Generic Clomipramine Hydrochloride Tablets

Generic Clomipramine Hydrochloride (Clofranil and Clonil tablets) is a tricyclic antidepressant used to treat depression and obsessive-compulsive disorder (OCD), panic disorder, major depressive disorder, and chronic pain.

1. Generic Clomipramine Hydrochloride Tablets
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Generic Clomipramine Hydrochloride (Clofranil and Clonil
tablets) is a tricyclic antidepressant used to treat
depression and obsessive-compulsive disorder (OCD),
panic disorder, major depressive disorder, and chronic
pain.

2. Clofranil and Clonil Tablets
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Clofranil Tablets are manufactured by
Sun Pharmaceutical Industries Ltd.
(Website: www.sunpharma.com)
Clonil Tablets are manufactured by
Intas Pharmaceuticals Ltd.
(Website: www.intaspharma.com )

3. Clomipramine Hydrochloride Tablets – Brand Names
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Clomipramine Hydrochloride tablets
are available as Anafranil Tab,
Depnil, Biolomin Tab, Clofranil Tab,
Clofranil-SR Tab, Clomidon Tab,
Clomidon-SR Tab, Clomifril Tab,
Clonil Tab and Clonil-SR Tab.

4. Active Ingredient
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The active ingredient contained in Clofranil
tablets and Clonil tablets is Clomipramine
Hydrochloride .
Each Clofranil tablet contains 10 mg, 25 mg,
50 mg or 75 mg of Clomipramine.
Each Clonil tablet contains 10 mg, 25 mg, 50
mg or 75 mg of Clomipramine.

5. Chemical Structure
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The structure of Clomipramine Hydrochloride
is given below:

6. Uses of Generic Clomipramine Tablets
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Generic Clomipramine Hydrochloride (Clofranil and
Clonil tablets) is used for treatment of 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.
This medicine is also used for treatment of patients
with Obsessive-compulsive syndromes, Phobias and
panic attacks, Cataplexy accompanying narcolepsy
and Chronic painful conditions.

7. Generic Clomipramine Dosage

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➢Depression, Obsessive-Compulsive Syndromes,
and Phobias: Start treatment with one coated
tablet of 25 mg 2 to 3 times daily. Raise the daily
dosage stepwise, for example 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 per day in divided doses.
The dosage of Generic Clomipramine tablets
(Clofranil or Clonil) is given below:

8. Generic Clomipramine Dosage

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➢Panic Attacks, Agoraphobia: Start with 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 required it can be increased to
150 mg.
The dosage of Generic Clomipramine
Hydrochloride (Clofranil and Clonil tablets) is
given below:

9. Generic Clomipramine Dosage

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➢Cataplexy Accompanying Narcolepsy: The daily dose
is 25 mg to 75 mg.
➢Chronic Painful Conditions: The dosage must be
individualised (10 mg to 150 mg daily), while taking
account of concomitant analgesic medication (and of
the possibility of reducing use of analgesics).
➢Elderly Patients: Start treatment with 1 tablet of 10
mg daily. Gradually increase 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.
The dosage of Generic Clomipramine
Hydrochloride (Clofranil and Clonil tablets) is
given below:

10. Storage Instructions

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Generic Clomipramine tablets (Clofranil
and Clonil tablets) have to be stored at
controlled room temperature i.e. from
20°C to 25°C (68°F to 77°F) .
Dispense in well-closed containers with
a child -resistant closure.
Keep this as well as all other medicines
away from children and pets.

11. Warnings

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Seizure was identified as the most significant risk of
Clomipramine use.
Caution should be used in administering Clomipramine
tablets to patients with a history of seizures or other
predisposing factors. e.g., brain damage of varying
etiology, alcoholism, and concomitant use with other
drugs that lower the seizure threshold.
Rare reports of fatalities in association with seizures
have been reported by post-marketing surveillance.
In some of these cases, Clomipramine had been
administered with other epileptogenic agents: in others,
the patients involved had possibly predisposing medical
conditions. Thus a causal association between
Clomipramine therapy and these fatalities has not been
established.

12. Warnings

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Doctors must discuss with patients the risk of taking
Clomipramine HCl while carrying out activities in
which sudden loss of consciousness could result in
serious injury to the patient or others, e.g., the
operation of complex machinery, driving, swimming,
climbing.
Since depression is a commonly associated feature
of OCD, the risk of suicide should be considered.
Tricyclic antidepressants, specially in high doses,
have been reported to produce sinus tachycardia,
changes in conduction time and arrhythmias. A few
instances of unexpected death have been reported
in patients with cardiovascular disorders. Myocardial
infarction and stroke have also been reported with
medicines of this class.

13. Warnings

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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.

14. Clofranil and Clonil Tablets
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Contraindications
Clofranil and Clonil tablets are Clomipramine
Hydrochloride contraindicated in patients with a
hypersensitivity to or any other component of this
medication.
This medicine is also contraindicated in patients with
Cross-hypersensitivity to tricyclic antidepressants of
the dibenzazepine group.
Concomitant use with a monoamine oxidase
(MAO) inhibitor, or within 14 days before or after
treatment with an irreversible MAO inhibitor, or
within 14 days before moclobemide, a reversible
MAO inhibitor is contraindicated.
Acute and recovery stages of myocardial infarction.
Congenital long QT syndrome.

15. Generic Clomipramine Side Effects
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➢The most commonly observed Generic
Clomipramine Hydrochloride (Clofranil and Clonil
tablets) Side Effects and not seen at an equivalent
incidence among placebo-treated patients were
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.

16. Generic Clomipramine Overdose
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Symptoms of Generic Clomipramine Hydrochloride
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, hyperpyrexia,
mydriasis, and oliguria or anuria may also be present.

17. Generic Clomipramine Overdose
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Obtain an ECG and immediately start cardiac
monitoring. Protect the patient’s airway, establish an
intravenous line, and begin 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 required.
In case signs of toxicity occur at any time during this
period, extended monitoring is required.
There are case reports of patients succumbing to fatal
dysrhythmias late after overdose; these patients had
clinical evidence of significant poisoning prior to
death and most received inadequate gastrointestinal
decontamination.

18. Clomipramine During Pregnancy
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Clomipramine Hydrochloride (Clofranil and
Clonil tablets) has been classified by the US
FDA as Pregnancy Category C.
There are no adequate or well-controlled
studies conducted in pregnant women.
Withdrawal symptoms, including jitteriness,
tremor, and seizures, have been reported in
neonates whose mothers had taken
Clomipramine until delivery.
Clomipramine should be used during
pregnancy only if the potential benefit
justifies the potential risk to the fetus.

19. Generic Clomipramine Tablets
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Generic Clomipramine Tablets click here
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Generic Clomipramine Hydrochloride
(Clofranil and Clonil tablets)