SPECTRASONE CAPSULES
SPECTRASONE 125 mg/5 mL POWDER FOR SUSPENSION
SPECTRASONE 250 mg/5 mL POWDER FOR SUSPENSION
SCHEDULING STATUS:
S4
PROPRIETARY NAME:
(and dosage form)
SPECTRASONE CAPSULES
SPECTRASONE 125 mg/5 mL POWDER FOR SUSPENSION
SPECTRASONE 250 mg/5 mL POWDER FOR SUSPENSION
COMPOSITION:
Capsules:
Each capsule contains Erythromycin Estolate equivalent to 250 mg of Erythromycin base.
Suspension after reconstitution:
Erythromycin Estolate equivalent to 250 mg/5 mL Erythromycin base,
preservative 0,4% m/v (Sodium Benzoate) and
Erythromycin Estolate equivalent to 125 mg/5 mL Erythromycin base,
preservative 0.2% m/v (Sodium Benzoate)
The suspension contains TARTRAZINE.
PHARMACOLOGICAL CLASSIFICATION:
A20.1.1 Broad and medium spectrum antibiotics
PHARMACOLOGICAL ACTION:
Erythromycin has bacteriostatic activities. It is active in vitro against some Gram-positive bacteria some Gram-negative bacteria (Nesseria), spirochaetes, some rickettsias, Streptococcus pneumoniae, haemolytic streptococci andCorynebacteria. Staphylococci and Haemophilus (including those resistant to penicillin) are rather less sensitive. Coliform bacilli, particularly at alkaline pH, have been reported to be sensitive to Erythromycin. It is active against multiplying organisms. The development of resistant strains is not usually a serious clinical problem during successful short courses of treatment. During prolonged treatment of infections more difficult to eradicate, the development of resistant strains is common.
INDICATIONS:
Pharyngitis, scarlet fever, and erysipelas produced by group-A Streptococcus pyogenes. Acute or chronic diphtheria bacillus carrier state. It must be stressed that in the acute disease, SPECTRASONE does not alter the course of the infection or the risk of complications, and a proper dose of specific antitoxin must be administered. Syphilis in penicillin-sensitive persons. Clostridium tetani is susceptible to SPECTRASONE, however antitoxin must be given simultaneously in cases of tetanus. Erythromycin is effective in the therapy of Pneumonia due to Mycoplasma pneumonia. In gonorrhoea, Erythromycin is a suitable substitute in penicillin-allergic patients.
CONTRA-INDICATIONS:
SPECTRASONE is contra-indicated in patients with known hypersensitivity to Erythromycin and in persons with impaired liver functions and when jaundice has developed during previous treatment.
WARNINGS:
The green colouring used in SPECTRASONE POWER FOR SUSPENSIONS contains F, D and C Yellow No. 5 (TARTRAZINE), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is currently thought to be low it is frequently seen in patients who have aspirin sensitivity.
DOSAGE AND DIRECTIONS FOR USE:
ADULTS:
250 mg every 6 hours before meals.
In severe infections this dose may be doubled and continued for up to two or even three weeks.
CHILDREN:
30 mg/kg weight daily in divided doses every 6 hours before meals.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, vomiting and diarrhoea may occur. Sensitisation to Erythromycin may occur. The hypersensitivity reactions include fever, eosinophilia and skin eruptions, each of which may occur alone or in combination; they disappear shortly after therapy has been stopped. The most striking allergic reaction to this drug is cholestatic hepatitis. The illness starts after about 10 to 20 days of treatment and is early characterised by nausea, vomiting and abdominal cramp, often mimicking the pain of acute cholecystitis. These symptoms are shortly followed by jaundice, fever, leucocytoeosiniphilia, and elevated plasma transaminase and bilirubin concentrations; the cholecystogram is negative. The syndrome resembles acute cholecystitis, extra hepatic biliary obstruction, pancreatitis, or viral hepatitis, similar to those observed with the hepatic disturbance produced by chlorpromazine. All manifestations usually clear entirely within a few days after cessation of drug therapy. The product must be administered with care to patients who have previously been treated with Erythromycin. It must not be given together with chloramphenicol or thiamphenicol. False elevations of serum glutamic oxalacetic transaminase may appear in patients taking Erythromycin.
Superinfection caused by resistant bacteria or fungi may occur. Pseudomembranous colitis may occur. Safety in pregnancy and lactation has not been established. Reversible deafness has occurred after high doses of Erythromycin. Erythromycin potentiates the effects of carbamazepine, corticosteroids and digoxin. High plasma levels of theophylline may result when Erythromycin is administered concomitantly. There have been reports of excessive prolongation of prothombin times in patients receiving Erythromycin concurrently with chronic coumarin-type anticoagulant therapy. Such patients, particularly the elderly who generally exhibit slower coumarin-type anticoagulant clearance, may be at risk for developing bleeding due to this interaction. In patients receiving Erythromycin during chronic treatment with a coumarin-type anticoagulant, prothombin times should be monitored closely and the coumarin-type anticoagulant dosage adjusted accordingly.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Gastro-intestinal symptoms and those mentioned under side-effects may occur. Treatment is supportive and symptomatic.
IDENTIFICATION:
Capsules: Green and white capsules.
Powder: The prepared suspensions are green with a lime flavour.
PRESENTATION:
Capsules: Containers of 20, 100 and 500.
Suspensions: Powder for reconstitution to 100 mL suspension containing 125 mg/5 mL in a 100 mL bottle and 250mg/5mL in a 50 mL bottle respectively.
STORAGE INSTRUCTIONS:
Potency of the reconstituted suspensions will be maintained for one week at room temperature and two weeks under refrigeration. Thereafter the remaining suspension should be discarded.
Store in well closed containers, in a cool, dry, dark place, (below 25° C)
KEEP OUT OF REACH OF CHILDREN.
RECONSTITUTION INSTRUCTIONS:
To prepare 100 mL of suspension containing:
125 mg/mL: Add 90 mL distilled water.
250 mg/mL: Add 85 mL distilled water.
NB: Add the distilled water in 2 portions, shake vigorously and stand for 5 minutes to allow complete hydration of the suspending agents. Shake well again and dispense.
REGISTRATION NUMBER:
Caps: L/2.1.1/92
Susp: L/20.1.1/93 (125 mg/5 mL)
Susp: W/20.1.1/402 (250 mg/5 mL)
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GEO SCHWULST LABORATORIES LIMITED
Co. Reg. No. 77/3055/06
17 Faraday St.
Village Main Jhb
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 1989
PM 05 12-7/94 |
