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Low Dose Naltrexone (LDN)

We frequently compound medications in doses that are not commercially available, often for other uses than the higher dose manufactured products. For example, naltrexone is a drug that is commercially available only as 50 mg oral tablets which are used to help manage alcohol or opioid dependence ("addiction"). Accumulating evidence indicates that low dose naltrexone (LDN) can stimulate the immune system and reduce autoimmune and cancer processes. LDN may also play a role in healing and repair of tissues, as well as relieving stress, helping with social bonding emotional well-being, and improving symptoms of autism and depression. Yet, it is doubtful that large scale studies will ever be done to investigate potential indications for the much lower dose of naltrexone (3.0-4.5 mg orally, taken once daily at bedtime) "because there's no profit motive to fund research on an inexpensive drug with an expired patent."

Med Hypotheses. 2009 Mar;72(3):333-7.
Health and Healing. May 2010. Vol. 20, No. 5

The safety and efficacy of Low Dose Naltrexone (LDN) were tested in patients with active Crohn's disease. 89% of patients responded to therapy and 67% achieved a remission. Quality of the patients' lives improved.

Am J Gastroenterol. 2007 Apr;102(4):820-8.

A study at the Multiple Sclerosis Center at the University of California in San Francisco evaluated the benefit of eight weeks of treatment with 4.5 mg naltrexone (LDN), taken each night at bedtime, on quality of life of in MS patients. 80 subjects with clinically confirmed multiple sclerosis were enrolled and 60 subjects completed the trial. LDN was well tolerated and serious side events did not occur. LDN was associated with significant improvement on mental health quality of life surveys.

Annals of Neurology, Volume 9999, Issue 999A, Feb 2010

At the Integrative Medical Center of New Mexico and New Mexico State University, a protocol utilizing LDN and intravenous alpha-lipoic acid (ALA/LDN) and a healthy lifestyle program has produced long-term survival without toxic side effects for patients with pancreatic cancer with or without metastases. Berkson and Rubin described the case of a male patient with pancreatic cancer and metastases to the liver who was told by a reputable university oncology center in October 2002 that there was little hope for his survival. In a followup report, the patient was alive and well 78 months after initial presentation: back at work, free from symptoms, and without appreciable progression of his malignancy. Three additional pancreatic cancer case studies were published in December, 2009. At that time, the first patient, GB, was alive and well 39 months after presenting with adenocarcinoma of the pancreas with metastases to the liver. The second patient, JK, who presented to the clinic with the same diagnosis was treated with the ALA/N protocol and after 5 months of therapy, PET scan demonstrated no evidence of disease. The third patient, RC, in addition to his pancreatic cancer with liver and retroperitoneal metastases, had a history of B-cell lymphoma and prostate adenocarcinoma. After 4 months of the ALA/LDN protocol, his PET scan demonstrated no signs of cancer. The authors discussed the value of alpha-lipoic acid as an agent that reduces oxidative stress and its discriminative ability to discourage the proliferation of malignant cells; plus the ability of low dose naltrexone to stimulate the immune system.

Integr Cancer Ther. 2009 Dec;8(4):416-22. Integr Cancer Ther. 2006 Mar;5(1):83-9.

Notes:

We are not suggesting that LDN be used in place of other treatment for cancer, but that it may be a reasonable adjunctive therapy.

Although sleep disturbances are rare, some patients using LDN have reported vivid dreams. To avoid this, therapy can be started with a lower dose and increased slowly over two months.

Low Dose Naltrexone (LDN) is available only by prescription from compounding pharmacies.

Copyright 2010, Storey Marketing - Compounding News. All rights reserved.

Fibromyalgia

Fibromyalgia (FM) is a common and potentially debilitating condition that can negatively impact every area of a person's life. This chronic painful condition, formerly called fibrositis, affects mainly women, with an onset at ages 25-50 years. FM is characterized by muscle aches, stiffness and localized tender points. Related symptoms include chronic insomnia, anxiety, depression, headaches, numbness, extreme fatigue and digestive problems. Patients commonly complain of widespread pain and tenderness, and exhaustion after minimal effort. Often they feel unrested after sleep, although sleep laboratory tests are usually normal. Pain can be so severe that it is often incapacitating; yet pathophysiologic or laboratory reports may not show any abnormalities. FM resembles Chronic Fatigue Immuno-Deficiency Syndrome (CFIDS), and FM occurs more frequently in women with Polycystic Ovary Syndrome (PCOS). Anxiety levels are also increased, particularly in women with concomitant FM and PCOS.

Fortunately, lifestyle and environmental changes, sometimes coupled with appropriate medications, can relieve symptoms or even make them disappear.  Medications such as antidepressants and muscle relaxants, are often used to treat FM. Pregabalin (Lyrica) and Milnacipran (Savella) are FDA-approved for the management of fibromyalgia, but are not effective in all patients, so there is continuous research to find other therapies. Gabapentin is a medication that is similar to pregabalin and has been shown to relieve FM pain.

Physicians and researchers at the Stanford Systems Neuroscience and Pain Lab are currently investigating whether the thyroid hormone T3 is one such treatment that may alleviate the symptoms of fibromyalgia. There is significant overlap between the symptoms of hypothyroidism (low thyroid hormone production), depression, chronic fatigue, and FM. Patients with low thyroid hormone production who have been treated with T3 for depression have had some improvement in symptoms. This is the first study to examine whether T3 may help with the symptoms of FM.  

Also, at Stanford University, a single-blind, crossover trial showed that Low Dose Naltrexone (LDN) produced a significant reduction in fibromyalgia symptoms. In addition, pain thresholds were improved by LDN. Side effects (including insomnia and vivid dreams) were rare, and described as minor and transient. At higher doses (50mg - 100mg), naltrexone is a drug used to block the effects of opioids. However, at low doses (less than 5mg), naltrexone may have the reverse effect and actually strengthen analgesia. While the exact mechanism of this action is unknown, it is possible that low doses of naltrexone block the receptors on glial cells that are responsible for fibromyalgia symptoms. The drug has been used for many years off-label for the treatment of fibromyalgia, although this is the first clinical study.

Vitamin B-12 levels are often low in patients with fibromyalgia or Chronic Fatigue Syndrome. A malfunctioning thyroid or adrenal gland can decrease the ability of the body to absorb and utilize vitamin B-12. Vitamin B-12 is necessary for a healthy nervous system; it has been known for many years that depression and fatigue can be caused by low B-12 levels. SAMe is a supplement with anti-inflammatory, analgesic, and antidepressant effects. Malic acid and magnesium may help to relieve pain and tenderness of fibromyalgia. Ask our compounding pharmacist about the most appropriate supplements.

Evidence continues to emerge about the importance of hormone balance. For optimal benefit, therapy should be individualized with multiple problems treated simultaneously. Studies have reported that there is an altered hypothalamic-pituitary-adrenal axis (HPA axis) in CFIDS/FM, which means that the various glands that produce the body's essential hormones may not respond to stimuli or feedback from another gland in a normal manner. This leads to altered function that is often overlooked when interpreting standard blood tests. Patients with CFIDS/FM typically have a number of hormonal deficiencies that must be addressed concurrently to assure successful treatment.

Low Dose Naltrexone (LDN) is available by prescription only from compounding pharmacies. We can also customize hormone therapy, including T3, to treat problems that have not responded to conventional therapy.

Copyright 2010, Storey Marketing - Compounding News. All rights reserved.

Restoring Hormonal Balance

Bioidentical Hormone Therapy (BHT) is the replacement of deficient hormones with hormones that are chemically identical to those that the body naturally produces, but which have declined due to aging or illness. BHT has improved the quality of life for millions of women who suffer from hormonal imbalance. The ideal process for achieving hormonal balance includes an assessment of hormone levels and complete evaluation of signs and symptoms, followed by replacement of the deficient hormones in the most appropriate dose via the most effective route for each woman, and monitoring to fine tune the therapy.

Estrogen is prescribed to relieve menopausal symptoms and treat postmenopausal problems such as vaginal dryness and tissue breakdown, painful intercourse, and various urinary disorders. Estrogens have been shown to decrease the risks of osteoporosis and colorectal cancer.

Progesterone is commonly prescribed for perimenopausal women to counteract "estrogen dominance", minimizes the risk of endometrial cancer in women who are receiving estrogen, and may enhance the beneficial effect of estrogen on lipid and cholesterol profiles. We do NOT recommend the use of synthetic imitations of progesterone, such as medroxyprogesterone acetate, which do not confer all of the benefits of natural progesterone.

Androgens are a class of hormones that include DHEA and testosterone, which are normally produced in a young healthy woman, and are important for libido as well as integrity of skin, bone, and muscle. When women enter menopause, testosterone and DHEA levels may decline. Experts now recognize the importance of supplementing androgens for women who are deficient. While women have benefited from therapy with bioidentical estrogens, progesterone, and androgens, researchers and health care professionals realize that this is just the "tip of the iceberg" when it comes to achieving hormonal balance. Thyroid and adrenal function, as well as nutritional status, should also be evaluated and treated when indicated.

Copyright 2010, Storey Marketing - Compounding News. All rights reserved.

Thyroid Hormone: T4-T3 Combination Therapy

Thyroid Hormone (TH) is produced by the thyroid gland in response to the release of thyroid stimulating hormone (TSH) from the pituitary gland. TH helps the body convert food into energy and heat, regulates body temperature, and impacts many other hormonal systems in the body.

TH exists in two major forms: thyroxine (T4), an inactive form that is produced exclusively by the thyroid gland; and triiodothyronine (T3), the active form of thyroid hormone. About 20 percent of T3 is produced by the thyroid gland, with the remainder produced through conversion of T4 in various tissues of the body when more T3 is needed. Some people may transform T4 into a non-usable form called Reverse T3.

TH helps control heart rate and blood pressure and therefore TH imbalance has a profound effect on cardiovascular fitness. When TH levels drop, the liver no longer functions properly and produces excess cholesterol, fatty acids, and triglycerides, which increase the risk of heart disease. Hypothyroidism (low levels of thyroid hormone) is the second leading cause of high cholesterol, after diet. High cholesterol may also increase the risk of Alzheimer's disease, and severe hypothyroidism can cause symptoms similar to those of Alzheimer's disease.

The drug most commonly used to treat hypothyroidism is a type of T4 known as levothyroxine (brand name Synthroid®). A study published in December 2009 in the European Journal of Endocrinology evaluated quality of life, depression and anxiety rating scales and patients' preferences and concluded that a combination of T4/T3 is superior to treatment with only T4 (levothyroxine) for hypothyroidism.

Some previous studies have shown the superiority of the combination therapy while others have found no difference. This inconsistency has led some experts to conclude that there is no benefit of using T3 for thyroid hormone therapy. Doctors often point to the risk of side effects with T3 therapy as a reason not to use T3, but the above mentioned study, which replaced part of the T4 dose with 20 mcg of T3, showed that there was no difference with regard to side effects. According to the authors, during the T4/T3 combination therapy, five people experienced side effects including palpitations, excessive sweating, and psychological instability. During the T4-only therapy, nine people reported the same side effects.

The theory behind the use of synthetic T4 alone (levothyroxine) is that the thyroid makes T4 which the body converts to T3. However, in some people, the conversion to T3 may be inadequate, and this is why T3 may therapy may also be needed in some patients. Synthetic T3 (liothyronine) is commercially available only as an immediate-acting preparation, which may cause undesirable side effects including heart palpitations in the recommended dose of 50-100 mcg. That is why some practitioners choose to use lower doses of T3 or provide T3 as a sustained release preparation, both of which are available from our compounding pharmacy.

Armour Thyroid® (Desiccated Natural Thyroid, Thyroid USP) is a blend of T4-T3 that is also used to treat hypothyroidism. Many patients prefer Desiccated Natural Thyroid, reporting that they simply do not feel as well when they take levothyroxine alone or with liothyronine. Recently, there has been a nationwide shortage of Armour Thyroid® in some strengths, and the manufacturer has not indicated any date when all strengths of the product will be back on the market.

Currently, Desiccated Natural Thyroid - Thyroid USP (porcine) - is available in all strengths only through compounding pharmacies. The specifications for Thyroid USP (porcine) powder require that each grain contains levothyroxine (T4) 34.2-41.8 mcg and liothyronine (T3) 8.1-9.9 mcg. This produces a T4:T3 ratio of 4.22:1 to meet the stringent standards for a U.S. Pharmacopeia monograph, with a permissible variance of ± 10%.

By prescription, we can compound Thyroid USP in the doses that your patients need, and can omit problem-causing fillers and excipients that are found in the commercial product but may not be tolerated by all patients. We welcome your questions and the opportunity to work with patients and their health care providers to solve medication problems.

Copyright 2010, Storey Marketing - Compounding News. All rights reserved.

Preventing and Treating Bug Bites and Plant Irritations

Our patients often tell us that they are concerned about using commercially available insect repellants, especially for children. And, some people simply can't tolerate the smell of "bug sprays". We can compound customized preparations to help prevent bug bites, often using natural ingredients.

• Catnip Oil is a natural mosquito repellent that can be applied to skin without the dangers associated with DEET. Catnip oil should be prepared as a topical solution or spray containing 1 to 5% of the essential oil. Rosemary oil can be added for additional effect.
• Citronella spray can be applied to clothing without the concerns associated with DEET.
• Red Bug Remedy and preparations to reduce and treat chigger bites can be compounded for our patients in the South and coastal areas.

When insects or plants that cause irritation have managed to find you without adequate protection, we have solutions to keep you comfortable:

• Itch relief spray contains multiple ingredients (hydrocortisone, pramoxine and menthol, with or without diphenhydramine) to relieve inflammation, itching, and sooth the discomfort.
• Pink paste is calamine lotion which dries the weeping from bug bites and provides temporary relief of pain and itching, with aluminum sulfate which can help to relieve the stinging associated with bug bites.

Seasonal changes and travel to different environments will present challenges, and we are here to help. We will work with you and your doctor to plan ahead and often prevent medication problems.

Copyright 2010, Storey Marketing - Compounding News. All rights reserved.

Drugs Used to Improve Bone Density May Actually Increase Risk of Fractures

Bisphosphonates are a class of drugs commonly used to treat osteoporosis, and include alendronate, etidronate, risedronate, and zoledronic acid. Bisphosphonates are designed to slow or stop the bone loss that occurs during the body's natural process that involves removal and replacement of bone tissue. In March 2010, at the annual meeting of the American Academy of Orthopaedic Surgeons, reports suggested that if bisphosphonates are used for four or more years, they may actually impair bone quality and increase the risk of certain bone fractures. Two separate studies by researchers from the Hospital for Special Surgery (HSS) and Columbia University Medical Center revealed data suggesting that long-term suppression of bone remodeling with bisphosphonates may alter the material properties of bone, potentially resulting in brittle bone and contributing to the risk of atypical fractures.
http://www3.aaos.org/education/anmeet/anmt2010/podium/podium.cfm?Pevent=339
Accessed March 22, 2010

Bisphosphonates have also been associated with osteonecrosis of the jaw (ONJ), an uncommon but potentially serious condition that can cause severe destruction of the jaw. Initially, it was thought that the greatest risk was in patients with cancer who received treatment with intravenous bisphosphonates. However, a recent study at the University of Southern California found that ONJ caused by oral aledronate was more common than previously suggested. The jaw problem was found in 9 of 208 patients receiving oral alendronate, or approximately 4% of the population. The findings from this study indicated that even short-term oral use of alendronate led to ONJ in a subset of patients after certain dental procedures were performed.
J Am Dent Assoc. 2009 Jan; 140(1):61-6.

Concerns about bisphosphonates have prompted many people to search for other forms of therapy to improve bone density and prevent osteoporosis.

Declining estrogen levels after menopause result in bone loss and increased fracture risk. Estrogen levels can be increased with transdermal estradiol, which is well tolerated and similarly effective to raloxifene (a drug approved for the prevention and treatment of postmenopausal osteoporosis) in preventing bone loss.
Menopause. 2009 May-Jun; 16(3):559-65.

In addition, we recommend that both men and women utilize a broad-spectrum bone support program beyond the basic calcium/magnesium/vitamin D in order to optimize bone density and quality and to reduce the risk of osteoporosis.

Copyright 2010, Storey Marketing - Compounding News. All rights reserved.

Clearing Up Fungal Nail

The first sign of a fungal nail infection is discoloration - yellow or white opacity - of the nail, most commonly on the big (great) toe. If left untreated, toenails can become thick, causing pressure and irritation, and thus act as a trigger for more severe complications. This can be particularly problematic in elderly patients and patients with diabetes, because fungal nail (clinically known as onychomycosis) is among the most significant predictors of foot ulcer, which can ultimately lead to severe infection and even amputation. As the severity of onychomycosis may be associated with the length of time the individual has had the infection, early intervention is advisable.  

Conventional therapy involves taking oral antifungal drugs for several months. When these medications are taken orally, the patient must have baseline and regular lab work to monitor liver function, as these medications can be harmful to the liver. The reason that topical antifungals typically are not used to treat fungal nail is that most commercially available topical creams are unable to penetrate the nail to reach the site of infection. Our compounding pharmacy can solve this problem by preparing customized formulations containing a penetration enhancer to increase the extent of absorption through the nail. When selecting the best form of treatment, the practitioner needs to consider the cause of the infection, other medications that the patient is taking in order to avoid drug interactions, and the potential for adverse events associated with antifungal therapy.  Topical treatment of onychomycosis offers a distinct advantage to oral therapy. Because topical preparations can be applied directly to the affected area and therefore result in lower drug levels in the blood, the potential for serious problems associated with oral antifungal therapy, such as drug interactions and liver problems, is decreased. Ask our compounding pharmacist for more information on customized therapies for fungal nail.

Am J Clin Dermatol. 2009;10(4):211-20.
J Dermatolog Treat. 2005 Feb;16(1):52-5
J Cutan Med Surg. 2004 Jan-Feb;8(1):25-30.
J Cutan Med Surg. 2004 Jan-Feb;8(1):25-30.
Prescrire Int. 2009 Feb;18(99):26-30.

Copyright 2010, Storey Marketing - Compounding News. All rights reserved.

Pure Sesame Oil for Treatment of Dry Nasal Mucosa

Many people experience problems with dryness of the tissue lining the inside of the nose, which is worse during the winter, in warm and dry inland climates or deserts, and after nasal irradiation. Complaints of nasal dryness may occur in situations involving low humidity including long journeys by airplane and air-conditioned environments. Normal saline (Isotonic sodium chloride solution; ISCS) has long been the most commonly used therapy for nasal dryness. But, it has been shown that normal saline produces little change and pure pharmaceutical grade sesame oil has been shown to be significantly more effective than normal saline for treatment of nasal dryness.

Our compounding pharmacy can place pure pharmaceutical grade sesame oil in a nasal spray. The recommended dose is 1 to 3 sprays in each nostril 3 times daily.

In studies, a few patients reported allergies to sesame seed. However, when they received oral 1-ml doses of pharmaceutical quality pure sesame oil, no allergic reactions were observed. Pharmaceutical grade pure sesame oil does not contain the proteins that typically cause allergic reactions.

Sesame oil contains a high concentration of tocopherols (vitamin E) that might neutralize oxidants and prevent tissue damage and inflammation that would otherwise occur.

Rhinology 2000 Dec;38(4):200-3
Arch Otolaryngol Head Neck Surg 2001 Nov;127:1353-1356

Copyright 2010, Storey Marketing - Compounding News. All rights reserved.

Medication Changes Needed after Gastric Bypass

Bariatric surgery is done to help patients lose weight, control diabetes, and improve cardiovascular risk. Roux-en-Y gastric bypass reduces the stomach size and bypasses part of the small intestine to limit absorption, and therefore medication form and doses may need to be adjusted after surgery. For example, patients should use liquid or non-oral meds (such as a transdermal gel) for weeks to months after bypass surgery to allow healing. It is important to avoid medications that contain sugar, sucrose, corn syrup, maltose, fructose, lactose, honey, mannitol, and sorbitol to reduce symptoms of dumping syndrome (nausea, pain, diarrhea, sweating, rapid heart rate, or fainting). We can compound medications that are free of these problem- causing additives.

After bypass surgery, absorption is unpredictable due to the shortened intestine, and medications should be switched to "immediate release" versus extended-release or enteric-coated forms. Our compounding pharmacist will work together with patients and their physicians to customize medication doses to meet each patient's specific needs.

When people lose weight, medications for problems such as diabetes and hypertension may no longer be necessary. Birth control may need to be changed

Due to decreased absorption of nutrients, patients who have had a Roux-en-Y procedure may need to increase their consumption of calcium, fat-soluble vitamins (especially vitamin D), folic acid, iron, thiamine, and vitamin B12. Ask our professional staff to recommend quality supplements.

Copyright 2009, Storey Marketing - Compounding News. All rights reserved.

Complex Regional Pain Syndrome (CRPS)

CRPS, also known as Reflex Sympathetic Dystrophy (RSD), is a complicated pain problem. The key symptom of CRPS is continuous, intense pain out of proportion to the severity of the initial injury, which may be as severe as a bullet wound or as simple as a sprained ankle, or even surgery. CRPS most often affects one of the arms, legs, hands, or feet, and is characterized by severe pain and progressive physical changes that persist long after the original injury has healed. Victims of CRPS usually describe the pain as burning or shooting with extreme sensitivity to touch. For example, an article of clothing rubbing the affected area will often cause severe, extraordinary discomfort.

CRPS develops slowly. Initially the area may appear swollen and feel warm due to inflammation, then the blood supply to the area diminishes and the area feels cool. The skin becomes shiny and waxy and there is a loss of hair and skin tone. Finally, there is wasting of the affected muscles and disabling pain which can become permanent.

Because of the complicated and progressive nature of this potentially devastating pain syndrome, treatment must be aggressive and must focus on rehabilitation as well as pain management. Doctors may prescribe topical gels that contain analgesics including NSAIDs, NMDA- receptor antagonists, tri-cyclic antidepressants, corticosteroids, and AEDs. Steroids may be prescribed short term to relieve symptoms and arrest their progression. Antidepressants are used to improve sleep and inhibit pain pathways. Anticonvulsants and oral anesthetic agents may also be helpful for CRPS. Nerve blocks are used to break the pain cycle and prevent progression of symptoms. Physical therapy is very important for pain relief and to maintain muscle strength and mobility. Biofeedback can assist individuals in learning to control blood flow and muscle tension to lessen symptoms.

Copyright 2009, Storey Marketing - Compounding News. All rights reserved.

FIGHTING OFF THE FLU

H1N1 is a virus that was first detected in people in the United States in April 2009. This virus was originally referred to as "swine flu" because laboratory testing showed that many of the genes in this new virus were very similar to influenza viruses that normally occur in pigs. But further study has shown that this new virus is very different from what normally circulates in North American pigs. Flu symptoms include:

• fever (not everyone with flu will have a fever)
• diarrhea and vomiting (sometimes)
• runny or stuffy nose, cough, sore throat
• body aches, headache
• chills, fatigue

Influenza is thought to spread from person-to-person mainly when infected people cough or sneeze. In 2009, most people with seasonal flu or H1N1 have had mild illness and have not needed medical care or antiviral drugs. However, some people are more likely to get flu complications, such as children younger than 5 years, adults 65 and older, pregnant women, and people who have weakened immune systems or cancer, lung disease, diabetes, or chronic disorders such as heart, kidney or liver disease. Also, it's possible for healthy people to develop severe illness from the flu so anyone concerned about their illness should consult a health care provider. The seasonal flu vaccine is not expected to protect against the 2009 H1N1 flu. The Centers for Disease Control (CDC) has issued guidelines for the 2009 H1N1 vaccine (www.cdc.gov).

Proper nutritional support can strengthen your immune system. The following supplements may help to reduce your risk of infection, as well as shorten the duration of symptoms if you do get the flu or a cold: Vitamin C, Zinc, Echinacea, Goldenseal, Elderberry extract, Astragalus, Beta 1- 3 glucan, Coenzyme Q10 (CoQ10), Vitamin D3, and Probiotics. Ask our pharmacist or professional staff to recommend a quality nutritional supplement.

In addition to fortifying your immune system, take everyday actions to stay healthy, such as covering your nose and mouth when you cough and sneeze, washing your hands often, and avoid touching your eyes, nose and mouth which promotes germ spread.

Tamiflu® Shortages - Tamiflu® is a medication which is a prescribed for more serious cases of H1N1 and seasonal flu. Tamiflu® is prescribed as a suspension for children, and our professional compounding staff can assist by compounding this suspension when the manufactured product is not available.

Our compounding pharmacy makes it easy to take your medicine, with customized dosage forms like lozenges and lollipops, medications in topical and transdermal creams and gels which can be absorbed through the skin, and pleasantly-flavored suspensions.

Copyright 2009, Storey Marketing - Compounding News. All rights reserved.

Low-Dose Naltrexone (LDN) for Autoimmune Disorders

Naltrexone is a medication that blocks the effects of drugs known as opioids such as morphine, heroin or codeine). It was originally used to treat dependence on opioid drugs but has recently been approved by the FDA as treatment for alcoholism.   

Low-dose naltrexone (LDN) has been used for over a decade for the treatment and prevention of various disorders. Accumulating evidence suggests that LDN can promote health by supporting immune function which may reduce various cancer and inflammatory autoimmune processes.

In 2005, the University of Iowa College of Medicine reported that there is overwhelming anecdotal evidence that in low doses naltrexone not only prevents relapses in multiple sclerosis (MS) but also reduces the progression of the disease. In 2008, a sixth month phase II multicenter- pilot trial of LDN was carried out in 40 patients with primary progressive multiple sclerosis (PPMS), and concluded "our data clearly indicate that LDN is safe and well tolerated in patients with PPMS."

Opioid antagonists such as naltrexone have been shown to play a role in healing and repair of tissues. In an open-labeled pilot prospective trial, LDN was reported to be well tolerated and clinically effective in patients with active Crohn's disease.

At low doses (4.5 mg), naltrexone may reverse central and peripheral inflammation. In a pilot clinical trial at the Division of Pain Management, Stanford University, the effectiveness of low- dose naltrexone in treating the symptoms of fibromyalgia was evaluated. Low-dose naltrexone therapy resulted in greater than 30% reduction of symptoms of fibromyalgia. Pain thresholds were improved by the drug. Side effects were rare, minor and transient. Researchers concluded that low- dose naltrexone may be an effective, highly tolerable, and inexpensive treatment for fibromyalgia.

Med Hypotheses. 2009 Mar;72(3):333-7.
Med Hypotheses 2005; 64(4):721-4
Mult Scler. 2008 Sep;14(8):1076-83.
Am J Gastroenterol. 2007 Apr;102(4):820-8.
Pain Med. 2009 May-Jun;10(4):663-72.

Copyright 2009, Storey Marketing - Compounding News. All rights reserved.

Suppositories-Rectal and Vaginal Therapy

The rectal route of administration can be used effectively when other routes of administration (oral, topical, injectable) are inadequate or unsuitable, or unacceptable to the patient; or to treat local infection, disease, or inflammation. Many hospice patients who are no longer able to take oral medications benefit from rectal administration, which may offer an alternative to intravenous therapy or IM or SC injections. Medications that have been administered rectally include analgesics, antibiotics, anti-seizure medications, corticosteroids and anesthetics, healing agents to treat radiation induced proctitis, and therapy for inflammatory disease or hemorrhoids.

Vaginal suppositories (pessaries) are particularly useful for local administration of hormones (for vaginal dryness or tissue breakdown, or to maintain pregnancy) or antibiotics. Suppositories melt or soften at body temperature and are less messy than creams.

Because the rate and extent of absorption vary between routes of administration, dosage adjustments are frequently required. When drugs are administered orally, they are absorbed from the gastrointestinal tract and pass through the liver (first pass) where the process of drug metabolism begins. Suppositories, like intravenous (IV), intramuscular (IM), and other transdermal methods of administration, bypass the "first pass" effect and go directly into the bloodstream without first encountering liver metabolism. This can be an important consideration when patients have fluctuating or declining hepatic function.

Ask us about:
Mesalamine (5-ASA) Suppositories in Remission Maintenance of Ulcerative Proctitis
Topical Therapies for Anal Fissure
Oxybutynin Rectal Suppositories for Treatment of Incontinence
Progesterone Vaginal Suppositories for the Prevention of Preterm Birth
Metronidazole Vaginal Suppositories to Treat Infections

Copyright 2009, Storey Marketing - Compounding News. All rights reserved.

Biomedical Therapies for Autism

Autism Spectrum Disorder (ASD), also known as Pervasive Developmental Disorder (PDD), is a complex neurodevelopmental disorder characterized by deficits in social interaction, language development, and a restricted or stereotypical pattern of interests and activities. The prevalence of autism has increased more than tenfold in the past 20 years, and recent reports indicate the incidence is 65 per 10,000 children.

A 2006 study showed that 74% of families of children with ASD were using some type of Complementary Alternative Medicine (CAM) therapy. The highest frequency of CAM use involves "biologically based" therapies, including modified diets, vitamins and minerals, and other nutritional supplements. The basis of a biomedical approach is that autism is a genetically- based disorder triggered by certain fetal, neonatal, and early childhood stimuli, and that this syndrome is associated with a variety of nutritional, gastrointestional, metabolic, and autoimmune abnormalities that can be partially or fully corrected.

Dysbiosis, or abnormalities of gastrointestinal microflora, is a common problem in children with autism. Studies have found that treatment with a non-absorbable antibiotic normalized the flora and that GI symptoms and autistic behaviors decreased significantly. Many children with ASD improve on specific diets and gut therapy. The Autism Research Institute reported that 63% of 1109 children improved on a casein-free/gluten-free diet, according to parent rating scales. Another GI abnormality commonly attributed to children who have autism is called the "leaky gut" phenomena, related to a theorized increased intestinal permeability. An overgrowth of yeast is widely believed part of dysbiosis and responsible for many GI and behavioral symptoms of autism, and many children are treated with antifungal agents as part of their "bowel detoxification" protocol.

Studies have demonstrated abnormalities in the metabolic functioning of autistic children. Metabolic interventions are based on the theory that autistic children have defects in methylation and sulfation and include the use of methylcobolamin, folic acid derivatives (eg, folinic acid), and trimethylglycine or dimethylglycine and other methylating agents to increase language and social functioning.

There have been 14 clinical trials of naltrexone for children with autism. "Naltrexone has been … found to be predominantly effective in decreasing self-injurious behavior. Naltrexone may also attenuate hyperactivity, agitation, irritability, temper tantrums, social withdrawal, and stereotyped behaviors. Patients may also exhibit improved attention and eye contact. Transient sedation was the most commonly reported adverse event."1 It has been suggested that low-dose naltrexone, at about 3-5 mg/day, may be beneficial for children with autism and may improve the regulation of their immune system.

The Autism Research Institute is a nonprofit organization of parents and professionals that supports dissemination of information about causes and treatment of ASD, and sponsors workshops and conferences. A series of treatments has been proposed by a group of practitioners who have joined together as Defeat Autism Now! (DAN!™).  Much of the support for these treatments is predicated on subjective data from practitioners and has not been substantiated by data published in peer-reviewed literature.

Our compounding pharmacists can customize medications to help solve problems associated with autism.

• Medications that are free of casein (dairy protein), gluten (wheat protein), corn, egg, and soy
• Sugar-free medications, t reduce the growth of yeast
• Non-oral dosage forms (transdermal, rectal, nasal, injectable) for patients wh have poor gut absorption secondary t inflammation, oxidative stress, and infections
• Dose and flavor specific for each patient

Examples of requested compounded prescription medications include:

• Oral liquids or capsules of antifungals such as amphotericin B, diflucan, ketoconazole, and itraconazole
• Oral liquids or capsules of "nonabsorbable" antibiotics, such as vancomycin t regulate gut microflora
• Detoxifiers and chelators such as DMSA, CaEDTA, and TTFD
• Antioxidants in oral, transdermal, and nebulized forms, such as GSH, NAC, and ALA
• Transdermal Low Dose Naltrexone (LDN)
• Vitamin formulations such as transdermal, nasal, and subcutaneous methylated B12 and hydroxyl B12; transdermal B complex, and transdermal Pyridoxal-5-Phosphate

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Relief for Excessive Sweating

Excessive sweating, or hyperhidrosis, is a socially embarrassing disorder that can affect the soles of the hands and feet, armpits, and face and scalp. Glycopyrrolate is a medication that can be compounded as a solution or cream that can be applied topically. The value of glycopyrrolate creams and lotions in strengths of 0.5% to 2% has been assessed in numerous double-blind studies, and the preparation has been shown to be effective in the treatment of hyperhidrosis after other treatments were ineffective. In one study, compared to placebo, glycopyrrolate decreased an induced sweat response by 82%.

Facial gustatory sweating (also called Frey's syndrome) is a fairly common manifestation of diabetes mellitus. Commercial topical antiperspirants have been investigated and found to be of limited benefit, and when this sweating is treated with oral drugs known as "anti- cholinergics", unacceptable side effects frequently result. The application of 1% glycopyrrolate roll-on lotion and cream was associated with an average of three days of complete control of gustatory sweating and a remarkably low incidence of side effects. The frequency of episodes of gustatory sweating during the treatment period was also reduced by 51%, with a nearly 100% reduction in the frequency of episodes of severe sweating. In one study, sweating reappeared when glycopyrrolate was briefly withdrawn to confirm its therapeutic effect.

Studies have concluded that topical application of glycopyrrolate is safe, effective and convenient. Generally, patients tolerate the preparation well, although some patients have reported side effects of blurred vision and dry mouth.

Br J Dermatol. 2008 May;158(5):1094-7 - Dermatol Ther. 2008 Sep-Oct;21(5):406-8 - Australas J Dermatol. 2004 Nov;45(4):208-12 - Arch Intern Med 1999 Apr 26;159(8):877-8 - Clin Exp Dermatol 1998 Sep;23(5):204-5 Diabetologia 1997 Mar;40(3):299-301 - Head Neck 1989 Jan- Feb;11(1):85-9 - Otolaryngol Head Neck Surg 1982 Jul-Aug;90(4):419-25

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