DRUGS & SUPPLEMENTS
Meditin Plus usesMeditin Plus consists of Domperidone, Ranitidine, Simethicone.
Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.
For oral use in horses only.
Meditin Plus (Domperidone) is D2 dopamine receptor antagonist. Chemically, Meditin Plus (Domperidone) is 6-chloro-3-[1-[3-(2-oxo-3H-benzimidazol-1-yl)propyl]piperidin-4-yl]-1H-benzimidazol-2-one.
The structural formula is:
For prevention of fescue toxicosis in periparturient mares.
DOSAGE AND ADMINISTRATION
Orally administer 0.5 mg/lb (1.1 mg/kg) once daily starting 10 to 15 days prior to Expected Foaling Date (EFD). Treatment may be continued for up to 5 days after foaling if mares are not producing adequate milk after foaling.
DIRECTIONS FOR ADMINISTRATION
This is a 25 cc multi-dose syringe. Please note that for subsequent doses, it will be necessary to adjust for previous doses. For example, if the intended dose for a horse is 5 cc, then the dial ring is set at 5 cc for the first dose, at 10 cc for the second dose, at 15 cc for the third dose, at 20 cc for the fourth dose, and at 25 cc for the fifth dose.
Horses with hypersensitivity to Meditin Plus (Domperidone) should not receive Meditin Plus (Domperidone) Gel.
Failure of passive transfer of immunoglobulins (IgG) may occur when using Meditin Plus (Domperidone) Gel even in the absence of leakage of colostrum or milk. All foals born to mares treated with Meditin Plus (Domperidone) Gel should be tested for serum IgG concentrations.
Do not use in horses intended for human consumption.
Not for use in humans. For oral use in animals only. Keep this and all drugs out of reach of children. Pregnant and lactating women should use caution when handling Meditin Plus (Domperidone) Gel, as systemic exposure to Meditin Plus (Domperidone) may affect reproductive hormones. Meditin Plus (Domperidone) is not approved for any indication in humans in the US. The safety of Meditin Plus (Domperidone) in lactating women and their nursing children has not been evaluated. Consult a physician in case of accidental human exposure.
Meditin Plus (Domperidone) Gel may lead to premature birth, low birth weight foals or foal morbidity if administered > 15 days prior to the expected foaling date. Accurate breeding date(s) and an expected foaling date are needed for the safe use of Meditin Plus (Domperidone) Gel.
The safety of Meditin Plus (Domperidone) Gel has not been evaluated in breeding, pregnant and lactating mares other than in the last 45 days of pregnancy and the first 15 days of lactation. The safety in stallions has not been evaluated. The long term effects on foals born to mares treated with Meditin Plus (Domperidone) Gel have not been evaluated.
Do not use in horses with suspected or confirmed gastrointestinal blockage, as Meditin Plus (Domperidone) is a prokinetic drug (it stimulates gut motility).
Use of Meditin Plus (Domperidone) Gel may cause a false positive on the milk calcium test used to predict foaling.
Meditin Plus (Domperidone) is a known P-glycoprotein substrate1 and its main metabolic pathway in humans is through CYP3A4. Significant inhibition of Meditin Plus (Domperidone) metabolism may occur when co-administered with drugs such as erythromycin2 and ketoconazole3. This could result in significantly greater Meditin Plus (Domperidone) drug exposure (multi-fold increase) when used with these drugs.
The most common adverse reactions associated with treatment with Meditin Plus (Domperidone) Gel are premature lactation (dripping of milk prior foaling) and failure of passive transfer.
In a laboratory effectiveness study with 32 periparturient mares (17 treated with Meditin Plus (Domperidone) Gel and 15 treated with vehicle control) 3/17 (18%) mares treated with Meditin Plus (Domperidone) Gel experienced premature lactation. In the 25 foals (16 foals of mares treated with Meditin Plus (Domperidone) Gel and 9 foals of vehicle control mares) evaluated for passive transfer, failure of passive transfer occurred in 13/16 (81%) foals of mares treated with Meditin Plus (Domperidone) Gel and 8/9 (89%) foals of control mares. Failure of passive transfer in foals of mares treated with Meditin Plus (Domperidone) Gel was not solely due to physical loss of colostrum through premature lactation, because 77% of Meditin Plus (Domperidone) Gel treated mares that did not drip milk prior to foaling had foals with failure of passive transfer.
In a field study with 279 periparturient mares treated with Meditin Plus (Domperidone) Gel, premature lactation was reported in 3 mares (1%) and failure of passive transfer was reported in 3 foals (1%).
In two additional field studies, a total of 2,556 mares were treated with Meditin Plus (Domperidone) Gel or a bioequivalent formulation for 2,730 breeding seasons. Horses in these studies were treated with Meditin Plus (Domperidone) Gel for varying durations. Of the 2,730 breeding seasons evaluated, premature lactation was reported in 262 mares (9.6%), failure of passive transfer was reported in 50 foals (1.8%), and premature parturition (gestation length ≤ 320 days) occurred in 13 mares (<0.5%).
INFORMATION FOR HORSE OWNERS
Owners should be aware that treatment with Meditin Plus (Domperidone) Gel may result in failure of passive transfer of immunoglobulins to the foal and that this may occur even when the mare does not drip milk. Owners should be advised that all foals born to mares treated with Meditin Plus (Domperidone) Gel should be tested for serum immunoglobulin (IgG) concentrations. Owners should be informed that Meditin Plus (Domperidone) Gel causes false positives on the milk calcium test used to predict foaling. Owners should be directed on the proper use of the multi-dose dosing syringe, including how to set the dial ring for accurate dosing after the first dose.
Meditin Plus (Domperidone) is a D2 dopamine receptor antagonist that blocks the agonistic action of fescue alkaloids at the cellular level. Unlike other D2 antagonist drugs, Meditin Plus (Domperidone) does not readily cross the blood-brain barrier4. Distribution studies with radio-labeled drug in animals have shown wide tissue distribution, but low brain concentration. Small amounts of the drug cross the placenta in rats5. In humans, Meditin Plus (Domperidone) is 91-93% bound to plasma proteins. Meditin Plus (Domperidone) in humans undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation1. Urinary and fecal excretions of Meditin Plus (Domperidone) in humans amount 31 and 66% of the oral dose, respectively. The proportion of the drug excreted unchanged in humans is small (10% of fecal excretion and approximately 1% of urinary excretion). The average terminal plasma half-life of Meditin Plus (Domperidone) administered orally to horses is approximately 6 hours with very low systemic bioavailability.
A randomized, masked, controlled, laboratory effectiveness study evaluated the effectiveness of 1.1 mg/kg Meditin Plus (Domperidone) Gel administered once daily beginning 10 to 15 days prior to the expected foaling date (EFD - defined as 340 days after the median breeding) and continuing up to 5 days after foaling for the prevention of fescue toxicosis. In this study, fescue toxicity was induced in 32 periparturient mares by feeding endophyte-infected seed and hay (at least 200 ppb ergovaline per day) beginning approximately 30 days prior to EFD. A total of 17 mares were treated with Meditin Plus (Domperidone) Gel and 15 mares were treated with a vehicle control. Twenty-seven mares (13 Meditin Plus (Domperidone) Gel and 14 vehicle control) were included in the statistical analysis. Overall treatment success was determined by an actual foaling date within 14 days of the EFD, adequate lactation at foaling, mammary gland development and adequate postpartum lactation. Meditin Plus (Domperidone) Gel was superior to the vehicle control.
One mare treated with Meditin Plus (Domperidone) Gel was carrying twins. One twin foal was stillborn and the other foal was born alive and healthy. Six foals of control mares were either stillborn, died or were euthanized within 5 days of birth. Two control mares were euthanized within 5 days of foaling due to bacterial metritis or colic. Dystocia occurred in 1 mare treated with Meditin Plus (Domperidone) Gel and 4 control mares. One mare treated with Meditin Plus (Domperidone) Gel and three control mares experienced retained placentas.
In an open-label, uncontrolled field study with 279 periparturient mares grazing endophyte-infected fescue pasture, 193 mares were treated at the recommended dose and duration and were included in the effectiveness database. Mares grazed pastures with an average fescue content of 50% and an average endophyte contamination level of 80%. The mares had an average gestation length of 340 days. Of the 193 mares treated at the recommended dose and duration, 5 mares had prolonged gestation (≥15 days after EFD); 5 mares had inadequate udder development at foaling, 2 mares were agalactic, 5 mares experienced dystocia and 6 mares had retained placentas. Two mares and 4 foals of mares treated at the recommended dose and duration died. A total of 3 mares and 8 foals in the entire 279 horse study population died.
In a target animal safety study Meditin Plus (Domperidone) Gel was administered orally to 32 healthy periparturient mares once daily at 0X, 1X, 3X or 5X the maximum exposure dose estimated for a 550 lb mare. Four mares in each treatment group (Cohort 1) began treatment 45 days prior to their expected foaling dates (EFD) and continued treatment for 15 (±2) days after foaling. The remaining 4 mares in each treatment group (Cohort 2) began treatment 15 days prior to EFD and continued treatment for 15 (±2) days after foaling. Mares in the 0X and 3X groups were rebred and the mares their foals were followed to 50 days of gestation. EFD was calculated as 340 days after the median breeding date.
Mares treated with Meditin Plus (Domperidone) Gel had a higher incidence of premature parturition. There was a significant decrease in gestation length, with corresponding lower birth weights of foals, in mares treated with Meditin Plus (Domperidone) Gel beginning 45 days prior to EFD (Cohort 1). Mares treated with Meditin Plus (Domperidone) Gel beginning 45 days prior to EFD foaled and average of 27 days early (range 12 to 40 days early.) Mares treated with Meditin Plus (Domperidone) Gel begininning 15 days prior to EFD foaled an average of 5 days early (range 12 days early to 5 days late). (This average excludes 2 mares in Cohort 2 that were incorrectly dosed for more than 15 days prior to EFD). Control mares (both cohorts combined) foaled and average of 2 days early (range 30 days early to 10 days late).
Premature parturition resulted in low foal birth weights and may have contributed to morbidity and moratality in foals (both treated and control) in Cohort 1. Four out of 12 foals born to mares treated with Meditin Plus (Domperidone) Gel on Cohort 1 died or were euthanized within 11 days of birth. These foals were born 12 to 40 days early. One control foal in Cohort 2 (born 30 days early) died at 14 days. Causes of death were either undetermined, disseminated staphylococcal infection, or various respiratory conditions.
Mares treated with Meditin Plus (Domperidone) Gel had a higher incidence of dripping milk (96%) prior to parturition than control mares (50%). More mares treated with Meditin Plus (Domperidone) Gel (71%) dripped milk 3 or more days prior to parurition than control mares (0%). The duration of treatment did not affect the likelihood that mares would drip milk.
Failure of passive transfer occured in all groups; however, there was a greater incidence of IgG concentrations <400 mg/dL in foals of mares treated with Meditin Plus (Domperidone) Gel. The incidence of failure of passive transfer also increased with dose. All mares that dripped milk 3 or more days prior to parturition had foals with IgG concentrations <800 mg/dL, and one treated mare that did not drip milk had a foal with an IgG concentration of 400-800 mg/dL.
Foals of mares treated with Meditin Plus (Domperidone) Gel experienced more diarrhea and loose stool than foals of control mares during the treatment phase (first 15 days of life). All episodes of diarrhea were self-limiting and resolved without treatment.
Mares treated with Meditin Plus (Domperidone) Gel generally had higher white blood cell counts (WBC) and/or granulocyte counts and gamma glutamyl transferase (GGT) and/or alkaline phosphatase (ALP) concentrations than control mares. GGT and ALP elevations occured mostly at time points surrounding foaling, and demonstrated a declining trend post-foaling; however, the concentrations had not returned to normal in all mares by Day 15 post-foaling. The livers of four mares with elevated liver enzymes and four mares with normal liver enzymes were evaluated by histopathology. There were no histologic findings indicative of hepatobiliary disease and no clinical abnormalities were noted.
More foals of mares treated with Meditin Plus (Domperidone) Gel had granulocyte and/or neutrophil counts below the reference range on the day of foaling than foals born to control mares. The decreased neutrophil counts in foals of mares treated with Meditin Plus (Domperidone) Gel occcured more commonly in foals born more than 25 days prior to EFD. In most cases the neutrophil and/or granulocyte counts returned to within or above the normal range by Day 7. Foals of mares treated with Meditin Plus (Domperidone) Gel had higher ALP concentrations than foals of control mares. Additionally, several foals of mares treated with Meditin Plus (Domperidone) Gel also had elevations in GGT.
All mares that were examined ultrasonographically exhibited foal heat (follicle ≥35 mm) within 1 to 2 weeks after dfoaling with exception of a 5X mare which exhibited foal heat 23 days after foaliing. Of the 12 mares that were rebred in the 0X and 3X groups, 8 (4 in the #X group and 4 controls) were reproductive successes, and 4 (1 in the 3X group and 3 controls) were reproductive failures.
Store at controlled room temperature 25°C (77°F) with excursions between 15°-30°C (59°-86°F) permitted. Recap after each use.
Meditin Plus (Domperidone) Gel is supplied in disposable, multi-dose, 25 cc syringes, each containing 2.75 g of Meditin Plus (Domperidone) suspended in an oral gel. Each cc of gel contains 110 mg of Meditin Plus (Domperidone). The net weight of each syringe is approximately 26 g. Syringes are supplied in single carton and six per carton.
NADA 141-314, Approved by FDA.
Dechra Veterinary Products, 7015 College Boulevard, Suite 525, Overland Park, KS 66211
For a copy of the Material Safety Data Sheet (MSDS) or to report adverse reactions call Dechra Veterinary Products at (866) 933-2472.
US Patents 5,372,818; 6,534,536; 6,224,895
© 2010 Dechra Ltd
Meditin Plus (Domperidone) Gel is a registered trademark of Dechra Ltd. All rights reserved.
Meditin Plus is a blocker of histamine H2-receptors. Inhibits basal and stimulated by histamine, gastrin and acetylcholine (to a lesser extent) the secretion of hydrochloric acid. Increases the pH of gastric contents and reduces the activity of pepsin. The duration of action of Meditin Plus (Ranitidine) with a single admission - 12 hours.
After oral administration, Meditin Plus (Ranitidine) is rapidly absorbed from the gastrointestinal tract. Eating and antacids significantly affect the extent of absorption. Subjected to the effect of "first passage" through the liver. Cmax in plasma is reached within 2 h after a single oral administration. After IM injection Meditin Plus (Ranitidine) rapidly and almost completely absorbed from the injection site. Cmax achieved within 15 min.
Protein binding - 15%. Vd - 1.4 L / kg. Meditin Plus (Ranitidine) is excreted in breast milk.
T1/2 is 2-3 h. About 30% of the dose excreted in the urine in unchanged form. Elimination rate decreases with abnormal liver function or renal function.
Why is Meditin Plus prescribed?
Gastric ulcer and duodenal ulcer in acute phase; prevention of relapse of peptic ulcer; symptomatic ulcer; erosive and reflux esophagitis; Zollinger-Ellison syndrome; prevention of "stress" ulcers of the gastrointestinal tract, postoperative ulcers, recurrent bleeding from upper gastrointestinal tract; prevention of aspiration of gastric juice during operations under general anesthesia.
Dosage and administration
Individual. For oral administration for treatment of adults and children over 14 years daily Meditin Plus dose is 300-450 mg; if necessary, the daily dose was increased to 600-900 mg; multiplicity of administration is 2-3 times / day. For the prevention of exacerbations of disease are used by 150 mg / day at bedtime. The duration of treatment is determined by the indications for use.
The dose of Meditin Plus (Ranitidine) for patients with renal insufficiency at the level of creatinine more than 3.3 mg / 100 ml is 75 mg 2 times / day.
IV or IM by 50-100 mg every 6-8 hours.
Meditin Plus (Ranitidine) side effects, adverse reactions
Cardio-vascular system: in a few cases (for IV administration) - AV-blockade.
Digestive system: rarely - diarrhea, constipation, and in isolated cases - hepatitis.
CNS: Rarely - headache, dizziness, fatigue, blurred vision, and in isolated cases (at seriously ill patients) - confusion, hallucinations.
Hematopoietic system: rarely - thrombocytopenia, prolonged use at high doses - leukopenia.
Metabolism: rarely - a slight increase of creatinine in serum at the beginning of treatment.
Endocrine system: long-term use in high doses may increase the content of prolactin, gynecomastia, amenorrhea, impotence, decreased libido.
From the musculoskeletal system: very rarely - arthralgia, myalgia.
Allergic reactions: rarely - a skin rash, urticaria, angioedema, anaphylactic shock, bronchospasm, hypotension.
Other: rarely - recurrent parotitis, and in isolated cases - hair loss.
Meditin Plus contraindications
Pregnancy, lactation (breastfeeding), increased sensitivity to Meditin Plus (Ranitidine).
Using during pregnancy and breastfeeding
Adequate and well controlled studies of the safety of Meditin Plus during pregnancy has not been conducted, therefore the use during pregnancy is contraindicated.
If necessary the use of Meditin Plus (Ranitidine) during lactation should stop breastfeeding.
With careful use in patients with impaired renal excretory function.
Before treatment with Meditin Plus (Ranitidine) is necessary to exclude the possibility of a malignant disease of the esophagus, stomach or duodenum.
With long-term treatment of debilitated patients under stress conditions may be bacterial lesions of the stomach with subsequent spread of infection.
Undesirable abrupt discontinuation of Meditin Plus (Ranitidine) because of the risk of recurrence of peptic ulcer. Effectiveness of prophylactic treatment of peptic ulcer above while taking Meditin Plus (Ranitidine) courses for 45 days in spring and autumn than during the reception. Quick intravenous injection of Meditin Plus (Ranitidine) in rare cases cause bradycardia, usually in patients predisposed to cardiac arrhythmias.
There are a few reports that Meditin Plus (Ranitidine) might contribute to the development of acute attacks of porphyria, in connection with what is necessary to avoid its use in patients with acute porphyria in history.
Therapy with Meditin Plus (Ranitidine) possible distortions of laboratory data: increased creatinine, the activity of gamma-glutamyl transpeptidase and liver transaminases in the blood plasma.
In cases where Meditin Plus (Ranitidine) is used in combination with antacids, the break between taking antacids and Meditin Plus (Ranitidine) should be at least 1-2 hours (antacids may cause undesired absorption of Meditin Plus (Ranitidine)).
Clinical data on the safety of Meditin Plus (Ranitidine) in pediatric patients is limited.
Meditin Plus drug interactions
In an application with antacids may decrease absorption of Meditin Plus (Ranitidine).
In an application of Meditin Plus (Ranitidine) with anticholinergics may be in breach of memory and attention in elderly patients.
Probably that histamine H2-blockers reduce receptor ulcerogenic action of NSAIDs on the gastric mucosa.
In an application with warfarin may decrease clearance of warfarin. There is one case of gipoprotrombinemiey and bleeding in patients receiving warfarin.
In an application with bismuth tripotassium dicitrate may increase unwanted absorption of bismuth, with glyburide - described the cases of hypoglycemia, with ketoconazole, itraconazole - decreased absorption of ketoconazole, itraconazole.
In an application with metoprolol may increase the plasma concentrations and increased AUC and T1 / 2 of metoprolol.
In an application with sucralfate in high doses (2 g) possible violation of the absorption of Meditin Plus (Ranitidine).
In an application Meditin Plus (Ranitidine) with procainamide may be decrease excretion of procainamide by the kidneys which leads to an increase in its concentration in blood plasma.
There is a data of increased absorption of triazolam in its simultaneous application, apparently due to changes in pH of gastric contents under the influence of Meditin Plus (Ranitidine).
Probably that while the application with phenytoin may increase the concentration of phenytoin in plasma and increased risk of toxicity.
In an application with furosemide moderately expressed increasing the bioavailability of furosemide.
There is a described case of ventricular arrhythmias (bigeminy) with simultaneous application of quinidine, with cisapride - described a case of cardiotoxicity.
It can not be excluded some increase in cyclosporine concentration in blood plasma in its simultaneous application with Meditin Plus (Ranitidine).
Meditin Plus in case of emergency / overdose
Symptoms: seizures, bradycardia, ventricular arrhythmias.
Treatment: induction of vomiting or gastric lavage, symptomatic therapy. In convulsions - diazepam IV, bradycardia - atropine, ventricular arrhythmias - lidocaine.
Meditin Plus (Simethicone) 20 mg
relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods
When using this product
do not exceed 12 doses per day
Keep out of reach of children. In case of overdose get medical help or contact a poison control center immediately.
store at room temperature
benzoic acid, flavor, magnesium aluminum silicate, purified water, Meditin Plus (Simethicone) emulsion, sorbitol, xanthan gum
Meditin Plus 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.
Meditin Plus 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.
Meditin Plus 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.
Meditin Plus 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.
Meditin Plus 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.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Meditin Plus?
Depending on the reaction of the Meditin Plus after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Meditin Plus 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 Meditin Plus 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.
ReviewsDrugs.com conducted a study on Meditin Plus, 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 Meditin Plus 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.
The information was verified by Dr. Arunabha Ray, MD Pharmacology