Loading…
TARO-AMCINONIDE is a brand name for Amcinonide, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ......................................................................... 3 CONTRAINDICATIONS .............................................................................................. 3 WARNINGS AND PRECAUTIONS ............................................................................. 4…
Verbatim from this product's HC label. Tap a section to expand.
Post-Market Adverse Drug Reactions The following adverse reactions are reported when topical corticosteroids are used as recommended. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.
g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, hyperglycemia/glucosuria, hypertension, increased weight/obesity, decreased endogenous cortisol levels, steroid withdrawal syndrome Eye disorders: glaucoma, cataract subcapsular Gastrointestinal disorders: upper abdominal pain General Disorders and Administration Site Conditions: Application site irritation/pain.
Immune system disorders: local hypersensitivity (see Skin and subcutaneous tissue disorders) Infections and infestations: secondary infection Investigations: Decreased glucose tolerance has also been reported Skin and subcutaneous tissue disorders: skin striae, skin atrophy, telangiectasia, purpura-like bleeding, acne, dermatitis, hypertrichosis, skin depigmentation, erythema, burning sensation, pruritus, eczema, dryness, itching, local irritation, atrophy of the subcutaneous tissues, pustules, miliaria, folliculitis, pyoderma, allergic contact dermatitis, acneiform eruptions, perioral dermatitis, rash, urticaria, pustular psoriasis, skin wrinkling, alopecia, trichorrhexis, skin infection.
Vascular disorders: thrombosis DRUG INTERACTIONS Overview No clinical trials were specifically designed to assess potential drug-drug, drug-food, drug-herb, or drug-laboratory interactions with amcinonide. g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic Page 9 of 18 exposure.
The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor. g. condoms, diaphragms) can result in reduction in the reliability and therefore impairment of the safety of these products due to the excipients.
Drug-Drug Interactions Interactions with other drugs have not been established. Drug-Food Interactions Interactions with food have not been established. Drug-Herb Interactions Interactions with herbal products have not been established.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Drug-Laboratory Interactions Interactions with laboratory tests have not been established. DOSAGE AND ADMINISTRATION Dosing Considerations Patients/caregivers should be instructed to use the minimum quantity of TARO- AMCINONIDE for the shortest duration of time necessary to achieve the desired therapeutic benefit because of the potential for corticosteroids to suppress the hypothalamic-pituitary-adrenal (HPA) axis and cause skin atrophy (See WARNINGS AND PRECAUTIONS).
If the condition worsens or does not improve within 2 weeks, treatment and diagnosis should be re-evaluated. Use in pediatric patients is not recommended. Pediatric patients are more likely to develop local and systemic toxicity from equivalent doses of topical corticosteroids because of their larger skin surface to body weight ratios.
Geriatric patients may be more susceptible to percutaneous absorption and the potential effects of systemic absorption. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs.
Page 10 of 18 Recommended Dose and Dosage Adjustment Apply a thin layer to affected area once or twice daily and gently rub in. Allow adequate time for absorption after each application before applying an emollient. TARO-AMCINONIDE should not be used for longer than 5 days on the face, axillae, scrotum and scalp (see WARNINGS AND PRECAUTIONS).
TARO-AMCINONIDE should not be used for longer than 2 to 3 weeks on the body (see WARNINGS AND PRECAUTIONS). If the condition worsens or does not improve within 2 weeks, treatment and diagnosis should be re-evaluated. Avoid abrupt discontinuation of TARO-AMCINONIDE therapy once control is achieved as rebound of pre-existing dermatoses can occur.
Continue an emollient as maintenance therapy.
Pediatrics (< 18 years of age):
The safety and effectiveness of amcinonide in pediatric patients less than 18 years of age have not been established (see WARNINGS AND PRECAUTIONS - Special Populations, Pediatrics (< 18 years of age)).
Geriatrics (> 65 years of age):
Amcinonide should be used with caution in geriatric patients due to increased risk of renal or hepatic impairment in this population. The minimum quantity should be used for the shortest duration to achieve the desired therapeutic benefit (see WARNINGS AND PRECAUTIONS - Special Populations, Geriatrics (> 65 years of age)).
Renal/Hepatic Impairment:
In patients with renal or hepatic impairment, the minimum quantity should be used for the shortest duration to achieve the desired therapeutic benefit (see WARNINGS AND PRECAUTIONS - Special Populations, Patients with renal / hepatic impairment).
Missed Dose In the event of a missed dose, TARO-AMCINONIDE should be applied as soon as possible after the missed dose is remembered. If this is close to the scheduled application time or the next dose, the patient should wait and apply the next scheduled dose.
The usual schedule should be resumed thereafter. Administration TARO-AMCINONIDE is for topical use only. Use with occlusive dressings is not recommended (see WARNINGS AND PRECAUTIONS). TARO-AMCINONIDE is not for use in or near the eye or on other mucous membranes.
Page 11 of 18 OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre. Topically applied corticosteroids can be absorbed in sufficient amounts to […]