. If you are vomit following your dose of buprenorphine you should contact your pharmacist. You are encouraged to have your buprenorphine as a daily dose, not 2nd daily dose.
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Nausea, vomiting and constipation commonly occur in pregnancy. Speak with your midwife or doctor - they may refer you to a dietitian. Healthy Pregnancy Hints (.pdf) is a brochure available for you to download and print.
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You may need dietary supplements such as iron, multivitamins and calcium throughout your pregnancy. All women should take folate before conceiving and for at least the first three months of their pregnancy.
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Eating well during pregnancy and while you are breastfeeding is important for the health of you and your baby. Eating Well & Pregnancy (.pdf) is a brochure available for you to download and print.
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Breastfeeding
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There is a lack of clinical evidence about the safety of breastfeeding for women who continue on buprenorphine after giving birth. You should consider the potential benefits and risks of breastfeeding your baby. Speak with your midwife or doctor to assist you in deciding about breastfeeding your baby.
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Although buprenorphine is found in breast milk, your baby is exposed to a proportionally less active ingredient than you are.
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It is advised that you wean your baby slowly with the advice from your maternal and child health nurse (MCHN).
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Ideally a developmental assessment of all babies exposed to buprenorphine during pregnancy and through breast milk should occur when they are 2 years old.
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Infant Development
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With the exception of alcohol, it is very difficult to prove that drug use in pregnancy results in any permanent long term behavioral or learning problems in children as they grow up.
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Most research suggests that if a child is raised in a caring and supportive family environment, they will do as well at school as any other child in similiar circumstances. However, alcohol consumption during pregnancy is a very different problem. Evidence suggests that regular daily consumption of more than one standard drink per day during pregnancy may result in obvious behavioral and learning problems in childrren that can persist into adult life. The more alcohol that is consumed during pregnancy, the more likely it is that the child will experience significant long term learning and behavioral problems.
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The combined use of alcohol and drugs, particularly cannabis and cocaine, is an especially high risk situation.
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Care of Infant
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Following birth, your baby will be seen by a paediatric doctor to ensure he/she is well.
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If you are on buprenorphine, co-sleeping with your baby is not recommended as drugs and/or alcohol can make you sleep more deeply. You may be less aware of where your baby is in your bed and less responsive to your baby's needs. Please refer to SIDS information below.
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Babies of women who have been regularly using opiates, including buprenorphine, during their pregnancy are at risk of developing a Neonatal Abstinence Syndrome (NAS) or infant withdrawal.
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NAS is a condition which can be treated safely and effectively. It is not possible to reliably predict before birth which babies may develop NAS. NAS does not appear to be related to the mother's dose of buprenorphine.
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Most babies will show some signs of withdrawal. This can vary from mild withdrawal symptoms which can be managed by supportive care (cuddling, quiet environment and using pacifiers) to more marked symptoms which require medication. All babies should remain in hospital for a 7 day period and be observed for signs of NAS.
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For information on assessment and treatment of NAS, see fact sheet on Neonatal Abstinence Syndrome.
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It is important that you provide a smoke free environment for your baby at all times.
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Sudden Infant Death Syndrome (SIDS)
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SIDS is the sudden unexpected death of a baby from no known cause. It is the most common cause of death for infants in Australia between the ages of one and twelve months. The risk of SIDS is greater if you smoke or use drugs and alcohol during pregnancy or after your baby is born.
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For more information, speak with your midwife or doctor or contact SIDS and Kids by phoning, for the cost of a local call, 1300 308 307 or log on to www.sidsandkids.org . Safe Sleeping for your Baby (.pdf) is a brochure developed by the Women's ADS in consultation with other organisations. It is available for you to download and print.
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Other services
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DirectLine is part of Turning Point's statewide telephone service network, providing 24-hour, seven day counselling, information and referral to alcohol and drug treatment and support services throughout Victoria. DirectLine is a free, anonymous and confidential service.
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Phone: 1800 888 236
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