Bon-One Tablet

8:56 PM
Active Form of Vitamin D3

Powerful drug
Designated drug
Alfacalcidol

Composition
Each tablet of Bon-One contains 0.25, 0.5 or 1.0μg of alfacalcidol.

Indications
Improvement of various symptoms (hypocalcemia, telany, bone pain, bone lesions, etc.) due to abnormal metabolism of vitamin D in the below-listed conditions.:
  • Chronic renal failure
  • Hypoparathyroidism
  • Vitamin D -resistant rickets and osteomalacia
Dosage and Administration
The dosage should be adjusted under careful monitoring of serum calcium level.
  • Chronic renal failure and ostcoporosis: For adults, Bon-One is orally administered at 0.5-1.0 μg as alfacalcidol once a day. The dose may be adjusted according to the age of patient and severity of symptoms.
  • Hypoparathyroidism and other diseases associated with abnormality of vitamin D metabolism: For adults, Bon-One is orally administered at 1.0-4.0μg as alfacalcidol once a day. The dose may be adjusted according to the age of patient, severity of symptoms and the type of disease.
Precautions for Use
General precautions
  1. To avoid overdose, it should be adjusted to keep the serum Ca level within normal range by the regular monitoring. Frequency of monitoring. Plasma calcium levels should be measured at weekly and monthly intervals depending on the progress of the patient. Frequent estimations are necessary in the early stages of treatment (particularly when the plasma calcium is already relatively high) and later when there is evidence of bone healing. Plasma calcium is levels should also be estimated regularly during the initial treatment of disorders without significant bone in involvement, e.g.hypoparathyroidism.
  2. In case of hypercalcemia, treatment with Bon-One should be stopped immediately. After the serum Ca level returns to normal, the treatment shall reinitialed at a lower dose. The risk of hypercalcemia depends on factors such as the degree of any mineralization defect, renal function and the dose of Bon One. Hypercalcemia will occure if the dose of Bon-One is not reduced appropriately when these is biochemical evidence of bone healing (e.g.return to words nominal is the level of plasma alkaline phosphatase). Prolonged hypercalcemia should be avoided particularly in chronic renal failure. In patients with renal bone disease, Bon-One should be given in combination with a phosphate, binding agent to prevent hyperphosphatemia which is known to increase the risk of metastatic calcification.
  3. Administration to Elderly: Careful administration shall be required due to generally lower physiologic functions.
  4. Administration to pregnant women: Delayed bone formation was observed in fetal rats at high doses. Since the safety of Bon-One during pregnancy has not been established, administration to pregnant women or women suspected in pregnancy should be limited to the cases where the therapeutic benefit is judged to outweigh the potential risks.
  5. Administration to Children: Acute toxicity was observed in young rats more than matured rats. For administration to children, it should be carefully used to avoid overdose by gradual dose increase after initial lower dose under close monitoring of serum Ca level, urinary Ca level, and creatinine.
  6. Overdose administration: Many cases of adverse reactions are considered to be caused by hypercalcemia. Therefore, in case of adverse reaction, monitoring of serum Ca level is appropriate. Refer to General Precautions for the treatment. Severe hypercalcemia may require additional treatment with a loop diuretic, intra venous fluids and corticosteroids.
  7. Others: In case of administration to patients with hyper phosphatemia, the serum phosphate level should be controlled using phosphate binders (such as aluminium hydroxide gel).
SIDE EFFECT
Adverse reactions (rarely : ‹ 0.1%, occasionally : 0.1% ‹ 5%, no adverb: ≥ 5% or incidence unknown).
  1. Digestive organs: Anorexia, nausea vomiting, stomach distention, diarrhea, constipation, stomach pain, stomach discomfort may occasionally occur. Dyspepsia, intraoral discomfort and thirst may rarely occur.
  2. Psychoneurotic system: Headache, insomnia, irritation, malaise, dizziness, feeling of numbness, sleepines, failure of memory, tinnitus, senile deafness, back pain, shoulder stiffness, feeling of spasticity of the lower limbs, and chest pain may rarely occur.
  3. Cardiovascular organs: Slight increase of blood pressure and palpitationmay rarely occur.
  4. Liver: Elevation of GOT, GPT, LDH, and/or γ-GTP may occasionally occur.
  5. Kidney: Elevation of BUN or sCr (indicating deterioration of kidney function) and renal calculus may rarely occur.
  6. Skin: Pruritus and eruption may occasionally occur. Feeling hot may rarely occur.
  7. Eye: Conjunctival congestion may occasionally occur.
  8. Bone: Ectopic calcification around joints may rarely occur.
  9. Others: Edema calculus and husky voice may rarely occur.
CONTRA INDICATION
Hypercalcemia, metastatic calcification.

DRUG INTERACTION
  • Magnesium containing drugs, hypermagnesemia has been reported.
  • Digitalis preparations, cardiac arrythmia may occur.
  • Calcium preparations, hypercalcemia may occur.
  • Vit.D and its derivates, hypercalcemia may occur.
  • Barbiturates or other anti convulsants may need larger doses of Bon-One to produce the desired effect.
Pharmacology
Following oral administration, the drug is rapidly absorbed at the intestine into the circulately blood, hydroxylated at the 25-position of the sidechain by a hepatic microsome. 25-hydroxylase, to be converted to an activity developing substance, 1 α , 25-(OH)2D3.
The substance binds with receptor existed at the intestinal tract and the target tissue such as the bone, and develops series physiological activites, e.g., enhancement of calcium absorption from the intestine, dissolving activity of bone mineral and bone remodeling activity.

Description
1. Description of the preparation
  • Bon-One tablet is white, round non-coated tablet. It has no odour. The content of the active ingredient is indicated on the tablet.
2. Physiochemical properties of the active ingredient
  • Generic name: Alfacalcidol
  • Chemical name: 9,10-secocholesta-5,7,10(19)-triene-l α, 3 β-diol
  • Molecular formula: C27H4402
  • Molecular amount: 400.64
  • Melting point: 137-142 °C
  • Description: Alfacalcidol is a white crystal or crystalline powder, and is freely soluble in methanol, dehydrated ethanol, chloroform or dichloromethan, soluble in acetone or ethanol, and practically insoluble in water or hexane.
Precautions in Handling
  1. Regulatory classification: This preparation is a powerful and designated drug.
  2. Storage: Store at room temperature shielded from humidity and light.
  3. Expiration date: 3 years. Refer to the expiration date indicated on the case.
Package
PTP package

0.25μg:
100 tablets (10 tablets X 10),
30 tablets (10 tablets X 3),
Reg. No. DKI 0258400110 Al

0.5μg:
100 tablets (10 tablets X 10),
30 tablets (10 tablets X 3),
Reg. No. DKI 0258400110 B 1

1.0μg:
100 tablets (10 tablets X 10),
30 tablets (10 tablets X 3),
Reg. No. DKI 0258400110 C1

Harus Dengan Resep Dokter

Importir, PT. Dipa Pharmalab Intersains
Jakarta-Indonesia

Manufactured by
TEIJIN PHARMA LIMITED
2-1, Hinode-cho, Iwakuni, Yamaguchi, Japan

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2 Komentar
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Very informative post! There is a lot of information here that can help any business get started with a successful social networking campaign. tabletki poronne

Balas
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Plz anybody tell me is bon-one and mimcipar is same drugs for same treatment for decreases pth levels????

Balas

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