Individual generic drug information

isotretinoin

Reference monograph

Part of registered formulation

ISOTRETINOIN

Reference record: Isotretinoin
Source: BNF 80 (2020–2021)
Printed source pages: 1359, 1360
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Isotretinoin only.

Indications And Dose

Severe acne (under expert supervision) | Acne which is associated with psychological problems (under expert supervision) | Acne which has not responded to an adequate course of a systemic antibacterial (under expert supervision) | Acne with scarring (under expert supervision) | Systemic treatment of nodulo-cystic and conglobate acne (under expert supervision) ▶BY MOUTH ▶Adult: Initially 500 micrograms/kg daily in 1–2 divided doses, increased if necessary to 1 mg/kg daily for 16–24 weeks, repeat treatment course after a period of at least 8 weeks if relapse after ﬁrst course; maximum 150 mg/kg per course

Source page 1359

Contra Indications

Hyperlipidaemia. hypervitaminosis A

Source page 1360

Cautions

Avoid blood donation during treatment and for at least 1 month after treatment. diabetes. dry eye syndrome (associated with risk of keratitis). history of depression (risk of neuropsychiatric reactions)

Source page 1360

Prescribing And Dispensing Information

Isotretinoin is an isomer of tretinoin. Prescribing for females of childbearing potential The Pregnancy Prevention Programme is supported by the following materials provided by the manufacturer: Checklists for prescribers and pharmacists, and Patient reminder cards. Each prescription for oral isotretinoin should be limited to a supply of up to 30 days’ treatment. Pregnancy testing should ideally be carried out on the same day as prescription issuing and dispensing.

Source page 1360

Safety

Extracted information for Isotretinoin only.

Important Safety Information

MHRA/CHM ADVICE: ISOTRETINOIN (ROACCUTANE ®): RARE REPORTS OF ERECTILE DYSFUNCTION AND DECREASED LIBIDO (OCTOBER 2017) An EU-wide review has concluded that on rare occasions, oral isotretinoin, indicated for severe acne, may cause sexual side-effects, including erectile dysfunction and decreased libido. MHRA/CHM ADVICE: ORAL RETINOID MEDICINES: REVISED AND SIMPLIFIED PREGNANCY PREVENTION EDUCATIONAL MATERIALS FOR HEALTHCARE PROFESSIONALS AND WOMEN (JUNE 2019) New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women and girls of childbearing potential taking oral acitretin, alitretinoin, or isotretinoin. Healthcare professionals are reminded that the use of oral retinoids is contra-indicated in pregnancy due to a high risk of serious congenital malformations, and any use in females must be within the conditions of the Pregnancy Prevention Programme (see Conception and contraception and Prescribing and dispensing information). Neuropsychiatric reactions have been reported in patients taking oral retinoids. Healthcare professionals are advised to monitor patients for signs of depression or suicidal ideation and refer for appropriate treatment, if necessary; particular care is needed in those with a history of depression. Patients should be advised to speak to their doctor if they experience any changes in mood or behaviour, and encouraged to ask family and friends to look out for any change in mood.

Source page 1359

Interactions

→Appendix 1: retinoids

Source page 1360

Side Effects

▶Common or very common Alopecia. anaemia. arthralgia. back pain. cheilitis. dry eye. eye discomfort. eye inﬂammation. haemorrhage. headache. increased risk of infection. myalgia. nasal dryness. neutropenia. proteinuria. skin fragility (trauma may cause blistering). skin reactions. thrombocytopenia. thrombocytosis ▶Rare or very rare Anxiety. arthritis. behaviour abnormal. bone disorders. bronchospasm. cataract. corneal opacity. depression. diabetes mellitus. dizziness. drowsiness. dry throat. gastrointestinal disorders. glomerulonephritis. hair changes. hearing impairment. hepatitis. hoarseness. Skin hyperhidrosis. hyperuricaemia. idiopathic intracranial hypertension. inﬂammatory bowel disease. lymphadenopathy. malaise. mood altered. nail dystrophy . nausea. pancreatitis. photosensitivity reaction. psychotic disorder. pyogenic granuloma. seizure. suicidal tendencies. tendinitis. vasculitis. vision disorders ▶Frequency not known Rhabdomyolysis. severe cutaneous adverse reactions (SCARs) SIDE-EFFECTS, FURTHER INFORMATION Risk of pancreatitis if triglycerides above 9 mmol/litre—discontinue if uncontrolled hypertriglyceridaemia or pancreatitis. Discontinue treatment if skin peeling severe or haemorrhagic diarrhoea develops. Visual disturbances require expert referral and possible withdrawal. Psychiatric side-effects could require expert referral.

Source page 1360

Conception And Contraception

The MHRA advises that women and girls of childbearing potential being treated with the oral retinoids acitretin, alitretinoin, or isotretinoin must be supported on a Pregnancy Prevention Programme with regular follow-up and pregnancy testing. Pregnancy prevention Effective contraception must be used. In females of childbearing potential, exclude pregnancy a few days before treatment, every month during treatment (unless there are compelling reasons to indicate that there is no risk of pregnancy), and 4 weeks after stopping treatment. Females must practise effective contraception for at least 1 month before starting treatment, during treatment, and for at least 1 month after stopping treatment. They should be advised to use at least 1 method of contraception, but ideally they should use 2 methods of contraception. Oral progestogen-only contraceptives are not considered effective. Barrier methods should not be used alone, but can be used in conjunction with other contraceptive methods. Females should be advised to discontinue treatment and to seek prompt medical attention if they become pregnant during treatment or within 1 month of stopping treatment.

Source page 1360

Pregnancy

Manufacturer advises avoid—teratogenic.

Source page 1360

Breast Feeding

Avoid.

Source page 1360

Hepatic Impairment

Manufacturer advises avoid— limited information available.

Source page 1360

Renal Impairment

Dose adjustments In severe impairment, reduce initial dose (e.g. 10 mg daily) and increase gradually up to 1 mg/kg daily as tolerated.

Source page 1360

Monitoring Requirements

Measure hepatic function and serum lipids before treatment, 1 month after starting and then every 3 months (reduce dose or discontinue if transaminase or serum lipids persistently raised).

Source page 1360

Dose and formulations

Extracted information for Isotretinoin only.

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 10, 11, 21 ▶Isotretinoin (Non-proprietary) Isotretinoin 5 mg Isotretinoin 5mg capsules | 30 capsule P £10.10–£10.15 | 56 capsule P £14.78–£14.79 DT = £14.79 Isotretinoin 10 mg Isotretinoin 10mg capsules | 30 capsule P £14.54 DT = £14.53 Isotretinoin 20 mg Isotretinoin 20mg capsules | 30 capsule P £20.00 DT = £16.66 | 56 capsule P £31.10–£37.85 Isotretinoin 40 mg Isotretinoin 40mg capsules | 30 capsule P £38.98 DT = £38.98 ▶Roaccutane (Roche Products Ltd) Isotretinoin 10 mg Roaccutane 10mg capsules | 30 capsule P £14.54 DT = £14.53 Isotretinoin 20 mg Roaccutane 20mg capsules | 30 capsule P £20.02 DT = £16.66

Source page 1360

Clinical care

Extracted information for Isotretinoin only.

Patient And Carer Advice

Warn patient to avoid wax epilation (risk of epidermal stripping), dermabrasion, and laser skin treatments (risk of scarring) during treatment and for at least 6 months after stopping; patient should avoid exposure to UV light (including sunlight) and use sunscreen and emollient (including lip balm) preparations from the start of treatment. Risk of neuropsychiatric reactions The MHRA advises patients and carers to seek medical attention if changes in mood or behaviour occur. Pregnancy Prevention Programme Pharmacists must ensure that female patients have a patient card—see also Important safety information.

Source page 1360

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Initially 500 micrograms/kg daily in 1–2 divided

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1359

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

isotretinoin

Reference monograph

Part of registered formulation

ISOTRETINOIN

Reference record: Isotretinoin
Source: BNF 80 (2020–2021)
Printed source pages: 1359, 1360
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Isotretinoin only.

Indications And Dose

Source page 1359

Contra Indications

Hyperlipidaemia. hypervitaminosis A

Source page 1360

Cautions

Source page 1360

Prescribing And Dispensing Information

Source page 1360

Safety

Extracted information for Isotretinoin only.

Important Safety Information

Source page 1359

Interactions

→Appendix 1: retinoids

Source page 1360

Side Effects

Source page 1360

Conception And Contraception

Source page 1360

Pregnancy

Manufacturer advises avoid—teratogenic.

Source page 1360

Breast Feeding

Avoid.

Source page 1360

Hepatic Impairment

Manufacturer advises avoid— limited information available.

Source page 1360

Renal Impairment

Dose adjustments In severe impairment, reduce initial dose (e.g. 10 mg daily) and increase gradually up to 1 mg/kg daily as tolerated.

Source page 1360

Monitoring Requirements

Measure hepatic function and serum lipids before treatment, 1 month after starting and then every 3 months (reduce dose or discontinue if transaminase or serum lipids persistently raised).

Source page 1360

Dose and formulations

Extracted information for Isotretinoin only.

Medicinal Forms

Source page 1360

Clinical care

Extracted information for Isotretinoin only.

Patient And Carer Advice

Source page 1360

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Initially 500 micrograms/kg daily in 1–2 divided

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1359

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.