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Parenteral anti-coagulants

Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-lla or antithrombin activity. At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin Sodium is primarily metabolised in the liver.

Treatment of deep vein thrombosis, with or without pulmonary embolism: Subcutaneously 100 anti-Xa lU/kg twice daily for 10 days or Subcutaneously 150 anti-Xa lU/kq once daily for 10 days. Oral anticoagulant therapy should be initiated when appropriate and Enoxaparin Sodium treatment should be continued until a therapeutic anticoaqulant effect has been achieved.

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa lU/kg twice daily for 2- 8 days. Should be administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Enoxaparin Sodium in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilization.

Prevention of thrombus formation in extra corporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa lU/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 50 anti-Xa lU/kg for double vascular access or 75 anti-Xa lU/kg for single vascular access. During hemodialysis, Enoxaparin Sodium should be introduced into the arterial line of the circuit at the beqinninq of the dialysis session.

Prophylaxis of venous thromboembolic disease in surgical patients:

• Patients undergoing general surgery with a moderate risk of thromboembolism (e.g. abdominal surgery): Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 2 hours before the surgical procedure.
• Patients undergoing orthopedic surgery with a high risk of thromboembolism: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 12 hours before the surgical procedure. Longer treatment duration may be appropriate in some patients like continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopaedic surqery.

Prophylaxis of venous thromboembolic disease in medical patients: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 6- 14 days.

Haemorrhage (bleeding), Thrombocytopenia, elevations of serum aminotransferase. Pain, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of Enoxaparin and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.

Enoxaparin Sodium should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during hemodialysis. Do not administer by the intramuscular route. Enoxaparin Sodium should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy and recent neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis. It is recommended that the platelet counts be measured before the initiation of the treatment and regularly thereafter during treatment.

It is recommended that agents which affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.

Pregnancy category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.

It is not known whether Enoxaparin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue Enoxaparin, taking into account the importance of Enoxaparin to the mother and the known benefits of nursing.

Dose in Elderly Patients: No dosage adjustment is necessary, unless kidney function is impaired.

Dose in Renal Impairment: Although no dosage adjustment is recommended in patients with moderate (creatinine clearance: 30-50 ml/min) and mild (creatinine clearance: 50 80 ml/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding. For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage adjustments are recommended: Prophylactic dose ranges: 2000 antiXa IU once daily; Therapeutic dose ranges: 100 anti-Xa lU/kg once daily.

Dose in Hepatic Impairment: Caution should be used in hepatically impaired patients.

Accidental overdosage following administration of Enoxaparin may lead to hemorrhagic complications. Injected Enoxaparin may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution) The dose of protamine sulfate should be equal to the dose of Enoxaparin injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Enoxaparin.

Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children

Parenteral anti-coagulants

Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-lla or antithrombin activity. At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin Sodium is primarily metabolised in the liver.

Treatment of deep vein thrombosis, with or without pulmonary embolism: Subcutaneously 100 anti-Xa lU/kg twice daily for 10 days or Subcutaneously 150 anti-Xa lU/kq once daily for 10 days. Oral anticoagulant therapy should be initiated when appropriate and Enoxaparin Sodium treatment should be continued until a therapeutic anticoaqulant effect has been achieved.

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa lU/kg twice daily for 2- 8 days. Should be administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Enoxaparin Sodium in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilization.

Prevention of thrombus formation in extra corporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa lU/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 50 anti-Xa lU/kg for double vascular access or 75 anti-Xa lU/kg for single vascular access. During hemodialysis, Enoxaparin Sodium should be introduced into the arterial line of the circuit at the beqinninq of the dialysis session.

Prophylaxis of venous thromboembolic disease in surgical patients:

• Patients undergoing general surgery with a moderate risk of thromboembolism (e.g. abdominal surgery): Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 2 hours before the surgical procedure.
• Patients undergoing orthopedic surgery with a high risk of thromboembolism: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 12 hours before the surgical procedure. Longer treatment duration may be appropriate in some patients like continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopaedic surqery.

Prophylaxis of venous thromboembolic disease in medical patients: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 6- 14 days.

Haemorrhage (bleeding), Thrombocytopenia, elevations of serum aminotransferase. Pain, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of Enoxaparin and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.

Enoxaparin Sodium should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during hemodialysis. Do not administer by the intramuscular route. Enoxaparin Sodium should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy and recent neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis. It is recommended that the platelet counts be measured before the initiation of the treatment and regularly thereafter during treatment.

It is recommended that agents which affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.

Pregnancy category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.

It is not known whether Enoxaparin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue Enoxaparin, taking into account the importance of Enoxaparin to the mother and the known benefits of nursing.

Dose in Elderly Patients: No dosage adjustment is necessary, unless kidney function is impaired.

Dose in Renal Impairment: Although no dosage adjustment is recommended in patients with moderate (creatinine clearance: 30-50 ml/min) and mild (creatinine clearance: 50 80 ml/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding. For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage adjustments are recommended: Prophylactic dose ranges: 2000 antiXa IU once daily; Therapeutic dose ranges: 100 anti-Xa lU/kg once daily.

Dose in Hepatic Impairment: Caution should be used in hepatically impaired patients.

Accidental overdosage following administration of Enoxaparin may lead to hemorrhagic complications. Injected Enoxaparin may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution) The dose of protamine sulfate should be equal to the dose of Enoxaparin injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Enoxaparin.

Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children

Parenteral anti-coagulants

Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-lla or antithrombin activity. At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin Sodium is primarily metabolised in the liver.

Treatment of deep vein thrombosis, with or without pulmonary embolism: Subcutaneously 100 anti-Xa lU/kg twice daily for 10 days or Subcutaneously 150 anti-Xa lU/kq once daily for 10 days. Oral anticoagulant therapy should be initiated when appropriate and Enoxaparin Sodium treatment should be continued until a therapeutic anticoaqulant effect has been achieved.

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa lU/kg twice daily for 2- 8 days. Should be administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Enoxaparin Sodium in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilization.

Prevention of thrombus formation in extra corporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa lU/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 50 anti-Xa lU/kg for double vascular access or 75 anti-Xa lU/kg for single vascular access. During hemodialysis, Enoxaparin Sodium should be introduced into the arterial line of the circuit at the beqinninq of the dialysis session.

Prophylaxis of venous thromboembolic disease in surgical patients:

• Patients undergoing general surgery with a moderate risk of thromboembolism (e.g. abdominal surgery): Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 2 hours before the surgical procedure.
• Patients undergoing orthopedic surgery with a high risk of thromboembolism: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 12 hours before the surgical procedure. Longer treatment duration may be appropriate in some patients like continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopaedic surqery.

Prophylaxis of venous thromboembolic disease in medical patients: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 6- 14 days.

Haemorrhage (bleeding), Thrombocytopenia, elevations of serum aminotransferase. Pain, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of Enoxaparin and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.

Enoxaparin Sodium should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during hemodialysis. Do not administer by the intramuscular route. Enoxaparin Sodium should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy and recent neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis. It is recommended that the platelet counts be measured before the initiation of the treatment and regularly thereafter during treatment.

It is recommended that agents which affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.

Pregnancy category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.

It is not known whether Enoxaparin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue Enoxaparin, taking into account the importance of Enoxaparin to the mother and the known benefits of nursing.

Dose in Elderly Patients: No dosage adjustment is necessary, unless kidney function is impaired.

Dose in Renal Impairment: Although no dosage adjustment is recommended in patients with moderate (creatinine clearance: 30-50 ml/min) and mild (creatinine clearance: 50 80 ml/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding. For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage adjustments are recommended: Prophylactic dose ranges: 2000 antiXa IU once daily; Therapeutic dose ranges: 100 anti-Xa lU/kg once daily.

Dose in Hepatic Impairment: Caution should be used in hepatically impaired patients.

Accidental overdosage following administration of Enoxaparin may lead to hemorrhagic complications. Injected Enoxaparin may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution) The dose of protamine sulfate should be equal to the dose of Enoxaparin injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Enoxaparin.

Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children

Parenteral anti-coagulants

Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-lla or antithrombin activity. At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin Sodium is primarily metabolised in the liver.

Treatment of deep vein thrombosis, with or without pulmonary embolism: Subcutaneously 100 anti-Xa lU/kg twice daily for 10 days or Subcutaneously 150 anti-Xa lU/kq once daily for 10 days. Oral anticoagulant therapy should be initiated when appropriate and Enoxaparin Sodium treatment should be continued until a therapeutic anticoaqulant effect has been achieved.

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa lU/kg twice daily for 2- 8 days. Should be administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Enoxaparin Sodium in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilization.

Prevention of thrombus formation in extra corporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa lU/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 50 anti-Xa lU/kg for double vascular access or 75 anti-Xa lU/kg for single vascular access. During hemodialysis, Enoxaparin Sodium should be introduced into the arterial line of the circuit at the beqinninq of the dialysis session.

Prophylaxis of venous thromboembolic disease in surgical patients:

• Patients undergoing general surgery with a moderate risk of thromboembolism (e.g. abdominal surgery): Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 2 hours before the surgical procedure.
• Patients undergoing orthopedic surgery with a high risk of thromboembolism: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 12 hours before the surgical procedure. Longer treatment duration may be appropriate in some patients like continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopaedic surqery.

Prophylaxis of venous thromboembolic disease in medical patients: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 6- 14 days.

Haemorrhage (bleeding), Thrombocytopenia, elevations of serum aminotransferase. Pain, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of Enoxaparin and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.

Enoxaparin Sodium should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during hemodialysis. Do not administer by the intramuscular route. Enoxaparin Sodium should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy and recent neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis. It is recommended that the platelet counts be measured before the initiation of the treatment and regularly thereafter during treatment.

It is recommended that agents which affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.

Pregnancy category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.

It is not known whether Enoxaparin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue Enoxaparin, taking into account the importance of Enoxaparin to the mother and the known benefits of nursing.

Dose in Elderly Patients: No dosage adjustment is necessary, unless kidney function is impaired.

Dose in Renal Impairment: Although no dosage adjustment is recommended in patients with moderate (creatinine clearance: 30-50 ml/min) and mild (creatinine clearance: 50 80 ml/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding. For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage adjustments are recommended: Prophylactic dose ranges: 2000 antiXa IU once daily; Therapeutic dose ranges: 100 anti-Xa lU/kg once daily.

Dose in Hepatic Impairment: Caution should be used in hepatically impaired patients.

Accidental overdosage following administration of Enoxaparin may lead to hemorrhagic complications. Injected Enoxaparin may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution) The dose of protamine sulfate should be equal to the dose of Enoxaparin injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Enoxaparin.

Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children

Parenteral anti-coagulants

Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-lla or antithrombin activity. At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin Sodium is primarily metabolised in the liver.

Treatment of deep vein thrombosis, with or without pulmonary embolism: Subcutaneously 100 anti-Xa lU/kg twice daily for 10 days or Subcutaneously 150 anti-Xa lU/kq once daily for 10 days. Oral anticoagulant therapy should be initiated when appropriate and Enoxaparin Sodium treatment should be continued until a therapeutic anticoaqulant effect has been achieved.

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa lU/kg twice daily for 2- 8 days. Should be administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Enoxaparin Sodium in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilization.

Prevention of thrombus formation in extra corporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa lU/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 50 anti-Xa lU/kg for double vascular access or 75 anti-Xa lU/kg for single vascular access. During hemodialysis, Enoxaparin Sodium should be introduced into the arterial line of the circuit at the beqinninq of the dialysis session.

Prophylaxis of venous thromboembolic disease in surgical patients:

• Patients undergoing general surgery with a moderate risk of thromboembolism (e.g. abdominal surgery): Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 2 hours before the surgical procedure.
• Patients undergoing orthopedic surgery with a high risk of thromboembolism: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 12 hours before the surgical procedure. Longer treatment duration may be appropriate in some patients like continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopaedic surqery.

Prophylaxis of venous thromboembolic disease in medical patients: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 6- 14 days.

Haemorrhage (bleeding), Thrombocytopenia, elevations of serum aminotransferase. Pain, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of Enoxaparin and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.

Enoxaparin Sodium should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during hemodialysis. Do not administer by the intramuscular route. Enoxaparin Sodium should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy and recent neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis. It is recommended that the platelet counts be measured before the initiation of the treatment and regularly thereafter during treatment.

It is recommended that agents which affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.

Pregnancy category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.

It is not known whether Enoxaparin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue Enoxaparin, taking into account the importance of Enoxaparin to the mother and the known benefits of nursing.

Dose in Elderly Patients: No dosage adjustment is necessary, unless kidney function is impaired.

Dose in Renal Impairment: Although no dosage adjustment is recommended in patients with moderate (creatinine clearance: 30-50 ml/min) and mild (creatinine clearance: 50 80 ml/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding. For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage adjustments are recommended: Prophylactic dose ranges: 2000 antiXa IU once daily; Therapeutic dose ranges: 100 anti-Xa lU/kg once daily.

Dose in Hepatic Impairment: Caution should be used in hepatically impaired patients.

Accidental overdosage following administration of Enoxaparin may lead to hemorrhagic complications. Injected Enoxaparin may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution) The dose of protamine sulfate should be equal to the dose of Enoxaparin injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Enoxaparin.

Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children

Parenteral anti-coagulants

Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-lla or antithrombin activity. At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin Sodium is primarily metabolised in the liver.

Treatment of deep vein thrombosis, with or without pulmonary embolism: Subcutaneously 100 anti-Xa lU/kg twice daily for 10 days or Subcutaneously 150 anti-Xa lU/kq once daily for 10 days. Oral anticoagulant therapy should be initiated when appropriate and Enoxaparin Sodium treatment should be continued until a therapeutic anticoaqulant effect has been achieved.

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa lU/kg twice daily for 2- 8 days. Should be administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Enoxaparin Sodium in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilization.

Prevention of thrombus formation in extra corporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa lU/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 50 anti-Xa lU/kg for double vascular access or 75 anti-Xa lU/kg for single vascular access. During hemodialysis, Enoxaparin Sodium should be introduced into the arterial line of the circuit at the beqinninq of the dialysis session.

Prophylaxis of venous thromboembolic disease in surgical patients:

• Patients undergoing general surgery with a moderate risk of thromboembolism (e.g. abdominal surgery): Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 2 hours before the surgical procedure.
• Patients undergoing orthopedic surgery with a high risk of thromboembolism: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 12 hours before the surgical procedure. Longer treatment duration may be appropriate in some patients like continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopaedic surqery.

Prophylaxis of venous thromboembolic disease in medical patients: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 6- 14 days.

Haemorrhage (bleeding), Thrombocytopenia, elevations of serum aminotransferase. Pain, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of Enoxaparin and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.

Enoxaparin Sodium should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during hemodialysis. Do not administer by the intramuscular route. Enoxaparin Sodium should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy and recent neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis. It is recommended that the platelet counts be measured before the initiation of the treatment and regularly thereafter during treatment.

It is recommended that agents which affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.

Pregnancy category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.

It is not known whether Enoxaparin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue Enoxaparin, taking into account the importance of Enoxaparin to the mother and the known benefits of nursing.

Dose in Elderly Patients: No dosage adjustment is necessary, unless kidney function is impaired.

Dose in Renal Impairment: Although no dosage adjustment is recommended in patients with moderate (creatinine clearance: 30-50 ml/min) and mild (creatinine clearance: 50 80 ml/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding. For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage adjustments are recommended: Prophylactic dose ranges: 2000 antiXa IU once daily; Therapeutic dose ranges: 100 anti-Xa lU/kg once daily.

Dose in Hepatic Impairment: Caution should be used in hepatically impaired patients.

Accidental overdosage following administration of Enoxaparin may lead to hemorrhagic complications. Injected Enoxaparin may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution) The dose of protamine sulfate should be equal to the dose of Enoxaparin injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Enoxaparin.

Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children

Parenteral anti-coagulants

Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-lla or antithrombin activity. At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin Sodium is primarily metabolised in the liver.

Treatment of deep vein thrombosis, with or without pulmonary embolism: Subcutaneously 100 anti-Xa lU/kg twice daily for 10 days or Subcutaneously 150 anti-Xa lU/kq once daily for 10 days. Oral anticoagulant therapy should be initiated when appropriate and Enoxaparin Sodium treatment should be continued until a therapeutic anticoaqulant effect has been achieved.

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa lU/kg twice daily for 2- 8 days. Should be administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Enoxaparin Sodium in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilization.

Prevention of thrombus formation in extra corporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa lU/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 50 anti-Xa lU/kg for double vascular access or 75 anti-Xa lU/kg for single vascular access. During hemodialysis, Enoxaparin Sodium should be introduced into the arterial line of the circuit at the beqinninq of the dialysis session.

Prophylaxis of venous thromboembolic disease in surgical patients:

• Patients undergoing general surgery with a moderate risk of thromboembolism (e.g. abdominal surgery): Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 2 hours before the surgical procedure.
• Patients undergoing orthopedic surgery with a high risk of thromboembolism: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 12 hours before the surgical procedure. Longer treatment duration may be appropriate in some patients like continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopaedic surqery.

Prophylaxis of venous thromboembolic disease in medical patients: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 6- 14 days.

Haemorrhage (bleeding), Thrombocytopenia, elevations of serum aminotransferase. Pain, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of Enoxaparin and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.

Enoxaparin Sodium should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during hemodialysis. Do not administer by the intramuscular route. Enoxaparin Sodium should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy and recent neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis. It is recommended that the platelet counts be measured before the initiation of the treatment and regularly thereafter during treatment.

It is recommended that agents which affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.

Pregnancy category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.

It is not known whether Enoxaparin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue Enoxaparin, taking into account the importance of Enoxaparin to the mother and the known benefits of nursing.

Dose in Elderly Patients: No dosage adjustment is necessary, unless kidney function is impaired.

Dose in Renal Impairment: Although no dosage adjustment is recommended in patients with moderate (creatinine clearance: 30-50 ml/min) and mild (creatinine clearance: 50 80 ml/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding. For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage adjustments are recommended: Prophylactic dose ranges: 2000 antiXa IU once daily; Therapeutic dose ranges: 100 anti-Xa lU/kg once daily.

Dose in Hepatic Impairment: Caution should be used in hepatically impaired patients.

Accidental overdosage following administration of Enoxaparin may lead to hemorrhagic complications. Injected Enoxaparin may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution) The dose of protamine sulfate should be equal to the dose of Enoxaparin injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Enoxaparin.

Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Clindamycin and Tretinoin gel is indicated for the topical treatment of Acne vulgaris.

Topical antibiotic & retinoid preparations

This is a combination of lincosamide antibiotic Clindamycin phosphate and retinoid Tretinoin. Clindamycin binds with the 50s ribosomal subunit of susceptible bacteria and prevents elongation of peptide chain by interfering with the peptidyl transfer, thereby suppressing bacterial protein synthesis. Clindamycin inhibits the activity of Propionibacterium acne as reduces the occurrence of acne. Tretinoin decreases the cohesiveness of follicular epithelial cells and increases the turn over thereby brings the comedones out.

Before sleep: Wash the face gently with a mild soap and water, then pat the skin dry. Apply the Gel with finger tips through the face gently.

In the morning: Apply a sunscreen after the application of Gel. Do not wash your face more than 2 or 3 times a day. Apply the sunscreen cream as needed.

Safety and effectiveness in children below 12 years of age have not been established.

Erythema, scaling, nasopharyngitis, dry skin, cough, sinusitis and diarrhea are the common side effects.

Clindamycin and Tretinoin should not be administered to individuals who are hypersensitive to Clindamycin or Tretinoin or any other component of the Gel.

Clindamycin and Tretinoin should not be applied to eyes, nose, ear, lips, cut, burn and other infections. After the application of the Gel, keep away from sunlight.

It is not known whether Clindamycin or Tretinoin is excreted in human milk. Exercise special caution while applying Clindamycin or Tretinoin to a nursing mother.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

This is indicated in onychomycosis caused by dermatophytes, yeasts and moulds.

Other preparations

Amorolfine is a topical antimycotic. It belongs to a new chemical class of Morpholine, Its fungistatic or fungicidal effect is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. Amorolfine has a broad spectrum of action. Amorolfine is effective against Yeasts. Dermatophytes. Moulds, Dematiaceae and Dimorphic Fungi.

Amorolfine Nail Lacquer should be applied to the affected finger or toenails once or twice a week as directed by the doctor It is important to use Amorolfine until the infection has cleared and healthy nails have grown back usually takes 6 months for fingernails and 9 to 12 months for toenails.

Step 1: File the nail: First file down the infected areas of nail including the nail surface, as much as possible using the nail file provided. Do not use this all file on healthy nails, otherwise the infection will be spread out Discard the nail file after use.

Step 2: Clean the nail: Use one of the alcohol pads provided to clean the nail surface. Repeat steps 1 and 2 for each affected nail.

Step 3: Take some lacquer from the bottle: Use a nail brush to apply the nail lacquer. The lacquer must not be wiped off the edge of the bottle before it is applied. Do not use the brush on healthy nails and wash the brush with hot water after use

Step 4: Apply the lacquer: Apply the lacquer evenly over the entire surface of the nail. Repeat these steps for each affected nail. Let the treated nail(s) dry for approximately 3 minutes. Close the nail lacquer bottle tightly. Dispose of the alcohol pad.

• Before using the nail lacquer again, first remove the old lacquer from your nails using a swab, then file down the nails again if necessary.
• Re-apply the lacquer as previously described
• When dry, the nail lacquer is unaffected by soap and water. So you may wash your hands and feet as normal.

Must not be reused by patients who have shown hypersensitivity to the treatment.

There are no known drug interactions.

No data available on the use of Amorolfine in pregnant women. There is no information on whether Amorolfine passes into human breast milk. There are no data on the use of Amorolfine in lactating women.

No information is available concerning over dosage in human.

Do not store above 30°C. Protect Clinell lacquer from heat. Keep the bottle tightly closed.

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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