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Instruction for use: Portal

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Dosage form: capsules

Active substance: Fluoxetine*

ATX

N06AB03 Fluoxetin

Pharmacological groups:

Antidepressant

The nosological classification (ICD-10)

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenoadressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double Depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome in psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F42 Obsessive-compulsive disorder: Obsessive-compulsive syndrome; Obsessive compulsive states; Obsessive-compulsive syndrome; The Obsession Syndrome; The obsession neurosis; Obsessive-compulsive neurosis; Obsessions

F42.0 Predominantly obsessive thoughts or reflections: Obsession neurosis; Obsessive-compulsive disorder; Obsessive thoughts and actions; Obsession state; Mental Chewing Gum; Obsessive thoughts; Obsessive experiences; Obsessive fears

Composition and release form

1 capsule contains fluoxetine hydrochloride 20 mg; in the blister 7 pcs., in the box 1, 2 and 4 blisters..

Pharmachologic effect

Pharmacological action - antidepressant.

Selectively and reversibly inhibits the reverse neuronal seizure of serotonin, which leads to an increase and prolongation of its effect on postsynaptic receptor sites.

Pharmacokinetics

Well absorbed. After a single intake (before meals), Cmax in the blood plasma is reached after 6-8 hours. It is characterized by a high degree of binding to plasma proteins, a large volume of distribution and intensive diffusion into tissues. T1 / 2 - 1-4 days. Metabolites (mainly glucuronides) are excreted in urine and feces. The main metabolite is norfluoxetine, it has T1 / 2 - 7-9 days.

Clinical Pharmacology

Does not cause orthostatic hypotension, not cardiotoxic. Patients suffering from diabetes may develop hypoglycemia (during treatment) and hyperglycemia (if canceled), therefore, a correction of insulin doses or hypoglycemic agents is necessary.

Indication of the drug Portal

Depression (all types and any degree of severity), obsessive states.

Contraindications

Hypersensitivity, severe renal failure (glomerular filtration less than 10 ml / min), simultaneous administration of MAO inhibitors.

Application in pregnancy and lactation

Not recommended.

Side effects

Slightly expressed, short-lived and occur with increasing dose.

From the side of the central nervous system: sleep disturbance, irritability or phase inversion, headache.

On the part of the intestine: nausea, loss of appetite.

Other: skin rash, increased sweating, decreased libido.

Interaction

Serotonergic effects enhance tryptophan. Can increase or decrease the level of lithium in the plasma. Increases the effect of alprazolam, diazepam and alcohol. Incompatible with MAO inhibitors (with simultaneous or earlier 5 weeks after cancellation of the Portal, administration of MAO inhibitors may lead to changes in vital functions, fatal reactions, hyperthermia, stiffness, myoclonus, vegetative lability, agitation, nonsense, coma).

Dosing and Administration

Inside - 20 mg / day in the morning. The maximum daily dose is not more than 80 mg (for elderly patients - 60 mg) in two divided doses (morning and afternoon). Maintenance therapy - 20 mg / day. Significant effect develops within 3-4 weeks.

Overdose

Practically safe. The usual supportive measures are recommended; the effectiveness of forced diuresis and dialysis is unlikely.

Precautionary measures

With caution appoint for epilepsy (possibly more frequent seizures). In patients with low body weight, the Portal's anorexigenic effect should be taken into account (likely progressive weight loss of the body). When patients develop skin rashes or reactions of unknown etiology, stop taking. The dose for patients with renal and hepatic insufficiency should be adjusted. It is forbidden to drive vehicles and work with mechanisms that require concentration of attention. Use in children is not recommended (efficacy and safety not studied).

Storage conditions for Portal

At temperatures below 25 ° C.

Keep out of the reach of children.

Shelf life of Portal

3 years.

Do not use after the expiry date printed on the package.


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