| Composition |
| Each film coated tablet contains: PAROXETINE (as HCL) 10 mg – 20 mg |
| Properties |
-Dam-Profen is Non-Steroidal anti-Inflammatory agent, With anti-Inflammatory
Analgesic and Antipyretic Properties .
- Dam-Profen is Absorbed From The Gastro-Intestinal Tract and is Rapidly Excreted in The Urine. |
| Pharmacodynamics properties |
The efficacy of CIROSAT ULTRA is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT).
In vitro studes indicate that paroxetine has little affinity for muscarinic, alpha 1-, alpha2-, eta-adrenergic-, dopamine (D2)-, 5-HT1 -5-HT2- and histamine (H1)-receptors. |
| Therapeutic indications |
CIROSAT ULTRA is indicated for:
1. The treatment of depression.
2. The treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD).
3. The treatment of panic disorder, with or without agoraphobia.
4. The treatment of social anxiety disorder, also known as social phobia.
5. The treatment of generalized anxiety disorder (GAD). |
| Side effect |
| Somnolence, insomnia, dizziness, nausea, dry mouth, asthenia, sweating, decreased appetite, tremor, ejaculatory disorders, constipation. |
| Warnings and precautions |
– Like other antidepressants, CIROSAT ULTRA should be used cautiously in patients with a history of seizures.
– Several cases of hyponatremia have been reported in Paroxetine-treated patients.
The hyponatremia appeared to be reversible when CIROSAT ULTRA was discontinued (especially in elderly, and during treatment with diuretics).
– There have been several reports of abnormal bleeding associated with CIROSAT ULTRA treatment, including a report of impaired platelet aggregation, while a causal relationship to paroxetine is unclear, impaired platelet aggregation may result from platelet serotonin depletion and contribute to such occurrences.
– Increased plasma concentrations of paroxetine occur in patients with sever renal impairment (creatinine clearance < 30 ml/min.) or severe hepatic impairment. A lower starting dose should be used in such patients.
– Patients should be advised to avoid alcohol while taking CIROSAT ULTRA.
– The safety and effectiveness in pediatric have not been established yet. |
| Contraindication |
– Concomitant use in patients taking either monoaminoxidase inhibitors (MAOIs) or thioridazine is
contraindicated.
– CIROSAT ULTRA is contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in product.
|
| Pregnancy and lactation |
– Pregnancy: There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
– Nursing Mothers: CIROSAT ULTRA is secreted in human milk, and caution should be exercised when CIROSAT ULTRA is administered to a nursing woman. |
| Drug interactions |
– As with other serotonin reuptake inhibitors, an interaction between paroxetine and tryptophan may occur when they are co-administered. Adverse experiences, consisting primarily of headache, nausea, sweating and dizziness, have been reported when tryptophan was administered to patients taking CIROSAT ULTRA.
– It recommended that CIROSAT ULTRA not be used within 14 days of discounting treatment with a MAOI.
– It is recommended that CIROSAT ULTRA not be used in combination with a MAOI. At least 2 weeks should be allowed after stopping CIROSAT ULTRA before starting a MAOI.
– Drugs which inhibit P450IID6, such as CIROSAT ULTRA, will elevate plasma levels of thioridazine. Therefore, it is recommended that CIROSAT ULTRA not be used in combination with thiorodazine.
– There may be an interaction between paroxetine and warfarin. Since there is little clinical experience, the concomitant administration of Paroxetine and warfarin should be undertaken with caution.
– There have been rare post marketing reports describing patients with weakness, hyperreflexia, and in coordination following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan.
If concomitant treatment with sumatriptan and an (SSRI) is clinically warranted, appropriate observation of the patient is advised.
– The metabolism and pharmacokinetics of paroxetine may be affected by the induction or inhibition of drug-metabolizing hepatic anzymes.
– Phenobarbital induces many cytochrome P450 (oxidative) enzymes. When CIROSAT ULTRA was administered at Phenobarbital steady state, paroxetine AUC and T 1/2 were reduced (by an average of 25% and 38%, respectively) compared to CIROSAT ULTRA administered alone.
Any dosage adjustment should be guided by clinical effect.
– Caution is indicated in the co-administration of tricyclic antidepressants (TCAs) with CIROSAT ULTRA, because CIROSAT ULTRA may inhibit TCA metabolism. Plasma TCA concentrations may need to be monitored, and the dose of TCA may need to be reduced, if a TCA is co-administered with CIROSAT ULTRA.
– Because CIROSAT ULTRA is highly bound to plasma protein, administration of CIROSAT ULTRA to a patient taking another drug that is highly protein bound may cause increased free concentrations of the other drug, potentially resulting in adverese events. Conversely, adverse effects could result from displacement of CIROSAT ULTRA by other highly bound drugs.
– The concurrent administration of Paroxetine and digoxin should be undertaken with caution.
– Reports of elevated theophylline levels associated with CIROSAT ULTRA treatment have been reported.
So, theophylline levels should be monitored when this drug is concurrently administrated.
– About drugs metabolized by P450IID6: co-administration with CIROSAT ULTRA including certain antidepressant
(Nortriptyline, Amitriptyline, Imipramine and Fluoxetine) Phenothiazine, and Type 1C
antiarrhythmics, or that inhibit this enzym, should be approached with caution. |
| DOSAGE & ADMINISTRATION |
(All the dosage are to be administered with or without food)
depression:
CIROSAT ULTRA should be administered as a single daily dose, usually in the morning with or without food.
The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the antidepressant effectiveness of CIROSAT ULTRA. Dose changes should occur at intervals of at least 1 week. Acute episodes of depression require several months or longer of sustained pharmacologic therapy.
obsessive compulsive disorder:
CIROSAT ULTRA should be administered as a single daily dose, usually in the mornign with or without food.
The recommended dose of CIROSAT ULTRA in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10 mg/day increments. Dose changes should occur at intervals of at least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of CIROSAT ULTRA in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.
Panic disorder:
CIROSAT ULTRA should be administered as a single daily dose, usually in the morning with or without food.
The target dose of CIROSAT ULTRA in the treatment of panic disorder is 40 mg/day.
Patients should be started on 10 mg/day.
Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 10 to 60 mg/day increments in the clinical trials demonstrating the effectiveness of CIROSAT ULTRA.
The maximum dosage should not exceed 60 mg/day.
social anxiety disorder:
CIROSAT ULTRA should be administered as a single daily dose, usually in the morning with or without food.
The recommended and initial dosage is 20 mg/day. In clinical trials the effectiveness of CIROSAT ULTRA was demonstrated in patients dosed in a range of 20 to 60 mg/day.
generalized anxiety disorder:
CIROSAT ULTRA should be administered as a single daily dose, usually in the morning.
In clinical trials the effectiveness of CIROSAT ULTRA was demonstrated in patients dosed in a range of 20 to 50 mg/day.
The recommended starting dosage and the established effective dosage is 20 mg/day.
Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week.
dosage for elderly or debilitated, and patients with severe renal or hepatic impairment:
The recommended initial dose is 10 mg/day. Increase may be made if indicated.
Dosage should not exceed 40 mg/day. |
| Overdose |
Patients should be evaluated carefully for history of drug abuse, and such patients should be observed for signs of abuse.
The physician who prescribe CIROSAT ULTRA for extended period should periodically re-evaluated the long-term usefulness of the drug for individual patient.
Patients should not exceed the recommended dosage, and call medical advise in case of over dosage. |
| Package |
cirosat uLtra 10: Box of 30 tablets.
cirosat uLtra 20: Box of 30 tablets |
| Storage |
| Store at temperature between 15° C – 30° C. |
