بوليميكسين ب

البوليميكسين ب (polymyxin B) مضاد حيوي تصفه نشرة مستحضر بيطري في قاعدة DailyMed بأنه واحد من مجموعة مضادات حيوية متقاربة مشتقة من Bacillus polymyxa. تذكر الوكالة الأوروبية للأدوية (EMA) أن البوليميكسين ب من البدائل القليلة المتاحة في الكلاب للعلاج الموضعي للتهاب الأذن الخطير الناجم عن عدوى سالبة الغرام.

ما هو الدواء وإلى أي صنف ينتمي

يذكر دليل MSD البيطري أن البوليميكسين ب والبوليميكسين إي، أي الكوليستين، ينتميان إلى مجموعة من مضادات الميكروبات عديدة الببتيدات موجبة الشحنة. تصف الوكالة الأوروبية للأدوية (EMA) الكوليستين والبوليميكسين ب بأنهما مضادان حيويان ببتيديان سريعا القتل للبكتيريا ينتميان إلى صنف البوليميكسينات. تصف نشرة مستحضر بيطري في قاعدة DailyMed كبريتات البوليميكسين ب بأنها مضاد حيوي ببتيدي واسع الطيف ينشط ضد الأنواع موجبة الغرام وسالبة الغرام.

آلية العمل

يذكر دليل MSD البيطري أن البوليميكسينات مبيدة للبكتيريا، وأنها تتفاعل بقوة مع الفوسفوليبيدات في أغشية الخلايا البكتيرية وتُخلّ إخلالاً شديداً بنفاذيتها ووظيفتها. تذكر نشرة مستحضر بيطري في قاعدة DailyMed أن البوليميكسينات سريعة القتل للبكتيريا، وأن فعل البوليميكسينات يقتصر على البكتيريا سالبة الغرام. يذكر دليل MSD البيطري أن البوليميكسينات أكثر فعالية ضد البكتيريا سالبة الغرام منها ضد موجبة الغرام. يذكر دليل MSD البيطري أن قدرة البوليميكسينات على الارتباط بجزء الليبيد-أ من عديد السكاريد الشحمي أسهمت في استعمال البوليميكسين ب لدى الخيول في حالات التسمم بالذيفان الداخلي. تذكر نشرة مستحضر بيطري في قاعدة DailyMed أن هناك دلائل على أن كبريتات البوليميكسين ب تملك بعض النشاط المضاد للفطريات. يذكر دليل MSD البيطري أن البوليميكسينات تعمل بتآزر عند جمعها مع السلفوناميدات المقوّاة والتتراسيكلينات وبعض المضادات الحيوية الأخرى، وأنها تخفض نشاط الذيفانات الداخلية في سوائل الجسم وقد تفيد في التسمم بالذيفان الداخلي. تذكر نشرة مستحضر بيطري في قاعدة DailyMed أن دراسة مخبرية أظهرت تأثيراً تآزرياً بين نترات الميكونازول وكبريتات البوليميكسين ب.

الاستعمالات البيطرية

يذكر دليل MSD البيطري أن طيف البوليميكسينات الضيق نسبياً يشمل Enterobacter وKlebsiella وSalmonella وPasteurella وBordetella وShigella وPseudomonas وEscherichia coli. يذكر دليل MSD البيطري أن الاستطباب الرئيسي للبوليميكسينات بالحقن هو العدوى المهددة للحياة الناجمة عن التسمم بالذيفان سالب الغرام أو العصيات أو Pseudomonas المقاومة لأدوية أخرى. يذكر دليل MSD البيطري أن البوليميكسينات تُستعمل عادةً في مستحضرات للعين والأذن ضمن توليفات ضد الكائنات الحساسة، وأنها أحد مكونات مراهم المضادات الحيوية الثلاثية المتاحة دون وصفة. تذكر نشرة مستحضر بيطري في قاعدة DailyMed أن المعلّق الأذني المحتوي كبريتات البوليميكسين ب يجمع، بمكوناته الفعالة الثلاثة، نشاطاً مضاداً للبكتيريا وللفطريات وللالتهاب. يذكر دليل MSD البيطري أن تراكيز البوليميكسينات في الدم تكون منخفضة عادةً لأنها ترتبط بأغشية الخلايا وبحطام الأنسجة والإفرازات القيحية.

السلامة

تذكر نشرة مستحضر بيطري في قاعدة DailyMed أن سلامة استعمال المعلّق الأذني المحتوي كبريتات البوليميكسين ب لم تُقيَّم في الكلاب المستعملة للتربية ولا أثناء الحمل ولا في الكلبات المرضعة.

الوضع التنظيمي

تذكر الوكالة الأوروبية للأدوية (EMA) في مشورتها عن تصنيف مضادات الميكروبات أن الكوليستين والبوليميكسين ب مرخّصان على المستوى الوطني في الاتحاد الأوروبي.

مقاومة البكتيريا

يذكر دليل MSD البيطري أن المقاومة الذاتية للبوليميكسينات معروفة لدى بعض البكتيريا، لكن المقاومة غير شائعة وتعتمد على الكروموسوم وحده.

The text below is quoted verbatim from approved veterinary drug labels published by the US FDA (Animal Drugs @ FDA) and DailyMed.

Indications (17)

Dogs (7)

Terramycin Ophthalmic Ointment with Polymyxin B Sulfate is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli, and A. aerogenes, such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions which may occur secondary to other infectious diseases in the above species.
Terramycin®
Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Anaprime® Ophthalmic Solution
For the treatment of bacterial infections associated with topical ophthalmological conditions such as corneal injuries, superficial keratitis, conjunctivitis, keratoconjunctivitis, and blepharitis.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Anaprime® Opthakote Ophthalmic
For the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Surolan®
Treatment of summer eczema, atopic dermatitis, interdigital eczema and otitis externa caused by bacteria susceptible to neomycin, penicillin, and polymyxin B.
For use in dogs only. Shake drug thoroughly and clean lesion before using. If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Forte Topical® Ointment
Treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to susceptible organisms.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Bac-Neo-Poly Ophthalmic Ointment
Treating acute or chronic conjunctivitis caused by susceptible organisms.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment

Cats (4)

Terramycin Ophthalmic Ointment with Polymyxin B Sulfate is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli, and A. aerogenes, such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions which may occur secondary to other infectious diseases in the above species.
Terramycin®
Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Anaprime® Ophthalmic Solution
Treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to susceptible organisms.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Vetropolycin Ophthalmic Ointment
Treating acute or chronic conjunctivitis caused by susceptible organisms.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment

Cattle (1)

Terramycin® is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli, and A.aerogenes, such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions whichmay occur secondary to other infectious diseases in the above species.
Terramycin®

Sheep (1)

Terramycin Ophthalmic Ointment with Polymyxin B Sulfate is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli, and A. aerogenes, such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions which may occur secondary to other infectious diseases in the above species.
Terramycin®

Horses (1)

Terramycin Ophthalmic Ointment with Polymyxin B Sulfate is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli, and A. aerogenes, such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions which may occur secondary to other infectious diseases in the above species.
Terramycin®

Species not stated (3)

Terramycin is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli, and A. aerogenes, such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions which may occur secondary to other infectious diseases in the above species.
Terramycin®
For the treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to organisms susceptible to one or more of the antibiotics contained in the ointment
Federal law restricts this drug to use by or on the order of a licensed veterinarian
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment
SUROLAN is indicated for the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
Surolan™ Rx otic suspension (miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

Contraindications (1)

Species not stated (1)

SUROLAN is contraindicated in dogs with suspected or known hypersensitivity to miconazole nitrate, polymyxin B sulfate, or prednisolone acetate. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity.
Surolan™ Rx otic suspension (miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

Warnings (2)

Species not stated (2)

Serious, life threatening, hypersensitivity (anaphylactic) reactions have been reported in some cats following application of antibiotic ophthalmic preparations. If your cat has swelling of the face, itching, appears weak, vomits, or has difficulty breathing within 4 hours of application you should discontinue treatment and contact your veterinarian immediately. Note: The use of oxytetracycline and other antibiotics may result in an overgrowth of resistant organisms such as Monilia, staphylococci, and other species of bacteria. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken.
Terramycin®
Not for use in humans. Keep this and all drugs out of reach of children.
Surolan™ Rx otic suspension (miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

Adverse reactions (1)

Species not stated (1)

In the field study, 161 dogs treated with SUROLAN were included in the safety database. Two dogs experienced reduced hearing at the end of treatment; on follow-up one dog had normal hearing capacity while the other case was lost for follow-up. The owner of another dog reported that on day 4 of treatment, build-up of the medication decreased the dog's hearing. At the end of treatment, this dog had normal hearing as assessed by the investigator. Residue build-up was reported in 1 dog and pain upon drug application in another dog. A total of 161 dogs treated with the active control was included in the safety database and adverse reactions were reported in 8 dogs treated with the active control. One dog experienced reduced hearing at the end of treatment. Residue build-up was noted in 1 dog. Four dogs vomited during treatment, 1 dog showed red pustules on the pinna and head shaking was observed in another dog. Foreign market experience: the following adverse events were reported voluntarily during post-approval use of the product in foreign markets: deafness, reduced hearing, topical hypersensitivity reactions and red blisters on pinna. For a copy of the Safety Data Sheet (SDS), for technical assistance or to report a suspected adverse drug reaction, contact Elanco Animal Health at 1-888-545-5973. Alternatively, suspected adverse drug reactions may be reported to FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae
Surolan™ Rx otic suspension (miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

Dosage (15)

Dogs (6)

Rub a small amount into the involved area 1 to 3 times a day. After definite improvement, it may be applied once a day or every other day.
Topical
For use in dogs only. Shake drug thoroughly and clean lesion before using. If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Forte Topical® Ointment
Instill 5 drops in the ear canal twice daily and massage the ear. Therapy should continue for 7 consecutive days.
Otic
For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Surolan®
Apply a thin film over the cornea three or four times daily.
Ophthalmic
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment
Administered topically to the eye 2-4 times daily.
Ophthalmic
Terramycin®
Instill 1 to 2 drops per eye every 6 hours.
Ophthalmic
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Anaprime® Opthakote Ophthalmic
Apply 2 to 3 drops per eye, every 4 hours.
Ophthalmic
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Anaprime® Ophthalmic Solution

Cats (3)

Apply a thin film over the cornea three or four times daily.
Ophthalmic
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment
Administered topically to the eye 2-4 times daily.
Ophthalmic
Terramycin®
Apply 2 to 3 drops per eye, every 4 hours.
Ophthalmic
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Anaprime® Ophthalmic Solution

Cattle (1)

Administered topically to the eye 2-4 times daily.
Ophthalmic
Terramycin®

Sheep (1)

Administered topically to the eye 2-4 times daily.
Ophthalmic
Terramycin®

Horses (1)

Administered topically to the eye 2-4 times daily.
Ophthalmic
Terramycin®

Species not stated (3)

Shake well before use. The external ear should be thoroughly cleaned and dried before the initiation of treatment. Verify that the eardrum is intact. Instill 5 drops of SUROLAN in the ear canal twice daily and massage the ear. Therapy should continue for 7 consecutive days.
AURICULAR (OTIC)
Surolan™ Rx otic suspension (miconazole nitrate, polymyxin B sulfate, prednisolone acetate)
Terramycin (Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment) should be administered topically to the eye 2–4 times daily.
TOPICAL
Terramycin®
Apply a thin film over the cornea 3 or 4 times daily
Ophthalmic
Federal law restricts this drug to use by or on the order of a licensed veterinarian
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment

Available strengths (22)

Product	Dosage form	Available strengths
Anaprime® Ophthalmic Solution	Liquid	Each milliliter of ophthalmic preparation contains 0.10 milligram flumethasone, 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 units of polymyxin B sulfate, without hydroxypropyl methylcellulose.
Anaprime® Ophthalmic Solution	Liquid	Each milliliter of ophthalmic preparation contains 0.10 milligram flumethasone, 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 units of polymyxin B sulfate, without hydroxypropyl methylcellulose.
Terramycin®	Ointment	Each gram of ointment contains oxytetracycline HCl equivalent to 5 mg of oxytetracycline and 10,000 units of polymyxin B as the sulfate.
Terramycin®	Ointment	Each gram of ointment contains oxytetracycline HCl equivalent to 5 mg of oxytetracycline and 10,000 units of polymyxin B as the sulfate.
Terramycin®	Ointment	Each gram of ointment contains oxytetracycline HCl equivalent to 5 mg of oxytetracycline and 10,000 units of polymyxin B as the sulfate.
Terramycin®	Ointment	Each gram of ointment contains oxytetracycline HCl equivalent to 5 mg of oxytetracycline and 10,000 units of polymyxin B as the sulfate.
Terramycin®	Ointment	Each gram of ointment contains oxytetracycline HCl equivalent to 5 mg of oxytetracycline and 10,000 units of polymyxin B as the sulfate.
Anaprime® Opthakote Ophthalmic	Liquid	Each milliliter of ophthalmic preparation contains 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), 0.10 milligram flumethasone, and 10,000 Units of polymyxin B sulfate.
Optiprime® Opthakote Ophthalmic Solution	Liquid (Solution)	Each milliliter of the ophthalmic preparation contains 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 Units of polymyxin B sulfate.
Forte Topical® Ointment	Ointment	Each milliliter of suspension contains 25 milligrams of neomycin sulfate equivalent to 17.5 milligrams of neomycin, 10,000 international units of penicillin G procaine, 5,000 international units of polymyxin B sulfate, 2 milligrams of hydrocortisone acetate, and 1.25 milligrams of hydrocortisone sodium succinate.
Bac-Neo-Poly Ophthalmic Ointment	Ointment	Each gram contains 400 units of bacitracin zinc, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B.
Vetropolycin Ophthalmic Ointment	Ointment	Each gram contains 400 units of bacitracin zinc, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B.
Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment	Ointment	Each gram of ointment contains 400 units of bacitracin zinc, 10,000 units of polymyxin B sulfate, 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), and 10 milligrams of hydrocortisone acetate.
Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment	Ointment	Each gram of ointment contains 400 units of bacitracin zinc, 10,000 units of polymyxin B sulfate, 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), and 10 milligrams of hydrocortisone acetate.
Mycitracin® Sterile Ophthalmic Ointment	Ointment	Each gram contains 500 units of bacitracin, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B.
Mycitracin® Sterile Ophthalmic Ointment	Ointment	Each gram contains 500 units of bacitracin, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B.
Cortisporin Veterinary Ophthalmic Ointment	Ointment	Each gram of ointment contains 400 units of bacitracin zinc, 10,000 units of polymyxin B sulfate, 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), and 10 milligrams of hydrocortisone.
Cortisporin Veterinary Ophthalmic Ointment	Ointment	Each gram of ointment contains 400 units of bacitracin zinc, 10,000 units of polymyxin B sulfate, 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), and 10 milligrams of hydrocortisone.
Neosporin Ophthalmic Ointment	Ointment	Each gram contains 400 units of bacitracin zinc, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B.
Neosporin Ophthalmic Ointment	Ointment	Each gram contains 400 units of bacitracin zinc, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B.
Surolan®	Liquid (Suspension)	23 mg/mL miconazole nitrate, 0.5293 mg/mL polymyxin B sulfate, 5 mg/mL prednisolone acetate
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment	Ointment	Each gram of ointment contains: polymyxin B sulfate 10,000 units, bacitracin zinc 400 units, and neomycin sulfate 5 mg (equivalent to 3.5 mg neomycin base).