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Effects on Ability to Drive and Use Machines
Not applicable.
Undesirable Effects
Clinical Trial Data
Adverse drug reactions reported among 834 patients who received miconazole 2% cream and/or placebo cream base in 21 double-blind clinical trials are presented in Table 1 below. Included in the table are all adverse events considered to be related to study drug. A dash indicates that the adverse reaction was not reported by patients in the specified treatment group.
Table 1: Adverse Drug Reactions Reported by Patients in Either Treatment Group in 21 Double-blind Clinical Trials of Miconazole 2% Cream versus Placebo.
|
System Organ Class
Adverse Drug Reaction |
Miconazole 2% Cream
(n=426), % |
Placebo Cream Base
(n=408), % |
|
Overall Adverse Drug Reactions |
1.9 |
1.2 |
|
Skin and Subcutaneous
Tissue Disorders |
|
|
|
Skin burning sensation |
0.2 |
0.7 |
|
Skin inflammation |
0.2 |
-- |
|
Skin hypopigmentation |
0.2 |
-- |
|
General Disorders and
Administration Site Conditions |
|
|
|
Application site irritation |
0.7 |
0.5 |
|
Application site burning |
0.2 |
0.2 |
|
Application site pruritus |
0.2 |
-- |
|
Application site reaction NOS |
0.2 |
-- |
|
Application site warmth |
0.2 |
-- |
Note: Individual patients may have reported more than a single event.
Postmarketing Data
Adverse drug reactions from spontaneous reports during the worldwide post-marketing experience with DAKTARIN that meet threshold criteria are included in Table 2. The adverse drug reactions are ranked by frequency, using the following convention:
Very common
≥ 1/10
Common
≥ 1/100 and < 1/10
Uncommon
≥ 1/1,000 and < 1/100
Rare
≥ 1/10,000, < 1/1,000
Very rare < 1/10,000, including
isolated reports
The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates of incidence that might be obtained in clinical or epidemiological studies.
Table 2: Postmarketing Reports of
Adverse Drug Reactions
Immune System Disorders
Very rare anaphylactic reaction,
hypersensitivity, angioneurotic
edema
Skin and Subcutaneous Tissue Disorders
Very rare urticaria, contact dermatitis, rash,
erythema, pruritus, skin burning
sensation
General Disorders and Administration Site Conditions
Very rare application site reactions, including application site irritation
Overdose
Cream, Powder
Symptoms
Topical use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.
Treatment
Accidental ingestion: DAKTARIN Cream and Powder are intended for topical use, not for oral use. Should accidental oral ingestion of large quantities of these products occur, an appropriate method of gastric emptying may be used if considered necessary.
Accidental inhalation of talc-containing powder: Massive accidental aspiration of DAKTARIN Powder may cause impaction blockage of airways. Respiratory arrest should be treated with intensive supportive therapy and oxygen. If respiration is compromised, endotracheal intubation, removal of impacted material, and assisted breathing should be considered.
Tincture
Symptoms
Topical use: Excessive use can result in skin irritation, which usually disappears after discontinuation of the therapy.
Accidental ingestion: Stomach irritation may occur.
Treatment
Accidental ingestion: A specific antidote is not available. Treatment is symptomatic and supportive. However, the quantity of alcohol that has been ingested must be taken into account, especially in children.
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