Methaderm 0.1%

Methaderm 0.1% Uses, Dosage, Side Effects, Food Interaction and all others data.

Methaderm 0.1% is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Methaderm 0.1%'s duration of action varies depending on the route. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.

Trade Name Methaderm 0.1%
Availability Prescription only
Generic Dexamethasone
Dexamethasone Other Names Dexametasona, Dexamethasone, Dexaméthasone, Dexamethasonum
Related Drugs Entyvio, Humira, Otezla, Cosentyx, Dupixent, Gilenya, Promacta, Tysabri, Zeposia, Colazal
Type
Formula C22H29FO5
Weight Average: 392.4611
Monoisotopic: 392.199902243
Protein binding

Dexamethasone is approximately 77% protein bound in plasma. The majority of protein binding is with serum albumin.[A188559] Dexamethasone does not significantly bind to corticosteroid binding protein.[A188559]

Groups Approved, Investigational, Vet approved
Therapeutic Class Glucocorticoids
Manufacturer
Available Country Japan
Last Updated: September 19, 2023 at 7:00 am
Methaderm 0.1%
Methaderm 0.1%

Uses

Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency, pre operatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer

Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis, synovitis of osteoarthritis, rheumatoid arthritis including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), acute and sub-acute bursitis, epicondylitis, acute nonspecific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis.

Collagen diseases: During an exacerbation or as maintenance therapy in selected cases of Systemic lupus erythematosus and acute rheumatic carditis

Dermatologic diseases: Pemphigus,Severe erythema multiforme (Stevens-Johnson syndrome), Exfoliative dermatitis, Bullous dermatitis herpetiformis, Severe seborrheic dermatitis,Severe psoriasis, Mycosis fungoides

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, seasonal or perennial allergic rhinitis, drug hypersensitivity reactions, urticarial transfusion reactions, acute non-infectious laryngeal edema (epinephrine is the drug of first choice)

Ophthalmic diseases: Severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation, allergic conjunctivitis, keratitis, allergic corneal marginal ulcers.

Gastrointestinal diseases: To tide the patient over a critical period of the disease in ulcerative colitis (systemic therapy), regional enteritis (systemic therapy) Respiratory diseases Symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculous chemotherapy, Loeffler's syndrome not manageable by other means, aspiration pneumonitis.

Hematologic disorders: Acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura in adults (I.V. only: I.M administration is contraused), secondary thrombocytopenia in adults, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplasticanemia

Neoplastic diseases: For palliative management of leukemias and lymphomas in adults, acute leukemia of childhood.

Edematous states: To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy,Trichinosis with neurologic or myocardial involvement

Cerebral Edema: Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

Methaderm 0.1% is also used to associated treatment for these conditions: Acne Rosacea, Acute Gouty Arthritis, Acute Otitis Externa, Acute Otitis Media, Adrenal cortical hypofunctions, Adrenocortical Hyperfunction, Alopecia Areata (AA), Ankylosing Spondylitis (AS), Anterior Segment Inflammation, Aspiration Pneumonitis, Asthma, Atopic Dermatitis (AD), Berylliosis, Bullous dermatitis herpetiformis, Bursitis, Chorioretinitis, Choroiditis, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Conjunctivitis, Conjunctivitis allergic, Corneal Inflammation, Cushing's Syndrome, Dermatitis, Dermatitis exfoliative generalised, Dermatitis, Contact, Diabetic Macular Edema (DME), Discoid Lupus Erythematosus (DLE), Drug hypersensitivity reaction, Edema of the cerebrum, Epicondylitis, Episcleritis, Erythroblastopenia, Eye Infections, Eye allergy, Eye swelling, Glaucoma, Hypercalcemia, Idiopathic Thrombocytopenic Purpura, Infection, Inflammation, Inflammation of the External Auditory Canal, Intraocular Inflammation, Iridocyclitis, Iritis, Keloid Scars, Leukemia, Acute, Lichen Planus (LP), Lichen simplex chronicus, Loeffler's syndrome, Macular Edema, Malignant Lymphomas, Middle ear inflammation, Mucosal Inflammation of the eye, Multiple Myeloma (MM), Muscle Inflammation caused by Cataract Surgery of the eye, Mycosis Fungoides (MF), Necrobiosis lipoidica diabeticorum, Noninfectious Posterior Uveitis, Ocular Infections, Irritations and Inflammations, Ocular Inflammation, Ocular Inflammation and Pain, Ocular Irritation, Ophthalmia, Sympathetic, Optic Neuritis, Otitis Externa, Pemphigus, Perennial Allergic Rhinitis (PAR), Phlyctenular keratoconjunctivitis, Post-traumatic Osteoarthritis, Postoperative Infections of the eyes caused by susceptible bacteria, Regional Enteritis, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Sarcoidosis, Scleritis, Seasonal Allergic Conjunctivitis, Seasonal Allergic Rhinitis, Secondary thrombocytopenia, Serum Sickness, Severe Seborrheic Dermatitis, Stevens-Johnson Syndrome, Synovitis, Systemic Lupus Erythematosus (SLE), Trichinosis, Tuberculosis (TB), Tuberculosis Meningitis, Ulcerative Colitis, Uveitis, Vernal Keratoconjunctivitis, Acquired immune hemolytic anemia, Acute nonspecific tenosynovitis, Acute rheumatic carditis, Corticosteroid-responsive dermatoses, Ear infection-not otherwise specified caused by susceptible bacteria, Granuloma annulare lesions, Non-suppurative Thyroiditis, Ocular bacterial infections, Severe Psoriasis, Steroid-responsive inflammation of the eye, Varicella-zoster virus acute retinal necrosis, Watery itchy eyes

How Methaderm 0.1% works

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

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.

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

Dosage

Methaderm 0.1% dosage

Intraarticular-

Inflammatory joint diseases:

  • Adult: 0.8-4 mg depending on the size of the affected joint. For soft-tissue inj, 2-6 mg may be used. May repeat inj every 3-5 days to every 2-3 wk.

Intravenous-

Prophylaxis of nausea and vomiting associated with cytotoxic therapy:

  • Adult: Prevention: 10-20 mg 15-30 minutes before admin of chemotherapy on each treatment day. For continuous infusion regimen: 10 mg every 12 hr on each treatment day. For midly emetogenic regimen: 4 mg every 4-6 hr.

Unresponsive shock:

  • Adult: As phosphate: Initially, 40 mg or 1-6 mg/kg as a single IV inj, may repeat every 2-6 hr. Continue high-dose treatment only until patient's condition has stabilised and not to be continued beyond 48-72 hr.

Bacterial meningitis:

  • Adult: 0.15 mg/kg 4 times daily, to be given 10-20 min before or with the 1st dose of anti-infective treatment. Treatment should be given for the first 2-4 days of the anti-infective treatment.
  • Child: As phosphate: 2 mth-18 yr: 150 mcg/kg every 6 hr for 4 days, starting before or with 1st dose of antibacterial treatment.

Cerebral oedema caused by malignancy:

  • Adult: As phosphate: 10 mg IV followed by 4 mg IM every 6 hr until response is achieved, usually after 12-24 hr. May reduce dosage after 2-4 days then gradually discontinued over 5-7 days. In severe cases, an initial dose of 50 mg IV may be given on day 1, with 8 mg every 2 hr, reduced gradually over 7-13 days. Maintenance dose: 2 mg 2-3 times daily.
  • Child: As phosphate: 35 kg: Initially 25 mg, then 4 mg every 2 hr for 3 days, then 4 mg every 4 hr for 1 day, then 4 mg every 6 hr for 4 days, then decrease by 2 mg daily. Doses are given via IV inj.

Oral-

Anti-inflammatory:

  • Adult: 0.75-9 mg daily in 2-4 divided doses; may also be given via IM/IV admin.
  • Child: 1 mth-18 yr: 10-100 mcg/kg daily in 1-2 divided doses via oral admin, adjusted according to response; up to 300 micrograms/kg daily may be used in emergency situations.

Screening test for Cushing's syndrome:

  • Adult: 0.5 mg every 6 hr for 48 hr after determining baseline 24-hr urinary 17-hydroxycorticosteroid (17-OHCS) concentrations. During the second 24 hr of dexamethasone admin, urine is collected and analysed for 17-OHCS. Alternatively, after a baseline plasma cortisol determination, 1 mg may be given at 11 pm and plasma cortisol determined at 8 am the next morning. Plasma cortisol and urinary output of 17-OHCS are depressed after dexamethasone admin in normal individuals but remain at basal levels in patients with Cushing's syndrome.

Acute exacerbations in multiple sclerosis:

  • Adult: 30 mg daily for 1 wk followed by 4-12 mg daily for 1 mth.
  • Child: 1 mth-12 yr: 100-400 mcg/kg daily in 1-2 divided doses; 12-18 yr: Initially 0.5-24 mg daily. Max. 24 mg daily.

Side Effects

Methaderm 0.1% is generally well tolerated in standard low doses, Nausea, vomiting, increased appetite, and obesity may occur. Higher doses may result behavioral personality changes. Following adverse reactions have been associate with prolonged systemic glucocorticoid therapy, endocrine & metabolic disturbances, fluid & electrolyte disturbances, musculo-skeletal effects like osteoporosis etc; GI effects like ulcer, bleeding, perforation; Opthelmic effects like Glaucoma, increased intraocular pressure etc; immunosuppressive effects like increased susceptibility to infection etc.

Toxicity

The oral LD50 in female mice was 6.5g/kg and 794mg/kg via the intravenous route.

Overdoses are not expected with otic formulations. 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.

Precaution

The lowest possible dose of corticosteroids should be used to control the conditions under treatment. Methaderm 0.1% should be used with caution in patient with cardiomyopathy, heart failure, hypertension, or renal insufficiency, drug induced secondary adrenocortical insufficiency, peptic ulcer, diverticulitis, intestinal anastomosis, ulcerative colitis, osteoporosis, & latent tuberculosis etc.

Interaction

Drug interaction can be occurred with following drugs:Diuretics, cardiac glycosides, antidiabetics, NSAIDs, anticoagulants, antacids etc. Besides, if patients undergo long-term therapy of glucororticoids with concomitant salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.

Food Interaction

  • Avoid alcohol.
  • Take with food. Food reduces irritation.

Methaderm 0.1% Cholesterol interaction

[Moderate] Corticosteroids may elevate serum triglyceride and LDL cholesterol levels if used for longer than brief periods.

Patients with preexisting hyperlipidemia may require closer monitoring during prolonged corticosteroid therapy, and adjustments made accordingly in their lipid-lowering regimen.

Methaderm 0.1% Hypertension interaction

[Moderate] Corticosteroids may cause hypernatremia, hypokalemia, fluid retention, and elevation in blood pressure.

These mineralocorticoid effects are most significant with fludrocortisone, followed by hydrocortisone and cortisone, then by prednisone and prednisolone.

The remaining corticosteroids, betamethasone, dexamethasone, methylprednisolone, and triamcinolone, have little mineralocorticoid activities.

However, large doses of any corticosteroid can demonstrate these effects, particularly if given for longer than brief periods.

Therapy with corticosteroids should be administered cautiously in patients with preexisting fluid retention, hypertension, congestive heart failure, and

Dietary sodium restriction and potassium supplementation may be advisable.

Volume of Distribution

A 1.5mg oral dose of dexamethasone has a volume of distribution of 51.0L, while a 3mg intramuscular dose has a volume of distribution of 96.0L.

Elimination Route

Absorption via the intramuscular route is slower than via the intravenous route. A 3mg intramuscular dose reaches a Cmax of 34.6±6.0ng/mL with a Tmax of 2.0±1.2h and an AUC of 113±38ng*h/mL. A 1.5mg oral dose reaches a Cmax of 13.9±6.8ng/mL with a Tmax of 2.0±0.5h and an AUC of 331±50ng*h/mL. Oral dexamethasone is approximately 70-78% bioavailable in healthy subjects.

Half Life

The mean terminal half life of a 20mg oral tablet is 4 hours. A 1.5mg oral dose of dexamethasone has a half life of 6.6±4.3h, while a 3mg intramuscular dose has a half life of 4.2±1.2h.

Clearance

A 20mg oral tablet has a clearance of 15.7L/h. A 1.5mg oral dose of dexamethasone has a clearance of 15.6±4.9L/h while a 3.0mg intramuscular dose has a clearance of 9.9±1.4L/h.

Elimination Route

Corticosteroids are generally eliminated predominantly in the urine. However, dexamethasone is 15

Pregnancy & Breastfeeding use

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies. Glucocorticoids appear in breast milk, Mothers taking high dosages of corticosteroids should be advised not to breast-feed.

Contraindication

In case of adrenal insufficiency, no absolute contraindications are applicable. In the treatment of non endocrine diseases where pharmacological doses are more likely to be used, the contraindications have to be considered carefully.

Relative contraindications include the followings: patient with Cushing’s syndrome, Osteoporosis, Diabetes mellitus, renal insufficiency, gastrointestinal ulcers, systemic fungal infection & acute infection.

Acute Overdose

Overdose is unlikely; however, treatment of overdose is by supportive and symptomatic therapy.

Storage Condition

Store at 15-30° C.

Innovators Monograph

You find simplified version here Methaderm 0.1%

Methaderm 0.1% contains Dexamethasone see full prescribing information from innovator Methaderm 0.1% Monograph, Methaderm 0.1% MSDS, Methaderm 0.1% FDA label

FAQ

What is Methaderm 0.1% used for?

Methaderm 0.1% is a glucocorticoid medication used to treat rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, eye pain following eye surgery, superior vena cava syndrome, and along with antibiotics in tuberculosis. It also is used to treat many different inflammatory conditions such as allergic disorders and skin conditions. Methaderm 0.1% is used to treat ulcerative colitis, arthritis, lupus, psoriasis, and breathing disorders.

How safe is Methaderm 0.1%?

Methaderm 0.1% is generally safe. It presents a favourable benefit-risk profile, particularly in patients with severe forms of pneumonia, while the benefit is less prominent in patients with non-severe pneumonia. As the treatment is short, even at high doses, corticosteroids are not associated with serious side effects. Potentially higher blood glucose levels are temporary.

How does Methaderm 0.1% work?

Patients with severe or critical COVID-19 develop an overstimulation of the immune system, which can be very harmful to their health. Methaderm 0.1% act to suppress this overstimulation.

What are the common side effects of Methaderm 0.1%?

Common side effects of Methaderm 0.1% are include:

  • upset stomach
  • stomach irritation
  • vomiting
  • headache
  • dizziness
  • insomnia
  • restlessness
  • depression
  • anxiety
  • acne
  • increased hair growth
  • easy bruising
  • irregular or absent menstrual periods

Is Methaderm 0.1% safe during pregnancy?

Methaderm 0.1% associated with a high risk of premature birth. The lowest possible steroid dose needed to control disease activity should be used in pregnancy.

Is Methaderm 0.1% safe during breastfeeding?

The benefits of using Methaderm 0.1% while breastfeeding will usually outweigh any risks. Methaderm 0.1% does pass into breast milk, but low doses taken by the mother are unlikely to significantly affect a nursing baby.

Can I drink alcohol with Methaderm 0.1%?

Yes, you can drink alcohol while taking Methaderm 0.1%.

Can I drive after taking Methaderm 0.1%?

Methaderm 0.1% is not likely to affect you being able to drive or use any tools or machines.

When should be taken of Methaderm 0.1%?

You usually take Methaderm 0.1% tablets or liquid once a day. It's best to take it in the morning so it does not affect your sleep.

Can I take Methaderm 0.1% on an empty stomach?

Take Methaderm 0.1% with after eating a meal or snack, or immediately after eating. Do not take it on an empty stomach.

How often can I take Methaderm 0.1%?

You'll usually take Methaderm 0.1% once a day. If your dose is 6mg, your doctor may tell you to take three 2mg tablets at the same time.

How long does Methaderm 0.1% take to work?

There was a growing trend to a lower croup score in the Methaderm 0.1% group, evident from 10 min and statistically significant from 30 min. For children with croup an oral dose of 0.15 mg/kg Methaderm 0.1% offers benefit by 30 min, much earlier than the 4 hour suggested by the Cochrane Collaboration.

How long does Methaderm 0.1% stay in my system?

Methaderm 0.1% is a long-acting corticosteroid with a half-life of 36 to 72 hours.

Can I take Methaderm 0.1% for a long time?

Taking Methaderm 0.1% for several months can increase the risk of some other side effects. If you take it long term you can get thinner bones, eyesight problems and slower growth in children and teenagers. If you have diabetes, Methaderm 0.1% can affect blood sugar control.

What happens if I overdose?

Seek emergency medical attention . An overdose of Methaderm 0.1% is not expected to produce life threatening symptoms. Long term use of high doses can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Methaderm 0.1%.

Who should not take Methaderm 0.1%?

Methaderm 0.1% you should not take  if:

  • you have ever had an allergic reaction to dexamethasone or any other medicine in the past
  • you have recently been in contact with someone with shingles, chickenpox or measles
  • you have an infection or any unhealed wounds
  • you have liver or kidney problems
  • you have ever had mental health problems (or a close family member has)
  • you have ever had tuberculosis (TB)
  • you have high blood pressure, heart failure or recently had a heart attack
  • you have diabetes
  • you have epilepsy
  • you have glaucoma
  • you have an underactive thyroid
  • you have osteoporosis (thinning bones)
  • you have a stomach ulcer
  • you have myasthenia gravis, a rare condition that causes muscle weakness
  • you have recently had vaccinations, or are due to have vaccinations
  • you're pregnant, trying to get pregnant or breastfeeding

What happens when I stop taking Methaderm 0.1%?

Do not stop taking Methaderm 0.1% without talking to your doctor. Stopping the drug abruptly can cause loss of appetite, upset stomach, vomiting, drowsiness, confusion, headache, fever, joint and muscle pain, peeling skin, and weight loss.

Can Methaderm 0.1% affects my heart ?

Methaderm 0.1% decreased resting heart rate, high-sensitivity C-reactive protein, and aldosterone and tended to attenuate nitroglycerin-mediated vasodilatation.

Can Methaderm 0.1% affect my fertility?

Methaderm 0.1% enhances fertility and fecundity possible through an effect of prolactin on follicle development, or by other direct effects on the ovary. These results may improve our understanding of the usefulness of DEX in assisted reproductive therapies for women.

Can Methaderm 0.1% affects my liver?

Methaderm 0.1% reduced liver damage produced by bile duct obstruction.

*** Taking medicines without doctor's advice can cause long-term problems.
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