Oral antibiotic treatments

Drugs used not listed here:

• Lymecycline, doxycycline, and oxytetracycline, see section 5.1.3 Tetracyclines
• Erythromycin, see section 5.1.5 Macrolides
• Trimethoprim, see section 5.1.8 Sulfonamides and trimethoprim

Hormone treatment for acne

Co-cyprindiol

• Tablets (cyproterone acetate 2000micrograms / ethinylestradiol 35micrograms) (£10.76 = 63 tablets)

Indications

• Moderate to severe acne caused by polycystic ovary syndrome.

Dose

• 1 tablet daily for 21 days starting on day 1 of menstrual cycle; subsequent courses repeated after a 7-day interval (during which withdrawal bleeding occurs)
  • Time to relief of symptoms is at least three months. The need to continue treatment should be evaluated periodically by the treating physician, with a view to withdrawing treatment once the skin condition has improved.

Notes

1. There is an increased risk of venous thromboembolism in women taking co-cyprindiol, particularly during the first year of use. The incidence of venous thromboembolism is 1.5–2 times higher in women using co-cyprindiol than in women using combined oral contraceptives containing levonorgestrel, but the risk may be similar to that associated with use of combined oral contraceptives containing third generation progestogens (desogestrel and gestodene) or drospirenone.
2. Co-cyprindiol also slightly increases the risk of cardiovascular disease, such as myocardial infarction and ischaemic stroke. Females requiring co-cyprindiol may have an inherently increased risk of cardiovascular disease such as that associated with polycystic ovary syndrome.
3. Co-cyprindiol should not be used solely for contraception. Patients should not take other hormonal contraceptives while being treated with co-cyprindiol.
4. Refer to the manufacturer's Summary of Product Characteristics (SPC) for further prescribing guidance.

Oral retinoids for acne

Isotretinoin

• Capsules 5mg, 10mg, 20mg

Indications

• Severe acne
• Acne which is associated with psychological problems
• Acne which has not responded to an adequate course of a systemic antibacterial and topical therapies
• Acne with scarring
• Systemic treatment of nodulo-cystic and conglobate acne

Notes

1. MHRA Drug Safety Update (October 2023): Isotretinoin (Roaccutane): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age. Advice for healthcare professionals:
   
   1. all patients must be counselled about the benefits and risks of treatment before isotretinoin is prescribed, including possible mental health and sexual function side effects
      
   2. isotretinoin is teratogenic; all patients of childbearing potential must be entered into the Pregnancy Prevention Programme
      
   3. prescribers should assess patients’ mental health before prescribing isotretinoin including the use of patient-reported outcome measures
      
   4. ask patients about any sexual function concerns before prescribing isotretinoin
      
   5. give the patient sufficient time to consider, reflect and ask questions before starting isotretinoin treatment
      
   6. use the new regulatory risk minimisation materials with all patients: Acknowledgement of Risk Form, Patient Reminder Card, Pharmacist Checklist
      
   7. the Lead Prescriber, who initiates isotretinoin treatment, must have expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements
      
   8. initiation of isotretinoin treatment in patients under 18 years of age now requires agreement by 2 independent healthcare professionals that there is no other appropriate effective treatment before it is prescribed. This means that isotretinoin should only be prescribed for severe acne that is resistant to adequate courses of standard therapy
      
   9. review patients approximately 1 month after initiation of treatment in a face-to-face (in-person) appointment
      
   10. monitor patients for side effects including mental health and sexual function side effects at each follow up appointment including objective mental health patient reported outcome measures
       
   11. Full details of the new requirements can be found in the Report of The Commission on Human Medicines
2. British Association of Dermatologists: Clinical resources for isotretinoin
   1. CHM/MHRA 2023 reports
   2. Acknowledgement of Risk Form, Patient Reminder Card, Pharmacist Checklist, SmPC
   3. BAD clinical resources
   4. Quality of life questionnaires
   5. Patient information
   6. Video resources
   7. Frequently Asked Questions
3. MHRA Drug Safety Update (June 2019): Oral retinoid medicines: revised and simplified pregnancy prevention educational materials for healthcare professionals and women, and advice about the risk of neuropsychiatric reactions
   1. Due to a high risk of serious congenital malformations, isotretinoin must not be used in pregnancy, and any use in women and girls must be within the conditions of a Pregnancy Prevention Programme (PPP)
   2. Patients treated with an oral retinoid should be monitored or signs of depression or suicidal ideation and refer for appropriate treatment, if necessary; particular care needs to be taken in patients with history of depression
   3. Advise patients taking an oral retinoid that they may experience changes in their mood or behaviour and that they should speak to their doctor if their mood is affected; they should be encouraged to let family and friends know they are taking an oral retinoid so they can look out for any change in mood
4. See also resources for: contraception for drugs with teratogenic potential, and prescribing in pregnancy and lactation.
5. MHRA Drug Safety Update (September 2010) risk of serious skin reactions.
   1. Serious skin reactions (erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis) have been reported in association with isotretinoin, which may result in hospitalisation, disability, life-threatening events, or death.
   2. Isotretinoin must be immediately discontinued, and appropriate supportive care given if symptoms of develop.
   3. Patients starting isotretinoin treatment should be informed of the signs and symptoms of these serious skin eruptions and advised to stop treatment and contact their healthcare professional immediately if any of these arise.
6. Please refer to the manufacturer's Summary of Product Characteristics (SPC) for further prescribing guidance.