Clarithromycin

FORMULATION
Each film-coated tablet contains:
Clarithromycin …….. 250 mg

PHARMACOKINETICS
Clarithromycin is rapidly absorbed from the gastrointestinal tract, and undergoes first-pass metabolism; the bioavailability of the parent drug.

INDICATION
It is used in the treatment and prophylaxis of venous thromboembolism and to prevent clotting during extracorporeal circulation. It is used in the management of unstable angina.

DOSAGE AND ADMINISTRATION
Prophylaxis of venous thromboembolism during surgical procedures – Enoxaparin sodium is given by subcutaneous injection; treatment is continued for 7 to 10 days or until the patient is ambulant. Patients at low to moderate risk are given 20 mg (2000 units) once daily with the first dose about 2 hours pre-operatively. In patients at high risk, such as those undergoing orthopedic surgery, the dose should be increased to 40 mg (4000 units) once daily with the initial dose given about 12 hours before the procedure. Alternatively, a dose of 30 mg (3000 units) may be given subcutaneously twice daily, starting within 12 to 24 hours after operation. After hip replacement surgery, Enoxaparin sodium may be continued in a dose of 40 mg (4000 units) once daily for a further 3 weeks. For the prophylaxis of thromboembolism in immobilized medical patients, the dose is 40 mg (4000 units) once daily for at least 6 days; treatment should be continued until the patient is fully ambulant, up to a maximum of 14 days. For the treatment of deep-vein thrombosis- Enoxaparin sodium is given subcutaneously in a dose of I mg/kg (100 units/kg) every 12 hours, or 1.5 mg/kg (150 units/kg) once daily, for at least 5 days and until oral anticoagulation is established. For prevention of clotting in the extracorporeal circulation during hemodialysis- Enoxaparin sodium I mg/kg (100 units/kg) is introduced into the arterial line of the circuit at the beginning of the dialysis session. A further dose of 0.5 to 1 mg/kg (50 to 100 units/kg) may be given if required. The dose should be reduced in patients at high risk of hemorrhage. In the management of unstable angina- Enoxaparin sodium is given subcutaneously in a dose of I mg/kg (100 units/kg) every 12 hours. Treatment is usually continued for 2 to 8 days and low-dose aspirin should be also be given. The dose of Enoxaparin sodium should be reduced in patients with severe renal impairment.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.

PRECAUTIONS
Low-molecular-weight Heparins should not be given to patients who have developed thrombocytopenia with heparin and who have a positive in-vitro platelet aggregation test (that is, cross-reactivity) with the particular low-molecular-weight Heparin to be used. Monitoring of plasma-anti-factor-Xa activity may be considered in patients with an increased risk of bleeding, for example the elderly or those with renal impairment or extremes of body-weight, and in patients with active bleeding F Low-molecular-weight Heparins are not generally recommended for use in patients with prosthetic heart valves as they may not provide adequate prophylaxis against thromboembolism even at high doses. Patients with low body-weight (women below 45 kg, men below 57 kg) may be at higher risk of bleeding with prophylactic doses of Enoxaparin and require careful monitoring.

ADVERSE EFFECTS
Severe bleeding with Enoxaparin may be reduced by the slow intravenous injection of Protamine sulfate; 1 mg of Protamine sulfate is stated to inhibit the effects of 1 mg (100 units) of Enoxaparin sodium.

INTERACTIONS
Drugs that affect hemostasis -potential pharmacodynamic effect (increased of hemorrhage) with concurrent use of drugs that affect hemostasis (e.g. oral anticoagulants and/or drugs that affect platelet function, including Aspirin, salicylate salts, Ketorolac tromethamine, Dipyridamole, and Sulfinpyrazone. Discontinue such drugs prior to initiating Enoxaparin therapy. Monitor carefully if concurrent administration of such drugs and Enoxaparin are considered essential.

CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

STORAGE CONDITION
Store at temperatures not exceeding 300C.

Keep all medicines out of children’s reach.

AVAILABILITY
Alu-Alu Blister of pack x 10’s (Box of 10’s)

“For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph“.