Gastritis and Ulcer / Gastrointestinal tract and Liver

Rabemak 14s 20 mg coated tablets

Brands: Macleods (India)

$21.70

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Rabemak 14s 20 mg coated tablets quantity

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188657db23f0

Brands:: Macleods (India)

Description

The instruction for medical
use
of RABEMAK 10 medicine
RABEMAK 20

the Trade name
Rabemak 10
Rabemak 20

International unlicensed

name Rabeprazol Lekarstvennaya
the Tablet form, covered with a kishechnorastvorimy cover, 10 mg and 20 mg

Structure
One tablet contains
active substance – sodium rabeprazol 10 mg or 20 mg,
excipients: Mannitolum, hydroxypropyl cellulose (L-HPC LH-21), magnesium oxide heavy, ethyl cellulose 7 cps, the talc purified magnesium stearate,
structure of a cover: methacrylic acid a kopolimer of L-100, diethyl phthalate, the titan E171 dioxide, gland (III) oxide yellow E 172 (for a dosage of 10 mg), gland (III) oxide red E 172 (for a dosage of 20 mg), a hydromelloza 5cps, propylene glycol.

The description
of the Tablet round, biconvex, covered with a kishechnorastvorimy cover of yellow color, with risky on one party and smooth on the other hand (for a dosage of 10 mg).
Round tablets, biconvex, covered with a kishechnorastvorimy cover of henna-red color from risky on one party and smooth on the other hand (for a dosage of 20 mg).

Pharmacotherapeutic group
Antiulcerous drugs and drugs for treatment of a gastroesophageal reflux. Inhibitors of the protonew pump.
The code of automatic telephone exchange A02BC04

the Pharmacological

Pharmacokinetics Food properties and time of reception do not influence absorption.
Rabeprazol of sodium is quickly absorbed from intestines and is defined in blood plasma by 1 h, reaching peak concentration (Cmax) approximately in 3.5 hours (Tmax) after reception of a dose of 20 mg. Cmax and AUC values (the area under a curve concentration time) a rabeprazola of sodium are linear at the range of dosages from 10 mg to 40 mg.
The absolute bioavailability is 52%. Linking with proteins of blood plasma – 96.3%.
It is metabolized in a liver with participation of isoenzymes of CYP2C9 and CYP3A cytochrome. The main metabolites in plasma are monothioester and carboxylic acid. Minor metabolites (are present at low concentration) – sulphone, demetiltioefir and a conjugate of mercapturic acid. Only the dimethyl metabolite has insignificant anti-secretory activity.
Elimination half-life averages 0.82 h, clearance – 283 ± 98 ml/min. It is removed by kidneys – 90% in the form of two metabolites of a conjugate of mercapturic acid and carboxylic acid, through intestines – 10%.
At the patients with a stable terminal renal failure needing the supporting hemodialysis (clearance of creatinine & lt, 5 ml/min. / 1.73м2) significant changes of distribution of a rabeprazol are not noted. AUC and Cmax at such patients are about 35% lower than norm. Elimination half-life of a rabeprazol patients during a hemodialysis – 0.95 h, at patients after a hemodialysis have 3.6 h. The clearance of drug at patients with diseases of the kidneys needing a hemodialysis is approximately twice higher than normal indicators.
At elderly patients the elimination of a rabeprazol is slowed a little down. Signs of cumulation of a rabeprazol are not noted.
The pharmacodynamics
Rabemak belongs to a class of anti-secretory connections and is the substituted benzimidazole – inhibitor of the protonew pump. Suppresses secretion of hydrochloric acid of gastric juice by inhibition gastric H+/K+-ATP-elements in covering cells of a stomach. Action of a rabeprazol depends on a dose and leads to inhibition of basal and stimulated secretion of hydrochloric acid irrespective of an irritant.
Thus, rabeprazol blocks channels for passing of ions of hydrogen (in exchange for potassium ions) in a gleam of glands at the expense of what secretion of hydrochloric acid decreases.
Rabemak inhibits secretion of hydrochloric acid irrespective of a type of its stimulation, possesses direct bactericidal action (in vitro) and synergism with antibacterial drugs concerning H.pylori, has cytoprotective effect. After intake in a dose of 20 mg the anti-secretory effect occurs within 1 hour and reaches a maximum in 2 – 4 hours. Oppression of basal and stimulated secretion of hydrochloric acid in 23 hours after reception of a single dose makes about 62 and 82% respectively, action duration — 48 hours. The stable anti-secretory effect is reached in 3 days after an initiation of treatment. After the end of reception Rabemak the secretory activity is normalized within 2–3 days. Rabemak is split under the influence of hydrochloric acid therefore he is applied in an enterosoluble dosage form.

Indications
– the peptic ulcer of a stomach and duodenum including associated with H.pylori
– a gastroesophageal reflux disease
– Zollingera-Ellison’s syndrome

the Route of administration and doses
the Peptic ulcer of a stomach and a 12-perstny gut: 20 mg once a day in the morning within 4-8 weeks. For Helicobacter pylori eradikation Rabemak is used in a combination with antibacterial agents.
Gastroesophageal reflux disease: 20 mg once a day within 4-8 weeks.
Zollingera-Ellison’s syndrome: 60 mg once a day.
Tablets are swallowed entirely, without chewing and without crushing.
Duration of treatment is defined individually.

Side effects
Often
– a headache, dizziness, insomnia, drowsiness, hyperexcitability
– dryness in a mouth, dyspepsia, nausea, vomiting, an abdominal pain, a meteorism, diarrhea, a constipation
– an asthenia
Seldom
– allergic reactions: the skin rash, an erythema, bullous or urtikarny rashes usually disappearing after the termination of administration of drug
– thrombocytopenia, a neutropenia, a leykotsitopeniya
– hepatitis, increase in activity of liver enzymes in blood plasma, jaundice, hepatic encephalopathy at patients with cirrhosis
Very seldom
– a fever and temperature increase, a grippopodobny syndrome, pharyngitis, rhinitis, cough, bronchitis, sinusitis, infections of urinary tract
– interstitial nephrite
– a gynecomastia
– acute system allergic reactions: the multiformny erythema, the toxic epidermal necrolysis (TEN), Stephen-Johnson’s syndrome
– nonspecific dorsodynias, stethalgias, myalgia, spasms of gastrocnemius muscles,

Contraindication arthralgias
– hypersensitivity to a rabeprazol, the substituted benzimidazoles or other components of drug
– malignant diseases of a digestive tract
– a heavy liver failure
– pregnancy and the period of a lactation
– children’s and teenage age up to 18 years

Medicinal interactions
Rabemak is metabolized by the enzymes entering the hepatic system of P-450 (CYP450) cytochrome i.e. isoenzymes of CYP450 system (CYP2C19 and CYP3A). Has no stimulating and inhibiting impact on metabolism of CYP3A4 and cyclosporine. Rabemak does not enter clinically significant interactions with drugs, metaboliziruyemy enzymes of CYP450 system: amoxicillin, warfarin, Phenytoinum, theophylline and diazepam, etc.
At combined use, drug reduces concentration in blood plasma of a ketokonazol by 30% and digoxin – for 29% therefore dose adjustment of these drugs at co-administration with Rabemak is recommended.
Concentration of a rabeprazol and an active metabolite of a klaritromitsin in plasma at a concomitant use increase by 24% and 50% respectively.
Rabemak reduces concentration of an atazanavir in blood that can lead to decrease in therapeutic activity of drug or ment of a rezistentost.
In view of possible interaction with antiacid drugs, Rabemak it is necessary to accept in one hour prior to or in two hours after reception of antiacid means.

Special instructions
Before Rabemak’s reception it is necessary to exclude existence of a malignant new growth of a digestive tract as administration of drug can mask symptoms and delay production of the correct diagnosis. The patients receiving long-term treatment (within more than one year) have to be under regular medical control.
Features of influence of medicine on ability to run transport or potentially dangerous mechanisms
Considering side effects of drug it is necessary to be careful at control of transport or potentially dangerous mechanisms

Overdose
Symptoms: strengthening of side effects is possible.
Treatment: gastric lavage and symptomatic therapy.
There is no specific antidote. Rabemak does not leave at dialysis.

A form of release and packing
On 7 or 10 tablets in planimetric bezyacheykovy packing from aluminum foil.
On 2 blister strip packagings (for 7 tablets) or 3 planimetric packs (for 10 tablets) together with the instruction for medical use in the state and Russian languages place in a cardboard pack.

To Store storage conditions in dry, protected from light, the place at a temperature not over 250C.
To store out of children’s reach!

A period of storage
2 years
not to apply after an expiration date

Prescription status
According to the prescription

Macleods Pharmaceuticals Limited Producer, India
304, Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai – 400,059, India.

The owner of the registration certificate
of Macleods Pharmaceuticals Limited, India

the Address of the organization admitting claims from consumers on quality of products Representation to RK Makleods Pharmasyyutikalz Limited of RK, Almaty, Tulebayev St. 38, office 307ATel. / fax. +7,727 3562832E-mails:

vijay9376@yahoo.com

Additional information