Fusid-h

Uses

Hydrocortisone is used for the use in the following conditions: Primary or secondary adrenocortical insufficiency, Acute adrenocortical insufficiency, Shock unresponsive to conventional therapy, Congenital adrenal hyperplasia, Hypercalcemia associated with cancer, Nonsuppurative thyroiditis, Rheumatic Disorders, Dermatologic Diseases (Allergic States, Severe seborrheic dermatitis, Severe psoriasis, Pemphigus, Severe erythema multiforme), Control of severe or incapacitating allergic conditions (Bronchial asthma, Contact dermatitis, Atopic dermatitis, Serum sickness, Seasonal or perennial allergic rhinitis, Drug hypersensitivity reactions, Urticarial transfusion reactions, Acute noninfectious laryngeal edema), Ophthalmic Diseases (Herpes zoster ophthalmicus, Iritis, iridocyclitis, Chorioretinitis, Diffuse posterior uveitis and choroiditis, Optic neuritis), Gastrointestinal Diseases, Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, Loeffler's syndrome, Aspiration pneumonitis, Hematologic Disorders (Acquired, autoimmune hemolytic anemia, Idiopathic thrombocytopenic purpura in adults, Secondary thrombocytopenia, Erythroblastopenia), Neoplastic Diseases (Leukemias and lymphomas in adults, Acute leukemia of childhood), Edematous States, Acute exacerbations of multiple sclerosis

Sodium fluoride is an antiseptic & anticavity mouthwash which-

• Restores enamel to strengthen teeth
• Protects teeth from cavity
• Helps to prevent tooth decay
• Controls tartar that can discolor teeth
• whitens teeth safety

Fusid-h is also used to associated treatment for these conditions: Acute Gouty Arthritis, Acute Otitis Externa, Adrenal Insufficiency, Allergic Rhinitis (AR), Allergic corneal marginal ulcers, Anal Fissures, Ankylosing Spondylitis (AS), Anterior Segment Inflammation, Aspiration Pneumonitis, Asthma, Atopic Dermatitis (AD), Berylliosis, Bullous dermatitis herpetiformis, Chorioretinitis, Choroiditis, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Corneal Inflammation, Crohn's Disease (CD), Dermatitis, Dermatitis exfoliative generalised, Dermatitis, Contact, Dermatomyositis, Dermatosis, Drug hypersensitivity reaction, Epicondylitis, Erythroblastopenia, Hemorrhoids, Herpes Labialis, Hypercalcemia of Malignancy, Idiopathic Thrombocytopenic Purpura, Infection of the Fenestration Cavity, Infection of the Mastoidectomy Cavity, Iridocyclitis, Iritis, Itching caused by Hemorrhoids, Itching of the Anus, Leukemia, Acute, Leukemias, Loeffler's syndrome, Lymphomas NEC, Malignant Lymphomas, Mycosis Fungoides (MF), Ophthalmia, Sympathetic, Optic Neuritis, Pain caused by Hemorrhoids, Pemphigus, Post-traumatic Osteoarthritis, Primary adrenocortical insufficiency, Proctitis, Proteinuria, Psoriatic Arthritis, Rectal inflammations NEC, Rheumatic heart disease, unspecified, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Seasonal Allergic Conjunctivitis, Secondary adrenocortical insufficiency, Secondary thrombocytopenia, Serum Sickness, Severe Seborrheic Dermatitis, Skin Diseases, Stevens-Johnson Syndrome, Synovitis, Systemic Lupus Erythematosus (SLE), Trichinosis, Tuberculous Meningitis, Ulcerative Colitis, Acquired immune hemolytic anemia, Acute Bursitis, Acute Tenosynovitis, Acute rheumatic carditis, Cryptitis, Disseminated Pulmonary Tuberculosis, Fulminating Pulmonary Tuberculosis, Itching skin, Non-suppurative Thyroiditis, Severe Erythema multiforme, Severe Psoriasis, Subacute Bursitis, Superficial infection of the external auditory canal with inflammation, Symptomatic Sarcoidosis, Systemic Dermatomyositis, Varicella-zoster virus acute retinal necrosis, PalliativeCaries; Enamel, Cavity, Dental Cavity, Dental Decay, Dental Health, Partial Denture Wearers Wear of the Natural Enamel, Tooth Sensitivity, Trace Element Deficiency, Wear of the Natural Enamel caused by teeth grinding, Parenteral Nutrition

How Fusid-h works

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation.[A187463] Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days.[A187463]

Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10.[A187463]

Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive.[A187463] High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.[A187463]

The prevention of dental caries by topical fluoride is achieved by various mechanisms. Sodium fluoride kills bacteria that cause caries, such a Streptococcus mutans and lactobacilli by interfering with their metabolic activities that result in the formation of lactic acid. Fluoride ions cause the inhibition of glycolytic and other enzymes involved in bacterial metabolism. It changes the permeability of cell membranes, lowering the pH in the cytoplasm of the cell, leading to a decrease in acidity, which is normally implicated in tooth decay.

When administered at low topical doses, fluoride in both saliva and plaque and saliva prevent the demineralization of healthy tooth enamel while remineralizing teeth that have previously been demineralized. Sodium fluoride is absorbed by the surface of hydroxyapatite crystals on the teeth, which are necessary for mineralization. This renders the teeth more resistant to demineralization by changing the apatite crystal solubility. Sodium fluoride inhibits the demineralization of teeth in a pH-related manner. When used in high doses, in formulations such as the fluoride varnishes or gels, sodium fluoride forms a layer on the surface of tooth enamel. When the pH of the mouth is reduced due to acid production by bacteria such as S.mutans, fluoride is released, interfering with bacterial metabolism, and then acts to remineralize the teeth.

Dosage

Fusid-h dosage

Tablet: The initial dosage of Hydrocortisone Tablets may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Hydrocortisone Tablets should be discontinued and the patient transferred to other appropriate therapy.

It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patients.After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If, after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.

Injection:

• Adult: By IM injection or slow IV injection or infusion. The initial dose of Hydrocortisone sterile powder is 100 mg to 500 mg, depending on the severity of the condition. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient's response and clinical condition.
• Children: By slow IV injection, up to 1 year 25 mg, 1-5 years 50 mg, 6-12 years 100 mg.

Rinse (gargle) with fall strength Sodium fluoride for 30 seconds with 20 ml (with the help of supplied cup) two times daily (morning and evening). Do not swallow. Don’t eat or drink within 30 minutes after rinsing with Sodium fluoride restoring.

Side Effects

Hydrocortisone is generally well tolerated except in prolonged high doses. It may cause cardiac arrhythmia, esophageal candidiasis, menstrual irregularity, decreased carbohydrate & glucose tolerance, fluid retention, increased appetite, weight gain, euphoria, mood swings, depression, insomnia, acne etc.

Hypersensitivity reactions, rash, nausea, vomiting. Products containing stannous fluoride may cause teeth staining.

Toxicity

Data regarding acute overdoses of glucocorticoids are rare. Chronic high doses of glucocorticoids can lead to the development of cataract, glaucoma, hypertension, water retention, hyperlipidemia, peptic ulcer, pancreatitis, myopathy, osteoporosis, mood changes, psychosis, dermal atrophy, allergy, acne, hypertrichosis, immune suppression, decreased resistance to infection, moon face, hyperglycemia, hypocalcemia, hypophosphatemia, metabolic acidosis, growth suppression, and secondary adrenal insufficiency. Overdose may be treated by adjusting the dose or stopping the corticosteroid as well as initiating symptomatic and supportive treatment.

The oral LD50 of sodium fluoride is 44 mg/kg in mice and 31 mg/kg in rats. The oral LD50 of sodium fluoride in rabbits is 200 mg/kg.

Overdose information

The ingestion of toothpaste is the major cause of sodium fluoride overdose. This is followed by sodium fluoride supplements and mouth rinses. Most causes of sodium fluoride toxicity have been observed in children under the age of 6 years old. The manifestations of a sodium fluoride overdose may include gastrointestinal disturbance, abdominal pain, alterations in taste, seizures, salivation, bradycardia, tachycardia, headache, tremor, and shallow breathing. Gastrointestinal bleeding may also occur in addition to a sensation of burning in the mouth. Hypotension, bronchospasm, fixed mydriasis, and elevated potassium can also occur which, in turn, may lead to arrhythmias and cardiac arrest.

Management

If a dose greater than 5 mg fluoride per kilogram of body weight (2.3 mg fluoride per pound of body weight) has been taken, it is advisable to induce vomiting. Administer calcium in an oral, soluble form (for example, 5% calcium gluconate, a solution of calcium lactate, or milk). The patient should seek immediate medical attention. If a sodium fluoride ingestion of 15 mg fluoride/kg of body weight or more occurs (i.e. higher than 6.9 mg fluoride per pound), immediately induce vomiting, provide supportive care, and admit the patient to the hospital for observation.

Precaution

Hydrocortisone should be used with caution in patients with a history of peptic ulceration as it increases the incidence of peptic ulceration. This drug should be used with caution in patients with congestive heart failure, hypertension, glaucoma, diabetic mellitus and epilepsy.

Prolonged treatment with large amounts of fluoride may result in dental fluorosis and osseous changes; do not exceed recommended dosage. Renal impairment. Pregnancy.

Interaction

Drug interaction of hydrocortisone has been reported with amphotericin B, potassium-depleting agents, macrolide antibiotics, warfarin, antidiabetics, isoniazid, digitalis glycosides, estrogens, barbiturates, phenytoin, carbamazepine, ketoconazole, aspirin etc.

Absorption of fluoride may be reduced by aluminium, calcium and magnesium salts.

Volume of Distribution

Total hydrocortisone has a volume of distribution of 39.82L, while the free fraction has a volume of distribution of 474.38L.

Fluoride distributes to the saliva, bones, and teeth, and is also found in lesser quantities in the breastmilk and sweat. After the ingestion of sodium fluoridated drinking water, the fluoride ions are found to distribute to the plasma and blood cells. Plasma levels of fluoride concentrations are twice as the concentrations found in blood cells. Adults have been found to retain 36% of ingested fluoride and children have been found to retain about 50% of a dose. Most of the retained fluoride is localized to bone and teeth and 1% accumulates in soft tissues. Fluoride crosses the placenta and the blood-brain barrier. The central nervous system concentrations of sodium fluoride are estimated to reach 20% the plasma concentrations. Studies conducted in communities with high levels of fluoride in water did not show any increase in birth defects. The placenta is able to regulate the accumulation of excess fluoride, possibly protecting the fetus from high levels of fluoride. Despite this, excessively high exposure to fluoride in utero may lead to skeletal fluorosis.

Elimination Route

Oral hydrocortisone at a dose of 0.2-0.3mg/kg/day reached a mean C_max of 32.69nmol/L with a mean AUC of 90.63h*nmol/L A 0.4-0.6mg/kg/day dose reached a mean C_max of 70.81nmol/L with a mean AUC of 199.11h*nmol/L. However, the pharmacokinetics of hydrocortisone can vary by 10 times from patient to patient.

Topical hydrocortisone cream is 4-19% bioavailable[8546995] with a T_max of 24h.

Hydrocortisone retention enemas are have a bioavailability of 0.810 for slow absorbers and 0.502 in rapid absorbers. Slow absorbers take up hydrocortisone at a rate of 0.361±0.255/h while fast absorbers take up hydrocortisone at a rate of 1.05±0.255/h.

A 20mg IV dose of hydrocortisone has an AUC of 1163±277ng*h/mL.

Sodium fluoride is 90% absorbed from the gastrointestinal tract, with 77% of absorption in the proximal intestine and about 25% in the stomach. The rate of absorption may vary according to gastric pH. Cmax is reached 20-60 minutes after ingestion. Cmax was estimated to be 848 ± 116 ng/mL after a 20mg sodium fluoride solution was ingested, with a Tmax of 0.46 ± 0.17 hours. The bioavailability of sodium fluoride tablets administered in the fasted state during one pharmacokinetic study approached 100%. Another resource reports a sodium fluoride AUC of 1.14 ± 0.12 μg × h/mL after the ingestion of fluoridated water.

Half Life

Total hydrocortisone via the oral route has a half life of 2.15h while the free fraction has a half life of 1.39h. A 20mg IV dose of hydrocortisone has a terminal half life of 1.9±0.4h.

The terminal plasma elimination half-life following the ingestion of fluoridated drinking water generally ranges from 3 to 10 hours. The half-life of sodium fluoride in the bones is 20 years.

Clearance

Total hydrocortisone by the oral route has a mean clearance of 12.85L/h, while the free fraction has a mean clearance of 235.78L/h. A 20mg IV dose of hydrocortisone has a clearance of 18.2±4.2L/h.

Sodium fluoride is rapidly cleared by the kidneys and depends on various factors, including glomerular filtration rate, urine flow, and urine pH. According to one clinical study evaluating the pharmacokinetics of oral sodium fluoride tablets in healthy young adults, the renal clearance was determined to be 77.4 ± 11.2mL/min for acidic urine and 78.4 ± 6.9mL/min for alkaline urine. Another reference estimates the renal clearance of fluoride ions from sodium fluoridated water at 35–45 mL/min.

Elimination Route

Corticosteroids are eliminated predominantly in the urine.[A187436] However, data regarding the exact proportion is not readily available.

Sodium fluoride is rapidly excreted, mainly in the urine. About 90% of fluoride is filtered by the glomerulus and reabsorbed by the renal tubules. About 10% is excreted in the feces.

Pregnancy & Breastfeeding use

Pregnancy category C. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in nursing mother: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Contraindication

Hydrocortisone is contraindicated in severe systemic fungal infections and patients with known hypersensitivity to any component of this product.

Not to use 1 mg tablets in children less then 3 yr of age or when drinking water fluoride content is >= 0.3 ppm.

Special Warning

Use in elderly patients: Clinical studies were not done in patients’ aged 65 and above. In general dose selection for an elderly patients should be cautious, usually starting at the low end of the dosing range.

Acute Overdose

In acute poisoning, symptoms include a salty or soapy taste, increased salivation, GI disturbances, abdominal pain, weakness, drowsiness, faintness and shallow breathing; more serious effects include hypocalcaemia, hypomagnesaemia, hyperkalaemia, tremors, convulsions, cardiac arrhythmias, shock, respiratory arrest and cardiac failure. Death may occur within 2-4 hr. Treatment includes gastric lavage with lime water or a weak solution of another calcium salt to precipitate fluoride. Maintain high urine output, slow IV inj of calcium gluconate 10% may be used for hypocalcaemia and tetany. Magnesium sulfate may be given to treat hypomagnesaemia, and aluminium hydroxide may help to reduce fluoride absorption. Haemodialysis may be considered. Chronic fluoride poisoning may cause skeletal fluorosis resulting in bone pain, stiffness, limited movment and in severe cases, crippling deformities. In children, prolonged excessive intake during tooth development before eruption may cause dental fluorosis characterised by mottled enamel.

Storage Condition

Store at 15-30°C.

Store in tight plastic containers.

Innovators Monograph

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