Mekophar Lincomycin 500 mg Capsule

MEKOPHAR LINCOMYCIN®
Capsules

 

COMPOSITION

Lincomycin 500mg

Excipients q.s 1 capsule

 

PHARMACODYNAMICS

Lincomycin is a lincosamide antibiotic with a primarily bacteriostatic action against Gram-positive aerobes (Staphylococcus, Streptococcus, Pneumococcus, Bacillus anthracis, Corynebacterium diphtheriae) and a wide range anaerobic bacteria (Eubacterium, Propionibacterium, Peptococcus, Peptostreptococcus spp., and many strains of Clostridium perfringens and Cl. tetani).

 

PHARMACOKINETICS

– Food markedly reduces the rate and extent of absorption of lincomycin. Lincomycin is widely distributed in the tissues including bone and body fluids but diffusion into the CSF is poor, it diffuses across the placenta.

– Lincomycin is partially inactivated in the liver and is excreted as unchanged drug or metabolites in the urine and feces.

 

INDICATIONS

Treatment of serious infections of ear-nose-throat, mouth, skin, genital tract, bone, joint, postoperative abdominal area, bronchopulmonary infections, septicemia.

 

DOSAGE AND ADMINISTRATION

– Take on an empty stomach (1 hour before or 2 hours after meal).

– As prescribed by physician.

– Usual dosage: + Adults: 1 capsule, 3 times daily. In severe cases: 2 capsules 3 times daily.

+ Children: 30mg/kg/day in 3 – 4 divided doses. In severe cases: 60mg/kg/day in 3 – 4 divided dose.

– This formulation is suitable for children > 6 years.

– Patients with renal impairment may require a reduction to one third to one half of the usual dose.

 

CONTRAINDICATIONS

– Hypersensitivity to lincomycin or other lincosamides.

– Meningitis (lincomycin doesn’t reach the cerebrospinal fluid in significant concentrations).

 

PRECAUTIONS

– Patients with GI diseases, especially those with history of colitis.

– Elderly and women may be prone to develop severe diarrhea or pseudomembranous colitis.

– Patients with allergy.

– Periodic tests of liver and blood counts have been recommended in patients receiving prolonged therapy and in infants.

– Caution should be exercised in patients receiving neuromuscular blocking agents.

 

PREGNANCY AND LACTATION

– Caution should be exercised when it is given to pregnant women.

– Nursing mothers should not use or stop nursing when using this medication.

 

INTERACTIONS

– Kaolin containing antidiarrheal preparations tends to decrease intestinal absorption of lincomycin. To avoid this take lincomycin 2 hours apart from kaolin administration.

– Sodium cyclamate may decrease lincomycin absorption.

– Oral contraceptive effect may be inhibited or decreased due to GI microflora disturbance that lead to intestine-liver cycle inhibition.

 

SIDE-EFFECTS

– Common: nausea, vomiting, diarrhea.

– Occasional: urticaria, skin rashes.

– Rare: anaphylaxis, neutropenia (reversible), elevated liver enzymes (reversible), pseudomembranous colitis, esophagitis.

– Inform your doctor about side-effects when using this medicine.

 

OVERDOSAGE

– After an acute oral overdose, patients may experience nausea, vomiting or diarrhea. Life threatening allergic reactions may occur. There is no specific antidote. Management generally involves symptomatic and supportive measures and may include enhanced elimination by suitable means. Maintain an open airway, and assist ventilation, if necessary. Replace fluid loss if required.

– Serum levels of lincomycin are not appreciably affected by hemodialysis and peritoneal dialysis.

– Should overdosage occur, turn to the nearest healthcare facility for medical attention of the healthcare professionals.

 

SHELF LIFE

24 months from the manufacturing date.

Never use beyond the expiry date clearly indicated on the outer packaging.

 

STORAGE

Store in a cool, dry place, not exceeding 25°C and away from light.

 

PRESENTATION

– Blister of 10 capsules. Box of 1 blister.

– Blister of 10 capsules. Box of 10 blisters.

 

Always keep out of reach of children.

Read the directions carefully before use.

For further information, please refer to your doctor.

Only on prescription.

 

Manufactured by

MEKOPHAR CHEMICAL PHARMACEUTICAL JOINT-STOCK COMPANY

297/5 Ly Thuong Kiet Street – District 11 – Ho Chi Minh City – Vietnam

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