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DRUGS & SUPPLEMENTS
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When are you taking this medicine? |
Ammonium Lactate:
Ichtyosoft (Ammonium Lactate) Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.
Ichtyosoft (Ammonium Lactate) Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
Sun exposure (natural or artificial sunlight) to areas of the skin treated with Ichtyosoft (Ammonium Lactate) Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Ichtyosoft (Ammonium Lactate) Lotion, 12% should be discontinued if any hypersensitivity is observed.
For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded. Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied.
Patients using Ichtyosoft (Ammonium Lactate) Lotion, 12% should receive the following information and instructions:
The topical treatment of CD-1 mice with 12%, 21% or 30% Ichtyosoft formulations for two-years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% Ichtyosoft (Ammonium Lactate) formulations enhanced the rate of ultraviolet light-induced skin tumor formation.
The mutagenic potential of Ichtyosoft (Ammonium Lactate) formulations was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative.
In dermal Segment I and III studies with Ichtyosoft (Ammonium Lactate) formulations there were no effects observed in fertility or pre- or postnatal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m2/day), approximately 0.4 times the human topical dose.
Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively and have revealed no evidence of impaired fertility or harm to the fetus due to Ichtyosoft (Ammonium Lactate) formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ichtyosoft (Ammonium Lactate) Lotion, 12% should be used during pregnancy only if clearly needed.
Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ichtyosoft (Ammonium Lactate) is administered to a nursing woman.
Safety and effectiveness of Ichtyosoft have been demonstrated in infants and children. No unusual toxic effects were reported.
Clinical studies of Ichtyosoft (Ammonium Lactate) lotion, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.
The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness, and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).
The oral administration of Ichtyosoft (Ammonium Lactate) to rats and mice showed this drug to be practically non-toxic (LD50>15 mL/kg).
Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Ichtyosoft Lotion, 12% is available as follows:
225 g bottle (NDC 45802-419-54)
400 g bottle (NDC 45802-419-26)
Store at 20-25°C (68-77°F).
Manufactured By Perrigo, Bronx, NY 10457
Distributed By Perrigo, Allegan, MI 49010
0K5A7 RC F6
Rev 01-17
Salicylic Acid:
Ichtyosoft is pharmaceytical active ingredient for topical use. Inhibits the secretion of the sebaceous and sweat glands. At low concentrations it has keratoplastic and in high doses keratolytic effect. Ichtyosoft (Salicylic Acid) has a weak antimicrobial activity.
Monotherapy with Ichtyosoft (Salicylic Acid) and as part of combination therapies for inflammatory, infectious and other skin lesions, including burns, psoriasis, eczema, dyskeratosis, ichthyosis, acne vulgaris, warts, hyperkeratosis, corn, callus, oily seborrhea, scaly skin disease, hair loss, sweating feet.
Ichtyosoft is applied to the skin surface 2-3 times / day.
Rarely: local reactions such as itching, burning, skin rashes, allergic reactions.
Hypersensitivity to Ichtyosoft (Salicylic Acid), renal failure, infancy.
The composition of the solution for topical use include ethanol.
Ichtyosoft (Salicylic Acid) is pharmaceutically not compatible with resorcinol (forms melted mixture) and zinc oxide (forms insoluble forms of zinc salicylate).
Depending on the reaction of the Ichtyosoft after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ichtyosoft not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Ichtyosoft addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology