SPECTRACIL CAPSULES
SPECTRACIL POWDER FOR SUSPENSION 125 mg/5 mL
SPECTRACIL POWDER FOR SUSPENSION 250 mg/5 mL
SCHEDULING STATUS:
S4
PROPRIETARY NAME
(and dosage form):
SPECTRACIL CAPSULES
SPECTRACIL POWDER FOR SUSPENSION 125 mg/5 mL
SPECTRACIL POWDER FOR SUSPENSION 250 mg/5 mL
COMPOSITION:
Ampicillin trihydrate equivalent to 250 mg ampicillin base per capsule.
Suspension: After reconstitution:
Ampicillin trihydrate equivalent to 250 mg ampicillin activity per 5 mL,
preservative 0,125% m/v and
Ampicillin trihydrate equivalent to 125 mg ampicillin activity per 5 mL,
preservative 0,0625% m/v.
(Preservative: Sodium Benzoate)
PHARMACOLOGICAL CLASSIFICATION:
A20.1.2 Antibiotics -- Penicillins
PHARMACOLOGICAL ACTION:
Ampicillin is bactericidal with a broad spectrum of activity.
INDICATIONS:
Ampicillin is effective in conditions caused by gram-positive non-penicillinase producing staphylococci, haemolytic and non-haemolytic streptococci, diplococcus pneumoniae, clostridia sp. and streptococcus faecalis. Also gram-negative cocci (neisseria sp.), H. influenzae, E. coli, proteus mirabilis and many strains of brucellae, salmonellae and shigellae. It has been determined that certain organisms which were previously sensitive are already showing resistance.
CONTRA-INDICATIONS:
Ampicillin should not be given to patients known to be sensitive to penicillin nor, in the neo-natal period, to babies born to hypersensitive mothers.
DOSAGE AND DIRECTIONS FOR USE:
ADULTS: 250 mg to 750 mg every 6 hours.
CHILDREN: 0 - 6 years: One quarter of the adult dose every 6 hours.
Children 6 - 10 years: Half the adult dose every 6 hours.
Children over 10 years: Adult dose.
Much higher doses (up to 12 g daily in adults) may be safely given.
In severe infections doses may be safely increased or higher doses given by injection.
Oral preparations should be taken ½ to 1 hour before meals.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
If symptoms due to overgrowth of non-susceptible organisms (aerobacter aerogenes, Pseudomonas, Candida, etc.) appear, the medicine should be discontinued and specific or supportive therapy instituted. Side effects are usually mild, transitory and infrequent and are similar to those found with other penicillins. Transient diarrhoea, nausea, heartburn and pruritus ani may occur. When ampicillin is administered to a hypersensitive patient, allergic reactions may occur. Urticaria and skin rashes are common, exfoliative dermatitis, eosinophilia, angioneurotic oedema, fever and swollen joints are less frequent.
Occasionally severe allergic reactions which may be fatal occur. These reactions may be common after parenteral use but may also occur after oral administration of any penicillin derivative in persons who have become hypersensitized after a previous course of treatment. The onset of the symptoms varies: it may occur within a few hours or days of the beginning of treatment or not until therapy with a penicillin derivative is resumed on a subsequent occasion, in cases of ampicillin treatment of mononucleosis, a rash usually appears.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosing is virtually impossible. However, in patients with renal impairment dosage may be reduced if required. Should a serious allergic reaction occur, the medicine should be discontinued and the patient treated with the usual agents (adrenaline and corticosteroids and antihistamines).
CONDITIONS OF REGISTRATION:
Advertise to the Professions only.
IDENTIFICATION:
Capsules: Maroon & white capsules.
Suspension: Amber glass bottle containing a white powder for the preparation of 100 mL Blackberry flavoured suspension.
PRESENTATION:
Capsules:
Container of 20, 100, 500 & 1000 capsules.
Suspension:
Powder for the preparation of 100 mL of suspension 250 mg/5 mL in 150 mL bottles.
Powder for the preparation of 100 mL of suspension 125 mg/5 mL in 100 mL bottles
RECONSTITUTION INSTRUCTIONS:
To prepare 100 mL of suspension containing:
* 250 mg per 5 mL:- Add 65 mL of distilled water, shake well.
125 mg/mL:- Add 85 mL of distilled water, shake well.
* Note: This product is packed in 150 mL bottles.
Once dispensed this suspension must be used within 7 days or within 14 days if stored in a refrigerator.
STORAGE INSTRUCTIONS:
Potency of the reconstituted suspension will be maintained for one week at room temperature and two weeks under refrigeration. Thereafter the remaining suspension should be discarded.
Store in a cool place (below 25°C)
Keep out of reach of children.
REGISTRATION NUMBER:
Caps L/20.1.2/94
Susp L/20.1.2/95 (250 mg)
Susp R/20.1.2/312 (125 mg)
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GEO SCHWULST LABS. LIMITED
Needham Park
1 Manchester Road
Wadeville
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
JANUARY 1981
PSO-2-11/91
PSO-3-11/91
Markprint 493-26? |
