Oratane Use In Pregnancy & Lactation

Oratane should NEVER be used by pregnant women or by women who intend to become pregnant, during or for one month after, their Oratane treatment.
All possibility of pregnancy must be ruled out before the patient starts Oratane treatment. Strict birth control methods should be used for one month before starting Oratane, during the whole Oratane treatment and for one month after the patient stops taking Oratane.
One month after finishing Oratane, the patient can resume the normal practices.
Further information about Oratane and birth defects can be found as follows.
There is no known risk to males who wish to father children.
If the patient is female, it is extremely important that the patient reads and understands the information in this section.
Pregnancy Prevention: Even if the patient is not sexually active it is important to understand the effects that Oratane can have on the unborn child should the patient become pregnant while taking Oratane.
The medication in Oratane, isotretinoin, is teratogenic. This means that it can cause birth defects, that is, the unborn child can become deformed.
Birth defects can only be caused by Oratane if the patient uses it while pregnant, becomes pregnant while using Oratane or becomes pregnant within one month of stopping taking Oratane.
A pregnancy test may be given to the patient to ensure that patient is not pregnant before allowing to start taking Oratane. Should the patient become pregnant while taking Oratane or within one month after the end of Oratane treatment, advise the patient the need to discuss the action that may need to be taken with the doctor. This is a very serious situation.
For this reason, it is vitally important to advise the patient to follow strict birth control procedures.
All women of child bearing potential should be careful. This means any woman or girl, who is taking Oratane, who has started menstruating needs to follow a strict birth control procedure.
Before the patient can begin taking Oratane the patient may be required to take a pregnancy test.
The patient MUST use strict birth control for at least one month before starting Oratane treatment, during the entire Oratane treatment and for at least one month after stopping Oratane.
The patient should wait until the 2nd or 3rd day of the next menstrual period before starting Oratane. This is an extra check to make sure the patient is not pregnant.
If the patient does become pregnant while taking Oratane, the patient should immediately stop taking Oratane and advise the patient to inform the doctor straight away.
Oratane does not affect the fertility in the long term. So even after taking Oratane the patient can be able to become pregnant in the future.
The patient is responsible for making sure that she doesn't get pregnant. The only person who can make sure that she does not get pregnant while taking Oratane. It is relatively easy to prevent pregnancy. The details of the recommended strict birth control procedure are explained as follows.
Before the patient begins taking Oratane, the risks associated with Oratane and pregnancy should be gone through. A Consent form may be asked to sign. Signing this form means that the patient understands these risks and that will do everything possible to make sure not to become pregnant while taking Oratane or for one month after stopping Oratane.
Strict Birth Control: Strict birth control or contraception means carefully following a procedure to make sure the patient does not become pregnant. The most effective form of birth control or contraception is 'the pill' (oral contraceptive) plus a barrier method (condom or diaphragm). The patient should carefully follow all the directions for the use of these methods of contraception.
More information about contraception should be provided. The patient will need a prescription for 'the pill', which can be provided by the doctor or local family planning clinic.
When to stop being so careful: One month after the end of Oratane treatment the risk of birth defects is no greater than normal.
Should the patient wish to become pregnant, the patient can do so one month after stopping taking Oratane.
Where to get more help and information: For further information about contraception, advise the patient to contact a family doctor or local family planning clinic.