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SODIUM SULFACETAMIDE, SULFUR
Overview
What is Avar?
Each gram contains 95 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium magnesium silicate, sodium thiosulfate, stearyl alcohol, and xanthan gum. This product also contains tetrafluoroethane (propellant).
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C
H
N
NaO
S·H
O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.
What does Avar look like?
What are the available doses of Avar?
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What should I talk to my health care provider before I take Avar?
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How should I use Avar?
This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
WASH-OFF APPLICATION
LEAVE-ON APPLICATION
What interacts with Avar?
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What are the warnings of Avar?
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What are the precautions of Avar?
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What are the side effects of Avar?
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What should I look out for while using Avar?
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.
Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.
What might happen if I take too much Avar?
The oral LD
of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately.
Manifestations:
How should I store and handle Avar?
Dispense in a well-closed container as defined in the USP.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].This product is supplied in the following size(s):3.5 oz. (100 g) can, 0178-0658-01 To report Manufactured for:MISSION PHARMACAL COMPANYSan Antonio, TX 78230 1355This product is supplied in the following size(s):3.5 oz. (100 g) can, 0178-0658-01 To report Manufactured for:MISSION PHARMACAL COMPANYSan Antonio, TX 78230 1355This product is supplied in the following size(s):3.5 oz. (100 g) can, 0178-0658-01 To report Manufactured for:MISSION PHARMACAL COMPANYSan Antonio, TX 78230 1355This product is supplied in the following size(s):3.5 oz. (100 g) can, 0178-0658-01 To report Manufactured for:MISSION PHARMACAL COMPANYSan Antonio, TX 78230 1355This product is supplied in the following size(s):3.5 oz. (100 g) can, 0178-0658-01 To report Manufactured for:MISSION PHARMACAL COMPANYSan Antonio, TX 78230 1355This product is supplied in the following size(s):3.5 oz. (100 g) can, 0178-0658-01 To report Manufactured for:MISSION PHARMACAL COMPANYSan Antonio, TX 78230 1355
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported.
The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of
and the formation of free fatty acids.
Non-Clinical Toxicology
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.
Serotonergic Drugs
Based on the mechanism of action of SNRIs and SSRIs including citalopram, and the potential for serotonin syndrome, caution is advised when citalopram is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, tramadol, or St. John's Wort (see -Serotonin Syndrome). The concomitant use of citalopram with other SSRIs, SNRIs or tryptophan is not recommended (see - ).
Triptans
There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of citalopram with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see - Serotonin Syndrome).
CNS Drugs
Given the primary CNS effects of citalopram, caution should be used when it is taken in combination with other centrally acting drugs.
Alcohol
Although citalopram did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by depressed patients taking citalopram is not recommended.
Monoamine Oxidase Inhibitors (MAOIs) - See and .
Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)
Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when citaloram is initiated or discontinued.
Cimetidine
In subjects who had received 21 days of 40 mg/day citlaopram, combined administration of 400 mg/day cimetidine for 8 days resulted in an increase in citalopram AUC and C of 43% and 39%, respectively.
Citalopram 20 mg/day is the maximum recommended dose for patients taking concomitant cimetidine because of the risk of QT prolongation (see and ).
Digoxin
In subjects who had received 21 days of 40 mg/day citalopram, combined administration of citalopram and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either citalopram or digoxin.
Lithium
Coadministration of citalopram (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the pharmacokinetics of citalopram or lithium. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of citalopram, caution should be exercised when citalopram and lithium are coadministered.
Pimozide
In a controlled study, a single dose of pimozide 2 mg co-administered with citalopram 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately 10 msec compared to pimozide given alone. Citalopram did not alter the mean AUC or C of pimozide. The mechanism of this pharmacodynamic interaction is not known.
Theophylline
Combined administration of citalopram (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of citalopram was not evaluated.
Sumatriptan
There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram) is clinically warranted, appropriate observation of the patient is advised.
Warfarin
Administration of 40 mg/day citalopram for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the clinical significance of which is unknown.
Carbamazepine
Combined administration of citalopram (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although trough citalopram plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of citalopram should be considered if the two drugs are coadministered.
Triazolam
Combined administration of citalopram (titrated to 40 mg/day for 28 days) and the CYP3A4 substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either citalopram or triazolam.
Ketoconazole
Combined administration of citalopram (40 mg) and ketoconazole (200 mg) decreased the C and AUC of ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of citalopram.
CYP2C19 Inhibitors
Citalopram 20 mg/day is the maximum recommended dose for patients taking concomitant CYP2C19 inhibitors because of the risk of QT prolongation (see , , AND ).
Metoprolol
Administration of 40 mg/day citlaopram for 22 days resulted in a two-fold increase in the plasma levels of the beta-adrenergic blocker metoprolol. Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of citalopram and metoprolol had no clinically significant effects on blood pressure or heart rate.
Imipramine and Other Tricyclic Antidepressants (TCAs)
In vitro
Electroconvulsive Therapy (ECT)
There are no clinical studies of the combined use of electroconvulsive therapy (ECT) and citalopram.
General:
Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.
Information for Patients:
Drug Interactions:
Carcinogenesis, Mutagenesis and Impairment of Fertility:
Pregnancy:
Category C.
Nursing Mothers:
Pediatric Use:
Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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