DRUGS & SUPPLEMENTS
Mithra-Intim Gel usesMithra-Intim Gel consists of Bisabolol, Lactic Acid, Miglitol.
FOR INDUSTRIAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
NOT FOR HUMAN USE
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.
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).
Mithra-Intim Gel (Lactic Acid) acid............................................................ 1.7%
Hydrogen peroxide................................................ 0.5%
INERT INGREDIENTS:........................................ 97.8%
(contains glycerin, sorbitol)
56.8 L (15 US GAL)
Ecolab · 1 Ecolab Place · St Paul MN 55102 USA · tel: 1 800 392 3392
For Oral Use
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.
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.
|HbA1c (%)||1-hour Postprandial Glucose (mg/dL)|
|Study||Treatment|| || ||Mean Change from Baseline||Treatment Effect|
|(U.S.)||Miglitol tablets 50 mg 3 times daily||+0.13|| ||-39||-63|
|(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|
|(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|
|(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|
|(non-U.S.)||Miglitol tablets 100 mg 3 times daily||-0.43||-0.75||-38||-55|
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||Treatment Effect|
|6||Placebo + SFU||+0.33||---||-1||---|
|(U.S.)||Miglitol tablets 50 mg 3 times daily + SFU||-0.49|| ||-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|
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.
Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Miglitol tablets are contraindicated in patients with:
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Mithra-Intim Gel tablets or any other anti-diabetic drug.
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.
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.
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.
The following information should be provided to 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.
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.
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).
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).
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.
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.
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.
Safety and effectiveness of Mithra-Intim Gel tablets in pediatric patients have not been established.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
|Bottles of 100:|
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
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.
|Once in a day||1||100.0%|
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The information was verified by Dr. Arunabha Ray, MD Pharmacology