DRUGS & SUPPLEMENTS
What is the dose of the medication you are taking?
Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.
For oral use in horses only.
Sofraz-D (Domperidone) is D2 dopamine receptor antagonist. Chemically, Sofraz-D (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.
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.
|cc||Sofraz-D (Domperidone) |
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 Sofraz-D (Domperidone) should not receive Sofraz-D (Domperidone) Gel.
Failure of passive transfer of immunoglobulins (IgG) may occur when using Sofraz-D (Domperidone) Gel even in the absence of leakage of colostrum or milk. All foals born to mares treated with Sofraz-D (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 Sofraz-D (Domperidone) Gel, as systemic exposure to Sofraz-D (Domperidone) may affect reproductive hormones. Sofraz-D (Domperidone) is not approved for any indication in humans in the US. The safety of Sofraz-D (Domperidone) in lactating women and their nursing children has not been evaluated. Consult a physician in case of accidental human exposure.
Sofraz-D (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 Sofraz-D (Domperidone) Gel.
The safety of Sofraz-D (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 Sofraz-D (Domperidone) Gel have not been evaluated.
Do not use in horses with suspected or confirmed gastrointestinal blockage, as Sofraz-D (Domperidone) is a prokinetic drug (it stimulates gut motility).
Use of Sofraz-D (Domperidone) Gel may cause a false positive on the milk calcium test used to predict foaling.
Sofraz-D (Domperidone) is a known P-glycoprotein substrate1 and its main metabolic pathway in humans is through CYP3A4. Significant inhibition of Sofraz-D (Domperidone) metabolism may occur when co-administered with drugs such as erythromycin2 and ketoconazole3. This could result in significantly greater Sofraz-D (Domperidone) drug exposure (multi-fold increase) when used with these drugs.
The most common adverse reactions associated with treatment with Sofraz-D (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 Sofraz-D (Domperidone) Gel and 15 treated with vehicle control) 3/17 (18%) mares treated with Sofraz-D (Domperidone) Gel experienced premature lactation. In the 25 foals (16 foals of mares treated with Sofraz-D (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 Sofraz-D (Domperidone) Gel and 8/9 (89%) foals of control mares. Failure of passive transfer in foals of mares treated with Sofraz-D (Domperidone) Gel was not solely due to physical loss of colostrum through premature lactation, because 77% of Sofraz-D (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 Sofraz-D (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 Sofraz-D (Domperidone) Gel or a bioequivalent formulation for 2,730 breeding seasons. Horses in these studies were treated with Sofraz-D (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%).
Owners should be aware that treatment with Sofraz-D (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 Sofraz-D (Domperidone) Gel should be tested for serum immunoglobulin (IgG) concentrations. Owners should be informed that Sofraz-D (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.
Sofraz-D (Domperidone) is a D2 dopamine receptor antagonist that blocks the agonistic action of fescue alkaloids at the cellular level. Unlike other D2 antagonist drugs, Sofraz-D (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, Sofraz-D (Domperidone) is 91-93% bound to plasma proteins. Sofraz-D (Domperidone) in humans undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation1. Urinary and fecal excretions of Sofraz-D (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 Sofraz-D (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 Sofraz-D (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 Sofraz-D (Domperidone) Gel and 15 mares were treated with a vehicle control. Twenty-seven mares (13 Sofraz-D (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. Sofraz-D (Domperidone) Gel was superior to the vehicle control.
|Treatment Group |
|Pearson X2 Test|
|Vehicle Control (14)||7% (1 / 14)||Test statistic = 16.320|
|Sofraz-D (Domperidone) Gel (13)||92% (12 / 13)||p-value < 0.0000|
|Treatment Group |
|Mean gestation length in days||Percent adequate milk production at foaling||Percent adequate mammary gland development at foaling|
|Vehicle Control (14)||346||33% (3 / 9) ||30% (3 / 10) |
|Sofraz-D (Domperidone) Gel (13)||337||100% (13 / 13)||100% (13 / 13)|
|Test Statistic||t statistic = 3.754 |
p = 0.0014
|Pearson X2 = 8.793 |
p = 0.0030
|Pearson X2 = 9.984 |
p = 0.0016
One mare treated with Sofraz-D (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 Sofraz-D (Domperidone) Gel and 4 control mares. One mare treated with Sofraz-D (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 Sofraz-D (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.
|Number of mares started on treatment:|
|Treatment group||Dose||45 days before EFD |
|15 days before EFD |
|1|| (0X) 0.0 mg/kg ||4||4|
|2||(1X) 1.46 mg/kg||4||4|
|3||(3X) 4.38 mg/kg||4||4|
|4||(5X) 7.30 mg/kg||4||4|
Mares treated with Sofraz-D (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 Sofraz-D (Domperidone) Gel beginning 45 days prior to EFD (Cohort 1). Mares treated with Sofraz-D (Domperidone) Gel beginning 45 days prior to EFD foaled and average of 27 days early (range 12 to 40 days early.) Mares treated with Sofraz-D (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 Sofraz-D (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 Sofraz-D (Domperidone) Gel had a higher incidence of dripping milk (96%) prior to parturition than control mares (50%). More mares treated with Sofraz-D (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 Sofraz-D (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 (percentage)||Overall incidence |
of <800 mg/dL
|Treatment Group||#Foals||<400 mg/dL||400-800 mg/dL||≥800 mg/dL|
|0X||8||3 (38%)||2 (25%)||3 (38%)||63%|
|1X|| 6 ||3 (50%)||1 (17%)||2 (33%)||67%|
|3X|| 7 ||5 (71%)||1 (14%)||1 (14%)||86%|
|5X||8||7 (88%)||1 (13%)||0 (0%)||100%|
Foals of mares treated with Sofraz-D (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.
|Treatment group |
|# Foals |
Mares treated with Sofraz-D (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 Sofraz-D (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 Sofraz-D (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 Sofraz-D (Domperidone) Gel had higher ALP concentrations than foals of control mares. Additionally, several foals of mares treated with Sofraz-D (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.
|Treatment group||# Mares bred||Pregnant at Day 50 (percentage)|
Store at controlled room temperature 25°C (77°F) with excursions between 15°-30°C (59°-86°F) permitted. Recap after each use.
Sofraz-D (Domperidone) Gel is supplied in disposable, multi-dose, 25 cc syringes, each containing 2.75 g of Sofraz-D (Domperidone) suspended in an oral gel. Each cc of gel contains 110 mg of Sofraz-D (Domperidone). The net weight of each syringe is approximately 26 g. Syringes are supplied in single carton and six per carton.
|Sofraz-D (Domperidone) Gel 1 Syringe Carton||NDC 17033-326-01|
|Sofraz-D (Domperidone) Gel 6 Syringe Carton||NDC 17033-326-06|
NADA 141-314, Approved by FDA.
|OBSERVE LABEL |
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
Sofraz-D (Domperidone) Gel is a registered trademark of Dechra Ltd. All rights reserved.
Sofraz-D is an inhibitor of H+ K+ ATPase. This medication inhibits the activity of H+-K+-ATPase in gastric parietal cells and thus blocks the final stage of hydrochloric acid secretion. This leads to a reduction in basal and stimulated secretion, regardless of the nature of the stimulus. Due to the reduction of acid secretion Sofraz-D (Omeprazole) reduces or normalizes the effects of acid in the esophagus in patients with reflux esophagitis.
Sofraz-D (Omeprazole) has a bactericidal effect on Helicobacter pylori. Eradication of H. pylori when Sofraz-D (Omeprazole) used with antibiotics allows to quickly arrest the symptoms, to take a high degree of healing of damaged mucosa and persistent long-term remission and reduce the likelihood of bleeding from the gastrointestinal tract.
After oral administration Sofraz-D (Omeprazole) is rapidly absorbed from the gastrointestinal tract. This drug penetrates the parietal cells of gastric mucosa. Plasma protein binding is about 95% (predominantly albumin). Sofraz-D (Omeprazole) is biotransformed in the liver. Excreted by the kidneys - 72-80%, in the faeces - about 20%. T1/2 is 0.5-1 h. In patients with chronic liver diseases T1/2 increases up to 3 hours.
Gastric ulcer and duodenal ulcer in acute phase (including associated with Helicobacter pylori), reflux esophagitis, Zollinger-Ellison syndrome, erosive and ulcerative lesions of gastric and duodenal ulcers associated with taking NSAIDs.
The dosing regimen of Sofraz-D is individual. When this medication is administered orally of the single dose is 20-40 mg. The daily dose is 20-80 mg, the frequency of use is 1-2 times / day. The duration of treatment is 2-8 weeks.
Digestive system: rarely - nausea, diarrhea, constipation, abdominal pain, flatulence.
CNS: rarely - headache, dizziness, weakness.
Hemopoietic system: in some cases - anemia, eosinopenia, neutropenia, thrombocytopenia.
Urinary system: in some cases - hematuria, proteinuria.
Musculoskeletal system: in some cases - arthralgia, muscle weakness, myalgia.
Allergic reactions: rarely - skin rash.
Chronic liver disease (including in history), hypersensitivity to Sofraz-D (Omeprazole).
In the absence of clinical experience with Sofraz-D it is not recommended to use this drug during pregnancy. If necessary to use during Sofraz-D (Omeprazole) lactation it should been solve the issue of termination of breastfeeding.
Category effects on the fetus by FDA - C.
Before the treatment with Sofraz-D (Omeprazole) it is necessary to exclude the possibility of a malignant process (especially gastric ulcer) because Sofraz-D (Omeprazole) treatment can mask symptoms and delay the correct diagnosis.
Therapy with Sofraz-D (Omeprazole) may affects results of laboratory studies of liver and gastrin concentrations in blood plasma.
Due to lack of experience in clinical application of Sofraz-D (Omeprazole) this medicine is not recommended for children.
This medication alters the bioavailability of any drug, absorption depends on pH (ketoconazole, iron salts, etc.). Sofraz-D (Omeprazole) slows down the elimination of drugs metabolized in the liver by microsomal oxidation (warfarin, diazepam, phenytoin, etc.).
Sofraz-D (Omeprazole) enhances the action of coumarin and diphenine, does not change - NSAIDs. This drug increases (relative) the concentration of clarithromycin in the blood; may increases the leukopenic and thrombocytopenic effects of depressants hematopoiesis drugs. Substance for intravenous infusion is compatible only with saline and dextrose (using other solvents may decrease the stability of Sofraz-D (Omeprazole) due to changes in pH of infusion medium).
Symptoms: dry mouth, nausea, blurred vision, headache, increased sweating, flushing, tachycardia, drowsiness, confusion.
Treatment: symptomatic, dialysis is ineffective.
Depending on the reaction of the Sofraz-D after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Sofraz-D 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 Sofraz-D 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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The information was verified by Dr. Rachana Salvi, MD Pharmacology