Lac-Hydrin (Lactic Acid)
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
Lac-Hydrin (Lactic Acid)

Lac-Hydrin®
(ammonium lactate) Lotion, 12%

For Dermatologic use only. Not for Ophthalmic, Oral or Intravaginal use.

DRUG DESCRIPTION

Lac-Hydrin specially formulates 12% lactic acid, neutralized with ammonium hydroxide, as ammonium lactate to provide a lotion pH of 4.5-5.5. Lac-Hydrin (ammonium lactate) Lotion, 12% also contains cetyl alcohol, fragrance, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methyl- and propylparabens, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula:

Lac-Hydrin®  (ammonium lactate) Structural Formula Illustration

What are the possible side effects of ammonium lactate?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using the medication and call your doctor if you have severe burning, stinging, redness, or peeling of the skin treated with ammonium lactate.

Less serious side effects may include:

  • mild skin peeling or dryness;
  • mild skin redness or irritation;
  • bruising or other discoloration; or
  • darkening of the treated skin.

This is not a complete list of side effects and others may...

Read All Potential Side Effects and See Pictures of Lac-Hydrin »

What are the precautions when taking lactic acid (Lac-Hydrin)?

Before using ammonium lactate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: wounds or sores on the skin.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your...

Read All Potential Precautions of Lac-Hydrin »

Last reviewed on RxList: 12/17/2007
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Lac-Hydrin (lactic acid) is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.

DOSAGE AND ADMINISTRATION

Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

HOW SUPPLIED

Lac-Hydrin® (ammonium lactate) Lotion, 12% is available in a 225g (NDC 0072-5712-08) plastic bottle and a 400g (NDC 0072-5712-14) plastic bottle.

Store at controlled room temperature 15°C-30°C (59°F-86°F).

Manufactured for: Bristol-Myers Squibb Co. Princeton, NJ 08543 USA. by: Contract Pharmaceuticals Limited Niagara Buffalo, NY 14213 USA. FDA revision date: 11/9/2007

Last reviewed on RxList: 12/17/2007
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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).

Read the Lac-Hydrin (lactic acid) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 12/17/2007
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Sun exposure to areas of the skin treated with Lac-Hydrin (ammonium lactate) Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Lac-Hydrin (lactic acid) Lotion should be discontinued if hypersensitivity is observed.

PRECAUTIONS

General

For external use only. Stinging or burning may occur when applied to skin with fissures, erosions or that is otherwise abraded (for example, after shaving the legs). 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The topical treatment of CD-1 mice with 12%, 21% or 30% ammonium lactate 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% ammonium lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.

The mutagenic potential of ammonium lactate formulations was evaluated in the Ames assay and in the mousein vivo micronucleus assay, both of which were negative.

In dermal Segment I and III studies with ammonium lactate formulations there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m²/day), approximately 0.4 times the human topical dose.

Pregnancy

Teratogenic Effects: Pregnancy Category B

Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m²/day in the rat and 7200 mg/m²/day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to 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, Lac-Hydrin (lactic acid) Lotion should be used during pregnancy only if clearly needed.

Nursing Mothers

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 Lac-Hydrin (lactic acid) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Lac-Hydrin (lactic acid) have been demonstrated in infants and children. No unusual toxic effects were reported.

Geriatric Use

Clinical studies of Lac-Hydrin (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.

Last reviewed on RxList: 12/17/2007
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

The oral administration of Lac-Hydrin (lactic acid) to rats and mice showed this drug to be practically non-toxic (LD50>15 mL/kg).

CONTRAINDICATIONS

Lac-Hydrin (lactic acid) Lotion is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

Last reviewed on RxList: 12/17/2007
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Lactic acid is an alpha-hydroxy acid. It is a normal constituent of tissues and blood. The alpha-hydroxy acids (and their salts) may act as humectants when applied to the skin. This property may influence hydration of the stratum corneum. In addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion. The mechanism(s) by which this is accomplished is not yet known.

An in vitro study of percutaneous absorption of Lac-Hydrin (lactic acid) Lotion using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.

Last reviewed on RxList: 12/17/2007
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients using Lac-Hydrin (ammonium lactate) Lotion, 12% should receive the following information and instructions:

  1. This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
  2. Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.
  3. This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
  4. If the skin condition worsens with treatment, the medication should be promptly discontinued.

Last reviewed on RxList: 12/17/2007
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Patients using Lac-Hydrin (ammonium lactate) Lotion, 12% should receive the following information and instructions:

  1. This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
  2. Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.
  3. This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
  4. If the skin condition worsens with treatment, the medication should be promptly discontinued.

Last reviewed on RxList: 12/17/2007
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Lac-Hydrin Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

AMMONIUM LACTATE 12% - TOPICAL

(a-MOE-nee-um LAK-tate)

COMMON BRAND NAME(S): Hydrolac, Lac-Hydrin

USES: This medication is used to treat dry, scaly skin conditions (e.g., xerosis, ichthyosis vulgaris) and can also help relieve itching from these conditions. This medication works by increasing the moisture in the skin.

HOW TO USE: If you are using the lotion, shake the bottle well before using.

Apply a thin layer of this medication to the affected areas of the skin, usually twice daily or as directed by your doctor. Rub the medication thoroughly into the skin.

Be careful to avoid your eyes, lips, inside your mouth/nose, the vaginal area, and any areas of broken skin. Stinging or burning may occur when this medication is applied on the face, on chapped skin, or on a recently shaved area of the skin. Consult your doctor or pharmacist for more details.

Inform your doctor if your skin condition does not improve or worsens.

Disclaimer

Lac-Hydrin Consumer (continued)

SIDE EFFECTS: Stinging, burning, and redness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: darkening/lightening of the skin, small red dots on the skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Lac-Hydrin (lactic acid) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using ammonium lactate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: wounds or sores on the skin.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Lac-Hydrin Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other skin products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing/overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Some ways to help prevent dry skin include using lukewarm (not hot) water when bathing, taking baths/showers less often (e.g., every 1-2 days), keeping baths/showers short, and using a humidifier when the air is very dry.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Refer to storage information printed on your package for the exact temperature range. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Lac-Hydrin Patient Information Including Side Effects

Brand Names: Amlactin, AmLactin Foot Cream Therapy, Amlactin XL, Kerasal AL, Lac-Hydrin, Lac-Hydrin 5, Laclotion

Generic Name: ammonium lactate topical (Pronunciation: a MOE nee um LAK tate)

What is ammonium lactate (Lac-Hydrin)?

Ammonium lactate is a combination of lactic acid and ammonium hydroxide. Ammonium lactate is a moisturizer.

Ammonium lactate is used to treat dry, scaly, itchy skin.

Ammonium lactate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ammonium lactate?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using the medication and call your doctor if you have severe burning, stinging, redness, or peeling of the skin treated with ammonium lactate.

Less serious side effects may include:

  • mild skin peeling or dryness;
  • mild skin redness or irritation;
  • bruising or other discoloration; or
  • darkening of the treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the Lac-Hydrin (lactic acid) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about ammonium lactate?

Do not apply ammonium lactate to your face unless your doctor has told you to.

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not apply ammonium lactate topical after shaving or use it on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Ammonium lactate can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Call your doctor if your skin condition does not improve or if it gets worse even with ammonium lactate treatment.

Stop using the medication and call your doctor if you have severe burning, stinging, redness, or peeling of the skin treated with ammonium lactate.

Side Effects Centers

Lac-Hydrin Patient Information including How Should I Take

What should I discuss with my healthcare provider before using ammonium lactate topical?

You should not use this medication if you are allergic to ammonium lactate.

Ammonium lactate may be more likely to cause skin irritation in people who have fair or sensitive skin.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ammonium lactate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Ammonium lactate should not be used on a child without the advice of a doctor.

How should I apply ammonium lactate?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Shake the lotion form of this medication well just before using it.

Ammonium lactate is usually applied twice a day. Follow your doctor's instructions.

Wash your hands before and after applying this medication, unless you are using it to treat a hand condition.

Do not apply ammonium lactate to your face unless your doctor has told you to.

Call your doctor if your skin condition does not improve or if it gets worse even with ammonium lactate treatment.

Store ammonium lactate at room temperature away from moisture and heat.

Side Effects Centers

Lac-Hydrin Patient Information including If I Miss a Dose

What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of ammonium lactate is unlikely to occur.

What should I avoid while using ammonium lactate?

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not apply ammonium lactate topical after shaving or use it on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Ammonium lactate can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What other drugs will affect ammonium lactate?

It is not likely that other drugs you take orally or inject will have an effect on topically applied ammonium lactate. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ammonium lactate topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com