Budenofalk

Budenofalk

budesonide

Manufacturer:

Dr Falk

Distributor:

Zuellig
/
Agencia Lei Va Hong

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Budesonide
Indications/Uses
Acute treatment of ulcerative colitis that is limited to the rectum & sigmoid colon.
Dosage/Direction for Use
Adult >18 yr 1 actuation (2 mg) daily.
Contraindications
Hypersensitivity; hepatic cirrhosis.
Special Precautions
TB, HTN, DM, osteoporosis, peptic ulcer (gastric or duodenal ulcer), glaucoma, cataract, family history of diabetes or glaucoma, or any other condition in which glucocorticosteroids may have undesirable effects. Risk of systemic effects of glucocorticosteroids when prescribed at high doses & for prolonged periods. Increased susceptibility to infections & their severity. Caution against chickenpox or shingles (herpes zoster) & measles especially in immunocompromised patients. Reports of visual disturbances w/ systemic & topical corticosteroid use. May cause suppression of HPA axis & reduce the stress response. Do not administer live vaccines to individuals w/ chronic glucocorticosteroid use. Ab response to other (inactivated) vaccines may be diminished. Avoid concomitant treatment w/ ketoconazole or other CYP3A inhibitors. Patients w/ severely impaired hepatic function. Pregnancy & lactation. Should not be used in childn & adolescents. Transfer from another glucocorticosteroid therapy may result in reappearance or recurrence symptoms relating to the change in systemic steroid levels. May cause local skin irritation due to cetyl alcohol & propylene glycol content.
Adverse Reactions
Cushing's syndrome; increased risk of infection; muscle & joint pain, muscle weakness & twitching, osteoporosis; headache; depression, irritability, euphoria; allergic exanthema, petechiae, delayed wound healing, contact dermatitis. Dyspepsia; burning in the rectum & pain.
Drug Interactions
Potentiated action of glycoside by K deficiency. Increased K excretion w/ saluretics. Increased plasma conc w/ potent CYP3A4 inhibitors eg, ketoconazole, ritonavir, itraconazole, clarithromycin, grapefruit juice. Reduced systemic & local exposure of budesonide at the gut mucosa w/ CYP3A inducers eg, carbamazepine & rifampicin. CYP3A substrates eg, ethinyl estradiol compete in the metabolism of budenoside. Elevated plasma conc & increased effects of glucocorticosteroids w/ oestrogens or OCs.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
ATC Classification
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
Presentation/Packing
Form
Budenofalk rectal foam 2 mg/spray actuation
Packing/Price
14 actuation x 1's
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