Synalar Infantil

Adult Patients with Atopic Dermatitis

Fluocinolone Acetonide (Synalar Infantil)/FS® (Fluocinolone Acetonide (Synalar Infantil)) is indicated for the topical treatment of atopic dermatitis in adult patients.

Pediatric Patients with Atopic Dermatitis

Fluocinolone Acetonide (Synalar Infantil)/FS® (Fluocinolone Acetonide (Synalar Infantil)) is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.

Limitations of Use

Apply the least amount of Fluocinolone Acetonide (Synalar Infantil)/FS® (Fluocinolone Acetonide (Synalar Infantil)) needed to cover the affected areas. As with other corticosteroids, Fluocinolone Acetonide (Synalar Infantil)/FS® (Fluocinolone Acetonide (Synalar Infantil)) should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks.

Fluocinolone Acetonide (Synalar Infantil)/FS (Fluocinolone Acetonide (Synalar Infantil)) should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use.

Fluocinolone Acetonide (Synalar Infantil)/FS (Fluocinolone Acetonide (Synalar Infantil)) should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions..

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin (Synalar Infantil) Sulfate tablets and other antibacterial drugs, Neomycin (Synalar Infantil) 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

Neomycin (Synalar Infantil) 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.

Hepatic Coma (Portal-Systemic Encephalopathy)

Neomycin (Synalar Infantil) 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.

Phenylephrine (Synalar Infantil) is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa.

Polymyxin B (Synalar Infantil) (Polymyxin B (Synalar Infantil) sulfate) sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa.

It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: H influenzae, specifically meningeal infections. Escherichia coli, specifically urinary tract infections. Aerobacter aerogenes, specifically bacteremia. Klebsiella pneumoniae, specifically bacteremia.

NOTE: IN MENINGEAL INFECTIONS, POLYMYX-IN B SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Polymyxin B (Synalar Infantil) (Polymyxin B (Synalar Infantil) sulfate) and other antibacterial drugs, Polymyxin B (Synalar Infantil) (Polymyxin B (Synalar Infantil) sulfate) 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.

Treating an eye problem caused by diabetes (macular edema). It may also be used for other conditions as determined by your doctor.

Fluocinolone Acetonide (Synalar Infantil) implant is a corticosteroid. Exactly how it works is not known. It may decrease the production of certain substances that cause inflammation.

Neomycin (Synalar Infantil) is an antibiotic that fights bacteria in the body.

Neomycin (Synalar Infantil) is used to reduce the risk of infection during surgery of your intestines. Neomycin (Synalar Infantil) is also used to reduce the symptoms of hepatic coma.

Neomycin (Synalar Infantil) may also be used for purposes not listed in this medication guide.

Phenylephrine (Synalar Infantil) ophthalmic causes constriction of blood vessels in the eyes. It also enlarges the pupils, reduces the production of fluid in the eyes, and increases the amount of fluid that drains from the eyes.

Phenylephrine (Synalar Infantil) ophthalmic available over-the-counter is used to relieve redness, burning, irritation, and dryness of the eye caused by wind, sun, and other minor irritants. Prescription-strength Phenylephrine (Synalar Infantil) ophthalmic is used to constrict blood vessels in the eye and to dilate (make bigger) the pupil for conditions such as glaucoma, before surgery, and before eye examinations.

Phenylephrine (Synalar Infantil) ophthalmic may also be used for purposes other than those listed in this medication guide.

Polymyxin B (Synalar Infantil) injection is used to treat bacterial infections in many different parts of the body.

Polymyxin B (Synalar Infantil) belongs to the group of medicines known as antibiotics. It works by killing bacteria or preventing their growth. However, Polymyxin B (Synalar Infantil) will not work for colds, flu, or other virus infections.

Polymyxin B (Synalar Infantil) is to be given only by or under the direct supervision of a doctor.

Fluocinolone Acetonide (Synalar Infantil)/FS (Fluocinolone Acetonide (Synalar Infantil)) is not for oral, ophthalmic, or intravaginal use.

The dosing of Fluocinolone Acetonide (Synalar Infantil)/FS (Fluocinolone Acetonide (Synalar Infantil)) is different for adult and pediatric patients.

Adult Patients with Atopic Dermatitis

Apply Fluocinolone Acetonide (Synalar Infantil)/FS (Fluocinolone Acetonide (Synalar Infantil)) as a thin film to the affected areas three times daily.

Pediatric Patients with Atopic Dermatitis

Moisten skin and apply Fluocinolone Acetonide (Synalar Infantil)/FS (Fluocinolone Acetonide (Synalar Infantil)) as a thin film to the affected areas twice daily for up to four weeks.

How supplied

Dosage Forms And Strengths

Fluocinolone Acetonide (Synalar Infantil)/FS® (Fluocinolone Acetonide (Synalar Infantil)),

Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces.

Fluocinolone Acetonide (Synalar Infantil)/FS (Fluocinolone Acetonide (Synalar Infantil)) is supplied in bottles containing 4 fluid ounces. It is labeled as Body Oil (NDC # 28105-150-04).

Storage:

Store at 25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F).

Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773. Date: 12/2007. FDA Rev date: 12/12/2007

To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.

Hepatic Coma

For use as an adjunct in the management of hepatic coma, the recommended dose is 4-12 grams per day given in the following regimen:

1. Withdraw protein from diet. Avoid use of diuretic agents.

2. Give supportive therapy, including blood products, as indicated.

3. Give Neomycin (Synalar Infantil) Sulfate Tablets in doses of 4-12 grams of Neomycin (Synalar Infantil) sulfate per day (eight to 24 tablets) in divided doses. Treatment should be continued over a period of five to six days, during which time protein should be returned incrementally to the diet.

4. If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, Neomycin (Synalar Infantil) in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of Neomycin (Synalar Infantil)-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory. Also, Neomycin (Synalar Infantil) serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of Neomycin (Synalar Infantil) in the tissues.

Preoperative Prophylaxis for Elective Colorectal Surgery

Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 am. 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. Neomycin (Synalar Infantil) 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.

How supplied

Neomycin (Synalar Infantil) Sulfate Tablets, USP, 500 mg (equivalent to 350 mg of Neomycin (Synalar Infantil) base per tablet) are available as round, off-white, unscored tablets, imprinted "BL" and "18", in bottles of 100 tablets.

Store at controlled room temperature 15°-30° C( 59°-86° F). Dispense in tight containers as defined in the USP/NF.

CAUTION: Federal law prohibits dispensing without prescription.

Prolonged exposure to air or strong light may cause oxidation and discoloration. Do not use if solution is brown or contains a precipitate.

Vasoconstriction and Pupil Dilatation

Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions are especially useful when rapid and powerful dilatation of the pupil and reduction of congestion in the capillary bed are desired. A drop of a suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of the Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions on the upper limbus. The anesthetic prevents stinging and consequent dilution of the solution by lacrimation. It may occasionally be necessary to repeat the instillation after one hour, again preceded by the use of the topical anesthetic.

Uveitis: Posterior Synechiae

Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions may be used in patients with uveitis when synechiae are present or may develop. The formation of synechiae may be prevented by the use of the 10 percent ophthalmic solutions and atropine to produce wide dilatation of the pupil. It should be emphasized, however, that the vasoconstrictor effect of Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride may be antagonistic to the increase of local blood flow in uveal infection.

To free recently formed posterior synechiae, 1 drop of the 10 percent ophthalmic solutions may be applied to the upper surface of the cornea. On the following day, treatment may be continued if necessary. In the interim, hot compresses should be applied for five or ten minutes three times a day, with 1 drop of a 1 or 2 percent solution of atropine sulfate before and after each series of compresses.

Glaucoma

In certain patients with glaucoma, temporary reduction of intraocular tension may be attained by producing vasoconstriction of the intraocular vessels; this may be accomplished by placing 1 drop of the 10 percent ophthalmic solutions on the upper surface of the cornea. This treatment may be repeated as often as necessary.

Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride may be used with miotics in patients with wide angle glaucoma. It reduces the difficulties experienced by the patient because of the small field produced by miosis, and still it permits and often supports the effect of the miotic in lowering the intraocular pressure. Hence, there may be marked improvement in visual acuity after using Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride in conjunction with miotic drugs.

Surgery

When a short-acting mydriatic is needed for wide dilatation of the pupil before intraocular surgery, the 10 percent ophthalmic solutions or 2.5 percent ophthalmic solution may be applied topically from 30 to 60 minutes before the operation.

Refraction

Prior to determination of refractive errors, Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution may be used effectively with homatropine hydrobromide, atropine sulfate, or a combination of homatropine and cocaine hydrochloride.

For adults, a drop of the preferred cycloplegic is placed in each eye, followed in five minutes by 1 drop of Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution and in ten minutes by another drop of the cycloplegic. In 50 to 60 minutes, the eyes are ready for refraction.

For children, a drop of atropine sulfate 1 percent is placed in each eye, followed in 10 to 15 minutes by 1 drop of Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution and in five to ten minutes by a second drop of atropine sulfate 1 percent. In one to two hours, the eyes are ready for refraction.

For a “one application method,” Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution may be combined with a cycloplegic to elicit synergistic action. The additive effect varies depending on the patient. Therefore, when using a “one application method,” it may be desirable to increase the concentration of the cycloplegic.

Ophthalmoscopic Examination

One drop of Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilatation lasts from one to three hours.

Diagnostic Procedures

Provocative Test for Angle Block in Patients with Glaucoma: The 2.5 percent ophthalmic solution may be used as a provocative test when latent increased intraocular pressure is suspected. Tension is measured before application of Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride and again after dilatation. A 3 to 5 mm of mercury rise in pressure suggests the presence of angle block in patients with glaucoma; however, failure to obtain such a rise does not preclude the presence of glaucoma from other causes.

Shadow Test (Retinoscopy): When dilatation of the pupil without cycloplegic action is desired for the shadow test, the 2.5 percent ophthalmic solution may be used alone.

Blanching Test: One or 2 drops of the 2.5 percent ophthalmic solution should be applied to the injected eye. After five minutes, examine for perilimbal blanching. If blanching occurs, the congestion is superficial and probably does not indicate iritis.

How supplied

In Mono-Drop ® plastic dropper bottle: Low surface tension solutions

2.5 percent ophthalmic solution - Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride 2.5 percent in a sterile, isotonic, buffered, low surface tension vehicle with sodium phosphate, sodium biphosphate, boric acid, and, as antiseptic preservative, benzalkonium chloride, NF, 1:7500. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 15 mL (NDC 0024-1358-01).

10 percent ophthalmic solution- Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride 10 percent in a sterile, buffered, low surface tension vehicle with sodium phosphate, sodium biphosphate, and, as antiseptic preservative, benzalkonium chloride 1:10,000. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 5 mL (NDC 0024-1359-01).

Viscous solution

10 percent ophthalmic solution- Phenylephrine (Synalar Infantil) (Phenylephrine (Synalar Infantil) hydrochloride ophthalmic solution) hydrochloride 10 percent in a sterile, buffered, viscous vehicle with sodium phosphate, sodium biphosphate, methylcellulose, and, as antiseptic preservative, benzalkonium chloride 1:10,000. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 5 mL (NDC 0024-1362-01).

Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F)

Manufactured for Sanofi-Synthelabo Inc. New York, NY 10016 by Abbott Laboratories North Chicago, IL 60064. Revised September 1999. FDA revision date: n/a

Parenteral:

Intravenous:

Adults and children: 15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day.

Infants: Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.

Intramuscular:

Adults and children: 25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals.

Infants: Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.

Note: Doses as high as 45,000 units/kg/day have been used in limited clinical studies in treating prematures and newborn infants for sepsis caused by Ps aeruginosa.

Intrathecal: A treatment of choice for Ps aeruginosameningitis. Dissolve 500,000 Polymyxin B (Synalar Infantil) (Polymyxin B (Synalar Infantil) sulfate) units in 10 mL sodium chloride injection USP for 50,000 units per mL dosage unit.

Adults and children over 2 years of age: Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.

Children under 2 years of age: 20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.

IN THE INTEREST OF SAFETY, SOLUTIONS OF PARENTERAL USE SHOULD BE STORED UNDER REFRIGERATION, AND ANY UNUSED PORTIONS SHOULD BE DISCARDED AFTER 72 HOURS.

Topical:

Ophthalmic:

For the treatment of Ps aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates.

Subconjunctival injection of up to 100,000 units/day may be used for the treatment of Ps aeruginosa infections of the cornea and conjunctiva.

Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.

How supplied

Polymyxin B (Synalar Infantil) for Injection (Polymyxin B (Synalar Infantil) (Polymyxin B (Synalar Infantil) sulfate) sulfate), 500,000 Polymyxin B (Synalar Infantil) (Polymyxin B (Synalar Infantil) sulfate) units per vial is supplied in rubber-stoppered glass vial with flip off cap, carton of 10, NDC 55390-139-10.

Storage recommendations

Before reconstitution: Store at controlled room temperature 15° to 30°C (59° to 86°F).

Protect from light. Retain in carton until time of use.

After reconstitution: Product must be stored under refrigeration, between 2° to 8°C (36° to 46°F) and any unused portion should be discarded after 72 hours.

Manufactured for: Bedford Laboratories™, Bedford, OH 44146. Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146. February 2004. FDA Rev date: 5/15/2002

See also:
What is the most important information I should know about Fluocinolone Acetonide (Synalar Infantil)?

Fluocinolone Acetonide (Synalar Infantil) 0.01%

Topical Oil is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

This product contains refined peanut oil NF.

See also:
What is the most important information I should know about Neomycin (Synalar Infantil)?

You should not take this medicine if you are allergic to Neomycin (Synalar Infantil) or similar antibiotics such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

You should not take Neomycin (Synalar Infantil) if you have ulcerative colitis, Crohn's disease, a blockage in your intestines, or other inflammatory bowel disease.

Do not use Neomycin (Synalar Infantil) if you are pregnant. It could harm the unborn baby.

Before you take Neomycin (Synalar Infantil), tell your doctor if you have kidney disease, myasthenia gravis, or Parkinson's disease.

Never take Neomycin (Synalar Infantil) in larger amounts than recommended, or for longer than 2 weeks. High doses or long-term use of Neomycin (Synalar Infantil) can cause serious kidney problems, or hearing loss that may not be reversible. The longer you take Neomycin (Synalar Infantil), the more likely you are to develop these serious side effects.

To be sure this medication is not causing harmful effects, your kidney function, and your nerve and muscle function will need to be tested often. You may also need hearing tests. Neomycin (Synalar Infantil) can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood or urine tests.

Neomycin (Synalar Infantil) can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using Neomycin (Synalar Infantil), tell your doctor about all other medicines you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

If you are being treated for hepatic coma, avoid eating foods that are high in protein. Follow your doctor's instructions about any other restrictions on food, beverages, or activity.

See also:
What is the most important information I should know about Phenylephrine (Synalar Infantil)?

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying Phenylephrine (Synalar Infantil) ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Phenylephrine (Synalar Infantil) ophthalmic may contains preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

Do not use Phenylephrine (Synalar Infantil) ophthalmic more often or continuously for longer than 48 to 72 hours without consulting a doctor. Chronic use of this medication may damage the blood vessels (veins and arteries) in the eyes. Consult a doctor if your symptoms do not improve or appear to worsen.

Use caution when driving, operating machinery, or performing other hazardous activities. Phenylephrine (Synalar Infantil) ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Hypersensitivity to Polymyxin B (Synalar Infantil) or any component of the formulation

Use Fluocinolone Acetonide (Synalar Infantil) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Before applying the corticosteroid solution, cleanse the affected area with the cleanser unless your doctor tells you otherwise. If you are unsure how to use the cleanser, contact your doctor or pharmacist.
• Dry the skin well before you apply the solution.
• Apply a thin film of the corticosteroid solution to the affected area. Gently rub it in until it is evenly distributed. Wash your hands after applying Fluocinolone Acetonide (Synalar Infantil), unless your hands are part of the treated area.
• Do not bandage or wrap the treated skin area unless directed otherwise by your doctor. If Fluocinolone Acetonide (Synalar Infantil) was prescribed to treat the diaper area of a child, avoid using tight-fitting diapers or plastic pants.
• If Fluocinolone Acetonide (Synalar Infantil) is applied to a hairy site, the hair should be parted to allow the medicine direct contact with the skin.
• If you miss a dose of Fluocinolone Acetonide (Synalar Infantil), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluocinolone Acetonide (Synalar Infantil).

Use Neomycin (Synalar Infantil) solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Neomycin (Synalar Infantil) solution by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Take Neomycin (Synalar Infantil) solution with plenty of water to avoid dehydration.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Take Neomycin (Synalar Infantil) solution on a regular schedule to get the most benefit from it.
• To clear up your infection completely, use Neomycin (Synalar Infantil) solution for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Neomycin (Synalar Infantil) solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If more than one dose is missed, contact your health care provider.

Ask your health care provider any questions you may have about how to use Neomycin (Synalar Infantil) solution.

Use Phenylephrine (Synalar Infantil) drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Phenylephrine (Synalar Infantil) drops is for use in the eye only. Avoid contact with the nose or mouth.
• To use Phenylephrine (Synalar Infantil) drops, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.
• Do not wear contact lenses while you are using Phenylephrine (Synalar Infantil) drops. Sterilize contact lenses according to the manufacturer's directions and check with your doctor before using them.
• Do not use Phenylephrine (Synalar Infantil) drops if it is brown or contains particles.
• If you miss a dose of Phenylephrine (Synalar Infantil) drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Phenylephrine (Synalar Infantil) drops.

Fluocinolone Acetonide (Synalar Infantil) is used to reduce inflammation of the eye caused by various diseases, particularly diabetes (diabetic macular edema). It is also used to treat various skin infections such as eczema and psoriasis.

Oral Neomycin (Synalar Infantil) is used before the operation of the gut to kill the bacteria which normally live in the gut that may cause a serious infection and in treatment of patients with coma due to liver disease (hepatic coma).

Use: Labeled Indications

Hypotension/shock: Treatment of hypotension, vascular failure in shock. Note: Not recommended for routine use in the treatment of septic shock; use should be limited until more evidence demonstrating positive clinical outcomes becomes available (Rhodes 2017).

Guideline recommendations:

Cardiogenic shock: The 2017 American Heart Association (AHA) scientific statement for the Contemporary Management of Cardiogenic Shock recommends Phenylephrine (Synalar Infantil), if needed, be considered for initial vasoactive management of cardiogenic shock due to aortic stenosis, mitral stenosis, or dynamic left ventricular outflow tract (LVOT) obstruction (AHA [van Diepen 2017]).

Hypotension during anesthesia: As a vasoconstrictor in regional analgesia

Nasal congestion: As a decongestant [OTC]

Off Label Uses

Hypotension in patients with obstructive hypertrophic cardiomyopathy

Phenylephrine (Synalar Infantil) is a pure alpha1 agonist that will increase systemic vascular resistance without increasing heart rate or contractility. This is advantageous in patients with obstructive hypertrophic cardiomyopathy and hypotension since increases in both heart rate and contractility may cause the obstruction to worsen, leading to a decrease in cardiac output. Other vasopressors like dopamine, epinephrine, and norepinephrine may increase contractility and/or heart rate. Additional trials may be necessary to further define the role of Phenylephrine (Synalar Infantil) in this condition.

Based on the American Urological Association guidelines for the management of priapism, due to the low risk of cardiovascular side effects intracavernous injection of Phenylephrine (Synalar Infantil) is recommended for ischemic priapism that persists following aspiration/irrigation.

Use: Labeled Indications

Infections, acute:

Pseudomonal infections: Treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Pseudomonas aeruginosa

Serious infections: Treatment of serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: H. influenzae, specifically meningeal infections; Escherichia coli, specifically urinary tract infections; Aerobacter aerogenes, specifically bacteremia; Klebsiella pneumoniae, specifically bacteremia

In meningeal infections, Polymyxin B (Synalar Infantil) sulfate should be administered only by the intrathecal route.

See also:
What other drugs will affect Fluocinolone Acetonide (Synalar Infantil)?

The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

See also:
What other drugs will affect Neomycin (Synalar Infantil)?

Acarbose: Neomycin (Synalar Infantil) may enhance the adverse/toxic effect of Acarbose. Neomycin (Synalar Infantil) may decrease the metabolism of Acarbose. Monitor therapy

Amphotericin B: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Arbekacin: May enhance the nephrotoxic effect of Aminoglycosides. Arbekacin may enhance the ototoxic effect of Aminoglycosides. Monitor therapy

Ataluren: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, an increased risk of nephrotoxicity may occur with the concomitant use of ataluren and aminoglycosides. Avoid combination

Bacitracin (Systemic): Neomycin (Synalar Infantil) may enhance the nephrotoxic effect of Bacitracin (Systemic). Avoid combination

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Bisphosphonate Derivatives: Aminoglycosides may enhance the hypocalcemic effect of Bisphosphonate Derivatives. Monitor therapy

Botulinum Toxin-Containing Products: Aminoglycosides may enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Monitor therapy

Capreomycin: May enhance the neuromuscular-blocking effect of Aminoglycosides. Monitor therapy

CARBOplatin: Aminoglycosides may enhance the ototoxic effect of CARBOplatin. Especially with higher doses of carboplatin. Monitor therapy

Cardiac Glycosides: Aminoglycosides may decrease the serum concentration of Cardiac Glycosides. This effect has only been demonstrated with oral aminoglycoside administration. Monitor therapy

Cefazedone: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalosporins (2nd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalosporins (3rd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalosporins (4th Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalothin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephradine: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

CISplatin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Colistimethate: Aminoglycosides may enhance the nephrotoxic effect of Colistimethate. Aminoglycosides may enhance the neuromuscular-blocking effect of Colistimethate. Management: Avoid coadministration of colistimethate and aminoglycosides whenever possible due to the risk of nephrotoxicity and neuromuscular blockade. If coadministration cannot be avoided, monitor renal and neuromuscular function. Consider therapy modification

CycloSPORINE (Systemic): Aminoglycosides may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Monitor therapy

Distigmine: Aminoglycosides may diminish the therapeutic effect of Distigmine. Monitor therapy

Foscarnet: May enhance the nephrotoxic effect of Aminoglycosides. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Loop Diuretics: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, nephrotoxicity and ototoxicity. Monitor therapy

Mannitol (Systemic): May enhance the nephrotoxic effect of Aminoglycosides. Avoid combination

Mecamylamine: Aminoglycosides may enhance the neuromuscular-blocking effect of Mecamylamine. Avoid combination

Methoxyflurane: Aminoglycosides may enhance the nephrotoxic effect of Methoxyflurane. Avoid combination

Neuromuscular-Blocking Agents: Aminoglycosides may enhance the therapeutic effect of Neuromuscular-Blocking Agents. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May decrease the excretion of Aminoglycosides. Data only in premature infants. Monitor therapy

Oxatomide: May enhance the ototoxic effect of Aminoglycosides. Monitor therapy

Penicillins: May decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Exceptions: Amoxicillin; Ampicillin; Bacampicillin; Cloxacillin; Dicloxacillin; Nafcillin; Oxacillin; Penicillin G (Parenteral/Aqueous); Penicillin G Benzathine; Penicillin G Procaine; Penicillin V Benzathine; Penicillin V Potassium. Consider therapy modification

Regorafenib: Neomycin (Synalar Infantil) may decrease serum concentrations of the active metabolite(s) of Regorafenib. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

SORAfenib: Neomycin (Synalar Infantil) may decrease the serum concentration of SORAfenib. Monitor therapy

Tenofovir Products: Aminoglycosides may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. Monitor therapy

Vancomycin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Vitamin K Antagonists (eg, warfarin): Neomycin (Synalar Infantil) may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

See also:
What other drugs will affect Phenylephrine (Synalar Infantil)?

Acetaminophen: May increase the serum concentration of Phenylephrine (Synalar Infantil) (Systemic). Monitor therapy

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Benzylpenicilloyl Polylysine: Alpha1-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Consider therapy modification

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Chloroprocaine: May enhance the hypertensive effect of Phenylephrine (Synalar Infantil) (Systemic). Monitor therapy

CloZAPine: May diminish the therapeutic effect of Phenylephrine (Synalar Infantil) (Systemic). Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Ergot Derivatives: May enhance the hypertensive effect of Alpha1-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha1-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination

FentaNYL: Alpha1-Agonists may decrease the serum concentration of FentaNYL. Specifically, fentanyl nasal spray serum concentrations may decrease and onset of effect may be delayed. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Hyaluronidase: May enhance the vasoconstricting effect of Phenylephrine (Synalar Infantil) (Systemic). Management: Avoid the use of hyaluronidase to enhance dispersion or absorption of Phenylephrine (Synalar Infantil). Use of hyaluronidase for other purposes in patients receiving Phenylephrine (Synalar Infantil) may be considered as clinically indicated. Avoid combination

Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Avoid combination

Ioflupane I 123: Phenylephrine (Synalar Infantil) (Systemic) may diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Exceptions: Linezolid. Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

Propacetamol: May increase the serum concentration of Phenylephrine (Synalar Infantil) (Systemic). Management: Monitor patients closely for increased side effects of Phenylephrine (Synalar Infantil) if propacetamol is used concomitantly. Patients with underlying blood pressure issues or arrhythmias may need closer monitoring and may warrant consideration of alternative therapies. Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Tricyclic Antidepressants: May enhance the therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic effect of Alpha1-Agonists. Monitor therapy

Bacitracin (Systemic): Polymyxin B (Synalar Infantil) may enhance the nephrotoxic effect of Bacitracin (Systemic). Avoid combination

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Capreomycin: May enhance the neuromuscular-blocking effect of Polymyxin B (Synalar Infantil). Monitor therapy

Cefazedone: May enhance the nephrotoxic effect of Polymyxin B (Synalar Infantil). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination

Colistimethate: Polymyxin B (Synalar Infantil) may enhance the neuromuscular-blocking effect of Colistimethate. Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Mecamylamine: Polymyxin B (Synalar Infantil) may enhance the neuromuscular-blocking effect of Mecamylamine. Avoid combination

Methoxyflurane: May enhance the nephrotoxic effect of Polymyxin B (Synalar Infantil). Avoid combination

Neuromuscular-Blocking Agents: Polymyxin B (Synalar Infantil) may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Management: If possible, avoid concomitant use of neuromuscular-blocking agents and Polymyxin B (Synalar Infantil). If concomitant use cannot be avoided, monitor for deeper, prolonged neuromuscular-blocking effects (eg, respiratory paralysis) in patients receiving this combination. Consider therapy modification

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

See also:
What are the possible side effects of Fluocinolone Acetonide (Synalar Infantil)?

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 practice.

Clinical Studies Experience: Evaluation of Facial Use in Pediatric Subjects

An, open-label, study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of Fluocinolone Acetonide (Synalar Infantil)/FS® (Fluocinolone Acetonide (Synalar Infantil)) when applied to the face twice daily for 4 weeks. The following adverse reactions were reported:

Incidence of Adverse Reactions (%)

N=58

Clinical Studies Experience: Evaluation in Pediatric Subjects 3 months to 2 years old

An open-label safety study was conducted in 29 children to assess the HPA axis by ACTH stimulation testing following use of Fluocinolone Acetonide (Synalar Infantil)/FS (Fluocinolone Acetonide (Synalar Infantil)) twice daily for 4 weeks. The following adverse reactions were reported in the study :

Adverse Reactions (%)

N=30*

See also:
What are the possible side effects of Neomycin (Synalar Infantil)?

Applies to Neomycin (Synalar Infantil): oral solution, oral tablet

In addition to its needed effects, some unwanted effects may be caused by Neomycin (Synalar Infantil) (the active ingredient contained in Neomycin (Synalar Infantil)). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Neomycin (Synalar Infantil):

Rare

• Any loss of hearing
• clumsiness
• diarrhea
• difficulty in breathing
• dizziness
• drowsiness
• greatly decreased frequency of urination or amount of urine
• increased amount of gas
• increased thirst
• light-colored, frothy, fatty-appearing stools
• ringing or buzzing or a feeling of fullness in the ears
• skin rash
• unsteadiness
• weakness

Minor Side Effects

Some of the side effects that can occur with Neomycin (Synalar Infantil) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Irritation or soreness of the mouth or rectal area
• nausea or vomiting

See also:
What are the possible side effects of Phenylephrine (Synalar Infantil)?

Applies to Phenylephrine (Synalar Infantil): intravenous solution

In addition to its needed effects, some unwanted effects may be caused by Phenylephrine (Synalar Infantil) (the active ingredient contained in Phenylephrine (Synalar Infantil)). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking Phenylephrine (Synalar Infantil), check with your doctor or nurse immediately:

Incidence not known:

• Blurred vision
• chest pain or discomfort
• difficult or labored breathing
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• headache
• nausea or vomiting
• nervousness
• pain in the shoulders, arms, jaw, or neck
• pounding in the ears
• sweating
• tightness in the chest
• unusual tiredness

If any of the following symptoms of overdose occur while taking Phenylephrine (Synalar Infantil), get emergency help immediately:

Symptoms of overdose:

• Feeling of fullness in the head
• pounding or rapid pulse
• tingling in the arms or legs
• vomiting

Minor Side Effects

Some of the side effects that can occur with Phenylephrine (Synalar Infantil) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known:

• Heartburn
• itching skin
• nausea
• pain in the neck
• pain or discomfort in chest, upper stomach, or throat

See also:
What are the possible side effects of Polymyxin B (Synalar Infantil)?

Allergic reactions following topical application of Polymyxin B (Synalar Infantil) and bacitracin zinc have rarely been reported.

Anaphylactic reactions have been reported, as rare events, following topical application of zinc bacitracin.

A glucocorticoid derivative used topically in the treatment of various skin disorders. It is usually employed as a cream, gel, lotion, or ointment. It has also been used topically in the treatment of inflammatory eye, ear, and nose disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732). It is also being investigatied by pSivida and Alimera, under the brand name Fluocinolone Acetonide (Synalar Infantil), as a sustained release intraocular implant for the treatment of diabetic macular edema.

A component of Neomycin (Synalar Infantil) that is produced by Streptomyces fradiae. On hydrolysis it yields neamine and neobiosamine B. (From Merck Index, 11th ed). Neomycin (Synalar Infantil) is a bactericidal aminoglycoside antibiotic that binds to the 30S ribosome of susceptible organisms. Binding interferes with mRNA binding and acceptor tRNA sites and results in the production of non-functional or toxic peptides.

Phenylephrine (Synalar Infantil) is a sympathomimetic amine that acts predominantly on α-adrenergic receptors. It is mainly used to treat nasal congestion, but may also be useful in treating hypotension and shock, hypotension during spinal anaesthesia, prolongation of spinal anaesthesia, paroxysmal supraventricular tachycardia, symptomatic relief of external or internal hemorrhoids, and to increase blood pressure as an aid in the diagnosis of heart murmurs.

Polymyxin B (Synalar Infantil) sulfate is a mixture of polymyxins B1 and B2, obtained from Bacillus polymyxa strains. They are basic polypeptides of about eight amino acids and have cationic detergent action on cell membranes. Polymyxin B (Synalar Infantil) is used for infections with gram-negative organisms, but may be neurotoxic and nephrotoxic. All gram-positive bacteria, fungi, and the gram-negative cocci, N. gonorrhea and N. menigitidis, are resistant. It is appropriate for treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Pseudomonas aeruginosa.