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 Ciclopirox | Actavis Mid Atlantic Llc and its suitability with breastfeeding.
What is Ciclopirox | Actavis Mid Atlantic Llc used for?
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% (Nail Lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. • No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended. • Ciclopirox Topical Solution, 8% (Nail Lacquer), should be used only under medical supervision as described above. • The effectiveness and safety of Ciclopirox Topical Solution, 8% (Nail Lacquer), in the following populations has not been studied. The clinical trials with use of Ciclopirox Topical Solution, 8% (Nail Lacquer), excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded. • The safety and efficacy of using Ciclopirox Topical Solution, 8% (Nail Lacquer), daily for greater than 48 weeks have not been established. Clinical Trials Data: The results of use of Ciclopirox Topical Solution, 8% (Nail Lacquer), in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the US. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) in conjunction with monthly removal of the unattached, infected toenail by the investigator. Ciclopirox Topical Solution, 8% (Nail Lacquer), was applied for 48 weeks. At baseline, patients had 20–65% involvement of the target great toenail plate. Statistical significance was demonstrated in one of two studies for the endpoint “complete cure” (clear nail and negative mycology), and in two studies for the endpoint “almost clear” (≤ 10% nail involvement and negative mycology) at the end of study. These results are presented below. At Week 48 (plus Last Observation Carried Forward) for the Intent-to-Treat (ITT) Population Study 312 Study 313 Active Vehicle Active Vehicle * Clear nail and negative mycology ** ≤10% nail involvement and negative mycology *** Negative KOH and negative culture Complete Cure* 6/110 (5.5%) 1/109 (0.9%) 10/118 (8.5%) 0/117 (0%) Almost Clear** 7/107 (6.5%) 1/108 (0.9%) 14/116 (12%) 1/115 (0.9%) Negative Mycology Alone*** 30/105 (29%) 12/106 (11%) 41/115 (36%) 10/114 (9%) The summary of reported patient outcomes for the ITT population at 12 weeks following the end of treatment are presented below. Note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure. Post-treatment Week 12 Data for Patients Who Achieved Complete Cure at Week 48 Study 312 Study 313 Active Vehicle Active Vehicle *Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry data. Number of Treated Patients 112 111 119 118 Complete Cure at Week 48 6 1 10 0 Post-treatment Week 12 Outcomes: Patients Missing All Week 12 Assessments 2 0 2 0 Patients with Week 12 Assessments 4 1 8 0 Complete Cure 3 1 4 0 Almost Clear 2* 1 1* 0 Negative Mycology 3 1 5 0
What are the risk associated with Ciclopirox | Actavis Mid Atlantic Llc usage while breastfeeding? What precautions shall I take while using it in breastfeeding?
Active ingredient in Ciclopirox | Actavis Mid Atlantic Llc is Ciclopirox and based on our analysis of Ciclopirox it appears that using Ciclopirox | Actavis Mid Atlantic Llc is safe in breastfeeding. Below is analysis of Ciclopirox while breastfeeding.
Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when Ciclopirox Topical Solution, 8% (Nail Lacquer), is administered to a nursing woman.
Ciclopirox | Actavis Mid Atlantic Llc Breastfeeding Analsys
Ciclopirox while Breastfeeding Safe
CAS Number: 29342-05-0
Antifungal agent that is used as a component of creams, gels, suspensions or pessaries. At latest update no published data were found on excretion into breast milk. Less than 5% of the applied dose is absorbed.Because the small dose used and low level achieved in the plasma of most topical dermatological preparations make unlikely the passage of significant amounts into breast milk.Even more, its high plasma protein-binding capacity makes unlikely excretion into milk. Do not apply on the chest to prevent infant ingestion; otherwise, apply it after a feeding and clean thoroughly with water before the next one.
Ciclopirox | Actavis Mid Atlantic Llc Breastfeeding Analsys - 2
Ciclopirox while Breastfeeding
CAS Number: 29342-05-0
Topical ciclopirox has not been studied during breastfeeding. Because only about 1.3% is absorbed after topical application, it is considered a low risk to the nursing infant. Avoid application to the nipple area and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.
What should I do if I am breastfeeding mother and I am already exposed to Ciclopirox | Actavis Mid Atlantic Llc?
As usage of Ciclopirox | Actavis Mid Atlantic Llc is mostly safe while breastfeeding hence there should not be any concern. In case of any change in behavior or health of your baby you should inform your health care provider about usage of Ciclopirox | Actavis Mid Atlantic Llc else no further action is required.
I am nursing mother and my doctor has suggested me to use Ciclopirox | Actavis Mid Atlantic Llc, is it safe?
Usage of Ciclopirox | Actavis Mid Atlantic Llc is safe for nursing mothers and baby, No worries.
If I am using Ciclopirox | Actavis Mid Atlantic Llc, will my baby need extra monitoring?
Who can I talk to if I have questions about usage of Ciclopirox | Actavis Mid Atlantic Llc 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