Clomipramine Tablets (Clonil) – Product Information
Clomipramine tablets are used for the treatment of obsessions and compulsions in adult patients with obsessive compulsive disorder (OCD). The obsessions and compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning.
It is also used in the treatment of depression associated with schizophrenia and personality disorders, Phobias and panic attacks, chronic painful conditions, Cataplexy accompanying narcolepsy, depressive syndromes due to presenility or senility, and chronic somatic diseases, and depressive mood disorders of a reactive, neurotic or psychopathic nature. It is also used to treat Irritable Bowel Syndrome.
Clonil tablets are available in strengths of 10 mg, 25 mg, 50 mg and 75 mg SR.
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Name of Drug
Clonil. Clonil tablets are also known as Generic Clomipramine tablets and Clomipramine Hydrochloride tablets.
Manufacturer of Clonil Tablets
Intas Pharmaceuticals Ltd.
Website:intaspharma.com
Active Pharmaceutical Ingredient
The active pharmaceutical ingredient contained in Clonil tablets is Clomipramine Hydrochloride. Each Clonil tablet contains 10 mg, 25 mg, 50 mg or 75 mg of Clomipramine.
Drug Uses
Clonil (Clomipramine Hydrochloride tablets) is indicated for the treatment of depression. Clonil also appears to have a mild sedative effect which may be helpful in alleviating the anxiety component often accompanying depression.
Clomipramine tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD). The obsessions and compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning.
Obsessive-compulsive disorder (OCD) is an anxiety disorder characterized by intrusive thoughts that are recurrent, persistent ideas, thoughts, images and produce uneasiness, apprehension, fear, or worry. In response to an obsession there are repetitive, purposeful, and intentional behaviors aimed at reducing the associated anxiety or by a combination of such obsessions and compulsions.
Clomipramine Tablets (Clonil) – Dosage
The dosage of Clonil (Clomipramine Hydrochloride tablets) should be individualized as per the requirements of each patient. Clomipramine tablets are available in strengths of 10 mg, 25 mg and 50 mg. The recommended initial dosage of Clomipramine tablets is given below:
Adults:
Clomipramine therapy should be initiated at daily doses of 25 mg. Dosage may be increased by 25 mg increments, as tolerated, at 3 to 4 day intervals up to a total daily dose of 150 mg by the end of 2 weeks.
Elderly And Debilitated Patients:
In general, lower dosages are recommended for these patients. Initially, 20 to 30 mg daily in divided doses is suggested, with very gradual increments, depending on tolerance and response.
Drug Class and Mechanism
The action of Clomipramine on the human electroencephalogram is one of desynchronization. Clomipramine causes a persistent increase in the frequency of shifts into stage I sleep and produces marked reduction or suppression of rapid eye movement sleep (REM or paradoxical sleep). Partial recovery occurs within 3 to 4 weeks as does a rebound after drug withdrawal which appears to last approximately the same time. In normal human volunteers tricyclic antidepressants tend to produce a sedative effect accompanied by atropine-like symptoms and may produce some difficulty in concentrating and thinking.
Clomipramine is rapidly and completely absorbed after oral administration in humans. Peak plasma levels are usually reached two hours after dosage, but much individual variation occurs.
What to do in Case You Miss a Dose of
In case you miss a dose of Clomipramine tablets, take the missed dose as soon as you remember it. In case, it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Storage Instructions for Clomipramine Tablets (Clonil)
Store Clomipramine tablets at 20°C to 25°C(68°F to 77°F). Protect from heat and moisture. Store in a tight, light-resistant container. Keep out of the reach of children.
Warnings and Precautions to be taken when using Clomipramine Tablets
Before using Clomipramine tablets (Clonil) please inform your doctor all the medicines that you take including no prescription medications, over the counter medicines and herbal remedies. The other precautions to be taken when using Clonil (Clomipramine tablets) are:
- Since depression is a commonly associated feature of OCD, the risk of suicide must be considered.
- Modest orthostatic decreases in blood pressure and modest tachycardia were each seen in approximately 20% of patients taking clomipramine in clinical trials; but patients were frequently asymptomatic.
- Patients treated with clomipramine have been reported to show a variety of neuropsychiatric signs and symptoms including delusions, hallucinations, psychotic episodes, confusion, and paranoia.
- During premarketing testing of clomipramine in patients with affective disorder, hypomania or mania was precipitated in several patients. Activation of mania or hypomania has also been reported in a small proportion of patients with affective disorder treated with marketed tricyclic antidepressants, which are closely related to clomipramine.
- During premarketing testing, clomipramine was occasionally associated with elevations in SGOT and SGPT of potential clinical importance. Rare reports of more severe liver injury, some fatal, have been recorded in foreign postmarketing experience. Caution is indicated in treating patients with known liver disease, and periodic monitoring of hepatic enzyme levels is recommended in such patients.
- Although no instances of severe hematologic toxicity were seen in the premarketing experience with clomipramine, there have been postmarketing reports of leukopenia, agranulocytosis, thrombocytopenia, anemia, and pancytopenia in association with clomipramine use.
- More than 30 cases of hyperthermia have been recorded by nondomestic postmarketing surveillance systems. Most cases occurred when clomipramine was used in combination with other drugs.
- The rate of sexual dysfunction in male patients with OCD who were treated with clomipramine in the premarketing experience was markedly increased compared with placebo controls
- In controlled studies of OCD, weight gain was reported in 18% of patients receiving clomipramine, compared with 1% of patients receiving placebo.
- As with closely related tricyclic antidepressants, concurrent administration of clomipramine with electroconvulsive therapy may increase the risks; such treatment should be limited to those patients for whom it is essential.
- Prior to elective surgery with general anesthetics, therapy with clomipramine hydrochloride should be discontinued for as long as is clinically feasible.
- As with closely related tricyclic antidepressants, clomipramine should be used with caution in hyperthyroid patients or patients receiving thyroid medication, patients with increased intraocular pressure, patients with tumors of the adrenal medulla and patients with significantly impaired renal function.
- A variety of withdrawal symptoms have been reported in association with abrupt discontinuation of clomipramine, including dizziness, nausea, vomiting, headache, malaise, sleep disturbance, hyperthermia, and irritability. In addition, such patients may experience a worsening of psychiatric status.
Side Effects of Clomipramine Tablets
The possible common side effects of Clomipramine tablets are gastrointestinal complaints, including dry mouth, constipation, nausea, dyspepsia, and anorexia; nervous system complaints, including somnolence, tremor, dizziness, nervousness, and myoclonus; genitourinary complaints, including changed libido, ejaculatory failure, impotence, and micturition disorder; and other miscellaneous complaints, including fatigue, sweating, increased appetite, weight gain, and visual changes.
Clomipramine Tablets – Contraindications
Clomipramine tablets (Clonil) is contraindicated in the following cases:
- Hypersensitivity to Clomipramine Hydrochloride, other tricyclic antidepressants or any inactive ingredient present in Clomipramine tablets.
- Use of MAOIs intended to treat psychiatric disorders with Clomipramine or within 14 days of stopping treatment with Clomipramine is contraindicated.
- Starting Clomipramine in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
- Clomipramine is contraindicated during the acute recovery period after a myocardial infarction.
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