Terra-Cortril ointment

Summary of Product Characteristics Updated 08-Feb-2016 | Intrapharm Laboratories Limited

1. Name of the medicinal product

Terra-Cortril®

2. Qualitative and quantitative composition

Each gram of Terra-Cortril Ointment contains 30mg oxytetracycline as oxytetracycline hydrochloride Ph Eur and 10mg hydrocortisone Ph. Eur.

3. Pharmaceutical form

Ointment for topical administration.

4. Clinical particulars
4.1 Therapeutic indications

Terra-Cortril Ointment is indicated in the following disorders: exudative and secondarily infected eczema including atopic eczema, primary irritant dermatitis, allergic and seborrhoeic dermatitis. Secondarily infected insect bite reactions.

In exudative flexural intertrigo Terra-Cortril Ointment can be used for up to seven days.

Like other tetracyclines, oxytetracycline is generally ineffective against Pseudomonas and Proteus species. Because these are recognised secondary infecting organisms in exudative dermatoses, preliminary identification of the organism and determination of antibiotic sensitivity is important.

4.2 Posology and method of administration

After thorough cleansing of the affected skin areas, a small amount of the ointment should be applied gently. Applications should be made two to four times daily.

Terra-Cortril Ointment is for topical administration only.

Use in the elderly No special precautions.

Use in children Not recommended. (See 'Contra-indications').

Use in renal or hepatic impairment No special precautions.

4.3 Contraindications

Hypersensitivity to one of the components of the preparation.

Primary bacterial infections eg impetigo, pyoderma, furunculosis.

Pregnancy, lactation and in infants and small children because of the theoretical risk of damage to permanent dentition.

4.4 Special warnings and precautions for use

Terra-Cortril Ointment should not be continued for more than seven days in the absence of any clinical improvement, since in this situation occult extension of infection may occur due to the masking effect of the steroid.

Extended or recurrent application may increase the risk of contact sensitisation and should be avoided.

The use of oxytetracycline and other antibiotics may result in an overgrowth of resistant organisms - particularly Candida and staphylococci. Careful observation of the patient for this possibility is essential. If new infections due to nonsusceptible bacteria of fungi appear during therapy, Terra-Cortril should be discontinued. If extensive areas are treated or if the occlusive technique is used, there may be increased systemic absorption of the corticosteroid and suitable precautions should be taken.

If irritation develops, the product should be discontinued.

Terra-Cortril Ointment is not recommended for ophthalmic use.

4.5 Interaction with other medicinal products and other forms of interaction

None established.

4.6 Pregnancy and lactation

Terra-Cortril Ointment is contra-indicated during pregnancy and in nursing mothers, because of the theoretical risk of damage to permanent dentition.

4.7 Effects on ability to drive and use machines

Terra-Cortril Ointment is not expected to have an influence on the ability to drive or operate machinery.

4.8 Undesirable effects

Hydrocortisone and oxytetracycline are well tolerated by the epithelial tissues and may be used topically with minimal untoward effects. Allergic reactions, including contact dermatitis may occur occasionally, but are rare.

Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitisations.

The following local side effects have been reported with topical corticosteroids, especially under occlusive dressings; burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.

The use of Terra-Cortril Ointment should be discontinued if such reactions occur.

Secondary infection The development of secondary bacterial or fungal infection has occurred after use of combinations containing steroids and antimicrobials.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

There is no specific antidote available. In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Terra-Cortril Ointment possesses both the anti-inflammatory activity of hydrocortisone and the broad spectrum antibacterial activity of oxytetracycline, which is active against a wide variety of Gram-positive and Gram-negative organisms.

5.2 Pharmacokinetic properties

Oxytetracycline There is no published information on the systemic absorption of oxytetracycline following dermal application.

Hydrocortisone Following topical steroid application, variable absorption has been reported especially when applied to large surfaces, under occlusive dressing or for prolonged periods of time.

5.3 Preclinical safety data

None stated

6. Pharmaceutical particulars
6.1 List of excipients

Liquid paraffin Ph. Eur., white soft paraffin B.P.

6.2 Incompatibilities

None documented.

6.3 Shelf life

5 Years.

6.4 Special precautions for storage

Store below 25 °C

6.5 Nature and contents of container

Aluminium Tube with screw cap containing 15g ointment.

Aluminium Tube with screw cap containing 30g ointment.

6.6 Special precautions for disposal and other handling

None

7. Marketing authorisation holder

Intrapharm Laboratories Limited,

The Courtyard Barns,

Choke Lane,

Cookham Dean,

Maidenhead,

Berkshire,

SL6 6PT,

UNITED KINGDOM.

8. Marketing authorisation number(s)

PL 17509/0075

9. Date of first authorisation/renewal of the authorisation

6th November 2015

10. Date of revision of the text
Company Contact Details
Intrapharm Laboratories Limited
Address

The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT

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+(0)1628 771 524

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+44 (0)330 1359 437

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Telephone

+44 (0)1628 771 800

E-mail
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