Prozac | Fluoxetine Hydrochloride Capsule while Breastfeeding

Do you know that important immune protective proteins are present in breast milk? Breast milk also contains required vitamins, minerals, saturated and un saturated fats. These things are extremely important for development of healthy brain. If you are taking any medicine for short term or for the chronic reason then that passes in breast milk as well, that is why you should always check the drug with your health care provider. Here at DrLact we try to analyze drugs based on available researches and in this sheet we will present our analysis for Prozac | Fluoxetine Hydrochloride Capsule.

What is Prozac | Fluoxetine Hydrochloride Capsule used for?


PROZAC® is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2) Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) PROZAC and olanzapine in combination for: Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1.5) Acute treatment of Treatment Resistant Depression in adults (Major Depressive Disorder in adult patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) (1.6) 1.1 Major Depressive Disorder PROZAC® is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)]. The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated [see Dosage and Administration (2.1)]. 1.2 Obsessive Compulsive Disorder PROZAC is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. The effectiveness of PROZAC in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use PROZAC for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)]. 1.3 Bulimia Nervosa PROZAC is indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. The physician who elects to use PROZAC for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)]. 1.4 Panic Disorder PROZAC is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)]. The effectiveness of PROZAC in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use PROZAC for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.4)]. 1.5 PROZAC and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder When using PROZAC and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®. PROZAC and olanzapine in combination is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder in adult patients. PROZAC monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. 1.6 PROZAC and Olanzapine in Combination: Treatment Resistant Depression When using PROZAC and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax. PROZAC and olanzapine in combination is indicated for the acute treatment of treatment resistant depression (Major Depressive Disorder in adult patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). PROZAC monotherapy is not indicated for the treatment of treatment resistant depression.

What are the risk associated with Prozac | Fluoxetine Hydrochloride Capsule usage while breastfeeding? What precautions shall I take while using it in breastfeeding?

Prozac | Fluoxetine Hydrochloride Capsule low risk for breastfeeding
Prozac | Fluoxetine Hydrochloride Capsule contains only one active ingredient that is Fluoxetine. We have analyzed the usage of Fluoxetine in breastfeeding and our analysis suggest that Fluoxetine poses Low risk for infant while breastfeeding and hence Prozac | Fluoxetine Hydrochloride Capsule itself shall be considered Low risk item for breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Because PROZAC is excreted in human milk, nursing while on PROZAC is not recommended. In one breast-milk sample, the concentration of fluoxetine plus norfluoxetine was 70.4 ng/mL. The concentration in the mother's plasma was 295.0 ng/mL. No adverse effects on the infant were reported. In another case, an infant nursed by a mother on PROZAC developed crying, sleep disturbance, vomiting, and watery stools. The infant's plasma drug levels were 340 ng/mL of fluoxetine and 208 ng/mL of norfluoxetine on the second day of feeding.

Prozac | Fluoxetine Hydrochloride Capsule Breastfeeding Analsys


Fluoxetine while Breastfeeding

Low Risk

CAS Number: 54910-89-3

Higher excretion into breast milk than other related antidepressant drugs. The active metabolite called Norfluoxetine has a longer half-life (4 to 16 days). Like other antidepressant drugs may induce hyperprolactinemia and galactorrhea. Few cases of colicky pain, irritability, insomnia, anorexia and slow weight gain have been described. However, most reported cases have failed to show harm effect outside the newborn period. Large experience with the use of Fluoxatine did not find harm effect on weight gain and neurological development of infants either at short or long term. Most problems have appeared in the early neonatal period either in newborns or premature infants whose mothers were on Fluoxetine during pregnancy. Stop or switch to other medication either at some days before delivery or in the first month postpartum would be recommended. Same considerations should be done in case of prematurity, however, medication must be continued if necessary. Women on anti-depressant treatment are in need of stronger support because of higher risk of breastfeeding failure.


Prozac | Fluoxetine Hydrochloride Capsule Breastfeeding Analsys - 2


Fluoxetine while Breastfeeding

CAS Number: 54910-89-3

Prozac | Fluoxetine Hydrochloride Capsule and breastfeeding

The average amount of drug in breastmilk is higher with fluoxetine than with most other SSRIs and the long-acting, active metabolite, norfluoxetine, is detectable in the serum of most breastfed infants during the first 2 months postpartum and in a few thereafter. Adverse effects such as colic, fussiness, and drowsiness have been reported in some breastfed infants. Decreased infant weight gain was found in one study, but not in others. No adverse effects on development have been found in a few infants followed for up to a year. If fluoxetine is required by the mother, it is not a reason to discontinue breastfeeding. If the mother was taking fluoxetine during pregnancy or if other antidepressants have been ineffective, most experts recommend against changing medications during breastfeeding. Otherwise, agents with lower excretion into breastmilk may be preferred, especially while nursing a newborn or preterm infant. The breastfed infant should be monitored for behavioral side effects such as colic, fussiness or sedation and for adequate weight gain. Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding, although this might be a reflection of their disease state.[1] These mothers may need additional breastfeeding support. Breastfed infants exposed to an SSRI during the third trimester of pregnancy have a lower risk of poor neonatal adaptation than formula-fed infants.


Prozac | Fluoxetine Hydrochloride Capsule safe for breastfeeding

I already used Prozac | Fluoxetine Hydrochloride Capsule and meanwhile I breastfed my baby should I be concerned?

During whole lactation period you shall first discuss with your doctor and then together you shall decide whether you shall take that drug or not however if you have already taken Prozac | Fluoxetine Hydrochloride Capsule then you shall inform your doctor, But you should not be worried too much as Prozac | Fluoxetine Hydrochloride Capsule comes in category of low risk drug.


My health care provider has asked me to use Prozac | Fluoxetine Hydrochloride Capsule, what to do?

Prozac | Fluoxetine Hydrochloride Capsule comes in category of low risk and if your doctor is aware that you are breastfeeding it should be ok to use without much concerns.


If I am using Prozac | Fluoxetine Hydrochloride Capsule, will my baby need extra monitoring?

Not much


Who can I talk to if I have questions about usage of Prozac | Fluoxetine Hydrochloride Capsule in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week