As per US FDA guidelines as per USPDA 1997

It is the intention to bring out the salient features. Hence relevent details as prescribed by US FDA guidelines as per USPDA 1997  are brought out clearly in the following chapters. 

Descriptons are detailed only to the Group Head and the indiviual items can be seen by visiting the Web Site

ANTIDIABETIC 

Incllude- Acetohexamide, Chlorpropamide, Glicazide, Glyburide, Tolazamide, Tolbutamide, Insulin human, Insulin isophane, Insulin Zinc

HYPER  and HYPOGLYCEMICS-

Oral antidiberics are used for for no-insulin depedendent (NIDDM type II) diabestes

SULPHONYLUREAS-

Includes-

Chlopropamide, Glibenclamide, Tolbutamide, Gliclazide, Glipizide , Glimepiride

Produces hypoglycemic action primarily by stimulating the release of insulin. They also inhibit the release of glucose by the liver and increase the sensitivity of peripheral tissues to the effects of insulin

METFORMIN

Exerts its efect primarily by increasing the peripheral uptake of glucose . In large doses it decreases the intestinal absorption of glucose

PIOGLITAZONE

 Improves insulin-mediated glucosedisposal by enhancing sensitivity to insulin in the liver, adipose tissue  and skeletal muscle 

It is indicated for use with metformin in obese patients, or a sulphonylurea  in patients  with an intolerance or contraidication to metformin, in type II diabetes insufficiently controlled by either agents alone

It may be used in patients asa monotherapy with intolerance or contraindication to metformin.

The drug Must not be used as a first line of therapy

PRANDIAL GLUCOSE REGULATORS-

Repglinide and Neteglinide  are non-sulphonylurea  oral hypoglycemic agents that stimulate the release of insulin from pancreatic beta cells. They are taken before each main meal  which can be where and when the patient chooses

ALPHA-GLUCOSIDASE INHIBITORS-

Acarbose can be used as a monotheraoy as an adjunct to diet or in combination with oral hypoglycemics n NIDDM( Maturity- onseet Diabetes). When taken with a meal acarbose reduces the post-prandial glucose peaks by retarding glucose uptake from the intestines

Refer- Metformin

1. Inform patients of the potentail risks of metformin and of alternative modes of therapy

2. Inform them about the importance of adherence to dietary instructions, of a regular excercise program and regular testing of blood glucose, glycosylated hemoglobin, renal function and hematologic parameters

3. Expain the risk of lactic acidosis, its symptoms, and conditions that predispose to its development.

4. Advice patients to discontinue metformin immediately and to promptly notify their health practioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence,or other nonspecific symptoms occur

5. One a patient is stabilised on metformin, GI symptoms , which are common during initiation of therapy, are likely to be drug related. Later occurance of GI symptoms could be due to lactic acididosis or other serious disease.

6. Counsel patients excessive alcohol intake while receiving metformin

7. Metformin alone dose not usually cause hypoglycemia, although it may occur when metformin is used in conjunction with oral sulfonylureas. When initiating combination therapy, explain the risk of hypoglycemia, its symptoms and treatment, and conditions that predipose to its development

8.Allergies- tell your doctor if you have ever had any unusual or allergic reaction to metformin. Also tell your doctor if you are allergic to any other substances, such as foods, presrvatives or dyes.

9.Pregnancy - metformin has not shown to cause birth defects or problems in humans. However, metformin is not used in pregnancy

10.Breast feeding- metformin passes into breast milk. It has not been shown to cause problems in nursing babies

11.Children - no specific information comparing use of metformin in children with use in other age groups

12.  Elderly- if you have blood disorrdeers or kidney problems your doctor may adjust your dose or tell you to stop taking this medicine.

13. Other medicines - Let your doctor know what other medicines you are taking, so that he can advice you accordingly. Alcohol- large amount of alcohol taken in one sitting without any food can increase the effect of metformin. This can keep the blood pressure down for a longer period of time. Amiloride or Calcium channel blockers or Cimetidine or Digoxin or Furosemide or Morphine or Procainamide or Qunidine or Quinine or Ranitidine or Triamterene or Vancomycin - use with metformin may cause high blood levels of metformin which may increase the chance of low blood sugar or side effects

14. Other medical problems - Tell your doctor if you have any other medical problems especially - Acid in blood or Burns or Dehydration or Diabetic coma or Diarrhea or Female hormone changes during pregnancy, puberty etc or High fever or Infection or Injury or Ketones in urine or Mental sress or Overactive adrenal gland or Problems with intestines or Slow stomach emptying or Surgery or Vomiting or Any other condition that causes problems with eating or absorbing food or Any other condition in which blood sugar changes rapidly - metformin in many cases will be replaced by your doctor with insulin , possibly for a short time.

Heart or blood vesel dosorders or Kidney disease or kidney problems or Liver disease - lactic acidosis can occur in these conditions Kidney , heart or other problems requiring medical tests - metformin should be stopped 2 days before medical examination or diagnostic tests that might cause less urine than normal

Overactive thyroid or Under active thyroid - until the thyroid condition is controlled it may change the amount or the type of antidiabetic medicine that you need Underactive adrenal gland or Underactive pituitary gland or Undernourished condition or Weakened physical condition or Any other condition that causes low blood pressure - patients with these conditions are more likely to develop low blood sugar which can affect the dose of metformin you need

15. Missed dose - If you miss a dose of this medicine, take it as soon as possible. however, if it is almost time for the next dose, skip the missed dose. Do not double doses. 12. Storage - Keep out of reach of children. Store away from heat or direct sunlight. Do not store the capsule in bathroom, near the kitchen sink, or in other damp places.

16. Outdated medicines - Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of reach of children.

Refer- Thioazolinedione

1.Administration of thiazolinedione with oral contraceptive containing ethinyl estradiol and norethindrone reduces the plasma concentration of both the hormones by approximately 30%, which could result in the loss of the contraceptive.

2.Caution to be excercised in patients receiving oral contraceptive.

3.In vitro, ketoconazole appears to significantly inhibit the metabolism of pioglitazone.

4.Patients receiving ketoconazole with pioglitazone should be evaluated.