Auro-Citalopram Tablets

AURO-CITALOPRAM is indicated for the treatment of:

• Depression and prevention of relapse
• Panic disorders with or without agoraphobia
• Obsessive-compulsive disorder (OCD)

Depression: 20 mg a day as a single dose. Dosage may be increased by 20 mg a day at intervals of at least one week to a maximum of 60 mg depending on the patientu2019s response.

Panic Disorder: 10 mg a day as a single dose for the first week then increasing to 20 mg a day. The dose may be increased thereafter as required to a maximum of 60 mg a day depending on the patientu2019s response.

Obsessive-Compulsive Disorder: 20 mg a day as a single dose. This dose can be increased by 20 mg increments to a maximum of 60 mg a day depending on the patientu2019s response.

Special Populations:

• Elderly: 20 mg a day as a single dose. Depending on the patientu2019s response the dose can be increased to a maximum of 30 mg a day.
• Reduced hepatic function: Dose should be halved.
• Reduced renal function: Dose adjustment is not necessary in cases of mild or moderate renal impairment.

The onset of action is seen within 2 to 4 weeks. Treatment should be continued for an appropriate length of time (up to six months) after recovery in order to prevent relapse. The medicine should be gradually withdrawn during a couple of weeks when stopping therapy (See SIDE-EFFECTS AND SPECIAL PRECAUTIONS). AURO-CITALOPRAM may be taken with or without food in the morning or evening.

• Hypersensitivity to citalopram or any of the ingredients in the formulation.
• Concurrent use with a monoamine oxidase inhibitor (MAOI). At least 14 days should elapse between discontinuing the MAOI and initiating therapy with AURO-CITALOPRAM. MAOIu2019s should not be introduced for 7 days after discontinuation of AURO-CITALOPRAM. (See INTERACTIONS).
• Severe renal impairment (creatine clearance less than 20 mI/min).
• Safety and efficacy in pregnancy and lactation has not been established.
• Children under the age of 18 years. (See WARNINGS and SIDE-EFFECTS AND SPECIAL PRECAUTIONS.)

AURO-CITALOPRAM should be used with caution in:

• Elderly patients u2014 Longer half-life and decreased clearance due to a reduced rate of metabolism. A lower dose is recommended in the elderly.
• Hepatic impairment u2014 Clearance of AURO-CITALOPRAM is reduced. Cautious dosage titration and a lower maximum dose are recommended.
• Renal impairment u2014 Elimination is decreased. If creatine clearance is less than 20 mI/min AURO-CITALOPRAM should not be used. (See CONTRA-INDICATIONS)
• Seizures or history thereof - There is an increased risk of seizures. AURO-CITALOPRAM should be used with caution in patients with controlled epilepsy and avoided in patients who are poorly controlled epileptics. Care is advised in patients receiving electroconvulsive therapy.
• Mania or history of mania u2014 Condition may be re-activated. AURO-CITALOPRAM should be discontinued if the patient enters the manic phase.
• AURO-CITALOPRAM may cause a reduction in heart rate. Caution is advised in patients with a pre-existing slow heart rate.
• Diabetes mellitus - Rare occurrences of hypoglycaemia have been reported.

Patients with major depressive disorder, both adults and children, may experience worsening of their depression and or the emergence of suicidal ideation and behaviour, whether or not they are taking antidepressant medicines. This risk may persist until significant remission occurs. A causal role, however, for antidepressant medicines in inducing such behaviour has not been established. Patients being treated with AURO-CITALOPRAM should, nevertheless, be observed closely for clinical worsening and suicidality, especially at the beginning of a course of therapy, or at any time of dose changes, either increases or decreases.

Because of the possibility of co-morbidity between major depressive disorders and other psychiatric and non-psychiatric disorders, the same precautions observed when treating patients with major depressive disorder should be observed when treating patients with other psychiatric and non-psychiatric disorders. The following symptoms have been reported in patients being treated with antidepressants for major depressive disorders as well as for other indications, both psychiatric and non-psychiatric: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing AURO-CITALOPRAM, in patients for whom such symptoms are severe, abrupt in onset, or were not part of the patients presenting symptoms.

If the decision is made to discontinue treatment, AURO-CITALOPRAM should be tapered (See PRECAUTIONS and DOSAGE AND DIRECTIONS FOR USE). Safety and efficacy in children under 18 years of age have not been established. (See CONTRA-INDICATIONS and SIDE-EFFECTS AND SPECIAL PRECAUTIONS).

• Monoamine oxidase inhibitors (MAOI) - Concurrent use is contra-indicated. Serious and potentially fatal reactions have occurred such as: hyperthermia, rigidity, myoclonus, autonomic instability with rapid fluctuation of vital signs and mental status changes including extreme agitation progressing to delirium and coma. (See CONTRA-INDICATIONS)
• Imipramine - An increase in the concentration of desimipramine (the active metabolite of imipramine) may occur. It appears that AURO-CITALOPRAM does not cause a marked increase in plasma levels of some tricyclic antidepressants.
• Other serotonergic medicines or medicines with serotonergic activity - Increased risk of developing the serotonin syndrome, a rare but potentially fatal hyperserotonergic state.
• Moclobemide - Serotonin syndrome has developed after taking overdoses of moclobemide and AURO-CITALOPRAM.
• Alcohol - The effects of alcohol may be increased.
• Warfarin - The anticoagulant activity of warfarin may be increased.
• Cimetidine - The AUC and the maximum plasma concentration of AURO-CITALOPRAM are increased when AURO-CITALOPRAM is administered concurrently with cimetidine.

Safety and efficacy in pregnancy and lactation has not been established. AURO-CITALOPRAM is excreted into the breast milk.

AURO-CITALOPRAM may impair performance of skilled tasks. If affected these patients should not operate machinery or drive.

Side Effects:

Cardiac disorders:

• Frequent: Palpitations, tremor
• Less frequent: Bradycardia

Nervous system disorders:

• Frequent: Sleep disturbances, paraesthesia, restlessness, somnolence, headache, dizziness, fatigue.
• Less frequent: Agitation, confusion, impaired concentration, malaise, mania, convulsions, serotonin syndrome, neuroleptic malignant syndrome

Endocrine disorders:

• Frequent: Weight changes.

Gastrointestinal disorders:

• Frequent: Nausea, constipation, diarrhoea, dyspepsia, dry mouth.
• Less frequent: Salivation.

Renal and urinary disorders:

• Frequent: Micturition disorders.

Reproductive system and breast disorders:

• Less frequent: Sexual dysfunction including ejaculation disorder, decreased libido, anorgasmia

Hepato-biliary disorders:

• Less frequent: Hepatitis.

Musculoskeletal, connective tissue and bone disorders:

• Frequent: Asthenia.

Eye disorders:

• Frequent: Accommodation disturbances.
• Less frequent: Mydriasis.

Respiratory, thoracic and mediastinal disorders:

• Less frequent: Nasal congestion.

Skin and subcutaneous tissue disorders:

• Frequent: Sweating.
• Less frequent: Rash.

Other:

• Less frequent: Yawning. Hostility, suicidal ideation and self harm have been reported in children.

Symptoms of overdose: Tiredness, weakness, sedation, dizziness, tremor, nausea, somnolence and sinus tachycardia.

Treatment of overdose: Treatment is symptomatic and supportive. There is no specific antidote to AURO-CITALOPRAM. The stomach should be emptied as soon as possible by emesis or gastric lavage. Monitoring of cardiac and vital signs is necessary and medical surveillance is advisable for about 24 hours.