Medical  Explorer

Custom Search

Drugs A to Z  :  A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  R  S  T  U  V  W  X  Y  Z
Medicinal Ingredients : A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

Beauty Products : A  B  C  D  E  F  G  I  M  N  O  P  R  S  T  V

Aging      Allergies     Alzheimer's      Arthritis    Asthma      Bacteria   new Cancer    Chickenpox     Colds     Constipation      Diabetes      Epilepsy     Fatigue     Fever     Genetics       Haemorrhoids       newHeadaches      Hepatitis    Immunity      Infection      Insomnia       Leprosy       Menopause      Obesity      Osteoporosis     Other Diseases    Pain      PMS     Parasites     Sinusitis     newStroke     Toxicology    Urology




Arthritis medications
Acupuncture
Alcohol
Patients
newGeneral Health
Medicinal food
Chinese medicine
Nutrients
Smoking
Vitamins
OTC Drugs
Health Products
Therapy
Symptom
Parasitology
 
 

Cipram

SSRI - Antidepressant

1. NAME OF MEDICINAL PRODUCT

Cipram 10 mg film-coated tablets

Cipram 20 mg film-coated tablets

Cipram 40 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipram 10 mg: Each tablet contains 10 mg citalopram (as 12.49 mg citalopram hydrobromide)

Cipram 20 mg: Each tablet contains 20 mg citalopram (as 24.98 mg citalopram hydrobromide)

Cipram 40 mg: Each tablet contains 40 mg citalopram (as 49.96 mg citalopram hydrobromide)

For excipients, see section 6.1

3. PHARMACEUTICAL FORM

Film-coated tablets.

3.1 Description of the tablets
10 mg tablets are round, white, film-coated, marked with "CL" on one side.
20 mg: White, oval, scored, film-coated tablets marked "C" and "N" symmetrically around the score.
40 mg: White, oval, scored, film-coated tablets marked "C" and "R" symmetrically around the score.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications
Treatment of depression and prevention of relapse/recurrence.

Panic disorder with or without agoraphobia. Obsessive-compulsive disorder (OCD)

4.2 Posology and method of administration

4.2.1 Posology
Adults
Treating depression
Cipram should be administered as a single oral dose of 20 mg daily.
Dependent on individual patient response and severity of depression the dose may be increased to a maximum of 60 mg daily.

Treating panic disorder
A single oral dose of 10 mg is recommended for the first week before increasing the dose to 20 mg daily. The dose may be further increased, up to a maximum of 60 mg daily dependent on individual patient response.

Treating OCD
An initial dose of 20 mg daily is recommended. The dose can be increased in increments of 20 mg to 60 mg daily if necessary, based on clinical judgment.

Elderly patients (65 years of age)
In elderly patients the dose may be increased to a maximum of 40 mg daily.

Children and adolescents (<18 years)
Not recommended, as safety and efficacy have not been established in this population.

Reduced renal function
Dosage adjustment is not necessary in patients with mild or moderate renal impairment. No information is available on treatment of patients with severely reduced renal function (creatinine clearance <20 ml/min).

Reduced hepatic function
Patients with reduced hepatic function should receive dosages of no more than 30 mg/ day.

Duration of treatment
The antidepressant effect usually sets in after 2 to 4 weeks. Treatment with antidepressants is symptomatic and must therefore be continued for an appropriate length of time, usually up to 6 months after recovery in order to prevent relapse. In patients with recurrent depression (unipolar) maintenance therapy may need to be continued for a number of years to prevent new episodes.

Maximum effectiveness of Cipram in treating panic disorder is reached after about 3 months and the response is maintained during continued treatment.

The onset of action in treating OCD is 2-4 weeks with further improvement overtime.

When stopping therapy the drug should be gradually withdrawn during a couple of weeks.

4.2.2 Method of administration
Cipram tablets are administered as a single daily dose.
Cipram tablets can be taken anytime of the day without regard to food intake.

4.3 Contra-indications
Hypersensitivity to citalopram or to any of the excipients.

MAOIs (monoamine oxidase inhibitors)
Cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with monoamine oxidase inhibitor (MAOI), including the selective MAO-B inhibitor selegiline and the reversible MAOI (RIMA), moclobemide and in patients who have recently discontinued an SSRI and have been started on a MAOI.

Some cases presented with features resembling serotonin syndrome.

Cipram must not be used in combination with a MAOI including selegiline in doses above 10 mg daily. Treatment with citalopram may be instituted 14 days after discontinuation of non-selective MAOIs and minimum one day after discontinuation of moclobemide. Treatment with MAOIs may be introduced 7 days after discontinuation of citalopram (see 4.5 Interactions).

4.4 Special warnings and special precautions for use.
Cipram should not be used in the treatment of children and adolescents under the age of 18 years. Suicide related behaviours (suicide attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patients should be carefully monitored for the appearance of suicidal symptoms.

Treatment of elderly patients and patient with reduced kidney and liver function, see 4.2.1 Posology.

Paradoxical anxiety
Some patients with panic disorder may experience intensified anxiety symptoms at the start of treatment with antidepressants. This paradoxical reaction usually subsides within the first two weeks of starting treatment. A low starting dose is advised to reduce the likelihood of a paradoxical anxiogenic effect (see section 4.2).

Hyponatraemia
Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported as a rare adverse reaction with the use of SSRIs. Especially elderly female patients seem to be a risk group.

Suicide
The possibility of suicide attempt is inherent in depression and may persist until significant improvement occurs, either spontaneously or following treatment.

Patients being treated with antidepressants should be monitored carefully especially at the beginning of treatment for clinical worsening and/or the emergence of suicidality (suicidal ideation and behaviour). This precaution should also be observed when treating other psychiatric disorders because of the possibility of co-morbidity with major depressive disorder.

Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised to closely observe the patient and to communicate with the prescribes.

Mania
In patients with manic-depressive illness a change towards the manic phase may occur. Should the patient enter a manic phase citalopram should be discontinued.

Seizures
Although animal experiments have shown that citalopram has no epileptogenic potential it should, like other antidepressants, be used with caution in patients with a history of seizures.

Diabetes
As described for other psychotropics citalopram may modify insulin and glucose responses calling for adjustment of the antidiabetic treatment in diabetic patients; in addition the depressive illness itself may affect patients' glucose balance.

Serotonin syndrome
Rarely, the occurrence of "serotonin syndrome" has been reported in patients receiving SSRIs. A combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia, may indicate the development of this condition

Haemorrhage
There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura with SSRIs. Caution is advised in patients taking SSRIs, particularly with concomitant use of oral anticoagulants; drugs known to affect platelet function (e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs), ticlopidine and dipyridamole) as well as in patients with a history of bleeding disorders (see section 4.5).

Withdrawal symptoms
After prolonged administration abrupt cessation of SSRIs may produce withdrawal symptoms such as dizziness, paraesthesia, tremor, anxiety, nausea and palpitation in some patients. It is recommended that withdrawal of treatment should proceed by tapering off the dosage over one to two weeks to avoid occurrence of discontinuation symptoms. These symptoms are not indicative of addiction.

Excipients
The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not receive this medicine.

1    2    3

Abdomen
Blood
Bone
Breast
Ear

Eye

Face
Hair

Head

Heart
Kidney
Liver
Limbs
Lungs
newMind
Mouth
Muscles
Nails

Neck

newNerves
Nose

Skin

Teeth

Throat

Tongue
 
Health news
 
Cardiovascular Guide
 
Natural Remedies
 
Treatment of Cancer
 
Women's Health
 
Irritable bowel syndrome
 
Common Childhood Illnesses
 
Prescribed Drugs
 
 

     
         
     

 

Disclaimer