AmLactin AP

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AmLactin AP uses

AmLactin AP consists of Lactic Acid, Pramoxine Hydrochloride.

Lactic Acid:



FOR INDUSTRIAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

NOT FOR HUMAN USE

Attention

For External Use Only

Wash hands thoroughly after handling.

Do not mix with bleach or other chlorinated products – will cause chlorine gas.

Get medical advice/ attention if you feel unwell.

DIRECTIONS:

IMPORTANT: Do not further dilute with water or mix with any other teat dips. If product in dip cup becomes visibly dirty, discard contents and replenish with fresh product. Do not reuse or return any unused product to the original container.

Udder Prep: When using an udder wash step before milking, make sure to wash teats with appropriate udder wash solution using proper cleaning procedures. Teats should then be dried with single-service towels.

Directions for Teat Dipping

Pre-Milk Dipping: Before each cow is milked, and using fresh AmLactin AP (Lactic Acid), dip each teat full-length into the teat dip cup. Wipe teats after dipping using single-service towels to avoid contamination of milk.

Post-Milk Dipping: Using fresh AmLactin AP (Lactic Acid), dip each teat full-length into the teat dip cup. Do not wipe. Allow to air dry. Do not turn cows out in freezing weather until the product is completely dry.

Directions for Teat Spraying

Pre-Milk Spraying: Before each cow is milked, and using fresh AmLactin AP (Lactic Acid), spray entire teat. Wipe teats after dipping using single-service towels to avoid contamination of milk.

Post-Milk Spraying: Using fresh AmLactin AP (Lactic Acid), spray entire teat immediately after each milking. Do not wipe. Allow to air dry. Do not turn cows out in freezing weather until the product is completely dry.

Expanded Usage: When freshening cows, begin dipping teats twice daily for about 10 days before calving. PRECAUTION: AmLactin AP (Lactic Acid) is not intended to cure or help the healing of chapped or irritated teats. As with any germicide, irritation or sensitization may occur in sensitive animals. In case of teat irritation or chapping, have the condition examined and, if necessary, treated by a veterinarian.

Consult your Ecolab representative for specific use instructions and recommended dispensing equipment.

READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT

EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).

Ecolab

AmLactin AP (Lactic Acid)

Sanitizing Teat Dip

An Aid in Reducing the Spread of Organisms Which May Cause Mastitis

ACTIVE INGREDIENTS:

AmLactin AP (Lactic Acid) acid... 1.7%

Hydrogen peroxide... 0.5%

INERT INGREDIENTS:... 97.8%

(contains glycerin, sorbitol)

TOTAL:...100.0%

56.8 L (15 US GAL)

6301977

Ecolab · 1 Ecolab Place · St Paul MN 55102 USA · tel: 1 800 392 3392

© 2016 Ecolab USA Inc. · All rights reserved

www.ecolab.com · 766469/5300/1016



Pramoxine Hydrochloride:



DESCRIPTION: AmLactin AP (Pramoxine Hydrochloride)® (hydrocortisone acetate 1% and AmLactin AP (Pramoxine Hydrochloride) hydrochloride 1%) is a topical aerosol foam containing: hydrocortisone acetate 1% and AmLactin AP (Pramoxine Hydrochloride) hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and PEG 100 stearate blend, laureth-23, polyoxyl-40 stearate, methylparaben, propylparaben, trolamine, purified water and inert propellants: isobutane and propane.

AmLactin AP (Pramoxine Hydrochloride)® contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.

Hydrocortisone acetate

Molecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1mg/100mL.

Chemical name: Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-.

AmLactin AP (Pramoxine Hydrochloride) hydrochloride

Molecular weight: 329.86. AmLactin AP (Pramoxine Hydrochloride) hydrochloride is freely soluble in water.

Chemical name: morpholine, 4-[3-(4-butoxyphenoxy) propyl]-, hydrochloride.

chemical structure - Hydrocortisone acetate chemical structure - AmLactin AP (Pramoxine Hydrochloride) hydrochloride

CLINICAL

Pharmacology: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

AmLactin AP (Pramoxine Hydrochloride) Hydrochloride: A surface or local anesthetic which is not chemically related to the "caine" types of local anesthetics. Its unique chemical structure is likely to minimize the danger of cross-sensitivity reactions in patients allergic to other local anesthetics.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or disease processes in the skin increase the percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS: Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

WARNINGS: Not for prolonged use. If redness, pain, irritation or swelling persists, discontinue use and consult a physician. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). Keep this and all medicines out of the reach of children.

PRECAUTIONS:

General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

In pediatric patients absorption may result in higher blood levels and thus more susceptibility to systemic toxicity. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions:

  • This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  • Do not use this medication for any disorder other than for which it has been prescribed.
  • The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
  • Report any signs of local adverse reactions especially under occlusive dressings.
  • Do not use any tight fitting diapers or plastic pants on a pediatric patient being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression:




Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women of teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Caution should be exercised when any topical corticosteroids are administered to a nursing woman.

Pediatric Use: PEDIATRIC PATIENTS MAY DEMONSTRATE GREATER SUSCEPTIBILTY TO TOPICAL CORTICOSTEROID-INDUCED HPA AXIS SUPPRESSION AND CUSHING'S SYNDROME THAN MATURE PATIENTS BECAUSE OF A LARGER SKIN SURFACE AREA TO BODY WEIGHT RATIO.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisone levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Geriatric Use: Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-848-6610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence:

Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria

OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

DOSAGE AND ADMINISTRATION: Apply to affected area 3 to 4 times daily.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Directions For Use:

  • Shake the container vigorously for 5-10 seconds before each use.
  • While holding container upright, prime the container by pressing down several times on container cap until foam appears. Apply a small amount directly to affected area 3-4 times daily depending on severity of the condition. Alternatively, dispense a small amount to a pad and apply to affected areas.

    NOTE: The aerosol container should never be inserted into vagina or anus.

  • The container and cap should be disassembled and rinsed with warm water after use.
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HOW SUPPLIED:

Epifoam® is supplied in 10 g pressurized cans.

NDC 0037-6824-10 10 g

Store upright at controlled room temperature 20° – 25°C (68° – 77°F). DO NOT REFRIGERATE.

Distributed by:

MEDA PHARMACEUTICALS®

Meda Pharmaceuticals Inc.

Somerset, New Jersey 08873-4120

©2013 Meda Pharmaceuticals Inc.

For Medical Inquiries, call toll-free 1-877-848-6610

AmLactin AP (Pramoxine Hydrochloride) and MEDA PHARMACEUTICALS are registered trademarks of Meda AB or a related entity.

IN-682410-01

CIA71192B

Rev. 7/2013

NDC 0037-6824-10

STORE UPRIGHT

10 g net wt

AmLactin AP (Pramoxine Hydrochloride)®

(hydrocortisone acetate 1% and

AmLactin AP (Pramoxine Hydrochloride) hydrochloride 1%)

topical aerosol

Rx Only

HOLD UPRIGHT TO DISPENSE

WARNINGS: Contents of

the container are under

pressure. Do not burn or

puncture the aerosol

container. Do not store at

temperatures above 120°F

(49°C).

MEDA

PHARMACEUTICALS

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AmLactin AP pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


AmLactin AP available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


AmLactin AP destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


AmLactin AP Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


AmLactin AP pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."AL LABORATORIES GOLDEN MIX ACTIVE (LACTIC ACID) LIQUID [EXL LABORATORIES, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."SALLY HANSEN ZERO BUMP BIKINI (PRAMOXINE HYDROCHLORIDE) SPRAY [COTY US LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."LACTIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming AmLactin AP?

Depending on the reaction of the AmLactin AP after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider AmLactin AP 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 AmLactin AP 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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Review

sdrugs.com conducted a study on AmLactin AP, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of AmLactin AP consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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