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Pediatrics

pediatrics

We work together with prescribers, children, and their families to customize medications and meet specific needs.

Children pose many challenges when it comes to medication: they may resist having to take a medication, dislike the taste or texture, have difficulty swallowing solid dosage forms, and are fearful of injections.

The limited pediatric market for most drugs may be the leading reason for the lack of investment in drug development for this population by the pharmaceutical industry. Most medications are not labeled for pediatric populations, and when a medication is not approved for use in infants and children, it usually is not available in a suitable pediatric dosage form. Fortunately, our compounding pharmacy is able to help. We can compound oral medications into pleasantly flavored suspensions, solutions, concentrates, freezerpops, “gummy bears” or lozenges, in colors that entice the child to take the medication. A palatable formulation is more likely to improve compliance and minimize spillage or waste during administration. Lollipops are an ideal alternative to “swish and swallow” medications that need to be retained in the mouth for a prolonged period of time. Most drugs can be compounded into transdermal gels that can easily be applied to an appropriate site, such as the child’s wrist, for absorption through the skin.

Professional compounding is not just diluting existing medications, or mixing powders with bases. We must consider physical and chemical properties of each active and inactive ingredient in order to prepare an effective and safe customized medication with the desired taste, color, fragrance, viscosity, uniformity, texture, and stability. The efficacy of any compounded medication is influenced by the technique and equipment used in preparing the formulation, the purity and quality of the ingredients, choice of vehicle (base), and proper use of additives such as penetration enhancers.


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Acne

Emergence of resistant pathogens emphasizes the need for alternatives to antimicrobial agents for acne therapy. We can compound cosmetically-appealing customized formulations which can contain numerous medications to provide a synergistic effect for treatment of resistant acne.

Int J Dermatol 1995 Jun;34(6):434-7
Topical nicotinamide compared with clindamycin gel in the treatment of inflammatory acne vulgaris.

Shalita AR, Smith JG, Parish LC, Sofman MS, Chalker DK
Department of Dermatology, State University of New York, College of Medicine, Brooklyn, USA.

Click here to access the PubMed abstract of this article.

J Dermatol 1996 Apr;23(4):243-6
Topical spironolactone reduces sebum secretion rates in young adults.

Yamamoto A, Ito M
Department of Dermatology, Niigata University School of Medicine, Japan.

Click here to access the PubMed abstract of this article.


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Attention Deficit Hyperactivity Disorder

The use of medications to treat ADHD has greatly increased, yet the dosage requirements for many children differ from strengths that are commercially available. This often necessitates a midday dose at school, which can be embarrassing to a child. Slow-release dosage forms can be compounded to contain the precise dose of medication needed by each child.

Pediatr Clin North Am 1999;46:945-963


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Autism

Autism spectrum disorder (ASD) is diagnosed on the basis of behavioral parameters, yet there are many underlying biomedical factors which can contribute to these symptoms. Therapies directed at these underlying factors may be helpful in decreasing symptoms of autism. For example, recent studies have found chronic inflammation in the brains of children with autism, raising the possibility that treatments directed against inflammation may be helpful.

The Autism Research Institute asked parents to rate the effectiveness of numerous biomedical treatments. As of 2008, over 26,000 parents had evaluated more than 80 interventions. Detoxification was considered helpful by 74% of parents. Other highly rated therapies included gluten/casein-free diet, food allergy treatment, methylcobalamin, and essential fatty acid therapy. It is thought that the earlier treatment is started, the better the results.

Gluten-Free and Casein-Free Preparations
Children with autism may benefit from a gluten-free and casein-free diet. Many commonly used medications contain gluten. Some probiotics contain casein. We can compound preparations that are free of gluten and casein to solve problems for sensitive individuals.

Therapy for Gut Dysbiosis
Autistic children frequently have abnormalities in gut permeability, defects or deficiencies in intestinal enzymes, and/or abnormal intestinal flora. Yeast overgrowth can be prevented or treated by oral administration of Lactobacillus or other probiotics. If response is insufficient, oral antifungals may be needed. Prescription medications can be compounded for oral administration to help reduce yeast in the gut.

Compromised digestive function, often secondary to inflammation of the bowel, may lead to the absorption of toxins (“leaky gut”). Children can benefit from balanced nutrition, treatment of imbalanced gut flora, and enhancement of immune function.

Nutritional Therapy for Autism
Most children with autism have a need for increased amounts of vitamins, minerals, and some amino acids. Some detoxification agents may remove essential minerals, creating a need for additional minerals. Vitamin C, vitamin B6, vitamin A, omega-3 fatty acids, calcium, magnesium, zinc, and selenium are often needed in addition to a broad-spectrum vitamin/mineral supplement. Copper should be avoided in many cases, since the levels in autistic children are sometimes high. Amino acid, nutritional, and supplemental therapies can be customized for each child. Once the physician has determined the specific nutrients that are needed, compatible supplements can be combined in flavored suspensions to simplify administration.

Many children with autism are zinc deficient. Zinc deficiency affects taste perception and children then become averse to eating certain foods and taking supplements. In this case, transdermal preparations can be very helpful by completely bypassing the oral route of administration. Commonly needed nutrients which can easily be given in a transdermal form include vitamin A, vitamin D, and zinc.

Glutathione is the major antioxidant in cells and is important for detoxification and elimination of environmental toxins. Its active form is reduced in about 80 percent of autistic children. Oxidative stress, a suspected contributor in many disease processes like heart disease and cancer, also plays a role in autism, and occurs when antioxidants are not present in sufficient levels to clear the body of free radicals. Free radicals can damage cells in the brain, gastrointestinal tract and immune system. Children with low glutathione levels may be more vulnerable to this damage, so supplementation with oral or transdermal glutathione and other antioxidants may be beneficial.

Methylcobalamin – Vitamin methyl-B12 helps support the methylation pathway, which is important for detoxification. This pathway is often not working optimally in children with ASD.

Melatonin appears to be a safe and well-tolerated treatment for insomnia in children with ASD.

J Child Neurol. 2008 Jan 8 [Epub ahead of print]
Melatonin for Insomnia in Children With Autism Spectrum Disorders.

Andersen IM, Kaczmarska J, McGrew SG, Malow BA.
Vanderbilt Children’s Hospital, Vanderbilt University School of Medicine, Nashville, Tennessee.

Click here to access the PubMed abstract of this article.
Detoxification (including chelation)
Some children with autism may suffer from heavy metal toxicity, and may potentially benefit from therapies which support detoxification. Some may also benefit from chelation (removal of heavy metals). Oral DMSA (dimercaptosuccinic acid) is approved by the FDA for treating lead poisoning in children as young as one year of age. It has also been demonstrated to be able to bind and remove a wide range of toxic metals, including mercury, arsenic, tin, nickel, and antimony. Oral DMSA has been used off-label for this purpose. It is important to monitor kidney and liver function and complete blood counts when using DMSA, and although rare, serious side effects may occur.

Please note: These therapies have not been approved by the FDA for the treatment of autism, and should be used only under direct supervision of an experienced and knowledgeable health care professional after parents or guardians have received adequate information and given consent.

References:
http://www.autism.com/treatable/form34qr.htm (accessed April 2008)
Ann Neurol 2005;57:67–81
Ann N Y Acad Sci. 2007 Jun;1107:92-103.
Cell Mol Neurobiol. 2004 Apr;24(2):219-41
Neuroendocrinology Letters 2002;23:303-8
Dev Brain Dysfunction 1997;10:40-43
J Inherit Metab Dis.1993;16(4):762-770
Pediatrics 1995;95:255-8
J Nutr Env Med 2000;10:25-32


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Diaper Rash

Approximately two-thirds of infants experience diaper rash (dermatitis). Customized diaper rash preparations -ointments, powders, or creams- can be compounded to treat each child’s specific symptoms, using ingredients which will protect the skin from additional irritation, soothe and encourage healing, and prevent secondary infections. Skin protectants (zinc oxide, petrolatum) provide a physical barrier against external irritants such as urine or gastrointestinal enzymes in stool. Antifungal creams can be used when a yeast (Candida) infection is suspected.

We can also compound a bile acid sequestrant, such as cholestyramine ointment, to prevent skin irritation, which is especially helpful for ostomy patients.

Ann Pharmacother 1996 Sep;30(9):954-6
Cholestyramine ointment to treat buttocks rash and anal excoriation in an infant.

White CM, Gailey RA, Lippe S.
Albany College of Pharmacy, NY 12208, USA.

Click here to access the PubMed abstract of this article.


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Fungal Infections

Athlete’s foot, jock itch, and onychomycosis (fungal nail) are common, particularly in athletes. Research points to the practicality “of using ibuprofen, alone or in combination with azoles, in the treatment of candidosis, particularly when applied topically, taking advantage of the drug’s antifungal and anti-inflammatory properties.” Various synergistic combinations are used for antifungal therapy.

J Med Microbiol 2000 Sep;49(9):831-40
Antifungal activity of ibuprofen alone and in combination with fluconazole against Candida species.

Pina-Vaz C, Sansonetty F, Rodrigues AG, Martinez-De-Oliveira J, Fonseca AF, Mardh PA.
Department of Microbiology, Porto School of Medicine, University of Porto, Portugal

Click here to access the PubMed abstract of this article.


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Head Lice/Scabies

Concerns about emerging resistance and the potential harm of using permethrins have prompted a search for effective pediculicidal therapies that are not harmful to children with repeated use. An herbal formulation has been shown to be effective for head lice.9 Ivermectin can also be compounded for topical application or as an oral dose titrated for each patient for the treatment of head lice and scabies.

Clin Exp Dermatol 2002 Jun;27(4):264-7
Treatment of 18 children with scabies or cutaneous larva migrans using ivermectin.

Del Mar Saez-De-Ocariz M, McKinster CD, Orozco-Covarrubias L, Tamayo-Sanchez L, Ruiz-Maldonado R.
Department of Dermatology, National Institute of Pediatrics, Mexico City, Mexico.

Click here to access the PubMed abstract of this article.

Trop Med Parasitol 1994 Sep;45(3):253-4
Efficacy of ivermectin for the treatment of head lice (Pediculosis capitis).

Glaziou P, Nyguyen LN, Moulia-Pelat JP, Cartel JL, Martin PM.
Institut Territorial de Recherches Medicales Louis Malarde, Papeete, Tahiti, French Polynesia.

Twenty six male and female patients aged 5 to 17 years had head lice infestation confirmed by eggs presence and received treatments with a single 200 microgram/kg oral dose of. At day 14 after treatment, 20 had responded to the treatment (77%), and 6 patients (23%) presented with a complete disappearance of eggs and all clinical symptoms. At day 28, 7 patients appeared clear of infestation (27%), but 4 of the 6 patients with no eggs at day 14 presented with signs of reinfestation. This study suggests that ivermectin is a promising treatment of head lice, and a second dose at day 10 may be appropriate.

Click here to access the PubMed abstract of this article.

J Dermatol 2001 Sep;28(9):481-4
Oral ivermectin in scabies patients: a comparison with 1% topical lindane lotion.

Madan V, Jaskiran K, Gupta U, Gupta DK.
Department of Dermatology, NSCB, Medical College, Jabalpur, MP, India.

Two hundred scabies patients were randomly allocated to receive either oral ivermectin in a single dose of 200 micrograms/kg body weight, or 1% lindane lotion for topical application overnight. Patients were assessed after 48 hours, two weeks and four weeks. After a period of four weeks, 82.6% of the patients in the ivermectin group showed marked improvement; only 44.44% of the patients in the lindane group showed a similar response. Oral ivermectin is easy to administer as a single oral dose, induces an early and effective improvement in signs and symptoms, and compliance is accordingly increased.

Click here to access the PubMed abstract of this article.

Isr Med Assoc J. 2002 Oct;4(10):790-3
The in vivo pediculicidal efficacy of a natural remedy.

Mumcuoglu KY, Miller J, Zamir C, Zentner G, Helbin V, Ingber A.
Department of Parasitology, Hebrew University Medical School, Jerusalem, Israel.

Click here to access the PubMed abstract of this article.


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Molluscum Contagiosum

Resistant warts and molluscum contagiosum have been treated successfully with compounded topical medications, avoiding discomfort associated with freezing, scraping, electrocautery and laser therapy.

The following study found that 5% KOH aqueous solution proved to be as effective and less irritating when compared to the 10% KOH solution. This trial also emphasizes the effectiveness of topical KOH in the treatment of molluscum contagiosum, sparing affected children from more aggressive physical modalities of treatment.

Pediatr Dermatol 2000 Nov-Dec;17(6):495
Evaluation of the effectiveness of 5% potassium hydroxide for the treatment of molluscum contagiosum.

Romiti R, Ribeiro AP, Romiti N.
Department of Dermatology, University of Sao Paulo, Sao Paulo, Brazil.

Click here to access the PubMed abstract of this article.


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Nausea & Vomiting

Orally administered anti-emetics can be difficult for a nauseated child to “keep down”, and rectal suppositories may not be well accepted by children. Even persistent nausea can often be effectively controlled by using a combination of medications tailored to meet an individual’s specific needs. Dosage forms include transdermal gels, suppositories, lollipops, and more.

Promethazine is commonly compounded for topical or transdermal application to treat nausea, vomiting, and vertigo, but this preparation may be used as an antiemetic for cases ranging from chemotherapy to motion sickness. The dose is typically 25mg for adults, and the dose is decreased for children. The gel is applied to an area of soft skin, such as the inside of the wrist or arm, the side of the torso, or the inside of the thigh. For children, doses are often applied to the inside of one wrist, and then the wrists are rubbed together.
US Pharmacist, August 1999; 74-5


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Topical Anesthesia

Topical anesthesia is needed for common pediatric procedures such as suturing, wound cleaning, and injection administration. The ideal topical anesthetic would provide complete anesthesia following a simple pain-free application, not contain narcotics or controlled substances, and have an excellent safety profile. The combination of topical anesthetics lidocaine and tetracaine and the vasoconstrictor epinephrine has been used successfully for anesthesia prior to suturing linear scalp and facial lacerations in children. A triple-anesthetic gel containing benzocaine, lidocaine, and tetracaine (“BLT”) has also been reported to be effective when applied prior to laser and cosmetic procedures. Convenience of application without need for occlusion is an advantage of these topical anesthetics.

The following article concludes: “LAT gel (4% lidocaine, 1:2000 adrenaline, 0.5% tetracaine) worked as well as TAC gel (0.5% tetracaine, 1:2000 adrenaline, 11.8% cocaine) for topical anesthesia in facial and scalp lacerations. Considering the advantages of a noncontrolled substance and less expense, LAT gel appears to be better suited than TAC gel for topical anesthesia in laceration repair in children.”

Pediatrics 1995 Feb;95(2):255-8
Lidocaine adrenaline tetracaine gel versus tetracaine adrenaline cocaine gel for topical anesthesia in linear scalp and facial lacerations in children aged 5 to 17 years.

Ernst AA, Marvez E, Nick TG, Chin E, Wood E, Gonzaba WT
Department of Medicine, Louisiana State University, New Orleans.

Click here to access the PubMed abstract of this article.

The following article reported that a triple-anesthetic gel containing benzocaine, lidocaine, and tetracaine (“BLT”) applied prior to treatment with a 532-nm KTP laser resulted in significantly lower pain scores than with 3 other topical anesthetics at 15, 30, 45, and 60 minutes after application.

Cosmetic Dermatology 2003 Apr;16(4):35-7
Topical Triple-Anesthetic Gel Compared With 3 Topical Anesthetics

Lee MWC
Department of Dermatologic Surgery, University of California, San Francisco


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Pulmonary Arterial Hypertension

Sildenafil has the potential to improve hemodynamics and exercise capacity for up to 12 months in children with Pulmonary arterial hypertension (PAH), and this medication can be compounded as a stable oral suspension.

Circulation. 2005 Jun 21;111(24):3274-80
Beneficial effect of oral sildenafil therapy on childhood pulmonary arterial hypertension: twelve-month clinical trial of a single-drug, open-label, pilot study.

Humpl T, Reyes JT, Holtby H, Stephens D, Adatia I.
Department of Critical Care Medicine, Hospital for Sick Children and University of Toronto Medical School, Toronto, Canada

Click here to access the PubMed abstract of this article.

Am J Health Syst Pharm. 2006 Feb 1;63(3):254-7
Extemporaneous sildenafil citrate oral suspensions for the treatment of pulmonary hypertension in children.

Nahata MC, Morosco RS, Brady MT.
The Ohio State University, Columbus, OH 43210, USA. nahata.1@osu.edu

Click here to access the PubMed abstract of this article.


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Seizures/AED

Intranasal Midazolam for Managing Prolonged Seizures

Intranasal midazolam is a safe and practical alternative to rectal diazepam for managing prolonged seizures in non-hospitalized patients.

J Intellect Dev Disabil 2006 Sep;31(3):131-8
Community use of intranasal midazolam for managing prolonged seizures.
Click here to access the PubMed abstract of this article.

Am J Emerg Med 2006 May;24(3):343-6
Intranasal midazolam therapy for pediatric status epilepticus.
Click here to access the PubMed abstract of this article.


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Examples of compounded medications

  • BLT or LAT topical gel or spray
  • Cholestyramine ointment
  • Clotrimazole in DMSO solution
  • Fluconazole/Ibuprofen topical
  • Ivermectin topical
  • KOH solution – 5% and 10%
  • Nicotinamide/Spironolactone topical
  • Promethazine transdermal gel
  • Urea 40% plasters

The above list is just a few of the preparations that we can compound for pediatric use. We work together with prescriber and patient to solve problems, and all formulations are customized per prescription to meet the unique needs of each child.

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