Dermogen

Dexamethasone Sodium Phosphate:

• Pharmacological action
• Pharmacokinetics
• Why is Dermogen prescribed?
• Dosage and administration
• Dermogen (Dexamethasone Sodium Phosphate) side effects, adverse reactions
• Dermogen contraindications
• Using during pregnancy and breastfeeding
• Dermogen (Dexamethasone Sodium Phosphate) in case of emergency / overdose
• Dermogen (Dexamethasone Sodium Phosphate) reviews

Pharmacological action

Dermogen is a glucocorticosteroid. This medication Inhibits the function of leukocytes and tissue macrophages. Dermogen (Dexamethasone Sodium Phosphate) restricts the migration of leukocytes in the area of inflammation. This drug violates the ability of macrophages to phagocytosis and the formation of interleukin-1. Dermogen (Dexamethasone Sodium Phosphate) decreases capillary permeability caused by histamine release. This medicine inhibits the activity of fibroblasts and collagen formation.

Dermogen (Dexamethasone Sodium Phosphate) inhibits the activity of phospholipase A2, which leads to suppression of the synthesis of prostaglandins and leukotrienes.

With direct application to the vessels this drug has a vasoconstrictor effect.

Dermogen (Dexamethasone Sodium Phosphate) has a pronounced dose-dependent effect on the metabolism of carbohydrates, proteins and fats.

In high doses Dermogen (Dexamethasone Sodium Phosphate) may increase the excitability of brain tissue and contributes to lowering the threshold of convulsive readiness.

With systemic use of therapeutic activity of Dermogen (Dexamethasone Sodium Phosphate) is due to anti-inflammatory, antiallergic, immunosuppressive and antiproliferative action.

For external and local use of therapeutic activity of Dermogen (Dexamethasone Sodium Phosphate) is due to anti-inflammatory, antiallergic and antiexudative (due to vasoconstrictor effect) effect.

Pharmacokinetics

The plasma protein binding is 60-70%. This medication penetrates histohematic barriers. In a small amount it is excreted in breast milk. Dermogen (Dexamethasone Sodium Phosphate) metabolized in a liver. T_1/2 is 2-3 hours. This drug is excreted by kidneys.

When Dermogen (Dexamethasone Sodium Phosphate) applied topically in ophthalmology it absorbed through the cornea with intact epithelium in moisture anterior chamber. When inflammation of the tissues of the eye or mucosal damage and corneal absorption rate of Dermogen (Dexamethasone Sodium Phosphate) significantly increased.

Why is Dermogen prescribed?

For oral administration: Biermer's disease; acute and subacute thyroiditis, hypothyroidism, progressive ophthalmopathy associated with thyrotoxicosis; bronchial asthma; rheumatoid arthritis in the acute phase; ulcerative colitis; connective tissue disease; autoimmune hemolytic anemia, thrombocytopenia, aplasia and hypoplasia of hematopoiesis, agranulocytosis, serum sickness; acute erythroderma, pemphigus (normal), acute eczema (early treatment); malignant tumor (as a palliative therapy); congenital adrenogenital syndrome; cerebral edema (usually after a preliminary parenteral corticosteroids).

For parenteral administration: shock of various origins; swelling of the brain (with brain tumors, head injury, neurosurgical intervention, brain hemorrhage, encephalitis, meningitis, radiation damage); asthmatic status; severe allergic reactions (angioedema, bronchospasm, dermatosis, acute anaphylactic reaction to medication, transfusion serum, pyrogenic reactions); acute hemolytic anemia, thrombocytopenia, acute lymphoblastic leukemia, agranulocytosis; serious infectious diseases (in combination with antibiotics); acute adrenal insufficiency, acute croup; arthropathy (scapulohumeral periarthritis, epicondylitis, styloiditis, bursitis, tenosynovitis, compression neuropathy, osteochondrosis, arthritis of various etiologies, osteoarthritis).

For use in ophthalmic practice: not purulent and allergic conjunctivitis, keratitis, keratoconjunctivitis without damaging the epithelium, iritis, iridocyclitis, blefaroconjuntivitis, blepharitis, episcleritis, scleritis, inflammation of injuries and eye surgeries, sympathetic ophthalmia.

Dosage and administration

The dosing regimen is individual. Orally for severe disease at the beginning of treatment it is prescribed to 10-15 mg / day, maintenance dose may be 2-4.5 mg / day or more. The daily dose divided into 2-3 doses. In small doses Dermogen is taken 1 time in the morning.

For parenteral administration this medication is administered IV slowly bolus or infusion (acute and urgent conditions); IM; it is possible also periarticular and intraarticular injection. During the day it can be administered from 4 to 20 mg of Dermogen (Dexamethasone Sodium Phosphate) 3-4 times / day. The duration of parenteral administration is usually 3-4 days, then move on to maintenance therapy of oral form. In the acute period in various diseases and early treatment Dermogen (Dexamethasone Sodium Phosphate) used in higher doses. Upon reaching the effect the dose is decreased within a few days before reaching the maintenance dose or until discontinuation of treatment.

When used in ophthalmology for acute conditions this drug instilled into conjunctival sac 1-2 drops every 1-2 hours, then with a decrease in inflammation after every 4-6 hours. The duration of treatment is from 1-2 days to several weeks depending on the clinical course of disease.

Dermogen (Dexamethasone Sodium Phosphate) side effects, adverse reactions

Endocrine system: impaired glucose tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, suppression of adrenal function, Itsenko-Cushing syndrome (including moon face, obesity, pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae), delayed sexual development in children.

Metabolism: increased excretion of calcium, hypocalcemia, weight gain, negative nitrogen balance (increased protein breakdown), increased sweating, hypernatremia, hypokalemia.

CNS: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, pseudotumor cerebellum, headache, convulsions.

Cardio-vascular system: arrhythmia, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of chronic heart failure, ECG changes typical of hypokalemia, increased blood pressure, hypercoagulability, thrombosis. In patients with acute and subacute myocardial infarction - spread necrosis, slowing the formation of scar tissue that can lead to rupture of the heart muscle; with intracranial introduction - nosebleeds.

Digestive system: nausea, vomiting, pancreatitis, steroid gastric and duodenal ulcers, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increase or decrease in appetite, flatulence, hiccups; rarely - increased activity of hepatic transaminases and alkaline phosphatase.

Sensory organs: posterior subcapsular cataracts, increased intraocular pressure with possible damage to the optic nerve, propensity to develop secondary bacterial, fungal or viral infections of the eye, trophic changes of the cornea, exophthalmos.

Musculoskeletal system: growth retardation and ossification processes in children (premature closure of epiphyseal growth zones), osteoporosis (very rare - a pathological bone fractures, aseptic necrosis of head of humerus and femur), rupture of tendons of muscles, steroid myopathy, reduced muscle mass (atrophy).

Dermatological reactions: delayed wound healing, petechiae, ecchymosis, skin thinning, hyper or hypopigmentation, steroid acne, stretch marks, susceptibility to the development of pyoderma and candidiasis.

Allergic reactions: generalized (including skin rash, itching, anaphylactic shock) and when applied topically.

Effects associated with immunosuppressive action: development or worsening of infection (the appearance of this side effect contribute jointly used immunosuppressive drugs, and vaccinations).

Local reactions: when Dermogen (Dexamethasone Sodium Phosphate) administered parenteral - tissue necrosis.

For external use: rarely - itching, redness, burning, dryness, folliculitis, acne, hypopigmentation, perioral dermatitis, allergic dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria. With prolonged use or application to large areas of skin may develop systemic side effects characteristic of SCS.

Dermogen contraindications

For short-term use for health reasons - increased sensitivity to Dermogen (Dexamethasone Sodium Phosphate).

For intra-articular injection and injection directly into the lesion: previous arthroplasty, abnormal bleeding (endogenous or caused by the use of anticoagulants), intra-articular fracture, infection (sepsis) inflammation in the joints and periarticular infections (including in history), as well as general infectious disease, pronounced juxta-articular osteoporosis, no signs of inflammation in the joints ("dry" joint, such as osteoarthritis without synovitis), severe bone destruction and deformity of the joint (a sharp narrowing of joint space, ankylosis), instability of the joint as a result of arthritis, aseptic necrosis of the epiphyses of bones forming the joint.

For external use: bacterial, viral, fungal skin diseases, tuberculosis, skin, cutaneous manifestations of syphilis, skin tumors, post-vaccination period, violation of the integrity of the skin (ulcers, wounds), children's age (up to 2 years, with itching in the anal area - up to 12 years), rosacea, acne vulgaris, perioral dermatitis.

For use in ophthalmology: bacterial, viral, fungal eye diseases, tuberculosis eye damage, tampering with the ocular epithelium, acute form of purulent eye infection in the absence of specific therapy, diseases of the cornea, combined with defects in the epithelium, trachoma, glaucoma.

Using during pregnancy and breastfeeding

During pregnancy and lactating Dermogen (Dexamethasone Sodium Phosphate) is used taking into account the expected therapeutic effect and adverse effect on the fetus. Long-term therapy during pregnancy does not exclude the possibility of violations of fetal growth. In the case of the end of pregnancy there is a danger of atrophy of the adrenal cortex of the fetus, which may require replacement therapy in the newborn.

Category effects on the fetus by FDA - C.

Dermogen (Dexamethasone Sodium Phosphate) in case of emergency / overdose

Symptoms: increased side effects.

Treatment: the development of adverse reactions - symptomatic therapy, the Itsenko-Cushing syndrome - the prescription of aminoglutethimide.

Neomycin Sulfate:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Dermogen (Neomycin Sulfate) reviews

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Dermogen (Neomycin Sulfate) tablets and other antibacterial drugs, Dermogen (Neomycin Sulfate) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Suppression of Intestinal Bacteria

Dermogen (Neomycin Sulfate) tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION ).

Hepatic Coma (Portal-Systemic Encephalopathy)

Dermogen (Neomycin Sulfate) has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.

CONTRAINDICATIONS

Dermogen (Neomycin Sulfate) oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.

Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin. Dermogen (Neomycin Sulfate) oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.

WARNINGS

Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.

The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman.

Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

PRECAUTIONS

General

Prescribing Dermogen tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

As with other antibiotics, use of oral neomycin may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.

Neomycin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of neomycin.

Cross-allergenicity among aminoglycosides has been demonstrated.

Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.

Small amounts of orally administered neomycin are absorbed through intact intestinal mucosa.

There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of neomycin. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.

An oral neomycin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.

Orally administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.

Information for The Patient

Patients should be counseled that antibacterial drugs including Dermogen (Neomycin Sulfate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Dermogen (Neomycin Sulfate) tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Dermogen (Neomycin Sulfate) tablets or other antibacterial drugs in the future.

Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.

Laboratory Tests

Patients with renal insufficiency may develop toxic neomycin blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve function.

Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.

Drug Interactions

Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin (see boxed WARNINGS ).

Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate neomycin sulfate’s neuromuscular blocking effects.

Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.

Oral Dermogen (Neomycin Sulfate) may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed with Dermogen to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy Category D

See WARNINGS section.

Nursing Mothers

It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efficacy of oral Dermogen (Neomycin Sulfate) in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.

ADVERSE REACTIONS

The most common adverse reactions to oral Dermogen (Neomycin Sulfate) are nausea, vomiting and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).

OVERDOSAGE

Because of low absorption, it is unlikely that acute overdosage would occur with oral Dermogen (Neomycin Sulfate). However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.

Hemodialysis will remove Dermogen (Neomycin Sulfate) from the blood.

DOSAGE AND ADMINISTRATION

To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.

Hepatic Coma

For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:

• Withdraw protein from diet. Avoid use of diuretic agents.
• Give supportive therapy, including blood products, as indicated.
• Give Dermogen (Neomycin Sulfate) tablets in doses of 4 to 12 grams of Dermogen (Neomycin Sulfate) per day (eight to 24 tablets) in divided doses. Treatment should be continued over a period of five to six days, during which time protein should be returned incrementally to the diet.
• If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, neomycin in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory (see PRECAUTIONS ). Also, neomycin serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of neomycin in the tissues.

Preoperative Prophylaxis for Elective Colorectal Surgery

Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.

Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.

Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.

Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Dermogen (Neomycin Sulfate) (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.

Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.

HOW SUPPLIED

Dermogen (Neomycin Sulfate) tablets USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as white to off-white, round, standard convex tablets debossed "LCI" on one side and "1210", on the other side and are supplied in:

Bottles of 100 (NDC 0527-1210-01)

Store at 20° to 25°C (68° to 77°F).

Dispense in tight containers as defined in the USP/NF.

Distributed By:

Lannett Company, Inc.

Philadelphia, PA 19154

Made in the USA

Rev. 01/17

CIB71710A