Tododermil

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Tododermil uses

Tododermil consists of Erythromycin Estolate, Hydrocortisone Acetate.

Erythromycin Estolate:


Pharmacological action

Tododermil is a macrolide antibiotic. Has bacteriostatic action. However at higher doses against susceptible organisms has a bactericidal effect. erythromycin is reversibly bound to the ribosome of bacteria, thereby inhibiting protein synthesis. Tododermil (Erythromycin Estolate) is active against gram-positive bacteria: Staphylococcus spp. (strains producing and not producing penicillinase), Streptococcus spp. (including Streptococcus pneumoniae); gram-negative bacteria: Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis, Brucella spp., Legionella spp., Bacillus anthracis, Corynebacterium diphtheriae; anaerobic bacteria: Clostridium spp. erythromycin is also active against Mycoplasma spp., Chlamydia spp., Spirochaetaceae, Rickettsia spp. To erythromycin resistant gram-negative bacilli, including Escherichia coli, Pseudomonas aeruginosa, Shigella spp., Salmonella spp.

Pharmacokinetics

Tododermil (Erythromycin Estolate) bioavailability is 30-65%. Distributed in most tissues and body fluids. Plasma protein binding is 70-90%. Metabolised in the liver, partly with the formation of inactive metabolites. T1/2 is 1.4-2 hours. It is derived from bile and urine.

Why is Tododermil prescribed?

Infectious-inflammatory diseases caused by microorganisms sensitive to erythromycin, including diphtheria, pertussis, trachoma, brucellosis, a disease Legionnaires, sore throat, scarlet fever, otitis media, sinusitis, cholecystitis, pneumonia, gonorrhea, syphilis. Also Tododermil (Erythromycin Estolate) used for the treatment of infectious-inflammatory diseases caused by pathogens (eg staphylococci) are resistant to penicillin, tetracycline, chloramphenicol, streptomycin.

For external use: acne vulgaris.

For local use: the infectious-inflammatory diseases of eyes.

Dosage and administration

Tododermil prescribed individually depending on the location and severity of infection, the sensitivity of the parasite. In adults use a daily dose of 1-4 g. Children under the age of 3 months - 20-40 mg / kg / day, aged from 4 months to 18 years - 30-50 mg / kg / day. Multiplicity is 4 times / day. The treatment course - 5-14 days after the disappearance of symptoms treatment should be continued for a further 2 days. Accepts up to 1 hour before eating or 2-3 hours after eating.

Solution for external applications lubricate the affected skin.

The ointment is applied to the affected area and in diseases of the eye lay behind the lower eyelid. The dose, frequency and duration of application is determined individually.

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Tododermil (Erythromycin Estolate) side effects, adverse reactions

Digestive system: nausea, vomiting, epigastric pain, cholestatic jaundice, tenesmus, diarrhea, dysbacteriosis; rarely - pseudomembranous enterocolitis, abnormal liver function, increase in liver transaminases, pancreatitis.

Allergic reactions: skin rash, urticaria, eosinophilia, rarely - anaphylactic shock.

Effects due to the influence of chemotherapy: oral candidiasis, vaginal candidiasis.

From the senses: the reversible ototoxicity - hearing loss and / or tinnitus (in the application of high doses - more than 4 g / day).

Since the cardiovascular system: rarely - tachycardia, prolongation of the QT interval on ECG, flickering and / or atrial flutter (patients with long QT interval on the ECG).

Local reactions: phlebitis at the site of / in the introduction.

Tododermil contraindications

Jaundice in history, marked disturbances of liver function, hypersensitivity to macrolides.

Using during pregnancy and breastfeeding

Erythromycin crosses the placental barrier, excreted in breast milk.

In the application of erythromycin in pregnancy should assess the intended benefits to the mother and the potential risk to the fetus. If necessary, use during lactation should decide on the termination of breastfeeding.

Special instructions

With careful use Tododermil when disorders of liver function and / or kidneys. Medications that increase the acidity of gastric juice and acidic drinks inactivate erythromycin. erythromycin can not drink milk and dairy products.

Precautionary measures

The use of erythromycin containing benzene for IV injection sometimes accompanied by the development of a fatal syndrome Gaspinga in children, as well as acute hepatitis drug in adults and children.

Tododermil drug interactions

With simultaneous use of Tododermil (Erythromycin Estolate) with theophylline, aminophylline, caffeine, there is an increase in their concentration in blood plasma and thus increases the risk of toxic effects.

Erythromycin increases the concentrations of cyclosporine in the blood plasma and may increase the risk of nephrotoxicity.

Drugs that block tubular secretion prolongs T1/2 of erythromycin.

Incompatible with lincomycin, clindamycin and chloramphenicol (antagonism).

Tododermil (Erythromycin Estolate) reduces the bactericidal action of beta-lactam antibiotics (penicillins, cephalosporins, carbapenems).

With simultaneous use of erythromycin increases the concentration of theophylline.

At the same time receiving chemotherapy, which is carried metabolism in the liver (carbamazepine, valproic acid, hexobarbital, phenytoin, alfentanil, dizopiramid, lovastatin, bromocriptine), may increase the concentration of these drugs in plasma (an inhibitor of microsomal liver enzymes).

IV injection of erythromycin increases the effects of ethanol (accelerating gastric emptying and decrease the duration of alcohol dehydrogenase in the gastric mucosa).

Erythromycin reduces the clearance of triazolam and midazolam and therefore may increase the pharmacological effects of benzodiazepines.

At the same time taking with terfenadine or astemizole may develop arrhythmias (fibrillation and ventricular flutter, ventricular tachycardia, until death); with dihydroergotamine or non hydrated ergot alkaloids may vasoconstriction to spasm, dysesthesia.

With simultaneous application Tododermil (Erythromycin Estolate) slows elimination (increases the effect) of methylprednisolone, felodipine and anticoagulants of cumarine series.

In a joint appointment with lovastatin increased rhabdomyolysis.

Erythromycin increases the bioavailability of digoxin.

Erythromycin reduces the effectiveness of hormonal contraceptives.

Tododermil in case of emergency / overdose

Symptoms: disruption of the liver until the acute liver failure, and hearing loss.

Treatment: gastric lavage, forced diuresis, hemo-and peritoneal dialysis. Produced a constant monitoring of vital functions (ECG, electrolyte composition of blood).

Hydrocortisone Acetate:


1 INDICATIONS AND USAGE

Tododermil (Hydrocortisone Acetate)® (hydrocortisone probutate) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.

PANDEL® (hydrocortisone probutate) Cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.

2 DOSAGE AND ADMINISTRATION

Apply a thin film of Tododermil (Hydrocortisone Acetate) to the affected area once or twice a day depending on the severity of the condition. Massage gently until the medication disappears.

Occlusive dressings may be used for the management of refractory lesions of psoriasis and other deep-seated dermatoses, such as localized neurodermatitis (lichen simplex chronicus).

Discontinue Tododermil (Hydrocortisone Acetate) when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Do not use Tododermil (Hydrocortisone Acetate) with occlusive dressings unless directed by the physician. Do not apply Tododermil (Hydrocortisone Acetate) in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

- For topical use.

- Apply a thin film to the affected skin areas once daily or twice a day.

- Discontinue therapy when control is achieved.

- If no improvement is seen within 2 weeks, reassess diagnosis.

- Do not use with occlusive dressings unless directed by a physician.

3 DOSAGE FORMS AND STRENGTHS

Cream, 0.1%. Each gram of Tododermil (Hydrocortisone Acetate) contains 1 mg of Tododermil (Hydrocortisone Acetate) probutate in a cream base.

Cream, 0.1%.

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4 CONTRAINDICATIONS

None.

None.

5 WARNINGS AND PRECAUTIONS

- Tododermil can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. (5.1)

- Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can result from systemic absorption of topical corticosteroids. (5.1)

- Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. (5.1)

- High potency corticosteroids, large treatment surface area, prolong use, use of occlusion dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. (5.1)

- Modify use if HPA axis suppression develops. (5.1)

- Pediatric patients may be more susceptible to systemic toxicity. (5.1, 8.4)

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects

Tododermil (Hydrocortisone Acetate) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.

In a trial including 15 evaluable subjects 18 years of age or older with psoriasis or atopic dermatitis affecting more than 20% of body surface area, 1 subject (6.7%) had ACTH stimulation test results suggestive of adrenal suppression after treatment with Tododermil (Hydrocortisone Acetate) twice daily for 21 days. Recovery of HPA axis suppression for this subject is unknown [see Clinical Pharmacology ( 12.2 )].

Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and unmasking latent diabetes mellitus.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA-axis suppression.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations ( 8.4 )].

5.2 Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as observed with most topical products not containing corticosteroids. If irritation develops, discontinue Tododermil (Hydrocortisone Acetate) and institute appropriate therapy.

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6 ADVERSE REACTIONS

- Most frequent adverse reactions include burning, stinging, rash, papulovesicular rash, redness, itching, moderate paresthesia, and contact dermatitis.

To report SUSPECTED ADVERSE REACTIONS, contact PharmaDerm®, A division of Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most frequent adverse reactions reported for Tododermil (Hydrocortisone Acetate) during clinical trials were application site reactions, including burning in 4, stinging in 2, and moderate paresthesia in 1 out of 226 subjects.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Tododermil (Hydrocortisone Acetate) because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These adverse reactions are as follows:

Skin and Subcutaneous Tissue Disorders: rash, papulovesicular rash

Application Site Reactions: dryness, erythema, pruritus, allergic contact dermatitis.

The following local adverse reactions are reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infections, skin atrophy, striae, and miliaria.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There is no clinical information on Tododermil use in pregnant women to inform any drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, Tododermil (Hydrocortisone Acetate) probutate given by the subcutaneous route during the period of organogenesis was teratogenic at doses equal to or greater than 1 mg/kg/day in rats or 0.1 mg/kg/day in rabbits (12 times and 2 times the human topical dose, respectively) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

Effects on embryo-fetal development were evaluated in rats and rabbits following subcutaneous administration of Tododermil (Hydrocortisone Acetate) probutate during the period of organogenesis. Tododermil (Hydrocortisone Acetate) probutate was teratogenic in rats when given during the period of organogenesis at subcutaneous doses equal to or greater than 1 mg/kg/day (12 times the human average topical dose of Tododermil (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual). Abnormalities included delayed ossification of the caudal vertebrae and other skeletal variations, cleft palate, umbilical hernia, edema, and exencephalia.

In rabbits, Tododermil (Hydrocortisone Acetate) probutate given by the subcutaneous route was teratogenic at doses equal to or greater than 0.1 mg/kg/day (2 times the human average topical dose of Tododermil (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual). Fetal weight and survival were affected. Delayed ossification and increased incidences of malformations (skeletal abnormalities and cleft palate) were also noted.

No adverse effects were seen in rats following subcutaneous administration of up to 1 mg/kg/day of Tododermil (Hydrocortisone Acetate) probutate during the perinatal and postnatal period (12 times the human average topical dose of Tododermil (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual).

8.2 Lactation

Risk Summary

There is no information on the presence of Tododermil (Hydrocortisone Acetate) probutate in breast milk, or on its effects on the breastfed infant or on milk production. It is not known whether topical administration of Tododermil (Hydrocortisone Acetate) could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tododermil (Hydrocortisone Acetate) and any potential adverse effects on the breastfed infant from Tododermil (Hydrocortisone Acetate) or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use Tododermil (Hydrocortisone Acetate) on the smallest area of skin and for the shortest duration possible while breastfeeding.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at a greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

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

11 DESCRIPTION

Tododermil (Hydrocortisone Acetate)(hydrocortisone probutate) Cream, 0.1% contains Tododermil (Hydrocortisone Acetate) probutate, a synthetic corticosteroid. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.

Tododermil (Hydrocortisone Acetate) probutate is a tasteless and odorless white crystalline powder practically insoluble in hexane or water, slightly soluble in ether, and very soluble in dichloromethane, methanol and acetone. Chemically, it is 11β,17,21-trihydroxypregn-4-ene-3,20-dione 17-butyrate 21-propionate. The structural formula is:

Molecular Formula: C28H40O7

Molecular Weight: 488.62

Each gram of Tododermil (Hydrocortisone Acetate) (hydrocortisone probutate) Cream, 0.1% contains: 1 mg of Tododermil (Hydrocortisone Acetate) probutate in a cream base of propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.

Structural Formula

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid responsive dermatoses is unknown

12.2 Pharmacodynamics

Vasoconstrictor Assay

Studies performed with Tododermil indicate that it is in the medium range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

In an open label HPA axis suppression trial, 19 adult subjects (ages 23 to 82 years) with atopic dermatitis or plaque psoriasis covering greater than 20% Body Surface Area (BSA) were treated with Tododermil (Hydrocortisone Acetate) twice daily for 21 days and were assessed for HPA axis suppression. At baseline, the mean disease BSA involvement was 36%. The criterion for HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter at 30-minutes after cosyntropin stimulation. Of these subjects, 15 were considered evaluable with respect to their adrenal axis function post-treatment. One of the evaluable subjects (6.7%) showed laboratory evidence of suppression on Day 22. This subject had psoriasis covering 48% of BSA at baseline and was reported to have received 98% of the twice-daily applications of Tododermil (Hydrocortisone Acetate) over the 21 day treatment period. It is not known if this subject had recovery of adrenal function because follow-up testing was not performed.

12.3 Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Use of occlusive dressings with Tododermil (Hydrocortisone Acetate) for up to 24 hours has not been shown to increase penetration; however, occlusion of Tododermil (Hydrocortisone Acetate) for 96 hours does markedly enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate the carcinogenic potential of Tododermil (Hydrocortisone Acetate) probutate.

Tododermil (Hydrocortisone Acetate) probutate revealed no evidence of mutagenic or clastogenic potential based on the results of an in vitro genotoxicity test (Ames assay) and an in vivo genotoxicity test (mouse micronucleus assay).

Effects on fertility and early embryonic development were evaluated in rats following subcutaneous administration of up to 0.4 mg/kg/day Tododermil (Hydrocortisone Acetate) probutate (5 times the human average topical dose of Tododermil (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual) prior to and during mating and through early pregnancy. No treatment related effects on fertility or mating parameters were noted in this study.

16 HOW SUPPLIED/STORAGE AND HANDLING

Tododermil (Hydrocortisone Acetate), a white to off-white opaque cream is supplied as follows:

45 g tubes NDC 10337-153-46

80 g tubes NDC 10337-153-80

Store at 20° to 25°C (68° to 77°F).

17 PATIENT COUNSELING INFORMATION

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information).

Inform patients and/or caregivers of the following:

  • Discontinue therapy when control is achieved unless directed otherwise by the physician.
  • If no improvement is seen within two weeks, contact the physician.
  • Avoid contact with the eyes.
  • Do not use with occlusive dressing unless directed by the physician.
  • Report any signs or symptoms of local or systemic adverse reactions to the physician.
  • Do not treat diaper dermatitis. Do not apply Tododermil (Hydrocortisone Acetate) in the diaper area as diapers or plastic pants may constitute occlusive dressings.
  • Do not use on the face, underarms, or groin areas unless directed by the physician.
  • Advise a woman to use Tododermil (Hydrocortisone Acetate) on the smallest area of skin and for the shortest duration possible while breastfeeding.

Manufactured by:

PharmaDerm®

A division of Fougera

PHARMACEUTICALS INC.

Melville, New York 11747 www.pharmaderm.com


PATIENT INFORMATION

Tododermil (Hydrocortisone Acetate)® (pan-del)

(hydrocortisone probutate)

cream


Important: Tododermil (Hydrocortisone Acetate) is for use on skin only (topical). Avoid using Tododermil (Hydrocortisone Acetate) near or around your eyes.


What is Tododermil (Hydrocortisone Acetate)?

Tododermil (Hydrocortisone Acetate) is a prescription corticosteroid medicine used on the skin (topical) for the relief of inflammation and itching caused by certain skin conditions in people 18 years of age or older.

It is not known if Tododermil (Hydrocortisone Acetate) is safe and effective in children.


Before using Tododermil (Hydrocortisone Acetate) tell your healthcare provider about all of your medical conditions, including if you:

- have adrenal gland problems

- have liver problems

- have diabetes

- have thinning skin (atrophy) at the site to be treated.

- are pregnant or plan to become pregnant. It is not known if Tododermil (Hydrocortisone Acetate) will harm your unborn baby.

- are breastfeeding or plan to breastfeed. It is not known if Tododermil (Hydrocortisone Acetate) can pass into your breast milk and harm your baby.

  • o If you breastfeed during treatment with Tododermil (Hydrocortisone Acetate), clean the treated area of skin on and near your breast, and your nipple before breastfeeding. This will help prevent contact of Tododermil (Hydrocortisone Acetate) with your baby’s skin.
  • o You should use Tododermil (Hydrocortisone Acetate) on the smallest area of skin and for the shortest time possible while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


How should I use Tododermil (Hydrocortisone Acetate)?

- Use Tododermil (Hydrocortisone Acetate) exactly as your healthcare provider tells you to use it.

- Apply a thin film to the affected skin area. Gently rub Tododermil (Hydrocortisone Acetate) into your skin until it disappears.

- Tell your healthcare provider if your symptoms do not improve after 2 weeks of treatment.

- Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to.

- Do not apply Tododermil (Hydrocortisone Acetate) in the diaper area or use with plastic pants.

- Do not use Tododermil (Hydrocortisone Acetate) on your face, underarms (armpits) or groin areas unless your healthcare provider tells you to.

- Wash your hands after applying Tododermil (Hydrocortisone Acetate), unless your hands are being treated.


What are possible side effects with Tododermil (Hydrocortisone Acetate)?

Tododermil (Hydrocortisone Acetate) may cause serious side effects, including:

- Tododermil (Hydrocortisone Acetate) can pass through your skin and may cause adrenal gland problems. This is more likely to happen if you use Tododermil (Hydrocortisone Acetate) for too long, use it over a large treatment area, use it with other topical medicines that contain corticosteroids, cover the treated area, or have liver failure. Your healthcare provider may do blood tests to check your adrenal gland function during and after treatment with Tododermil (Hydrocortisone Acetate).

- Skin problems, including skin reactions or thinning of your skin (atrophy), skin infections, and allergic reactions (allergic contact dermatitis) at the treatment site. Tell your healthcare provider if you get any skinreactions such as pain, tenderness, swelling, or healing problems.

The most common side effects of Tododermil (Hydrocortisone Acetate) include burning and stinging and moderate tingling or prickling feeling.

These are not all the possible side effects with Tododermil (Hydrocortisone Acetate). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


How should I store Tododermil (Hydrocortisone Acetate)?

- Store Tododermil (Hydrocortisone Acetate) between 68°F to 77°F (20°C to 25°C).

Keep Tododermil (Hydrocortisone Acetate) and all medicines out of the reach of children.


General information about the safe and effective use of Tododermil (Hydrocortisone Acetate).

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tododermil (Hydrocortisone Acetate) for a condition for which it was not prescribed. Do not give Tododermil (Hydrocortisone Acetate) to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Tododermil (Hydrocortisone Acetate) that is written for health professionals.


What are the ingredients in Tododermil (Hydrocortisone Acetate)?

Active ingredient: Tododermil (Hydrocortisone Acetate) probutate

Inactive ingredients: propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.

Manufactured by:PharmaDerm® A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747

For more information, go to www.pharmaderm.com or call 1-800-645-9833.

  • This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 01/2017

PharmaDerm®

NDC 10337-153-80

Tododermil (Hydrocortisone Acetate)®

(hydrocortisone probutate) Cream, 0.1%

FOR DERMATOLOGIC USE ONLY.

NOT FOR OPHTHALMIC USE.

Rx only

80 g

carton

Tododermil 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.


Tododermil 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.


Tododermil 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.


Tododermil 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.


Tododermil 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."IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE: 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).
  3. "hydrocortisone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Tododermil?

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

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

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Visitor reported price estimates

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Visitor reported frequency of use

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Visitor reported doses

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Visitor reported time for results

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Visitor reported administration

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Visitor reported age

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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