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Anastrozole is indicated in-

• Treatment of early breast cancer in hormone receptor positive post-menopausal women.
• Adjuvant treatment of early breast cancer in hormone receptor positive
• postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
• Reduction in the incidence of contralateral breast cancers in post menopausal women receiving Anastrozole as adjuvant treatment for early breast cancer.
• Treatment of advanced breast cancer in post-menopausal women.

Hormonal Chemotherapy

Anastrazole exerts its anti-estrogenic effects via selective and competitive inhibition of the aromatase enzyme found predominantly in the adrenal glands, liver, and fatty tissues. Many breast cancers are hormone receptor-positive, meaning their growth is stimulated and/or maintained by the presence of hormones such as estrogen or progesterone. In postmenopausal women, estrogen is primarily derived from the conversion of adrenally-produced androgens into estrogens by the aromatase enzyme- by competitively inhibiting the biosynthesis of estrogen at these enzymes, anastrozole effectively suppresses circulating estrogen levels and, subsequently, the growth of hormone receptor-positive tumours.

Adults Including the Elderly: One tablet (1 mg) to be taken orally once a day.
Children: The use of Anastrozole is not recommended in children, as efficacy has not been established
Renal Impairment: No dose change is recommended.
Hepatic Impairment: No dose change is recommended.

Very common side effects: Hot flushes, asthenia, joint stiffness, arthritis, headache, nausea, rash etc. Common side effects: Hair thinning, allergic reactions, diarrhea, vomiting, somnolence etc.

Anastrozole is not recommended for use in children or in pre-menopausal women as safety and efficacy have not been established in these groups of patients.

• Anastrozole has not been investigated in patients with severe hepatic or severe renal impairment. The potential risk/benefit to such patients should be carefully considered before administration of Anastrozole.
• As Anastrozole lowers circulating estrogen levels, it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture.

Tamoxifen and/or other therapies containing estrogen should not be co-administered with Anastrozole.

Anastrozole must not be administered during pregnancy or lactation.

There is limited clinical experience of overdose of Anastrozole. There are no reports where a patient has taken a dose in excess of 60 mg. No toxicity was observed and no clinically relevant adverse effects have been seen.

Store in a cool & dry place, protected from light and moisture. Keep out of reach of children.

Anti-fibrinolytic drugs, Haemostatic drugs

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

Adults-

• The usual dose: 500-1000 mg 3 times daily.
• For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
• For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

• For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
• For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Anti-fibrinolytic drugs, Haemostatic drugs

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

Adults-

• The usual dose: 500-1000 mg 3 times daily.
• For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
• For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

• For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
• For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

First generation Cephalosporins

Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.

For oral administration-
Adults:

• Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
• Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
• Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.

Children:

• Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
• Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
• Maximum daily dosage: 4 gm

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-

• Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
• Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.

Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.

• Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
• Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
• Psychiatric disorders- Unknown: Confusion, sleep disturbances
• Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
• Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
• Renal and urinary disorders- Unknown: Reversible interstitial nephritis
• Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.

Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.

The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:

• CrCl: >20 ml/min: 500 mg every 6 hours
• CrCl: 5-20 ml/min: 250 mg every 6 hours
• CrCl: <5 ml/min: 250 mg every 50-70 hours.

Recommendations for patients on chronic, intermittent haemodialysis:

• 250 mg at the start of haemodialysis
• 250 mg 6 to 12 hours after the start
• 250 mg 36 to 48 hours after the start
• 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.

The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.

Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

First generation Cephalosporins

Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.

For oral administration-
Adults:

• Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
• Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
• Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.

Children:

• Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
• Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
• Maximum daily dosage: 4 gm

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-

• Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
• Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.

Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.

• Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
• Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
• Psychiatric disorders- Unknown: Confusion, sleep disturbances
• Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
• Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
• Renal and urinary disorders- Unknown: Reversible interstitial nephritis
• Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.

Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.

The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:

• CrCl: >20 ml/min: 500 mg every 6 hours
• CrCl: 5-20 ml/min: 250 mg every 6 hours
• CrCl: <5 ml/min: 250 mg every 50-70 hours.

Recommendations for patients on chronic, intermittent haemodialysis:

• 250 mg at the start of haemodialysis
• 250 mg 6 to 12 hours after the start
• 250 mg 36 to 48 hours after the start
• 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.

The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.

Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

First generation Cephalosporins

Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.

For oral administration-
Adults:

• Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
• Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
• Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.

Children:

• Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
• Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
• Maximum daily dosage: 4 gm

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-

• Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
• Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.

Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.

• Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
• Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
• Psychiatric disorders- Unknown: Confusion, sleep disturbances
• Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
• Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
• Renal and urinary disorders- Unknown: Reversible interstitial nephritis
• Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.

Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.

The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:

• CrCl: >20 ml/min: 500 mg every 6 hours
• CrCl: 5-20 ml/min: 250 mg every 6 hours
• CrCl: <5 ml/min: 250 mg every 50-70 hours.

Recommendations for patients on chronic, intermittent haemodialysis:

• 250 mg at the start of haemodialysis
• 250 mg 6 to 12 hours after the start
• 250 mg 36 to 48 hours after the start
• 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.

The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.

Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

First generation Cephalosporins

Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.

For oral administration-
Adults:

• Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
• Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
• Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.

Children:

• Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
• Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
• Maximum daily dosage: 4 gm

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-

• Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
• Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.

Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.

• Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
• Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
• Psychiatric disorders- Unknown: Confusion, sleep disturbances
• Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
• Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
• Renal and urinary disorders- Unknown: Reversible interstitial nephritis
• Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.

Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.

The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:

• CrCl: >20 ml/min: 500 mg every 6 hours
• CrCl: 5-20 ml/min: 250 mg every 6 hours
• CrCl: <5 ml/min: 250 mg every 50-70 hours.

Recommendations for patients on chronic, intermittent haemodialysis:

• 250 mg at the start of haemodialysis
• 250 mg 6 to 12 hours after the start
• 250 mg 36 to 48 hours after the start
• 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.

The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.

Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

First generation Cephalosporins

Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.

For oral administration-
Adults:

• Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
• Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
• Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.

Children:

• Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
• Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
• Maximum daily dosage: 4 gm

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-

• Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
• Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.

Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.

• Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
• Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
• Psychiatric disorders- Unknown: Confusion, sleep disturbances
• Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
• Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
• Renal and urinary disorders- Unknown: Reversible interstitial nephritis
• Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.

Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.

The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:

• CrCl: >20 ml/min: 500 mg every 6 hours
• CrCl: 5-20 ml/min: 250 mg every 6 hours
• CrCl: <5 ml/min: 250 mg every 50-70 hours.

Recommendations for patients on chronic, intermittent haemodialysis:

• 250 mg at the start of haemodialysis
• 250 mg 6 to 12 hours after the start
• 250 mg 36 to 48 hours after the start
• 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.

The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.

Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

• Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible bags in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of bag.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend bag from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
• Open flow control clamp to expel air from set.Close clamp.
• Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

• Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible bags in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of bag.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend bag from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
• Open flow control clamp to expel air from set.Close clamp.
• Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

• Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible bags in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of bag.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend bag from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
• Open flow control clamp to expel air from set.Close clamp.
• Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

Prevention and treatment of nausea, vomiting, dizziness, motion sickness, radiation sickness and vertigo associated with diseases of the vestibular system (e.g. Meniere's syndrome, labyrinthitis and other vestibular disturbances).

Anti-emetic drugs

Meclizine is a piperazine-derivative antihistamine that is used as an antiemetic. It has antiemetic, anticholinergic and antihistaminic properties. It reduces the sensitivity of the labyrinthine apparatus. The action may be mediated through nerve pathways to the vomiting center (VC) from the chemoreceptor trigger zone (CTZ), peripheral nerve pathways, the VC, or other CNS centers. Pyridoxine is vitamin B-6. It has been added to enhance the anti-emetic effects & as a dietary suppliment.

Adult and Children 12 years of age & over:

• Nausea and vomiting: 25-50 mg daily or as directed by a physician.
• Motion sickness: Take an initial dose of 25-50 mg, 1 hour prior to travel. May repeat the dose every 24 hours for the duration of the journey.
• Radiation sickness: 50 mg administered 2-12 hours prior to radiation treatment.
• Vertigo: 25-100 mg daily in divided doses.
• Prevention of nausea and vomiting associated with emergency contraceptive pill (ECP): 25-50 mg, 1 hour before first ECP dose; repeat if needed in 24 hours.

The safety and efficacy for use in children less than 12 years of age have not been established.

Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.

Meclizine Hydrochloride and Pyridoxine Hydrochloride is contraindicated in patients who are hypersensitive to these ingredients.

Patients should be warned that Meclizine Hydrochloride may impair their ability to perform hazardous activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle). Patients should avoid alcoholic beverages while taking this drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma or enlargement of the prostate gland.

The CNS depressant effects of Meclizine can be potentiated by concurrent use of Ethanol or other CNS depressant agents such as Benzodiazepines, Barbiturates, Tricyclic antidepressants, opiate agonists, skeletal muscle relaxants and antihistamines. Concurrent use of other anticholinergics can potentiate the anticholinergic effects of Meclizine. Meclizine can increase the absorption of digoxin by decreasing gastrointestinal motility.

Pregnancy Category B. Large-scale human studies have not demonstrated adverse fetal effects. It has been suggested that based on available data, Meclizine presents the lowest risk of teratogenicity and is the drug of first choice in treating nausea and vomiting during pregnancy. Safety for use in the nursing mother has not been established.

Symptoms: Extreme excitability, seizures, drowsiness and hallucinations.
Treatment: Appropriate supportive and symptomatic treatment. Consider dialysis

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

Anti-platelet drugs

Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.

Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.

It is given orally with or without food.

Clopidogrel is generally well tolerated drug.

• Common side effects: Bleeding, Diarrhoea, gastrointestinal discomfort, haemorrhage, Skin reactions.
• Rare side effects: Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.

Clopidogrel is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.

Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.

Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.

Anti-platelet drugs

Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen at 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.

Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.

The recommended oral dose is one tablet daily.

This combination is generally well tolerated.

This combination is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Oral anticoagulants, NSAIDs, Metamizole, SSRIs, CYP2C19 inhibitors increase the risk of bleeding. It shows interaction with Tonofovir, Valproic acid, Varicella vaccine, Acetazolamide and Nicorandil.

There are no adequate and well-controlled studies in pregnant women. It should be used during first and second trimesters of pregnancy only if clearly needed. It is contraindicated during the third trimester of pregnancy. It is unknown whether Clopidogrel is excreted in human breast milk but Aspirin is known to be excreted in human milk. This Drug should be discontinued during the breast feeding.

It should not be given to children, particularly those under 12 years, unless the expected benefits outweight the possible risks. Aspirin may be a contributory factor in the causation of Reye’s syndrome in some children.

Clopidogrel overdose may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability. In moderate aspirin intoxication dizziness, headache, tinnitus, confusion, and gastrointestinal symptoms may occur which can be treated by inducing vomiting followed by gastric lavage if needed. In severe Aspirin intoxication respiratory alkalosis respiratory acidosis, metabolic acidosis, hyperthermia, perspiration, dehydration can occur. It can be treated with haemodialysis and other symptomatic treatment.

Keep in a cool & dry place (below 30o C), protected from light & moisture. Keep out of the reach of children.

Penicillinase-resistant penicillins

Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.

Oral administration:

• Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
• Children (2-10 years): 1/2 of adult dose.
• Children (Under 2 years): 1/4 of adult dose.

Parenteral administration:
Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• 2-10 years: half of the adult dose.
• Under 2 years: a quarter of the adult dose.

Oral doses should be administered 1 hour before meal.

There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.

Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.

US FDA Pregnancy Category of Flucloxacillin is B. There are, 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. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.

In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.

Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Penicillinase-resistant penicillins

Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.

Oral administration:

• Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
• Children (2-10 years): 1/2 of adult dose.
• Children (Under 2 years): 1/4 of adult dose.

Parenteral administration:
Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• 2-10 years: half of the adult dose.
• Under 2 years: a quarter of the adult dose.

Oral doses should be administered 1 hour before meal.

There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.

Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.

US FDA Pregnancy Category of Flucloxacillin is B. There are, 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. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.

In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.

Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Penicillinase-resistant penicillins

Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.

Oral administration:

• Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
• Children (2-10 years): 1/2 of adult dose.
• Children (Under 2 years): 1/4 of adult dose.

Parenteral administration:
Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• 2-10 years: half of the adult dose.
• Under 2 years: a quarter of the adult dose.

Oral doses should be administered 1 hour before meal.

There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.

Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.

US FDA Pregnancy Category of Flucloxacillin is B. There are, 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. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.

In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.

Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

Keep in a dry place away from light and heat. Keep out of the reach of children.

হায়োসিন বিউটাইলব্রোমাইড একটি এন্টিকোলিনার্জিক ওষুধ, এবডোমিনাল ক্যাভিটির বিভিন্ন অংশের নরম মাংসপেশীর (smooth muscle) উপর যার খিঁচুনিবিরোধী (antispasmodic) ক্রিয়া রয়েছে। হায়োসিন বিউটাইলব্রোমাইড ট্যাবলেট গ্যাসট্রো ইন্টেসটিনাল ট্র্যাক্টে অথবা জেনিটো-ইউরিনারী ট্র্যাক্টের ভিসেরাল খিঁচুনি জনিত লক্ষণসমূহে নির্দেশিত। স্পাসমোডিক ডিসমেনোরিয়াতেও এটি নির্দেশিত। হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন গ্যাসট্রো-ইন্টেসটিনাল খিঁচুনি এবং রেনাল অথবা পিত্তের (billary) তীব্র ব্যথাতেও নির্দেশিত। রেডিওলজীতে প্রতিবন্ধকতার পার্থক্যমূলক রোগ নির্ণয়ে, পাইলোগ্রাফীতে খিঁচুনি ও ব্যথা কমাতে এবং গ্যাসট্রো-ডিওডেনাল এনডোস্কোপীর মত রোগ নির্ণয়ের অন্যান্য পদ্ধতিতেও খিঁচুনির সমস্যা দূর করার জন্য হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন ব্যবহার করা হয়।

Anticholinergics (antimuscarinics)/ Anti-spasmodics

খাওয়ার জন্য-

• প্রাপ্ত বয়স্ক: ২০ মিগ্রা দিনে চার বার। স্পাসমোডিক ডিসমেনোরিয়ার ক্ষেত্রে ঋতুস্রাব (menstruation) শুরুর সম্ভাব্য তারিখের কমপক্ষে দুদিন আগে থেকে চিকিৎসা শুরু করতে হবে এবং স্রাব শুরুর তিনদিন পরে পর্যন্ত তা অব্যাহত রাখতে হবে।
• শিশু ৬ থেকে ১২ বৎসর পর্যন্ত: ১০ মিগ্রা দিনে তিনবার অথবা চিকিৎসকের নির্দেশ অনুযায়ী। 

ইনজেকশন হিসেবে-

• প্রাপ্তবয়স্ক: মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য সাধারণ মাত্রা হচ্ছে ২০ মিগ্রা (১টি এ্যাম্পুল), প্রয়োজনে যা কিনা ৩০ মিনিট পর পুনরায় প্রয়োগ করতে হবে। এনডোস্কোপীর ক্ষেত্রে এই মাত্রা আরো ঘন ঘন প্রয়োগ করতে হবে।

হায়োসিন বিউটাইলব্রোমাইড এর পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে মুখ শুকিয়ে যাওয়া, পিউপিল এর প্রসরণ (dilatation), ইন্ট্রা-অকিউলার প্রেসার বৃদ্ধি, ফ্লাসিং, ত্বক শুকিয়ে যাওয়া, ব্র্যাডিকার্ডিয়া এবং তারপরেই ট্যাকিকার্ডিয়া ও এরিমিয়া। কখনো কখনো ক্লান্তি, বমি, মাথা ঝিমঝিম (giddiness) এবং ষ্ট্যাগারিং হতে পারে।

যে সব রোগীর প্রস্টেটিক বৃদ্ধি ঘটেছে তাদের ক্ষেত্রে এর ব্যবহার নিষিদ্ধ এবং বৃদ্ধদের ক্ষেত্রে এটি সতর্কতার সাথে ব্যবহার করতে হবে। যে সব রোগী প্যারালাইটিক ইলিয়াস অথবা পাইলোরিক ষ্টেনোসিসে ভুগছেন তাদের ক্ষেত্রেও ওষুধটির ব্যবহার নিষিদ্ধ। সম্ভাব্য মাইড্রিয়াটিক ক্ষতির কারণে যে সব রোগীর গ্লুকোমা রয়েছে তাদের ক্ষেত্রেও এটির ব্যবহার নিষিদ্ধ ।

সাবধানতা: হায়োসিন ঝিমুনি সৃষ্টি করতে পারে ও মানসিক সতর্কতা নিজে করে নিস্তেজ করে দিতে পারে। যে সকল রোগী হায়োসিন দিয়ে চিকিৎসাধীন রয়েছে তাদের গাড়ী বা অন্যান্য যানবাহন অথবা মানসিক একাগ্রতার অভাবে দুর্ঘটনা ঘটতে পারে এমন কোন যন্ত্রপাতি চালানো উচিত নয়। রোগীদের মদ্যপান করা থেকেও বিরত থাকা উচিত।

সতর্কতা: থাইরোটক্সিকোসিস, কার্ডিয়াক অপর্যাপ্ততা (insufficiency) বা ফেলিওর এবং হৃদপিন্ডে অস্ত্রোপচারের ক্ষেত্রে এই ওষুধ হৃদপিন্ডের গতি আরো বাড়িয়ে দিতে পারে বলে এর ব্যবহারে সতর্কতা অবলম্বন করা উচিত। অন্যান্য এন্টিকোলিনার্জিক ওষুধসমূহ যেমন এমানটেডিন, কোন কোন এন্টিহিস্টামিন, বিউটাইরোফেনন ও ফেনোথায়াজিন এবং ট্রাইসাইক্লিক এন্টিডিপ্রেসেন্ট হায়োসিনের সাথে একত্রে প্রয়োগের ফলে হায়োসিনের ক্রিয়া বেড়ে যেতে পারে বিধায় এ সব ক্ষেত্রে হায়োসিন ব্যবহার করতে হলে এর মাত্রা কমিয়ে নেয়া প্রয়োজন হতে পারে।

গর্ভাবস্থার প্রথম তিন মাসে অন্যান্য ওষুধের মতো একেও সতর্কতার সাথে ব্যবহার করতে হবে।

ডেক্সট্রান কিংবা ০.৯% সোডিয়াম ক্লোরাইড ইনজেকশনের তরল দিয়ে হায়োসিন বিউটাইলব্রোমাইড ইনজেকশনকে তরলীকরণ করা যাবে।

মেয়াদ উত্তীর্ণের পর ব্যবহার করবেন না। সকল ওষুধ শিশুদের নাগালের বাইরে রাখুন।  কেবলমাত্র রেজিস্টার্ড চিকিৎসকের ব্যবস্থাপত্র অনুযায়ী বিতরণযোগ্য।

হায়োসিন বিউটাইলব্রোমাইড একটি এন্টিকোলিনার্জিক ওষুধ, এবডোমিনাল ক্যাভিটির বিভিন্ন অংশের নরম মাংসপেশীর (smooth muscle) উপর যার খিঁচুনিবিরোধী (antispasmodic) ক্রিয়া রয়েছে। হায়োসিন বিউটাইলব্রোমাইড ট্যাবলেট গ্যাসট্রো ইন্টেসটিনাল ট্র্যাক্টে অথবা জেনিটো-ইউরিনারী ট্র্যাক্টের ভিসেরাল খিঁচুনি জনিত লক্ষণসমূহে নির্দেশিত। স্পাসমোডিক ডিসমেনোরিয়াতেও এটি নির্দেশিত। হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন গ্যাসট্রো-ইন্টেসটিনাল খিঁচুনি এবং রেনাল অথবা পিত্তের (billary) তীব্র ব্যথাতেও নির্দেশিত। রেডিওলজীতে প্রতিবন্ধকতার পার্থক্যমূলক রোগ নির্ণয়ে, পাইলোগ্রাফীতে খিঁচুনি ও ব্যথা কমাতে এবং গ্যাসট্রো-ডিওডেনাল এনডোস্কোপীর মত রোগ নির্ণয়ের অন্যান্য পদ্ধতিতেও খিঁচুনির সমস্যা দূর করার জন্য হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন ব্যবহার করা হয়।

Anticholinergics (antimuscarinics)/ Anti-spasmodics

খাওয়ার জন্য-

• প্রাপ্ত বয়স্ক: ২০ মিগ্রা দিনে চার বার। স্পাসমোডিক ডিসমেনোরিয়ার ক্ষেত্রে ঋতুস্রাব (menstruation) শুরুর সম্ভাব্য তারিখের কমপক্ষে দুদিন আগে থেকে চিকিৎসা শুরু করতে হবে এবং স্রাব শুরুর তিনদিন পরে পর্যন্ত তা অব্যাহত রাখতে হবে।
• শিশু ৬ থেকে ১২ বৎসর পর্যন্ত: ১০ মিগ্রা দিনে তিনবার অথবা চিকিৎসকের নির্দেশ অনুযায়ী। 

ইনজেকশন হিসেবে-

• প্রাপ্তবয়স্ক: মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য সাধারণ মাত্রা হচ্ছে ২০ মিগ্রা (১টি এ্যাম্পুল), প্রয়োজনে যা কিনা ৩০ মিনিট পর পুনরায় প্রয়োগ করতে হবে। এনডোস্কোপীর ক্ষেত্রে এই মাত্রা আরো ঘন ঘন প্রয়োগ করতে হবে।

হায়োসিন বিউটাইলব্রোমাইড এর পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে মুখ শুকিয়ে যাওয়া, পিউপিল এর প্রসরণ (dilatation), ইন্ট্রা-অকিউলার প্রেসার বৃদ্ধি, ফ্লাসিং, ত্বক শুকিয়ে যাওয়া, ব্র্যাডিকার্ডিয়া এবং তারপরেই ট্যাকিকার্ডিয়া ও এরিমিয়া। কখনো কখনো ক্লান্তি, বমি, মাথা ঝিমঝিম (giddiness) এবং ষ্ট্যাগারিং হতে পারে।

যে সব রোগীর প্রস্টেটিক বৃদ্ধি ঘটেছে তাদের ক্ষেত্রে এর ব্যবহার নিষিদ্ধ এবং বৃদ্ধদের ক্ষেত্রে এটি সতর্কতার সাথে ব্যবহার করতে হবে। যে সব রোগী প্যারালাইটিক ইলিয়াস অথবা পাইলোরিক ষ্টেনোসিসে ভুগছেন তাদের ক্ষেত্রেও ওষুধটির ব্যবহার নিষিদ্ধ। সম্ভাব্য মাইড্রিয়াটিক ক্ষতির কারণে যে সব রোগীর গ্লুকোমা রয়েছে তাদের ক্ষেত্রেও এটির ব্যবহার নিষিদ্ধ ।

সাবধানতা: হায়োসিন ঝিমুনি সৃষ্টি করতে পারে ও মানসিক সতর্কতা নিজে করে নিস্তেজ করে দিতে পারে। যে সকল রোগী হায়োসিন দিয়ে চিকিৎসাধীন রয়েছে তাদের গাড়ী বা অন্যান্য যানবাহন অথবা মানসিক একাগ্রতার অভাবে দুর্ঘটনা ঘটতে পারে এমন কোন যন্ত্রপাতি চালানো উচিত নয়। রোগীদের মদ্যপান করা থেকেও বিরত থাকা উচিত।

সতর্কতা: থাইরোটক্সিকোসিস, কার্ডিয়াক অপর্যাপ্ততা (insufficiency) বা ফেলিওর এবং হৃদপিন্ডে অস্ত্রোপচারের ক্ষেত্রে এই ওষুধ হৃদপিন্ডের গতি আরো বাড়িয়ে দিতে পারে বলে এর ব্যবহারে সতর্কতা অবলম্বন করা উচিত। অন্যান্য এন্টিকোলিনার্জিক ওষুধসমূহ যেমন এমানটেডিন, কোন কোন এন্টিহিস্টামিন, বিউটাইরোফেনন ও ফেনোথায়াজিন এবং ট্রাইসাইক্লিক এন্টিডিপ্রেসেন্ট হায়োসিনের সাথে একত্রে প্রয়োগের ফলে হায়োসিনের ক্রিয়া বেড়ে যেতে পারে বিধায় এ সব ক্ষেত্রে হায়োসিন ব্যবহার করতে হলে এর মাত্রা কমিয়ে নেয়া প্রয়োজন হতে পারে।

গর্ভাবস্থার প্রথম তিন মাসে অন্যান্য ওষুধের মতো একেও সতর্কতার সাথে ব্যবহার করতে হবে।

ডেক্সট্রান কিংবা ০.৯% সোডিয়াম ক্লোরাইড ইনজেকশনের তরল দিয়ে হায়োসিন বিউটাইলব্রোমাইড ইনজেকশনকে তরলীকরণ করা যাবে।

মেয়াদ উত্তীর্ণের পর ব্যবহার করবেন না। সকল ওষুধ শিশুদের নাগালের বাইরে রাখুন।  কেবলমাত্র রেজিস্টার্ড চিকিৎসকের ব্যবস্থাপত্র অনুযায়ী বিতরণযোগ্য।

Bisoprolol is indicated in-

• Hypertension
• Angina
• Moderate to severe heart failure

Bisoprolol is not recommended for the emergency treatment of hypertensive crises.

Anti adrenergic agent (Beta blockers), Beta-adrenoceptor blocking drugs, Beta-blockers

Bisoprolol Hemifumarate is the most selective ß1 blocker. It displays highest level of affinity for the ß1 receptor than any other beta-blocker available up to now. Selectively blocks ß1 adrenergic receptor in the heart and vascular smooth muscle and reduces heart rate and cardiac output resulting in decrease of arterial hypertension. Lipid metabolism can be adversely affected by ß-blockers, in patients with non-ß1 selective ß1-blocker, but Bisoprolol does not cause any change in the cholesterol fraction including the cardioprotective HDL-cholesterol, in long-term therapy.

Adult: In the treatment of mild to moderate hypertension, Bisoprolol fumarate must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily either added to a diuretic or alone. If the response to 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily. An appropriate interval for dose titration is 2 weeks. Increasing the dose beyond 20 mg once daily produces only a small incremental benefit.

Children: Safety and effectiveness in children have not been established.

Patients With Renal or Hepatic Impairment: In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min) as in other patients, the initial daily dose should be 5 mg. Because of the possibility of accumulation, caution must be used in dose titration. Since limited data suggest that bisoprolol fumarate is not dialysable, drug replacement is not necessary in patients undergoing dialysis.

Geriatrics: In the elderly, it is not usually necessary to adjust the dose, unless there is also significant renal or hepatic dysfunction

Bisoprolol, like any medication, may have some side effects. It is important that you keep your doctor informed of all side effects especially if you experience one of the following for several days. The most common side effects, whether or not caused by Bisoprolol, are: headache, fatigue, urinary tract infection, rhinitis or sinusitis (inflammation in the nose), diarrhea, dizziness, peripheral edema (swelling of the ankles), joint pain, cough, insomnia (trouble sleeping), nausea (feeling like vomiting), and sore throat. You must seek medical attention immediately if you experience an allergic reaction with symptoms of rash, itching, swelling, dizziness or trouble breathing.

Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. Discuss how you feel on Bisoprolol with your doctor or pharmacist. Do not stop or restart Bisoprolol on your own.

In patients with cardiogenic shock, overt heart failure, second or third degree A-V block, right ventricular failure secondary to pulmonary hypertension and sinus bradycardia.

Monitoring of renal, hepatic and hematopoietic function should be performed at regular intervals during long-term treatment with bisoprolol.

Other β-blocking Agents: Bisoprolol fumarate should not be combined with other β-blocking agents.

Catecholamine-Depleting Drugs: Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be monitored closely because the added β-adrenergic blocking action of bisoprolol fumarate may produce excessive reduction of sympathetic activity.

Centrally Active Antihypertensive Agents: β-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the β-blocker should be withdrawn several days before discontinuing clonidine. If replacing clonidine by β-blocker therapy, the introduction of β-blockers should be delayed for several days after clonidine administration has stopped (see also prescribing information for clonidine).

Antiarrhythmic Agents: Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of A-V conduction, such as certain calcium antagonists (particularly of the phenyl alkylamine (verapamil) and benzothiazepine (diltiazem) classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.

Calcium Channel Blockers: Combined use of β-blockers and calcium channel blockers with negative inotropic effects can lead to prolongation of S-A and A-V conduction, particularly in patients with impaired ventricular function or conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure.

Pregnancy: Bisoprolol fumarate was not teratogenic in rats at doses up to 150 mg/kg/day, which is 375 times the maximum recommended human daily dose. Bisoprolol fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and maternotoxic (decreased food intake and body-weight gain) at 150 mg/kg/day. Bisoprolol fumarate was not teratogenic in rabbits at doses up to 12.5 mg/kg/day, which is 31 times the maximum recommended human daily dose, but was embryolethal (increased early resorptions) at 12.5 mg/kg/day. There are no studies in pregnant women. Bisoprolol fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Small amounts of bisoprolol fumarate (<2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. If use of bisoprolol fumarate is considered essential, then mothers should stop nursing.

Keep in a dry place away from light and heat. Keep out of the reach of children.