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DRUGS & SUPPLEMENTS
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Fluocinolone Acetonide:
Synalar Bi-Otic Cream is a combination of Synalar Bi-Otic (Fluocinolone Acetonide) acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.
Synalar Bi-Otic (Fluocinolone Acetonide) Cream is a combination of Synalar Bi-Otic (Fluocinolone Acetonide) acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.
Synalar Bi-Otic (Fluocinolone Acetonide) Cream is NOT indicated for the maintenance treatment of melasma. After achieving control with Synalar Bi-Otic (Fluocinolone Acetonide) Cream, some patients may be managed with other treatments instead of triple therapy with Synalar Bi-Otic (Fluocinolone Acetonide) Cream. Melasma usually recurs upon discontinuation of Synalar Bi-Otic (Fluocinolone Acetonide) Cream.
The safety and efficacy of Synalar Bi-Otic (Fluocinolone Acetonide) Cream in patients of Fitzpatrick Skin Types V and VI have not been studied. Excessive bleaching resulting in undesirable cosmetic effect in patients with darker skin cannot be excluded.
The safety and efficacy of Synalar Bi-Otic (Fluocinolone Acetonide) Cream in the treatment of hyperpigmentation conditions other than melasma of the face have not been studied.
Because pregnant and lactating women were excluded from, and women of childbearing potential had to use birth control measures in the clinical trials, the safety and efficacy of Synalar Bi-Otic (Fluocinolone Acetonide) Cream in pregnant women and nursing mothers have not been established [see Use in Specific Populations (8.1, 8.3)].
Apply a thin film of Synalar Bi-Otic (Fluocinolone Acetonide) Cream to the effected area once daily, at least 30 minutes before bedtime.
Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply Synalar Bi-Otic (Fluocinolone Acetonide) Cream to the hyperpigmented areas of melasma including about 1/2 inch of normal appearing skin surrounding each lesion. Rub lightly and uniformly into the skin.
Therapy should be discontinued when control is achieved.
During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day.
Synalar Bi-Otic (Fluocinolone Acetonide) Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Cream, 0.01%/4%/0.05%.
Each gram of Synalar Bi-Otic (Fluocinolone Acetonide) Cream contains 0.1 mg of Synalar Bi-Otic (Fluocinolone Acetonide) acetonide, 40 mg of hydroquinone, and 0.5 mg of tretinoin in a light yellow, hydrophilic cream base.
Synalar Bi-Otic (Fluocinolone Acetonide) Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.
Synalar Bi-Otic (Fluocinolone Acetonide) Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible individuals. If anaphylaxis, asthma or other clinically significant hypersensitivity reactions occur, institute appropriate therapy and discontinue Synalar Bi-Otic (Fluocinolone Acetonide). Allergic contact dermatitis may also occur [see Warnings and Precautions 5.4].
Synalar Bi-Otic Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy. The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.
Synalar Bi-Otic (Fluocinolone Acetonide) Cream contains the corticosteroid Synalar Bi-Otic (Fluocinolone Acetonide) acetonide. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroid while on treatment. If HPA axis suppression is noted, the use of Synalar Bi-Otic (Fluocinolone Acetonide) Cream should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids.
The ACTH or cosyntropin stimulation test may be helpful in evaluating patients for HPA axis suppression.
Cutaneous hypersensitivity to the active ingredients of Synalar Bi-Otic (Fluocinolone Acetonide) Cream has been reported in the literature. In a patch test study to determine sensitization potential in 221 healthy volunteers, three volunteers developed sensitivity reactions to Synalar Bi-Otic (Fluocinolone Acetonide) Cream or its components.
Synalar Bi-Otic (Fluocinolone Acetonide) Cream contains hydroquinone and tretinoin that may cause mild to moderate irritation. Local irritation, such as skin reddening, peeling, mild burning sensation, dryness, and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued.
Patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentrations of alcohol and astringents, and other irritants or keratolytic drugs while on Synalar Bi-Otic (Fluocinolone Acetonide) Cream treatment. Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In the controlled clinical trials, adverse events were monitored in the 161 subjects who used Synalar Bi-Otic (Fluocinolone Acetonide) Cream once daily during an 8-week treatment period. There were 102 (63%) subjects who experienced at least one treatment-related adverse event during these trials. The most frequently reported events were erythema, desquamation, burning, dryness, and pruritus at the site of application. The majority of these events were mild to moderate in severity. Adverse events reported by at least 1% of patients and judged by the investigators to be reasonably related to treatment with Synalar Bi-Otic (Fluocinolone Acetonide) Cream from the controlled clinical trials are summarized (in decreasing order of frequency) as follows:
In an open-label trial, subjects who had cumulative treatment of melasma with Synalar Bi-Otic (Fluocinolone Acetonide) Cream for 6 months showed a similar pattern of adverse events as in the 8-week studies.
The following local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
Most common adverse reactions (incidence > 5%) are erythema, desquamation, burning, dryness, pruritus, and acne. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Synalar Bi-Otic Cream contains the teratogen, tretinoin, which may cause embryofetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. Synalar Bi-Otic (Fluocinolone Acetonide) Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. (8.1)
Teratogenic Effects: Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Synalar Bi-Otic (Fluocinolone Acetonide) Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Synalar Bi-Otic (Fluocinolone Acetonide) Cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits.
In clinical trials involving Synalar Bi-Otic (Fluocinolone Acetonide) Cream in the treatment of facial melasma, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy. However, 13 women became pregnant during treatment with Synalar Bi-Otic (Fluocinolone Acetonide) Cream. Most of the pregnancy outcomes are unknown. Three women gave birth to apparently healthy babies. One pregnancy was terminated prematurely, and another ended in miscarriage.
In general, use of drugs should be reduced to a minimum in pregnancy. If a patient has been inadvertently exposed to Synalar Bi-Otic (Fluocinolone Acetonide) Cream in pregnancy, she should be counseled on the risk of teratogenesis due to this exposure. The risk of teratogenesis due to topical exposure to Synalar Bi-Otic (Fluocinolone Acetonide) Cream may be considered low. However, exposure during the period of organogenesis in the first trimester is theoretically more likely to produce adverse outcome than in later pregnancy.
Tretinoin is considered to be highly teratogenic upon systemic administration. Animal reproductive studies are not available with topical hydroquinone. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
- In a dermal application study using Synalar Bi-Otic (Fluocinolone Acetonide) Cream in pregnant rabbits, there was an increase in the number of in utero deaths and a decrease in fetal weights in litters from dams treated topically with the drug product.
- In a dermal application study in pregnant rats treated with Synalar Bi-Otic (Fluocinolone Acetonide) Cream during organogenesis there was evidence of teratogenicity of the type expected with tretinoin. These morphological alterations included cleft palate, protruding tongue, open eyes, umbilical hernia, and retinal folding or dysplasia.
- In a dermal application study on the gestational and postnatal effects of a 10-fold dilution of Synalar Bi-Otic (Fluocinolone Acetonide) Cream in rats, an increase in the number of stillborn pups, lower pup body weights, and delay in preputial separation were observed. An increase in overall activity was seen in some treated litters at postnatal day 22 and in all treated litters at five weeks, a pattern consistent with effects previously noted in animals exposed in utero with retinoic acids. No adequate study of the late gestational and postnatal effects of the full-strength Synalar Bi-Otic (Fluocinolone Acetonide) Cream has been performed.
- It is difficult to interpret these animal studies on teratogenicity with Synalar Bi-Otic (Fluocinolone Acetonide) Cream, because the availability of the dermal applications in these studies could not be assured, and comparison with clinical dosing is not possible.
Corticosteroids, when systemically administered, appear in human milk. It is not known whether topical application of Synalar Bi-Otic Cream could result in sufficient systemic absorption to produce detectable quantities of Synalar Bi-Otic (Fluocinolone Acetonide) acetonide, hydroquinone, or tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when Synalar Bi-Otic (Fluocinolone Acetonide) Cream is administered to a nursing woman. Care should be taken to avoid contact between the infant being nursed and Synalar Bi-Otic (Fluocinolone Acetonide) Cream.
Safety and effectiveness of Synalar Bi-Otic (Fluocinolone Acetonide) Cream in pediatric patients have not been established.
Clinical studies of Synalar Bi-Otic (Fluocinolone Acetonide) Cream did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Synalar Bi-Otic (Fluocinolone Acetonide) (fluocinolone acetonide, hydroquinone, and tretinoin) Cream, 0.01%/4%/0.05% contains Synalar Bi-Otic (Fluocinolone Acetonide) acetonide, USP, hydroquinone, USP, and tretinoin, USP, in a light yellow, hydrophilic cream base for topical application.
Synalar Bi-Otic (Fluocinolone Acetonide) acetonide is a synthetic fluorinated corticosteroid. It is a white crystalline powder that is odorless and stable in light.
The chemical name for Synalar Bi-Otic (Fluocinolone Acetonide) acetonide is: (6α,11β,16α)-6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,-4-diene-3,20-dione.
The molecular formula is C24H30F2O6 and molecular weight is 452.50.
Synalar Bi-Otic (Fluocinolone Acetonide) acetonide has the following structural formula:
Hydroquinone is a melanin synthesis inhibitor. It is prepared from the reduction of p-benzoquinone with sodium bisulfite. It occurs as fine white needles that darken on exposure to air.
The chemical name for hydroquinone is: 1,4-benzenediol.
The molecular formula is C6H6O2 and molecular weight is 110.11.
Hydroquinone has the following structural formula:
Tretinoin, a retinoid, is all-trans-retinoic acid formed from the oxidation of the aldehyde group of retinene to a carboxyl group. It occurs as yellow to light-orange crystals or crystalline powder with a characteristic odor of ensilage. It is highly reactive to light and moisture.
The chemical name for tretinoin is: (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid.
The molecular formula is C20H28O2 and molecular weight is 300.44.
Tretinoin has the following structural formula:
Each gram of Synalar Bi-Otic (Fluocinolone Acetonide) Cream contains Active: Synalar Bi-Otic (Fluocinolone Acetonide) acetonide 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (0.5 mg). Inactive: butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol.
fluocinolone-mol hydro-mol tretinoin
The mechanism of action of the active ingredients in Synalar Bi-Otic Cream in the treatment of melasma is unknown.
Percutaneous absorption of unchanged tretinoin, hydroquinone and Synalar Bi-Otic (Fluocinolone Acetonide) acetonide into the systemic circulation of two groups of healthy volunteers (Total N=59) was found to be minimal following 8 weeks of daily application of 1g (Group I, n=45) or 6g (Group II, n=14) of Synalar Bi-Otic (Fluocinolone Acetonide) Cream.
For tretinoin quantifiable plasma concentrations were obtained in 57.78% (26 out of 45) of Group I and 57.14% (8 out of 14) of Group II subjects. The exposure to tretinoin as reflected by the Cmax values ranged from 2.01 to 5.34 ng/mL (Group I) and 2.0 to 4.99 ng/mL (Group II). Thus, daily application of Synalar Bi-Otic (Fluocinolone Acetonide) Cream resulted in a minimal increase of normal endogenous levels of tretinoin. The circulating tretinoin levels represent only a portion of total tretinoin-associated retinoids, which would include metabolites of tretinoin and that sequestered into peripheral tissues.
For hydroquinone, quantifiable plasma concentrations were obtained in 18% (8 out of 44) Group I subjects. The exposure to hydroquinone, as reflected by the Cmax values, ranged from 25.55 to 86.52 ng/mL. All Group II subjects (6g dose) had post-dose plasma hydroquinone concentrations below the quantitation limit. For Synalar Bi-Otic (Fluocinolone Acetonide) acetonide, Groups I and II subjects had all post-dose plasma concentrations below quantitation limit.
When Synalar Bi-Otic (Fluocinolone Acetonide) acetonide, hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 50%, 100%, and 150% of the concentrations in the clinical formulation of Synalar Bi-Otic (Fluocinolone Acetonide) Cream were applied topically to male and female CD-1 mice for up to 24 months at dosages approximating up to 50, 19,000, and 250 µg/kg/day, respectively (corresponding to dosages of 150, 57,000, and 750 μg/m2/day, respectively), no statistically significant changes in tumor incidence were observed.
When Synalar Bi-Otic (Fluocinolone Acetonide) acetonide, hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 25%, 50%, and 100% of the concentrations in the clinical formulation of Synalar Bi-Otic (Fluocinolone Acetonide) Cream were applied topically to male and female SD rats for up to 24 months at dosages approximating up to 10, 4000, and 50 µg/kg/day, respectively (corresponding to dosages of 60, 24,000, and 300 μg/m2/day, respectively), statistically significant increases in the incidences of islet cell adenomas and combined islet cell adenomas and carcinomas of the pancreas in both males and females were observed. The clinical relevance of these findings is unknown.
Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.
Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.
Mutagenicity studies were not conducted with this combination of active ingredients. Published studies have demonstrated that hydroquinone is a mutagen and a clastogen. Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay. Tretinoin has been shown to be negative for mutagenesis in the Ames assay. Additional information regarding the genetic toxicity potential of tretinoin and of Synalar Bi-Otic (Fluocinolone Acetonide) acetonide is not available.
A dermal reproductive fertility study was conducted in SD rats using a 10-fold dilution of the clinical formulation. No effect was seen on the traditional parameters used to assess fertility, although prolongation of estrus was observed in some females, and there was a trend towards an increase in pre-and post-implantation loss that was not statistically significant. No adequate study of fertility and early embryonic toxicity of the full-strength drug product has been performed. In a six-month study in minipigs, small testes and severe hypospermia were found when males were treated topically with the full strength drug product.
Two adequate and well-controlled efficacy and safety trials were conducted in 641 subjects between the ages of 21 to 75 years, having Fitzpatrick Skin types I-IV and moderate to severe melasma of the face. Synalar Bi-Otic (Fluocinolone Acetonide) Cream was compared with 3 possible combinations of 2 of the 3 active ingredients [(1) hydroquinone 4% (HQ) + tretinoin 0.05% (RA); (2) Synalar Bi-Otic (Fluocinolone Acetonide) acetonide 0.01% (FA) + tretinoin 0.05% (RA); (3) Synalar Bi-Otic (Fluocinolone Acetonide) acetonide 0.01% (FA) + hydroquinone 4% (HQ)], contained in the same vehicle as Synalar Bi-Otic (Fluocinolone Acetonide) Cream. Subjects were instructed to apply their study medication each night, after washing their face with a mild soapless cleanser, for 8 weeks. Instructions were given to apply a thin layer of study medication to the hyperpigmented lesion, making sure to cover the entire lesion including the outside borders extending to the normal pigmented skin. Subjects were provided a mild moisturizer for use as needed. A sunscreen with SPF 30 was also provided with instructions for daily use. Protective clothing and avoidance of sunlight exposure to the face was recommended.
Subjects were evaluated for melasma severity at Baseline and at Weeks 1, 2, 4, and 8 of treatment. Primary efficacy was based on the proportion of subjects who had an investigators’ assessment of treatment success, defined as the clearing of melasma at the end of the eight-week treatment period. The majority of subjects enrolled in the two trials were white (approximately 66%) and female (approximately 98%). Synalar Bi-Otic (Fluocinolone Acetonide) Cream was demonstrated to be significantly more effective than any of the other combinations of the active ingredients.
PRIMARY EFFICACY ANALYSIS:
p-value is from Cochran-Mantel-Haenszel chi-square statistics controlling for pooled investigator and comparing Synalar Bi-Otic (Fluocinolone Acetonide) Cream to the other treatment groups.
In the Investigators’ assessment of melasma severity at Day 56 of treatment, the following table shows the clinical improvement profile for all subjects treated with Synalar Bi-Otic (Fluocinolone Acetonide) Cream based on severity of their melasma at the start of treatment.
Assessment Scale: Cleared (melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation); Mild (slightly darker than the surrounding normal skin); Moderate (moderately darker than the surrounding normal skin); Severe (markedly darker than the surrounding normal skin).
Subjects experienced improvement of their melasma with the use of Synalar Bi-Otic (Fluocinolone Acetonide) Cream as early as 4 weeks. However, among 7 subjects who had clearing at the end of 4 weeks of treatment with Synalar Bi-Otic (Fluocinolone Acetonide) Cream, 4 of them did not maintain the remission after an additional 4 weeks of treatment.
After 8 weeks of treatment with the trial drug, subjects entered into an open-label extension period in which Synalar Bi-Otic (Fluocinolone Acetonide) Cream was given on an as-needed basis for the treatment of melasma. The remission periods appeared to shorten between progressive courses of treatment. Additionally, few subjects maintained complete clearing of melasma (approximately 1 to 2%).
Synalar Bi-Otic (Fluocinolone Acetonide) Cream is light yellow in color, and supplied in 30 g aluminum tubes, NDC 0299-5950-30.
Storage: Keep tightly closed. Store in a refrigerator, 2° - 8°C (36° - 46°F). Protect from freezing.
See FDA-approved patient labeling (Patient Information)
Inform patients of the following:
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, TX 76177 USA
Manufactured by:
Hill Dermaceuticals, Inc.
Sanford, FL 32773 USA
P51400-1
or
Manufactured by:
G Production Inc.
Baie d’Urfé, QC, H9X 3S4 Canada
Made in Canada
P52091-2
PATIENT INFORMATION
Synalar Bi-Otic (Fluocinolone Acetonide)® (try-LOOM-ah)
(fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05%)
Cream
Important information: Synalar Bi-Otic (Fluocinolone Acetonide) Cream is for use on skin only. Do not use Synalar Bi-Otic (Fluocinolone Acetonide) Cream in your mouth, eyes, or vagina.
What is the most important information I should know about Synalar Bi-Otic (Fluocinolone Acetonide) Cream?
Synalar Bi-Otic (Fluocinolone Acetonide) Cream may cause birth defects or death of the baby if used during pregnancy. The risk of birth defects or death of the baby may be greater if Synalar Bi-Otic (Fluocinolone Acetonide) Cream is used during the first trimester of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.
If you become pregnant while using Synalar Bi-Otic (Fluocinolone Acetonide) Cream, tell your doctor right away.
What is Synalar Bi-Otic (Fluocinolone Acetonide) Cream?
Synalar Bi-Otic (Fluocinolone Acetonide) Cream is a prescription medicine used for the short-term treatment of moderate to severe melasma of the face, in combination with sun avoidance and the use of sunscreens.
Synalar Bi-Otic (Fluocinolone Acetonide) Cream is not for continuous treatment of melasma.
It is not known if Synalar Bi-Otic (Fluocinolone Acetonide) Cream is safe and effective in children.
It is not known if Synalar Bi-Otic (Fluocinolone Acetonide) Cream is safe and effective in people with dark brown to black skin color.
It is not known if Synalar Bi-Otic (Fluocinolone Acetonide) Cream is safe and effective in the treatment of dark spots (hyperpigmentation) of the skin caused by conditions other than melasma of the face.
It is not known if Synalar Bi-Otic (Fluocinolone Acetonide) Cream is safe and effective in females who are pregnant or who are breastfeeding. See "What is the most important information I should know about Synalar Bi-Otic (Fluocinolone Acetonide) Cream? and What should I tell my doctor before using Synalar Bi-Otic (Fluocinolone Acetonide) Cream?"
Who should not use Synalar Bi-Otic (Fluocinolone Acetonide) Cream?
Do not use Synalar Bi-Otic (Fluocinolone Acetonide) Cream if you are allergic to it or any of the ingredients in Synalar Bi-Otic (Fluocinolone Acetonide) Cream. See the end of this leaflet for a complete list of ingredients in Synalar Bi-Otic (Fluocinolone Acetonide) Cream.
What should I tell my doctor before using Synalar Bi-Otic (Fluocinolone Acetonide) Cream?
Before you use Synalar Bi-Otic (Fluocinolone Acetonide) Cream, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements and skin products that you use.
How should I use Synalar Bi-Otic (Fluocinolone Acetonide) Cream?
What should I avoid while using Synalar Bi-Otic (Fluocinolone Acetonide) Cream?
What are the possible side effects of Synalar Bi-Otic (Fluocinolone Acetonide) Cream?
Synalar Bi-Otic (Fluocinolone Acetonide) Cream may cause serious side effects, including:
- allergic reactions. Synalar Bi-Otic (Fluocinolone Acetonide) Cream may cause allergic reactions that can be life threatening. Stop using Synalar Bi-Otic (Fluocinolone Acetonide) Cream and call your doctor or get medical help right away if you get any of the following symptoms:
- change in skin color. One of the medicines in Synalar Bi-Otic (Fluocinolone Acetonide) Cream can cause a blue-black darkening of your skin. Stop using Synalar Bi-Otic (Fluocinolone Acetonide) Cream and tell you doctor if you develop a blue-black darkening of your skin.
- Synalar Bi-Otic (Fluocinolone Acetonide) Cream can pass through your skin. Too much Synalar Bi-Otic (Fluocinolone Acetonide) Cream passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems.
- skin irritation. Stop using Synalar Bi-Otic (Fluocinolone Acetonide) Cream and call your doctor if you have:
The most common side effects of Synalar Bi-Otic (Fluocinolone Acetonide) Cream include:
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Synalar Bi-Otic (Fluocinolone Acetonide) Cream. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.
How should I store Synalar Bi-Otic (Fluocinolone Acetonide) Cream?
General information about the safe and effective use of Synalar Bi-Otic (Fluocinolone Acetonide) Cream
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Synalar Bi-Otic (Fluocinolone Acetonide) Cream for a condition for which it was not prescribed. Do not give Synalar Bi-Otic (Fluocinolone Acetonide) Cream to other people, even if they have the same symptoms you have. It may harm them.
If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Synalar Bi-Otic (Fluocinolone Acetonide) Cream that is written for health professionals.
What are the ingredients in Synalar Bi-Otic (Fluocinolone Acetonide) Cream?
Active ingredients: Synalar Bi-Otic (Fluocinolone Acetonide) acetonide, hydroquinone, and tretinoin
Inactive ingredients: butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol
This Patient Information has been approved by the U.S. Food and Drug Administration.
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, TX 76177 USA
Manufactured by:
Hill Dermaceuticals, Inc.
Sanford, FL 32773 USA
or
Manufactured by:
G Production Inc.
Baie dUrfé, QC, H9X 3S4 Canada
Made in Canada
Revised: March 2014
Synalar Bi-Otic (Fluocinolone Acetonide)® (fluocinolone acetonide, hydroquinone, tretinoin) cream, 0.01%/4%/0.05%
MUST BE REFRIGERATED
NDC 0299-5950-30
Rx Only
NET WT. 30 g
GALDERMA
Lot No.: Exp. Date:
For Topical Use Only. Not for Ophthalmic Use.
Usual
Dosage: Apply a thin film to affected areas once daily at night. See package insert for complete prescribing information.
Each gram contains: Active: Synalar Bi-Otic (Fluocinolone Acetonide) acetonide 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (0.5 mg). Inactive: butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol.
Storage: Store in a refrigerator, 2° to 8°C (36° to 46°F). Protect from freezing.
www.triluma.com
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Galderma is a registered trademark.
P51399-2
MUST BE REFRIGERATED
p51399-2-tri-luma-30g-crm-crtn
Neomycin Sulfate:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Synalar Bi-Otic (Neomycin Sulfate) tablets and other antibacterial drugs, Synalar Bi-Otic (Neomycin Sulfate) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Suppression of Intestinal Bacteria
Synalar Bi-Otic (Neomycin Sulfate) tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION ).
Hepatic Coma (Portal-Systemic Encephalopathy)
Synalar Bi-Otic (Neomycin Sulfate) has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.
Synalar Bi-Otic (Neomycin Sulfate) oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.
Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin. Synalar Bi-Otic (Neomycin Sulfate) oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.
Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman.
Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Prescribing Synalar Bi-Otic tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antibiotics, use of oral neomycin may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.
Neomycin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of neomycin.
Cross-allergenicity among aminoglycosides has been demonstrated.
Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.
Small amounts of orally administered neomycin are absorbed through intact intestinal mucosa.
There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of neomycin. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.
An oral neomycin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.
Orally administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.
Patients should be counseled that antibacterial drugs including Synalar Bi-Otic (Neomycin Sulfate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Synalar Bi-Otic (Neomycin Sulfate) tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Synalar Bi-Otic (Neomycin Sulfate) tablets or other antibacterial drugs in the future.
Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.
Patients with renal insufficiency may develop toxic neomycin blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve function.
Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.
Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin (see boxed WARNINGS ).
Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate neomycin sulfate’s neuromuscular blocking effects.
Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.
Oral Synalar Bi-Otic (Neomycin Sulfate) may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.
No long-term animal studies have been performed with Synalar Bi-Otic to evaluate carcinogenic or mutagenic potential or impairment of fertility.
See WARNINGS section.
It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The safety and efficacy of oral Synalar Bi-Otic (Neomycin Sulfate) in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.
The most common adverse reactions to oral Synalar Bi-Otic (Neomycin Sulfate) are nausea, vomiting and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).
Because of low absorption, it is unlikely that acute overdosage would occur with oral Synalar Bi-Otic (Neomycin Sulfate). However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.
Hemodialysis will remove Synalar Bi-Otic (Neomycin Sulfate) from the blood.
To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.
Hepatic Coma
For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:
Preoperative Prophylaxis for Elective Colorectal Surgery
Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.
Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.
Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.
Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Synalar Bi-Otic (Neomycin Sulfate) (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.
Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.
Synalar Bi-Otic (Neomycin Sulfate) tablets USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as white to off-white, round, standard convex tablets debossed "LCI" on one side and "1210", on the other side and are supplied in:
Bottles of 100 (NDC 0527-1210-01)
Store at 20° to 25°C (68° to 77°F).
Dispense in tight containers as defined in the USP/NF.
Distributed By:
Lannett Company, Inc.
Philadelphia, PA 19154
Made in the USA
Rev. 01/17
CIB71710A
Polymyxin B Sulfate:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Polymyxin and other antibacterial drugs, Synalar Bi-Otic (Polymyxin B Sulfate) for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY, INTRAVENOUSLY AND/OR INTRATHECALLY, IT SHOULD BE GIVEN ONLY TO HOSPITALIZED PATIENTS, SO AS TO PROVIDE CONSTANT SUPERVISION BY A PHYSICIAN.
RENAL FUNCTION SHOULD BE CAREFULLY DETERMINED AND PATIENTS WITH RENAL DAMAGE AND NITROGEN RETENTION SHOULD HAVE REDUCED DOSAGE. PATIENTS WITH NEPHROTOXICITY DUE TO Synalar Bi-Otic (Polymyxin B Sulfate) SULFATE USUALLY SHOW ALBUMINURIA, CELLULAR CASTS, AND AZOTEMIA. DIMINISHING URINE OUTPUT AND A RISING BUN ARE INDICATIONS FOR DISCONTINUING THERAPY WITH THIS DRUG.
NEUROTOXIC REACTIONS MAY BE MANIFESTED BY IRRITABILITY, WEAKNESS, DROWSINESS, ATAXIA, PERIORAL PARESTHESIA, NUMBNESS OF THE EXTREMITIES, AND BLURRING OF VISION. THESE ARE USUALLY ASSOCIATED WITH HIGH SERUM LEVELS FOUND IN PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR NEPHROTOXICITY.
THE CONCURRENT OR SEQUENTIAL USE OF OTHER NEUROTOXIC AND/OR NEPHROTOXIC DRUGS WITH Synalar Bi-Otic (Polymyxin B Sulfate) SULFATE, PARTICULARLY BACITRACIN, STREPTOMYCIN, NEOMYCIN, KANAMYCIN, GENTAMICIN, TOBRAMYCIN, AMIKACIN, CEPHALORIDINE, PAROMOMYCIN, VIOMYCIN, AND COLISTIN SHOULD BE AVOIDED.
THE NEUROTOXICITY OF Synalar Bi-Otic (Polymyxin B Sulfate) SULFATE CAN RESULT IN RESPIRATORY PARALYSIS FROM NEUROMUSCULAR BLOCKADE, ESPECIALLY WHEN THE DRUG IS GIVEN SOON AFTER ANESTHESIA AND/OR MUSCLE RELAXANTS.
USAGE IN PREGNANCY: THE SAFETY OF THIS DRUG IN HUMAN PREGNANCY HAS NOT BEEN ESTABLISHED.
Synalar Bi-Otic (Polymyxin B Sulfate) Sulfate is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous). Synalar Bi-Otic (Polymyxin B Sulfate) sulfate is the sulfate salt of Polymyxins B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillacea). It has a potency of not less than 6000 Synalar Bi-Otic (Polymyxin B Sulfate) units per mg, calculated on the anhydrous basis. The structural formulae are:
Synalar Bi-Otic (Polymyxin B Sulfate) 1 (R=CH 3) Polymyxin B 2 (R=H)
Each vial contains 500,000 Synalar Bi-Otic (Polymyxin B Sulfate) units for parenteral or ophthalmic administration.
Synalar Bi-Otic (Polymyxin B Sulfate) for Injection is in powder form suitable for preparation of sterile solutions for intramuscular, intravenous drip, intrathecal, or ophthalmic use.
In the medical literature, dosages have frequently been given in terms of equivalent weights of pure Synalar Bi-Otic (Polymyxin B Sulfate) base. Each milligram of pure Synalar Bi-Otic (Polymyxin B Sulfate) base is equivalent to 10,000 units of Synalar Bi-Otic (Polymyxin B Sulfate) and each microgram of pure Synalar Bi-Otic (Polymyxin B Sulfate) base is equivalent to 10 units of Synalar Bi-Otic (Polymyxin B Sulfate).
Aqueous solutions of Synalar Bi-Otic (Polymyxin B Sulfate) sulfate may be stored up to 12 months without significant loss of potency if kept under refrigeration. In the interest of safety, solutions for parenteral use should be stored under refrigeration and any unused portion should be discarded after 72 hours. Synalar Bi-Otic (Polymyxin B Sulfate) sulfate should not be stored in alkaline solutions since they are less stable.
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Synalar Bi-Otic (Polymyxin B Sulfate) sulfate has a bactericidal action against almost all gram-negative bacilli except the Proteus group. Polymyxins increase the permeability of bacterial cell wall membranes. All gram-positive bacteria, fungi, and the gram-negative cocci, N gonorrhoeae and N meningitidis, are resistant.
Synalar Bi-Otic (Polymyxin B Sulfate) has bactericidal action against almost all Gram-negative bacilli except the Proteus group. Polymyxins increase the permeability of the bacterial cell membrane leading to death of the cell. All Gram-positive bacteria, fungi, and Gram-negative cocci, are resistant to Synalar Bi-Otic (Polymyxin B Sulfate). Appropriate methods should be used when performing in vitro susceptibility testing of Synalar Bi-Otic (Polymyxin B Sulfate) (1,2,3). The following in vitro susceptibility test criteria should only be used for interpreting the results of Synalar Bi-Otic (Polymyxin B Sulfate) susceptibility testing against P. aeruginosa when the indicated quality control parameters are met during testing.
In vitro susceptibility test interpretive criteria for Synalar Bi-Otic (Polymyxin B Sulfate) sulfate against Pseudomonas aeruginosa | ||||||
Minimal Inhibitory Concentration (MIC) (mcg/mL) | Disk Diffusion Interpretive Criteria (mm) (300 unit disk) | |||||
Pathogen | Susceptible | Intermediate | Resistant | Susceptible | Intermediate | Resistant |
Pseudomonas aeruginosa | ≤2 | 4 | ≥8 | ≥12 | - | ≤11 |
In vitro susceptibility test quality control ranges for Synalar Bi-Otic (Polymyxin B Sulfate) sulfate against Pseudomonas aeruginosa | ||
Quality Control Organism (ATCC* Number) | Minimum Inhibatory Concentration (MIC) Range (mcg/mL) | Disk Diffusion Quality Control Range (300 unit disk) (mm) |
Pseudomonas aeruginosa (27853) | 1 - 4 | 14 - 18 |
Synalar Bi-Otic (Polymyxin B Sulfate) sulfate is not absorbed from the normal alimentary tract. Since the drug loses 50 percent of its activity in the presence of serum, active blood levels are low. Repeated injections may give a cumulative effect. Levels tend to be higher in infants and children. The drug is excreted slowly by the kidneys. Tissue diffusion is poor and the drug does not pass the blood brain barrier into the cerebrospinal fluid. In therapeutic dosage, Synalar Bi-Otic (Polymyxin B Sulfate) sulfate causes some nephrotoxicity with tubule damage to a slight degree.
Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa.
Synalar Bi-Otic (Polymyxin B Sulfate) sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa.
It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated:
H influenzae, specifically meningeal infections.
Escherichia coli, specifically urinary tract infections.
Aerobacter aerogenes, specifically bacteremia.
Klebsiella pneumoniae, specifically bacteremia.
NOTE: IN MENINGEAL INFECTIONS, Synalar Bi-Otic (Polymyxin B Sulfate) SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Synalar Bi-Otic (Polymyxin B Sulfate) for Injection USP and other antibacterial drugs, Synalar Bi-Otic (Polymyxin B Sulfate) for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
This drug is contraindicated in persons with a prior history of hypersensitivity reactions to polymyxins.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Synalar Bi-Otic (Polymyxin B Sulfate) for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile and surgical evaluation should be instituted as clinically indicated.
General.
Prescribing Synalar Bi-Otic for Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increase the risk of the development of drug-resistant bacteria.
See WARNING box.
Baseline renal function should be done prior to therapy, with frequent monitoring of renal function and blood levels of the drug during parenteral therapy.
Avoid concurrent use of a curariform muscle relaxant and other neurotoxic drugs (ether, tubocurarine, succinylcholine, gallamine, decamethonium and sodium citrate) which may precipitate respiratory depression. If signs of respiratory paralysis appear, respiration should be assisted as required, and the drug discontinued.
As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi.
If superinfection occurs, appropriate therapy should be instituted.
Information for Patients.
Patients should be counseled that antibacterial drugs including Synalar Bi-Otic (Polymyxin B Sulfate) for injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Synalar Bi-Otic (Polymyxin B Sulfate) for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Synalar Bi-Otic (Polymyxin B Sulfate) for injection or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
See “WARNING” box.
Nephrotoxic reactions: Albuminuria, cylinduria, azotemia, and rising blood levels without any increase in dosage.
Neurotoxic reactions: Facial flushing, dizziness progressing to ataxia, drowsiness, peripheral paresthesias (circumoral and stocking glove), apnea due to concurrent use of curariform muscle relaxants, other neurotoxic drugs or inadvertent overdosage, and signs of meningeal irritation with intrathecal administration, e.g., fever, headache, stiff neck and increased cell count and protein cerebrospinal fluid.
Other reactions occasionally reported: Drug fever, urticarial rash, pain (severe) at intramuscular injection sites, and thrombophlebitis at intravenous injection sites.
To report SUSPECTED ADVERSE EVENTS, contact FDA at 1-800-FDA-1088 or www.fda.gov.
PARENTERAL:
Intravenous. Dissolve 500,000 Synalar Bi-Otic (Polymyxin B Sulfate) units in 300 to 500 mL solutions for parenteral dextrose injection 5 percent for continuous drip.
Adults and children. 15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day.
Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.
Intramuscular. Not recommended routinely because of severe pain at injection sites, particularly in infants and children. Dissolve 500,000 Synalar Bi-Otic (Polymyxin B Sulfate) units in 2 mL sterile water for injection or sodium chloride injection or procaine hydrochloride injection 1 percent.
Adults and children. 25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals.
Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.
Note: Doses as high as 45,000 units/kg/day have been used in limited clinical studies in treating prematures and newborn infants for sepsis caused by Ps aeruginosa.
Intrathecal. A treatment of choice for Ps aeruginosa meningitis. Dissolve 500,000 Synalar Bi-Otic (Polymyxin B Sulfate) units in 10 mL sodium chloride injection USP for 50,000 units per mL dosage unit.
Adults and children over 2 years of age. Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.
Children under 2 years of age. 20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.
IN THE INTEREST OF SAFETY, SOLUTIONS OF PARENTERAL USE SHOULD BE STORED UNDER REFRIGERATION, AND ANY UNUSED PORTIONS SHOULD BE DISCARDED AFTER 72 HOURS.
TOPICAL:
Ophthalmic. Dissolve 500,000 Synalar Bi-Otic (Polymyxin B Sulfate) units in 20 to 50 mL sterile water for injection or sodium chloride injection USP for a 10,000 to 25,000 units per mL concentration.
For the treatment of Ps aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates.
Subconjunctival injection of up to 100,000 units/day may be used for the treatment of Ps aeruginosa infections of the cornea and conjunctiva.
Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.
Synalar Bi-Otic (Polymyxin B Sulfate) FOR INJECTION USP, 500,000 Synalar Bi-Otic (Polymyxin B Sulfate) units per vial is available in single vial cartons NDC# 39822-0166-5.
Storage recommendations:
Before reconstitution: Store at 20° to 25°C (68° to 77°F).
Protect from light. Retain in carton until time of use.
After reconstitution: Product must be stored under refrigeration, between 2° to 8°C (36° to 46°F) and any unused portion should be discarded after 72 hours.
Sterile, Nonpyrogenic, Preservative-free.
The container closure is not made with natural rubber latex.
Manufactured for:
X-Gen Pharmaceuticals, Inc.
Big Flats, NY 14845
POLY-PI-06
Revised December 2012
Depending on the reaction of the Synalar Bi-Otic after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Synalar Bi-Otic not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Synalar Bi-Otic addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology