Spectinomycin Hydrochloride for Injection [Drug name] INN: Spectinomycin hydrochloride for injection The main component is sterile powder of spectinomycin hydrochloride. Its chemical name is: the pentahydrate of the dihydrochloride of (2R,4aR,5aR,6S,7S,8R,9S,9aR,10aS) -4a,7,9-trihydroxy- 2-methyl-6,8-bis (methylamino) decahydro-4H-pyrano[2,3-b][1,4]benzodioxin-4-one dihydrochloride. Formula: C14H24N2O7·2HCI·5H20 M.W.: 495.35 [Description] White or almost white crystalline powder. [Indication] The product is indicated in the treatment of urethritis, cervicitis and proctitis caused by gonococci, and of infections caused by bacteria with drug-resistant to penicillin and tetracycline etc. Since most of the patients with gonorrhea may be infected by chlamydia trachomatis at the same time, so after the treatment of this product, treatment of tetracycline or doxycycline or erythromycin of 7 days continuously should be followed. [Specification] 2g (2million IU)(Calculated as CHNO) [Dosage and administration] For intramuscular use only. Dissolve 2g (one vial) of the product in 3.2ml (one ampoule) of 0.9% benzyl alcohol injection before use. Shake to produce a suspension. For adults: For the treatment of gonorrheal cervicitis, proctitis and urethritis, 2g (one vial) once a time; For the disseminated gonococci infection, 2g every 12 hours for 3 days continuously. The maximum dosage is 4g (2 vials) per time, perform injection in left and right sides of buttock. For infants: The product is prohibited to use in newborn babies. For children whose body-weight is below 45kg, the recommended dose is 40mg of the product per kg of the body weight by intramuscular injection. For those above 45kg of body weight, 2g per time by intramuscular injection. [Adverse reaction] Occasionally individual patient undergoes such reactions as pain at the injection location, temporary dizziness, nausea, insomnia and so on; Occasionally anaphylaxis such as fever and tetter, decrease in hemoglobin and hematocrit, decrease in creatinine clearance rate, and increase of alkaline phosphatase, urea nitrogen and serum aminopherase are found. Also some cases of urine output reduction occurs [Contraindication] The product is prohibited to use in patients previously sensitive to it or aminoglycoside antibiotics, and in patients with renal diseases as well. [Cautions] (1)This product is prohibited to use via vein injection. It should be injected intramuscularly deeply into the upper outer quadrant of the gluteal muscle. On the same injection site the dosage for one time should not be more than 2g (5ml). (2) There is no cross hypersusceptibility between this product and penicillin. (3) When adverse reaction occurs, adrenalin, cortex hormone or antihistamine can be administered to serious patients, and measures such as keeping respiratory tract from blocked and supplying oxygen can be taken. [Pregnancy or nursing mother] (1) This product is prohibited to use in pregnant women. (2) It is still unclear for using in nursing mothers. Lactation should be stopped during administration of this product. [Pediatric Use] (1) This product is prohibited to use in newborn babies since the diluent of the product contains 0.9% of benzyl alcohol which may cause lethal gasp syndrome for newborn babies. (2) This product can be used in infants with gonorrhea who are sensitive to penicillin or cephalosporin. (3)Since this product is diluted with benzyl alcohol injection, it is prohibited to use intramuscularly in infants. [Geriatric Use] The test has not been performed yet and there is no reliable reference literature available. [Interaction with other drugs] Based on literature data, toxicity of lithium carbonate appears in individual patient when combined with this product. [Overdosage] This test has not been performed and there is no reliable reference literature available. [Pharmacology and toxicology] Pharmacological action: This product is an aminoglycoside antibiotic produced by streptomyces spectabilis. It manifests strong antibacterial action against gonococci and also shows good antibacterial activity against those gonococci producing beta-lactamase. It also shows moderate antibacterial action against many kinds of Enterobacteriacea bacteria. Providencia and pseudomonas aeruginosa show resistance to this product. It is also found that strains resistant to this product are still sensitive to streptomycin, gentamycin and tobramycin. This product shows activity to ureaplasma urealyticum, and no activity to chlamydia trachomatis and treponem apallidum. This product can restrain the synthesis of protein by combining with 30S sub-unit of ribosome of bacteria. Toxicological study: This test has not been performed and there is no reliable reference literature available. [Pharmacokinetics] Absorbed well when inject intramuscularly. When inject 2g via intramuscular in a single dose, the maximal concentration in blood is approximately 100mg/L, reaches in an hour, and the concentration in blood is 15mg/Lin 8 hours. The concentration in blood will double when double the dosage. The product does not combine with serum protein. The elimination half time in blood (T1/2) is 1~3 hours, for patients with lower kidney function (creatinine clearance rate<20ml/min) T1/2 can be prolonged to 10~30 hours. This product can be eliminated mainly through kidney in prototype, 100% of the product in prototype can be eliminated in urine within 48 hours after injection one time. The concentration in blood can be reduced by 50% in the case of hemodialysis. [Storage] Sealed tightly, store in the dry place. [Package] One vial of Spectinomycin hydrochloride for injection and one ampoule of benzyl alcohol injection. [Shelf life] 3 years.
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