SULFAMYLON Powder for solution (2018)
Βιβλιογραφική αναφορά
Συγγραφείς
Mylan Institutional Inc.
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
1. Description
Mafenide acetate, USP is a synthetic antimicrobial agent designated chemically as α-amino-<em>p</em>-toluenesulfonamide monoacetate. It has the following structural formula: Mafenide acetate, USP is a ...
2. Clinical Pharmacology
Mechanism of Action The mechanism of action of mafenide is not known, but is different from that of the sulfonamides. Mafenide is not antagonized by pABA, serum, pus or tissue exudates, and there is no ...
3. Indications and Usage
SULFAMYLON for 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn ...
4. Contraindications
SULFAMYLON for 5% Topical Solution is contraindicated in patients who are hypersensitive to mafenide acetate. It is not known whether there is cross sensitivity to other sulfonamides.
5. Warnings
Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with mafenide acetate.
6.1. General
Mafenide acetate and its metabolite, <em>p</em>-carboxybenzenesulfonamide, inhibit carbonic anhydrase, which may result in metabolic acidosis, usually compensated by hyperventilation. In the presence of ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate the carcinogenic potential of mafenide acetate; however, the drug did not induce mutations in L5178Y mouse lymphoma cells at the TK locus. Animal ...
6.7. Pregnancy
Teratogenic Effects A teratology study performed in rats using oral doses of up to 600 mg/kg/day revealed no evidence of harm to the fetus due to mafenide acetate. There are no adequate data regarding ...
6.9. Nursing Mothers
It is not known whether mafenide acetate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from mafenide ...
6.10. Pediatric Use
The safety and effectiveness of SULFAMYLON for 5% Topical Solution have been established in the age groups 3 months to 16 years.
6.11. Geriatric Use
No studies have been conducted to specifically examine the effects of mafenide acetate on burn wounds in geriatric patients.
7. Adverse Reactions
In the clinical setting of severe burns, it is often difficult to distinguish between an adverse reaction to mafenide acetate and burn sequelae. In a clinical study of pediatric patients with acute burns ...
9. Overdosage
Single oral doses of 2000 mg/kg of mafenide acetate as a 5% solution did not cause mortality or clinical symptoms of toxicity in rats.
10. Dosage and Administration
Directions for Preparation of the Solution SULFAMYLON (mafenide acetate) for 5% Topical Solution is supplied as a sterile powder and is to be reconstituted with Sterile Water for Irrigation, USP or 0.9% ...
11. How Supplied
SULFAMYLON (mafenide acetate, USP) for 5% Topical Solution is available in packets (NDC 51079-624-84) containing 50 g of sterile mafenide acetate to be prepared using 1000 mL Sterile Water for Irrigation, ...
12. Storage and Handling
Packets Store PACKETS in a dry place at room temperature 15° to 30°C (59° to 86°F). Prepared Solution Store SOLUTION at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F) ...