Sulfacetamide; Prednisolone

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Sulfacetamide; Prednisolone uses

Sulfacetamide; Prednisolone consists of Prednisolone Sodium Phosphate, Sulfacetamide Sodium.

Prednisolone Sodium Phosphate:


Pharmacological action

Sulfacetamide; Prednisolone is a glucocorticosteroid (GCS). This medication inhibits the function of leukocytes and tissue macrophages. Sulfacetamide; Prednisolone (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. Sulfacetamide; Prednisolone (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. Sulfacetamide; Prednisolone (Prednisolone Sodium Phosphate) inhibits the activity of fibroblasts and collagen formation.

Sulfacetamide; Prednisolone (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.

Sulfacetamide; Prednisolone (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.

Sulfacetamide; Prednisolone (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.

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

Sulfacetamide; Prednisolone (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, Sulfacetamide; Prednisolone (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.

Sulfacetamide; Prednisolone (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.

Sulfacetamide; Prednisolone (Prednisolone Sodium Phosphate) also has catabolic effects in lymphoid and connective tissue, muscle, adipose tissue, skin, bone tissue. To a lesser extent than hydrocortisone Sulfacetamide; Prednisolone (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 Sulfacetamide; Prednisolone (Prednisolone Sodium Phosphate) is due to anti-inflammatory, antiallergic, immunosuppressive and antiproliferative action.

For external and local application the therapeutic activity of Sulfacetamide; Prednisolone (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 Sulfacetamide; Prednisolone (Prednisolone Sodium Phosphate) is 4 times greater, the mineralocorticoid activity is 0.6 times smaller.

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Pharmacokinetics

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

T1/2 is about 200 minutes.

Why is Sulfacetamide; Prednisolone 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 Sulfacetamide; Prednisolone 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.

Sulfacetamide; Prednisolone (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.

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Sulfacetamide; Prednisolone (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.

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Sulfacetamide; Prednisolone contraindications

For short-term use for health reasons - increased sensitivity to Sulfacetamide; Prednisolone (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 Sulfacetamide; Prednisolone (Prednisolone Sodium Phosphate) is used only for health reasons. If necessary use of Sulfacetamide; Prednisolone (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 Sulfacetamide; Prednisolone (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 Sulfacetamide; Prednisolone (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 Sulfacetamide; Prednisolone (Prednisolone Sodium Phosphate) should not be used for more than 14 days. In case of application for ordinary or pink acne perhaps exacerbation.

Sulfacetamide; Prednisolone drug interactions

Simultaneous administration of Sulfacetamide; Prednisolone (Prednisolone Sodium Phosphate) with:

  • salicylates may increase the likelihood of bleeding;
  • diuretics possible aggravation of violations of electrolyte metabolism;
  • hypoglycemic agents reduced the rate of decrease in blood glucose levels;
  • cardiac glycosides increases the risk of glycoside intoxication;
  • rifampin may weaken the therapeutic action of rifampicin;
  • antihypertensive drugs may reduce their effectiveness;
  • coumarin derivatives may weaken the anticoagulant effect;
  • rifampin, phenytoin, barbiturates, may weaken the effect of Sulfacetamide; Prednisolone (Prednisolone Sodium Phosphate);
  • hormonal contraceptives - strengthening of Sulfacetamide; Prednisolone (Prednisolone Sodium Phosphate);
  • acetylsalicylic acid may reduce the content of salicylates in blood;
  • praziquantel can reduce its concentration in the blood;
  • m-choline blockers (including antihistamines, tricyclic antidepressants), nitrate promotes increase in intraocular pressure;The appearance of hirsutism and acne it promotes the simultaneous use of other corticosteroids, androgens, estrogens, oral contraceptives, and anabolic steroid. The risk of developing cataracts increases with the use of corticosteroids against antipsychotic drugs, carbutamide and azathioprine.

    Sulfacetamide; Prednisolone in case of emergency / overdose

    Risk of overdose increases with prolonged use of prednisone, particularly in large doses.

    Symptoms: increased blood pressure, peripheral edema, increased side effects of the drug.

    Treatment of acute overdose: an immediate gastric lavage or induction of vomiting, specific antidote is not found.

    Treatment of chronic overdose: should reduce the dose of the drug.

  • Sulfacetamide Sodium:


    DESCRIPTION

    Sulfacetamide; Prednisolone ® ophthalmic suspension is a sterile, topical anti-inflammatory/anti-infective combination product for ophthalmic use.

    Structural Formulas

    MW=254.24 C8H9N2NaO3S·H2O MW=402.49 C23H30O6

    Structural Formulas

    Chemical Names

    Sulfacetamide; Prednisolone (Sulfacetamide Sodium) sodium: N-sulfanilylacetamide monosodium salt monohydrate.

    Prednisolone acetate: 11ß, 17, 21-trihydroxypregna-1, 4-diene-3, 20-dione 21-acetate.

    Each mL of Sulfacetamide; Prednisolone (Sulfacetamide Sodium) ® ophthalmic suspension contains:

    Actives: Sulfacetamide; Prednisolone (Sulfacetamide Sodium) sodium 10%, prednisolone acetate (microfine suspension) 0.2%.

    Inactives: benzalkonium chloride (0.004%); edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; potassium phosphate, monobasic; purified water; sodium phosphate, dibasic; sodium thiosulfate; hydrochloric acid and/or sodium hydroxide to adjust pH (6.6 to 7.2).

    CLINICAL PHARMACOLOGY

    Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antibacterial drug may be used when this inhibition is considered to be clinically significant in a particular case.

    When a decision to administer both a corticosteroid and an antibacterial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered. When both types of drugs are in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained. The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.

    Microbiology

    Sulfacetamide; Prednisolone (Sulfacetamide Sodium) sodium exerts a bacteriostatic effect against susceptible bacteria by restricting the synthesis of folic acid required for growth through competition with p-aminobenzoic acid.

    Some strains of these bacteria may be resistant to Sulfacetamide; Prednisolone (Sulfacetamide Sodium) or resistant strains may emerge in vivo.

    The anti-infective component in these products is included to provide action against specific organisms susceptible to it. Sulfacetamide; Prednisolone (Sulfacetamide Sodium) sodium is active in vitro against susceptible strains of the following microorganisms: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens.

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    INDICATIONS AND USAGE

    Sulfacetamide; Prednisolone (Sulfacetamide Sodium) ® ophthalmic suspension is a steroid/anti-infective combination drug indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

    Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.

    The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

    The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens.

    A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

    CONTRAINDICATIONS

    Sulfacetamide; Prednisolone (Sulfacetamide Sodium) ® ophthalmic suspension is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

    Sulfacetamide; Prednisolone (Sulfacetamide Sodium) ® ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides and to other corticosteroids. (Hypersensitivity to the antimicrobial component occurs at a higher rate than for other components.)

    WARNINGS

    NOT FOR INJECTION INTO THE EYE.

    Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.

    If the product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

    The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

    In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical corticosteroids.

    In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.

    The use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.

    Prolonged use of Sulfacetamide; Prednisolone (Sulfacetamide Sodium) ® ophthalmic suspension may suppress the host response and thus increase the hazard of secondary ocular infections.

    Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi.

    A significant percentage of staphylococcal isolates are completely resistant to sulfonamides.

    Acute anterior uveitis may occur in susceptible individuals, primarily Blacks.

    Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Sensitization may recur when a sulfonamide is readministered, irrespective of the route of administration.

    If signs of hypersensitivity, skin rash, or other serious reactions occur, discontinue use of this preparation. Cross-sensitivity among corticosteroids has been demonstrated.

    PRECAUTIONS

    General

    The initial prescription and renewal of the medication order beyond 20 milliliters of the suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

    The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.

    Use with caution in patients with severe dry eye.

    The p-aminobenzoic acid present in purulent exudates competes with sulfonamides and can reduce their effectiveness.

    Information for Patients

    If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

    Contact lenses should not be worn during the use of this product.

    This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the applicator tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Protect from light. Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity. Keep out of the reach of children.

    Laboratory Tests

    Eyelid cultures and tests to determine the susceptibility of organisms to Sulfacetamide; Prednisolone (Sulfacetamide Sodium) may be indicated if signs and symptoms persist or recur in spite of the recommended course of treatment with Sulfacetamide; Prednisolone (Sulfacetamide Sodium) ® ophthalmic suspension.

    Drug Interactions

    Sulfacetamide; Prednisolone ® ophthalmic suspension is incompatible with silver preparations. Local anesthetics related to p-aminobenzoic acid may antagonize the action of the sulfonamides.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Prednisolone has been reported to be noncarcinogenic. Long-term animal studies for carcinogenic potential have not been performed with Sulfacetamide; Prednisolone (Sulfacetamide Sodium).

    One author detected chromosomal nondisjunction in the yeast Saccharomyces cerevisiae following application of Sulfacetamide; Prednisolone (Sulfacetamide Sodium) sodium. The significance of this finding to topical ophthalmic use of Sulfacetamide; Prednisolone (Sulfacetamide Sodium) sodium in the human is unknown.

    Mutagenic studies with prednisolone have been negative. Studies on reproduction and fertility have not been performed with Sulfacetamide; Prednisolone (Sulfacetamide Sodium). A long-term chronic toxicity study in dogs showed that high oral doses of prednisolone prevented estrus. A decrease in fertility was seen in male and female rats that were mated following oral dosing with another glucocorticosteroid.

    Pregnancy

    Teratogenic Effects

    Animal reproduction studies have not been conducted with Sulfacetamide; Prednisolone sodium. Prednisolone has been shown to be teratogenic in rabbits, hamsters, and mice. In mice, prednisolone has been shown to be teratogenic when given in doses 1 to 10 times the human ocular dose. Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women dosed with corticosteroids.

    Kernicterus may be precipitated in infants by sulfonamides being given systemically during the third trimester of pregnancy. It is not known whether Sulfacetamide; Prednisolone (Sulfacetamide Sodium) sodium can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.

    Sulfacetamide; Prednisolone (Sulfacetamide Sodium) ® ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Nursing Mothers

    It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for serious adverse reactions in nursing infants from Sulfacetamide; Prednisolone (Sulfacetamide Sodium) sodium and prednisolone acetate ophthalmic suspensions, a decision should be made whether to discontinue nursing or to discontinue the medication.

    Pediatric Use

    Safety and effectiveness in pediatric patients below the age of 6 years have not been established.

    ADVERSE REACTIONS

    The following adverse reactions have been identified during use of Sulfacetamide; Prednisolone (Sulfacetamide Sodium) ® ophthalmic suspension. Because reactions are 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.

    Adverse reactions have occurred with corticosteroid/antibacterial combination drugs which can be attributed to the corticosteroid component, the antibacterial component, or the combination.

    Reactions occurring with Sulfacetamide; Prednisolone (Sulfacetamide Sodium) ® ophthalmic suspension include: cataract, dizziness, eye discharge, eyelid edema, eyelid erythema, eye irritation, eye pain, eye pruritus, and hypersensitivity including rash, skin pruritus, urticaria, ocular hyperemia, and visual disturbance (blurry vision).

    Reactions occurring most often from the presence of the antibacterial ingredient are allergic sensitizations. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.

    The reactions due to the corticosteroid component in decreasing order of frequency are: delayed wound healing, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, and posterior subcapsular cataract formation.

    Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical corticosteroids.

    Corticosteroid-containing preparations can also cause acute anterior uveitis or perforation of the globe. Mydriasis, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.

    Secondary Infection

    The development of secondary infection has occurred after use of combinations containing corticosteroids and antibacterials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.

    Secondary bacterial ocular infection following suppression of host responses also occurs.

    DOSAGE AND ADMINISTRATION

    SHAKE WELL BEFORE USING. Two drops should be instilled into the conjunctival sac every four hours during the day and at bedtime.

    Not more than 20 milliliters should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

    Sulfacetamide; Prednisolone (Sulfacetamide Sodium) ® dosage may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application.

    If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

    HOW SUPPLIED

    Sulfacetamide; Prednisolone (Sulfacetamide Sodium) ® (sulfacetamide sodium–prednisolone acetate ophthalmic suspension, USP) is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with white high impact polystyrene (HIPS) caps as follows:

    • 5 mL in 10 mL bottle - NDC 11980-022-05
    • 10 mL in 15 mL bottle - NDC 11980-022-10

    Note: Shake well before using.

    Storage: Store at 8°-24°C (46°-75°F) in an upright position. PROTECT FROM LIGHT. Protect from freezing.

    Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity.

    KEEP OUT OF REACH OF CHILDREN.

    Revised: 07/2017

    © 2017 Allergan. All rights reserved.

    All trademarks are the property of their respective owners.

    Irvine, CA 92612

    Made in the U.S.A.

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    Sulfacetamide; Prednisolone 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.


    Sulfacetamide; Prednisolone 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.


    Sulfacetamide; Prednisolone 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.


    Sulfacetamide; Prednisolone 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.


    Sulfacetamide; Prednisolone 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."SULFACETAMIDE SODIUM SOLUTION/ DROPS [AKORN, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    2. Dailymed."PREDNISOLONE SODIUM PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    3. Dailymed."SULFACETAMIDE: 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).

    Frequently asked Questions

    Can i drive or operate heavy machine after consuming Sulfacetamide; Prednisolone?

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

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

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