U.S. BRAND NAMES — Aphthasol®
PHARMACOLOGIC CATEGORY
Anti-inflammatory, Locally Applied
DOSING: ADULTS — Aphthous ulcers: Topical: Administer ~1/4 inch (0.5 cm) directly on ulcers 4 times/day following oral hygiene, after meals, and at bedtime.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Paste, oral:
Aphthasol®: 5% (3 g) [contains benzyl alcohol]
DOSAGE FORMS: CONCISE
Paste, oral:
Aphthasol®: 5% (3 g)
GENERIC EQUIVALENT AVAILABLE — No
USE — Treatment of aphthous ulcers (ie, canker sores)
USE - UNLABELED / INVESTIGATIONAL — Allergic disorders
ADVERSE REACTIONS SIGNIFICANT
1% to 2%:
Dermatologic: Allergic contact dermatitis
Gastrointestinal: Oral irritation
<1% (Limited to important or life-threatening): Contact mucositis
CONTRAINDICATIONS — Hypersensitivity to amlexanox or any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Mucositis: Discontinue therapy if contact mucositis develops. Rash: Discontinue therapy if rash develops.
Special populations: Pediatrics: Safety and efficacy have not been established in children.
DRUG INTERACTIONS — There are no known significant interactions.
PREGNANCY RISK FACTOR — B (show table)
PREGNANCY IMPLICATIONS — Due to lack of data, avoid use in pregnancy, if possible.
LACTATION — Excretion in breast milk unknown/use caution
PRICING — (data from drugstore.com)
Paste (Aphthasol)
5% (3): $29.99
INTERNATIONAL BRAND NAMES — Elics (JP); Solfa (JP)
MECHANISM OF ACTION — As a benzopyrano-bipyridine carboxylic acid derivative, amlexanox has anti-inflammatory and antiallergic properties; it inhibits chemical mediatory release of the slow-reacting substance of anaphylaxis (SRS-A) and may have antagonistic effects on interleukin-3
PHARMACODYNAMICS / KINETICS
Absorption: Some from swallowed paste
Metabolism: Hydroxylated and conjugated metabolites
Half-life elimination: 3.5 hours
Time to peak, serum: 2 hours
Excretion: Urine (17% as unchanged drug)
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The information contained in the "Infomed Drug Guide" is aimed at medical professionals and students of medicine and pharmacology. All of the data has been carefully compiled and checked, however, errors may occur. These errors may also result due to changes that have taken place in the medical sciences since the publication of the Drug Guide in 1994/2008, and cannot be excluded. In case of doubt, readers are encouraged to confirm the information contained herein with other sources before a drug is prescribed. Non-professionals should be aware that the "Infomed Drug Guide" does not seek to replace professional medical advice and/or treatment. Neither Infomed, nor the authors, claim that the information is in every respect accurate or complete. As a result, neither can be held responsible for any errors or omissions, or for any consequences resulting from the use of such information.
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