Midecamycin Meiji

Midecamycin Meiji





Full Prescribing Info
Midecamycin is a macrolide antibiotic developed by Meiji Seika Kaisha, Ltd. It is produced by a strain of Streptomyces mycarofaciens isolated from soil collected in Onomichi City, Hiroshima Prefecture, Japan. Midecamycin is a white, odorless, crystalline powder with a bitter taste. It is very soluble in methanol, freely soluble in ethanol, acetone, chloroform, ethyl acetate and butyl acetate, very slightly soluble in water, and practically insoluble in petroleum ether and hexane. Molecular Formula: C41H67NO15. Molecular Weight: 813.99
Microbiology: Antibacterial Activity: Midecamycin is highly active against various gram-positive organisms and also against Neisseria gonorrhoeae, Neisseria meningitidis and Mycoplasma pneumoniae. (See Table 1.)
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Pharmacokinetics: The blood concentration after a single oral administration of 400 mg (potency) of midecamycin to adults reaches a peak of about 1 mcg/mL 2 hrs after administration and then gradually decreases with time. The excretion rate in the urine is 2-3% within the first 6 hrs.
Clinical Data: Clinical Efficacy: The results of general clinical and double-blind comparative clinical trials including 1451 cases are as follows:
The efficacy rate was 79.6% (301/378 case) for such superficial suppurative diseases as furuncle, phlegmon, etc; 67.1% (57/85) for such deep suppurative diseases as lymphadenitis, osteomyelitis, etc; 86.7% (176/203) for such upper respiratory tract infections as pharyngitis, tonsillitis, etc; 70.2% (153/218) for such lower respiratory tract infections as bronchitis, pneumonia, etc; 86.2% (25/29) for primary atypical pneumonia; 70.4% (57/81) for cystitis and urethritis; 60.6% (20/33) for dacryocystitis and sty; 67% (128/191) for otitis media; 80% (16/20) for sinusitis; 78.9% (168/213) for infections in the field of oral surgery eg, osteomyelitis of the jaw, periserotinitis of wisdom teeth, etc.
Side Effects: Among 7012 cases reported by clinicians nationwide, the following 191 episodes of side effects were manifested: 23 episodes (0.33%) of skin injury, 9 (0.13%) of CNS injury, 1 (0.01%) of visual damage, 144 (2.05%) of gastrointestinal disorders, 3 (0.04%) of hepatic/renal damage, 3 (0.04%) of effects on the pulse and rhythm of the heart, 2 (0.03%) of hematological disorders, 3 (0.04%) of urological damage and 3 (0.04%) of damage to the general health.
Toxicology: Nonclinical Tests: Acute Toxicity: See Table 2.
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Acute and Chronic Toxicities: Based on the results of a subacute toxicity test performed on rats administered midecamycin orally for 35 days, the maximum non-effective dose was surmised to be 250 mg/kg. Based on the results of a chronic toxicity test performed on rats when they administered the drug orally for 182 days, the maximum non-effective dose was surmised to be 250 mg/kg.
In another study, no toxicological effects were seen when midecamycin was orally administered to dogs in doses of 50, 150 and 300 mg/kg for 182 days.
Reproduction Study: No teratogenicity was seen in mice or rats when they administered midecamycin orally in doses of 0.5-3 g/kg.
Antigenicity: No antigenicity was seen in a test using rabbits.
Tissue Concentration: The peak tissue concentrations of midecamycin in mice were highest in the lung followed by the spleen, kidney, serum and liver. The organ concentrations were generally higher than the serum concentration.
The following infections caused by midecamycin-susceptible strains of Staphylococci, Streptococci, Pneumococci and Mycoplasma pneumoniae*: Furuncle, carbuncle, impetigo, subcutaneous abscess, phlegmon, felon, infectious atheroma, erysipelas, mastitis, lymphadenitis, osteomyelitis, pharyngitis, laryngitis, tonsillitis, bronchitis, infections associated with bronchiectasis, pneumonia, pulmonary suppuration, primary atypical pneumonia*, cystitis, urethritis, sty, dacryocystitis, otitis media, sinusitis, alveolar periostitis, periserotinitis of wisdom teeth, alveolar abscess, gingival abscess, periodontitis, osteomyelitis of the jaw, infectious cyst and infections after tooth extraction.
Dosage/Direction for Use
The usual daily dosage for adults is 800-1200 mg (potency), given orally in 3-4 equally divided doses. For infants and children, 30 mg (potency)/kg a day is given orally in 3-4 equally divided doses. The dosage should be adjusted in consideration of the patient's age or severity of the symptoms.
Special Precautions
Hypersensitivity: Occasionally, symptoms of hypersensitivity may occur. In such cases, administration of the drug should be discontinued.
Digestive Tract: Administration of the drug may occasionally cause gastrointestinal disorders eg, anorexia, nausea, vomiting, stomach discomfort, stomach pain, abdominal pain, loose stool, diarrhea, etc.
Others: Glossitis and coating of the tongue may rarely occur.
Store at room temperature.
MIMS Class
ATC Classification
J01FA03 - midecamycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Cap 200 mg (red cap and a slightly pink body) x 100's, 500's.
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