MINOCYCLINE Film-coated tablet Ref.[7903] Active ingredients: Minocycline

Posology

Unlike earlier tetracyclines, absorption of minocycline is not significantly impaired by food or moderate amounts of milk.

Adults

Routine antibiotic use: 200mg daily in divided doses.

Acne: 50mg twice daily. Treatment should continue for a minimum of six weeks. If, after six months, there is no satisfactory response minocycline should be discontinued and other therapies considered. If minocycline is to be continued for longer than six months, patients should be monitored at least at three monthly intervals thereafter for signs and symptoms of hepatitis or SLE or unusual pigmentation of the skin. (See other special warnings and precautions).

Gonorrhoea:* In adult males: 200mg initially followed by 100mg every 12 hours for a minimum of 4 days with post-therapy cultures within 2-3 days. Adult females may require more prolonged therapy.

Prophylaxis of asymptomatic meningococcal carriers: 100mg twice daily for five days, usually followed by a course of rifampicin.

Paediatric population

Children over 12 years: 50mg every 12 hours.

Children under 12 years: Not recommended.

Elderly

Minocycline may be used at the normal recommended dosage in elderly patients,

Renal Impairment: minocycline may be used at the normal recommended dosage in mild to moderate renal impairment, however caution is advised in patients with severe renal impairment.

Method of Administration

For oral administration. To reduce the risk of oesophageal irritation and ulceration, the tablets should be swallowed whole with plenty of fluid, while sitting or standing. Unlike earlier tetracyclines, absorption of minocycline is not significantly impaired by food or moderate amounts of milk.

Dizziness, nausea and vomiting are the adverse effects most commonly seen with overdose. There is no specific antidote. In cases of overdose, discontinue medication, treat symptomatically and with appropriate supportive measures. Minocycline is not removed in significant quantities by haemodialysis or peritoneal dialysis.

Three years from the date of manufacture.

Shelf-life after dilution/reconstitution: Not applicable.

Shelf-life after first opening: Not applicable.

Store below 25°C in a dry place.

Protect from light.

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps and polyfoam wad or cotton wool.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28’s, 30’s, 50’s, 56’s, 60’s, 84’s, 90’s, 100’s, 112’s, 120’s, 168’s, 180’s, 500’s, 1000’s

Not all pack sizes may be marketed.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

Not applicable.