Drugs List

Therapeutic Indications

Uses

Mild-to-moderate active ulcerative colitis: adjunctive treatment

Contraindications

Children under 18 years
Galactosaemia
Severe hepatic impairment

Precautions and Warnings

Adrenal insufficiency
Breastfeeding
Cataract
Diabetes mellitus
Gastrointestinal ulcer
Glaucoma
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of steroid-induced psychosis
Lactose intolerance
Osteoporosis
Pregnancy
Psychiatric disorder
Renal impairment
Severe hypertension
Tuberculosis

Consider supplementary corticosteroids if subject to stress or surgery
Exclude fungal infection before treatment
Exclude tubercular infection before treatment
Exclude viral infection before treatment
Initiate antibiotic therapy if intestinal infection occurs
Contains lactose
If visual disturbances occur, perform ophthalmic evaluation
Prolonged or high dose may lead to adrenal suppression
Patient should report worrying psychological changes esp. suicidal thoughts
Not recommended for use longer than 4 weeks

Pregnancy and Lactation

Pregnancy

Use beclometasone with caution during pregnancy.

The manufacturer does not recommend using beclometasone during pregnancy unless considered necessary after a risk benefit evaluation.

Data suggests there is no adverse health effects to the newborn when inhaling beclometasone in quantities of 1mg. There is limited data regarding doses greater than 1mg, including oral 5mg beclometasone dipropionate. High doses of systemic corticosteroids may cause intrauterine growth retardation when used for long periods. Animal studies have shown reproductive toxicity.

Lactation

Use beclometasone with caution during breastfeeding.

The manufacturer does not recommend using beclometasone during breastfeeding, unless considered necessary after a risk benefit evaluation.

The presence of beclometasone in human breast milk is unknown. A risk to the newborn cannot be excluded.

Side Effects

Abdominal pain
Adrenal suppression
Anxiety
Behavioural disturbances
Benign intracranial hypertension
Blurred vision
Cataracts
Cognitive impairment
Constipation
Cushingoid changes
Euphoria
Glaucoma
Granulocytosis
Headache
Hiccups
Influenza-like symptoms
Irritability
Lipohypertrophy
Lymphopenia
Menorrhagia
Monocytopenia
Mood changes
Muscle cramps
Nausea
Obesity
Oropharyngeal candidiasis
Osteoporosis
Psychotic reactions
Reduction in serum cortisol levels
Rosacea
Sleep disturbances
Somnolence

Presentation

Oral formulations of beclometasone.

Drugs List

Therapeutic Indications

Uses

Mild-to-moderate active ulcerative colitis: adjunctive treatment

Dosage

Adults

Contraindications

Children under 18 years
Galactosaemia
Severe hepatic impairment

Precautions and Warnings

Adrenal insufficiency
Breastfeeding
Cataract
Diabetes mellitus
Gastrointestinal ulcer
Glaucoma
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of steroid-induced psychosis
Lactose intolerance
Osteoporosis
Pregnancy
Psychiatric disorder
Renal impairment
Severe hypertension
Tuberculosis

Consider supplementary corticosteroids if subject to stress or surgery
Exclude fungal infection before treatment
Exclude tubercular infection before treatment
Exclude viral infection before treatment
Initiate antibiotic therapy if intestinal infection occurs
Contains lactose
If visual disturbances occur, perform ophthalmic evaluation
Prolonged or high dose may lead to adrenal suppression
Patient should report worrying psychological changes esp. suicidal thoughts
Not recommended for use longer than 4 weeks

Pregnancy and Lactation

Pregnancy

Use beclometasone with caution during pregnancy.

The manufacturer does not recommend using beclometasone during pregnancy unless considered necessary after a risk benefit evaluation.

Data suggests there is no adverse health effects to the newborn when inhaling beclometasone in quantities of 1mg. There is limited data regarding doses greater than 1mg, including oral 5mg beclometasone dipropionate. High doses of systemic corticosteroids may cause intrauterine growth retardation when used for long periods. Animal studies have shown reproductive toxicity.

Lactation

Use beclometasone with caution during breastfeeding.

The manufacturer does not recommend using beclometasone during breastfeeding, unless considered necessary after a risk benefit evaluation.

The presence of beclometasone in human breast milk is unknown. A risk to the newborn cannot be excluded.

Side Effects

Abdominal pain
Adrenal suppression
Anxiety
Behavioural disturbances
Benign intracranial hypertension
Blurred vision
Cataracts
Cognitive impairment
Constipation
Cushingoid changes
Euphoria
Glaucoma
Granulocytosis
Headache
Hiccups
Influenza-like symptoms
Irritability
Lipohypertrophy
Lymphopenia
Menorrhagia
Monocytopenia
Mood changes
Muscle cramps
Nausea
Obesity
Oropharyngeal candidiasis
Osteoporosis
Psychotic reactions
Reduction in serum cortisol levels
Rosacea
Sleep disturbances
Somnolence

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: August 2019

Reference Sources

Summary of Product Characteristics: Clipper 5mg gastro-resistant prolonged release tablets. Chiesi Ltd. Revised May 2019.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 14 August 2019

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Beclomethasone Last revised: 31 October 2018
Last accessed: 14 August 2019