Vol - 1 Issue - 3 Oct. - Dec. 2016

Editorial

Safety Alerts

Safety Alets & New Drug Approval

Counseling Tips for Antidiabetic Drugs

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Common Antidiabetic Drugs and Counseling Tips

Vol - 1 Issue - 3 Oct. - Dec. 2016

Generic Mechanisim of Action Administratiom Medication Counseling

METFORMIN HYDROCHLORIDE.

* Improves glucose tolerance in patients with type 2 diabetes * Lowers both basal and postprandial plas-ma glucose by de-creasing hepatic glu-cose production and intestinal absorption * Improves insulin sensitivity by increas-ing peripheral glucose uptake and utilization.

* (Immediate-release tab-lets, oral solution) give with meals. * (Extended release tablets) give with the evening meal. Swallow whole; never crush or chew. * Do not administer at the time of and 48 hours after radiologic studies involving intravascular iodinated con-trast materials; reinstitute only after confirming renal function is normal; lactic acidosis has been associated with studies done in pa-tients receiving metformin .

* Drug may cause diarrhea, dyspepsia, flatulence, nausea, vomiting, hyper- or hypoglycemia, or asthe-nia. * Report signs/symptoms of lactic acidosis (nausea, vomiting, abdominal pain, tachypnea). Elderly pa-tients (80 years and older) are at increased risk. * Take tablets with meals and extended-release tablets with the evening meal. * Maintain adequate hydration to prevent renal dys-function. * Notify healthcare provider of metformin use before having radiologic studies using IV dye. * Do not drink alcohol while taking this drug.

GLIPIZIDE

* Belongs to the sul-fonylurea class. * Acts by stimulat-ing insulin secretion from functioning beta cells in the pan-creas, especially in response to a meal. * May also increase insulin sensitivity and lower hepatic glucose production.

* (Immediate-release) Take approximately 30 minutes before a meal (preferably breakfast). * (Extended-release) Take with breakfast or the first meal of day. Do not break, crush, dissolve, chew, or cut tablets.

* Avoid activities requiring coordination un-til drug effects are realized, as drug may cause dizziness. * The drug may cause cutaneous hypersensi-tivity, diarrhea, nausea, or headache. * Immediately report signs/symptoms of Ste-vens-Johnson syndrome (flu-like symptoms, spreading red rash, or skin/mucous mem-brane blistering). * Monitor for signs/symptoms of hyper- or hypoglycemia and report difficulties with glycemic control, especially during times of stress caused by infection, fever, trauma, or surgery. * Tablet should be taken 30 min before a meal, preferably breakfast.

GLIMEPIRIDE

* Lowers blood glucose in patients with type 2 diabetes by stimulating the release of insulin from functioning pan-creatic beta cells. *Also produces an in-crease in the sensitivity of peripheral tissues to insulin via an extrapan-creatic mechanism.

* Take with breakfast or the first main meal

* Administer at least 4 hours prior to Co-lesevelam if used concomitantly

* Drug may cause severe hypoglycemia that may im-pair concentration and reaction times. * Use caution when doing activities requiring mental alertness or coordination, such as driving a car or op-erating heavy machinery. * The drug may cause nausea, asthenia, flu-syndrome, headache, or dizziness.. * Monitor for signs/symptoms of hypoglycemia. * Take drug with breakfast or first main meal of the day. * There are multiple significant drug-drug interactions for this drug. Consult healthcare professional prior to new drug use (including OTC and herbal drugs). * Do not drink alcohol while taking this drug.

ACARBOSE

* Lowers p.p. blood glu-cose concentrations by competitive, reversible inhibition of pancreatic alpha-amylase and mem-brane-bound intestinal alpha-glucoside hydro-lases

* Take with the first bite of food at each main meal

* Concurrent use with sulfonylureas may cause hypo-

glycemia. Treat hypoglycemia with oral glucose

(dextrose), and not sucrose (cane sugar), as acarbose

may delay the absorption time of sucrose.

* May cause abdominal pain, diarrhea, and flatulence.

These side effects should subside in frequency and

intensity with continued use.

For any query on drugs, (Damdawi chungchangah zawh-na I neih chuan):

Mail to- Drug Information Centre Department of Pharmacy, RIPANS. Zemabawk, Aizawl. Pin 796017

Email: dicripans@gmail.com Facebook page: DRUG INFORMATION CEN-TRE,RIPANS. SMS: 8730955168 Please login to the website: www.ripans.in

DIC Bulletin Appreciation Letter

Vol - 1 Issue - 3 Oct.– Dec. 2016 Vol - 1 Issue - 3 Oct-Dec. 2016

Editorial Diabetes mellitus is one of the most popular disease in the world, it is a progressive disease characterized by elevat-ed levels of blood glucose. There are two main types, type 1 diabetes and type 2 diabetes. Gestational diabetes affects about four percent of pregnant woman. According to WHO, as of 2014, an estimated 422 million people were living with diabetes worldwide, diabetes caused 1.5 million deaths in 2012, higher than optimal glucose level caused additional 2.2 million deaths.

The clinical symptoms of include increased thirst, fre-quent urination, hunger, fatigue and blurred vision and in some cases there may be no symptoms. If left untreated, many complications can happen which includes heart attack, stroke, kidney failure, leg amputation, vision loss and nerve damage.

Early diagnosis of diabetes is very important, once a per-son is diagnosed with high blood glucose level he should undergo proper treatment to prevent further complications. Prevention and treatment involve maintaining a healthy diet, regular physical exercise, maintaining normal body-weight, avoiding use of tobacco and medication adherence. In this issue, counselling points of drugs commonly used

for the treatment of diabetes are highlighted. We hope that

patients and the prescribers will make use of it for better

drug use and outcome of the treatment.

SAFETY ALERT:

Pioglitazone-containing Medicines: Increased Risk of Blad-der Cancer: As a result of an updated review, the FDA has con-cluded that use of the type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer. FDA alerted the public about the possible risk of bladder cancer in September 2010 and June 2011 based on interim results from a 10-year epidemiologic study. FDA changed the labels of pioglita-zone-containing medicines in August 2011 to include warnings about this risk, and required the manufacturer to modify and con-tinue the 10-year study. The FDA recommended that health care professionals should not use pioglitazone in patients with active bladder cancer, and should carefully consider the benefits and risks before using pioglitazone in patients with a history of bldder cancer. Patients should contact their health care professionals if they experience any of the following signs or symptoms after starting pioglitazone, as these may be due to bladder cancer:

→Blood or a red color in the urine →New or worsening urge to urinate →Pain when urinating Pioglitazone is approved to improve blood sugar control, along with diet and exercise, in adults with type 2 diabetes. Pioglita-zone works by increasing the body’s sensitivity to insulin, a natu-ral hormone that helps control blood sugar levels. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

Reference: Drug Safety Communications, US FDA, 12 Decem-ber 2016 (www.fda.gov )

Direct-Acting Antivirals for Hepatitis C: Risk of Hepatitis B Reac-tivating: The FDA is warning about the risk of hepatitis B virus (HBV) becom-ing an active infection again in any patient who has a current or previ-ous infection with HBV and is treated with certain direct-acting antivi-ral (DAA) medicines for hepatitis C virus. In a few cases, HBV reacti-vation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks. FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18, 2016. This number includes only cases submitted to FDA, so there are likely additional cases about which FDA is unaware. Of the cases re-ported, two patients died and one required a liver transplant. HBV re-activation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV co-infection were excluded from the trials. Health care professionals are recommended to screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up. Patients should tell your health care professional if you have a history of hepati-tis B infection or other liver problems. Direct-acting antiviral medicines are used to treat chronic hepatitis C virus (HCV) infection, an infection that can last a lifetime. These medi-cines reduce the amount of HCV in the body by preventing HCV from multiplying, and in most cases, they cure HCV. Without treatment, HCV can lead to serious liver problems including cirrhosis, liver can-cer, and death. Ref: Drug Safety Communications, US FDA, 4 October 2016

Zunthlum (Diabetes mellitus) hi khawvela natna lar berte zing ami a ni a, thisen a glucose level sang tak a awmin a lang chhuak thin a. Zunthlum hi chi hnih a awm a, zunthlum lo awm chhan a zirin type 1 leh type 2 a then a ni. Raipuar zaah pali hian rai avanga zunthlum (gestational diabetes) an nei thin bawk.. WHO in 2016 report a a tarlan dan chuan 2014 thleng khan khawvel pumah mihring maktaduaih 422 in zunthlum natna hi an vei a, kum khat chhungin maktaduaih 1.5 zunthlum avangin an thih phah bakah zunthlum kaihhnawih avangin maktaduaih 2.2 in nunna an chan phah bawk. Miin zunthlum a vei hian taksaah a lanchhuah dan tlangpui chu tuihal huam huam reng, zunchhuak zing lutuk, riltam zing, chauh ngawih ngawih leh khawhmuh fiahlote a ni a, hetiang insawiselna nei miahlo hi an awm fo bawk. Zunthlum hi enkawl vat a nihloh chuan harsatna lian zawk, heng lung lam thatlohna, thluaka thisen zam chat leh ping avanga harsatna (stroke), kal thalo, ke tan ngai, mitdelna leh hriatna thazam thalo leh thil dang dang pawh a thlen thei a ni. Zunthlum hi hma taka hriatchhuah hi a pawimawh em em a, miin zunthlum a lo vei tawh chuan uluk taka inenkawl a ngai thin a ni. Zunthlum laka invenna leh enkawlna zinga pawimawh zualte chu ei leh in hrisel, taksa sawizawi ngun, taksa rih zawng vawn that, mei zukloh leh damdawi mumal leh tha taka ei leh hman te hi a ni. He issue-ah hian zunthlum enkawlna damdawi thenkhat chungchanga hriat tur pawimawh tlem tarlan a ni a, damlo enkawltute doctor-te leh damlote ten kan tangkaipui ngei kan beisei.

SAFETY ALERT:

General Anesthetic and Sedation Drugs: New Warnings for Young Children and Pregnant Women. FDA has has issued a drug safety communication warning that re-peated or lengthy use of general anesthetic and sedation drugs dur-ing surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the develop-ment of children’s brains. Consistent with animal studies, recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. However, further research is needed to fully characterize how early life anesthetic exposure affects children’s brain development. Label warnings will now be required by the FDA to inform the pub-lic about the potential risk to children’s brain development. The use of general anesthetic and sedation drugs will continue to be moni-tored by the FDA for further information about adverse events. The FDA encourages health care professionals to assess appropriate use of these drugs and balance the benefits against potential risks with each patient, especially for procedures taking longer than 3 hours or in multiple procedures required for children younger than 3 years old. Anesthetic and sedation drugs are sometimes needed for use in in-fants, children, and pregnant women who must undergo surgery or other painful procedures, and it is often necessary in life-threatening conditions Reference: Drug Safety Communications, US FDA, 14 December 2016 (www.fda.gov )

NEW APPROVAL : FDA approves first drug for spinal muscular atro-phy. SMA is a hereditary disease that causes weakness and muscle wasting be-cause of the loss of lower motor neurons controlling movement. There is wide variability in age of onset, symptoms and rate of progression. There has been a long-standing need for a treatment for spinal muscular atrophy, the most common genetic cause of death in infants, and a disease that can affect people at any stage of life. On the 23rd December 2016, the U.S. Food and Drug Administration ap-proved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA). Spinraza is an injection admin-istered into the fluid surrounding the spinal cord. The FDA worked closely with the sponsor during development to help de-sign and implement the analysis upon which this approval was based. The efficacy of Spinraza was demonstrated in a clinical trial in 121 patients with infantile-onset SMA who were diagnosed before 6 months of age and who were less than 7 months old at the time of their first dose. Patients were randomized to receive an injection of Spinraza, into the fluid surrounding the spinal cord, or undergo a mock procedure without drug injection (a skin prick). Twice the number of patients received Spinraza compared to those who underwent the mock procedure. The trial assessed the percentage of patients with improvement in motor milestones, such as head control, sit-ting, ability to kick in supine position, rolling, crawling, standing and walk-ing. The most common side effects found in participants in the clinical trials on Spinraza were upper respiratory infection, lower respiratory infection and constipation. Warnings and precautions include low blood platelet count and toxicity to the kidneys (renal toxicity). Toxicity in the nervous system (neurotoxicity) was observed in animal studies. Reference: News and Events, US FDA, 23 December 2016 (www.fda.gov)

Generic Mechanisim of Action Administratiom Medication Counseling

PIOGLITAZONE HY-DROCHLORIDE

* A thiazolidinedione antidiabetic agent and a potent peroxisome prolifera-tor-activated receptor-gamma (PPAR(gamma)) agonist,. * Dependent on the presence of insulin for its mechanism of action. * It increases insulin-dependent glucose disposal and decreases hepatic glucose output by decreasing insulin resistance in the periphery and in the liver.

* Give without regard to meals

* Report signs/symptoms of congestive heart fail-ure (rapid weight gain, edema, dyspnea). * Warn premenopausal, anovulatory patient to use reliable contraception, as drug may stimulate ovu-lation in this population. * May cause headaches, myalgia, pharyngitis, sinusitis, and upper respiratory tract infections. * May increase the risk for fractures, especially in females. * Report signs/symptoms of hepatotoxicity. * Monitor for signs/symptoms of hypoglycemia and report difficulties with glycemic control, es-pecially when combined with other hypoglycemic agents. * Report signs/symptoms of bladder cancer (hematuria, urinary urgency, pain on urination, back/abdominal pain).

GLICLAZIDE

* A second-generation sul-fonylurea oral, The hypogly-cemic mechanism of action of gliclazide is related to stimu-lation of insulin secretion from pancreatic beta cells,

possibly via direct ef-fects on intracellular cal-cium transport.

* Take with morning break-

fast or the first main meal * Maintainance dose may be taken two times a day with meals.

* May increase hypoglycaemic effect w/ phenylbutazone. * May increase anticoagulant effect of warfarin. * Monitor fasting blood glucose, glycosylated Hb, signs and symptoms of hypoglycaemia.. * Tablets should be taken with food.

Common Antidiabetic Drugs and Counseling Tips