HEALTHY BETIC^TM: Sugar Reducer composed of vitamins, minerals, antioxidants, and herbs that act toward normal glucose metabolism for energy production, including insulin production and secretion process, insulin transport process, glucose entry process, enzymatic reactions in the energy production process in cytosol, enzymatic reactions in the energy production process in mitochondria, energy release process, reactive oxygen species (ROS) production and reduction process, etc.

A Few functions of various vitamins, minerals, antioxidants, and herbs are outlined from various literatures as follows:

• Most of vitamins B series are essential for assembly and proper functioning of several enzymes involved in sugar metabolism and energy production processes in the body. For instance thiamin, riboflavin, pantothenic acid, niacin are all involved in the metabolic process as coenzyme like thiamine pyrophosphate (TPP), riboflavin as FADH2, pantothenic acid as coenzyme A (CoASH) and niacin/niacinamide as NADH.
• Most of the vitamins act as an antioxidant keeping cells stress free during biochemical processes, neutralizing unwanted Reactive Oxygen Species (ROS) that may be produced during the biochemical reactions. Both water soluble and fat soluble antioxidants are needed depending on where the oxidants are produced and need to be neutralized.
• These vitamins may help insulin sensitivity by decreasing insulin resistance. Vitamin D and calcium combine to improve the beta cell function and insulin sensitivity. Vitamin D also may lower the amount of C-reactive protein which is responsible for painful inflammation. Vitamin A may improve eye health.
• Vitamin C and vitamin B6 may reduce formation of Advanced Glycation End products. Reduction of (AGEs) may be beneficial to normal kidney, nerve, eye, and heart functions.
• Minerals like magnesium act as cofactors in various enzymes responsible for the glucose metabolic processes. It also improves muscle contractibility and heart muscle functions, improves relaxing of smooth muscle and may relieve stress and leg discomfort at night. Calcium and potassium play roles in the stimulus-secretion coupling process in the pancreatic beta cells. Copper, manganese and zinc also act as a co factor of various metabolic enzymes.
• Alpha lipoic acid, L-carnitine, and N-acetyl cystine also play roles as an antioxidant during metabolic processes and improve cells integrity and functionality.
• American Ginseng and Quercetin may play an important role in increasing insulin production in pancreas beta cell. Berberine may act to reduce glucose production in the liver as well as reduce glucose absorption from intestine thus helping reduce blood sugar levels.
• SUGAR REDUCER may improve: glucose utilization, energy production, fatigue, concentration, moods, and overall general health.
• Keep glucose tablets/sugar substance handy in case becomes low sugar level.
• Consult with your doctor when taking any of these supplements. Advanced Diabetes HealthTM does not provide medical advice, diagnosis or treatment.

Dietary resistant soluble fiber as maltodextrin modulate microbiota and its activities and inflammation, specially the production of anti-inflammatory short-chain fatty acids (SCFA), especially butyric acid. Increased production of SCFA is assumed to be beneficial by reducing hepatic glucose output and improving lipid homeostasis.

Dietary resistant soluble fiber as maltodextrin has the potential for improving general health through multiple mechanisms as follows: i) enhancing gut microbiota profile and production of SCFAs, ii) Improving gut barrier functions, iii) increasing gut peptides that are important in glucose homeostasis and lipid metabolism, and iv) mimicking many of the effects of calorie restriction.

The SCFAs produced in the fermentation can make substantial contribution to the maintenance energy requirement. The main SCFAs like butyric acid, the main nutrient for the intestinal lining and also serves the natural process of aerobic energy metabolism.

Pfizer recently implemented a new manufacturing process for Medrol^® (methylprednisolone tablets, USP) 2 mg Tablets. The new tablets will be formulated without the colorant and will be white. This process requires a new NDC for Medrol^® 2 mg Tablets.

Please make a note of the new NDC and product description for future reference.

Packages with the new NDC for Medrol^® 2 mg are expected to be available for shipment during the week listed above. In addition, the tablet imprint will not change. Please note the images below of the new and old tablets.

Indication(s):

Relapsing forms of multiple sclerosis (MS).

Pharmacology:

Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The mechanism by which teriflunomide exerts its therapeutic effect is unknown but may involve a reduction in the number of activated lymphocytes in CNS.

Clinical Trials:

The efficacy of teriflunomide was demonstrated in Study 1, a double-blind, placebo-controlled study that evaluated patients with relapsing forms of multiple sclerosis (RMS) over 108 weeks. A total of 1088 patients with RMS were randomized to receive 7mg (n=366) or 14mg (n=359) of teriflunomide or placebo (n=363). The primary endpoint was the annualized relapse rate (ARR). The ARR was significantly reduced in patients treated with either 7mg or 14mg of teriflunomide compared to patients who received ­placebo (0.370, 0.369 vs. 0.539, respectively).

The time to disability progression sustained for 12 weeks (as measured by at least a 1-point increase from baseline Expanded Disability Status Scale (EDSS) ≤ 5.5 or a 0.5 point increase for those with a baseline EDSS > 5.5) was statistically significantly reduced only in the teriflunomide 14mg group compared to placebo. The change in total lesion volume from baseline was significantly lower in the 7mg and 14mg groups than in the placebo group. Patients in both teriflunomide groups had significantly fewer gadolinium-enhancing lesions per T1-weighted scan than those in the placebo group.

The effect of teriflunomide on MRI activity was also demonstrated in Study 2. The mean number of unique active lesions per brain MRI scan during the 36-week treatment period was lower in patients treated with teriflunomide 14mg (0.98) and 7mg (1.06) as compared to placebo (2.69), the difference being statistically significant for both (P=0.0052 and P=0.0234, respectively).

Legal Classification:

Rx

Adults:

7mg or 14mg once daily.

Children:

Not established.

Contraindication(s):

Severe hepatic impairment. Pregnancy (Category X), women of childbearing potential not using reliable contraception. Co-administration with leflunomide.

Warnings/Precautions:

Perform accelerated elimination procedure (see literature) after drug discontinuance. Severe liver injury may be possible; obtain transaminase and bilirubin levels within 6 months before starting, monitor ALT at least monthly for 6 months after starting. Discontinue if drug-induced liver injury suspected; monitor liver tests weekly until normalized. Pre-existing liver disease: increased risk of developing elevated serum transaminases. Obtain CBCs within 6 months prior to starting. Severe immunodeficiency, bone marrow disease, or severe, uncontrolled infections: not recommended. Screen for latent TB; do not start therapy until infection resolved. Monitor BP before starting and periodically. Diabetes, >60 years: increased risk of peripheral neuropathy. Monitor for new onset or worsening pulmonary symptoms, discontinue if interstitial lung disease suspected. Male patients: undergo elimination procedure before fathering child. Nursing mothers: not recommended.

Interaction(s)

See Contraindications. Live vaccines: not recommended. Risk of liver injury with ­hepatotoxic drugs. Risk of peripheral neuropathy with neurotoxic drugs. Potentiates drugs metab­olized by CYP2C8 (eg, repaglinide, paclitaxel, ­pioglitazone, rosiglitazone), oral contraceptives. Antagonizes drugs metabolized by CYP1A2 (eg, duloxetine, alosetron, theophylline, tizanidine). Monitor INR. Concomi­tant immunosuppressives, immunomodulators: not evaluated.

Adverse Reaction(s)

ALT increased, alopecia, diarrhea, influenza, nausea, paresthesia; bone marrow suppression, immunosuppression potential, infection (consider suspending therapy), peripheral neurop­athy; hyperkalemia, acute renal failure (check K⁺ ­levels); possible severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis; ­discontinue if occurs), respiratory effects.

How Supplied:

Tabs—5, 28

SPECTRACEF^® is an effective antibiotic therapy in a patient-friendly dose pack offering convenience and promoting compliance.

Indication: SPECTRACEF^® (cefditoren pivoxil) tablets are indicated for treatment of mild to moderate infections in patients 12 years of age or older caused by susceptible strains of the following microorganisms.

SPECTRACEF dose packs provide convenience and promote compliance

Coupons available to reduce the out-of-pocket expense for SPECTRACEF patients

Important Safety Information

SPECTRACEF is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components. SPECTRACEF is contraindicated in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency, because use of SPECTRACEF causes renal excretion of carnitine. SPECTRACEF tablets contain sodium caseinate, a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered SPECTRACEF.

BEFORE THERAPY WITH SPECTRACEF (CEFDITOREN PIVOXIL) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFDITOREN PIVOXIL, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFDITOREN PIVOXIL IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG ß-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFDITOREN PIVOXIL OCCURS, THE DRUG SHOULD BE DISCONTINUED. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefditoren pivoxil, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile (C. difficile) is a primary cause of antibiotic-associated colitis.

SPECTRACEF is not recommended when prolonged antibiotic treatment is necessary, since other pivalate-containing compounds have caused clinical manifestations of carnitine deficiency when used over a period of months. As with other antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Cephalosporins may be associated with a fall in prothrombin activity.

It is not recommended that cefditoren pivoxil be taken concomitantly with antacids, H₂ receptor antagonists, or probenecid because these medications alter the absorption of SPECTRACEF.

In clinical trials with SPECTRACEF, treatment-related adverse events occurring in ≥1% of patients with cefditoren pivoxil 200 mg or 400 mg BID were diarrhea, nausea, headache, abdominal pain, vaginal moniliasis, dyspepsia, and vomiting.

Dose adjustment for moderate or severe renal impairment: The recommended maximum dose for patients with moderate renal impairment (CL_cr: 30–49 mL/min/1.73 m²) is 200 mg BID, and for patients with severe renal impairment (CL_cr: 2) is 200 mg QD. The appropriate dose in patients with end-stage renal disease has not been determined.

Please see full Prescribing Information or visit www.spectracef.com for more information.

Reference: 1. SPECTRACEF^®(cefditoren pivoxil) prescribing information, Cornerstone Therapeutics Inc. September, 2009.

SPECTRACEF is a registered trademark of Meiji Seika Kaisha, Ltd.
©2012 Methapharm Inc. All rights reserved.

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Indication(s):

Treatment of symptoms associated with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in patients ≥12 years of age.

Pharmacology:

Ciclesonide is a prodrug that is enzymatically hydrolyzed to its active metabolite, des-ciclesonide following intranasal application. Des-ciclesonide has anti-inflammatory activity with affinity for the glucocorticoid receptor that is 120 times higher than the parent compound. The precise mechanism through which ciclesonide affects allergic rhinitis symptoms is not known.

Clinical Trials:

The efficacy of Zetonna Nasal Aerosol was evaluated in one randomized, double-blind, parallel-group, multicenter, placebo-controlled dose-ranging trial (74mcg, 148mcg, and 282mcg once daily) and 3 confirmatory trials (74mcg and 148mcg once daily) involving 3,001 patients with allergic rhinitis. Patients enrolled in the trials were 12–81 years of age with a history of SAR or PAR, a positive skin test to at least one relevant allergen, and active symptoms of allergic rhinitis at study entry. Assessment of efficacy in these trials was based on patient recording of four nasal symptoms (runny nose, nasal itching, sneezing, and nasal congestion) on a 0–3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) as reflective or instantaneous total nasal symptom scores (rTNSS and iTNSS respectively). Additional secondary efficacy variables were assessed, including the total ocular symptom score (TOSS) in the SAR trials and the Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities [RQLQ(S)] in both SAR and PAR trials.

In the dose-ranging trial, the primary efficacy endpoint was the difference from placebo in the change from baseline of the average of AM and PM rTNSS averaged over the 2-week treatment period. The rTNSS showed a statistically significant estimated treatment difference from placebo of 0.81 (95% CI: 0.32, 1.29); 0.90 (95% CI: 0.40, 1.39); and 0.66 (95% CI: 0.16, 1.16) for 282mcg, 148mcg and 74mcg, respectively.

In the confirmatory SAR and PAR trials, Zetonna 74mcg once daily was statistically significantly different from placebo. The rTNSS showed a statistically significant estimated treatment difference from placebo; SAR was 0.9 (95% CI: 0.6, 1.3), and PAR was 0.7 (95% CI: 0.4, 1.0). Statistically significant differences in the AM pre-dose iTNSS indicate that the effect was maintained over the full 24-hour dosing interval for both trials. In the SAR trials, Zetonna 74mcg demonstrated a statistically significant decrease from baseline in the rTOSS compared to placebo. Similarly, a clinically significant decrease (≥ 0.5) from baseline vs. placebo for the RQLQ(S) was also shown. In the PAR trial, Zetonna 74mcg did not demonstrate a clinically significant change from baseline in the overall RQLQ(S) compared to placebo. TOSS was not evaluated in this trial. In both SAR and PAR trials, Zetonna 148mcg once daily did not provide an efficacy benefit over the 74mcg once daily dose.

Legal Classification:

Rx

Adults:

One actuation in each nostril once daily (37mcg/actuation); max 74mcg/day.

Children:

Not established.

Warnings/Precautions:

Conduct nasal examination before starting treatment. Discontinue if nasal erosion, ulceration, or perforation occurs. Active or quiescent respiratory tract tuberculosis. Infections (eg, ocular herpes simplex). If exposed to measles or chickenpox, consider immunoglobulin prophylactic therapy. If adrenal suppression exists following systemic corticosteroid therapy, replacement with topical steroids may exacerbate symptoms of adrenal insufficiency. Monitor for hypercorticism and HPA axis suppression (if occur discontinue gradually), and for candida infection and other nasal cavity changes. Monitor for growth suppression in children. Monitor for vision changes or if history of increased intraocular pressure, glaucoma or cataracts. Avoid spraying in eyes or directly onto the nasal septum. Pregnancy (Cat. C). Nursing mothers.

Interaction(s):

May be potentiated by ketoconazole.

Adverse Reaction(s):

Nasal discomfort, headache, epistaxis; ulcerations, nasal septal perforation, candida infection, impaired wound healing.

How Supplied:

Nasal aerosol—6.1g (60 actuations)