Generic Clomipramine Hydrochloride Tablets

Generic Clomipramine Hydrochloride Tablets (Clofranil and Clonil) - Product Information

Generic Clomipramine Hydrochloride (Clofranil tablets and Clonil tablets) is a tricyclic antidepressant which is used to treat symptoms of obsessive-compulsive disorder (OCD) such as recurrent thoughts or feelings and repetitive actions. It is also used to treat patients with Phobias and panic attacks, Cataplexy accompanying narcolepsy, Chronic painful conditions, masked and involutional forms of depression, depression associated with schizophrenia and personality disorders, depressive syndromes due to presenility or senility and premature ejaculation.

Clofranil tablets are manufactured by Sun Pharmaceutical Industries Ltd. in the strengths of 10 mg, 25 mg, 50 mg and 75 mg SR. Clonil tablets are manufactured by Intas Pharmaceuticals Ltd. also in the same strengths. We supply either Clofranil or Clonil depending on availability.

 We also have in stock Generic Nortriptyline (Primox tablets) which is used to treat the symptoms of depression.

Name of the Drug

We supply original Clofranil manufactured by Sun Pharmaceutical Industries Limited or Clonil tablets manufactured by Intas Pharmaceuticals Limited.

Manufacturer of Clofranil Tablets

Sun Pharmaceutical Industries Ltd.  
Website:www.sunpharma.com

Manufacturer of Clonil Tablets

Intas Pharmaceuticals Ltd.  
Website:www.intaspharma.com

Active Ingredient present in Clofranil Tablets

The active ingredient present in Clofranil Tablets is Clomipramine Hydrochloride. Each Clofranil tablet contains 10 mg, 25 mg, 50 mg or 75 mg of Clomipramine.

Active Ingredient present in Clonil Tablets

The active ingredient present in Clonil Tablets is Clomipramine Hydrochloride. Each Clonil tablet contains 10 mg, 25 mg, 50 mg or 75 mg of Clomipramine.

Uses of Generic Clomipramine Hydrochloride Tablets

Generic Clomipramine Hydrochloride Tablets is used 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 diagnosis of OCD.

This medicine is also used for the treatment of Cataplexy associated with narcolepsy, Major depression, depressive states (in adults only) including endogenous, reactive, neurotic, organic, masked and involutional forms of depression, depression associated with schizophrenia and personality disorders, depressive syndromes due to presenility or senility, chronic painful conditions, and chronic somatic diseases, and depressive mood disorders of a reactive, neurotic or psychopathic nature.

Generic Clomipramine Tablets (Clofranil tablets and Clonil tablets) helps reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, checking) that interfere with daily living.

How To Use Clomipramine For Premature Ejaculation

The most effective medicines to treat Premature Ejaculation appear to be the antidepressant medications known as selective serotonin reuptake inhibitors (SSRIs) like Dapoxetine Hydrochloride (Poxet tablets). In case they are not effective Clomipramine Hydrochloride Tablets (Clofranil and Clonil) are used to treat men with premature ejaculation.

Clomipramine tablets (Clofranil) significantly increased the latency to ejaculation during sexual activity from approximately 2 minutes to 8 minutes in men with primary premature ejaculation.

There were no significant effects in controls and men with premature ejaculation plus erectile dysfunction. Laboratory appraisal showed that men with primary premature ejaculation were better able to control ejaculatory response with Clomipramine therapy. In these men treatment with Clomipramine tablets also resulted in increased satisfaction with sex life and relationship.

Clofranil (Clomipramine Generic) Dosage For Premature Ejaculation

Clofranil (Clomipramine tablets) 25 mg as required effectively increases ejaculatory latency in men with primary premature ejaculation, while treatment with this medicine is not effective in those with premature ejaculation and erectile dysfunction.

Generic Clomipramine Hydrochloride Tablets (Clofranil and Clonil) - Dosage

The dosage and method of administration of Generic Clomipramine must be adapted to the individual patient's condition inorder to achieve an optimum effect while keeping the doses as low as possible.

Depression, OCD, Obsessive-Compulsive Syndromes, and Phobias:
The starting dosage for treatment of Obsessive Compulsive Disorder (OCD), Depression, Obsessive-Compulsive Syndromes, and Phobias is one tablet of 25 mg 2 to 3 times daily. The daily dosage has to be raised stepwise, eg. 25 mg every few days (depending on how the medication is tolerated) to 4 to 6 tablets of 25 mg during the first week of treatment. In severe cases, this dosage can be increased up to a maximum of 250 mg daily. Once there is a distinct improvement, adjust the daily dosage to a maintenance level of about 2 to 4 tablets of 25mg.

Panic Attacks, Agoraphobia:
The starting dosage for treatment of Panic Attacks and Agoraphobia is one tablet of 10 mg daily, possibly in combination with a benzodiazepine. Depending on how the medicine is tolerated, raise the dosage until the desired response is obtained, while gradually withdrawing the benzodiazepine. The daily dosage required varies greatly from patient to patient and lies between 25 mg and 100 mg. If necessary it can be increased to 150 mg. It is advisable for treatment not to be discontinued for at least 6 months and for the maintenance dose to be reduced slowly during this time.

Cataplexy Accompanying Narcolepsy:
The recommended daily dose for treatment of Cataplexy Accompanying Narcolepsy is 25 mg to 75 mg.

Chronic Painful Conditions:
For treatment of Chronic Painful Conditions the dosage must be individualized (10 mg to 150 mg daily), while taking note of concomitant analgesic medication being administered and of the possibility of reducing use of analgesics.

Elderly Patients
Start treatment with 1 tablet of 10mg daily. Gradually raise the dosage to an optimum level of 30 mg to 50 mg daily, which should be reached after about 10 days and then maintained until the end of treatment.

Generic Clomipramine Hydrochloride Tablets Storage

Store Generic Clomipramine Hydrochloride Tablets at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from light. Protect from moisture. Patients should be advised to keep Generic Clomipramine Hydrochloride Tablets (Clofranil and Clonil) out of reach of children.

Clofranil (Generic Clomipramine) Contraindications

Clofranil tablets and Clonil tablets are contraindicated in patients with a hypersensitivity to Clomipramine Hydrochloride, cross-sensitivity to tricyclic antidepressants of the dibenzazepine group or any inactive ingredient present in tablets. Clofranil tablets and Clonil tablets are also contraindicated in the following cases:

• Clomipramine is contraindicated for the treatment of depression in patients 12 years of age or less.
• Clomipramine is contraindicated for the treatment of nocturnal enuresis.
• Clomipramine should not be given in combination, or within 14 days before or after treatment, with a MAO inhibitor.
• The concomitant treatment with selective, reversible MAO-A inhibitors, such as moclobemide, is also contraindicated.
• Recent Myocardial Infarction: Generic Clomipramine is contraindicated during the acute recovery period after a myocardial infarction.
• Starting Generic Clomipramine Tablets (Clofranil and Clonil) in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
• Congenital long QT syndrome

Warnings and Precautions

The warnings and precautions associated with the use of Generic Clomipramine Tablets (Clofranil and Clonil) are as follows: Clinical Worsening and Suicide Risk: The risk of suicide is inherent in depression and may remain until significant remission occurs. This risk must be considered in all depressed patients.

Patients with depression could experience worsening of their depressive symptoms and/or the emergence of suicidal ideation and behaviors (suicidality) whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Clofranil(Generic Clomipramine Tablets), alone but particularly when administered along with other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Seizures: During premarket evaluation, the seizure was identified as the most significant risk of Generic Clomipramine use.

Cardiovascular Effects: Modest orthostatic decreases in blood pressure and modest tachycardia were each observed in approximately 20% of patients taking Clomipramine Tablets (Clofranil and Clonil) in clinical trials, but patients were frequently asymptomatic.

Psychosis, Confusion, and Other Neuropsychiatric Phenomena: Patients treated with Clomipramine Tablets have been reported to show a variety of neuropsychiatric signs and symptoms including delusions, hallucinations, psychotic episodes, confusion, and paranoia.

Mania/Hypomania: During premarketing testing of Anafranil in patients with affective disorder, hypomania or mania was precipitated in several patients.

Hepatic Changes: During premarketing testing, Anafranil was occasionally associated with elevations in SGOT and SGPT (pooled incidence of approximately 1% and 3%, respectively) of potential clinical importance.

Hematologic Changes: Although no instances of severe hematologic toxicity were seen in the premarketing experience with Generic Clomipramine, there have been postmarketing reports of leukopenia, agranulocytosis, thrombocytopenia, anemia, and pancytopenia in association with the use of Clomipramine tablets.

Central Nervous System: More than 30 cases of hyperthermia have been recorded by postmarketing surveillance systems.

Sexual Dysfunction: The rate of sexual dysfunction in male patients with OCD who were treated with Clomipramine HCl tablets in the premarketing experience was markedly increased compared with placebo controls

Weight Changes: During controlled studies of OCD, weight gain was reported in 18% of patients being administered Clomipramine HCl tablets, compared with 1% of patients receiving placebo. In these studies, 28% of patients receiving Clomipramine HCl tablets had a weight gain of at least 7% of their initial body weight, compared with 4% of patients receiving placebo.

Electroconvulsive Therapy: As with closely related tricyclic antidepressants, concurrent administration of Clomipramine HCl tablets with electroconvulsive therapy may increase the risks;

Surgery: Prior to elective surgery with general anesthetics, therapy with Clomipramine HCl tablets should be discontinued for as long as is clinically feasible, and the anesthetist should be advised

Use in Concomitant Illness: As with closely related tricyclic antidepressants, Clomipramine HCl tablets must be used with caution in the following:
(1) Hyperthyroid patients or patients receiving thyroid medication, because of the possibility of cardiac toxicity;
(2) Patients with increased intraocular pressure, a history of narrow-angle glaucoma, or urinary retention, because of the ant icholinergic properties of the drug;
(3) Patients with tumors of the adrenal medulla (e.g., pheochromocytoma, neuroblastoma) in whom the drug may provoke hypertensive crises;
(4) Patients with significantly impaired renal function.

Withdrawal Symptoms: A variety of withdrawal symptoms have been reported in cases with sudden discontinuation of this medicine, including dizziness, nausea, vomiting, headache, malaise, sleep disturbance, hyperthermia, and irritability. In addition, such patients may experience a worsening of psychiatric status.

Clomipramine Hydrochloride Tablets Side Effects

The common and very common (1% and more of treated patients) possible Clomipramine Hydrochloride side effects include Dryness of the mouth, sweating, constipation, disorders of visual accommodation, blurred vision, disturbances of micturition, Hot flushes, mydriasis, Drowsiness, transient fatigue, feelings of unrest, increased appetite, Confusion accompanied by disorientation and hallucinations (particularly in elderly patients and patients with Parkinson’s disease), anxiety states, agitation, sleep disturbances, mania, hypomania, aggressiveness, impaired memory, yawning, depersonalisation, insomnia, nightmares, aggravated depression, impaired concentration, Dizziness, tremor, headache, myoclonus, Delirium, speech disorders, paraesthesia, muscle weakness, muscle hypertonia, Postural hypotension, sinus tachycardia, clinically irrelevant ECG changes in patients of normal cardiac status, palpitations, Nausea, constipation, Vomiting, abdominal disorders, diarrhoea, anorexia, Elevated transaminases, elevated alkaline phosphatase, Allergic skin reactions (rash, urticaria), photosensitivity, pruritus, Weight gain, disturbances of libido and potency, Galactorrhoea, breast enlargement, Tinnitus and taste perversion.

The common withdrawal Symptoms that follow sudden discontinuation of treatment or reduction of the dose are nausea, vomiting, abdominal pain, diarrhoea, insomnia, headache, nervousness, anxiety, dizziness and worsening of psychiatric status.

Epidemiological studies, mostly conducted in patients 50 years of age and older, show an increased risk of bone fracture in patients receiving SSRIs and tricyclic antidepressants.

Effects on ability to drive and use machines

Patients being administered Clomipramine tablets must be warned that blurred vision, drowsiness and other nervous system and psychiatric related disorders such as somnolence, disturbance in attention, confusion, disorientation, aggravation of depression, delirium etc have been observed. Due to the presence of such effects, patients should not drive, operate machinery or do anything else which may require alertness or quick actions.

Clomipramine Hydrochloride Tablets Overdosage

Signs and symptoms vary in severity depending upon factors such as the amount of drug absorbed, the age of the patient, and the time elapsed since drug ingestion.

Critical signs and symptoms of overdose include cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic toxicity.

Other CNS manifestations may include drowsiness, stupor, ataxia, restlessness, agitation, delirium, severe perspiration, hyperactive reflexes, muscle rigidity, and athetoid and choreiform movements. Cardiac abnormalities may include tachycardia, signs of congestive heart failure, and in very rare cases, cardiac arrest. Respiratory depression, cyanosis, shock, vomiting, hyperpyr exia, mydriasis, and oliguria or anuria may also be present.

2 deaths occurred in 12 reported cases of acute overdosage with Clomipramine Tablets either alone or in combination with other medicines. One death involved a patient suspected of ingesting a dose of 7000 mg. The second death involved a patient suspected of ingesting a dose of 5750 mg.

Obtain an ECG and immediately start cardiac monitoring. Protect the patient’s airway, establish an intravenous line, and initiate gastric decontamination. A minimum of 6 hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary.

In case signs of toxicity appear at any time during this period, extended monitoring is necessary. There are case reports of patients succumbing to fatal dysrhythmias late after an overdose.

All patients suspected of tricyclic overdose must receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured before lavage. Emesis is contraindicated.

All patients suspected of tricyclic overdose must receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage. Emesis is contraindicated.

A maximal limb-lead QRS duration of 0.10 seconds or greater may be the best indication of the severity of the overdose. In patients with CNS depression, early intubation is recommended due to the potential for abrupt deterioration. Seizures must be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants.

Clomipramine Hydrochloride Tablets During Pregnancy

Clomipramine Hydrochloride has been classified by the US FDA as Pregnancy Category C. No teratogenic effects were observed in studies performed in rats and mice at doses up to 100 mg/kg, which is 24 times the maximum recommended human daily dose (MRHD) on a mg/kg basis. There are no adequate or well-controlled studies in pregnant women. Withdrawal symptoms, including jitteriness, tremor, and seizures, have been reported in neonates whose mothers had taken Clomipramine HCl Tablets until delivery. Clomipramine tablets could be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Do not use this medicine without your doctor's consent in case you are pregnant. Stop using this medication and inform your doctor immediately if you become pregnant during treatment.

Nursing Considerations

As Clomipramine passes into human milk, babies should be weaned or the medication must be gradually withdrawn.
Due to the possibility of adverse reactions, a decision should be made whether to discontinue nursing or to discontinue the medicine, taking into account the importance of the drug to the mother. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Buy Generic Clomipramine 10 mg, 25 mg, 50 mg and 75 mg SR Pills Online at Only $0.20 per Pill

You can buy Clomipramine Hydrochloride tablets (Clonil and Clofranil) online from Clear Sky Pharmacy at a cheap price. Clofranil 10 mg, 25 mg, 50 mg and 75 mg SR tablets, manufactured by Sun Pharmaceutical Industries Ltd. India are supplied in a strip of 10 / 15 tablets. Clonil tablets manufactured by Intas Pharmaceuticals Ltd. are also supplied in the same strengths. The 10 mg tablets cost only $0.20 per unit when you place an order for 300 tablets.

Disclaimer

The above information is provided to the best of our knowledge and in good faith, it is without a warrant of any kind, expressed or implied.

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