AK-Pred

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of prednisolone eye drops in children. Safety and efficacy have been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prednisolone eye drops in the elderly.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin
• Rotavirus Vaccine, Live

Using this medicine 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.

• Aceclofenac
• Acemetacin
• Aldesleukin
• Amtolmetin Guacil
• Asparaginase
• Bemiparin
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Clonixin
• Darunavir
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Idelalisib
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olaparib
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pixantrone
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Ritonavir
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sorafenib
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using this medicine 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.

• Alcuronium
• Amobarbital
• Aspirin
• Atracurium
• Desogestrel
• Dienogest
• Drospirenone
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Levonorgestrel
• Licorice
• Medroxyprogesterone Acetate
• Mestranol
• Metocurine
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Phenytoin
• Primidone
• Rifampin
• Saiboku-To
• Vecuronium

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma—Prednisolone eye drops contain a sulfite which can trigger attacks in patients with this condition.

• Cataract or
• Cornea (part of the eye) problems, history of or
• Glaucoma or
• Sclera (part of the eye) problems, history of—Use with caution. May make these conditions worse.

• Eye infection with pus, untreated or
• Fungal eye infection or
• Herpes simplex eye infection or
• Mycobacterial (tuberculosis) eye infection or
• Vaccinia (smallpox) eye infection or
• Varicella (chickenpox) eye infection—Should not be used in patients with these conditions.

Your eye doctor will want to examine your eyes at regular visits to make sure this medicine is working properly and to check for unwanted effects, especially if you will be using this medicine for 10 days or longer.

Check with your doctor right away if you have an eye injury, eye infection, or plan to have eye surgery.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

If your symptoms do not improve after 2 days or if they become worse, check with your eye doctor (ophthalmologist) right away.

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:

• Blindness
• blurred vision
• burning, dry, itching eyes
• change in vision
• decreased vision
• difficulty in focusing
• drooping of the upper eyelids
• eye discharge, excessive tearing
• feeling of having something in the eye
• redness, irritation, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• sensitivity of the eye to light
• slow wound healing

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:

• Change in taste
• headache
• loss of taste

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.

• It is used to treat eye swelling.

Use AK-Pred as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• Use as you have been told, even if your signs get better.
• Wash your hands before and after use.
• Take out contact lenses before using this medicine. Lenses may be put back in 15 minutes after AK-Pred is given. Do not put contacts back in if your eyes are irritated or infected.
• Do not touch the container tip to the eye, lid, or other skin.
• Tilt your head back and drop drug into the eye.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.

0.12% and 1% Ophthalmic Suspensions: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 2 to 4 times a day; during the initial 24 to 48 hours, may increase dosing frequency if necessary

Comments:
-If signs/symptoms fail to improve after 2 days of treatment, the patient should be re-evaluated.
-Care should be taken as to not discontinue therapy prematurely.
-Anti-infective agents should me employed if a bacterial infection is present.
-Withdrawal of treatment should be carried out by gradually decreasing the frequency of applications when treating chronic conditions.

1% Ophthalmic Solution:
-Initial dose: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) up to every hour during the day and every 2 hours during the night as needed
-Maintenance dose: When a favorable response is observed, reduce dose to 1 drop every 4 hours; subsequent reduction to 1 drop 3 to 4 times a day may be adequate to control symptoms

Comments:
-Duration of therapy varies depending upon the type of lesion and may extend from a few days to several weeks, based on therapeutic response.
-Relapses, which are more common in chronic active lesions than in self-limited conditions, usually respond to retreatment.

Uses: For the treatment of steroid responsive mild to moderate noninfectious allergic and inflammatory disorders of the eye (e.g., allergic conjunctivits, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides); and for the treatment of corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; according to some experts, use should be avoided. AU TGA pregnancy category: B3 US FDA pregnancy category: C

Animal studies have revealed evidence of teratogenicity at doses 1 to 10 times the human dose. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Summary of Use during Lactation

Amounts of prednisolone in breastmilk are very low. No adverse effect have been reported in breastfed infants with maternal use of any corticosteroid during breastfeeding. With high maternal doses, avoiding breastfeeding for 4 hours after a dose should markedly decrease the dose received by the infant. However, this maneuver is not necessary with short-term use. High doses might occasionally cause temporary loss of milk supply.

Because absorption from the eye is limited, ophthalmic prednisolone would not be expected to cause any adverse effects in breastfed infants. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Drug Levels

Maternal Levels. Seven women were given 5 mg of radiolabeled prednisolone orally. A total of 0.14% of the total radioactivity was recovered from breastmilk over the next 48 to 61 hours.[1]

After oral prednisolone, levels of 23 to 40 mcg/L occurred with doses of 10 to 20 mg in 3 women, while peak levels of 106 and 137 mcg/L occurred after doses of 30 and 45 mg, respectively, and a peak prednisolone level of 317 mcg/L occurred after a dose of 80 mg. The ratio of the peak milk to peak plasma prednisolone levels were about 0.1 with doses of 20 mg or less, while it was 0.2 with doses of 30 mg or more. The ratios of the areas under the curve reached 0.2 only with an 80 mg dose. The higher ratios with higher doses are thought to be due to saturation of serum protein binding sites. Peak milk prednisolone levels occur about 1 hour after an oral dose of prednisolone and dropped with a half-life similar to the serum half-life. The authors estimated that a breastfed infant would receive less than 0.1% of the mother's total dosage of prednisolone; however, using the higher accepted milk intake value (150 mL/kg daily), this value would be less than 0.015% of the mother's dose.[2]

Three women were given 50 mg of prednisolone sodium phosphate intravenously. Thirty minutes after injection, milk prednisolone concentrations varied from about 200 to 400 mcg/L and dropped with a half-life slightly faster than the 2.5 hour half-life in serum. The authors estimated that a nursing infant would receive an average 0.074% of the total dose administered to the mother.[3]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

None reported with prednisone or any other corticosteroid. In a prospective follow-up study, 6 nursing mothers reported taking prednisone (dosage unspecified) with no adverse infant effects.[4] There are several reports of mothers breastfeeding during long-term use of corticosteroids with no adverse infant effects: prednisone 10 mg daily (2 infants)[5][6] and prednisolone 5 to 7.5 mg daily (14 infants).[7]

A woman who was nursing (extent not stated) her newborn infant was treated for pemphigus with oral prednisolone 25 mg daily, with the dosage increased over 2 weeks to 60 mg daily. She was also taking cetirizine 10 mg daily and topical betamethasone 0.1% twice daily to the lesions. Because of a poor response, the betamethasone was changed to clobetasol propionate ointment 0.05%. She continued breastfeeding throughout treatment and her infant was developing normally at 8 weeks of age and beyond.[8]

A woman with pemphigoid gestationis was treated with prednisolone in a dosage tapering from 0.7 mg/kg daily to 1 mg daily during breastfeeding. She also received courses of intravenous immune globulin 2 grams/kg over 3 days at 4, 9 and 13 weeks postpartum. She breastfed her infant (extent not stated) for 3 months with no problems noted.[9]

Two mothers with systemic lupus erythematosus were reported who took prednisolone 30 or 40 mg daily during pregnancy and lactation as well as tacrolimus 3 mg daily. Three years after birth, both children were healthy. The durations of lactation were not stated.[10]

Effects on Lactation and Breastmilk

Published information on the effects of dexamethasone on serum prolactin or on lactation in nursing mothers was not found as of the revision date. However, medium to large doses of depot corticosteroids injected into joints have been reported to cause temporary reduction of lactation.[11][12][13]

A study of 46 women who delivered an infant before 34 weeks of gestation found that a course of another corticosteroid (betamethasone, 2 intramuscular injections of 11.4 mg of betamethasone 24 hours apart) given between 3 and 9 days before delivery resulted in delayed lactogenesis II and lower average milk volumes during the 10 days after delivery. Milk volume was not affected if the infant was delivered less than 3 days or more than 10 days after the mother received the corticosteroid.[14] An equivalent dosage regimen of prednisolone might have the same effect.

A study of 87 pregnant women found that betamethasone given as above during pregnancy caused a premature stimulation of lactose secretion during pregnancy. Although the increase was statistically significant, the clinical importance appears to be minimal.[15] An equivalent dosage regimen of prednisolone might have the same effect.

Alternate Drugs to Consider

Methylprednisolone, Prednisone

References

1. McKenzie SA, Selley JA, Agnew JE. Secretion of prednisolone into breast milk. Arch Dis Child. 1975;50:894-6. PMID: 1211963

2. Ost L, Wettrell G, Bjorkhem I, Rane A. Prednisolone excretion in human milk. J Pediatr. 1985;106:1008-11. PMID: 3998938

3. Greenberger PA, Odeh YK, Frederiksen MC et al. Pharmacokinetics of prednisolone transfer to breast milk. Clin Pharmacol Ther. 1993;53:324-8. PMID: 8453851

4. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID: 8498418

5. Moretti ME, Sgro M Johnson DW et al. Cyclosporine excretion into breast milk. Transplantation. 2003;75:2144-6. PMID: 12829927

6. Munoz-Flores-Thiagarajan KD, Easterling T, Davis C et al. Breast-feeding by a cyclosporine-treated mother. Obstet Gynecol. 2001;97(5 pt 2):816-8. PMID: 11336764

7. Nyberg G, Haljamae U, Frisenette-Fich C et al. Breast-feeding during treatment with cyclosporine. Transplantation. 1998;65:253-5. PMID: 9458024

8. Westermann L, Hugel R, Meier M et al. Glucocorticosteroid-resistant pemphigoid gestationis: successful treatment with adjuvant immunoadsorption. J Dermatol. 2012;39:168-71. PMID: 22379622

9. Gan DC, Welsh B, Webster M. Successful treatment of a severe persistent case of pemphigoid gestationis with antepartum and postpartum intravenous immunoglobulin followed by azathioprine. Australas J Dermatol. 2012;53:66-9. PMID: 22309336

10. Izumi Y, Miyashita T, Migita K. Safety of tacrolimus treatment during pregnancy and lactation in systemic lupus erythematosus: A report of two patients. Tohoku J Exp Med. 2014;234:51-6. PMID: 25175032

11. McGuire E. Sudden loss of milk supply following high-dose triamcinolone (Kenacort) injection. Breastfeed Rev. 2012;20:32-4. PMID: 22724311

12. Babwah TJ, Nunes P, Maharaj RG. An unexpected temporary suppression of lactation after a local corticosteroid injection for tenosynovitis. Eur J Gen Pract. 2013;19:248-50. PMID: 24261425

13. Smuin DM, Seidenberg PH, Sirlin EA et al. Rare adverse events associated with corticosteroid injections: A case series and literature review. Curr Sports Med Rep. 2016;15:171-6. PMID: 27172081

14. Henderson JJ, Hartmann PE, Newnham JP, Simmer K. Effect of preterm birth and antenatal corticosteroid treatment on lactogenesis ii in women. Pediatrics. 2008;121:e92-100. PMID: 18166549

15. Henderson JJ, Newnham JP, Simmer K, Hartmann PE. Effects of antenatal corticosteroids on urinary markers of the initiation of lactation in pregnant women. Breastfeed Med. 2009;4:201-6. PMID: 19772378