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Ophthalmic antibacterial drugs

Besifloxacin acts against Gram positive and Gram negative bacteria due to the inhibition of both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme required for replication, transcription and repair of bacterial DNA. Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division.

Adults and children (1 year of age and older): Instill one drop in the affected eye(s) 3 times a day for 7 days.

Pediatric Use: The safety and effectiveness of Besifloxacin in infants below one year of age have not been established.

The most frequently reported ocular adverse event was conjunctival redness, reported in approximately 2% of patients. Other adverse events reported in patients receiving Besifloxacin occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.

Hypersensitivity to the active ingredient or any component of this formulation.

This drug is for topical ophthalmic use only and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. To prevent contamination do not touch the tip of the dropper to eye, eyelid or any surface of the affected eye. Patients should not wear contact lenses during the course of therapy with this drug. Shake well before use.

No such information found. Topical ophthalmic use only

Pregnancy Category C. No adequate and well-controlled studies are established in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Besifloxacin is secreted in human milk or not. Caution should be exercised when Besifloxacin is administered to a nursing mother.

No data are available regarding the over dose of Besifloxacin.

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.

Ophthalmic antibacterial drugs

Besifloxacin acts against Gram positive and Gram negative bacteria due to the inhibition of both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme required for replication, transcription and repair of bacterial DNA. Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division.

Adults and children (1 year of age and older): Instill one drop in the affected eye(s) 3 times a day for 7 days.

Pediatric Use: The safety and effectiveness of Besifloxacin in infants below one year of age have not been established.

The most frequently reported ocular adverse event was conjunctival redness, reported in approximately 2% of patients. Other adverse events reported in patients receiving Besifloxacin occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.

Hypersensitivity to the active ingredient or any component of this formulation.

This drug is for topical ophthalmic use only and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. To prevent contamination do not touch the tip of the dropper to eye, eyelid or any surface of the affected eye. Patients should not wear contact lenses during the course of therapy with this drug. Shake well before use.

No such information found. Topical ophthalmic use only

Pregnancy Category C. No adequate and well-controlled studies are established in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Besifloxacin is secreted in human milk or not. Caution should be exercised when Besifloxacin is administered to a nursing mother.

No data are available regarding the over dose of Besifloxacin.

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.

Ophthalmic antibacterial drugs

Besifloxacin acts against Gram positive and Gram negative bacteria due to the inhibition of both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme required for replication, transcription and repair of bacterial DNA. Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division.

Adults and children (1 year of age and older): Instill one drop in the affected eye(s) 3 times a day for 7 days.

Pediatric Use: The safety and effectiveness of Besifloxacin in infants below one year of age have not been established.

The most frequently reported ocular adverse event was conjunctival redness, reported in approximately 2% of patients. Other adverse events reported in patients receiving Besifloxacin occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.

Hypersensitivity to the active ingredient or any component of this formulation.

This drug is for topical ophthalmic use only and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. To prevent contamination do not touch the tip of the dropper to eye, eyelid or any surface of the affected eye. Patients should not wear contact lenses during the course of therapy with this drug. Shake well before use.

No such information found. Topical ophthalmic use only

Pregnancy Category C. No adequate and well-controlled studies are established in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Besifloxacin is secreted in human milk or not. Caution should be exercised when Besifloxacin is administered to a nursing mother.

No data are available regarding the over dose of Besifloxacin.

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.

Ophthalmic antibacterial drugs

Besifloxacin acts against Gram positive and Gram negative bacteria due to the inhibition of both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme required for replication, transcription and repair of bacterial DNA. Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division.

Adults and children (1 year of age and older): Instill one drop in the affected eye(s) 3 times a day for 7 days.

Pediatric Use: The safety and effectiveness of Besifloxacin in infants below one year of age have not been established.

The most frequently reported ocular adverse event was conjunctival redness, reported in approximately 2% of patients. Other adverse events reported in patients receiving Besifloxacin occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.

Hypersensitivity to the active ingredient or any component of this formulation.

This drug is for topical ophthalmic use only and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. To prevent contamination do not touch the tip of the dropper to eye, eyelid or any surface of the affected eye. Patients should not wear contact lenses during the course of therapy with this drug. Shake well before use.

No such information found. Topical ophthalmic use only

Pregnancy Category C. No adequate and well-controlled studies are established in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Besifloxacin is secreted in human milk or not. Caution should be exercised when Besifloxacin is administered to a nursing mother.

No data are available regarding the over dose of Besifloxacin.

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.

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 is indicated for the treatment and prophylaxis of Iron, Folic acid, Vitamin B complex and Vitamin C deficiency, or to meet extra need of these vitamins and minerals especially in pregnancy or when planning for pregnancy.

Iron & Vitamin Combined preparations

Iron is an essential mineral, with several important roles in the body. For example, it helps to make red blood cells, which carry oxygen around the body. A lack of iron can lead to iron deficiency anaemia. Liver is a good source of iron, don't eat it if you are pregnant. This is because it is also rich in vitamin A which, in large amounts, can harm your unborn baby.

Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.

Vitamin C is necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.

Vitamin B complex: The building blocks for good health come from a variety of foods, even if they are from the same family of nutrients. Such is the case with vitamin B, a key player in maintaining cell health and keeping you energized.

Not all types of vitamin B do the same thing. Additionally, the different types of vitamin B all come from different types of foods.

Vitamin B deficiencies can lead to health problems. Sometimes a doctor will prescribe a supplement when they think you’re not getting enough.

Recommended adult dose is one capsule daily. In more severe deficiency states, 2 capsules a day may be required or as directed by the physician.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Iron therapy is contraindicated in haemachromatosis and haemosiderosis, and in patients receiving repeated blood transfusion or with anaemia not due to by iron deficiency. It should be given cautiously to patients taking Levodopa as one of the ingredients (Pyridoxine) reduces the effect of Levodopa.

Care should be taken in patients who may develop iron overload, such as those with hemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.

Care should be taken when given to patients with Iron storage or Iron absorption disease. Iron form chelates with antacids and Tetracycline and absorption of all these may be impaired if taken concurrently

It is recommended during pregnancy and lactation.

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children fewer than 6. Avoid higher doses if you have liver disease or hemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours. Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No cases of Folic acid overdosages have been reported. Acute ingestion of Ascorbic acid, even of massive doses, is unlikely to cause significant effects.

Store in a dry place below 25° C. Protect from light.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

This is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus:

• Treatment of moderate to severe vasomotor symptoms associated with menopause
• Prevention of postmenopausal osteoporosis

Female Sex hormones

This tablet pairs conjugated estrogens with bazedoxifene. Conjugated estrogens and bazedoxifene function by binding to and activating estrogen receptors (ER) α and β, which vary in proportion from tissue to tissue. Conjugated estrogens are composed of multiple estrogens and are agonists of ER- α and β. Bazedoxifene is an estrogen agonist/antagonist that acts as an agonist in some estrogen-sensitive tissues and an antagonist in others (e.g., uterus). The pairing of conjugated estrogens with bazedoxifene produces a composite effect that is specific to each target tissue. The bazedoxifene component reduces the risk of endometrial hyperplasia that can occur with the conjugated estrogens component.

In four prospective, randomized, placebo-controlled trials the common adverse reactions (incidence ≥5%) were muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain.

No drug interaction studies were conducted with This tablet. Estrogens are metabolized partially by CYP3A4. Concomitant use of this tablet with CYP3A4 inhibitors may increase the exposure of conjugated estrogens and thereby may increase the risk of endometrial hyperplasia.

Pregnancy Category X. This tablet must not be used in women who are or may become pregnant. No studies were performed on animals to evaluate the effects on reproduction with conjugated estrogens/bazedoxifene. This tablet should not be used by lactating women. It is not known whether this drug is excreted in human milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving conjugated estrogens. Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk

Pediatric Use: This tablet is not indicated for use in children.

Geriatric Use: This tablet was not studied in women aged 75 or older; use in this population is not recommended. An increased risk of probable dementia in women over 65 years of age was reported in the Women’s Health Initiative Memory ancillary studies of the Women’s Health Initiative.

Renal Impairment: This tablet was not studied in women with renal impairment; use in this population is not recommended.

Body Mass Index: Women with BMI >27 kg/m 2 may have an increased risk of endometrial hyperplasia.

In case of overdosage, there is no specific antidote, and the treatment should be symptomatic. Symptoms of overdosage of estrogen-containing products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur.

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

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.

This Cream is indicated for the treatment of corticosteroid-responsive dermatoses when complicated by infections caused by bacteria and fungi. This is also effective in the treatment of tinea pedis, tinea cruris & tinea corporis, acute and chronic eczema.

Betamethasone & Combined preparations

This Cream combines the anti-inflammatory, antipruritic and vasoconstrictive actions of Betamethasone Dipropionate with the broad spectrum antifungal activity of Clotrimazole and the wide-spectrum bactericidal antibiotic activity of Gentamicin Sulfate. Clotrimazole appears to act on the fungal cell membrane, causing leakage of cell contents. Gentamicin provides highly effective topical treatment in primary and secondary bacterial infections of the skin.

Apply gently into the affected skin areas twice daily. Duration of therapy varies depending upon the extent and location of disease and patient response. For effective treatment, This Cream should be applied regularly.

Adverse reactions have been reported very rarely and include hypochromia, burning, erythema, exudation etc.

This Cream is contraindicated in those patients with a history of sensitivity reactions to any of its components.

Do not combine with any other product containing corticosteroid. Not for application to the face, avoid contact with eyes. Not for prolonged use or use in extensive areas, under an occlusive dressing, open wound, injured areas, exterior genital areas and skin folds.

Concomitant use with nephrotoxic drugs including other aminoglycosides, vancomycin and some of cephalosporins; or ototoxic drugs such as ethacrynic acid and furosemide may increase the risk of toxicity.

Since safety of topical corticosteroid in pregnant women has not been established, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the lactating mother.

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.