Remac125 mg/5 ml

Remac 125 mg/5 ml is indicated in- Streptococcal pharyngitis Sinusitis Infective exacerbations of chronic bronchitis Community-acquired pneumonia Atypical pneumonia Skin and soft tissue infection Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.

Macrolides

Remac 125 mg/5 ml acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S sub- unit of the bacterial ribosome and preventing translocation to that site. Remac 125 mg/5 ml is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Remac 125 mg/5 ml’s activity is the same as, or greater than, that of erythromycin in vitro against most Gram-positive bacteria. Remac 125 mg/5 ml is more acid stable than erythromycin and therefore, is better tolerated. Remac 125 mg/5 ml has twice the activity of erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Remac 125 mg/5 ml because of failure to penetrate to the target.

Adults: Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days. Acute maxillary sinusitis 500 mg every 12 hours for 14 days. Chronic bronchitis 250-500 mg every 12 hours for 7-14 days. Pneumonia 250 mg every 12 hours for 7-14 days. Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days. Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days. Children: Bodyweight under 8 kg: 7.5 mg/kg twice daily. Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily. Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily. Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily. Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.

Remac 125 mg/5 ml may be given with or without meals.

Theophylline: Concomitant use of Remac 125 mg/5 ml who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Remac 125 mg/5 ml may alter the metabolism of Terfenadine.

Hypersensitivity to Remac 125 mg/5 ml, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Remac 125 mg/5 ml is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Remac 125 mg/5 ml is not recommended for pregnant women. Breast milk from mothers receiving Remac 125 mg/5 ml should not be given to infants until treatment is completed.

Remac 125 mg/5 ml is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Remac 125 mg/5 ml may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Remac 125 mg/5 ml should be discontinued and appropriate therapy should be instituted.

Reports indicate that the ingestion of large amounts of Remac 125 mg/5 ml can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of Remac 125 mg/5 ml and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, Remac 125 mg/5 ml serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.

Remac 125 mg/5 ml may be used in neonates and children in appropriate doses.

Children older than 12 years and Adult: The usual duration of treatment is 6 to 14 days. Eradication of H. pylori in patients with duodenal ulcers: Adults: The usual duration of treatment is 6 to 14 days.

45 ml of water is to be added to the granules in the bottle and shaken to yield 70 ml of reconstituted suspension. The concentration of Remac 125 mg/5 ml in the reconstituted suspension is 125 mg per 5 ml.

Macrolides

Remac 125 mg/5 ml acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Remac 125 mg/5 ml is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Remac 125 mg/5 ml's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Remac 125 mg/5 ml is more acid-stable than Erythromycin and therefore, is better tolerated. Remac 125 mg/5 ml has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Remac 125 mg/5 ml because of failure to penetrate the target.

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Remac 125 mg/5 ml should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Remac 125 mg/5 ml is not recommended.