Tritospot крем из египта инструкция

Торговое название:

  • Тритоспот
  • Tritospot

Состав:

Каждые 100 грамм крема содержит:

  • Гидрохинон – 3 г
  • Третиноин – 0.02 г
  • Гидрокортизона ацетат – 1 г
  • Евзолекс – 4 г

Свойства:

Крем Тритоспот представляет собой комбинацию четырех эффективных компонентов для уменьшения гиперпигментации кожи. Гидрохинон является депигментирующим средством для кожи при таких состояниях, как хлоазма, меланодермия и веснушки. Присутствие Евзолекс в качестве солнцезащитного средства уменьшает шансы на репигментацию кожи. Третиноин стимулирует эпителий, создавая менее сплоченный роговой слой, который легче отслаивается. Гидрокортизон помогает улучшить результаты и в то же время уменьшает воспаление, которое может возникнуть.

Показания:

Для постепенного отбеливания гиперпигментации при таких кожных заболеваниях, как:

  • Хлоазма
  • Меланодермия
  • Веснушки
  • Старческое лентиго
  • Другие нежелательные области гиперпигментации.

Способ применения и дозы:

Взрослые и старше 12 лет:

Крем наносить небольшим количеством один раз в сутки на кожу с пигментацией ( наносить не более чем на 10% общей поверхности кожи).

Курс лечения 7 недель.

Иногда курс лечения можно продлить до 3 месяцев.

Противопоказания:

  • Приобретенные немеланиновые пигментации, витилиго и подозрение на меланому, непереносимость третиноина или любого другого компонента препарата.
  • Острые воспаления и экзема кожи.
  • Детский до 12 лет.
  • Кожные инфекции, реакции на вакцинацию, кожные язвы, угри, розацеа и периоральный дерматит являются противопоказанием для местного применения кортикостероидов. Поскольку количество абсорбированного гидрохинона не оценивается, крем Тритоспот не следует наносить на большие поверхности или при заболеваниях почек.

Меры предосторожности:

Не наносить на слизистые оболочки.

Тест на чувствительность следует проводить, нанося небольшое количество на непрерывное пятно на коже и проверяя в течение 24 часов.

Незначительное покраснение не является противопоказанием, но при появлении зуда, образовании пузырьков или чрезмерной воспалительной реакции, дальнейшее лечение не рекомендуется.

Побочные эффекты:

Кожные поражения в виде эритемы, раздражения, зуда, шелушения и ожогов могут проявляться особенно на ранних этапах лечения.

Способ хранения:

Хранить при температуре не выше 30°С.

Упаковка:

Картонная коробка вмещает тубу по 15 г, бумажную инструкцию.

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Tritospot Whitening Cream for Skin and Dark Spot Removal lighting cream

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TabletWise.com

  • Overview
  • Uses
  • Side-effects
  • Precautions
  • Interactions
  • Contraindications

Overview

Tritospot cream is used for Lightens light brown color patches on skin, Acne, Skin discolorations associated with pregnancy, Age spots, Birth control pills, Dry, Rough patches and tiny bumps on skin, Hemorrhoids, Itching/swelling in the rectum and anus, Intestinal problems, Ulcerative colitis of the rectum and other conditions. Tritospot cream may also be used for purposes not listed in this medication guide.

Tritospot cream works by preventing the formation, activity and release of different cells and chemicals causing skin problems; reducing the accumulation of skin pigment and hampers important processes within the cells; slowing the growth of diseased blood cells;

Detailed information related to Tritospot cream’s uses, composition, dosage, side effects and reviews is listed below.

Uses

Side-effects

Precautions

Before using Tritospot cream, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side-effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below.

  • Avoid becoming pregnant during and within one month after stopping treatment
  • Avoid exposure to sunlight and UV light
  • Avoid getting this cream in your eyes, nose, or mouth
  • Avoid unnecessary sun exposures and cover the treated areas with clothing
  • Consult your doctor for the right method of contraception you can use
  • Consult your doctor if you are pregnant or planning to become pregnant or breastfeeding
  • Discontinue use and contact your doctor immediately if you develop allergic skin reaction or notice blue-black darkening of skin
  • Do not drive or operate machinery
  • Do not stop usage of this cream if your skin condition appears to worsen for the first 2 to 3 weeks of treatment
  • Extreme caution is required in children younger than 12 years old

Interactions with Tritospot cream

If you use other drugs or over the counter products at the same time, the effects of Tritospot cream may change. This may increase your risk for side-effects or cause your drug not to work properly. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that you doctor can help you prevent or manage drug interactions. Tritospot cream may interact with the following drugs and products:

  • Alcohol
  • Benzoyl peroxide
  • Carbamazepine
  • Clarithromycin
  • Estradiol
  • Minoxidil
  • Phenobarbital
  • Pyridostigmine
  • Resorcinol
  • Retinol

When not to use Tritospot cream

Hypersensitivity to Tritospot cream is a contraindication. In addition, Tritospot cream should not be used if you have the following conditions:

  • Allergic reactions
  • Application on eczematous
  • Hypersensitivity
  • Irritated or injured skin
  • Lactation
  • Mifepristone
  • Peroxides
  • Phenol
  • Pregnancy
  • Rectal obstruction

Composition and Active Ingredients

Packages and Strengths

Tritospot cream is available in the following packages and strengths

Tritospot cream — Packages: 30 gram, 15 tube

Frequently asked Questions

  • Is Tritospot cream safe to use when pregnant?

    • Euselx Oily: Please consult with your doctor for case-specific recommendations.
    • Hydrocortisone Acetate: Please consult with your doctor for case-specific recommendations.
    • Hydroquinone: Please consult with your doctor for case-specific recommendations.
    • Tretinoin: No
  • Is Tritospot cream safe while breastfeeding?

    • Euselx Oily: Please discuss the risks and benefits with your doctor.
    • Hydrocortisone Acetate: Please discuss the risks and benefits with your doctor.
    • Hydroquinone: Please discuss the risks and benefits with your doctor.
    • Tretinoin: No
  • Can Tritospot cream be used for lightens light brown color patches on skin and acne?

    Yes, lightens light brown color patches on skin and acne are among the most common reported uses for Tritospot cream. Please do not use Tritospot cream for lightens light brown color patches on skin and acne without consulting first with your doctor. Click here and view survey results to find out what other patients report as common uses for Tritospot cream.

  • How long do I need to use Tritospot cream before I see improvement of my conditions?

    TabletWise.com website users have reported 1 month and 1 week as the most common time it takes before they saw improvements in their conditions. These times may not be reflective of what you may experience or how you should use this medicine. Please consult with your doctor to check how long do you need to use Tritospot cream. Click here and view survey results to find out what other patients report as time for effectiveness for Tritospot cream.

  • Should I use Tritospot cream empty stomach, before food or after food?

    TabletWise.com website users have most commonly reported using Tritospot cream anytime. However, this may not be reflective of how you should use this medicine. Please follow your doctor’s advice on how you should use this medicine. Click here and view survey results to find out what other patients report as timing of using Tritospot cream.

  • Is it safe to drive or operate heavy machinery when using this product?

    If you experience drowsiness, dizziness, hypotension or a headache as side-effects when using Tritospot cream medicine then it may not be safe to drive a vehicle or operate heavy machinery. One should not drive a vehicle if using the medicine makes you drowsy, dizzy or lowers your blood-pressure extensively. Pharmacists also advise patients not to drink alcohol with medicines as alcohol intensifies drowsiness side-effects. Please check for these effects on your body when using Tritospot cream. Always consult with your doctor for recommendations specific to your body and health conditions.

  • Is this medicine or product addictive or habit forming?

    Most medicines don’t come with a potential for addiction or abuse. Usually, the government’s categorizes medicines that can be addictive as controlled substances. Examples include schedule H or X in India and schedule II-V in the US. Please consult the product package to make sure that the medicine does not belong to such special categorizations of medicines. Lastly, do not self-medicate and increase your body’s dependence to medicines without the advice of a doctor.

  • Can i stop using this product immediately or do I have to slowly wean off the use?

    Some medicines need to be tapered or cannot be stopped immediately because of rebound effects. Please consult with your doctor for recommendations specific to your body, health and other medications that you may be using.

Other important Information on Tritospot cream

Missing a dose

In case you miss a dose, use it as soon as you notice. If it is close to the time of your next dose, skip the missed dose and resume your dosing schedule. Do not use extra dose to make up for a missed dose. If you are regularly missing doses, consider setting an alarm or asking a family member to remind you. Please consult your doctor to discuss changes in your dosing schedule or a new schedule to make up for missed doses, if you have missed too many doses recently.

Overdosage of Tritospot cream

  • Do not use more than prescribed dose. Taking more medication will not improve your symptoms; rather they may cause poisoning or serious side-effects. If you suspect that you or anyone else who may have overdosed of Tritospot cream, please go to the emergency department of the closest hospital or nursing home. Bring a medicine box, container, or label with you to help doctors with necessary information.
  • Do not give your medicines to other people even if you know that they have the same condition or it seems that they may have similar conditions. This may lead to overdosage.
  • Please consult your physician or pharmacist or product package for more information.

Storage of Tritospot cream

  • Store medicines at room temperature, away from heat and direct light. Do not freeze medicines unless required by package insert. Keep medicines away from children and pets.
  • Do not flush medications down the toilet or pour them into drainage unless instructed to do so. Medication discarded in this manner may contaminate the environment. Please consult your pharmacist or doctor for more details on how to safely discard Tritospot cream.

Expired Tritospot cream

  • Taking a single dose of expired Tritospot cream is unlikely to produce an adverse event. However, please discuss with your primary health provider or pharmacist for proper advice or if you feel unwell or sick. Expired drug may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use expired drugs. If you have a chronic illness that requires taking medicine constantly such as heart condition, seizures, and life-threatening allergies, you are much safer keeping in touch with your primary health care provider so that you can have a fresh supply of unexpired medications.

Dosage Information

Please consult your physician or pharmacist or refer to the product package.

Cite this page

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  • Tritospot cream — Product — TabletWise.com. (n.d.). Retrieved April 22, 2023, from https://www.tabletwise.com/egypt/tritospot-cream

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  • «Tritospot cream — Product — TabletWise.com» Tabletwise.com. N.p., n.d. Web. 22 Apr. 2023.

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  • «Tritospot cream — Product — TabletWise.com» Tabletwise. Accessed April 22, 2023. https://www.tabletwise.com/egypt/tritospot-cream.

More about Tritospot cream

  • Uses
  • Reviews
  • What are the uses of Tritospot cream?
  • What are the side-effects of Tritospot cream?
  • What other medicines does Tritospot cream interact with?
  • When should you not use Tritospot cream?
  • What precautions should you take while using Tritospot cream?

Last updated date

This page was last updated on 9/27/2020.

This page provides information for Tritospot cream Product in English.

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Tritospot

Hydrocortisone is a naturally occurring corticosteroid, which causes profound and varied metabolic effects. In addition, they modify body’s immune response to diverse stimuli. Hydrocortisone sodium succinate has the same metabolic and anti-inflammatory actions as hydrocortisone.

Hydrocortisone binds to the glucocorticoid receptor leading to downstream effects such as inhibition of phospholipase A2, NF-kappa B, other inflammatory transcription factors, and the promotion of anti-inflammatory genes.[A187463] Hydrocortisone has a wide therapeutic index and a moderate duration of action. Patients should stop taking the medication if irritation or sensitization occurs.

Hydroquinone is a topical depigmentating agent that produces a reversible depigmentation of the skin by inhibiting enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine and suppressing melanocyte metabolic processes.

Tretinoin is structurally and pharmacologically related to vitamin A. Current evidence suggests that topical Tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedone formation. Additionally, Tretinoin stimulates mitotic activity and increases turnover of follicular epithelial cells, causing extrusion of the comedones

Tretinoin, also known as all-trans-retinoic acid (ATRA), is a naturally occurring derivative of vitamin A (retinol). Retinoids such as tretinoin are important regulators of cell reproduction, proliferation, and differentiation and are used to treat acne and photodamaged skin and to manage keratinization disorders such as ichthyosis and keratosis follicularis. Tretinoin also represents the class of anticancer drugs called differentiating agents and is used in the treatment of acute promyelocytic leukemia (APL).

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Uses

Hydrocortisone is used for the use in the following conditions: Primary or secondary adrenocortical insufficiency, Acute adrenocortical insufficiency, Shock unresponsive to conventional therapy, Congenital adrenal hyperplasia, Hypercalcemia associated with cancer, Nonsuppurative thyroiditis, Rheumatic Disorders, Dermatologic Diseases (Allergic States, Severe seborrheic dermatitis, Severe psoriasis, Pemphigus, Severe erythema multiforme), Control of severe or incapacitating allergic conditions (Bronchial asthma, Contact dermatitis, Atopic dermatitis, Serum sickness, Seasonal or perennial allergic rhinitis, Drug hypersensitivity reactions, Urticarial transfusion reactions, Acute noninfectious laryngeal edema), Ophthalmic Diseases (Herpes zoster ophthalmicus, Iritis, iridocyclitis, Chorioretinitis, Diffuse posterior uveitis and choroiditis, Optic neuritis), Gastrointestinal Diseases, Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, Loeffler’s syndrome, Aspiration pneumonitis, Hematologic Disorders (Acquired, autoimmune hemolytic anemia, Idiopathic thrombocytopenic purpura in adults, Secondary thrombocytopenia, Erythroblastopenia), Neoplastic Diseases (Leukemias and lymphomas in adults, Acute leukemia of childhood), Edematous States, Acute exacerbations of multiple sclerosis

Hydroquinone is used —

  • For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.
  • To reduce hyperpigmentation caused by photosensitization associated with inflammation or with the use of certain cosmetics.
  • For the treatment of acne vulgaris in which comedones, papules and pustules predominate.
  • For the treatment of hyperpigmentation, roughness and fine wrinkling of photodamaged skin due to chronic sun exposure.
  • For the treatment of Acute promyelocytic leukaemia

Tritospot is also used to associated treatment for these conditions: Acute Gouty Arthritis, Acute Otitis Externa, Adrenal Insufficiency, Allergic Rhinitis (AR), Allergic corneal marginal ulcers, Anal Fissures, Ankylosing Spondylitis (AS), Anterior Segment Inflammation, Aspiration Pneumonitis, Asthma, Atopic Dermatitis (AD), Berylliosis, Bullous dermatitis herpetiformis, Chorioretinitis, Choroiditis, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Corneal Inflammation, Crohn’s Disease (CD), Dermatitis, Dermatitis exfoliative generalised, Dermatitis, Contact, Dermatomyositis, Dermatosis, Drug hypersensitivity reaction, Epicondylitis, Erythroblastopenia, Hemorrhoids, Herpes Labialis, Hypercalcemia of Malignancy, Idiopathic Thrombocytopenic Purpura, Infection of the Fenestration Cavity, Infection of the Mastoidectomy Cavity, Iridocyclitis, Iritis, Itching caused by Hemorrhoids, Itching of the Anus, Leukemia, Acute, Leukemias, Loeffler’s syndrome, Lymphomas NEC, Malignant Lymphomas, Mycosis Fungoides (MF), Ophthalmia, Sympathetic, Optic Neuritis, Pain caused by Hemorrhoids, Pemphigus, Post-traumatic Osteoarthritis, Primary adrenocortical insufficiency, Proctitis, Proteinuria, Psoriatic Arthritis, Rectal inflammations NEC, Rheumatic heart disease, unspecified, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Seasonal Allergic Conjunctivitis, Secondary adrenocortical insufficiency, Secondary thrombocytopenia, Serum Sickness, Severe Seborrheic Dermatitis, Skin Diseases, Stevens-Johnson Syndrome, Synovitis, Systemic Lupus Erythematosus (SLE), Trichinosis, Tuberculous Meningitis, Ulcerative Colitis, Acquired immune hemolytic anemia, Acute Bursitis, Acute Tenosynovitis, Acute rheumatic carditis, Cryptitis, Disseminated Pulmonary Tuberculosis, Fulminating Pulmonary Tuberculosis, Itching skin, Non-suppurative Thyroiditis, Severe Erythema multiforme, Severe Psoriasis, Subacute Bursitis, Superficial infection of the external auditory canal with inflammation, Symptomatic Sarcoidosis, Systemic Dermatomyositis, Varicella-zoster virus acute retinal necrosis, PalliativeAcne Vulgaris, Melasma, Skin hyperpigmentation, Moderate Melasma, Severe MelasmaAcne Vulgaris, Alopecia, Cornification and dystrophic skin disorders, FAB classification M3 Acute promyelocytic leukemia, Skin hyperpigmentation, Solar Lentigines, Facial fine wrinkling, Keratinization disorders of the feet, Keratinization disorders of the hand, Moderate Melasma, Mottled hyperpigmentation, Severe Melasma, Severe, recalcitrant Cystic acne, Tactile roughness of facial skin

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How Tritospot works

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation.[A187463] Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days.[A187463]

Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10.[A187463]

Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive.[A187463] High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.[A187463]

Hydroquinone reduces melanin pigment production through inhibition of the tyrosinase enzyme, which is involved in the initial step of the melanin pigment biosynthesis pathway. Hydroquinone takes several months to take effect.

Tretinoin binds to alpha, beta, and gamma retinoic acid receptors (RARs). RAR-alpha and RAR-beta have been associated with the development of acute promyelocytic leukemia and squamous cell cancers, respectively. RAR-gamma is associated with retinoid effects on mucocutaneous tissues and bone. Although the exact mechanism of action of tretinoin is unknown, current evidence suggests that the effectiveness of tretinoin in acne is due primarily to its ability to modify abnormal follicular keratinization. Comedones form in follicles with an excess of keratinized epithelial cells. Tretinoin promotes detachment of cornified cells and the enhanced shedding of corneocytes from the follicle. By increasing the mitotic activity of follicular epithelia, tretinoin also increases the turnover rate of thin, loosely-adherent corneocytes. Through these actions, the comedo contents are extruded and the formation of the microcomedo, the precursor lesion of acne vulgaris, is reduced. Tretinoin is not a cytolytic agent but instead induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo. When Tretinoin is given systemically to APL patients, tretinoin treatment produces an initial maturation of the primitive promyelocytes derived from the leukemic clone, followed by a repopulation of the bone marrow and peripheral blood by normal, polyclonal hematopoietic cells in patients achieving complete remission (CR). The exact mechanism of action of tretinoin in APL is unknown.

Structure

Tritospot

Hydroquinone + Hydrocortisone + Tretinoin Structure

Table Of contents

  • Tritospot
  • Uses
  • Dosage
  • Side Effect
  • Precautions
  • Interactions
  • Uses during Pregnancy
  • Uses during Breastfeeding
  • Accute Overdose
  • Food Interaction
  • Half Life
  • Volume of Distribution
  • Clearance
  • Interaction With other Medicine
  • Contradiction
  • Storage

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Dosage

Tritospot dosage

Tablet: The initial dosage of Hydrocortisone Tablets may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Hydrocortisone Tablets should be discontinued and the patient transferred to other appropriate therapy. 

It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patients. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If, after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.

Injection

  • Adult: By IM injection or slow IV injection or infusion. The initial dose of Hydrocortisone sterile powder is 100 mg to 500 mg, depending on the severity of the condition. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient’s response and clinical condition.
  • Children: By slow IV injection, up to 1 year 25 mg, 1-5 years 50 mg, 6-12 years 100 mg.

Apply a thin film of Hydroquinone Cream to the effected area once daily, at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply Hydroquinone Cream to the hyperpigmented areas of melasma including about ½ inch of normal appearing skin surrounding each lesion. Rub lightly and uniformly into the skin.

Therapy should be discontinued when control is achieved. During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day. Hydroquinone Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Tretinoin cream: Tretinoin cream should be applied sparingly to the whole affected area once or twice daily. The skin should be thoroughly cleaned and dried before application. Patient should be advised that 6 to 8 weeks of treatment may be required before a therapeutic effect is observed. Moisturisers and cosmetics may be used during treatment with Cosmotrin cream but should not be applied to the skin at the same time. Astringent toiletries should be avoided.    

Tretinoin gel: Tretinoin gel should be applied once or twice a day, before retiring, to the skin where lesions appear, using enough to cover the entire affected area lightly. The frequency of application can be adjusted to obtain maximum clinical efficacy with minimal erythema and scaling.    

If Tretinoin gel is applied excessively, no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur. Should this occur accidentally or through over-enthusiastic use, application should be discontinued for few days.    

Patience is needed in this treatment, since the therapeutic effects will not usually be observed until after 6-8 weeks of treatment. During the early weeks of treatment, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen comedones and papules. Once the acne lesions have responded satisfactorily, it should be possible to maintain the improvement with less frequent applications.    

Moisturizers and cosmetics may be used during treatment with Tretinoin gel but should not be applied to the skin at the same time. The skin should be thoroughly washed before application of Tretinoin gel. Astringent toiletries should be avoided.    

Capsule: The recommended dose is 45 mg/m2/day administered as two evenly divided doses until complete remission is documented. Therapy should be discontinued 30 days after achievement of complete remission or after 90 days of treatment, whichever occurs first.    

If after initiation of treatment of Tretinoin the presence of the translocation is not confirmed by cytogenetics and/or by polymerase chain reaction studies and the patient has not responded to Tretinoin, alternative therapy appropriate for acute myelogenous leukemia should be considered.

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Side Effects

Hydrocortisone is generally well tolerated except in prolonged high doses. It may cause cardiac arrhythmia, esophageal candidiasis, menstrual irregularity, decreased carbohydrate & glucose tolerance, fluid retention, increased appetite, weight gain, euphoria, mood swings, depression, insomnia, acne etc.

No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued.

True allergic contact dermatitis is rare but a primary irritant dermatitis, manifesting itself as irritation, erythema, peeling and sensation of warmth, is common. Slight stinging is common as a mild reaction in many people but usually settles with continuous use and/or reduction in the frequency of application of the drug.

Toxicity

Data regarding acute overdoses of glucocorticoids are rare. Chronic high doses of glucocorticoids can lead to the development of cataract, glaucoma, hypertension, water retention, hyperlipidemia, peptic ulcer, pancreatitis, myopathy, osteoporosis, mood changes, psychosis, dermal atrophy, allergy, acne, hypertrichosis, immune suppression, decreased resistance to infection, moon face, hyperglycemia, hypocalcemia, hypophosphatemia, metabolic acidosis, growth suppression, and secondary adrenal insufficiency. Overdose may be treated by adjusting the dose or stopping the corticosteroid as well as initiating symptomatic and supportive treatment.

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Precaution

Hydrocortisone should be used with caution in patients with a history of peptic ulceration as it increases the incidence of peptic ulceration. This drug should be used with caution in patients with congestive heart failure, hypertension, glaucoma, diabetic mellitus and epilepsy.

Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin to check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. If no bleaching or lightening effect is noted after 2 months of treatment, the medication should be discontinued.

Contact with the eyes and lips should be avoided. Hydroquinone should not be applied to cut or abraded skin.

Interaction

Drug interaction of hydrocortisone has been reported with amphotericin B, potassium-depleting agents, macrolide antibiotics, warfarin, antidiabetics, isoniazid, digitalis glycosides, estrogens, barbiturates, phenytoin, carbamazepine, ketoconazole, aspirin etc.

Particular caution should be exercised in using preparations containing peeling agents (i.e. sulfur, resorcinol, benzoyl peroxide or salicylic acid). Use of topical preparations with high concentrations of alcohol, menthol, spices or lime- such as shaving lotions, astringents and perfume- should be avoided, especially during initial therapy.

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Volume of Distribution

Total hydrocortisone has a volume of distribution of 39.82L, while the free fraction has a volume of distribution of 474.38L.

Elimination Route

Oral hydrocortisone at a dose of 0.2-0.3mg/kg/day reached a mean Cmax of 32.69nmol/L with a mean AUC of 90.63h*nmol/L A 0.4-0.6mg/kg/day dose reached a mean Cmax of 70.81nmol/L with a mean AUC of 199.11h*nmol/L. However, the pharmacokinetics of hydrocortisone can vary by 10 times from patient to patient.

Topical hydrocortisone cream is 4-19% bioavailable[8546995] with a Tmax of 24h.

Hydrocortisone retention enemas are have a bioavailability of 0.810 for slow absorbers and 0.502 in rapid absorbers. Slow absorbers take up hydrocortisone at a rate of 0.361±0.255/h while fast absorbers take up hydrocortisone at a rate of 1.05±0.255/h.

A 20mg IV dose of hydrocortisone has an AUC of 1163±277ng*h/mL.

1-31% (topical)

Half Life

Total hydrocortisone via the oral route has a half life of 2.15h while the free fraction has a half life of 1.39h. A 20mg IV dose of hydrocortisone has a terminal half life of 1.9±0.4h.

0.5-2 hours

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Clearance

Total hydrocortisone by the oral route has a mean clearance of 12.85L/h, while the free fraction has a mean clearance of 235.78L/h. A 20mg IV dose of hydrocortisone has a clearance of 18.2±4.2L/h.

Elimination Route

Corticosteroids are eliminated predominantly in the urine.[A187436] However, data regarding the exact proportion is not readily available.

Pregnancy & Breastfeeding use

Pregnancy category C. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in nursing mother: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Lactation: It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.

Tretinoin is contraindicated in pregnancy or suspected pregnancy. The drug should be avoided by breast feeding mothers.

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Contraindication

Hydrocortisone is contraindicated in severe systemic fungal infections and patients with known hypersensitivity to any component of this product.

Hydroquinone is contraindicated to patients with prior history of hypersensitivity or allergic reaction to hydroquinone or other ingredients in the preparation.

Tretinoin is contraindicated in patients who are allergic to this drug. It is contraindicated in pregnancy or suspected pregnancy. It is also contraindicated in personal or familial history of cutaneous epithelioma.    

Local irritation: The presence of cutaneous irritative signs (e.g. erythema, peeling, pruritus, sunburn, etc.) should prohibit initiation or recommencement of treatment with Tretinoin until the symptoms resolve. Tretinoin has been reported to cause severe irritation on eczematous skin  and should be used with caution in patients with this condition.    

Exposure to sunlight: Exposure to sunlight, including ultraviolet sun-lamps, should be avoided or minimised during the use of Tretinoin.    

General precaution: Before application of Tretinoin, areas to be treated should be cleansed thoroughly. Abstain from washing the treated area frequently; twice daily is sufficient. Use of mild soap is recommended. Dry the skin without rubbing.    

Avoid contact with eyes, eyelids, nostrils, mouth and mucous membranes. If contact in these areas occurs, careful washing with water is recommended.

Special Warning

Use in elderly patients: Clinical studies were not done in patients’ aged 65 and above. In general dose selection for an elderly patients should be cautious, usually starting at the low end of the dosing range.

Acute Overdose

There have been no systemic reactions from the use of topical hydroquinone. Some patients may experience a transient reddening of skin and mild burning sensation which does not preclude treatment.

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Storage Condition

Store at 15-30°C.

Store between 20-25° C. Protect from light.

Store in a cool and dry place, away from light. Keep out of reach of children.

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