This information is intended for use by health professionals

1. Name of the medicinal product

Metanium Nappy Rash Ointment

2. Qualitative and quantitative composition

Titanium Dioxide

20.0% w/w

Titanium Peroxide

5.0% w/w

Titanium Salicylate

3.0% w/w

3. Pharmaceutical form

Ointment for topical administration.

4. Clinical particulars
4.1 Therapeutic indications

As a treatment for nappy rash

4.2 Posology and method of administration

Posology:

Topical.

Adults:

Not applicable.

Elderly:

Not applicable.

Children:

Dab a small amount of Metanium over the sore area. Spread the ointment thinly so the skin texture can be clearly seen through it. Repeat at each nappy change.

4.3 Contraindications

Hypersensitivity to the drug formulation.

4.4 Special warnings and precautions for use

If no response occurs, or the condition worsens, consult your doctor.

For external use only.

4.5 Interaction with other medicinal products and other forms of interaction

Not known.

4.6 Fertility, pregnancy and lactation

Not known.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Rarely: skin irritations.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Overdose is unlikely when Metanium Nappy Rash Ointment is used as instructed for treating nappy rash. However, as this product contains titanium salicylate, accidental ingestion or excessive topical application could lead to symptoms of salicylate poisoning.

Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.

Symptoms

Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases. A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier. Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema. Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.

Management

Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.

Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.

5. Pharmacological properties
5.1 Pharmacodynamic properties

The combination of titanium salts with a water repellent siliconised base forms a tenacious non-occlusive film on the skin which protects against irritation and repeated hydration.

5.2 Pharmacokinetic properties

Metanium is indicated for topical use and has an action similar to zinc oxide preparations.

5.3 Preclinical safety data

Not applicable.

6. Pharmaceutical particulars
6.1 List of excipients

Dimethicone 350

Light Liquid Paraffin

Tincture of Benzoin

White Soft Paraffin.

6.2 Incompatibilities

Not known.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Aluminium collapsible tube with membrane seal and spiked polypropylene cap.

Pack sizes: 25 g, 30 g.

6.6 Special precautions for disposal and other handling

No special precautions necessary.

7. Marketing authorisation holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

8. Marketing authorisation number(s)

PL 00240/0366

9. Date of first authorisation/renewal of the authorisation

30/04/02.

10. Date of revision of the text

18/02/2015