DRUGS & SUPPLEMENTS
Sialar-FC usesSialar-FC consists of Ciprofloxacin, Clotrimazole, Fluocinolone, Neomycin.
Sialar-FC is a broad-spectrum antimicrobial drug of fluoroquinolone group with bactericidal action. Inhibits DNA gyrase and inhibits the synthesis of bacterial DNA. Highly active against most gram-negative bacteria: Pseudomonas aeruginosa, Haemophilus influenzae, Escherichia coli, Shigella spp., Salmonella spp., Neisseria meningitidis, Neisseria gonorrhoeae.
Sialar-FC (Ciprofloxacin) is active against Staphylococcus spp. (including strains producing and not producing penicillinase, methicillin-resistant strains), some strains of Enterococcus spp., Campylobacter spp., Legionella spp., Mycoplasma spp., Chlamydia spp., Mycobacterium spp.
Sialar-FC (Ciprofloxacin) is active against bacteria producing beta-lactamases.
Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides resistant to Sialar-FC (Ciprofloxacin). The effect on Treponema pallidum is studied not enough.
Sialar-FC (Ciprofloxacin) rapidly absorbed from the gastrointestinal tract. Bioavailability after oral administration of 70%. Eating has a little effect on the absorption of Sialar-FC (Ciprofloxacin). Plasma protein binding is 20-40%. Distributed in tissues and body fluids. It penetrates the cerebrospinal fluid: the concentration of Sialar-FC (Ciprofloxacin) for not inflamed meninges reach 10% with inflammation - up to 37%. High concentrations are achieved in bile. Excreted in the urine and bile.
Why is Sialar-FC prescribed?
Infectious-inflammatory diseases caused by microorganisms susceptible to Sialar-FC (Ciprofloxacin), including respiratory diseases, diseases of abdominal and pelvic organs, bones, joints, skin, septicemia; severe infections of ENT organs. Treatment of postoperative infections. Prevention and treatment of infections in patients with reduced immunity.
For Sialar-FC (Ciprofloxacin) local use: acute and subacute conjunctivitis, blepharoconjunctivitis, blepharitis, bacterial corneal ulcers, keratitis, keratoconjunctivitis, chronic dacryocystitis, meybomity. Infectious lesions in the eyes from injury or contact with foreign bodies. Preoperative prophylaxis in ophthalmic surgery.
Dosage and administration
Individual. For oral administration dose of Sialar-FC is 250-750 mg 2 times / day. Treatment duration is from 7-10 days to 4 weeks.
For IV administration a single dose is 200-400 mg, the multiplicity of the introduction is 2 times / day, duration of treatment - 1-2 weeks and more if necessary. May be IV injected as jet but more preferably a drip for 30 minutes.
When Sialar-FC (Ciprofloxacin) applied topically instilled 1-2 drops into the lower conjunctival sac of the affected eye every 1-4 hours. After improving the intervals between instillation can be increased. The maximum oral daily dose for adults is 1.5 g.
Sialar-FC (Ciprofloxacin) side effects, adverse reactions
Digestive system: nausea, vomiting, diarrhea, abdominal pain, increase in liver transaminases, alkaline phosphatase, LDH, bilirubin, pseudomembranous colitis.
CNS: headache, dizziness, fatigue, insomnia, nightmares, hallucinations, fainting, disorders of vision.
Urinary system: crystalluria, glomerulonephritis, dysuria, polyuria, albuminuria, hematuria, transient increase of serum creatinine.
Hemopoietic system: eosinophilia, leukopenia, neutropenia, changes in the number of platelets.
Cardiovascular system: tachycardia, cardiac arrhythmias, hypotension.
Allergic reactions: itching, urticaria, Quincke's edema, Stevens-Johnson syndrome, arthralgia.
Adverse reactions associated with the chemotherapeutic effect: candidiasis.
Local reactions: pain, phlebitis (for IV injections). When applying eye drops in some cases may be mild pain and conjunctival hyperemia.
Pregnancy, lactation, childhood and adolescence to 15 years, increased sensitivity to Sialar-FC (Ciprofloxacin) and other drugs hinolonovogo series; deficiency of glucose-6-phosphate dehydrogenase; in ophthalmology: viral keratitis.
Sialar-FC (Ciprofloxacin) Cipla: restrictions to using
Pronounced cerebral arteriosclerosis, cerebral circulatory disorder, mental illness, epilepsy, epileptic syndrome, marked renal and / or hepatic insufficiency.
Using during pregnancy and breastfeeding
Contraindicated in pregnancy ; Sialar-FC (Ciprofloxacin) crosses the placenta, excreted in breast milk.
In experimental studies found that it causes arthropathy. In experiments on rats and mice treated with Sialar-FC (Ciprofloxacin) in doses exceeding the usual daily dose for a person 6 times, adverse effects on the fetus is not revealed. In experiments on rabbits treated with oral dose of Sialar-FC (Ciprofloxacin) 30 and 100 mg / kg, it is shown that the drug causes disruption of the gastrointestinal tract, leading to loss of body weight in females and increase the number of miscarriages but teratogenicity not found. When IV introduction to the doses of 20 mg / kg Sialar-FC (Ciprofloxacin) did not exert toxic effects on the mother and embryo, showed no teratogenicity. The use of local forms of Sialar-FC (Ciprofloxacin) in pregnancy is possible if the anticipated benefits exceed the potential risk to the fetus.
Category of the fetus by FDA - C.
Sialar-FC (Ciprofloxacin) is excreted in breast milk, so the period of lactation should decide, stop taking Sialar-FC (Ciprofloxacin) or breastfeeding based on the degree of importance of the use of drugs for the mother.
With careful use of local forms of Sialar-FC (Ciprofloxacin) in breast-feeding (not known whether Sialar-FC (Ciprofloxacin) is excreted in breast milk when applied topically).
Patients with impaired renal function requires correction dosing regimen. With caution used in elderly patients, with cerebral arteriosclerosis, cerebral circulatory disorders, epilepsy, convulsive syndrome of unknown etiology.
During treatment patients with Sialar-FC (Ciprofloxacin) should receive enough amounts of liquids.
In the case of persistent diarrhea Sialar-FC (Ciprofloxacin) should not be taken.
At the same time of Sialar-FC (Ciprofloxacin) IV introduction and barbiturates is necessary to monitor heart rate, blood pressure, ECG. In the course of treatment is necessary to monitor blood concentrations of urea, creatinine, hepatic transaminases.
In the period of treatment may decrease the reactivity (especially when used with alcohol).
Not allowed the introduction of Sialar-FC (Ciprofloxacin) subconjunctival or directly into the anterior chamber of the eye.
Due to the threat of adverse reactions from the CNS Sialar-FC should be used only according to the life in the pathology of the CNS in history: organic brain lesions, epilepsy, lowering the convulsive threshold, severe atherosclerosis of the brain (risk of circulatory disorders, stroke), the elderly, with severely impaired renal function and liver (requires monitoring concentrations in blood plasma).
Patients with allergic reactions to fluoroquinolone derivatives in history may develop reactions to Sialar-FC (Ciprofloxacin). During the period of treatment should avoid sunlight and UV radiation, intense physical exercise, control of drinking mode, pH of urine.
Reported cases of crystalluria, particularly in patients with alkaline reaction of urine (pH 7 or more). In order to avoid the development of crystalluria unacceptable excess of the recommended daily dose, should also be adequate fluid intake and maintaining acidic urine.
If you have pain in the tendons or the first signs tendovaginitah treatment should be discontinued (described isolated cases of inflammation or tendon rupture during fluoroquinolone treatment).
It can reduce the speed of psychomotor reactions, especially against the backdrop of alcohol, that should be considered for patients who work with potentially dangerous machinery or drive vehicles.
If you have severe diarrhea, pseudomembranous colitis should be excluded (for which Sialar-FC (Ciprofloxacin) is contraindicated). At the same time of barbiturates IV injections requires monitoring function of the cardiovascular system (heart rate, BP, ECG). Teenagers under 18 years shall be appointed only if the pathogen resistance to other chemotherapeutic drugs. The solution in the form of eye drops are not designed for intraocular injections. The use of other ophthalmic means the interval between injections should be at least 5 minutes.
Sialar-FC (Ciprofloxacin) drug interactions
Activity increases when combined with beta-lactam antibiotics, aminoglycosides, vancomycin, clindamycin, metronidazole. Sukralfat, bismuth preparations, antacids containing aluminum ions, magnesium or calcium, cimetidine, ranitidine, vitamin and mineral supplement, iron sulfate, zinc, didanosine (recommended for 2 hours before or 4 hours after these drugs) reduce the suction. Probenecid, azlocillin increase the concentration in the blood. Decreases clearance and increases in plasma caffeine, aminophylline and theophylline (increased likelihood of side effects). Sialar-FC (Ciprofloxacin) enhances the effect of warfarin and other oral anticoagulants (prolongs bleeding time). Increases nephrotoxicity of cyclosporine, increase the risk of CNS excitability and convulsive reactions against the background of NSAIDs. Medicines alkalinizing the urine (citrates, sodium bicarbonate, carbonic anhydrase inhibitors) reduce the solubility (increases the probability of crystalluria). Infusion solutions of Sialar-FC (Ciprofloxacin) ready to use can be combined with infusion solutions: 0.9% sodium chloride solution, Ringer's solution, Ringer lactate, 5 and 10% dextrose, 10% solution of fructose, and a solution containing 5% dextrose with 0,225 or 0.45% sodium chloride. Incompatible with solutions having a pH > 7.
Sialar-FC in case of emergency / overdose
May occur after receiving a single large dose or prolonged use. If a single dose of less than 150 mg / kg, acute poisoning feel light, 150-300 mg / kg - moderate, when using higher doses - heavy.
Symptoms: No specific symptoms.
Treatment: gastric lavage, the use of emetic drugs, the introduction of large quantities of liquid, the creation of acidic urine, in addition - hemodialysis and peritoneal dialysis (can be derived only 10% of the drug), all events are held on the background to maintain vital functions. The specific antidote is unknown.
Sialar-FC is an antifungal agent of imidazole derivatives group for topical use. This medication has an effect at the expense of the synthesis of ergosterol, which is part of the cell membrane of fungi. Sialar-FC (Clotrimazole) has a broad spectrum of action.
Sialar-FC (Clotrimazole) is active against dermatophytes, molds, fungi of the genus Candida, Malassezia furfur.
This drug is also active against Corynebacterium minutissimum, Streptococcus spp., Staphylococcus spp., Trichomonas vaginalis.
For external use Sialar-FC (Clotrimazole) is well into the various layers of the skin reaching therapeutic concentrations. When this medication applied topically a small amount of it absorbed into the bloodstream.
Why is Sialar-FC prescribed?
Fungal skin and mucous membranes: ringworm, tinea, trichophytosis, athlete, mikrosporiya, candidiasis, a fungal interdigital erosion, fungal paronychia; fungal infections complicated by a secondary pyoderma; colorful lichen, erythrasma; thrush; Candida vulvitis, vulvovaginitis, balanitis, trichomoniasis; for the renovation of the birth canal before delivery.
Dosage and administration
When Sialar-FC used externally it applied to affected skin 2-3 times / day in 2-4 weeks.
For local orally this medicine used 1-2 times / day, no more than 7 days.
Intravaginal - on 100-500 mg for 1-6 days.
Sialar-FC (Clotrimazole) side effects, adverse reactions
Local reactions: contact allergic dermatitis, redness, burning sensation.
When applied topically to the skin: erythema, blisters, swelling, burning and tingling, irritation and flaking skin.
When applied topically for the treatment of urogenital infections: itching, burning, redness and swelling of the mucous membrane, vaginal discharge, frequent urination, intercurrent cystitis, burning sensation in the penis with a partner, pain during sexual intercourse.
When applied topically in the oral cavity: redness of the oral mucosa, burning sensation and tingling at the site of application, irritation.
Hypersensitivity to Sialar-FC (Clotrimazole), I trimester of pregnancy.
Using during pregnancy and breastfeeding
In experimental studies there have been found that Sialar-FC used in high doses exerts embryotoxic effect.
It is not known whether Sialar-FC (Clotrimazole) released in breast milk. Although Sialar-FC (Clotrimazole) is not contraindicated during pregnancy and lactation, it should be considered a potential risk when selecting antifungal therapy.
Prescribed intravaginal Dosage forms of Sialar-FC (Clotrimazole) is not used during menstruation.
To prevent reinfection it should be simultaneous treatment of sexual partners.
Sialar-FC (Clotrimazole) is not recommended for use in ophthalmology.
Sialar-FC drug interactions
Simultaneous administration of Sialar-FC (Clotrimazole) with amphotericin B, nystatin, natamycin activity of Sialar-FC (Clotrimazole) decreases.
Sialar-FC in case of emergency / overdose
Symptoms: anorexia, nausea, vomiting, stomachodynia, abnormal liver function, rarely - drowsiness, hallucinations, thamuria, allergic skin reactions.
Treatment: taking activated charcoal, symptomatic therapy.
1 INDICATIONS AND USAGE
Sialar-FC Cream is a combination of Sialar-FC (Fluocinolone) 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.
Sialar-FC (Fluocinolone) Cream is a combination of Sialar-FC (Fluocinolone) 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.
1.2 Limitations of Use
Sialar-FC (Fluocinolone) Cream is NOT indicated for the maintenance treatment of melasma. After achieving control with Sialar-FC (Fluocinolone) Cream, some patients may be managed with other treatments instead of triple therapy with Sialar-FC (Fluocinolone) Cream. Melasma usually recurs upon discontinuation of Sialar-FC (Fluocinolone) Cream.
The safety and efficacy of Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream in pregnant women and nursing mothers have not been established [see Use in Specific Populations (8.1, 8.3)].
2 DOSAGE AND ADMINISTRATION
Apply a thin film of Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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.
Sialar-FC (Fluocinolone) Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
3 DOSAGE FORMS AND STRENGTHS
Each gram of Sialar-FC (Fluocinolone) Cream contains 0.1 mg of Sialar-FC (Fluocinolone) acetonide, 40 mg of hydroquinone, and 0.5 mg of tretinoin in a light yellow, hydrophilic cream base.
Sialar-FC (Fluocinolone) Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.
5 WARNINGS AND PRECAUTIONS
Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone). Allergic contact dermatitis may also occur [see Warnings and Precautions 5.4].
5.2 Exogenous Ochronosis
Sialar-FC 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.
5.3 Effects on Endocrine System
Sialar-FC (Fluocinolone) Cream contains the corticosteroid Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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.
5.4 Cutaneous Reactions
Cutaneous hypersensitivity to the active ingredients of Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream or its components.
Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream treatment. Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
6 ADVERSE REACTIONS
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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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.
8 USE IN SPECIFIC POPULATIONS
Sialar-FC Cream contains the teratogen, tretinoin, which may cause embryofetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. Sialar-FC (Fluocinolone) 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. Sialar-FC (Fluocinolone) Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Sialar-FC (Fluocinolone) Cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits.
In clinical trials involving Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream has been performed.
- It is difficult to interpret these animal studies on teratogenicity with Sialar-FC (Fluocinolone) Cream, because the availability of the dermal applications in these studies could not be assured, and comparison with clinical dosing is not possible.
8.3 Nursing Mothers
Corticosteroids, when systemically administered, appear in human milk. It is not known whether topical application of Sialar-FC Cream could result in sufficient systemic absorption to produce detectable quantities of Sialar-FC (Fluocinolone) acetonide, hydroquinone, or tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when Sialar-FC (Fluocinolone) Cream is administered to a nursing woman. Care should be taken to avoid contact between the infant being nursed and Sialar-FC (Fluocinolone) Cream.
8.4 Pediatric use
Safety and effectiveness of Sialar-FC (Fluocinolone) Cream in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of Sialar-FC (Fluocinolone) 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.
Sialar-FC (Fluocinolone) (fluocinolone acetonide, hydroquinone, and tretinoin) Cream, 0.01%/4%/0.05% contains Sialar-FC (Fluocinolone) acetonide, USP, hydroquinone, USP, and tretinoin, USP, in a light yellow, hydrophilic cream base for topical application.
Sialar-FC (Fluocinolone) acetonide is a synthetic fluorinated corticosteroid. It is a white crystalline powder that is odorless and stable in light.
The chemical name for Sialar-FC (Fluocinolone) 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.
Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream contains Active: Sialar-FC (Fluocinolone) 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.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The mechanism of action of the active ingredients in Sialar-FC Cream in the treatment of melasma is unknown.
Percutaneous absorption of unchanged tretinoin, hydroquinone and Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) acetonide, Groups I and II subjects had all post-dose plasma concentrations below quantitation limit.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
When Sialar-FC (Fluocinolone) acetonide, hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 50%, 100%, and 150% of the concentrations in the clinical formulation of Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) acetonide, hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 25%, 50%, and 100% of the concentrations in the clinical formulation of Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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.
14 CLINICAL STUDIES
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. Sialar-FC (Fluocinolone) Cream was compared with 3 possible combinations of 2 of the 3 active ingredients [(1) hydroquinone 4% (HQ) + tretinoin 0.05% (RA); (2) Sialar-FC (Fluocinolone) acetonide 0.01% (FA) + tretinoin 0.05% (RA); (3) Sialar-FC (Fluocinolone) acetonide 0.01% (FA) + hydroquinone 4% (HQ)], contained in the same vehicle as Sialar-FC (Fluocinolone) 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%). Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream as early as 4 weeks. However, among 7 subjects who had clearing at the end of 4 weeks of treatment with Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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%).
16 HOW SUPPLIED/STORAGE AND HANDLING
Sialar-FC (Fluocinolone) 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:
GALDERMA LABORATORIES, L.P.
Fort Worth, TX 76177 USA
Hill Dermaceuticals, Inc.
Sanford, FL 32773 USA
G Production Inc.
Baie d’Urfé, QC, H9X 3S4 Canada
Made in Canada
Sialar-FC (Fluocinolone)® (try-LOOM-ah)
(fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05%)
Important information: Sialar-FC (Fluocinolone) Cream is for use on skin only. Do not use Sialar-FC (Fluocinolone) Cream in your mouth, eyes, or vagina.
What is the most important information I should know about Sialar-FC (Fluocinolone) Cream?
Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream, tell your doctor right away.
What is Sialar-FC (Fluocinolone) Cream?
Sialar-FC (Fluocinolone) 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.
Sialar-FC (Fluocinolone) Cream is not for continuous treatment of melasma.
It is not known if Sialar-FC (Fluocinolone) Cream is safe and effective in children.
It is not known if Sialar-FC (Fluocinolone) Cream is safe and effective in people with dark brown to black skin color.
It is not known if Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream? and What should I tell my doctor before using Sialar-FC (Fluocinolone) Cream?"
Who should not use Sialar-FC (Fluocinolone) Cream?
Do not use Sialar-FC (Fluocinolone) Cream if you are allergic to it or any of the ingredients in Sialar-FC (Fluocinolone) Cream. See the end of this leaflet for a complete list of ingredients in Sialar-FC (Fluocinolone) Cream.
What should I tell my doctor before using Sialar-FC (Fluocinolone) Cream?
Before you use Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream?
What should I avoid while using Sialar-FC (Fluocinolone) Cream?
What are the possible side effects of Sialar-FC (Fluocinolone) Cream?
Sialar-FC (Fluocinolone) Cream may cause serious side effects, including:
- allergic reactions. Sialar-FC (Fluocinolone) Cream may cause allergic reactions that can be life threatening. Stop using Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream can cause a blue-black darkening of your skin. Stop using Sialar-FC (Fluocinolone) Cream and tell you doctor if you develop a blue-black darkening of your skin.
- Sialar-FC (Fluocinolone) Cream can pass through your skin. Too much Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream and call your doctor if you have:
The most common side effects of Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream?
General information about the safe and effective use of Sialar-FC (Fluocinolone) Cream
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Sialar-FC (Fluocinolone) Cream for a condition for which it was not prescribed. Do not give Sialar-FC (Fluocinolone) 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 Sialar-FC (Fluocinolone) Cream that is written for health professionals.
What are the ingredients in Sialar-FC (Fluocinolone) Cream?
Active ingredients: Sialar-FC (Fluocinolone) 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.
GALDERMA LABORATORIES, L.P.
Fort Worth, TX 76177 USA
Hill Dermaceuticals, Inc.
Sanford, FL 32773 USA
G Production Inc.
Baie dUrfé, QC, H9X 3S4 Canada
Made in Canada
Revised: March 2014
Sialar-FC (Fluocinolone)® (fluocinolone acetonide, hydroquinone, tretinoin) cream, 0.01%/4%/0.05%
MUST BE REFRIGERATED
NET WT. 30 g
Lot No.: Exp. Date:
For Topical Use Only. Not for Ophthalmic Use.
Dosage: Apply a thin film to affected areas once daily at night. See package insert for complete prescribing information.
Each gram contains: Active: Sialar-FC (Fluocinolone) 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.
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Galderma is a registered trademark.
MUST BE REFRIGERATED
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sialar-FC (Neomycin) sulfate tablets and other antibacterial drugs, Sialar-FC (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
Sialar-FC (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)
Sialar-FC (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.
Sialar-FC (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 Sialar-FC (Neomycin). Sialar-FC (Neomycin) sulfate oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of Sialar-FC (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 Sialar-FC (Neomycin) have not been conducted. If Sialar-FC (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 Sialar-FC sulfate 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 Sialar-FC (Neomycin) may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.
Sialar-FC (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 Sialar-FC (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 Sialar-FC (Neomycin) are absorbed through intact intestinal mucosa.
There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of Sialar-FC (Neomycin). If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.
An oral Sialar-FC (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 Sialar-FC (Neomycin) increases fecal bile acid excretion and reduces intestinal lactase activity.
Information for The Patient
Patients should be counseled that antibacterial drugs including Sialar-FC (Neomycin) sulfate tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Sialar-FC (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 Sialar-FC (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 Sialar-FC 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 (eighth cranial 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 Sialar-FC (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 Sialar-FC (Neomycin) sulfate’s neuromuscular blocking effects.
Oral Sialar-FC (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 Sialar-FC (Neomycin) sulfate may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed with Sialar-FC sulfate to evaluate carcinogenic or mutagenic potential or impairment of fertility.
Pregnancy Category D
See WARNINGS section.
It is not known whether Sialar-FC 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 Sialar-FC (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, Sialar-FC (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 Sialar-FC (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 Sialar-FC (Neomycin) sulfate. However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.
Hemodialysis will remove Sialar-FC (Neomycin) sulfate from the blood.
DOSAGE AND ADMINISTRATION
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.
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. Sialar-FC (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.
Sialar-FC (Neomycin) sulfate tablets USP, 500 mg (equivalent to 350 mg of Sialar-FC (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.
Lannett Company, Inc.
Philadelphia, PA 19154
Made in the USA
Sialar-FC pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Sialar-FC available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Sialar-FC destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Sialar-FC Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Sialar-FC pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Sialar-FC?
Depending on the reaction of the Sialar-FC after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Sialar-FC 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 Sialar-FC 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.
Reviewsdrugs.com conducted a study on Sialar-FC, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Sialar-FC consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reported usefulNo survey data has been collected yet
Visitor reported side effectsNo survey data has been collected yet
Visitor reported price estimatesNo survey data has been collected yet
Visitor reported frequency of useNo survey data has been collected yet
Visitor reported dosesNo survey data has been collected yet
Visitor reported time for resultsNo survey data has been collected yet
Visitor reported administrationNo survey data has been collected yet
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The information was verified by Dr. Arunabha Ray, MD Pharmacology