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Corticosteroid

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Betamethasone phosphate has a short duration of action as it is rapidly hydrolyzed to betamethasone. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.

Short term treatment:

• 2000-3000 mcg (4-6 tablets) daily for the first few days, then
• Your doctor may reduce the daily dose by 250-500 mcg (1/2 or 1 tablet) every two to five days, depending upon the response.

Rheumatoid arthritis:

• 500-2000 mcg (1-4 tablets) daily
• For long-term treatment the dose may be lower.

Most other conditions:

• 1500-5000 mcg (3-10 tablets) daily for one to three weeks
• Your doctor may then gradually reduce this to a lower dose
• Larger doses may be needed for mixed connective tissue diseases and ulcerative colitis
• If you need to take half a tablet you should break one in half. Use the break line on one side of the tablet to help you snap it.

Feeling depressed, including thinking about suicide; Feeling high (mania) or moods that go up and down; Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory; Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

Do not take Betamethasone Soluble Tablets:

• if you are allergic to betamethasone or any of the other ingredients of this medicine
• if you have an infection and have not yet started taking medicine (e.g. antibiotics) to treat it.

Talk to your doctor, pharmacist or nurse before taking Betamethasone Soluble Tablets-

• if you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Betamethasone Soluble Tablets;
• if any of your close family has had these illnesses;
• if you have or have ever had tuberculosis (TB);
• if you have epilepsy (fits), severe mental illness, heart disease, hypertension (high blood pressure), stomach or duodenal ulcers;
• if you have osteoporosis (thinning of the bones). Post menopausal women are particularly at risk of this;
• if you or any of your family have ever had glaucoma (raised eye pressure);
• if you have recently had a heart attack;
• if you have recently been in contact with someone who has chickenpox, shingles or measles or recently had chickenpox, shingles or measles yourself. This product may make chickenpox, shingles or measles much worse;
• if you or any of your family are diabetic;
• if you have an underactive thyroid gland;
• if you have myasthenia gravis (a disease which causes muscle weakness);
• if you have ever suffered from muscle wasting due to corticosteroids;
• if you have liver, kidney or heart disease;
• if you have just been or are about to be immunised;
• if you have an infection;
• if you are pregnant or breast-feeding
• if you experience blurred vision or other visual disturbances.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Taking steroids often or for a long time during pregnancy can slow the baby’s growth in the womb or may temporarily affect the baby’s heart and body movements. If you are breast-feeding, the steroid may enter the baby and lower their hormone levels, if you are taking high doses for a long time.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Do not store above 25ºC.

Corticosteroid

Betamethasone Valerate BP is a synthetic adrenocorticosteroid, which is glucocorticoid in nature. It is an analog of prednisolone that also possesses a slight degree of mineral corticosteroid activity. Due to its anti-inflammatory, antipruritic and vasoconstrictive activity, it is very effective and suitable for dermatological use. It is absorbed from the skin and inflammation and/or another disease process in the skin increase percutaneous absorption from the skin. Occlusive dressings substantially increase its percutaneous absorption.

Apply sparingly to the affected area two or three times daily until improvement occurs, then twice daily or less. The usual maximum duration of therapy is three weeks.

The following local adverse reactions are more common with the use of high doses, long term use and with the use of occlusive dressings of Cream/Ointment: dryness, itching, burning, skin thinning, local irritation, features of hypercorticolism, telagiectasia, striaea, skin atrophy. hypertrichosis, change in pigmentation, secondary infection, perioral dermatiis, allergic contact dermatitis, maceration of the skin, acneform eruption, exacerbation of symptoms.

Betamethasone Valerate cream or ointment is contraindicated in the following conditions :

• Hypersensitivity to any of the ingredients in the preparation.
• Rosaceae & acne vulgaris.
• Perioral dermatitis, perianal & genital pruritis.
• Viral infections of the skin, e.g. herpes simplex & chicken pox.
• Primary infected skin lesions caused by fungi or bacteria.
• Dermatoses in children under one year of age.

Betamethasone Cream/Ointment is usually well tolerated but if signs of hypersensitivity appear, application should be stopped. Long term continuous topical therapy should be avoided where possible, particularly in children as adrenal suppression may occur even without occlusion. When extensive areas are treated, sufficient systemic absorption may occur to produce symptoms of hypercorticolism. This effect is more likely if occlusive dressings are used, or if the treatment is prolonged. The face or other areas of the body may exhibit atrophic changes after prolonged treatment. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. Any spread of the infection requires withdrawal of topical corticosteroid therapy.

There are no significant drug interactions reported with Betamethasone Cream/Ointment.

It should not be used extensively in pregnancy.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Corticosteroid

Betamethasone Valerate BP is a synthetic adrenocorticosteroid, which is glucocorticoid in nature. It is an analog of prednisolone that also possesses a slight degree of mineral corticosteroid activity. Due to its anti-inflammatory, antipruritic and vasoconstrictive activity, it is very effective and suitable for dermatological use. It is absorbed from the skin and inflammation and/or another disease process in the skin increase percutaneous absorption from the skin. Occlusive dressings substantially increase its percutaneous absorption.

Apply sparingly to the affected area two or three times daily until improvement occurs, then twice daily or less. The usual maximum duration of therapy is three weeks.

The following local adverse reactions are more common with the use of high doses, long term use and with the use of occlusive dressings of Cream/Ointment: dryness, itching, burning, skin thinning, local irritation, features of hypercorticolism, telagiectasia, striaea, skin atrophy. hypertrichosis, change in pigmentation, secondary infection, perioral dermatiis, allergic contact dermatitis, maceration of the skin, acneform eruption, exacerbation of symptoms.

Betamethasone Valerate cream or ointment is contraindicated in the following conditions :

• Hypersensitivity to any of the ingredients in the preparation.
• Rosaceae & acne vulgaris.
• Perioral dermatitis, perianal & genital pruritis.
• Viral infections of the skin, e.g. herpes simplex & chicken pox.
• Primary infected skin lesions caused by fungi or bacteria.
• Dermatoses in children under one year of age.

Betamethasone Cream/Ointment is usually well tolerated but if signs of hypersensitivity appear, application should be stopped. Long term continuous topical therapy should be avoided where possible, particularly in children as adrenal suppression may occur even without occlusion. When extensive areas are treated, sufficient systemic absorption may occur to produce symptoms of hypercorticolism. This effect is more likely if occlusive dressings are used, or if the treatment is prolonged. The face or other areas of the body may exhibit atrophic changes after prolonged treatment. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. Any spread of the infection requires withdrawal of topical corticosteroid therapy.

There are no significant drug interactions reported with Betamethasone Cream/Ointment.

It should not be used extensively in pregnancy.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Corticosteroid

Betamethasone Valerate BP is a synthetic adrenocorticosteroid, which is glucocorticoid in nature. It is an analog of prednisolone that also possesses a slight degree of mineral corticosteroid activity. Due to its anti-inflammatory, antipruritic and vasoconstrictive activity, it is very effective and suitable for dermatological use. It is absorbed from the skin and inflammation and/or another disease process in the skin increase percutaneous absorption from the skin. Occlusive dressings substantially increase its percutaneous absorption.

Apply sparingly to the affected area two or three times daily until improvement occurs, then twice daily or less. The usual maximum duration of therapy is three weeks.

The following local adverse reactions are more common with the use of high doses, long term use and with the use of occlusive dressings of Cream/Ointment: dryness, itching, burning, skin thinning, local irritation, features of hypercorticolism, telagiectasia, striaea, skin atrophy. hypertrichosis, change in pigmentation, secondary infection, perioral dermatiis, allergic contact dermatitis, maceration of the skin, acneform eruption, exacerbation of symptoms.

Betamethasone Valerate cream or ointment is contraindicated in the following conditions :

• Hypersensitivity to any of the ingredients in the preparation.
• Rosaceae & acne vulgaris.
• Perioral dermatitis, perianal & genital pruritis.
• Viral infections of the skin, e.g. herpes simplex & chicken pox.
• Primary infected skin lesions caused by fungi or bacteria.
• Dermatoses in children under one year of age.

Betamethasone Cream/Ointment is usually well tolerated but if signs of hypersensitivity appear, application should be stopped. Long term continuous topical therapy should be avoided where possible, particularly in children as adrenal suppression may occur even without occlusion. When extensive areas are treated, sufficient systemic absorption may occur to produce symptoms of hypercorticolism. This effect is more likely if occlusive dressings are used, or if the treatment is prolonged. The face or other areas of the body may exhibit atrophic changes after prolonged treatment. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. Any spread of the infection requires withdrawal of topical corticosteroid therapy.

There are no significant drug interactions reported with Betamethasone Cream/Ointment.

It should not be used extensively in pregnancy.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Corticosteroid

Betamethasone Valerate BP is a synthetic adrenocorticosteroid, which is glucocorticoid in nature. It is an analog of prednisolone that also possesses a slight degree of mineral corticosteroid activity. Due to its anti-inflammatory, antipruritic and vasoconstrictive activity, it is very effective and suitable for dermatological use. It is absorbed from the skin and inflammation and/or another disease process in the skin increase percutaneous absorption from the skin. Occlusive dressings substantially increase its percutaneous absorption.

Apply sparingly to the affected area two or three times daily until improvement occurs, then twice daily or less. The usual maximum duration of therapy is three weeks.

The following local adverse reactions are more common with the use of high doses, long term use and with the use of occlusive dressings of Cream/Ointment: dryness, itching, burning, skin thinning, local irritation, features of hypercorticolism, telagiectasia, striaea, skin atrophy. hypertrichosis, change in pigmentation, secondary infection, perioral dermatiis, allergic contact dermatitis, maceration of the skin, acneform eruption, exacerbation of symptoms.

Betamethasone Valerate cream or ointment is contraindicated in the following conditions :

• Hypersensitivity to any of the ingredients in the preparation.
• Rosaceae & acne vulgaris.
• Perioral dermatitis, perianal & genital pruritis.
• Viral infections of the skin, e.g. herpes simplex & chicken pox.
• Primary infected skin lesions caused by fungi or bacteria.
• Dermatoses in children under one year of age.

Betamethasone Cream/Ointment is usually well tolerated but if signs of hypersensitivity appear, application should be stopped. Long term continuous topical therapy should be avoided where possible, particularly in children as adrenal suppression may occur even without occlusion. When extensive areas are treated, sufficient systemic absorption may occur to produce symptoms of hypercorticolism. This effect is more likely if occlusive dressings are used, or if the treatment is prolonged. The face or other areas of the body may exhibit atrophic changes after prolonged treatment. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. Any spread of the infection requires withdrawal of topical corticosteroid therapy.

There are no significant drug interactions reported with Betamethasone Cream/Ointment.

It should not be used extensively in pregnancy.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Corticosteroid

Betamethasone Valerate BP is a synthetic adrenocorticosteroid, which is glucocorticoid in nature. It is an analog of prednisolone that also possesses a slight degree of mineral corticosteroid activity. Due to its anti-inflammatory, antipruritic and vasoconstrictive activity, it is very effective and suitable for dermatological use. It is absorbed from the skin and inflammation and/or another disease process in the skin increase percutaneous absorption from the skin. Occlusive dressings substantially increase its percutaneous absorption.

Apply sparingly to the affected area two or three times daily until improvement occurs, then twice daily or less. The usual maximum duration of therapy is three weeks.

The following local adverse reactions are more common with the use of high doses, long term use and with the use of occlusive dressings of Cream/Ointment: dryness, itching, burning, skin thinning, local irritation, features of hypercorticolism, telagiectasia, striaea, skin atrophy. hypertrichosis, change in pigmentation, secondary infection, perioral dermatiis, allergic contact dermatitis, maceration of the skin, acneform eruption, exacerbation of symptoms.

Betamethasone Valerate cream or ointment is contraindicated in the following conditions :

• Hypersensitivity to any of the ingredients in the preparation.
• Rosaceae & acne vulgaris.
• Perioral dermatitis, perianal & genital pruritis.
• Viral infections of the skin, e.g. herpes simplex & chicken pox.
• Primary infected skin lesions caused by fungi or bacteria.
• Dermatoses in children under one year of age.

Betamethasone Cream/Ointment is usually well tolerated but if signs of hypersensitivity appear, application should be stopped. Long term continuous topical therapy should be avoided where possible, particularly in children as adrenal suppression may occur even without occlusion. When extensive areas are treated, sufficient systemic absorption may occur to produce symptoms of hypercorticolism. This effect is more likely if occlusive dressings are used, or if the treatment is prolonged. The face or other areas of the body may exhibit atrophic changes after prolonged treatment. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. Any spread of the infection requires withdrawal of topical corticosteroid therapy.

There are no significant drug interactions reported with Betamethasone Cream/Ointment.

It should not be used extensively in pregnancy.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

This cream is usually useful for the treatment of superficial infections caused by gram-positive and gramnegative microorganisms. It is also useful in burns, regeneration of new skin in wounds and ulceration, otitis externa, postoperative infections, neuro-dermatitis and eczema. It may be used as an adjunct to systemic steroid therapy in special kind of pyoderma.

Aural steroid & antibiotic combined preparations

Betamethasone is an active topical corticosteroid, which produces a rapid response in the inflammatory dermatoses and cures psoriasis types of skin diseases. Neomycin Sulfate is a topical broad-spectrum bactericidal amino-glycoside effective against various kinds of gram-positive and gramnegative pathogens such as Proteus vulgaris, Staphylococcus aureus etc. This preparation has effective penetration and uniform distribution capacity, so it is very effective in hairy and intertriginous places. This preparation is very effective for the treatment of wet ulceration of the skin.

Use in adults: This preparation should be applied to the affected parts of the skin as a thin layer for 3 to 4 times daily. In chronic conditions, withdrawal of treatment is carried out by decreasing the frequency of application until the cream is applied as infrequently as once a week. Or as directed by the physician.

Use in children: Do not use it on children under 1 year of age. A course of treatment for a child should not normally last more than 5 days unless otherwise stated by your physician.

This preparation is well tolerated. But prolonged and high doses may cause Cushing's syndrome, acne, thinning and dilatation of blood vessels, particularly when occlusive dressings are used.

This preparation is contraindicated to the patients who are hypersensitive to any of its components. It should not be used for the treatment of otitis externa when the eardrum is perforated. It is contraindicated in skin lesions caused by infection with viruses and fungi.

Long term continuous topical therapy of this preparation should be avoided, which may produce many resistant micro organisms. So, accurate dose of this preparation should be used in infected areas only.

There are no significant drug interactions reported with Betamethasone Valerate BP and Neomycin Sulphate BP Cream/Ointment.

This preparation should not be used extensively in pregnancy.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

This cream is usually useful for the treatment of superficial infections caused by gram-positive and gramnegative microorganisms. It is also useful in burns, regeneration of new skin in wounds and ulceration, otitis externa, postoperative infections, neuro-dermatitis and eczema. It may be used as an adjunct to systemic steroid therapy in special kind of pyoderma.

Aural steroid & antibiotic combined preparations

Betamethasone is an active topical corticosteroid, which produces a rapid response in the inflammatory dermatoses and cures psoriasis types of skin diseases. Neomycin Sulfate is a topical broad-spectrum bactericidal amino-glycoside effective against various kinds of gram-positive and gramnegative pathogens such as Proteus vulgaris, Staphylococcus aureus etc. This preparation has effective penetration and uniform distribution capacity, so it is very effective in hairy and intertriginous places. This preparation is very effective for the treatment of wet ulceration of the skin.

Use in adults: This preparation should be applied to the affected parts of the skin as a thin layer for 3 to 4 times daily. In chronic conditions, withdrawal of treatment is carried out by decreasing the frequency of application until the cream is applied as infrequently as once a week. Or as directed by the physician.

Use in children: Do not use it on children under 1 year of age. A course of treatment for a child should not normally last more than 5 days unless otherwise stated by your physician.

This preparation is well tolerated. But prolonged and high doses may cause Cushing's syndrome, acne, thinning and dilatation of blood vessels, particularly when occlusive dressings are used.

This preparation is contraindicated to the patients who are hypersensitive to any of its components. It should not be used for the treatment of otitis externa when the eardrum is perforated. It is contraindicated in skin lesions caused by infection with viruses and fungi.

Long term continuous topical therapy of this preparation should be avoided, which may produce many resistant micro organisms. So, accurate dose of this preparation should be used in infected areas only.

There are no significant drug interactions reported with Betamethasone Valerate BP and Neomycin Sulphate BP Cream/Ointment.

This preparation should not be used extensively in pregnancy.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Betamethasone & Combined preparations

Betamethasone Dipropionate is a potent topically-active corticosteroid producing prompt, marked and prolonged anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive properties, without curing the underlying condition. These effects can be enhanced under occlusive conditions due to increased penetration of stratum corneum (by approximately a factor of 10).

Calcipotriol is a non-steroidal antipsoriatic agent, derived from vitamin D. Calcipotriol exhibits a vitamin D-like effect by competing for the 1,25(OH)₂D₃ receptor. Calcipotriol is as potent as 1,25(OH)₂D₃, the naturally occurring active form of vitamin D, in regulating cell proliferation and cell differentiation, but much less active than 1,25(OH)₂D₃ in its effect on calcium metabolism. Calcipotriol induces differentiation and suppresses proliferation (without any evidence of a cytotoxic effect) of keratinocytes, thus reversing the abnormal keratinocyte changes in psoriasis. The therapeutic goal envisaged with Calcipotriol is thus a normalization of epidermal growth.

Ointment: This Ointment is indicated for topical use only. The phototoxic effects have not been studied in psoriasis patients. All psoriasis-affected areas treated with this Ointment should be, where possible, protected from direct sunlight and UV-light with items of clothing.

• Adults: This ointment should be applied topically to the affected area once daily. The maximum daily dose should not exceed 15 gm. The maximum recommended weekly dose of ointment is 100 gm/week. The treated area should not be more than 30% of the body surface. The use of this ointment should be intermittent for up to one year under close medical supervision. Treatment should be limited to four week periods with Calcipotriol used alone for one month between periods of use of this ointment as needed.
• Children: This ointment is not recommended for use in children and adolescents below the age of 18 years.

Topical Suspension: Apply required quantity of spray of Topical Suspension once daily to the affected areas and gently rub in using the tips of the fingers. Treatment may be continued for up to 8 weeks. Treatment may be discontinued earlier, if symptoms are cleared. The maximum weekly dose should not exceed 100 gm. Shake before use. This Topical Suspension is not for oral, ophthalmic or intravaginal use.

The most common adverse reactions are folliculitis and burning sensation of skin.

Betamethasone and Calcipotriol containing preparation is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It is also contraindicated in patients with known disorders of calcium metabolism. Patients with severe renal insufficiency or severe hepatic disorders are also contraindicated.

Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize. Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and unmask latent diabetes. Rate of adrenal suppression increased with treatment duration. Systemic absorption may require evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption. Local adverse reactions may include atrophy, striae, irritation, acne form eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids. Use is not recommended on face, axillae, groin or where atrophy is present. Children may be more susceptible to systemic toxicity when treated with topical corticosteroids.

Additive adverse effects when used with other steroids.

There are no adequate and well-controlled studies in pregnant women. Ointment or suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcipotriol and Betamethasone ointment or suspension is administered to a nursing woman.

Store in a cool (below 25ºC) & dry place & protect from light. Do not refrigerate. Keep out of the reach of children.

This topical preparation is indicated for the topical treatment of inflammatory dermal infections like-

• Tinea pedis
• Tinea cruris
• Tinea corporis etc.

Betamethasone & Combined preparations

Clotrimazole is a broad-spectrum antifungal agent used for the treatment of superficial infections caused by species of pathogenic dermatophytes, yeasts and Malassezia furfur. The mechanism of action involves inhibition of the synthesis of ergosterol, a major sterol in the fungal cell membrane. This leads to instability of the cell membrane and eventual death of the fungus. Betamethasone dipropionate is a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. But the exact mechanism of action of corticosteroids is not clearly known.

Sufficient topical preparation should be applied onto the affected and surrounding skin areas twice a day, in the morning and evening, for 2 weeks in tinea cruris and tinea corporis and for 4 weeks in tinea pedis. The use of this cream for longer than four weeks is not recommended.

The safety and effectiveness of the preparation have not been established in children below the age of 12 years.

Adverse reactions reported for the preparation in clinical trials were paresthesia in 1.9% of patients, rash, edema and secondary infection, each in less than 1% of patients. Other adverse reactions reported with the preparation were burning and dry skin in 1.6% of patients and stinging in less than 1% of patients

This topical preparation is contraindicated to those patients who are sensitive to any of its components or to other corticosteroids or to imidazoles. If irritation or sensitization develops with the use of the cream, treatment should be discontinued and appropriate therapy instituted. The cream is contraindicated in facial rosacea, acne vulgaris, perioral dermatits, perianal and genital pruritus, napkin eruptions and bacterial or viral infections. Systemic absorption of topical corticosteroides can produce reversible hypothalmic-pituitary-adrenal (HPA) axis suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug or to reduce the frequency of application. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their large skin surface to body mass ratios.

No information is available of drug interaction.

There is inadequate evidence of safety in pregnancy. Clotrimazole has no teratogenic effect in animals but is foetotoxic at high oral doses. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. Hence the cream should only be used in pregnancy if the benefit justifies the potential risk to the fetus and such use should not be extensive,i.e. in large amounts or for long periods. It is not known whether the components of the preparation are excreted in human milk and therefore caution should be exercised when treating nursing mothers.

Acute overdose with the cream is unlikely and would not be expected to lead to a life-threatening situation. The cream should not be used for longer than the prescribed time period.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Betrixaban is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness and at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

Anti-platelet drugs

Betrixaban is a factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. Betrixaban inhibits free factor Xa and prothrombinase activity. By directly inhibiting factor Xa, Betrixaban decreases thrombin generation (TG). Betrixaban has no direct effect on platelet aggregation.

The recommended dose of Betrixaban is an initial single dose of 160 mg, followed by 80 mg once daily. Daily oral doses should be given at the same time of day with food. The recommended duration of treatment is 35 to 42 days.

Most common adverse reaction is bleeding, epidural or spinal hematoma may develop during spinal/epidural anesthesia or puncture.

Betrixaban is contraindicated in patients with active pathological bleeding. It is also contraindicated in patients with severe hypersensitivity reaction to Betrixaban

Risk of Bleeding: Can cause bleeding. Promptly evaluate any signs or symptoms of blood loss.

Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. Do not remove an epidural catheter earlier than 72 hours after the last administration of Betrixaban. Do not administer the next Betrixaban dose earlier than 5 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of Betrixaban for 72 hours.

Severe Renal Impairment: Increase risk of bleeding events.

Concomitant P-gp Inhibitors: Increase risk of bleeding events.

P-gp Inhibitors: Increase the blood level of Betrixaban.
P-gp Inducers: Decrease the blood level of Betrixaban.
Anticoagulants, Antiplatelets and Thrombolytics: May increase the risk of bleeding

Use in Pregnancy: There are no data with the use of Betrixaban in pregnant women, but treatment is likely to increase the risk of hemorrhage during pregnancy and delivery.

Lactation: No data are available regarding the presence of Betrixaban or its metabolites in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.

Patients with Severe Renal Impairment: No dose adjustment is needed for mild or moderate renal impairment (CrCl>30 mL/min). For patients with severe renal impairment (CrCl≥15 to <30 mL/min) the recommended dose of Betrixaban is an initial single dose of 80 mg followed by 40 mg once daily.

Patients with Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Avoid use in patients with moderate to severe hepatic impairment.

Protect from light and moisture, store below 30°C. Keep the medicine out of reach of children.

Betrixaban is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness and at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

Anti-platelet drugs

Betrixaban is a factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. Betrixaban inhibits free factor Xa and prothrombinase activity. By directly inhibiting factor Xa, Betrixaban decreases thrombin generation (TG). Betrixaban has no direct effect on platelet aggregation.

The recommended dose of Betrixaban is an initial single dose of 160 mg, followed by 80 mg once daily. Daily oral doses should be given at the same time of day with food. The recommended duration of treatment is 35 to 42 days.

Most common adverse reaction is bleeding, epidural or spinal hematoma may develop during spinal/epidural anesthesia or puncture.

Betrixaban is contraindicated in patients with active pathological bleeding. It is also contraindicated in patients with severe hypersensitivity reaction to Betrixaban

Risk of Bleeding: Can cause bleeding. Promptly evaluate any signs or symptoms of blood loss.

Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. Do not remove an epidural catheter earlier than 72 hours after the last administration of Betrixaban. Do not administer the next Betrixaban dose earlier than 5 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of Betrixaban for 72 hours.

Severe Renal Impairment: Increase risk of bleeding events.

Concomitant P-gp Inhibitors: Increase risk of bleeding events.

P-gp Inhibitors: Increase the blood level of Betrixaban.
P-gp Inducers: Decrease the blood level of Betrixaban.
Anticoagulants, Antiplatelets and Thrombolytics: May increase the risk of bleeding

Use in Pregnancy: There are no data with the use of Betrixaban in pregnant women, but treatment is likely to increase the risk of hemorrhage during pregnancy and delivery.

Lactation: No data are available regarding the presence of Betrixaban or its metabolites in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.

Patients with Severe Renal Impairment: No dose adjustment is needed for mild or moderate renal impairment (CrCl>30 mL/min). For patients with severe renal impairment (CrCl≥15 to <30 mL/min) the recommended dose of Betrixaban is an initial single dose of 80 mg followed by 40 mg once daily.

Patients with Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Avoid use in patients with moderate to severe hepatic impairment.

Protect from light and moisture, store below 30°C. Keep the medicine out of reach of children.

Short-term treatment of steroid responsive in inflammatory conditions of the eye after clinical exclusion of bacterial, viral or fungal infections. Non-infected inflammatory conditions of the ear or nose.

Corticosteroid

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Betamethasone phosphate has a short duration of action as it is rapidly hydrolyzed to betamethasone. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.

Eye: 1 or 2 drops to each affected eye every 1 or 2 hours until control is achieved, then the frequency may be reduced.
Ear: 2 or 3 drops to each affected ear every 2 or 3 hours until control is achieved, then the frequency may be reduced.
Nose: 2 or 3 drops instilled into each nostril 2 or 3 times daily.

Hypersensitivity reactions may occur leading to irritation, burning, stinging, itching and dermatitis. Topical corticosteroid use may result in corneal ulceration, increased intraocular pressure leading to optic nerve damage, reduced visual acuity. Intensive or prolonged use of topical corticosteroids may lead to formation of posterior subcapsular cataracts. In those diseases causing thinning of the cornea or sclera, corticosteroid therapy may result in thinning of the globe leading to perforation. Mydriasis, ptosis and epithelial punctate keratitis have also been reported following ophthalmic use of corticosteroids.

Topical corticosteroids should never be given for an undiagnosed red eye. Ophthalmic treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.

Specific drug interaction studies have not been conducted.

There are no adequate and well controlled studies for pregnant woman. It should not be used extensively in pregnant woman. There is no information available whether it is secreted in the milk or not.

Long-term intensive topical use may lead to systemic effects.

This should be protected from light, store below 25°C. Keep out of reach of children. Do not use more than 4 weeks after opening.

Ophthalmic steroid - antibiotic combined preparations

Betamethasone is a corticosteroid which is effective in inflammatory dermatoses. It is also effective in less responsive conditions such as psoriasis.  Betamethasone has a 16β-methyl group that enhances the anti-inflammatory action of the molecule and reduces the sodium and water retaining properties of the fluorine atom bound at carbon 9.

Neomycin sulfate is bactericidal against many bacteria which are commonly associated with skin infections. Neomycin is a broad spectrum antibiotic which actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30s subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30s subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.

Drops:

• Eye: 1 drop instilled into the eye every one or two hours until control is achieved, when the frequency may be reduced.
• Ear: 2 or 3 drops instilled into the ear, every two or three hours until control is achieved, when the frequency can be reduced.
• Nose: 2 or 3 drops instilled into each nostril two or three times daily.

Eye Ointment: It should be applied thinly and evenly to the conjunctival sac at night (If eye drops used during day) or 3-4 times daily (if ointment used alone).

Acute sensitization to neomycin is a rare event but can occur after topical application to the eye. Eye drops containing corticosteroids cause a serious rise in intra-ocular pressure in a small percentage of the population, including most of those with a family history of glaucoma. A milder rise may be experienced by a larger proportion of subjects if treatment is continued for longer than a few weeks. Thinning of the cornea leading to perforation has occurred with use of topical corticosteroids. Cataract is reported to have occurred after unduly prolonged treatment of eye conditions with topical corticosteroids.

Viral, fungal, tuberculous or purulent conditions. Use in the eye is contra-indicated if glaucoma is present or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Inadvertent use of topical steroids in the latter condition can lead to extension of the ulcer and marked visual deterioration. Preparations containing neomycin should not be used for treating otitis externa when the ear drum is perforated, because of the risk of ototoxicity.

Steroids should not be administered to "red eyes" until a definitive diagnosis has been made. Ophthalmological treatment with steroid preparations should not be repeated or prolonged without regular review to exclude raised intra-ocular pressure or unsuspected infections. The unnecessary topical use of neomycin containing products should be avoided in order to minimize the occurrence of neomycin-resistant organisms (and organism cross-resistant to other aminoglycosides).

Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category. Topical administration of corticosteroid to pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.

Store below 25° C

Ophthalmic steroid - antibiotic combined preparations

Betamethasone is a corticosteroid which is effective in inflammatory dermatoses. It is also effective in less responsive conditions such as psoriasis.  Betamethasone has a 16β-methyl group that enhances the anti-inflammatory action of the molecule and reduces the sodium and water retaining properties of the fluorine atom bound at carbon 9.

Neomycin sulfate is bactericidal against many bacteria which are commonly associated with skin infections. Neomycin is a broad spectrum antibiotic which actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30s subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30s subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.

Drops:

• Eye: 1 drop instilled into the eye every one or two hours until control is achieved, when the frequency may be reduced.
• Ear: 2 or 3 drops instilled into the ear, every two or three hours until control is achieved, when the frequency can be reduced.
• Nose: 2 or 3 drops instilled into each nostril two or three times daily.

Eye Ointment: It should be applied thinly and evenly to the conjunctival sac at night (If eye drops used during day) or 3-4 times daily (if ointment used alone).

Acute sensitization to neomycin is a rare event but can occur after topical application to the eye. Eye drops containing corticosteroids cause a serious rise in intra-ocular pressure in a small percentage of the population, including most of those with a family history of glaucoma. A milder rise may be experienced by a larger proportion of subjects if treatment is continued for longer than a few weeks. Thinning of the cornea leading to perforation has occurred with use of topical corticosteroids. Cataract is reported to have occurred after unduly prolonged treatment of eye conditions with topical corticosteroids.

Viral, fungal, tuberculous or purulent conditions. Use in the eye is contra-indicated if glaucoma is present or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Inadvertent use of topical steroids in the latter condition can lead to extension of the ulcer and marked visual deterioration. Preparations containing neomycin should not be used for treating otitis externa when the ear drum is perforated, because of the risk of ototoxicity.

Steroids should not be administered to "red eyes" until a definitive diagnosis has been made. Ophthalmological treatment with steroid preparations should not be repeated or prolonged without regular review to exclude raised intra-ocular pressure or unsuspected infections. The unnecessary topical use of neomycin containing products should be avoided in order to minimize the occurrence of neomycin-resistant organisms (and organism cross-resistant to other aminoglycosides).

Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category. Topical administration of corticosteroid to pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.

Store below 25° C

Betamethasone Dipropionate cream and ointment is
indicated for the relief of the inflammatory and pruritic manifestations of resistant or severe corticosteroid-responsive dermatoses. These include-

• Atopic eczema
• Nummular eczema
• Contact dermatitis
• Neurodermatitis
• Anogenital and senile pruritus
• Lichen planus
• Psoriasis

Corticosteroid

Betamethasone Dipropionate is a topical corticosteroid with anti-inflammatory, antipruritic and vasoconstrictive properties. Betamethasone Dipropionate induces peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme that causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine.

Pharmacokinetics: Betamethasone Dipropionate can be absorbed from normal intact skin. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver.lt excreted by the kidneys.

Apply a thin film once or twice daily to cover completely the affected area. Patients with chronic psoriasis who have achieved at least a marked improvement in their psoriatic lesion (i.e., approximately 80% improvement) with Betamethasone Dipropionate may be maintained in remission with a pulse dosing regimen consisting of three consecutive applications of up to 3.5 g each of Betamethasone Dipropionate cream and ointment, twelve hours apart (e.g., morning, evening, following morning) to the previously affected areas once each week. For this purpose, Betamethasone Dipropionate cream and ointment should be applied to the lesion sites previously affected and treated. Patients on this pulse dose regimen who relapse should be reverted back to the conventional dosing regimen.

The most frequent side effects reported with Betamethasone Dipropionate are mild to moderate transient burning/stinging, dry skin, pruritus, irritation and folliculitis. Rarely reported adverse effects include tingling, prickly skin/tightening or cracking of skin, warm feeling,laminar scaling and perilesional scaling,follicular rash, skin atrophy, erythema, urticaria, vesiculation, telangiectasia, acneiform papules and hyperaesthesia.

Adverse reactions reported with the use of the Betamethasone Dipropionate ointment pulse dose regimen were mild intermittent hypertension and paraesthesia. Other local adverse reactions that have been reported with the use of topical corticosteroids include: itching, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, miliaria and exacerbation of untreated infections

Hypersensitivity to Betamethasone Dipropionate, other corticosteroids or any components in this preparation. Like other topical corticosteroids, Betamethasone Dipropionate is contraindicated in viral infections of the skin, such as vaccinia, varicella and Herpes simplex, also tuberculosis, acne rosacea, fungal skin infections (moniliasis), perioral dermatitis and ulcerative conditions.

Betamethasone Dipropionate should not be used in or near the eyes, as there is a potential risk of developing glaucoma and cataract. If irritation or sensitisation develops with the use of Betamethasone Dipropionate, treatment should be discontinued and appropriate therapy instituted. In the presence of an infection, an appropriate antifungal or antibacterial agent should be administered. If a favourable response does not occur promptly, Betamethasone Dipropionate should be discontinued until the infection has been controlled adequately.

Corticosteroids are known to be absorbed percutaneously, therefore in patients under prolonged and extensive topical treatment, the possibility of systemic effects should be kept in mind. Betamethasone Dipropionate is not intended for use under occlusive dressings since this will also increase systemic absorption of the corticosteroid. In infants the napkin may act as an occlusive dressing and increase absorption. Suitable precautions should be taken when using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation. Prolonged use of topical corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue. If this occurs, treatment should be discontinued.

There is no evidence of any kind of interaction.

Acute overdose with the ointment is unlikely and would not be expected to lead to a life-threatening situation. The ointment should not be used for longer than the prescribed time period.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Betamethasone Dipropionate cream and ointment is
indicated for the relief of the inflammatory and pruritic manifestations of resistant or severe corticosteroid-responsive dermatoses. These include-

• Atopic eczema
• Nummular eczema
• Contact dermatitis
• Neurodermatitis
• Anogenital and senile pruritus
• Lichen planus
• Psoriasis

Corticosteroid

Betamethasone Dipropionate is a topical corticosteroid with anti-inflammatory, antipruritic and vasoconstrictive properties. Betamethasone Dipropionate induces peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme that causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine.

Pharmacokinetics: Betamethasone Dipropionate can be absorbed from normal intact skin. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver.lt excreted by the kidneys.

Apply a thin film once or twice daily to cover completely the affected area. Patients with chronic psoriasis who have achieved at least a marked improvement in their psoriatic lesion (i.e., approximately 80% improvement) with Betamethasone Dipropionate may be maintained in remission with a pulse dosing regimen consisting of three consecutive applications of up to 3.5 g each of Betamethasone Dipropionate cream and ointment, twelve hours apart (e.g., morning, evening, following morning) to the previously affected areas once each week. For this purpose, Betamethasone Dipropionate cream and ointment should be applied to the lesion sites previously affected and treated. Patients on this pulse dose regimen who relapse should be reverted back to the conventional dosing regimen.

The most frequent side effects reported with Betamethasone Dipropionate are mild to moderate transient burning/stinging, dry skin, pruritus, irritation and folliculitis. Rarely reported adverse effects include tingling, prickly skin/tightening or cracking of skin, warm feeling,laminar scaling and perilesional scaling,follicular rash, skin atrophy, erythema, urticaria, vesiculation, telangiectasia, acneiform papules and hyperaesthesia.

Adverse reactions reported with the use of the Betamethasone Dipropionate ointment pulse dose regimen were mild intermittent hypertension and paraesthesia. Other local adverse reactions that have been reported with the use of topical corticosteroids include: itching, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, miliaria and exacerbation of untreated infections

Hypersensitivity to Betamethasone Dipropionate, other corticosteroids or any components in this preparation. Like other topical corticosteroids, Betamethasone Dipropionate is contraindicated in viral infections of the skin, such as vaccinia, varicella and Herpes simplex, also tuberculosis, acne rosacea, fungal skin infections (moniliasis), perioral dermatitis and ulcerative conditions.

Betamethasone Dipropionate should not be used in or near the eyes, as there is a potential risk of developing glaucoma and cataract. If irritation or sensitisation develops with the use of Betamethasone Dipropionate, treatment should be discontinued and appropriate therapy instituted. In the presence of an infection, an appropriate antifungal or antibacterial agent should be administered. If a favourable response does not occur promptly, Betamethasone Dipropionate should be discontinued until the infection has been controlled adequately.

Corticosteroids are known to be absorbed percutaneously, therefore in patients under prolonged and extensive topical treatment, the possibility of systemic effects should be kept in mind. Betamethasone Dipropionate is not intended for use under occlusive dressings since this will also increase systemic absorption of the corticosteroid. In infants the napkin may act as an occlusive dressing and increase absorption. Suitable precautions should be taken when using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation. Prolonged use of topical corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue. If this occurs, treatment should be discontinued.

There is no evidence of any kind of interaction.

Acute overdose with the ointment is unlikely and would not be expected to lead to a life-threatening situation. The ointment should not be used for longer than the prescribed time period.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

This topical preparation is indicated for the topical treatment of inflammatory dermal infections like-

• Tinea pedis
• Tinea cruris
• Tinea corporis etc.

Betamethasone & Combined preparations

Clotrimazole is a broad-spectrum antifungal agent used for the treatment of superficial infections caused by species of pathogenic dermatophytes, yeasts and Malassezia furfur. The mechanism of action involves inhibition of the synthesis of ergosterol, a major sterol in the fungal cell membrane. This leads to instability of the cell membrane and eventual death of the fungus. Betamethasone dipropionate is a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. But the exact mechanism of action of corticosteroids is not clearly known.

Sufficient topical preparation should be applied onto the affected and surrounding skin areas twice a day, in the morning and evening, for 2 weeks in tinea cruris and tinea corporis and for 4 weeks in tinea pedis. The use of this cream for longer than four weeks is not recommended.

The safety and effectiveness of the preparation have not been established in children below the age of 12 years.

Adverse reactions reported for the preparation in clinical trials were paresthesia in 1.9% of patients, rash, edema and secondary infection, each in less than 1% of patients. Other adverse reactions reported with the preparation were burning and dry skin in 1.6% of patients and stinging in less than 1% of patients

This topical preparation is contraindicated to those patients who are sensitive to any of its components or to other corticosteroids or to imidazoles. If irritation or sensitization develops with the use of the cream, treatment should be discontinued and appropriate therapy instituted. The cream is contraindicated in facial rosacea, acne vulgaris, perioral dermatits, perianal and genital pruritus, napkin eruptions and bacterial or viral infections. Systemic absorption of topical corticosteroides can produce reversible hypothalmic-pituitary-adrenal (HPA) axis suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug or to reduce the frequency of application. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their large skin surface to body mass ratios.

No information is available of drug interaction.

There is inadequate evidence of safety in pregnancy. Clotrimazole has no teratogenic effect in animals but is foetotoxic at high oral doses. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. Hence the cream should only be used in pregnancy if the benefit justifies the potential risk to the fetus and such use should not be extensive,i.e. in large amounts or for long periods. It is not known whether the components of the preparation are excreted in human milk and therefore caution should be exercised when treating nursing mothers.

Acute overdose with the cream is unlikely and would not be expected to lead to a life-threatening situation. The cream should not be used for longer than the prescribed time period.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

This topical preparation is indicated for the topical treatment of inflammatory dermal infections like-

• Tinea pedis
• Tinea cruris
• Tinea corporis etc.

Betamethasone & Combined preparations

Clotrimazole is a broad-spectrum antifungal agent used for the treatment of superficial infections caused by species of pathogenic dermatophytes, yeasts and Malassezia furfur. The mechanism of action involves inhibition of the synthesis of ergosterol, a major sterol in the fungal cell membrane. This leads to instability of the cell membrane and eventual death of the fungus. Betamethasone dipropionate is a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. But the exact mechanism of action of corticosteroids is not clearly known.

Sufficient topical preparation should be applied onto the affected and surrounding skin areas twice a day, in the morning and evening, for 2 weeks in tinea cruris and tinea corporis and for 4 weeks in tinea pedis. The use of this cream for longer than four weeks is not recommended.

The safety and effectiveness of the preparation have not been established in children below the age of 12 years.

Adverse reactions reported for the preparation in clinical trials were paresthesia in 1.9% of patients, rash, edema and secondary infection, each in less than 1% of patients. Other adverse reactions reported with the preparation were burning and dry skin in 1.6% of patients and stinging in less than 1% of patients

This topical preparation is contraindicated to those patients who are sensitive to any of its components or to other corticosteroids or to imidazoles. If irritation or sensitization develops with the use of the cream, treatment should be discontinued and appropriate therapy instituted. The cream is contraindicated in facial rosacea, acne vulgaris, perioral dermatits, perianal and genital pruritus, napkin eruptions and bacterial or viral infections. Systemic absorption of topical corticosteroides can produce reversible hypothalmic-pituitary-adrenal (HPA) axis suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug or to reduce the frequency of application. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their large skin surface to body mass ratios.

No information is available of drug interaction.

There is inadequate evidence of safety in pregnancy. Clotrimazole has no teratogenic effect in animals but is foetotoxic at high oral doses. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. Hence the cream should only be used in pregnancy if the benefit justifies the potential risk to the fetus and such use should not be extensive,i.e. in large amounts or for long periods. It is not known whether the components of the preparation are excreted in human milk and therefore caution should be exercised when treating nursing mothers.

Acute overdose with the cream is unlikely and would not be expected to lead to a life-threatening situation. The cream should not be used for longer than the prescribed time period.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

This cream is usually useful for the treatment of superficial infections caused by gram-positive and gramnegative microorganisms. It is also useful in burns, regeneration of new skin in wounds and ulceration, otitis externa, postoperative infections, neuro-dermatitis and eczema. It may be used as an adjunct to systemic steroid therapy in special kind of pyoderma.

Aural steroid & antibiotic combined preparations

Betamethasone is an active topical corticosteroid, which produces a rapid response in the inflammatory dermatoses and cures psoriasis types of skin diseases. Neomycin Sulfate is a topical broad-spectrum bactericidal amino-glycoside effective against various kinds of gram-positive and gramnegative pathogens such as Proteus vulgaris, Staphylococcus aureus etc. This preparation has effective penetration and uniform distribution capacity, so it is very effective in hairy and intertriginous places. This preparation is very effective for the treatment of wet ulceration of the skin.

Use in adults: This preparation should be applied to the affected parts of the skin as a thin layer for 3 to 4 times daily. In chronic conditions, withdrawal of treatment is carried out by decreasing the frequency of application until the cream is applied as infrequently as once a week. Or as directed by the physician.

Use in children: Do not use it on children under 1 year of age. A course of treatment for a child should not normally last more than 5 days unless otherwise stated by your physician.

This preparation is well tolerated. But prolonged and high doses may cause Cushing's syndrome, acne, thinning and dilatation of blood vessels, particularly when occlusive dressings are used.

This preparation is contraindicated to the patients who are hypersensitive to any of its components. It should not be used for the treatment of otitis externa when the eardrum is perforated. It is contraindicated in skin lesions caused by infection with viruses and fungi.

Long term continuous topical therapy of this preparation should be avoided, which may produce many resistant micro organisms. So, accurate dose of this preparation should be used in infected areas only.

There are no significant drug interactions reported with Betamethasone Valerate BP and Neomycin Sulphate BP Cream/Ointment.

This preparation should not be used extensively in pregnancy.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.