Pronil Plus

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Pronil Plus uses

Pronil Plus consists of Alprazolam, Fluoxetine.

Alprazolam:


Pharmacological action

Pronil Plus 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 Pronil Plus (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. Pronil Plus (Alprazolam) and its metabolites are mainly excreted by kidneys.

Why is Pronil Plus 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 Pronil Plus 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 Pronil Plus (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 Pronil Plus (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.

    Pronil Plus (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

    Pronil Plus (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 Pronil Plus (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 Pronil Plus (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 Pronil Plus for drivers of vehicles and people whose profession is associated with increased concentration.

    Pronil Plus (Alprazolam) drug interactions

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

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

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

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

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

    Pronil Plus (Alprazolam) increases the concentration of imipramine in plasma.

    Simultaneous administration with itraconazole, ketoconazole increases the effects of Pronil Plus (Alprazolam).

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

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

    Simultaneous administration of Pronil Plus (Alprazolam) with fluoxetine may increase the concentration of Pronil Plus (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 Pronil Plus (Alprazolam) for simultaneous administration with erythromycin.

    Pronil Plus 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).

  • Fluoxetine:


    Pharmacological action

    Pronil Plus is an antidepressant, propylamine derivative. The mechanism of action is associated with selective blockade of the inverse of neuronal serotonin reuptake in the CNS. Pronil Plus (Fluoxetine) is a weak antagonist of choline, adrenergic and histamine receptors. Unlike most antidepressants Pronil Plus (Fluoxetine) apparently does not cause reduction of functional activity of postsynaptic beta-adrenergic receptors. This medication improves mood, reduces anxiety and stress, eliminates dysphoria. Pronil Plus (Fluoxetine) does not cause sedation. When you receive a medium therapeutic doses of this drug it does not affect the function of cardiovascular and other systems.

    Pharmacokinetics

    Pronil Plus (Fluoxetine) absorbed from the gastrointestinal tract. This medication is poorly metabolized in the "first pass" through the liver. The ingestion did not affect the extent of absorption, although it may slow its speed. Cmax in plasma is reached after 6-8 hours. Css in plasma is reached only after a continuous reception in a few weeks. The protein binding is 94.5%. Pronil Plus (Fluoxetine) easily penetrates through the BBB.

    Pronil Plus (Fluoxetine) metabolized in the liver by demethylation to form the main active metabolite norfluoxetine.

    T1/2 of Pronil Plus (Fluoxetine) is 2-3 days, norfluoxetine - 7-9 days.

    Why is Pronil Plus prescribed?

    Depressions of various origins, obsessive-compulsive disorders, bulimic neurosis.

    Dosage and administration

    The initial dose of Pronil Plus is 20 mg 1 time / day in the morning, if necessary, the dose may be increased in 3-4 weeks. The frequency of reception is 2-3 times / day.

    The maximum oral daily dose for adults is 80 mg.

    Pronil Plus (Fluoxetine) side effects, adverse reactions

    CNS: anxiety, tremors, nervousness, drowsiness, headache, sleep disturbances.

    Digestive system: diarrhea, nausea.

    Metabolism: increased sweating, hypoglycemia, hyponatremia (especially in elderly patients and when hypovolemia).

    Reproductive system: decreased libido.

    Allergic reactions: skin rash, itching.

    Other: pain in joints and muscles, shortness of breath, increased body temperature.

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    Pronil Plus contraindications

    Glaucoma, bladder atony, severe renal dysfunction, benign prostatic hyperplasia, co-administration of MAO inhibitors, convulsions of various origins, epilepsy, pregnancy, lactation, hypersensitivity to Pronil Plus (Fluoxetine).

    Using during pregnancy and breastfeeding

    Pronil Plus is contraindicated during pregnancy and lactation.

    Special instructions

    Pronil Plus (Fluoxetine) should be used with caution in patients with impaired liver and kidney, with a history of epileptic seizures, cardio-vascular diseases.

    Patients with diabetes may change in blood glucose levels that require correction dosing regimen of hypoglycemic drugs. When applied in debilitated patients with Pronil Plus (Fluoxetine) increases the risk of epileptic seizures.

    With the simultaneous application of Pronil Plus (Fluoxetine) and electroconvulsive therapy may develop prolonged seizures.

    Pronil Plus (Fluoxetine) can be applied not earlier than 14 days after discontinuation of MAO inhibitors. The period after the abolition of Pronil Plus (Fluoxetine) before therapy MAO inhibitors should not be less than 5 weeks.

    Elderly patients need correction of dosing regimen.

    Safety of Pronil Plus (Fluoxetine) in children has not been established.

    During the period of treatment it needed to avoid use alcohol.

    During the period of treatment should refrain from potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

    Pronil Plus drug interactions

    Simultaneous administration of Pronil Plus (Fluoxetine) with:

  • drugs providing a depressing effect on the central nervous system and with ethanol it is possibly significantly increased inhibitory action on the CNS, as well as increasing the likelihood of developing seizures;
  • MAO inhibitors, furazolidone, procarbazine, tryptophan may develop serotonin syndrome (confusion, hypomanic state, motor restlessness, agitation, convulsions, dysarthria, hypertensive crisis, fever, tremor, nausea, vomiting, diarrhea);
  • Pronil Plus (Fluoxetine) inhibits the metabolism of tricyclic and tetracyclic antidepressants, trazodone, carbamazepine, diazepam, metoprolol, terfenadine, phenytoin, thereby increasing their concentration in serum, increase their therapeutic and side effects;
  • it is possible inhibition of the biotransformation of drugs metabolized with the participation of isoenzyme CYP2D6;
  • hypoglycemic agents may increase their activities;
  • haloperidol, fluphenazine, maprotiline, metoclopramide, perphenazine, pyrathiazine, pimozide, risperidone, sulpiride, trifluoperazine there were describes cases of extrapyramidal symptoms and dystonia; with dextromethorphan - described a case of hallucinations; with digoxin - the case of increasing the concentration of digoxin in plasma;
  • with lithium salts may increase or decrease the concentration of lithium in blood plasma;
  • may increase the concentration of imipramine and desipramine in plasma is 2-10 times (and may persist for 3 weeks after discontinuation of Pronil Plus (Fluoxetine) Sanis Health);
  • propofol there was described a case in which spontaneous movements were observed; with phenylpropanolamine - described a case in which were observed dizziness, weight loss, hyperactivity;
  • may increase the effects of flecainide, mexiletine, propafenone, thioridazine, zuclopenthixol. There are reports on the strengthening effects of warfarin in its simultaneous application with Pronil Plus (Fluoxetine).

    Pronil Plus in case of emergency / overdose

    Symptoms: nausea, vomiting, agitation, restlessness, hypomania, seizures, large seizures. There were describes two deaths from acute overdose of Pronil Plus (Fluoxetine) (in combination with maprotiline, codeine, temazepam).

    Treatment: gastric lavage, taking activated charcoal, sorbitol, ECG monitoring, symptomatic and supportive therapy, when convulsions - diazepam. There is no specific antidote. Forced diuresis, peritoneal dialysis, hemodialysis, blood transfusions are ineffective.

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    Pronil 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.


    Pronil 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.


    Pronil 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.


    Pronil 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.


    Pronil 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.


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    References

    1. Dailymed."NIRAVAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [STAT RX USA LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    2. Dailymed."FLUOXETINE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    3. Dailymed."ALPRAZOLAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

    Frequently asked Questions

    Can i drive or operate heavy machine after consuming Pronil Plus?

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

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    Review

    sdrugs.com conducted a study on Pronil 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 Pronil 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.

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    The information was verified by Dr. Rachana Salvi, MD Pharmacology

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