Alplax Net

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Alplax Net uses

Alplax Net consists of Alprazolam, Domperidone, Simethicone.

Alprazolam:


Pharmacological action

Alplax Net is an anxiolytic drug (tranquilizer), a derivative of triazolo-benzodiazepine. This medication has anxiolytic, sedative, hypnotic, anticonvulsant, central muscle relaxant effect. The mechanism of action is to enhance the inhibitory effect of endogenous GABA in the CNS by increasing the sensitivity of the GABA-receptor mediator as a result of stimulation of benzodiazepine receptors located in the allosteric center of postsynaptic GABA-receptor activating ascending reticular formation of brain stem neurons and the lateral horns of the spinal cord; reduces the excitability of the subcortical brain structures (the limbic system, thalamus, hypothalamus), inhibits the polysynaptic spinal reflexes.

Pronounced anxiolytic activity (reduction of emotional tension, easing anxiety, fear, anxiety) is combined with moderate soporific effect; it shortens the period of sleep, increases sleep duration and reduces the number of nighttime awakenings. The mechanism of hypnotic action is inhibition of cell reticular formation of the brain.

Pharmacokinetics

After oral administration Alplax Net (Alprazolam) is rapidly and completely absorbed from the gastrointestinal tract. Cmax plasma levels achieved within 1-2 hours. Binding to plasma proteins is 80%. This drud metabolized in the liver. T1/2 is an average of 12-15 hours. Alplax Net (Alprazolam) and its metabolites are mainly excreted by kidneys.

Why is Alplax Net prescribed?

  • anxiety, neurosis accompanied by anxiety, danger, stress, deterioration of sleep, irritability, and somatic disorders
  • mixed anxiety-depressive conditions
  • neurotic reactive depression accompanied by depressed mood, loss of interest in his surroundings, anxiety, loss of sleep, decreased appetite, and somatic disorders
  • anxiety and neurotic depression that developed on the background of systemic diseases
  • panic disorder in combination and without symptoms of phobias

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    Dosage and administration

    Individual. It is recommended to use the minimum effective dose of Alplax Net Aurobindo. The dose is corrected in the treatment process depending on the achieved effect and tolerability. If necessary, increase the dose should be increased gradually, first in the evening and then in the daytime reception.

    The initial dose of Alplax Net (Alprazolam) is 250-500 mcg 3 times / day, if necessary, it gradually increases to 4.5 mg / day.

    For elderly or debilitated patients the initial dose is 250 mcg 2-3 / day, maintenance doses - 500-750 mcg / day, if necessary, taking into account the tolerance dose can be increased.

    Cancellation or reduction of the dose of Alplax Net (Alprazolam) should be done gradually by reducing the daily dose of no more than 500 mcg every 3 days; sometimes can needed even more slowly cancelling.

    Alplax Net (Alprazolam) side effects, adverse reactions

    CNS: at the beginning of treatment (especially in elderly patients) drowsiness, fatigue, dizziness, decreased ability to concentrate, ataxia, disorientation, unsteady gait, slowing of mental and motor responses; rare - headache, euphoria, depression, tremors, memory loss, impaired coordination of movements, depressed mood, confusion, extrapyramidal dystonic reactions (involuntary movements, including for eyes), weakness, myasthenia gravis, dysarthria; in some cases - paradoxical reactions (aggressive flare, confusion, psychomotor agitation, fear, suicidal tendencies, muscle spasms, hallucinations, agitation, irritability, anxiety, insomnia).

    Digestive system: possible dry mouth or excessive salivation, heartburn, nausea, vomiting, decreased appetite, constipation or diarrhea, abnormal liver function, elevated liver transaminases and alkaline phosphatase, jaundice.

    Hematopoietic system: possible leukopenia, neutropenia, agranulocytosis (chills, pyrexia, sore throat, extreme tiredness or weakness), anemia, thrombocytopenia.

    Urinary tract: possible urinary incontinence, urinary retention, renal failure, decreased or increased libido, dysmenorrhea.

    Endocrine system: possible change in body weight, disturbances in libido, menstrual irregularities.

    Cardiovascular system: possible decrease in blood pressure, tachycardia.

    Allergic reactions: possible skin rash, itching.

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    Contraindications

    Coma, shock, myasthenia gravis, angle-closure glaucoma, acute alcohol poisoning (with the weakening of the vital functions), narcotic analgesics, hypnotics and psychotropic drugs, chronic obstructive airways disease with incipient respiratory failure, acute respiratory failure, severe depression (suicidal tendencies may occur), pregnancy (especially the I trimester), lactation, childhood and adolescence to 18 years, increased sensitivity to benzodiazepines.

    Using during pregnancy and breastfeeding

    Alplax Net (Alprazolam) has a toxic effect on the fetus and increases the risk of birth defects when used in the I trimester of pregnancy. The constant use during pregnancy can cause physical dependence with the development of withdrawal syndrome in the newborn. Reception at therapeutic doses in the later stages of pregnancy can cause neonatal CNS depression. Using of Alplax Net (Alprazolam) immediately before birth or during labor can cause neonatal respiratory depression, decreased muscle tone, hypotension, hypothermia and a weak act of sucking (sucking flaccid syndrome baby).

    It is possible to excretion of the benzodiazepines in breast milk that can cause drowsiness in the newborn and hinder feeding.

    In experimental studies have been shown that Alplax Net (Alprazolam) and its metabolites are excreted in breast milk.

    Special instructions

    Keep in mind that anxiety or conditions related to everyday stress usually does not require treatment with anxiolytics.

    If you experience paradoxical reactions then stop taking the drug. During the period of treatment is unacceptable to use of alcoholic drinks. With caution use Alplax Net for drivers of vehicles and people whose profession is associated with increased concentration.

    Alplax Net (Alprazolam) drug interactions

    The simultaneous use of Alplax Net (Alprazolam) with psychotropic, anticonvulsant medications and ethanol is observed enhancement inhibitory action Alplax Net (Alprazolam) on the CNS.

    The simultaneous use with blockers of histamine H2-receptor reduce the clearance of Alplax Net (Alprazolam) and increase the inhibitory effect of Alplax Net (Alprazolam) on the CNS; macrolide antibiotics reduce the clearance of Alplax Net (Alprazolam).

    The simultaneous use with hormonal oral contraceptives increased T1/2 of Alplax Net (Alprazolam).

    Simultaneous administration of Alplax Net (Alprazolam) with dextropropoxyphene observed a more pronounced CNS depression than in combination with other benzodiazepines, as may increase the concentration of Alplax Net (Alprazolam) in blood plasma.

    Simultaneous treatment with digoxin increases the risk of intoxication by cardiac glycosides.

    Alplax Net (Alprazolam) increases the concentration of imipramine in plasma.

    Simultaneous administration with itraconazole, ketoconazole increases the effects of Alplax Net (Alprazolam).

    Simultaneous administration with paroxetine may increases the effects of Alplax Net (Alprazolam) due to the inhibition of its metabolism.

    Fluvoxamine increases the concentration of Alplax Net (Alprazolam) in plasma and risk of its side effects.

    Simultaneous administration of Alplax Net (Alprazolam) with fluoxetine may increase the concentration of Alplax Net (Alprazolam) in plasma by decreasing its metabolism and clearance under the influence of fluoxetine which is accompanied by psychomotor disorders.

    It can not be exclude the possibility of strengthening effect of Alplax Net (Alprazolam) for simultaneous administration with erythromycin.

    Alplax Net in case of emergency / overdose

    Symptoms: Varying degrees of CNS oppression (from sleepiness to coma) - drowsiness, confusion; in more severe cases (especially in patients receiving other drugs depressing the central nervous system or alcohol) - ataxia, decreased reflexes, hypotension, coma.

    Treatment: induction of vomiting, gastric lavage, symptomatic therapy, monitor vital signs. In severe hypotension prescribed an injection of norepinephrine. Specific antidote is benzodiazepine receptor antagonist flumazenil (administration only in a hospital).

  • Domperidone:



    CAUTION

    Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

    For oral use in horses only.

    DESCRIPTION

    Alplax Net (Domperidone) is D2 dopamine receptor antagonist. Chemically, Alplax Net (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:

    Chemical Structure

    INDICATIONS

    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

    • Determine the appropriate dose for the body weight of the mare based on the dosing table below. One cc will treat 220 lb (100 kg) of body weight.
      Weight

      (lb)

      Weight

      (kg)

      cc Alplax Net (Domperidone)

      (mg)

      550-660 250-300 3 330
      661-880 301-400 4 440
      881-1100 401-500 5 550
      1101-1320 501-600 6 660
    • Turn the dial ring until the edge of the ring nearest the tip of the syringe lines up with the dose to be delivered.
    • Remove the syringe cap.
    • Make sure the horse's mouth is free of food or other obstructions.
    • Insert the nozzle of the syringe through the interdental space of the horse's mouth and deposit the gel on the back of the tongue by depressing the plunger.
    • Recap the syringe.

    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.

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    CONTRAINDICATION

    Horses with hypersensitivity to Alplax Net (Domperidone) should not receive Alplax Net (Domperidone) Gel.

    WARNINGS

    Failure of passive transfer of immunoglobulins (IgG) may occur when using Alplax Net (Domperidone) Gel even in the absence of leakage of colostrum or milk. All foals born to mares treated with Alplax Net (Domperidone) Gel should be tested for serum IgG concentrations.

    Do not use in horses intended for human consumption.

    HUMAN WARNINGS

    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 Alplax Net (Domperidone) Gel, as systemic exposure to Alplax Net (Domperidone) may affect reproductive hormones. Alplax Net (Domperidone) is not approved for any indication in humans in the US. The safety of Alplax Net (Domperidone) in lactating women and their nursing children has not been evaluated. Consult a physician in case of accidental human exposure.

    PRECAUTIONS

    Alplax Net (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 Alplax Net (Domperidone) Gel.

    The safety of Alplax Net (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 Alplax Net (Domperidone) Gel have not been evaluated.

    Do not use in horses with suspected or confirmed gastrointestinal blockage, as Alplax Net (Domperidone) is a prokinetic drug (it stimulates gut motility).

    Use of Alplax Net (Domperidone) Gel may cause a false positive on the milk calcium test used to predict foaling.

    Alplax Net (Domperidone) is a known P-glycoprotein substrate1 and its main metabolic pathway in humans is through CYP3A4. Significant inhibition of Alplax Net (Domperidone) metabolism may occur when co-administered with drugs such as erythromycin2 and ketoconazole3. This could result in significantly greater Alplax Net (Domperidone) drug exposure (multi-fold increase) when used with these drugs.

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    ADVERSE REACTIONS

    The most common adverse reactions associated with treatment with Alplax Net (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 Alplax Net (Domperidone) Gel and 15 treated with vehicle control) 3/17 (18%) mares treated with Alplax Net (Domperidone) Gel experienced premature lactation. In the 25 foals (16 foals of mares treated with Alplax Net (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 Alplax Net (Domperidone) Gel and 8/9 (89%) foals of control mares. Failure of passive transfer in foals of mares treated with Alplax Net (Domperidone) Gel was not solely due to physical loss of colostrum through premature lactation, because 77% of Alplax Net (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 Alplax Net (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 Alplax Net (Domperidone) Gel or a bioequivalent formulation for 2,730 breeding seasons. Horses in these studies were treated with Alplax Net (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 Alplax Net (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 Alplax Net (Domperidone) Gel should be tested for serum immunoglobulin (IgG) concentrations. Owners should be informed that Alplax Net (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.

    CLINICAL PHARMACOLOGY

    Alplax Net (Domperidone) is a D2 dopamine receptor antagonist that blocks the agonistic action of fescue alkaloids at the cellular level. Unlike other D2 antagonist drugs, Alplax Net (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, Alplax Net (Domperidone) is 91-93% bound to plasma proteins. Alplax Net (Domperidone) in humans undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation1. Urinary and fecal excretions of Alplax Net (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 Alplax Net (Domperidone) administered orally to horses is approximately 6 hours with very low systemic bioavailability.

    EFFECTIVENESS

    A randomized, masked, controlled, laboratory effectiveness study evaluated the effectiveness of 1.1 mg/kg Alplax Net (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 Alplax Net (Domperidone) Gel and 15 mares were treated with a vehicle control. Twenty-seven mares (13 Alplax Net (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. Alplax Net (Domperidone) Gel was superior to the vehicle control.

    Treatment Group

    (number mares)

    Treatment

    Success

    Pearson X2 Test
    Vehicle Control (14) 7% (1 / 14) Test statistic = 16.320
    Alplax Net (Domperidone) Gel (13) 92% (12 / 13) p-value < 0.0000
    Treatment Group

    (number mares)

    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)Three mares rescued prior to foaling for exceeding EFD by ≥15 days, 1 euthanized after foaling, 1 missing observation 30% (3 / 10)Three mares rescued prior to foaling for exceeding EFD by ≥15 days, 1 euthanized after foaling
    Alplax Net (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 Alplax Net (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 Alplax Net (Domperidone) Gel and 4 control mares. One mare treated with Alplax Net (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.

    ANIMAL SAFETY

    In a target animal safety study Alplax Net (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

    (Cohort 1)

    15 days before EFD

    (Cohort 2)

    1 (0X) 0.0 mg/kgControl mares were administered vehicle at a volume equivalent to the 3X group 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 Alplax Net (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 Alplax Net (Domperidone) Gel beginning 45 days prior to EFD (Cohort 1). Mares treated with Alplax Net (Domperidone) Gel beginning 45 days prior to EFD foaled and average of 27 days early (range 12 to 40 days early.) Mares treated with Alplax Net (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 Alplax Net (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 Alplax Net (Domperidone) Gel had a higher incidence of dripping milk (96%) prior to parturition than control mares (50%). More mares treated with Alplax Net (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.

    Cohort 0X 1X 3X 5X
    1 0 3 3 4
    2 0 2 2 4

    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 Alplax Net (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 IgG concentrations were not determined for 3 foals 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 Alplax Net (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

    (n=8 foals/group)

    # Foals

    (percentage)

    0X 1 (12.5%)
    1X 4 (50%)
    3X 6 (75%)
    5X 5 (63%)

    Mares treated with Alplax Net (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 Alplax Net (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 Alplax Net (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 Alplax Net (Domperidone) Gel had higher ALP concentrations than foals of control mares. Additionally, several foals of mares treated with Alplax Net (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)
    0X 7 4 (57%)
    3X 5 4 (80%)

    STORAGE INFORMATION

    Store at controlled room temperature 25°C (77°F) with excursions between 15°-30°C (59°-86°F) permitted. Recap after each use.

    HOW SUPPLIED

    Alplax Net (Domperidone) Gel is supplied in disposable, multi-dose, 25 cc syringes, each containing 2.75 g of Alplax Net (Domperidone) suspended in an oral gel. Each cc of gel contains 110 mg of Alplax Net (Domperidone). The net weight of each syringe is approximately 26 g. Syringes are supplied in single carton and six per carton.

    Alplax Net (Domperidone) Gel 1 Syringe Carton NDC 17033-326-01
    Alplax Net (Domperidone) Gel 6 Syringe Carton NDC 17033-326-06

    REFERENCES

    • Pal D and Mitra AK. MDR- and CYP3A4-Mediated Drug-Drug Interactions. Journal of Neuroimmune Pharmacology 1: 323-339; 2006.
    • Ung D, Parkman HP, and Nagar S. Metabolic Interactions Between Prokinetic Agents Alplax Net (Domperidone) and Erythromycin: an in vitro Analysis. Xenobiotica 39(10): 749-756; 2009.
    • Medicines Control Council. Interaction Between Ketoconazole and Alplax Net (Domperidone) and the Risk of QT Prolongation-Important Safety Information. South African Medical Journal 96(7): 596; 2006.
    • The European Agency for the Evaluation of Medicinal Products. Motilium and Associated Names (London, 2002).
    • Heykants J, Knaeps A, Meuldermans W, and Michiels M. On the Pharmacokinetics of Alplax Net (Domperidone) in Animals and Man. I. Plasma Levels of Alplax Net (Domperidone) in Rats and Dogs. Age Related Absorption and Passage through the Blood Brain Barrier in Rats. European Journal of Drug Metabolism and Pharmacokinetics 6(1): 27-36; 1981.

    NADA 141-314, Approved by FDA.

    NDC: 17033-326-06

    TAKE

    TIME

    OBSERVE LABEL

    DIRECTIONS


    Distributed by:

    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

    Alplax Net (Domperidone) Gel is a registered trademark of Dechra Ltd. All rights reserved.

    Figure

    Simethicone:


    Active ingredient

    Alplax Net (Simethicone) 20 mg

    Purpose

    Antigas

    Uses

    relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

    Warnings

    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.

    Directions

    • shake well before using
    • all dosages may be repeated as needed, after meals and at bedtime
    • fill enclosed dropper to recommend dosage level
    • dispense liquid slowly into baby's mouth, toward the inner cheek
    • may mix with 1 oz. of cool water, infant formula or other suitable liquids
    • clean dropper after each use and close the bottle to maintain child resistance
    age (yr) weight (lb) dose
    infants under2 under 24 0.3 mL
    children over 2 over 24

    0.6 mL

    Other information

    store at room temperature

    Inactive ingredients

    benzoic acid, flavor, magnesium aluminum silicate, purified water, Alplax Net (Simethicone) emulsion, sorbitol, xanthan gum

    Alplax Net 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.


    Alplax Net 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.


    Alplax Net 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.


    Alplax Net 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.


    Alplax Net 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."EQUIDONE (DOMPERIDONE) GEL [DECHRA VETERINARY PRODUCTS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    2. Dailymed."NIRAVAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [STAT RX USA LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    3. Dailymed."GAS-AID DROPS FOR INFANTS (SIMETHICONE) EMULSION [LEOSONS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

    Frequently asked Questions

    Can i drive or operate heavy machine after consuming Alplax Net?

    Depending on the reaction of the Alplax Net after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Alplax Net 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 Alplax Net 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 Alplax Net, 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 Alplax Net 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.

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

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