Duloxetine Hydrochloride 20 Mg | Duloxetine Capsule, Delayed Release while Breastfeeding

There are high number of clear evidence that breastfeeding provides best nutrition that you can give to your baby. It is also evident that lactation is good for mothers health as well. Evolution has designed breastfeeding in a way that it caters all nutritional need of your child. However modern medicine is quite new for evolution, that is why mothers body is not well prepared to filter unnecessary chemical found in medicines. It becomes a necessity to figure out which drug is safe and which drug is dangerous for your newborn while nursing. In this article we will understand function of Duloxetine Hydrochloride 20 Mg | Duloxetine Capsule, Delayed Release and its suitability with breastfeeding.

Duloxetine delayed-release capsuleis a 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 delayed-release capsules were 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 delayed-release capsules were 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 capsule is 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)].

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 delayed-release capsules 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 delayed-release capsules is not recommended [see Dosage and Administration (2.3)].