Impaza

Impaza
Impaza enhances endothelial NO synthase activity, restores production of nitric oxide (NO) by the endothelium during sexual stimulation, increases the levels of cyclic guanosine monophosphate (cGMP) in smooth muscles, and facilitates their relaxation, which leads to increased blood filling of the cavernous bodies. These effects ensure erection of sufficient strength and duration. The main peripheral mechanism of Impaza action has been confirmed by experimental findings: it implies increased enzymatic activity of endothelial NO-synthase, a key enzyme supporting penis erection. Changes in certain parameters associated with its action suggest the existence of central effects mediating its action on the mechanisms of erection. Impaza increases libido (sexual desire) and intercourse satisfaction. Impaza administration in patients with somatic diseases based on endothelial dysfunction leads to normalization of NO production level and prevents the development of erectile dysfunction. In addition, Impaza therapy is associated with increased libido and a trend towards increased testosterone level (in patients with initially lower level of testosterone). Higher efficacy of prolonged courses of Impaza therapy unconditionally proves its therapeutic effect. Impaza therapy not only affects the mechanisms of erection and improves male sexual functions, but also effectively prevents the development of erectile dysfunction in men with comorbid conditions and age-related hormonal deficit. Courses of Impaza therapy in patients with metabolic syndrome and traumatic urethra injury diminish the frequency and severity of erectile dysfunction. Impaza is the only drug that can be used for the correction of male climacteric syndrome (andropause) presenting as flushes, weakness, fatigue, low physical activity, and decreased libido. Different mechanisms of action of FDE-5 inhibitors and Impaza suggest their combined use in patients with advanced ED and inadequate efficacy of monotherapy. This combination provides higher efficacy and lower rate of adverse effects of FDE-5 inhibitors, since their doses can be significantly reduced while retaining therapeutic efficacy of treatment at the same level. Impaza administration at a dose of one tablet per day for 12 weeks provides for the restoration of erectile function; this effect is long-lasting. Tablet is to be held in the mouth until its complete dissolution; it should not be taken with food. In patients with advanced symptoms of erectile dysfunction, optimal effect is achieved with twice daily administration, in the morning and before sleep. If necessary, therapy may be repeated after 6 months. Preventive nature of Impaza action has been noted in patients with diabetes mellitus and cardiovascular diseases. The duration of preventive Impaza therapy should be at least 12 weeks (1 tablet every other day). Impaza may be used with nitrates in patients with coronaty heart disease and is a drug of choice and alternative to FDE-5 inhibitors in these patients. Combination of Impaza with beta-adrenoblockers, angiotensin-converting enzyme inhibitors, and calcium antagonists demonstrated good tolerability and lead to beneficial changes in cardiologic parameters. Advantages of Impaza treatment include its efficacy and a possibility to combine it with therapy of comorbid conditions, including CHD, hypertension, etc., virtually complete absence of adverse reactions or adverse systemic effects. In very rare cases, individual hypersensitivity reactions may occur to any formulation ingredient (lactose, microcrystalline cellulose, magnesium stearate). No adverse effects or overdosage have been reported in patients receiving prolonged Impaza therapy courses, so it is categorized as an over-the-counter drug.

Instructions
for use


Read this information carefully before using this medicine.
Ask your doctor or pharmacist if you need further information.

IMPAZA
Orodispersible tablets

Registration number: XXXXXXX
Trade name: Impaza
Composition: Each orodispersible tablet contains:
Active ingredient: Affinity purified antibodies to endothelial NO-synthase 3 mg (water-ethanol mixture or the active substance dilutions).
*Weight of lactose saturated with water-ethanol mixture of dilutions of the active substance with concentration not more than 10-15 ng/g.
Excipients: lactose, microcrystalline cellulose, magnesium stearate.
Description:
White to off-white, round, flat, scored on one side and beveled tablets, marked «MATERIA MEDICA» on one side and «IMPAZA» on the other.
Pharmacotherapeutic group
Drugs used in erectile dysfunction.
ATC codes: G04BE
Pharmacological properties
Pharmacodynamics: IMPAZA enhances the activity of endothelial nitric oxide (NO) synthase, restores production of NO by the endothelium under sexual stimulation, increases concentration of cyclic guanosine monophosphate (cGMP) in smooth muscles and facilitates their relaxation, which leads to increased blood inflow to the cavernous bodies. The abovementioned effects enable the beginning of erection which is sufficient in strength and duration.
Due to positive influence on central mechanisms of erection the medicine increases libido (sexual drive) and intercourse satisfaction.
Long-term use of the medicine contributes to an increase in total serum testosterone levels (in cases of partial androgen deficiency).
Pharmacokinetics: The sensitivity of contemporary physicochemical methods (gas-liquid chromatography, high performance liquid chromatography and mass spectrometry) does not allow assessing the content of ultralow doses of antibodies in biological fluids, organs and tissues; that makes technically impossible to investigate the pharmacokinetic properties of Impaza.
Therapeutic indications
Erectile disturbances (erectile dysfunction) of various origin. Vegetative disorders related to male climacterial period (weakness, rapid fatigue, decrease in physical activity, decrease in libido etc.)
Contraindications
Individual hypersensitivity to components of the medicine.
Posology and method of administration
Oral route.
One tablet per intake (the tablet should be held in the mouth until it is completely dissolved, not during the meal).
Therapeutic schedules:
Regular intake. To stabilize sexual potency (the ability for sexual intercourse) except cases of underlying organic causes, a 12 week treatment course is recommended. During the course the drug is taken with frequency from once on alternate days to 2 times per day, preferably in the evening hours.
If necessary, the therapeutic courses both for potency stabilization and treatment of symptoms of male climacterial period may be repeated at 3-6 months intervals.
On-demand use. In order to stimulate erection, 2 tablets should be taken 1-2 hours before intercourse.
There is no relevant indication for use of IMPAZA by children.
Undesirable effects
No side effects have been reported for the drug used in accordance with the specified indications in the recommended doses.
Individual hypersensitivity to components of the medicine is possible.
Inform doctors of any unwanted effects related to drug use.
Overdose
No cases of overdose have been reported.
Dyspepsia caused by excipients is possible in accidental overdose.
Effects on ability to drive and use machines
Impaza has no influence on the ability to drive and use machines.
Interaction with other medicinal products and other forms of interaction
IMPAZA can be used by patients suffering from coronary heart disease (angina pectoris of 1-2 functional class) and taking nitrates. IMPAZA can be co-administered with betaadrenergic blocking agents, diuretics, ACE inhibitors, calcium channel blockers.
Special warnings and precautions for use
Medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption should not take this medicine.
IMPAZA is not indicated for use by women.
No correction therapy for hepatic and renal failure.
Use in Pregnancy and lactation
There were no special clinical studies of IMPAZA on woman in period of pregnancy or lactation.
Pharmaceutical form
Orodispersible tablets.
Nature and contents of container
20 orodispersible tablets in PVC/Aluminum blister. 1 blister is inserted into a cardboard box with leaflet.
Storage conditions
Store in dry light-protected place at temperature below 300C.
Store in the original package.
Keep out of reach of children.
Shelf life
3 years since the manufacturing date. Do not use after the expiry date indicated on the package.

Specification: Manufacturer’s standard (In house).

Manufacturer:
ООО «NPF «MATERIA MEDICA HOLDING»
9, 3rd Samotyochny per., Moscow, Russia, 127473
Tel/fax: +7 (495) 684-43-33

Date of last revision: 2 of September 2011