2010/06/24

Azaphen MR

Composition, structure and packing

Enteric coating is yellowish-green, round, biconvex; exception of marbling.

1 tab. pipofezin 150 mg.

Excipients: gipromelloza (metotsel K4M Premium), kollidon 25 (povidone), microcrystalline cellulose, colloidal silicon dioxide (aerosil), talc (magnesium hydrosilicate), magnesium stearate.

Clinico-pharmacological group: antidepressant.

Pharmacological action

Tricyclic antidepressant of the group of indiscriminate capture of inhibitors of neuronal monoamines. Has timoanalepticheskoe and sedative effect. By blocking reverse neuronal capture of monoamine presynaptic membranes, increasing their content in the synaptic cleft, which leads to rapid relief of symptoms of depression, along with the inherent central pipofezinu antiserotoninovaya activity, determining its sedative effect. In contrast to other tricyclic antidepressants have anticholinergic properties. It has no effect on the activity of MAO.

Pharmacokinetics

Absorption

After oral administration quickly and almost completely absorbed from the gastrointestinal tract. Tmax in plasma is 1.2 hours

Metabolism

To a large extent Biotransformation in the liver with the formation of inactive metabolites.

Withdrawal

T1 / 2 - 9 am to derive mainly from urine.

Statement
depressive disorders of mild to moderate severity (including depression with chronic somatic diseases).

Dosage regimen

The drug taken by mouth. After determining the optimal daily dose in the application Azafena tablets 25 mg, appoint Azafen MB to 150 mg 1 time per day (morning), or 2 times a day (morning and evening) with a view of the effectiveness and tolerability.

Side effect
From the CNS: headache, dizziness.
On the part of the digestive system: nausea, vomiting.
Other: allergic reactions.

Contraindications
marked disturbances of liver function;
pronounced renal dysfunction;
CHD
state after acute ischemic;
serious infectious diseases;
diabetes;
Pregnancy
Lactation (breastfeeding);
childhood;
Hypersensitivity to the drug's components.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Application for violations of liver function

The drug is contraindicated for use in violation of liver function.

Application for violations of renal function

The drug is contraindicated for use in violation of renal function.

Cautions

In the period of treatment required periodic monitoring of liver function and kidney. It is recommended to limit the prescription of a person whose work requires quick physical and mental reactions, such as driving. During the period of treatment prohibited intake of alcohol.

There should be appointed with antidepressants MAO inhibitors or before 1-2 weeks after their withdrawal.

Overdose

Symptoms: increased side effects.

Treatment: the holding of symptomatic therapy.

Drug Interactions

Potentiates the effects of alcohol and other central depressant drug, antihistamine drugs and anticoagulants. Reduces the effectiveness of anticonvulsant therapy.

Terms and Conditions of storage

List of B. The product should be stored out of reach of children, dry, dark place at temperatures not above 25 ° C. Shelf life - 3 years.

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