COMPOSITION :

Each film coated tablet contains: Paroxetine HCl equivalent to Paroxetine 20 or 30 mg.

DESCRIPTION :

Saroxin (Paroxetine) is an antidepressant belong to group of drugs called selective serotonin reuptake inhibitors

(SSRIs), in which serotonin presents normally in human brain, that is responsible for elevation of mood , whereas its

concentration is less than normal in patients with depressants and anxiety. Paroxetine works by increasing the level of

serotonin to the normal level , it prevents the neuron from the reuptake of serotonin that secreted in the synaptic cleft in
the brain , hence increase the efficiency of this substance in preventing the depression and anxiety. In contrast to other
tricyclic antidepressants , Paroxetine has little effect on alpha , beta , dopamine and histamine receptors hence the side
effects on CVS and CNS are less. Paroxetine is well absorbed from GIT and needs about 24 hours to start the
elimination of its effect from the body.

INDICATIONS :

- Major Depressive Episodes.

- Obsessive Compulsive Disorder(OCD).

- Panic Disorder (agoraphobia).

- Social Anxiety Disorder/Social phobia.

- Generalised Anxiety Disorder

- Post-Traumatic Stress Disorder(e.g. following a car accident , natural disaster).

DOSAGE & ADMINISTRATION:

It is recommended to take the dose once daily in the morning with food.

Depressive episodes, Social anxiety disorders/social phobia, Generalised anxiety disorder&

Post-Traumatic stress disorder:

The recommended dose is 20mg daily. Can be increased to the maximum dose 50mg/day in gradually steps by increase

10mg/day every week. Long -term use should be regularly evaluated.

Obsessive Compulsive Disorder (OCD) & Panic disorder:

The recommended dose for each case is 40 mg daily but Patients with OCD should start with 20 mg/day, while patients

with Panic disorder should start with 10mg/day then the dose gradually increased by 10 mg/day increments every week

to the recommended dose and if necessary to 60mg/day as maximum dose.

Older patients: As the above determined doses but the maximum is 40mg daily.

RESTRICTIONS ON USE:

Contraindications

The following cases should not use Saroxin:

- Hypersensitivity to paroxetine.

- Patients who are taking Monoamine oxidase inhibitors or have been taken at last two weeks.

- Patients who are taking anti-psychotic drugs (Thioridazine or Pimozide).

- Paroxetine should not be used in the treatment of children and adolescents under the age of 18 years.

Precautions

Caution should be taken and consult the physician in following cases:

- History of mania or suffering from bipolar disorder (symptoms include serious mood swings between mania and
depression), history of suicide attempt or thinking about suicide, patients with epilepsy or suffering from seizures,
diabetes, cardiac patients, patients who had or still have glaucoma, patients with low sodium level in the blood.

- Patients with abnormal bleeding or taking drugs increasing the tendency of bleeding, depressant patients under electro
convulsion therapy.

-The patient should be under observation specially in starting treatment or if the dose changes to avoid serotonin
syndrome or any symptoms complication.

- Abrupt discontinuation should be avoided; the daily dose should be gradually deceased with 10mg weekly intervals. If
intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the
previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a
more gradual rate.

- The dose should be adjusted in patients with liver disease or kidney disease.

Use in Pregnancy and Lactation

Paroxetine is considered from D category, so it should not be used during pregnancy but only be used when strictly

indicated under physician supervision.

During the lactation period the doctor may allow the mother to take Paroxetine .
Effects on the ability to drive vehicles or use machines
Caution should be taken when drive or use machines during Saroxin.
DRUG INTERACTIONS :
- Concomitant use of Paroxetine with Tamoxifen should be avoided because the effect of Tamoxifen is reduced.
- Caution should be taken when Paroxetine is used with the following drugs:
* Procyclidine, may increase its level in plasma, so the dose of Procyclidine should be adjusted.
* Tryptophan, Johns Wort herb, SSRI, Tramadol, Lithium, because the effect of these drugs adds on the effect of
Paroxetine.
* Drugs metabolizing enzyme inducer such as Carbamazepine, Rifampicin, Phenobarbital, Phenytoin and
Fosamprenavir/Ritonavir.
* Drugs that metabolized by CYP2D6 enzyme (such as Tricyclic antidepressants, Risperidone, 1 C antiarrythmics )
because Paroxetine is inhibitor for this enzyme , hence the concentration of these drugs are increased in the blood.
* Oral anticoagulants and drugs that increase the risk of bleeding (NSAIDs, antipsychotics such as Clozapine and
phenothiazine and Tricyclic antidepressants).
SIDE EFFECTS:
The side effects may appear at the beginning of treatment are mild and transient that disappear after the first weeks of
treatment including nausea, delay ejaculation, decreased appetite, increases in cholesterol levels, somnolence,
insomnia, agitation, abnormal dreams (including nightmares), concentration impaired, dizziness, tremor, headache,
blurred vision, yawning, constipation, diarrhea, vomiting, dry mouth, sweating, asthenia and body weight gain.
OVER DOSAGE:
Symptoms of over dosage: nausea, vomiting, tremor, dilated pupils, dry mouth, irritability, sweating,
somnolence, fever and involuntary muscle contractions.
Treatment:
Administration of 20-30 g activated charcoal may be considered if possible within a few hours after overdose intake to
decrease absorption of paroxetine. Supportive care and treatment of symptoms with frequent monitoring of vital signs is
indicated.
STORAGE INSTRUCTIONS :
Store below 30°C, in a dry place.
PRESENTATION :
Saroxin 20 : pack of 30 tablets and hospital packs in different sizes.
Saroxin 30 : pack of 30 tablets and hospital packs in different sizes.