Breast milk is superior in nutrition, It provides resistance against infections and allergies, It is naturally sterile. Despite all the advantages of breastfeeding some mothers choose to pause the breastfeeding in fear of harmful effects of medicines passing in breast milk. Are you wondering about breastfeeding and using Duloxetine | Preferred Pharmaceuticals, Inc. ? Know what is Duloxetine | Preferred Pharmaceuticals, Inc. and how it can affect your breast milk and whether Duloxetine | Preferred Pharmaceuticals, Inc. is safe for your kid or not.
What is Duloxetine | Preferred Pharmaceuticals, Inc. used for?
Duloxetine delayed-release capsules are serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: • Major Depressive Disorder (MDD) (1.1) • Generalized Anxiety Disorder (GAD) (1.2) • Diabetic Peripheral Neuropathic Pain (DPNP) (1.3) • Chronic Musculoskeletal Pain (1.5) 1.1 Major Depressive Disorder Duloxetine delayed-release capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine was established in four short term and one maintenance trial in adults [see CLINICAL STUDIES (14.1) ]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. 1.2 Generalized Anxiety Disorder Duloxetine delayed-release capsules are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine was established in three short-term trials and one maintenance trial in adults [see CLINICAL STUDIES (14.2) ]. Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance. 1.3 Diabetic Peripheral Neuropathic Pain Duloxetine delayed-release capsules are indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy [see CLINICAL STUDIES (14.3) ]. 1.5 Chronic Musculoskeletal Pain Duloxetine delayed-release capsules are indicated for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis [see Clinical Studies (14.5)].
I am currently breastfeeding and I want to know if using Duloxetine | Preferred Pharmaceuticals, Inc. is safe for my kid? Does it have any effect on milk production?
Duloxetine is the only one ingredient used in manufacturing of Duloxetine | Preferred Pharmaceuticals, Inc., Which makes it easier to analyze its effect in breastfeeding. As per our analysis of Duloxetine it is safe to use Duloxetine | Preferred Pharmaceuticals, Inc. while lactating. We suggest you to check further details below about Duloxetine usage in breastfeeding.
Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Duloxetine is excreted into the milk of lactating women. The estimated daily infant dose on a mg/kg basis is approximately 0.14% of the maternal dose. Because the safety of duloxetine in infants is not known, nursing while on duloxetine is not recommended. However, if the physician determines that the benefit of duloxetine therapy for the mother outweighs any potential risk to the infant, no dosage adjustment is required as lactation did not influence duloxetine pharmacokinetics. The disposition of duloxetine was studied in 6 lactating women who were at least 12 weeks postpartum. Duloxetine 40 mg twice daily was given for 3.5 days. Like many other drugs, duloxetine is detected in breast milk, and steady state concentrations in breast milk are about one-fourth those in plasma. The amount of duloxetine in breast milk is approximately 7 mcg/day while on 40 mg BID dosing. The excretion of duloxetine metabolites into breast milk was not examined. Because the safety of duloxetine in infants is not known, nursing while on duloxetine is not recommended [see Dosage and Administration (2.3) ].
Duloxetine | Preferred Pharmaceuticals, Inc. Breastfeeding Analsys
Duloxetine while Breastfeeding Safe
CAS Number: 116539-59-4
It is a reuptake-inhibitor of Serotonin and Norepinephrine. Excreted into breast milk in clinically non-significant amount with no side-effects being observed in breastfed infants from treated mothers. Plasma level in those infants was very low or undetectable. Because there is less experience published than with other antidepressants of the same pharmacological group, it should be preferred the use of an alternative drug that is known to be safer in the neonatal period or prematurity. Galactorrhea has been observed but less frequently than with other antidepressants. Women who use antidepressant medication during pregnancy are in need of more support for breastfeeding since they are at risk for early weaning.
Duloxetine | Preferred Pharmaceuticals, Inc. Breastfeeding Analsys - 2
Duloxetine while Breastfeeding
CAS Number: 116539-58-3
Little published information is available on the use of duloxetine during breastfeeding; however, the dose in milk is low and serum levels were low in two breastfed infants. An alternate drug that has been better studied may be preferred, especially while nursing a newborn or preterm infant. If duloxetine is required by the mother, it is not a reason to discontinue breastfeeding. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of psychotropic drugs. Galactorrhea has been reported in women taking duloxetine.
What if I already have used Duloxetine | Preferred Pharmaceuticals, Inc.?
Duloxetine | Preferred Pharmaceuticals, Inc. is safe in breastfeeding and should not create any health problem for your baby but in case you feel any health issue associated with Duloxetine | Preferred Pharmaceuticals, Inc. you should contact your doctor or health care provider. Be it pregnancy or lactation you shall keep your doctor informed.
My health care provider has asked me to use Duloxetine | Preferred Pharmaceuticals, Inc., what to do?
Definitely, Duloxetine | Preferred Pharmaceuticals, Inc. is safe in lactation for baby. No wonder your doctor has recommended it.
If I am using Duloxetine | Preferred Pharmaceuticals, Inc., will my baby need extra monitoring?
No extra baby monitoring required while mother is using Duloxetine | Preferred Pharmaceuticals, Inc.
Who can I talk to if I have questions about usage of Duloxetine | Preferred Pharmaceuticals, Inc. in breastfeeding?
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday
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
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week