Fluoxetine Hydrochloride Capsule Breastfeeding

For most of the drugs advantages of taking medications overweighs the potential risks however some drugs could be really dangerous for breastfed baby hence every medication shall be considered separately. In this page we will discuss about purpose of Fluoxetine Hydrochloride Capsule and its risk associated with lactation. We will also discuss the usage of Fluoxetine Hydrochloride Capsule and some common side effects associated with Fluoxetine Hydrochloride Capsule.

What is Fluoxetine Hydrochloride Capsule used for?


Fluoxetine capsules are 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) Fluoxetine capsules and olanzapine in combination for: Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1.5) 1.1 Major Depressive Disorder Fluoxetine capsules are 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 Fluoxetine capsules are 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 fluoxetine capsules 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 fluoxetine capsules 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 Fluoxetine capsules are 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 fluoxetine capsules 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 Fluoxetine capsules are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4) ]. The effectiveness of fluoxetine capsules 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 fluoxetine capsules 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 Fluoxetine Capsules and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®. Fluoxetine capsules and olanzapine in combination are indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder in adult patients. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.

Fluoxetine Hydrochloride Capsule while breastfeeding safe or not? Can there be any side effects for infant while using it during breastfeeding?

Fluoxetine Hydrochloride Capsule low risk for breastfeeding
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 Fluoxetine Hydrochloride Capsule itself shall be considered Low risk item for breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Because fluoxetine is excreted in human milk, nursing while on fluoxetine 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 ng/mL. No adverse effects on the infant were reported. In another case, an infant nursed by a mother on fluoxetine 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.

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.


Fluoxetine Hydrochloride Capsule Breastfeeding Analsys - 2


Fluoxetine while Breastfeeding

CAS Number: 54910-89-3

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.



What should I do if I am breastfeeding mother and I am already exposed to Fluoxetine Hydrochloride Capsule?

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 Fluoxetine Hydrochloride Capsule then you shall inform your doctor, But you should not be worried too much as Fluoxetine Hydrochloride Capsule comes in category of low risk drug.


I am nursing mother and my doctor has suggested me to use Fluoxetine Hydrochloride Capsule, is it safe?

Though Fluoxetine Hydrochloride Capsule dose not comes in category of safe drugs rather it comes in category of low risk but if your doctor is aware that you are breastfeeding your baby and has still recommended it then its advantages must be outweighing the risks.


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

Not much


Who can I talk to if I have questions about usage of 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