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• Supranil indications
• Uses of Supranil in details
• Supranil description
• Supranil dosage
• Supranil interactions
• Supranil side effects
• Supranil contraindications

What is Supranil?

Supranil 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.

Supranil is a tricyclic antidepressant (TCA). It is thought to work in the brain by increasing the activity of the chemical serotonin.

Supranil is available only with your doctor's prescription.

Supranil indications

Supranil™ (Supranil 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 Supranil for the treatment of OCD was demonstrated in multicenter, placebocontrolled, 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 Supranil 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 Supranil for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

How should I use Supranil?

Use Supranil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Supranil comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Supranil refilled.
• Take Supranil by mouth with food to decrease stomach upset.
• It may take 2 to 3 weeks before you notice the effect of Supranil. Continue to use Supranil even if you feel well. Do not miss any doses.
• If you miss a dose of Supranil, 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 Supranil.

Uses of Supranil in details

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 Supranil in the treatment of major depressive disorder. Additional trials may be necessary to further define the role of Supranil in this condition.

According to the American Psychiatric Association treatment guidelines, Supranil is effective and recommended for the management of major depressive disorder. Although the WFSBP treatment guidelines also recommend Supranil, 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.

Panic disorder

Data from randomized, double-blind, placebo-controlled studies supports the use of Supranil 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 Supranil 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 Supranil 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.

Supranil description

Supranil, 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, Supranil does not affect mood or arousal, but may cause sedation. In depressed individuals, Supranil exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Tertiary amine TCAs, such as Supranil, 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. Supranil 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. Supranil is rapidly absorbed from the gastrointestinal tract and demethylated in the liver to its primary active metabolite, desmethylclomipramine.

Supranil dosage

Supranil Dosage

Generic name: Supranil 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 Supranil in 520 adults, and 91 children and adolescents with OCD. During initial titration, Supranil 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 Supranil 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, Supranil 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 Supranil, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of Supranil 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 Supranil. Conversely, at least 14 days should be allowed after stopping Supranil before starting an MAOI intended to treat psychiatric disorders.

Use of Supranil With Other MAOIs, Such as Linezolid or Methylene Blue

Do not start Supranil 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 Supranil 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, Supranil 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 Supranil 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 Supranil is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.

More about Supranil (Supranil)

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Consumer resources

• Supranil
• Supranil (Advanced Reading)

Professional resources

• Supranil (AHFS Monograph)
• Supranil (FDA)

Related treatment guides

• Obsessive Compulsive Disorder
• Panic Disorder
• Depression
• Irritable Bowel Syndrome
• Sleep Paralysis

Supranil interactions

See also:
What other drugs will affect Supranil?

The risks of using Supranil in combination with other drugs have not been systematically evaluated. Given the primary CNS effects of Supranil, caution is advised in using it concomitantly with other CNS-active drugs. Supranil should not be used with MAO inhibitors.

Close supervision and careful adjustment of dosage are required when Supranil 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 Supranil) 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 Supranil is going to be co-administered with another drug known to be an inhibitor of P450 2D6 (and/or P450 1A2).

Because Supranil is highly bound to serum protein, the administration of Supranil 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 Supranil by other highly bound drugs.

Monoamine Oxidase Inhibitors (MAOIs )

Serotonergic Drugs

Supranil side effects

See also:
What are the possible side effects of Supranil?

Applies to Supranil: oral capsule, oral tablet

In addition to its needed effects, some unwanted effects may be caused by Supranil (the active ingredient contained in Supranil). 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 Supranil:

More common:

• Bladder pain
• bloody or cloudy urine
• blurred vision
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion
• 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
• fever
• hearing changes
• irritability
• lower back or side pain
• muscle stiffness, tension, or tightness
• poor concentration
• rhythmic movement of muscles
• shortness of breath or troubled breathing
• sneezing
• tightness of the chest or wheezing
• unusual tiredness or weakness
• voice changes

• Anger that is hard to control
• breast enlargement
• burning while urinating
• changes in vision
• chills
• decrease in the frequency of urination
• difficulty in passing urine (dribbling)
• difficulty in speaking
• dry mouth
• fast, irregular, pounding, or racing heartbeat or pulse
• headache, severe and throbbing
• hyperventilation
• irregular heartbeats
• irritability
• nausea or vomiting
• numbness, tingling, pain, or weakness in the hands or feet
• pain during sexual intercourse
• panic attacks
• paranoia
• rapidly changing moods
• restlessness
• shaking
• swelling of the face, fingers, feet, or lower legs

Minor Side Effects

Some of the side effects that can occur with Supranil 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:

More common:

• Acid or sour stomach
• blistering, crusting, irritation, itching, or reddening of the skin
• change in taste
• constipation
• cracked, dry, or scaly skin
• change in interest in sexual intercourse
• diarrhea
• dry skin
• heartburn
• hives or welts, skin rash
• inability to have or keep an erection
• increased interest in sexual intercourse
• joint pain
• pimples
• redness of the face, neck, arms, and occasionally, upper chest
• shakiness in the legs, arms, hands, or feet
• stomach discomfort, upset, or pain
• swelling
• swollen joints
• trembling or shaking of the hands or feet

• Absent, missed, or irregular menstrual periods
• breast pain
• sores, ulcers, or white spots on the lips or tongue or inside the mouth

Supranil contraindications

See also:
What is the most important information I should know about Supranil?

Supranil is contraindicated in patients with a history of hypersensitivity to Supranil or other tricyclic antidepressants.

Monoamine Oxidase Inhibitors (MAOIs)

The use of MAOIs intended to treat psychiatric disorders with Supranil or within 14 days of stopping treatment with Supranil is contraindicated because of an increased risk of serotonin syndrome. The use of Supranil within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.

Starting Supranil in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.

Myocardial Infarction

Supranil is contraindicated during the acute recovery period after a myocardial infarction.

Active ingredient matches for Supranil:

Clomipramine in Egypt.

Clomipramine Hcl

References

1. PubChem. "clomipramine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
2. DrugBank. "clomipramine". http://www.drugbank.ca/drugs/DB01242 (accessed September 17, 2018).
3. DTP/NCI. "clomipramine: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology