KREMEZIN Spherical Carbon Adsorbent 2g Fine Granule 1's
RXDRUG-DR-XY37669-1pc
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Features
Brand
Kremezin
Full Details
Dosage Strength
2g
Drug Ingredients
- Spherical Carbon Adsorbent
Drug Packaging
Fine Granule 1's
Generic Name
Spherical Carbon Adsorbent
Dosage Form
Fine Granule
Registration Number
DR-XY37669
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
For improvement in uremic symptoms and for prolonging the time to initiation of dialysis in chronic renal failure (progressive).
Dosage/Direction for Use
For oral use, the usual adult dosage is 6 g of SPHERICAL CARBON ADSORBENT (Kremezin) divided 3 times daily.
Contraindications
SPHERICAL CARBON ADSORBENT (Kremezin) is contraindicated in the following patients: Patients with transit disorder in the digestive tract [SPHERICAL CARBON ADSORBENT (Kremezin) may interfere with the excretion].
Special Precautions
This product should be administered with care in the following patients: Patients with peptic ulcer or esophageal varix. Since this product is passed in solid state in the digestive tract, this product may irritate the affected area]. Patients with a predisposition to constipation.
This product may exacerbate constipation and increase ammonia in the blood in patients with hepatic disorder as an underlying disease.
Important precautions: Patients diagnosed as progressive chronic renal failure who are in the conservative therapy. The administration of this product should be considered after the chronic renal failure is confirmed to be the progressive stage by the increase of serum creatinine. As for prolonging the time to initiation of dialysis, the administration of this product should be considered after the increase in rate of serum creatinine (S-Cr) is confirmed to be moderate or more (changes in 1/S-Cr/month are 0.01 dL/mg or more). Clinical changes in serum creatinine and uremic symptom are observed appropriately in patients under the treatment with this product and the continuation of the administration is investigated around 6 months after the start of the administration.
When improvement is not observed, appropriate measures such as discontinuation of the treatment or replacement with other therapies should be taken.
When the improvement cannot be expected during the treatment with this product, appropriate measures such as the initiation of dialysis therapy should be taken.
When other drugs are used in combination, these drugs should not be used concurrently, considering that this product is an adsorbent.
There have been no reports for noticeable abnormalities in homeostasis of vitamins and hormones in vivo, but caution concerning physical status should be exercised especially on long-term treatment with this product, considering that this product is an adsorbent.
Use in Children: The safety of this product in a premature baby, a newborn baby, an infant, a baby or a little child has not been established (insufficient clinical data).
Use in the Elderly: This product should be administered under careful supervision. Since the elderly often have reduced physiological function, adverse drug reactions are likely to occur.
This product may exacerbate constipation and increase ammonia in the blood in patients with hepatic disorder as an underlying disease.
Important precautions: Patients diagnosed as progressive chronic renal failure who are in the conservative therapy. The administration of this product should be considered after the chronic renal failure is confirmed to be the progressive stage by the increase of serum creatinine. As for prolonging the time to initiation of dialysis, the administration of this product should be considered after the increase in rate of serum creatinine (S-Cr) is confirmed to be moderate or more (changes in 1/S-Cr/month are 0.01 dL/mg or more). Clinical changes in serum creatinine and uremic symptom are observed appropriately in patients under the treatment with this product and the continuation of the administration is investigated around 6 months after the start of the administration.
When improvement is not observed, appropriate measures such as discontinuation of the treatment or replacement with other therapies should be taken.
When the improvement cannot be expected during the treatment with this product, appropriate measures such as the initiation of dialysis therapy should be taken.
When other drugs are used in combination, these drugs should not be used concurrently, considering that this product is an adsorbent.
There have been no reports for noticeable abnormalities in homeostasis of vitamins and hormones in vivo, but caution concerning physical status should be exercised especially on long-term treatment with this product, considering that this product is an adsorbent.
Use in Children: The safety of this product in a premature baby, a newborn baby, an infant, a baby or a little child has not been established (insufficient clinical data).
Use in the Elderly: This product should be administered under careful supervision. Since the elderly often have reduced physiological function, adverse drug reactions are likely to occur.
Use In Pregnancy & Lactation
This product should be used in pregnant women, women who may possibly be pregnant, and nursing mothers only if the expected therapeutic benefits outweigh the possible risks associated with treatment. The safety of this product in pregnant women and nursing mothers has not been established.
Adverse Reactions
Adverse drug reactions were reported in 139 of the total of 2,617 patients (5.31%) and the major adverse drug reactions were gastrointestinal system disorders such as constipation, anorexia, nausea, vomiting and enlarged feeling of abdomen (4.51%) at the time of the end of the re-examination.
Skin and appendages (<1%): Itching, eruption.
Gastrointestinal system (1%, <2%): Constipation, anorexia, nausea and vomiting. (<1%): Enlarged feeling of abdomen, stomach heaviness, abdominal pain.
Skin and appendages (<1%): Itching, eruption.
Gastrointestinal system (1%, <2%): Constipation, anorexia, nausea and vomiting. (<1%): Enlarged feeling of abdomen, stomach heaviness, abdominal pain.
Storage
Store at temperatures not exceeding 25°C. Protect from moisture.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: When this product is administered orally to patients with chronic renal failure, it improves uremic symptoms and prolongs the time to initiation of dialysis, since the uremic toxins are adsorbed by this product in the digestive tract and excreted with the feces.
When this product is administered to model rats with renal failure, it exerted the inhibitory effect on aggravation of renal failure (maintenance of food consumption and body weight, inhibitory effect on increase of serum creatinine and blood urea nitrogen, inhibitory effect on decreasing glomerular filtration function and inhibition on aggravation of renal tissue lesion) and the number of the surviving days is prolonged.
When this product is administered orally to patients with chronic renal failure in the conservative therapy, it inhibits the increase of serum creatinine, improves uremic symptoms and prolongs the time to the initiation of dialysis.
Pharmacokinetics: When 14C-labeled SPH ERICAL CARBON ADSORBENT (Kremezin) was administered orally to mice, it was excreted with the feces almost completely within 24 hours after administration and no in vivo absorption or accumulation of this product were noted.
When this product is administered to model rats with renal failure, it exerted the inhibitory effect on aggravation of renal failure (maintenance of food consumption and body weight, inhibitory effect on increase of serum creatinine and blood urea nitrogen, inhibitory effect on decreasing glomerular filtration function and inhibition on aggravation of renal tissue lesion) and the number of the surviving days is prolonged.
When this product is administered orally to patients with chronic renal failure in the conservative therapy, it inhibits the increase of serum creatinine, improves uremic symptoms and prolongs the time to the initiation of dialysis.
Pharmacokinetics: When 14C-labeled SPH ERICAL CARBON ADSORBENT (Kremezin) was administered orally to mice, it was excreted with the feces almost completely within 24 hours after administration and no in vivo absorption or accumulation of this product were noted.
MedsGo Class
Other Drugs Acting on the Genito-Urinary System
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