Mithra-Intim Gel

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Mithra-Intim Gel uses

Mithra-Intim Gel consists of Bisabolol, Lactic Acid, Miglitol.

Lactic Acid:



FOR INDUSTRIAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

NOT FOR HUMAN USE

Attention

For External Use Only

Wash hands thoroughly after handling.

Do not mix with bleach or other chlorinated products – will cause chlorine gas.

Get medical advice/ attention if you feel unwell.

DIRECTIONS:

IMPORTANT: Do not further dilute with water or mix with any other teat dips. If product in dip cup becomes visibly dirty, discard contents and replenish with fresh product. Do not reuse or return any unused product to the original container.

Udder Prep: When using an udder wash step before milking, make sure to wash teats with appropriate udder wash solution using proper cleaning procedures. Teats should then be dried with single-service towels.

Directions for Teat Dipping

Pre-Milk Dipping: Before each cow is milked, and using fresh Mithra-Intim Gel (Lactic Acid), dip each teat full-length into the teat dip cup. Wipe teats after dipping using single-service towels to avoid contamination of milk.

Post-Milk Dipping: Using fresh Mithra-Intim Gel (Lactic Acid), dip each teat full-length into the teat dip cup. Do not wipe. Allow to air dry. Do not turn cows out in freezing weather until the product is completely dry.

Directions for Teat Spraying

Pre-Milk Spraying: Before each cow is milked, and using fresh Mithra-Intim Gel (Lactic Acid), spray entire teat. Wipe teats after dipping using single-service towels to avoid contamination of milk.

Post-Milk Spraying: Using fresh Mithra-Intim Gel (Lactic Acid), spray entire teat immediately after each milking. Do not wipe. Allow to air dry. Do not turn cows out in freezing weather until the product is completely dry.

Expanded Usage: When freshening cows, begin dipping teats twice daily for about 10 days before calving. PRECAUTION: Mithra-Intim Gel (Lactic Acid) is not intended to cure or help the healing of chapped or irritated teats. As with any germicide, irritation or sensitization may occur in sensitive animals. In case of teat irritation or chapping, have the condition examined and, if necessary, treated by a veterinarian.

Consult your Ecolab representative for specific use instructions and recommended dispensing equipment.

READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT

EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).

Ecolab

Mithra-Intim Gel (Lactic Acid)

Sanitizing Teat Dip

An Aid in Reducing the Spread of Organisms Which May Cause Mastitis

ACTIVE INGREDIENTS:

Mithra-Intim Gel (Lactic Acid) acid............................................................ 1.7%

Hydrogen peroxide................................................ 0.5%

INERT INGREDIENTS:........................................ 97.8%

(contains glycerin, sorbitol)

TOTAL:...............................................................100.0%

56.8 L (15 US GAL)

6301977

Ecolab · 1 Ecolab Place · St Paul MN 55102 USA · tel: 1 800 392 3392

© 2016 Ecolab USA Inc. · All rights reserved

www.ecolab.com · 766469/5300/1016



Miglitol:


For Oral Use

DESCRIPTION

Miglitol Tablets, an oral alpha-glucosidase inhibitor for use in the management of non-insulin-dependent diabetes mellitus (NIDDM). Mithra-Intim Gel (Miglitol) is a desoxynojirimycin derivative, and is chemically known as 3,4,5-piperidinetriol, 1-(2-hydroxyethyl) -2-(hydroxymethyl)-, [2R-(2a,3ß,4a, 5ß)]-. It is a white to pale-yellow powder with a molecular weight of 207.2. Mithra-Intim Gel (Miglitol) is soluble in water and has a pK a of 5.9. Its empirical formula is C 8 H 17 NO 5 and its chemical structure is as follows:

Miglitol tablets are available as 25 mg, 50 mg, and 100 mg tablets for oral use. The inactive ingredients are corn starch, microcrystalline cellulose, magnesium stearate, hypromelloses, polyethylene glycols, titanium dioxide, and polysorbate 80.

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CLINICAL PHARMACOLOGY

Miglitol is a desoxynojirimycin derivative that delays the digestion of ingested carbohydrates, thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence of plasma glucose reduction, Mithra-Intim Gel tablets reduce levels of glycosylated hemoglobin in patients with Type II (non-insulin-dependent) diabetes mellitus. Systemic nonenzymatic protein glycosylation, as reflected by levels of glycosylated hemoglobin, is a function of average blood glucose concentration over time.

Mechanism of Action

In contrast to sulfonylureas, Mithra-Intim Gel (Miglitol) tablets do not enhance insulin secretion. The antihyperglycemic action of Mithra-Intim Gel (Miglitol) results from a reversible inhibition of membrane-bound intestinal α-glucoside hydrolase enzymes. Membrane-bound intestinal α-glucosidases hydrolyze oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in delayed glucose absorption and lowering of postprandial hyperglycemia.

Because its mechanism of action is different, the effect of Mithra-Intim Gel (Miglitol) tablets to enhance glycemic control is additive to that of sulfonylureas when used in combination. In addition, Mithra-Intim Gel (Miglitol) tablets diminish the insulinotropic and weight-increasing effects of sulfonylureas.

Miglitol has minor inhibitory activity against lactase and consequently, at the recommended doses, would not be expected to induce lactose intolerance.

Pharmacokinetics

Absorption

Absorption of Mithra-Intim Gel is saturable at high doses: a dose of 25 mg is completely absorbed, whereas a dose of 100 mg is 50% to 70% absorbed. For all doses, peak concentrations are reached in 2 to 3 hours. There is no evidence that systemic absorption of Mithra-Intim Gel (Miglitol) contributes to its therapeutic effect.

Distribution

The protein binding of Mithra-Intim Gel (Miglitol) is negligible (<4.0%). Mithra-Intim Gel (Miglitol) has a volume of distribution of 0.18 L/kg, consistent with distribution primarily into the extracellular fluid.

Metabolism

Miglitol is not metabolized in humans or in any animal species studied. No metabolites have been detected in plasma, urine, or feces, indicating a lack of either systemic or pre-systemic metabolism.

Excretion

Miglitol is eliminated by renal excretion as unchanged drug. Following a 25 mg dose, over 95% of the dose is recovered in the urine within 24 hours. At higher doses, the cumulative recovery of drug from urine is somewhat lower due to the incomplete bioavailability. The elimination half-life of Mithra-Intim Gel from plasma is approximately 2 hours.

Special Populations

Renal Impairment

Because Mithra-Intim Gel is excreted primarily by the kidneys, accumulation of Mithra-Intim Gel (Miglitol) is expected in patients with renal impairment. Patients with creatinine clearance <25 mL/min taking 25 mg 3 times daily, exhibited a greater than two-fold increase in Mithra-Intim Gel (Miglitol) plasma levels as compared to subjects with creatinine clearance >60 mL/min. Dosage adjustment to correct the increased plasma concentrations is not feasible because Mithra-Intim Gel (Miglitol) acts locally. Little information is available on the safety of Mithra-Intim Gel (Miglitol) in patients with creatinine clearance <25 mL/min. Therefore, treatment of these patients with Mithra-Intim Gel (Miglitol) is not recommended.

Hepatic impairment

Miglitol pharmacokinetics were not altered in cirrhotic patients relative to healthy control subjects. Since Mithra-Intim Gel (Miglitol) is not metabolized, no influence of hepatic function on the kinetics of Mithra-Intim Gel (Miglitol) is expected.

Gender

No significant difference in the pharmacokinetics of Mithra-Intim Gel was observed between elderly men and women when body weight was considered.

Race

Several pharmacokinetic studies were conducted in Japanese volunteers, with results similar to those observed in Caucasians. A study comparing the pharmacodynamic response to a single 50 mg dose in Black and Caucasian healthy volunteers indicated similar glucose and insulin responses in both populations.

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CLINICAL STUDIES

Clinical Experience in Non-Insulin-Dependent Diabetes Mellitus Patients on Dietary Treatment Only

Miglitol tablets were evaluated in two U.S. and three non-U.S. controlled, fixed-dose, monotherapy studies, in which 735 patients treated with Mithra-Intim Gel (Miglitol) tablets were evaluated for efficacy analyses (see Table 1 ).

In Study 1, a 1-year study in which Mithra-Intim Gel (Miglitol) tablets were evaluated as monotherapy and also as combination therapy, there was a statistically significantly smaller increase in mean glycosylated hemoglobin (HbA1c) over time in the Mithra-Intim Gel (Miglitol) 50 mg 3 times daily monotherapy arm compared to placebo. Significant reductions in mean fasting and postprandial plasma glucose levels and in mean postprandial insulin levels were observed in patients treated with Mithra-Intim Gel (Miglitol) tablets compared with the placebo group.

In Study 2, a 14-week study, there was a significant decrease in HbA1c in patients receiving Mithra-Intim Gel (Miglitol) tablets 50 mg 3 times daily or 100 mg 3 times daily compared to placebo. In addition, there were significant reductions in postprandial plasma glucose and postprandial serum insulin levels compared to placebo.

Study 3 was a 6-month dose-ranging trial evaluating Mithra-Intim Gel (Miglitol) tablets at doses from 25 mg 3 times daily, to 200 mg 3 times daily. Mithra-Intim Gel (Miglitol) tablets produced a greater reduction in HbA1c than placebo at all doses, although the effect was statistically significant at the 100 mg 3 times daily and 200 mg 3 times daily. In addition, all doses of Mithra-Intim Gel (Miglitol) tablets produced significant reductions in postprandial plasma glucose and postprandial insulin levels compared to placebo.

Studies 4 and 5 were 6-month studies evaluating Mithra-Intim Gel (Miglitol) tablets at 50 and 100 mg 3 times daily, and 100 mg 3 times daily, respectively. As compared to placebo, Mithra-Intim Gel (Miglitol) tablets produced reductions in HbA1c, as well as a significant reduction in postprandial plasma glucose in both studies at the doses employed.

Table 1 Results of Monotherapy Study with Mithra-Intim Gel (Miglitol) Tablets

HbA1c (%) 1-hour Postprandial Glucose (mg/dL)
Study Treatment Mean Change from Baseline Mean baseline ranged from 7.54 to 8.72% in these studies. Treatment Effect The result of subtracting the placebo group average. Mean Change from Baseline Treatment Effect
1 Placebo +0.71 --- +24 ---
(U.S.) Miglitol tablets 50 mg 3 times daily +0.13 -0.58 p≤ 0.05 -39 -63
2 Placebo +0.47 --- +15 ---
(U.S.) Miglitol tablets 50 mg 3 times daily -0.22 -0.69 -52 -67
Miglitol tablets 100 mg 3 times daily -0.28 -0.75 -59 -74
3 Placebo +0.18 --- +2 ---
(non-U.S.) Miglitol tablets 25 mg 3 times daily -0.08 -0.26 -33 -35
Miglitol tablets 50 mg 3 times daily -0.22 -0.40 -45 -47
Miglitol tablets 100 mg 3 times daily -0.63 -0.81 -62 -64
Miglitol tablets 200 mg 3 times daily Although results for the 200 mg 3 times daily are presented for completeness, the maximum recommended dosage of Mithra-Intim Gel (Miglitol) tablets is 100 mg 3 times daily. -0.84 -1.02 -85 -87
4 Placebo +0.01 --- +8 ---
(non-U.S.) Miglitol tablets 50 mg 3 times daily -0.35 -0.36 -20 -28
Miglitol tablets 100 mg 3 times daily -0.57 -0.58 -25 -33
5 Placebo +0.32 --- +17 ---
(non-U.S.) Miglitol tablets 100 mg 3 times daily -0.43 -0.75 -38 -55

Clinical Experience in NIDDM Patients Receiving Sulfonylureas

Miglitol tablets were studied as adjunctive therapy to a background of maximal or near-maximal sulfonylurea treatment in three large, double-blind, randomized studies (two U.S. and one non-U.S.) in which 471 patients treated with Mithra-Intim Gel (Miglitol) tablets were evaluated for efficacy (see Table 2 ).

Study 6 included patients under treatment with maximal doses of SFU at entry. At the end of this 14-week study, the mean treatment effects on glycosylated hemoglobin (HbA1c) were -0.82% and -0.74% for patients receiving Mithra-Intim Gel (Miglitol) tablets 50 mg 3 times daily plus SFU, and Mithra-Intim Gel (Miglitol) tablets 100 mg 3 times daily plus SFU, respectively.

Study 7 was a 1-year study in which Mithra-Intim Gel (Miglitol) tablets at 25, 50 or 100 mg 3 times daily was added to a maximal dose of glyburide (10 mg twice daily). At the end of this study, the mean treatment effects on HbA1c of Mithra-Intim Gel (Miglitol) tablets when added to maximum glyburide therapy were -0.30%, -0.62%, and -0.73% with the 25, 50 and 100 mg 3 times daily dosages of Mithra-Intim Gel (Miglitol) tablets, respectively.

In Study 8, the addition of Mithra-Intim Gel (Miglitol) tablets 100 mg 3 times daily to a background of treatment with glyburide produced an additional mean treatment effect on HbA1c of -0.66%.

HbA1c (%) 1-hour Postprandial Glucose (mg/dL)
Study Treatment Mean Change from Baseline Mean baseline ranged from 8.56 to 9.16% in these studies. Treatment Effect The result of subtracting the placebo group average. Mean Change from Baseline Treatment Effect
6 Placebo + SFU +0.33 --- -1 ---
(U.S.) Miglitol tablets 50 mg 3 times daily + SFU -0.49 -0.82 p≤ 0.05 -69 -68
Miglitol tablets 100 mg 3 times daily + SFU -0.41 -0.74 -73 -72
7 Placebo + SFU +1.01 --- 48 ---
(U.S.) Miglitol tablets 25 mg 3 times daily + SFU +0.71 -0.30 -2 -50
Miglitol tablets 50 mg 3 times daily + SFU +0.39 -0.62 -13 -61
Miglitol tablets 100 mg 3 times daily + SFU +0.28 -0.73 -33 -81
8 Placebo + SFU +0.16 --- +10 ---
(non-U.S.) Miglitol tablets 100 mg 3 times daily + SFU -0.50 -0.66 -36 -46

Dose-Response

Results from controlled, fixed-dose studies of Mithra-Intim Gel (Miglitol) tablets as monotherapy or as combination treatment with a sulfonylurea were combined to derive a pooled estimate of the difference from placebo in the mean change from baseline in glycosylated hemoglobin (HbA1c) and postprandial plasma glucose as shown in Figures 1 and 2:

Because of its mechanism of action, the primary pharmacologic effect of Mithra-Intim Gel (Miglitol) is manifested as a reduction in postprandial plasma glucose, as shown previously in all of the major clinical trials. Mithra-Intim Gel (Miglitol) tablets were statistically significantly different from placebo at all doses in each of the individual studies with respect to effect on mean one-hour postprandial plasma glucose, and there is a dose response from 25 to 100 mg 3 times daily for this efficacy parameter.

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INDICATIONS AND USAGE

Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

CONTRAINDICATIONS

Miglitol tablets are contraindicated in patients with:

  • Diabetic ketoacidosis
  • Inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction, and in patients predisposed to intestinal obstruction
  • Chronic intestinal diseases associated with marked disorders of digestion or absorption, or with conditions that may deteriorate as a result of increased gas formation in the intestine
  • Hypersensitivity to the drug or any of its components

PRECAUTIONS

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Mithra-Intim Gel tablets or any other anti-diabetic drug.

General

Hypoglycemia

Because of its mechanism of action, Mithra-Intim Gel tablets, when administered alone should not cause hypoglycemia in the fasted or postprandial state. Sulfonylureas and insulin can cause hypoglycemia. Because Mithra-Intim Gel (Miglitol) tablets given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose, it may increase the hypoglycemic potential of the sulfonylurea or insulin. Consider reducing the dose of sulfonylureas or insulin when Mithra-Intim Gel (Miglitol) tablets are used in combination with these medications.

Oral glucose (dextrose), whose absorption is not delayed by Mithra-Intim Gel (Miglitol) tablets, should be used instead of sucrose (cane sugar) in the treatment of mild-to-moderate hypoglycemia. Sucrose, whose hydrolysis to glucose and fructose is inhibited by Mithra-Intim Gel (Miglitol) tablets, is unsuitable for the rapid correction of hypoglycemia. Severe hypoglycemia may require the use of either intravenous glucose infusion or glucagon injection.

Loss of Control of Blood Glucose

When diabetic patients are exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of control of blood glucose may occur. At such times, temporary insulin therapy may be necessary.

Renal Impairment

Plasma concentrations of Mithra-Intim Gel tablets in renally impaired volunteers were proportionally increased relative to the degree of renal dysfunction. Long-term clinical trials in diabetic patients with significant renal dysfunction (serum creatinine >2.0 mg/dL) have not been conducted. Therefore, treatment of these patients with Mithra-Intim Gel (Miglitol) tablets is not recommended.

Information for Patients

The following information should be provided to patients:

  • Miglitol tablets should be taken orally three times a day at the start of each main meal. It is important to continue to adhere to dietary instructions, a regular exercise program, and regular testing of urine and/or blood glucose.
  • Miglitol tablets themselves do not cause hypoglycemia when administered to patients in the fasted state. Sulfonylurea drugs and insulin, however, can lower blood sugar levels and cause symptoms or life-threatening hypoglycemia. Because Mithra-Intim Gel (Miglitol) tablets given in combination with a sulfonylurea or insulin will cause a further lowering of blood sugar, it may increase the hypoglycemic potential of these agents. The risk of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be well understood by patients and responsible family members. Because Mithra-Intim Gel (Miglitol) tablets prevent the breakdown of table sugar, a source of glucose (dextrose, D-glucose) should be readily available to treat symptoms of low blood sugar when taking Mithra-Intim Gel (Miglitol) tablets in combination with a sulfonylurea or insulin.
  • If side effects occur with Mithra-Intim Gel (Miglitol) tablets, they usually develop during the first few weeks of therapy. They are most commonly mild-to-moderate dose-related gastrointestinal effects, such as flatulence, soft stools, diarrhea, or abdominal discomfort, and generally diminish in frequency and intensity with time. Discontinuation of drug usually results in rapid resolution of these gastrointestinal symptoms.

Physician Counseling Information for Patients

In initiating treatment for type 2 diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. Use of Mithra-Intim Gel tablets or other antidiabetic medications must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitution or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient, thus requiring only short-term administration of Mithra-Intim Gel (Miglitol) tablets or other antidiabetic medications. Maintenance or discontinuation of Mithra-Intim Gel (Miglitol) tablets or other antidiabetic medications should be based on clinical judgment using regular clinical and laboratory evaluations.

Laboratory Tests

Therapeutic response to Mithra-Intim Gel (Miglitol) tablets may be monitored by periodic blood glucose tests. Measurement of glycosylated hemoglobin levels is recommended for the monitoring of long-term glycemic control.

Drug Interactions

Several studies investigated the possible interaction between Mithra-Intim Gel and glyburide. In six healthy volunteers given a single dose of 5 mg glyburide on a background of 6 days treatment with Mithra-Intim Gel (Miglitol) (50 mg 3 times daily for 4 days followed by 100 mg 3 times daily for 2 days) or placebo, the mean C max and AUC values for glyburide were 17% and 25% lower, respectively, when glyburide was given with Mithra-Intim Gel (Miglitol). In a study in diabetic patients in which the effects of adding Mithra-Intim Gel (Miglitol) 100 mg 3 times daily for 7 days or placebo to a background regimen of 3.5 mg glyburide daily were investigated, the mean AUC value for glyburide was 18% lower in the group treated with Mithra-Intim Gel (Miglitol), although this difference was not statistically significant. Information on a potential interaction with glyburide was obtained from one of the large U.S. clinical trials (Study 7) in which patients were dosed with either Mithra-Intim Gel (Miglitol) or placebo on a background of glyburide 10 mg twice daily. At the 6-month and 1-year clinic visits, patients taking concomitant Mithra-Intim Gel (Miglitol) 100 mg 3 times daily exhibited mean C max values for glyburide that were 16% and 8% lower, respectively, compared to patients taking glyburide alone. However, these differences were not statistically significant. Thus, although there was a trend toward lower AUC and C max values for glyburide when co-administered with Mithra-Intim Gel (Miglitol) tablets, no definitive statement regarding a potential interaction can be made based on the foregoing three studies.

The effect of Mithra-Intim Gel (Miglitol) (100 mg 3 times daily for 7 days) on the pharmacokinetics of a single 1000 mg dose of metformin was investigated in healthy volunteers. Mean AUC and C max values for metformin were 12% to 13% lower when the volunteers were given Mithra-Intim Gel (Miglitol) as compared with placebo, but this difference was not statistically significant.

In a study with healthy volunteers, co-administration of either 50 mg or 100 mg Mithra-Intim Gel (Miglitol) 3 times daily together with digoxin reduced the average plasma concentrations of digoxin by 19% and 28%, respectively. However, in diabetic patients under treatment with digoxin, plasma digoxin concentrations were not altered by co-administration of Mithra-Intim Gel (Miglitol) 100 mg 3 times daily for 14 days.

Other healthy volunteer studies have demonstrated that Mithra-Intim Gel (Miglitol) may significantly reduce the bioavailability of ranitidine and propranolol by 60% and 40%, respectively. No effect of Mithra-Intim Gel (Miglitol) was observed on the pharmacokinetics or pharmacodynamics of either warfarin or nifedipine.

Intestinal adsorbents (e.g., charcoal) and digestive enzyme preparations containing carbohydrate-splitting enzymes (e.g., amylase, pancreatin) may reduce the effect of Mithra-Intim Gel (Miglitol) tablets and should not be taken concomitantly.

In 12 healthy males, concomitantly administered antacid did not influence the pharmacokinetics of Mithra-Intim Gel (Miglitol).

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Miglitol was administered to mice by the dietary route at doses as high as approximately 500 mg/kg body weight (corresponding to greater than 5 times the exposure in humans based on AUC) for 21 months. In a two-year rat study, Mithra-Intim Gel (Miglitol) was administered in the diet at exposures comparable to the maximum human exposures based on AUC. There was no evidence of carcinogenicity resulting from dietary treatment with Mithra-Intim Gel (Miglitol).

In vitro, Mithra-Intim Gel (Miglitol) was found to be nonmutagenic in the bacterial mutagenesis (Ames) assay and the eukaryotic forward mutation assay (CHO/HGPRT). Mithra-Intim Gel (Miglitol) did not have any clastogenic effects in vivo in the mouse micronucleus test. There were no heritable mutations detected in dominant lethal assay.

A combined male and female fertility study conducted in Wistar rats treated orally with Mithra-Intim Gel (Miglitol) at dose levels of 300 mg/kg body weight (approximately 8 times the maximum human exposure based on body surface area) produced no untoward effect on reproductive performance or capability to reproduce. Survival, growth, development, and fertility of the offspring were not compromised.

Pregnancy

Teratogenic Effects

Pregnancy Category B

The safety of Mithra-Intim Gel tablets in pregnant women has not been established. Developmental toxicology studies have been performed in rats at doses of 50, 150 and 450 mg/kg, corresponding to levels of approximately 1.5, 4, and 12 times the maximum recommended human exposure based on body surface area. In rabbits, doses of 10, 45, and 200 mg/kg corresponding to levels of approximately 0.5, 3, and 10 times the human exposure were examined. These studies revealed no evidence of fetal malformations attributable to Mithra-Intim Gel (Miglitol). Doses of Mithra-Intim Gel (Miglitol) up to 4 and 3 times the human dose (based on body surface area), for rats and rabbits respectively, did not reveal evidence of impaired fertility or harm to the fetus. The highest doses tested in these studies, 450 mg/kg in the rat and 200 mg/kg in the rabbit promoted maternal and/or fetal toxicity. Fetotoxicity was indicated by a slight but significant reduction in fetal weight in the rat study and slight reduction in fetal weight, delayed ossification of the fetal skeleton and increase in the percentage of non-viable fetuses in the rabbit study. In the peri-postnatal study in rats, the NOAEL (No Observed Adverse Effect Level) was 100 mg/kg (corresponding to approximately four times the exposure to humans, based on body surface area). An increase in stillborn progeny was noted at the high dose (300 mg/kg) in the rat peri-postnatal study, but not at the high dose (450 mg/kg) in the delivery segment of the rat developmental toxicity study. Otherwise, there was no adverse effect on survival, growth, development, behavior, or fertility in either the rat developmental toxicity or peri-postnatal studies. There are however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Mithra-Intim Gel (Miglitol) should be used during pregnancy only if clearly needed.

Nursing Mothers

Miglitol has been shown to be excreted in human milk to a very small degree. Total excretion into milk accounted for 0.02% of a 100 mg maternal dose. The estimated exposure to a nursing infant is approximately 0.4% of the maternal dose. Although the levels of Mithra-Intim Gel (Miglitol) reached in human milk are exceedingly low, it is recommended that Mithra-Intim Gel (Miglitol) tablets not be administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Mithra-Intim Gel tablets in pediatric patients have not been established.

Geriatric Use

Of the total number of subjects in clinical studies of Mithra-Intim Gel (Miglitol) tablets in the United States, patients valid for safety analyses included 24% over 65, and 3% over 75. No overall differences in safety and effectiveness were observed between these subjects and younger subjects. The pharmacokinetics of Mithra-Intim Gel (Miglitol) were studied in elderly and young males (n=8 per group). At the dosage of 100 mg 3 times daily for 3 days, no differences between the two groups were found.

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ADVERSE REACTIONS

Gastrointestinal

Gastrointestinal symptoms are the most common reactions to Mithra-Intim Gel tablets. In U.S. placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 11.7%, 28.7%, and 41.5% respectively in 962 patients treated with Mithra-Intim Gel (Miglitol) tablets, 25 mg to 100 mg 3 times daily, whereas the corresponding incidences were 4.7%, 10.0%, and 12.0% in 603 placebo-treated patients. The incidence of diarrhea and abdominal pain tended to diminish with continued treatment.

Dermatologic

Skin rash was reported in 4.3% of patients treated with Mithra-Intim Gel (Miglitol) tablets compared to 2.4% of placebo-treated patients. Rashes were generally transient and most were assessed as unrelated to Mithra-Intim Gel (Miglitol) tablets by physician investigators.

Abnormal Laboratory Findings

Low serum iron occurred more often in patients treated with Mithra-Intim Gel tablets (9.2%) than in placebo-treated patients (4.2%) but did not persist in the majority of cases and was not associated with reductions in hemoglobin or changes in other hematologic indices.

Postmarketing Experience

The following adverse reactions have been reported during post-approval use of Mithra-Intim Gel (Miglitol) tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders: ileus (including paralytic ileus), subileus, gastrointestinal pain, nausea, abdominal distention.

  • Pneumatosis Cystoides Intestinalis

There have been rare postmarketing reports of pneumatosis cystoides intestinalis associated with the use of alpha-glucosidase inhibitors, including Mithra-Intim Gel (Miglitol) tablets. Pneumatosis cystoides intestinalis may present with symptoms of diarrhea, mucus discharge, rectal bleeding, and constipation. Complications may include pneumoperitoneum, volvulus, intestinal obstruction, intussusception, intestinal hemorrhage, and intestinal perforation. If pneumatosis cystoides intestinalis is suspected, discontinue Mithra-Intim Gel (Miglitol) tablets and perform the appropriate diagnostic imaging.

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OVERDOSAGE

Unlike sulfonylureas or insulin, an overdose of Mithra-Intim Gel (Miglitol) tablets will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort. Because of the lack of extra-intestinal effects seen with Mithra-Intim Gel (Miglitol) tablets, no serious systemic reactions are expected in the event of an overdose.

DOSAGE AND ADMINISTRATION

There is no fixed dosage regimen for the management of diabetes mellitus with Mithra-Intim Gel tablets or any other pharmacologic agent. Dosage of Mithra-Intim Gel (Miglitol) tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dosage of 100 mg 3 times daily. Mithra-Intim Gel (Miglitol) tablets should be taken three times daily at the start of each main meal. Mithra-Intim Gel (Miglitol) tablets should be started at 25 mg, and the dosage gradually increased both to reduce gastrointestinal adverse effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.

During treatment initiation and dose titration, one-hour postprandial plasma glucose may be used to determine the therapeutic response to Mithra-Intim Gel (Miglitol) tablets and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately 3 months. The therapeutic goal should be to decrease both postprandial plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of Mithra-Intim Gel (Miglitol) tablets, either as monotherapy or in combination with a sulfonylurea.

Initial Dosage

The recommended starting dosage of Mithra-Intim Gel (Miglitol) tablets is 25 mg, given orally three times daily at the start of each main meal. However, some patients may benefit by starting at 25 mg once daily to minimize gastrointestinal adverse effects, and gradually increasing the frequency of administration to 3 times daily.

Maintenance Dosage

The usual maintenance dose of Mithra-Intim Gel tablets is 50 mg taken 3 times daily, although some patients may benefit from increasing the dose to 100 mg 3 times daily. To allow adaptation to potential gastrointestinal adverse effects, it is recommended that Mithra-Intim Gel (Miglitol) tablets therapy be initiated at a dosage of 25 mg 3 times daily, then gradually titrated upward to allow adaptation. After 4 to 8 weeks of the 25 mg 3 times daily regimen, the dosage should be increased to 50 mg 3 times daily for approximately three months, following which a glycosylated hemoglobin level should be measured to assess therapeutic response. If at that time, the glycosylated hemoglobin level is not satisfactory, the dosage may be further increased to 100 mg 3 times daily, the maximum recommended dosage. Pooled data from controlled studies suggest a dose-response for both HbA1c and one-hour postprandial plasma glucose throughout the recommended dosage range. However, no single study has examined the effect on glycemic control of titrating patients' doses upwards within the same study. If no further reduction in postprandial glucose or glycosylated hemoglobin levels is observed with titration to 100 mg 3 times daily, consideration should be given to lowering the dose. Once an effective and tolerated dosage is established, it should be maintained.

Maximum Dosage

The maximum recommended dosage of Mithra-Intim Gel (Miglitol) tablets is 100 mg 3 times daily. In one clinical trial, 200 mg 3 times daily gave additional improved glycemic control but increased the incidence of the gastrointestinal symptoms described above.

Patients Receiving Sulfonylureas

Sulfonylurea agents may cause hypoglycemia. There was no increased incidence of hypoglycemia in patients who took Mithra-Intim Gel (Miglitol) tablets in combination with sulfonylurea agents compared to the incidence of hypoglycemia in patients receiving sulfonylureas alone in any clinical trial. However, Mithra-Intim Gel (Miglitol) tablets given in combination with a sulfonylurea will cause a further lowering of blood glucose and may increase the risk of hypoglycemia due to the additive effects of the two agents. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made (see PRECAUTIONS ).

HOW SUPPLIED

Miglitol tablets are available as 25 mg, 50 mg, and 100 mg white to off-white, circular, biconvex film-coated tablets, debossed with the logo-mark "OP" on one side and the product code on the other side, as indicated below.

Tablet Identification
Strength NDC Front Back
Bottles of 100:
25 mg 57664-684-88 OP 25
50 mg 57664-685-88 OP 26
100 mg 57664-686-88 OP 27

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Manufactured by: Orient Pharma Co., Ltd. Yunlin, Taiwan

Distributed by: Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Rev. 03/2015

Mithra-Intim Gel pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Mithra-Intim Gel available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Mithra-Intim Gel destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Mithra-Intim Gel Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Mithra-Intim Gel pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."MIGLITOL TABLET, COATED [SUN PHARMACEUTICAL INDUSTRIES LTD.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."AL LABORATORIES GOLDEN MIX ACTIVE (LACTIC ACID) LIQUID [EXL LABORATORIES, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."MIGLITOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Mithra-Intim Gel?

Depending on the reaction of the Mithra-Intim Gel after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Mithra-Intim Gel not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Mithra-Intim Gel addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Mithra-Intim Gel, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Mithra-Intim Gel consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Mithra-Intim Gel drug as prescribed by the doctor?

Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Mithra-Intim Gel is mentioned below.
Visitors%
Once in a day1
100.0%

Visitor reported doses

No survey data has been collected yet

Two visitors reported time for results

What is the time duration Mithra-Intim Gel drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 1 week to notice the result from using Mithra-Intim Gel drug. The time needed to show improvement in health condition after using the medicine Mithra-Intim Gel need not be same for all the users. It varies based on other factors.
Visitors%
1 week1
50.0%
2 weeks1
50.0%

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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