Название документа
  • Forsanek of the tab. of p/o of 120 mg No. 28

Forsanek – nonsteroid anti-inflammatory and antirheumatic drug.

Indications

Symptomatic therapy in an osteoarthritis, a pseudorheumatism, an ankylosing spondylitis and also in the pains and signs of inflammation connected with acute gouty arthritis.

Short treatment of the moderate postoperative pain connected with dental operations.

Structure

  • active ingredient: etoricoxib;
  • 1 tablet, film coated, contains etorikoksib 120 mg;
  • other components: calcium hydrophosphate anhydrous, cellulose microcrystalline, sodium of a kroskarmeloz, silicon dioxide colloidal anhydrous, magnesium stearate;
  • film covering: Opadry II 31G58920 white (hydroksipropilmetiltsellyuloza, monohydrate of lactose, titanium dioxide (E 171), polyethyleneglycols, talc).

Contraindication

  • Hypersensitivity to active ingredient or any excipient.
  • Active round ulcer or active gastrointestinal bleeding.
  • Bronchospasm, acute rhinitis, nasal polyps, a Quincke's disease, a small tortoiseshell or allergic reactions after use of acetylsalicylic acid or NPVS, including TsOG-2 inhibitors (cyclooxygenase-2).
  • Period of pregnancy or feeding by a breast.
  • Heavy abnormal liver functions (blood serum albumine <25 g/l or ≥ 10 points on a scale of Chaylda-Pyyu).
  • by
  • calculated renal clearance of creatinine <30 ml/min.
  • Age of the patient aged up to 16 years.
  • Inflammatory bowel diseases.
  • Arterial hypertension in which the ABP indicators constantly exceed 140/90 mm Hg. also are insufficiently controlled.
  • by
  • diagnosed coronary heart disease, diseases of peripheral arteries and cerebrovascular diseases.

Side reactions

Infection and invasion: often – an alveolar osteitis; infrequently – a gastroenteritis, upper respiratory tract infections, infections of an urinary path.

from blood and lymphatic system: seldom – anemia (mainly as a result of gastrointestinal bleeding), a leukopenia, thrombocytopenia.

from the immune system: seldom – giperchuvstvitelnostß; seldom – a Quincke's disease / anaphylactic/anaphylactoid reactions, including shock.

Disorder of metabolism and food: often – liquid hypostases/delay; seldom – decrease or strengthening of appetite, increase in body weight.

Mental disturbances: seldom – uneasiness, a depression, deterioration in mental activity, a hallucination; seldom – confusion of consciousness, a restless state.

from nervous system: often – dizziness, a headache; infrequently – a dysgeusia, insomnia, a paresthesia/hypesthesia, drowsiness.

Route of administration

Etorikoksib is applied by

orally regardless of meal. The beginning of effect of medicine comes rather at reception on an empty stomach. It should be considered in need of fast weakening of symptoms.

Tablet of 60 mg can be halved. Tablets of 90 mg and 120 mg – not to divide.

Osteoarthritis

Recommended dose makes 30 mg of 1 times a day (to apply in the form of 60 mg of a tablet which can be divided into equal parts). At some patients with the insufficient level of weakening of symptoms of a dose a day can increase efficiency to 60 mg of 1 times. In the absence of therapeutic advantage it is necessary to consider other options of therapeutic treatment.

Pseudorheumatism

Recommended dose makes 60 mg once a day. At some patients with insufficient weakening of symptoms of increase in a dose up to 90 mg of 1 times a day can increase efficiency. After the condition of the patient is stabilized from the clinical point of view, reduction of a dose up to 60 mg of 1 times a day can be required. In the absence of therapeutic advantage it is necessary to consider other options of therapeutic treatment.

Ankylosing spondylitis

Recommended dose makes 60 mg once a day. At some patients with insufficient weakening of symptoms of increase in a dose up to 90 mg of 1 times a day can increase efficiency. After the condition of the patient is stabilized from the clinical point of view, reduction of a dose up to 60 mg of 1 times a day can be required. In the absence of therapeutic advantage it is necessary to consider other options of therapeutic treatment.

Acute pain

At appearance of an acute pain etorikoksib can be applied only during the acute symptomatic period.

to

Use during pregnancy or feeding by a breast

to

Use of an etorikoksib is contraindicated to

Feature of use

during pregnancy. If the woman became pregnant during treatment, etorikoksib it is necessary to cancel.

Does not know to

whether gets etorikoksib into breast milk. It is known what at animals etorikoksib gets into milk. The women applying etorikoksib should not nurse.

to

Children

to

Etorikoksib is contraindicated to children up to 16 years.

Ability to influence speed of response at control of motor transport or other mechanisms

to Patients who at use of an etorikoksib have a dizziness vertigo or drowsiness, it is not necessary to run motor transport and to work with other mechanisms.

Overdose

Use of a single dose of an etorikoksib up to 500 mg or multiple dose up to 150 mg/days within 21 days did not cause essential toxic effects. Reported about

about acute overdose etorikoksiby though in most cases did not report about side reactions. The most often observed side reactions were comparable to a profile of safety of an etorikoksib (such as reactions from digestive tract, from heart and kidneys).

in case of overdose it is reasonable to p to take the usual supporting measures, for example removal of not absorbed medicament from digestive tract, conducting clinical observation and in case of need – performing the supporting treatment.

Etorikoksib is not removed by

at a hemodialysis; it is unknown whether medicament when carrying out peritoneal dialysis is removed.

Storage conditions

to Store

in original packing at a temperature not over 25 ºС.

to Store

out of children's reach.

Characteristics
Active ingredients Etorikoksib
Amount of active ingredient 120 mg
Applicant Kusum
Code of automatic telephone exchange M01AH05 Etorikoksib
Interaction with food It doesn't matter
Light sensitivity Not sensitive
Market status The branded generic
Origin Chemical
Prescription status According to the prescription
Primary packing blister
Producer KUSUM HELTKHKER PVT LTD
Quantity in packing 28 tablets (4 blisters on 7 pieces)
Release form tablets for internal use
Route of administration Oral
Sign Import
Storage temperature from 5 °C to 30 °C
Trade name Forsanek

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Forsanek of the tab. of p/o of 120 mg No. 28

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