Promil is used to treat obsessive compulsive disorder (OCD). OCD is a nervous condition where a person has recurring thoughts or ideas, or does repetitive things because they are anxious.
Promil is a tricyclic antidepressant (TCA). It is thought to work in the brain by increasing the activity of the chemical serotonin.
Promil is available only with your doctor's prescription.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Promil™ (Promil hydrochloride) Capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
The effectiveness of Promil for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.
The effectiveness of Promil for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Promil for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
How should I use Promil?
Use Promil as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Promil comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Promil refilled.
Take Promil by mouth with food to decrease stomach upset.
It may take 2 to 3 weeks before you notice the effect of Promil. Continue to use Promil even if you feel well. Do not miss any doses.
If you miss a dose of Promil, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you take 1 dose daily at bedtime, do not take the missed dose the next morning.
Ask your health care provider any questions you may have about how to use Promil.
Uses of Promil in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Obsessive-compulsive disorder: Treatment of obsessive-compulsive disorder
Off Label Uses
Major depressive disorder
Data from randomized, double-blind studies supports the use of Promil in the treatment of major depressive disorder. Additional trials may be necessary to further define the role of Promil in this condition.
According to the American Psychiatric Association treatment guidelines, Promil is effective and recommended for the management of major depressive disorder. Although the WFSBP treatment guidelines also recommend Promil, particularly for patients with severe depression or concomitant obsessive-compulsive disorder, the guidelines recommend prescribing a limited supply for severely depressed patients at risk of overdose.
Data from randomized, double-blind, placebo-controlled studies supports the use of Promil in the management of panic disorder with or without agoraphobia to decrease severity of anxiety and phobias, as well as severity and frequency of panic attacks. Additional trials may be necessary to further define the role of Promil in this condition.
Based on the American Psychiatric Association guidelines for the treatment of panic disorder, selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and benzodiazepines all have roughly comparable efficacy in the treatment of panic disorder, but SSRIs are likely to have the most favorable balance of efficacy and adverse effects for most patients. Based on the Canadian Psychiatric Association guidelines for the management of anxiety disorders, TCAs like Promil are second-line choices for panic disorder. Based on the World Federation of the Societies of Biological Psychiatry guidelines for the management of anxiety disorders, TCAs are recommended in panic disorder in patients who have not responded to SSRIs or SNRIs.
Promil, the 3-chloro analog of imipramine, is a dibenzazepine-derivative tricyclic antidepressant (TCA). TCAs are structurally similar to phenothiazines. They contain a tricyclic ring system with an alkyl amine substituent on the central ring. In non-depressed individuals, Promil does not affect mood or arousal, but may cause sedation. In depressed individuals, Promil exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Tertiary amine TCAs, such as Promil, are more potent inhibitors of serotonin reuptake than secondary amine TCAs, such as nortriptyline and desipramine. TCAs also down-regulate cerebral cortical β-adrenergic receptors and sensitize post-synaptic serotonergic receptors with chronic use. The antidepressant effects of TCAs are thought to be due to an overall increase in serotonergic neurotransmission. TCAs also block histamine-H1 receptors, α1-adrenergic receptors and muscarinic receptors, which accounts for their sedative, hypotensive and anticholinergic effects (e.g. blurred vision, dry mouth, constipation, urinary retention), respectively. See toxicity section below for a complete listing of side effects. Promil may be used to treat obsessive-compulsive disorder and disorders with an obsessive-compulsive component (e.g. depression, schizophrenia, Tourette’s disorder). Unlabeled indications include panic disorder, chronic pain (e.g. central pain, idiopathic pain disorder, tension headache, diabetic peripheral neuropathy, neuropathic pain), cataplexy and associated narcolepsy, autistic disorder, trichotillomania, onchophagia, stuttering, premature ejaculation, and premenstrual syndrome. Promil is rapidly absorbed from the gastrointestinal tract and demethylated in the liver to its primary active metabolite, desmethylclomipramine.
Generic name: Promil HYDROCHLORIDE 25mg
Dosage form: capsule
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
The treatment regimens described below are based on those used in controlled clinical trials of Promil in 520 adults, and 91 children and adolescents with OCD. During initial titration, Promil should be given in divided doses with meals to reduce gastrointestinal side effects. The goal of this initial titration phase is to minimize side effects by permitting tolerance to side effects to develop or allowing the patient time to adapt if tolerance does not develop.
Because both CMI and its active metabolite, DMI, have long elimination half-lives, the prescriber should take into consideration the fact that steady-state plasma levels may not be achieved until 2 to 3 weeks after dosage change. Therefore, after initial titration, it may be appropriate to wait 2 to 3 weeks between further dosage adjustments.
Initial Treatment/Dose Adjustment (Adults)
Treatment with Promil should be initiated at a dosage of 25 mg daily and gradually increased, as tolerated, to approximately 100 mg during the first 2 weeks. During initial titration, Promil should be given in divided doses with meals to reduce gastrointestinal side effects. Thereafter, the dosage may be increased gradually over the next several weeks, up to a maximum of 250 mg daily. After titration, the total daily dose may be given once daily at bedtime to minimize daytime sedation.
Initial Treatment/Dose Adjustment (Children and Adolescents)
As with adults, the starting dose is 25 mg daily and should be gradually increased (also given in divided doses with meals to reduce gastrointestinal side effects) during the first 2 weeks, as tolerated, up to a daily maximum of 3 mg/kg or 100 mg, whichever is smaller. Thereafter, the dosage may be increased gradually over the next several weeks up to a daily maximum of 3 mg/kg or 200 mg, whichever is smaller. As with adults, after titration, the total daily dose may be given once daily at bedtime to minimize daytime sedation.
Maintenance/Continuation Treatment (Adults, Children, and Adolescents)
While there are no systematic studies that answer the question of how long to continue Promil, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of Promil after 10 weeks has not been documented in controlled trials, patients have been continued in therapy under double-blind conditions for up to 1 year without loss of benefit. However, dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for treatment. During maintenance, the total daily dose may be given once daily at bedtime.
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Promil. Conversely, at least 14 days should be allowed after stopping Promil before starting an MAOI intended to treat psychiatric disorders.
Use of Promil With Other MAOIs, Such as Linezolid or Methylene Blue
Do not start Promil in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered.
In some cases, a patient already receiving Promil therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Promil should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until
24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Promil may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Promil is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.
The risks of using Promil in combination with other drugs have not been systematically evaluated. Given the primary CNS effects of Promil, caution is advised in using it concomitantly with other CNS-active drugs. Promil should not be used with MAO inhibitors.
Close supervision and careful adjustment of dosage are required when Promil is administered with anticholinergic or sympathomimetic drugs.
Several tricyclic antidepressants have been reported to block the pharmacologic effects of guanethidine, clonidine, or similar agents, and such an effect may be anticipated with CMI because of its structural similarity to other tricyclic antidepressants.
The plasma concentration of CMI has been reported to be increased by the concomitant administration of haloperidol; plasma levels of several closely related tricyclic antidepressants have been reported to be increased by the concomitant administration of methylphenidate or hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decreased by the concomitant administration of hepatic enzyme inducers (e.g., barbiturates, phenytoin), and such an effect may be anticipated with CMI as well. Administration of CMI has been reported to increase the plasma levels of phenobarbital, if given concomitantly.
Drugs Metabolized By P450 2D6
The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% of Caucasians are so-called “poor metabolizers”); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8 fold increase in plasma AUC of the TCA). In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, paroxetine, and fluvoxamine, inhibit P450 2D6, they may vary in the extent of inhibition. Fluvoxamine has also been shown to inhibit P450 1A2, an isoform also involved in TCA metabolism. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary). Concomitant use of agents in the tricyclic antidepressant class (which includes Promil) with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant agent or the other drug. Furthermore, whenever one of these drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant agent may be required. It is desirable to monitor TCA plasma levels whenever an agent of the tricyclic antidepressant class including Promil is going to be co-administered with another drug known to be an inhibitor of P450 2D6 (and/or P450 1A2).
Because Promil is highly bound to serum protein, the administration of Promil to patients taking other drugs that are highly bound to protein (e.g., warfarin, digoxin) may cause an increase in plasma concentrations of these drugs, potentially resulting in adverse effects. Conversely, adverse effects may result from displacement of protein-bound Promil by other highly bound drugs.
In addition to its needed effects, some unwanted effects may be caused by Promil (the active ingredient contained in Promil). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Promil:
bloody or cloudy urine
body aches or pain
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
difficult, burning, or painful urination
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
excessive muscle tone
fear or nervousness
feeling sad or empty
lower back or side pain
muscle stiffness, tension, or tightness
rhythmic movement of muscles
shortness of breath or troubled breathing
tightness of the chest or wheezing
unusual tiredness or weakness
Anger that is hard to control
burning while urinating
changes in vision
decrease in the frequency of urination
difficulty in passing urine (dribbling)
difficulty in speaking
fast, irregular, pounding, or racing heartbeat or pulse
headache, severe and throbbing
nausea or vomiting
numbness, tingling, pain, or weakness in the hands or feet
pain during sexual intercourse
rapidly changing moods
swelling of the face, fingers, feet, or lower legs
Minor Side Effects
Some of the side effects that can occur with Promil may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Acid or sour stomach
blistering, crusting, irritation, itching, or reddening of the skin
change in taste
cracked, dry, or scaly skin
change in interest in sexual intercourse
hives or welts, skin rash
inability to have or keep an erection
increased interest in sexual intercourse
redness of the face, neck, arms, and occasionally, upper chest
shakiness in the legs, arms, hands, or feet
stomach discomfort, upset, or pain
trembling or shaking of the hands or feet
Absent, missed, or irregular menstrual periods
sores, ulcers, or white spots on the lips or tongue or inside the mouth
Promil is contraindicated in patients with a history of hypersensitivity to Promil or other tricyclic antidepressants.
Monoamine Oxidase Inhibitors (MAOIs)
The use of MAOIs intended to treat psychiatric disorders with Promil or within 14 days of stopping treatment with Promil is contraindicated because of an increased risk of serotonin syndrome. The use of Promil within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.
Starting Promil in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
Promil is contraindicated during the acute recovery period after a myocardial infarction.
DailyMed. "PANTOTHENIC ACID: 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/dailyme... (accessed September 17, 2018).
DailyMed. "ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E: 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/dailyme... (accessed September 17, 2018).
DailyMed. "ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E: 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/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Promil are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Promil. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported useful
No survey data has been collected yet
Consumer reported price estimates
No survey data has been collected yet
1 consumer reported time for results
To what extent do I have to use Promil before I begin to see changes in my health conditions? As part of the reports released by ndrugs.com website users, it takes > 3 month and a few days before you notice an improvement in your health conditions. Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Promil. To get the time effectiveness of using Promil drug by other patients, please click here.
> 3 month
1 consumer reported age
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