Following the label, the label, the label

Just because a medicine is over-the-counter does not mean it is safe from overdosing! In fact, it is important to read the label for the active ingredient(s), strength of the ingredient(s), age recommendations, directions for use, and inactive ingredients (especially if you have known allergies to make sure cross-allergies do not occur). Other important information include warnings for use when your child has underlying conditions, like asthma (may result in an asthma attack), or having an increased risk of a heart attack or stroke when overusing (more or longer than directed) medications, like ibuprofen (brand names are Motrin and Advil). This addition to the label have been recently approved by the FDA for pediatric ibuprofen suspensions. Knowledge is helpful for safe medication use. We will be seeing more approvals for revisions to labels in upcoming months.

Speaking of ibuprofen, it is exciting that the FDA also recently approved an injectable formulation of the pain and fever reliever. The brand name is Caldolor. Although its use will be limited to hospital use only, it will be an important addition for pain treatment algorithms, especially for children with acute painful crises, such as those with sickle cell disease, and can't tolerate medication by mouth and need the combination of an opioid and a nonsteroidal antiinflammatory drug (ibuprofen). For postpartum pain, I preferred moderate doses of ibuprofen over opioids; the former was effective to control my pain after vaginal delivery and, surprisingly, after the c-section years later.

“Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. “But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”

Caldolor will be available for hospital use only. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary.

In a clinical trial of 319 women who had undergone an elective abdominal hysterectomy, patients were less likely to request morphine for pain on an as-needed basis when administered Caldolor.

Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots and those who have a prior history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions.

The most common adverse reactions reported in the controlled clinical trials were nausea, flatulence, vomiting, and headache.

Caldolor is manufactured by Cumberland Pharmaceuticals Inc., Nashville, Tenn."

Although pain is subjective, no one, not even a young child, should suffer from it.

Go generic; it can save you lots

There are some products that just aren't the same when they are the store brand, such as toilet paper, aluminum foil, and markers, so I try not to buy them. Generic, or store brand, medications, however, I trust. The FDA vouches that they are as safe and effective as the brand name versions. I buy generic whenever it is available. Many practitioners and patients may find that biological products (hormone injections) and some drugs (medicines for seizure control) that require specific blood levels of the drug may not be interchangeable. Work with the doctor and pharmacist; switching from a brand to a generic medicine may require more careful (frequent) monitoring of the blood level of the drug. If the medicine produces the same outcome, it will be a huge cost savings in the long run if you need this medicine long-term. For instance, yesterday I refilled my daughter's fluoride tablets. The last time I got the prescription, I paid $9.99 for 120 tablets. Of course, my insurance does not cover vitamins or supplements. This time it was a different generic company, but I got an even better deal: $3.99 for 120 tablets. They are purple and taste better, according to my daughter. That's great, because she was starting to try to refuse her medicine. Of note, generic products may look and taste different, but as long as the main ingredients (for example, acetaminophen or loratadine) and strength (mg or %) are the same, you're getting the same medicine. Hey, I just saved $6!

When I was still at the Children's Hospital at Montefiore, I wrote this piece about generic medicines for them. Please feel free to leave me comments if you have any questions!

Random information

I came across some interesting posts from the US Department of Health and Human Services, and the CDC this past week and wanted to share some links:

- Breastfeeding benefits babies AND moms, but you already knew that. What you may not have known is that it can help reduce the risk of heart disease, a heart attack, or stroke by 10% in postmenopausal women. Learn more at hhs.gov.

- From the CDC are tips for parents on how to protect your kids from skin cancer and playing it safe in the sun.

- Don't forget about protecting yourself, too. My diuretic makes me more prone to sunburns, so I am taking this seriously.

- Going nuts trying to fill up the summer schedule? Don't forget water safety, whether your kids are heading to the pool or to the beach!

- Tick tick tick tick...prevention.

Please let me know if there are other links to share.

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DEET or no DEET?

I was asked this question by a mom when she saw me looking at my options for insect repellent (bug spray) at a local pharmacy. She also recently moved to CT from NYC. Now that we live in the suburbs and are surrounded by wooded areas we have to worry about tick bites, in addition to mosquito bites. The mom was concerned about the safety of putting DEET on her infant. I reassured her that it is recommended and is safe as long as she follows the directions for application.

The CDC and AAP recommend the use of products that contain 30% or lower concentration of DEET in children older than 2 months of age. Just make sure it is applied correctly (avoiding the eyes and not covering areas that have been sprayed with another layer of clothing). The best way to avoid tick bites is to wear long pants that are tucked into socks; apply DEET-based repellents to exposed skin and to pants below the knees and the tops of socks. It is recommended to use products with at least a 20% DEET concentration; the higher the concentration, the longer the duration of protection. For instance, a product with 7-10% DEET will last about 90 minutes, whereas 25% will last up to 8 hours. Some products marketed for families only contain 7% DEET; this will increase the likelihood of being bitten first as compared to someone who is wearing a higher concentration of DEET. Keep an eye on the child who is wearing the lower concentration.

Avoid sunscreen/insect repellent combinations. It is ok to reapply sunscreen, but bug spray is only reapplied if the insects start to truly bother you after a few hours. So, it is best to buy separate products. More is not better. It is also recommended that sunscreen be applied first, followed by the bug spray, otherwise the sunscreen will be less effective if applied at the same time.

Be sure to perform "tick checks" (don't forget the armpits, groin, and neck areas) as soon as you return home from your outings (even if it's just your own backyard) and wash the areas that have been sprayed with soap and water.

Disclaimer: I have no affiliations with Vertellus. I just really liked their information about DEET.

Plop, plop then blink, blink, blink?

Ahhh, today was the first day that I woke up with minimal sneezing and eyes that didn't itch or look bloodshot. It has been torture for the past couple of weeks, but I survived with over-the-counter (OTC) cetirizine (Zyrtec) 10 mg that I took by mouth once a day and OTC ketotifen (Zatitor) eye drops twice daily. They don't make me symptom-free, but they definitely dampen my misery. I even started breaking my dose in half and taking it twice a day; 5 mg in the morning and 5 mg in the evening, and it's been working out. Sometimes this is done with other medications to maintain a better drug level in the blood.

Since I'm still nursing my son, my first concern is his safety; how will these antihistamines affect him? Cetirizine is generally considered safe, but it is unknown how much of the medicine will distribute into the breast milk. I have been watching him for excessive irritability and drowsiness, and he's been fine. There is little information about ketotifen and breastfeeding. So, I make sure I practice good technique when applying eye drops. The amount of drug that drains into the tear duct into the nose, where much of the drug will get absorbed into the bloodstream, can be minimized. Good tip to remember: put in the drops, gently put pressure on the tear duct with eyes closed for at least 30 seconds (up to 2 minutes). Of note, applying more drops is not better; 1 drop is more than enough, even if some of it drips out of the corner of your eye. If your doctor tells you to put in 2 drops, avoid the plop, plop method; put in one drop at a time. Try not to blink right away because that will flush the eye drop out of the eye like a windshield wiper.

Kids suffer from seasonal allergies, too. Some kids who also have asthma may need higher doses of their controller medicines, or start additional ones, like montelukast (Singulair), to prevent the asthma attacks triggered by seasonal allergies. Check with the pediatrician or pharmacist first if your child has other conditions (and especially if they are younger than 2 years of age) before giving them OTC antihistamines, like diphenhydramine (Benadryl) or loratadine (Claritin). Make sure the proper measuring tool is used for syrups. If the medicine is to be taken once daily, give it at bedtime so the morning symptoms are covered. Try to use the proper technique for eye drops. One plop, but no blinking...just light pressure on the tear duct. Oh, and be sure to wash your hands before and after.

Other resources:
The FDA has good information about breastfeeding, but other sources may be more current regarding the transfer of medications into breastmilk. Kellymom.com provides evidence-based information on breastfeeding and parenting. The American Academy of Allergy, Asthma, and Immunology (AAAAI) has kid-friendly information about allergies and asthma.

Achoo!

I first taught my daughter to sneeze into the crook of her arm about a year ago so that she would not spread her germs when she played with the toys at summer camp or held hands with her buddies. I also sent her with a pack of tissues in her pocket. She did not have a fever at any point and she played and ate normally, thus I knew it was a common cold and not the flu. The CDC has been very resourceful these past 2 weeks about getting information out to the public and to health care professionals. Here is a list of other common symptoms of the flu to look for and what to do if you notice them.

Even with two young children at home and a husband with asthma, I did not panic with all of the hype surrounding the pandemic swine flu (sorry H1N1 flu virus). I have been receiving email updates from the CDC, WHO, FDA, thank goodness for large storage capacity in cyberspace, but I have decided to just stay alert about the situation and not let it change our routines. The seriousness of the situation is real, but I felt like we, as a country, were living like a season of the show 24, only things happened over more than 24 hours. However, the intensity, drama, and ridiculousness of some of the reactions to the updates about the flu are the same. Now schools can reopen and guidelines have been released as to when schools should be closed. Sadly, some kids in some states have lost the opportunity to expand their knowledge because school trips have been canceled. Admittedly, we ARE getting mixed messages. First we're told not to panic, then some states declare emergencies even though there were only a handful of cases.

Seriously, let's just calm down, breathe, and take the normal precautions we usually do to avoid getting sick or getting others sick. If you want to prepare for the pandemic flu alert, the CDC provides a checklist. Actually, it's a pretty good list to go through to prepare for any emergency. Finally, teach your kids to wash their hands frequently (a thorough wash is to use soap and warm water and sing "happy birthday to you"), sneeze into the crook of their arm or use a tissue and throw it away immediately, stay away from others who are sick, and keep them home if they are sick. If the flu is suspected, though, do call your child's pediatrician; antiviral medications do shorten the course of illness if started soon after infection. The American Academy of Pediatrics has quick tips.

I bought some more alcohol-based hand sanitizer to keep in my bag and I'm doing laundry using hotter temperatures, but those are not drastic measures. How have you changed your routine because of the swine flu pandemic?