TROBICIN™ 2 g INJECTION Water for Injection with Benzyl Alcohol 0.9% m/v
COMPOSITION: When reconstituted with Bacteriostatic Water for Injection with Benzyl Alcohol 0.9% m/v, each vial yields 5 mL with a concentration of spectinomycin hydrochloride equivalent to 400 mg spectinomycin base per mL.
PHARMACOLOGICAL CLASSIFICATION: A:20.1.1 Broad and medium spectrum antibiotics.
PHARMACOLOGICAL ACTION: In the treatment of gonorrhoea a single intramuscular injection of TROBICIN gives satisfactory clinical and bacteriological results. TROBICIN bears no structural relationship to the penicillins and does not share their antigenicity. TROBICIN is an inhibitor of protein synthesis in the bacterial cell. The site of action is the 30S ribosomal sub-unit.
In vitro studies have shown TROBICIN to be active against most strains of Neisseria gonorrhoea (minimum inhibitory concentration <7.5 to 20 mcg/mL). Definitive in vitro studies have shown no cross-resistance of Neisseria gonorrhoea between TROBICIN and penicillin. The antibiotic is not significantly bound to plasma protein. TROBICIN is rapidly absorbed after intramuscular injection. A single two-gram injection produces peak serum concentrations averaging 100 mcg/mL at one hour. Serum concentrations inhibitory to most gonococcal strains persist for periods up to 8 hours.
Urinary excretion studies indicate that up to 100% of the administered dose is excreted in the urine within 48 hours in a biologically active form.
INDICATIONS:
TROBICIN is indicated in the treatment of uncomplicated acute gonorrhoeal urethritis and proctitis in the male, and acute gonorrhoeal cervicitis and proctitis in the female, when due to susceptible strains of N. gonorrhoea.
Ophthalmia neonatorum is not covered by TROBICIN thereby restricting its indication to neisserian infection of the genito urinary tract. Efficacy of Trobicin in the following conditions has not been established: disseminating gonorrhoea and gonorrhoeal pharyngitis.
Some strains of Neisseria gonorrhoea are resistant to spectinomycin.
CONTRA-INDICATIONS: The use of TROBICIN is contra-indicated in patients previously found hypersensitive to it.
WARNINGS:
Use in pregnancy:
Safety for use in pregnancy has not been established.
Use in infants:
Safety for use in infants has not been established.
Use in nursing mothers:
It is not known if spectinomycin is excreted in human milk.
TROBICIN is not effective in eradicating incubating syphilis or against concurrent infections with C. trachomatis. Antibiotics used in high doses for short periods of time to treat gonorrhoea may mask or delay the symptoms of incubating syphilis. Therefore, all patients with gonorrhoea should have a serological test for syphilis at the time of diagnosis. Patients treated with TROBICIN should have a follow up serological test for syphilis after three months.
DOSAGE AND DIRECTIONS FOR USE: The recommended dose of spectinomycin hydrochloride in the treatment of uncomplicated gonococcal urethritis and proctitis in men and gonococcal cervicitis and proctitis in women, is 2.0 g in one intramuscular injection. Up to 4.0 g of spectinomycin hydrochloride have been administered in difficult-to-treat cases and in areas where antibiotic resistance is known to occur. The clinical effectiveness of spectinomycin should be monitored to detect evidence of development of resistance by N. gonorrhoea.
Intramuscular injections should be made deep into the upper quadrant of the gluteal muscle. Adults: Inject a single 2 g dose (5 mL) I.M. If a 4 g dose (10 mL) is necessary, the 10 mL may be divided between two gluteal injection sites. Direction for use of the ampoule: No ampoule file is needed to open the ampoule. The neck of the ampoule is prescored at the point of constriction. A coloured dot on the ampoule helps to orientate the ampoule. Take the ampoule and face the coloured dot. The ampoule opens easily by placing the thumb on the coloured dot and gently pressing downwards as shown.
{illustrated} Preparation of drug for intramuscular injection: TROBICIN 2 g: Reconstitute with 3.2 mL of the accompanying diluent (Bacteriostatic Water for Injection with Benzyl Alcohol 0.9% m/v).
Shake vials vigorously immediately after adding diluent and before withdrawing dose. Prepared suspension should be stored at room temperature (15 - 30°C) and used within 24 hours. It is recommended that disposable syringes and needles be used to avoid contamination with penicillin residue, especially when treating patients known to be highly sensitive to penicillin. Use of a 20 gauge needle is recommended.
SIDE EFFECTS AND SPECIAL PRECAUTIONS: Pain at the injection site has been mild to moderate. The usual precautions should be observed with atopic individuals.
The following reactions have been observed during single dose clinical trials: urticaria, dizziness, nausea, chills, fever, rash, headache and a reduction in urine output.
The following reactions have been observed during multiple-dose therapy: rash, headache, a decrease in haemoglobin, haematocrit, and creatinine clearance; and an elevation of alkaline phosphatase, BUN, and SGPT.
Anaphylaxis or anaphylactoid reactions have been reported on rare occasions.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT: Treatment should be symptomatic and supportive.
IDENTIFICATION: Vials containing a white powder and ampoules with water.
PRESENTATION: Vial containing 2 g spectinomycin hydrochloride and a 3.2 mL ampoule with Bacteriostatic Water for Injection with Benzyl Alcohol 0.9% m/v.
STORAGE INSTRUCTIONS: Store unreconstituted product at room temperature (15° - 30°C)
Store prepared suspension at room temperature (15° - 30°C) and use within 24 hours.
Keep out of reach of children.
REGISTRATION NUMBERS: TROBICIN™ 2 g: C/20.1.1/212
Bacteriostatic Water for Injection with Benzyl Alcohol 0.9% m/v: H/34/60.
NAME AND ADDRESS OF APPLICANT: Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
MIDRAND 1685
R.S.A.
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 12/08/93
™ = Trademark New addition to this site: February 2005
Source: Pharmaceutical Industry
TROBICIN™ 2 g INJECTION