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Description

Clofranil® SR is manufactured by Sun Pharmaceuticals. Its main component is Clomipramine, a tricyclic antidepressant (TCA). Clofranil® SR releases Clomipramine at a predetermined rate in order to provide a steady drug concentration for a specific period of time causing minimum side effects.

Indications:

- depression or MDD (major depressive disorder) – feeling sad, inability to sleep properly or to enjoy life as one used to);

- OCD (obsessive compulsive disorders), or obsessive behaviors (compulsive or irrational preoccupation);

- phobias (strong fear of something, which is actually irrational);

- cataplexy (muscular weakness) associated with narcolepsy (sudden and uncontrolled attacks of deep sleep, often caused by strong emotion);

- off-label treatment of premature ejaculation (PE), (or too early ejaculation within 1 minute after penetration). Clomipramine is able to prolong the coitus time.

MOA (mechanism of action):

Clomipramine enhances the actions of norepinephrine and serotonin (chemical neurotransmitters in the brain used by nerves to communicate with each other) by blocking their reuptake and prolonging their activity. Clomipramine also has a wide pharmacological spectrum of action, which includes alpha1- adrenolytic, anticholinergic, antihistaminic, and antiserotonergic (5-HT-receptor blocking) properties.

Dosage

Clofranil® SR is used only in adults over 17 years of age.

Swallow Clofranil® SR tablet whole with a drink of water.

For depression: initially 10 mg, which can be increased to find a dose that works for you. This is normally 30-150 mg daily, maximum of 250 mg daily for severe conditions.

For obsessions and phobias: initially 25 mg, which can be increased to 100-150 mg daily.

For cataplexy: initially 10 mg, which can be increased to a maximum of 75 mg daily.

Elderly patients often need a lower dose. The maximum dose for elderly patients is 75 mg daily.

Precautions:

It can take 4 to 6 weeks for Clofranil® SR to start working. You should continue the treatment for at least 6 months after you feel better to stop depression from coming back.

Clofranil® SR can make feel sleepy so a doctor may advise patient taking a small dose when starting treatment. Then the dose can be increased gradually as the body gets used to it.

When stopping treatment with Clofranil® SR, it is best to decrease the dose gradually over a period of several weeks or months to minimize the withdrawal reactions.

Missing a dose

If you miss a dose you should take it as soon as you remember about your missing. If it is the time for the next dose you should continue your regular dosing schedule. Do not take a double dose of Clofranil® SR to compensate the missed dose.

Overdose

If you take an overdose of Clofranil® SR, you should seek emergency medical attention or contact your healthcare provider immediately.

Storage

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) and away from excess moisture and heat. Throw away any unused medicine after the expiration date. Keep out of the reach of children.

Side effects

The most common side effects associated with Clofranil® SR are:

  • allergic reactions
  • dry mouth
  • constipation
  • blurred vision
  • feeling sleepy
  • dizzy or tired
  • headache
  • feeling faint or light-headed
  • nausea
  • vomiting
  • diarrhea
  • sweating
  • hot flushes
  • difficulty in passing urine
  • increased appetite
  • feeling confused
  • feeling anxious or restless
  • disturbed sleep
  • lack of concentration
  • feeling shaky
  • muscle weakness
  • itchy skin rash
  • weight changes
  • changes in sexual function
  • breast tenderness
  • changes in taste
  • ringing in ears
  • yawning

Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.

Contraindications

Do not take Clofranil® SR if you are allergic to Clomipramine or any of the other ingredients in the tablets.

Do not take Clofranil® SR if you are taking or have taken other antidepressants like monoamine oxidase inhibitor drug (MAOI) (selegiline, moclobemide), or MAOI-like drug (linezolid) for depression, SSRI antidepressants (dapoxetine, fluoxetine, duloxetine).

Do not take Clofranil® SR if you have an overactive thyroid gland.

Do not take Clofranil® SR if you have liver disorders, epilepsy, diabetes mellitus, glaucoma, constipation over a long time, heart disorder or blood vessel disease.

Do not take Clofranil® SR if you have any difficulties passing urine, or if you have had prostate trouble.

Do not take Clofranil® SR if you have or have had a mental health problem (in particular, bipolar disorder or psychosis, schizophrenia).

If you have been told you have phaeochromocytoma, a tumor on your adrenal gland.

Do not take Clofranil® SR if you have porphyria, a rare inherited blood disorder.

Do not take Clofranil® SR if you have ever had suicidal thoughts.

Do not take Clofranil® SR if you have had a head injury or have suffered brain damage.

Do not take Clofranil® SR if you are going to have electric shock therapy (ECT).

Do not take Clofranil® SR if you have been told you have a low level of potassium in your blood (hypokalemia).

Clofranil® SR is only for use in adults over 17 years of age.

Do not take Clofranil® SR if you are pregnant, likely to become pregnant or are breastfeeding until your doctor decides if this medication is right for you.

Do not drive or operate machinery while treatment with Clofranil® SR.

Consult your doctor prior taking Clofranil® SR if you are taking any of the following medications: drugs for other mental health conditions (thioridazine, lithium, clozapine, pimozide, benzodiazepines), drugs for high blood pressure (guanethidine, betanidine, reserpine, clonidine or alpha methyldopa or norepinephrine), norepinephrine (noradrenaline) for low blood pressure, drugs for abnormal heart rhythm (disopyramide, procainamide, epinephrine (adrenaline), isoprenaline, amiodarone, quinidine, diltiazem and verapamil), beta-blockers (atenolol, sotalol), anticoagulants (warfarin), non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin, drugs for Parkinson's Disease (levodopa, biperiden, entacapone or selegiline), nicotine for nicotine replacement therapy, anticonvulsants (barbiturates), decongestants for colds and flu (ephedrine, phenylephrine), cimetidine for stomach ulcers or heartburn, methylphenidate used to treat ADHD, rifampicin for tuberculosis (TB), quinine, strong painkillers (tramadol, nefopam, morphine, codeine), narcotics (ecstasy), atropine or similar medicines (including eye drops), contraceptive pills or hormone replacement therapy, drugs for HIV (ritonavir, indinavir), terbinafine for fungal infections, colestipol and cholestyramine for high cholesterol levels, St. John’s wort (Hypericum perforatum), disulfiram for alcoholism, altretamine, baclofen, pentamidine for pneumonia, levacetylmethadol used to treat addiction to opioid drugs such as heroin.

Q: What is Clofranil® SR?

A: Clofranil® SR is an antidepressant aimed to treat depression, obsessive compulsive states, phobias (irrational fear of something), cataplexy with narcolepsy. Treatment with Clofranil® SR is usually long-term and shows efficacy in approximately 4-6 weeks.

Q: Does Clofranil® SR cause dependence?

A: Clofranil® SR is not addictive. However, sudden stopping or decrease in dose of Clofranil® SR may cause withdrawal reactions like dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting and shaking. Consult the doctor regarding the use of Clofranil® SR and discontinuation.

Q: Is Clofranil® SR a narcotic?

A: Clofranil® SR is a tricyclic antidepressant. It treats depression through inhibiting the neuronal reuptake of chemical substances present in the brain called noradrenaline and mainly serotonin (SSRI). It is not a narcotic.

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