Gyterna

Metronidazole:

• Pharmacological action
• Pharmacokinetics
• Why is Gyterna prescribed?
• Dosage and administration
• Gyterna (Metronidazole) side effects, adverse reactions
• Gyterna contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Gyterna drug interactions
• Gyterna in case of emergency / overdose
• Gyterna (Metronidazole) reviews

Pharmacological action

Gyterna is an anti protozoal agent. It is believed that the mechanism of action is associated with DNA damage-sensitive microorganisms. Active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia lamblia, Entamoeba histolytica, and obligate anaerobic bacteria (including Bacteroides spp., Fusobacterium spp.).

Aerobic bacteria are resistant to Gyterna (Metronidazole).

In combination with amoxicillin Gyterna (Metronidazole) is active against Helicobacter pylori. It is believed that amoxicillin inhibits the development of resistance of Helicobacter pylori to Gyterna (Metronidazole).

Pharmacokinetics

Gyterna (Metronidazole) well absorbed after oral administration. The bioavailability is 80%. Gyterna (Metronidazole) is distributed in tissues and body fluids. This medication crosses the placental barrier and the BBB. Binding to plasma proteins is 20%. Gyterna (Metronidazole) is metabolized in the liver by oxidation and binding to glucuronic acid. T_1/2 is 8 hours. This drug is excreted in the urine (60-80%) and feces (6-15%).

Why is Gyterna prescribed?

Trichomonazice vaginitis and urethritis in women, trichomonazice urethritis in men, giardiasis, amoebic dysentery, anaerobic infections caused by metronidazole-sensitive organisms, combination therapy of severe mixed aerobic-anaerobic infections. Preventing anaerobic infection in surgery (particularly abdominal, urinary tract). Chronic alcoholism.

Gyterna (Metronidazole) in combination with amoxicillin: chronic gastritis in acute phase, gastric ulcer and duodenal ulcer in acute phase, associated with Helicobacter pylori.

For external and topical use: treatment of acne vulgaris and pink, bacterial vaginosis, treatment of long-term healing of wounds and trophic ulcers.

Dosage and administration

Gyterna is administered for oral use for adults and children over 12 years in 7.5 mg / kg every 6 h or 250-750 mg 3-4 times / day. For children up to 12 years the dose is 5-16.7 mg / kg 3 times / day. For IV injections for adults and children over 12 years starting dose is 15 mg / kg, followed by 7.5 mg / kg every 6 hours or depending on the etiology of the disease - by 500-750 mg every 8 hours. The duration of treatment and frequency of tests is determined individually.

Intravaginally - 500 mg 1 time a night.

In combination with amoxicillin (2.25 g / day) daily dose of Gyterna (Metronidazole) is 1.5 g; multiplicity of admission - 3 times / day. For patients with severe renal impairment (creatinine clearance less than 30 ml / min) and / or liver daily dose of Gyterna (Metronidazole) is 1 g (amoxicillin - 1.5 g / day), the multiplicity of the reception is 2 times / day. This medication takes for external and local use 2 times / day, doses are determined individually.

The maximum daily dose for adults when taken orally and IV is 4 g.

Gyterna (Metronidazole) side effects, adverse reactions

Digestive system: nausea, vomiting, anorexia, metallic taste in the mouth.

CNS and peripheral nervous system: headache, nervousness, irritability, insomnia, dizziness, ataxia, weakness, confusion, depression, peripheral neuropathy, seizures, hallucinations.

Allergic reactions: skin rash, itching, hives.

Hemopoietic system: leucopenia.

Local reactions: irritation.

Other: arthralgia, burning sensation in the urethra.

Gyterna contraindications

Organic CNS lesions, blood diseases, liver problems, I trimester of pregnancy, hypersensitivity to Gyterna (Metronidazole).

Using during pregnancy and breastfeeding

Gyterna is rapidly crosses the placental barrier. In II and III trimester of pregnancy Gyterna (Metronidazole) is used only for health reasons.

Gyterna (Metronidazole) is excreted in breast milk. If necessary, use during lactation should solve the issue of termination of breastfeeding.

Special instructions

Patients should with careful use of Gyterna (Metronidazole) in liver diseases.

In combination with amoxicillin this medication is not recommended for patients younger than 18 years. During the treatment period it is necessary the regular control of pattern of peripheral blood.

During the treatment of Trichomonas vaginitis in women and Trichomonas urethritis in men patients should refrain from sexual activity, simultaneous treatment of both partners is mandatory.

During the taking of Gyterna (Metronidazole) there is a more dark staining of urine.

During treatment with Gyterna (Metronidazole) should avoid alcohol because to violations of the oxidation of alcohol can accumulate acetaldehyde. As a result may develop reactions similar to those characteristic of disulfiram (abdominal cramps, nausea, vomiting, headache, a sudden rush of blood to the face).

Gyterna drug interactions

Simultaneous administration of Gyterna (Metronidazole) with:

Neomycin Sulfate:

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

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gyterna (Neomycin Sulfate) tablets and other antibacterial drugs, Gyterna (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

Gyterna (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)

Gyterna (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

Gyterna (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. Gyterna (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 Gyterna 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 Gyterna (Neomycin Sulfate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Gyterna (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 Gyterna (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 Gyterna (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 Gyterna 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 Gyterna (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 Gyterna (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 Gyterna (Neomycin Sulfate). However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.

Hemodialysis will remove Gyterna (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 Gyterna (Neomycin Sulfate) tablets in doses of 4 to 12 grams of Gyterna (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. Gyterna (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

Gyterna (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

Nystatin:

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Gyterna (Nystatin) reviews

DESCRIPTION

Gyterna (Nystatin), USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:

• C₄₇H₇₅NO₁₇ M.W. 926.13

Gyterna (Nystatin) Tablets USP contain the inactive ingredients: Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring.

Structural formula for Gyterna (Nystatin)

CLINICAL PHARMACOLOGY

Pharmacokinetics

Gastrointestinal absorption of Gyterna is insignificant. Most orally administered Gyterna (Nystatin) is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of Gyterna (Nystatin) may occasionally occur.

Microbiology

Gyterna (Nystatin) is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi. Candida albicans demonstrates no significant resistance to Gyterna (Nystatin) in vitro on repeated subculture in increasing levels of Gyterna (Nystatin); other Candida species become quite resistant. Generally, resistance does not develop in vivo. Gyterna (Nystatin) acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Gyterna (Nystatin) exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE

Gyterna (Nystatin) tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

CONTRAINDICATIONS

Gyterna (Nystatin) tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

PRECAUTIONS

General

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Gyterna. It is also not known whether Gyterna (Nystatin) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gyterna (Nystatin) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Gyterna (Nystatin) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Gyterna (Nystatin) is administered to a nursing woman.

ADVERSE REACTIONS

Gyterna is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see PRECAUTIONS, General).

Gastrointestinal

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other

Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.

OVERDOSAGE

Oral doses of Gyterna (Nystatin) in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

DOSAGE AND ADMINISTRATION

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units Gyterna (Nystatin)) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

HOW SUPPLIED

Gyterna (Nystatin) Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 100 tablets (NDC 0093-0983-01).

Store at 20° to 25°C (68° to 77°F).

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep tightly closed.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured By:

TEVA CANADA LIMITED

Toronto, Canada M1B 2K9

Manufactured For:

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. N 2/2016

NDC 0093-0983-01

Gyterna (Nystatin)

Tablets USP

500,000 units (oral)

Rx only

100 TABLETS

TEVA

Prednisolone Sodium Phosphate:

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

Pharmacological action

Gyterna is a glucocorticosteroid (GCS). This medication inhibits the function of leukocytes and tissue macrophages. Gyterna (Prednisolone 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. Gyterna (Prednisolone Sodium Phosphate) contributes to the stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in inflammation. This medicine decreases capillary permeability caused by histamine release. Gyterna (Prednisolone Sodium Phosphate) inhibits the activity of fibroblasts and collagen formation.

Gyterna (Prednisolone Sodium Phosphate) inhibits the activity of phospholipase A2 which leads to suppression of the synthesis of prostaglandins and leukotrienes. This medication inhibits the release of COX (especially COX-2), which also helps reduce the production of prostaglandins.

Gyterna (Prednisolone Sodium Phosphate) reduces the number of circulating lymphocytes (T-and B-cells), monocytes, eosinophils and basophils as a result of their displacement from the bloodstream into lymphoid tissue; suppresses the formation of antibodies.

Gyterna (Prednisolone Sodium Phosphate) inhibits the release of pituitary ACTH and beta-lipotropina but it does not reduces the level of circulating beta-endorphin. This drug also inhibits the secretion of TSH and FSH.

Gyterna (Prednisolone Sodium Phosphate) has a vasoconstrictor effect with direct application to the vessels.

Gyterna (Prednisolone Sodium Phosphate) has a pronounced dose-dependent effect on the metabolism of carbohydrates, proteins and fats. It stimulates gluconeogenesis, amino acid contributes to the capture of the liver and kidneys and increases the activity of enzymes of gluconeogenesis. In the liver, Gyterna (Prednisolone Sodium Phosphate) enhances the deposition of glycogen by stimulating the activity of glikogensintetazy and synthesis of glucose from the products of protein metabolism. This medicine increases blood glucose activates the secretion of insulin.

Gyterna (Prednisolone Sodium Phosphate) inhibits glucose uptake by fat cells that leads to the activation of lipolysis. However, due to an increase in insulin secretion is stimulated lipogenesis which contributes to the accumulation of fat.

Gyterna (Prednisolone Sodium Phosphate) also has catabolic effects in lymphoid and connective tissue, muscle, adipose tissue, skin, bone tissue. To a lesser extent than hydrocortisone Gyterna (Prednisolone Sodium Phosphate) affects the processes of water and electrolyte metabolism: promotes the excretion of potassium and calcium, delay in the body of sodium and water. Osteoporosis and Itsenko-Cushing's syndrome are the main factors limiting the long-term therapy with corticosteroids. As a result of the catabolic actions it may suppress growth in children.

In high doses prednisone can increase the excitability of brain tissue and contributes to lowering the threshold of convulsive readiness. This medication stimulates the excessive production of hydrochloric acid and pepsin in the stomach which leads to the development of peptic ulcers.

When systemic use the therapeutic activity of Gyterna (Prednisolone Sodium Phosphate) is due to anti-inflammatory, antiallergic, immunosuppressive and antiproliferative action.

For external and local application the therapeutic activity of Gyterna (Prednisolone Sodium Phosphate) is due to anti-inflammatory, antiallergic and antiexudative (due to vasoconstrictor effect) effect.

As compared with hydrocortisone the anti-inflammatory activity of Gyterna (Prednisolone Sodium Phosphate) is 4 times greater, the mineralocorticoid activity is 0.6 times smaller.

Pharmacokinetics

After oral administration Gyterna (Prednisolone Sodium Phosphate) is well absorbed from the gastrointestinal tract. C_max in plasma observed after 90 min. In plasma most of Gyterna (Prednisolone Sodium Phosphate) is associated with transcortin (cortisol binding globulin). This drug metabolized primarily in the liver.

T_1/2 is about 200 minutes.

Why is Gyterna prescribed?

For oral and parenteral use: rheumatism; rheumatoid arthritis, dermatomyositis, periarteritis nodosa, scleroderma, ankylosing spondylitis, asthma, asthmatic status, acute and chronic allergic diseases, anaphylaxis, Addison's disease, acute adrenal insufficiency, adrenogenital syndrome; hepatitis, hepatic coma, hypoglycemic states, lipid nephrosis; agranulocytosis, various forms of leukemia, lymphoma, thrombocytopenic purpura, hemolytic anemia; chorea; pemphigus, eczema, pruritus, exfoliative dermatitis, psoriasis, pruritus, seborrheic dermatitis, SLE, erythroderma, alopecia.

For intra-articular administration: chronic arthritis, post-traumatic arthritis, osteoarthritis of large joints, rheumatic destruction of individual joints, arthritis.

For the introduction of infiltration in the tissue: epicondylitis, tenosynovitis, bursitis, frozen shoulder, keloids, sciatica, Dupuytren's contracture, rheumatism and similar lesions of joints and various tissues.

For use in ophthalmology: allergies, chronic and atypical conjunctivitis and blepharitis; inflammation of the cornea with intact mucosa; acute and chronic inflammation of the anterior segment of the choroid, sclera and episcleritis; sympathetic inflammation of the eyeball; after injuries and operations during prolonged stimulation of eyeballs.

Dosage and administration

When Gyterna administered orally for replacement therapy in adults the initial dose is 20-30 mg, maintenance dose is 10.5 mg / day. If necessary, the initial dose is may be 15-100 mg / day, the maintenance one is 5-15 mg / day. The daily dose should be reduced gradually. For children the starting dose is 1-2 mg / kg in 4-6 receptions, the maintenance one is 300-600 mg / kg / day.

For IM or IV dose administration the multiplicity and duration of application are determined individually.

When intra-articular administration in large joints it used a dose of 25-50 mg, for medium-sized joints - 10-25 mg for small joints - 5-10 mg. For the introduction of infiltration into the tissues depending on disease severity and magnitude of the defeat use doses from 5 mg to 50 mg.

Gyterna (Prednisolone Sodium Phosphate) used topically in ophthalmology 3 times / day, course of treatment is no more than 14 days; in dermatology - 1-3 times / day.

Gyterna (Prednisolone Sodium Phosphate) side effects, adverse reactions

Endocrine system: menstrual irregularities, suppression of adrenal function, Itsenko-Cushing's syndrome, suppression of pituitary-adrenal system, reduced tolerance to carbohydrates, steroid diabetes, or a manifestation of latent diabetes, growth retardation in children, delayed sexual development in children.

Digestive system: nausea, vomiting, steroid ulcer and duodenal ulcer, pancreatitis, esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups. In rare cases - elevated liver transaminases and alkaline phosphatase.

Metabolism: the negative nitrogen balance due to protein catabolism, increased excretion of calcium from the body, hypocalcemia, weight gain, increased sweating.

Cardiovascular system: the loss of potassium, hypokalemic alkalosis, arrhythmia, bradycardia (up to cardiac arrest); steroid myopathy, heart failure (the development or worsening of symptoms), ECG changes typical of hypokalemia, increased blood pressure, hypercoagulability, thrombosis. In patients with acute myocardial infarction - the spread of necrosis, slowing the formation of scar tissue that can lead to rupture of the heart muscle.

Musculoskeletal system: slowing growth and ossification processes in children (premature closure of epiphyseal growth zones) and osteoporosis (very rarely - pathological fractures, aseptic necrosis of the humeral head and femoral), rupture of tendons of muscles, muscle weakness, steroid myopathy, loss of muscle mass (atrophy).

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

Vision: the rear subcapsular cataracts, increased intraocular pressure (with the possible damage to the optic nerve), trophic changes of the cornea, exophthalmos, the propensity to develop secondary infections (bacterial, fungal, viral).

Dermatological reactions: petechiae, ecchymosis, thinning and fragility of the skin, hyper- or hypopigmentation, acne, stretch marks, susceptibility to the development of pyoderma and candidiasis.

Reactions due to immunosuppressive effect: slow process of regeneration, reduced resistance to infections.

For parenteral administration: in rare cases of anaphylactic and allergic reactions, hyper- or hypopigmentation, atrophy of skin and subcutaneous tissue, exacerbation after intrasinovialnogo applications such as Charcot arthropathy, sterile abscesses, when injected into pockets on the head - blindness.

Gyterna contraindications

For short-term use for health reasons - increased sensitivity to Gyterna (Prednisolone 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 marked juxta-articular osteoporosis, lack of 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), the instability of the joint as a result of arthritis, aseptic necrosis of the epiphyses of bones forming the joint.

For external use only: 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 disease, trachoma, violating the integrity of ocular epithelium.

Using during pregnancy and breastfeeding

During pregnancy Gyterna (Prednisolone Sodium Phosphate) is used only for health reasons. If necessary use of Gyterna (Prednisolone Sodium Phosphate) during lactation should carefully weigh the potential benefits of treatment for both mother and child at risk.

Special instructions

With care use for parasitic and infectious diseases of viral, fungal or bacterial origin - herpes simplex, herpes zoster (viraemic phase), chicken pox, measles, amoebiasis, strongyloidiasis, systemic mycosis, active and latent tuberculosis.

Be wary of up to 8 weeks before and 2 weeks after vaccination, and lymphadenitis after BCG, with immunodeficiency (including AIDS or HIV infection).

Be wary of diseases in gastrointestinal tract: gastric ulcers and duodenal ulcers, esophagitis, gastritis, acute or latent peptic ulcer, the newly created anastomosis intestinal ulcerative colitis with the threat of perforation or abstsedirovaniya, diverticulitis. Be wary of Gyterna (Prednisolone Sodium Phosphate) use in diseases of the cardiovascular system, including after recent myocardial infarction, with decompensated congestive heart failure, hypertension, hyperlipidemia, with endocrine diseases - diabetes mellitus, hyperthyroidism, hypothyroidism, pituitary basophilia, with severe chronic renal and / or liver failure, nefrourolitiaze, with hypoalbuminemia, with systemic osteoporosis, myasthenia gravis, acute psychosis, obesity III-IV stage, in poliomyelitis, open- and closed-angle glaucoma.

If necessary, intra-articular injection with caution in patients with severe general condition, failure (or brevity) of the 2 previous injections (with regard to individual properties apply GCS). During treatment (especially long-term) it needed to monitor at eye specialist, blood pressure control and water-electrolyte balance, and the pattern of peripheral blood glucose levels; to reduce the side effects can be assigned anabolic steroids, antibiotics, and increase the flow of potassium in the body (diet, potassium containing medications).

It is recommended to clarify the need for injection of ACTH after treatment with prednisone (after a skin test).

When Addison's disease should avoid the simultaneous use of barbiturates.

After cessation of treatment it may be experience a withdrawal syndrome, adrenal insufficiency and exacerbation of the disease, about which he was appointed Gyterna (Prednisolone Sodium Phosphate) Rotexmedica.

When intercurrent infections, septic conditions, and tuberculosis, must be simultaneous antibiotic therapy.

The children in the period of growth GCS should be used only if absolutely indicated and under close medical supervision.

Externally Gyterna (Prednisolone Sodium Phosphate) should not be used for more than 14 days. In case of application for ordinary or pink acne perhaps exacerbation.

Gyterna drug interactions

Simultaneous administration of Gyterna (Prednisolone Sodium Phosphate) with: