Adzhizim
Producer: Agio Pharmaceuticals Ltd. (Adzhio Pharmasyyutikals Ltd.) India
Code of automatic telephone exchange: A09AA02
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 212,5 mg of Pancreatinum that corresponds to enzymatic activity: amylases – 4500 FIP/ED, lipases – 6000 FIP/ED, proteases — 300 FIP/OD.
Excipients: cellulose microcrystallic, silicon dioxide colloid anhydrous, sodium talc, propylene glycol, cellulose ацетилфталат, diethyl phthalate, a macrogoal (polyethyleneglycol 6000) krakhmalglikolit (type A), magnesium stearate, sodium of a kroskarmeloz, a gipromeloz, titanium dioxide (Е 171).
Pharmacological properties:
Pharmacodynamics. Fermental drug. Pancreatic enzymes (amylase, a lipase and protease) which are its part facilitate digestion of carbohydrates, fats, proteins that promotes their full absorption in a small intestine. At pancreas diseases drug compensates insufficiency of its vneshnesekretorny function and promotes digestion process improvement.
Tablets have a protective cover, insoluble in acid contents of a stomach which prevents destruction of digestive enzymes under action рН a gastric juice.
Indications to use:
Insufficiency of vneshnesekretorny function of a pancreas of different genesis: chronic pancreatitis, a mucoviscidosis, a pancreatectomy, a total gastrectomy, a pancreatic cancer, operations with imposing of a gastrointestinal anastomosis (for example, a stomach resection according to Billroth of II, the obstruction of a pancreatic or general bilious channel and a disease which are followed by exocrine insufficiency of a pancreas). For improvement of digestion of food in case of errors in food. Preparation to radiological and to ultrasound examination of abdominal organs.
Route of administration and doses:
The dose is selected individually, depending on degree of insufficiency of function of a pancreas. Usually adults accept 1-2 tablets 3 times a day in time or right after food. Tablets should be swallowed whole, without chewing, washing down with a large amount of liquid (water, fruit juice). The average daily dose for adults makes 6 tablets. Depending on a type of food and weight of a digestive disturbance the daily dose can be increased. At full insufficiency of function of a pancreas (for example, cystous fibrosis) the dose has to be increased about 400 000 PIECES of a lipase (66 tablets) a day that corresponds to daily need of the adult in ліпазі.
For children the doctor has to establish a dosage. Usually for treatment of a mucoviscidosis an initial dose for children aged from 4 years – 500 PIECES of a lipase/kg of body weight (1 tablet on 12 kg of body weight on each meal. If the size of body weight of the child is in an interval between sizes, multiple 12, in an initiation of treatment it is recommended to apply a dose of drug which is appointed at smaller value of this interval (for example, at the body weight of the child of 20 kg in an initiation of treatment it is necessary to use a dose which is appointed at the body weight of 12 kg).
The dose should be selected individually, depending on disease severity, control of a steatorrhea and support of the appropriate nutritive status. The maximum daily dose should not exceed 100 000 PIECES of a lipase (16 tablets).
At a mucoviscidosis the dose of drug has to be adequate to amount of enzymes which is necessary for absorption of fats, considering quantity and quality of the consumed food. A sick mucoviscidosis it is not necessary to accept drug in doses more than 10 000 PIECES on 1 kg of body weight a day (in terms of a lipase) owing to increase in risk of development of strictures (fibrous колонопат і ї) in _leotsekalny department and the ascending colon.
The course of treatment can last of several days (at disturbance of digestion owing to errors in a diet) up to several months and even years (in need of continuous replacement therapy).
Before radiological and ultrasound examinations of abdominal organs (for the purpose of acceleration of removal of gases) accept 2 tablets 3 times a day within 2-3 days.
Features of use:
At prolonged use of Pancreatinum it is necessary to accept iron preparations in addition.
Use during pregnancy or feeding by a breast. Safety of use of Pancreatinum at pregnancy and during feeding by a breast is studied insufficiently. Use of drug is possible in cases when the expected advantage for mother exceeds potential risk for a fruit or the child. In pilot studies it is established that Pancreatinum has no teratogenic effect.
Ability to influence speed of response at control of motor transport or work with other mechanisms. Drug does not influence speed of response at control of motor transport or work with other mechanisms.
Children. In pediatric practice drug is used to children aged from 4 years only on doctor's orders.
Side effects:
In some cases – allergic reactions in the form of skin manifestations, sensations of discomfort in epigastric area, nausea, vomiting, a lock or diarrhea.
At prolonged use of drug in high doses development of a hyper uricosuria, in excessively high doses (more than 25 tablets a day) – increase in level of uric acid in a blood plasma is possible.
Interaction with other medicines:
Pancreas enzymes at prolonged use reduce digestion of folic acid.
Contraindications:
Acute pancreatitis, hypersensitivity (allergy) to Pancreatinum, the drug received from bodies of a pig and/or other components.
Overdose:
It is not described.
Storage conditions:
Period of validity - 3 years. Not to use drug after the termination of the period of validity specified on packaging. To store in the dry place at a temperature not above 25 °C. To store in the place, unavailable to children.
Issue conditions:
Without recipe
Packaging:
10 tablets in a strip. On 3 strips in a cardboard box.