Vicalvit D may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Vicalvit D in the following countries:
Colecalciferol is reported as an ingredient of Vicalvit D in the following countries:
International Drug Name Search
Soldesanil may be available in the countries listed below.
Dexamethasone phosphate (a derivative of Dexamethasone) is reported as an ingredient of Soldesanil in the following countries:
International Drug Name Search
Diralon may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Diralon in the following countries:
International Drug Name Search
es-tra-DYE-ol VAL-er-ate, dye-EN-oh-jest, es-tra-DYE-ol VAL-er-ate, dye-EN-oh-jest, es-tra-DYE-ol VAL-er-ate, es-tra-DYE-ol VAL-er-ate
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use; this risk increases in women who are over 35 years of age and with number of cigarettes smoked. COCs should not be used by women who are over 35 years of age and smoke .
In the U.S.
Estradiol valerate and dienogest combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, estrogens and progestins and, when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective. Discuss with your doctor your options for birth control.
Estradiol valerate and dienogest combination does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
estradiol valerate and dienogest is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For estradiol valerate and dienogest, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to estradiol valerate and dienogest or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies on the relationship of age to the effects of estradiol valerate and dienogest combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. estradiol valerate and dienogest may be used for birth control in teenage females but is not indicated before the start of menstruation.
Appropriate studies on the relationship of age to the effects of estradiol valerate and dienogest combination have not been performed in the geriatric population. estradiol valerate and dienogest is not indicated for use in elderly women.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | X | Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking estradiol valerate and dienogest, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using estradiol valerate and dienogest with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using estradiol valerate and dienogest with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using estradiol valerate and dienogest with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use estradiol valerate and dienogest, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of estradiol valerate and dienogest. Make sure you tell your doctor if you have any other medical problems, especially:
To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.
estradiol valerate and dienogest comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
estradiol valerate and dienogest is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.
When you begin using estradiol valerate and dienogest, your body will require at least 9 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 9 days of your first cycle of pills.
Take estradiol valerate and dienogest at the same time each day, such as after the evening meal or at bedtime. Do not skip or delay taking your pill by more than 12 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills, or about using another method of birth control.
You may have light bleeding or spotting when you first take the pill.
You may feel sick or nauseous, especially during the first few months that you take estradiol valerate and dienogest. If your nausea is continuous and does not go away, call your doctor.
If you vomit or have diarrhea within 3 to 4 hours of taking estradiol valerate and dienogest, follow the instructions in the patient leaflet or call your doctor.
If you are switching from a combination hormonal method (e.g., another pill, patch, vaginal ring) to using Natazia®, take the first dark yellow pill on the first day of your period. If you do not start your period, see your doctor for a pregnancy test. If you have used a vaginal ring or patch, take the pill on the day the ring or patch is removed. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 9 days you take estradiol valerate and dienogest.
If you are switching from a progestin-only method (e.g., progestin-only pill, implant, injection, intrauterine system) to using Natazia®, take the first dark yellow pill on the day you would have taken your next progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 9 days you take estradiol valerate and dienogest.
Do not eat grapefruit or drink grapefruit juice while you are using estradiol valerate and dienogest.
The dose of estradiol valerate and dienogest will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of estradiol valerate and dienogest. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it.
Call your doctor or pharmacist for instructions.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits to make sure estradiol valerate and dienogest is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.
Although you are using estradiol valerate and dienogest to prevent pregnancy, you should know that using estradiol valerate and dienogest while you are pregnant could harm the unborn baby. If you suspect that you may be pregnant, stop using estradiol valerate and dienogest immediately and check with your doctor.
Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.
Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.
Do not use estradiol valerate and dienogest if you smoke cigarettes or if you are over 35 years old. If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
Stop using estradiol valerate and dienogest and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; a sudden, severe headache; slurred speech; a sudden, unexplained shortness of breath; a sudden loss of coordination; or vision changes while using estradiol valerate and dienogest.
Check with your doctor immediately if you have problems wearing contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Stop using estradiol valerate and dienogest and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
estradiol valerate and dienogest may not work as well in women who are overweight. If you gain a lot of weight after you start taking estradiol valerate and dienogest, ask your doctor if you should change to another type of birth control pill.
Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.
Make sure any doctor or dentist who treats you knows that you are using estradiol valerate and dienogest. You may need to stop using estradiol valerate and dienogest several days before having surgery or certain medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Depo Eligard may be available in the countries listed below.
Leuprorelin acetate (a derivative of Leuprorelin) is reported as an ingredient of Depo Eligard in the following countries:
International Drug Name Search
| † Administered at the start of a light meal. ‡ Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose. | ||
| Dose† | AUC0-∞ (mcg.hr./mL) | Cmax (mcg/mL)‡ |
| amoxicillin | amoxicillin (±SD) | amoxicillin (±SD) |
| 400 mg (5 mL of suspension) | 17.1 (3.1) | 5.92 (1.62) |
| 400 mg (1 chewable tablet) | 17.9 (2.4) | 5.18 (1.64) |
| ¶ Dosing was following an overnight fast. †† Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose. | ||
| Dose¶ | AUC0-∞ (mcg.hr./mL) | Cmax (mcg/mL)†† |
| amoxicillin | amoxicillin | amoxicillin |
| 400 mg (5 mL of suspension) | 18.5 | 8.4 |
| 400 mg (one tablet for oral suspension) | 17.9 | 7.5 |
should be considered as resistant to amoxicillin.
| MIC (mcg/mL) | Interpretation |
| ≤ 8 | Susceptible (S) |
| ≥ 16 | Resistant (R) |
| MIC (mcg/mL) | Interpretation |
| ≤ 0.25 | Susceptible (S) |
| ≥ 0.5 | Resistant (R) |
| MIC (mcg/mL) | Interpretation |
| ≤ 0.25 | Susceptible (S) |
| 0.5 to 4 | Intermediate (I) |
| ≥ 8 | Resistant (R) |
| MIC (mcg/mL) | Interpretation |
| ≤ 2 | Susceptible (S) |
| 4 | Intermediate (I) |
| ≥ 8 | Resistant (R) |
| MIC (mcg/mL) | Interpretation |
| ≤ 8 | Susceptible (S) |
| 16 | Intermediate (I) |
| ≥ 32 | Resistant (R) |
| MIC (mcg/mL) | Interpretation |
| ≤ 1 | Susceptible (S) |
| 2 | Intermediate (I) |
| ≥ 4 | Resistant (R) |
| Microorganism | MIC (mcg/mL) |
| E. coli ATCC 25922 | 2 to 8 |
| E. faecalis ATCC 29212 | 0.5 to 2 |
| H. influenzae ATCC 49247d | 2 to 8 |
| S. aureus ATCC 29213 | 0.25 to 1 |
| Microorganism | MIC Range (mcg/mL) |
| S. pneumoniae ATCC 49619e | 0.03 to 0.12 |
| Zone Diameter (mm) | Interpretation |
| ≥ 17 | Susceptible (S) |
| ≤ 16 | Resistant (R) |
| Zone Diameter (mm) | Interpretation |
| ≥ 29 | Susceptible (S) |
| ≤ 28 | Resistant (R) |
| Zone Diameter (mm) | Interpretation |
| ≥ 26 | Susceptible (S) |
| 19 to 25 | Intermediate (I) |
| ≤18 | Resistant (R) |
| Zone Diameter (mm) | Interpretation |
| ≥ 17 | Susceptible (S) |
| 14 to 16 | Intermediate (I) |
| ≤ 13 | Resistant (R) |
| Zone Diameter (mm) | Interpretation |
| ≥ 22 | Susceptible (S) |
| 19 to 21 | Intermediate (I) |
| ≤ 18 | Resistant (R) |
| Microorganism | Zone Diameter (mm) |
| E. coli ATCC 25922 | 16 to 22 |
| H. influenzae ATCC 49247h | 13 to 21 |
| S. aureus ATCC 25923 | 27 to 35 |
| Microorganism | Zone Diameter (mm) |
| S. pneumoniae ATCC 49619i | 8 to 12 |
| Infection | Severity‡ | Usual Adult Dose | Usual Dose for Children >3 Months§ |
|---|---|---|---|
| ‡ Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. §The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. | |||
| Ear/nose/throat | Mild/Moderate | 500 mg every 12 hours or 250 mg every 8 hours | 25 mg/kg/day in divided doses every 12 hours |
| or | |||
| 20 mg/kg/day in divided doses every 8 hours | |||
| Severe | 875 mg every 12 hours or 500 mg every 8 hours | 45 mg/kg/day in divided doses every 12 hours | |
| or | |||
| 40 mg/kg/day in divided doses every 8 hours | |||
| Lower respiratory tract | Mild/Moderate or Severe | 875 mg every 12 hours or 500 mg every 8 hours | 45 mg/kg/day in divided doses every 12 hours |
| or | |||
| 40 mg/kg/day in divided doses every 8 hours | |||
| Skin/skin structure | Mild/Moderate | 500 mg every 12 hours or 250 mg every 8 hours | 25 mg/kg/day in divided doses every 12 hours |
| or | |||
| 20 mg/kg/day in divided doses every 8 hours | |||
| Severe | 875 mg every 12 hours or 500 mg every 8 hours | 45 mg/kg/day in divided doses every 12 hours | |
| or | |||
| 40 mg/kg/day in divided doses every 8 hours | |||
| Genitourinary tract | Mild/Moderate | 500 mg every 12 hours or 250 mg every 8 hours | 25 mg/kg/day in divided doses every 12 hours |
| or | |||
| 20 mg/kg/day in divided doses every 8 hours | |||
| Severe | 875 mg every 12 hours or 500 mg every 8 hours | 45 mg/kg/day in divided doses every 12 hours | |
| or | |||
| 40 mg/kg/day in divided doses every 8 hours | |||
| Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females | | 3 grams as single oral dose | Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES. |
Terby may be available in the countries listed below.
Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terby in the following countries:
International Drug Name Search
Bigsens may be available in the countries listed below.
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Bigsens in the following countries:
International Drug Name Search
Broxolflem may be available in the countries listed below.
Carbocisteine is reported as an ingredient of Broxolflem in the following countries:
International Drug Name Search
Class: Antibacterials
ATC Class: S01AB
VA Class: OP210
CAS Number: 6209-17-2
Brands: Bleph 10, Blephamide, FML-S
Sulfonamide anti-infective.107
Treatment of conjunctivitis, corneal ulcers, and other superficial infections of the eye caused by susceptible Staphylococcus aureus, Streptococcus pneumoniae, viridans streptococci, Haemophilus influenzae, Enterobacter, Escherichia coli, and Klebsiella.107 108 f
Used alone or in fixed combination with topical corticosteroids (e.g., fluorometholone, prednisolone) when such combination therapy is indicated.b c e g
Ineffective for treatment of infections caused by Neisseria, Serratia marcescens, or Pseudomonas aeruginosa.108 b c e f g Consider that staphylococci frequently are resistant to sulfonamides.108 b c e f g
Has been used as an adjunct to systemic anti-infectives for treatment of trachoma; 107 108 f however, systemic anti-infectives are recommended.106 No data to support use of topical anti-infectives in conjunction with systemic therapy.106
Apply topically to the eye(s) as an ophthalmic ointment, solution, or suspension.107 108 b c e f g
Not for injection;107 108 b c e f do not inject subconjunctivally or instill directly into the anterior chamber of the eye.g
Avoid contamination of the tip of the container.b c e f g
Shake suspension well prior to use.b g
Available as sulfacetamide sodium; dosage expressed in terms of the salt.f
Available as fixed combinations containing sulfacetamide sodium and prednisolone acetate, prednisolone sodium phosphate, or fluorometholone; dosage expressed in terms of the salt.b c e g
Children ≥2 months of age: Initially, 1 or 2 drops into the conjunctival sac of the affected eye(s) every 2–3 hours.f Reduce dosing frequency as infection improves.f Usual duration of treatment is 7–10 days.f
Children ≥2 years of age: 1 drop into the conjunctival sac of the affected eye(s) 4 times daily.g Reduce dosing frequency as infection improves.g
If improvement does not occur after 2 days, reevaluate the patient.g Do not discontinue prematurely.g
When discontinuing therapy in chronic conditions, gradually taper dosing frequency.g
Children ≥6 years of age: Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3 or 4 times daily during the day and once or twice during the night.c Reduce dosing frequency as infection improves.c
If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c
When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c
Children ≥6 years of age: 2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.b Reduce dosing frequency as infection improves.b
If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c
When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c
Children ≥6 years of age: 2 drops into the affected eye(s) every 4 hours.e Reduce dosing frequency as infection improves.e
If improvement does not occur after 2 days, reevaluate the patient.e Do not discontinue prematurely.e
When discontinuing therapy in chronic conditions, gradually taper dosing frequency.e
Sulfacetamide 10% in children ≥2 months of age: 2 drops into the conjunctival sac of the affected eye(s) every 2 hours in conjunction with systemic anti-infectives.f
Initially, 1 or 2 drops of solution into the conjunctival sac of the affected eye(s) every 2–3 hours.f Reduce dosing frequency as infection improves.f Usual duration of treatment is 7–10 days.f
1 drop into the conjunctival sac of the affected eye(s) 4 times daily.g Reduce dosing frequency as infection improves.g
If improvement does not occur after 2 days, reevaluate the patient.g Do not discontinue prematurely.g
When discontinuing therapy in chronic conditions, gradually taper dosing frequency.g
Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3 or 4 times daily during the day and once or twice during the night.c Reduce dosing frequency as infection improves.c
If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c
When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c
2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.b Reduce dosing frequency as infection improves.b
If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c
When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c
2 drops into the affected eye(s) every 4 hours.e Reduce dosing frequency as infection improves.e
If improvement does not occur after 2 days, reevaluate the patient.e Do not discontinue prematurely.e
When discontinuing therapy in chronic conditions, gradually taper dosing frequency.e
Sulfacetamide 10%: 2 drops into the conjunctival sac of the affected eye(s) every 2 hours, in conjunction with systemic anti-infectives.f
No special population dosage recommendations at this time.a b c e f g
Known or suspected hypersensitivity to sulfonamides or to any ingredient in the formulation.107 108 b c e f g
Severe, fatal reactions to sulfonamides have occurred rarely, including dermatologic reactions, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, or other blood dyscrasias.107 108 f g
Adverse reactions reported with systemic sulfonamides could occur with topical application.107
Topical application of sulfonamides may produce sensitization and preclude later systemic use of these drugs.107 a f g In addition, patients who have been sensitized by systemic sulfonamide administration may exhibit hypersensitivity reactions following topical application of the drugs.107 a f g
Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely following topical application in individuals with a history of hypersensitivity to systemic sulfonamides.107 108 f g
Cross-sensitivity occurs among the various sulfonamides.108 f
Discontinue sulfonamide therapy immediately at the first sign of hypersensitivity, rash, or other serious reaction.107 108 f g
Use of sulfonamides may result in the overgrowth of nonsusceptible organisms, including fungi.107 108 f g Bacterial and fungal corneal ulcers have developed during use of ophthalmic sulfonamide preparations.108
Discontinue drug and institute appropriate therapy if superinfection occurs.107
Ophthalmic ointments may delay corneal healing.c
Concomitant topical corticosteroids may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the antibiotic; or suppress hypersensitivity reactions to sulfonamides or other ingredients in the formulation.107 c
When sulfacetamide is used in fixed combination with a corticosteroid, consider the cautions, precautions, and contraindications associated with EENT corticosteroids.b c e g
Category C.108 f
Systemically absorbed sulfonamides can cause kernicterus in neonates and infants.108 f g Discontinue nursing or the drug.108 f g
Safety and efficacy of ophthalmic sulfacetamide sodium not established in infants <2 months of age.107 108 f
Safety and efficacy of fixed-combination ophthalmic sulfacetamide and prednisolone not established in children <6 years of age.b c e
Safety and efficacy of fixed-combination ophthalmic sulfacetamide and fluorometholone not established in children <2 years of age.g
No substantial differences in safety and efficacy relative to younger adults.g
Local irritation, transient stinging or burning.107 a f
Drug | Interaction | Comments |
|---|---|---|
Anesthetics, local (p-aminobenzoic acid related | Possible antagonism of action of sulfonamides107 | |
Gentamicin | In vitro antagonismb c e | Do not use concomitantlyb c e |
Sulfonamides do not appear to be appreciably absorbed from mucous membranes.107
Systemic sulfonamides cross the placenta and are distributed into human milk in low concentrations.h
Sulfonamide preparations darken on prolonged standing and exposure to heat and light.b e f Discard preparations that have darkened; yellow discoloration does not affect activity.b e f
Sulfacetamide sodium and prednisolone acetate: Tightly closed containers at 15–25°C.c
Sulfacetamide sodium: 8–25°C; protect from light and freezing.f
Sulfacetamide sodium and prednisolone sodium phosphate: 15–25°C; protect from light.e
Sulfacetamide sodium and fluorometholone: 15–30°C; protect from light and freezing.g
Sulfacetamide sodium and prednisolone acetate: Upright position at 8–24°C; protect from light and freezing.b
For information on systemic interactions resulting from concomitant use, see Interactions.
Sulfacetamide sodium is incompatible with preparations containing silver.107 108 f
Precipitation may occur if zinc sulfate is added to sulfacetamide sodium solutions, depending on the concentration of each drug.107
Usually bacteriostatic,f but may be bactericidal at very high concentrations.107 108
Sulfonamides interfere with utilization of aminobenzoic or aminobenzoic glutamic acids by susceptible organisms, thus inhibiting biosynthesis of folic acid which is essential for growth.107 a f Only organisms that synthesize their own folic acid are inhibited by sulfonamides; animal cells and bacteria that are capable of utilizing folic acid precursors or preformed folic acid are not affected.107
Antibacterial activity is decreased in the presence of blood or purulent exudates containing p-aminobenzoic acid.107 108 a f
Spectrum of activity includes some aerobic gram-positive and -negative bacteria.107 a
Gram-positive aerobic bacteria: Active against S. aureus, S. pneumoniae, and viridans streptococci.107 108 a f g Many staphylococci are resistant.107 108 g
Gram-negative aerobic bacteria: Active against H. influenzae, Enterobacter, E. coli, and Klebsiella.108 a f g
Cross-resistance usually occurs among the various sulfonamides.107 a f
Importance of not touching tip of container to eye, eyelid, or any other surface.108 b c e f g Advise patient to keep container tightly closed when not in use.g
Importance of discontinuing use and contacting clinician at first sign of hypersensitivity, increase in discharge, or if pain or swelling worsen.108 b c f
Advise patient not to share the drug with any other person.c g
Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chloride and of delaying reinsertion of the lenses for ≥5 minutes after administration.b i
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.f
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.f
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Bulk | Powder | |||
Ophthalmic | Ointment | 10%* | Sulfacetamide Sodium Ophthalmic Ointment | Fougera |
Solution | 10%* | Bleph 10 (with benzalkonium chloride) | Allergan | |
Sulfacetamide Sodium Ophthalmic Solution | Bausch & Lomb, Falcon |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | 10% Sulfacetamide Sodium and Prednisolone Acetate 0.2% | Blephamide (with phenylmercuric acetate) | Allergan |
Suspension | 10% Sulfacetamide Sodium and Prednisolone Acetate 0.2% | Blephamide (with benzalkonium chloride) | Allergan |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Solution | 10% with 0.25% Prednisolone Sodium Phosphate (0.23% of prednisolone phosphate)* | Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution | Bausch & Lomb, Falcon |
Ophthalmic | Suspension | 10% with Fluorometholone 0.1% | FML-S (with benzalkonium chloride and povidone) | Allergan |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Bleph-10 10% Solution (ALLERGAN): 5/$27.99 or 15/$61.97
Blephamide 10-0.2% Suspension (ALLERGAN): 10/$95.99 or 30/$275.97
Blephamide 10-0.2% Suspension (ALLERGAN): 5/$67.99 or 15/$189.98
Blephamide S.O.P. 10-0.2% Ointment (ALLERGAN): 3/$68.99 or 10/$185.96
Sulfacetamide Sodium 10% Solution (FALCON PHARMACEUTICALS): 15/$12.99 or 30/$18.98
Sulfacetamide-Prednisolone 10-0.23% Solution (BAUSCH & LOMB): 10/$30.99 or 20/$53.97
Sulfacetamide-Prednisolone 10-0.23% Solution (BAUSCH & LOMB): 5/$21.99 or 15/$53.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
Only references cited for selected revisions after 1984 are available electronically.
101. Allergan, Inc. Bleph-10 (sulfacetamide sodium) ophthalmic ointment prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 34th ed. Montvale, NJ: Thomson PDR; 2006:219-20.
102. Fougera. Sulfacetamide sodium ophthalmic ointment USP, 10% prescribing information. Melville, NY; 1998 Mar.
103. Falcon Pharmaceuticals, Ltd. Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution. Fort Worth, TX; 2003 Nov.
104. Allergan. FML-S (fluorometholone and sulfacetamide sodium ophthalmic suspension, USP) 0.1%/10% prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 34th ed. Montevale, NJ: Thomson PDR; 2006:226-7.
105. American Academy of Pediatrics. Red book: 2006 Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006;252-7.
106. American Academy of Ophthalmology. Preferred Practice Pattern: Conjunctivitis. 2003. From the American Academy of Ophthalmology website. Accessed 11 May 2006.
107. AHFS Drug Information 2003. McEvoy, GK, ed. Sulfonamides (ophthalmic). Bethesda, MD: American Society of Health-System Pharmacists; 2003:2613-4.
108. Akorn. AK-Sulf (sulfacetamide sodium) ophthalmic solution prescribing information. Buffalo Grove, IL: 2000 May.
109. Committee on Infectious Diseases, American Academy of Pediatrics. 2000 Red book: report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000:210.
110. Anon. The choice of antibacterial drugs. Med Lett Drugs Ther. 2001; 43:69-78. [PubMed 11518876]
111. Allergan, Inc. Bleph-10 (sulfacetamide sodium) ophthalmic ointment prescribing information. Irvine, CA; 1993 Sept.
a. AHFS drug information 2008. McEvoy, GK, ed. Sulfacetamide sodium. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2855-6.
b. Allergan, Inc. Blephamide (sulfacetamide sodium and prednisolone acetate, USP ophthalmic suspension) 10%/0.2% prescribing information. Irvine, CA; 2004 Jun.
c. Allergan, Inc. Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% prescribing information. Irvine, CA; 2004 Sept.
e. Falcon Pharmaceuticals, Ltd. Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution prescribing information. Fort Worth, TX; 2007 Jul.
f. Allergan, Inc. Bleph-10 (sulfacetamide sodium ophthalmic solution, USP) 10% prescribing information. Irvine, CA; 2005 Feb.
g. Allergan, Inc. FML-S (fluorometholone and sulfacetamide sodium ophthalmic suspension, USP) 0.1%/10% prescribing information. Irvine, CA; 2005 Feb.
h. Briggs CC, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation, 7th ed. Philadelphia, PA: Lippincott, Williams, & Wilkins; 2005: 1508-10.
i. Christensen MT, Barry JR, Turner FD. Five-minute removal of soft lenses prevents most absorption of a topical ophthalmic solution. CLAO J. 1998; 24:227-31. [PubMed 9800062]
