Depovit B12 Ampoules
The product contains benzyl alcohol. Not for use in
neonates and infants.
Company Name:
Amriya for Pharmaceuticals Industries.
Trade Name:
Depovit B” Ampoules.
Generic Name:
Hydroxocobalamin.
Composition:
Each 1 ml ampoule contains:
Active ingredient:Hydroxocobalamin acetate 1.20 mg (Equivalent to Hydroxocobalamin … 1000 ~g/ml)
Inactive ingredients:
Sodium dihydrogen phosphate, Benzyl alcohol, Water for injections
Pharmaceutical Farm:
mpoules
Pharmacology:
Depovit 8″ Ampoules contain hydroxocoblalmin, the commonest naturally occurring stable form of vitamin B” with prolonged action. Depovit B” gives a continuous supply of vitamin B” needed to replenish body stores, thus correcting and preventing vitamin B” deficiency. Vitamin B” acts as a coenzyme for various metabolic functions, including fat and carbohydrate metabolism and protein synthesis. Depovit B” plays important roles in the metabolic pathways involved in growth, cell reproduction,
hematopoiesis and nucleoprotein and myelin synthesis. Depovit B” helps in the production of nucleic acids which form the body genetic material. Deficiency of vitamin B” leads to the development of megaloblastic anemia and demyelination of nerve fibers and other neurological damages. Treatment with Depovit B” results in rapid hematological and neurological improvement. This is accompanied by an increase in strength, better appetite and improvement in the soreness of the mouth and tongue. Increased sense of well being Is also achieved within the first 24 hours after initiation 01 therapy and the memory and orientation show dramatic improvement. Depovit B” Ampoules are safe, well tolerated and have the advantage of causing no pain or irritation at the site of injection.
Pharmacokinetics:
Oepovit 8″ Ampoules is well absorbed following intramuscular injection. In the blood, vitamin B” is extensively bound to specific plasma proteins, e.g. transcobalamins. It is stored in the liver, excreted in the bile and undergoes enterohepatic recycling. Hydroxocobalamin is excreted more slowly than other synthetic forms of vitamin B” due to its high protein binding. Vitamin B” diffuses across the placenta and appears in the breast milk.
Indications:
– Treatment and prevention of vitamin B” deficiency as in the following conditions:
*Pernicious and megaloblastic anemia.
*Post-gastrectomy or ileal resection.
*Inadequate secretion of the intrinsic factor resulting from gastric atrophy or lesions that destroy gastric mucosa.
*Congenital cobalamin malabsorption (Imerslund- Graesbeck Syndrome) and congenital intrinsic factor deficiency.
*Strict vegetarians.
*Tobacco amblyopia.
*Infection with intestinal parasites or bacteria.
– Increased requirements of vitamin B” as in:
*Hemolytic anemia and hemorrhage.
*Thyrotoxicosis and malignancy.
*Hepatic and renal diseases.
*Prevention and treatment of cyanide toxicity associated with sodium nitroprusside.
*Correction of nervous manifestations and neurological disorders such as trigeminal neuralgia, herpes zoster, peripheral neuropathy and multiple sclerosis.
Dosage:
Anemia and severe deficiencies:1 ampoule (I.M.) every other day for 1-2 weeks, then 1 ampoule every 3 months for maintenance.
NeuroloGical cases:1 ampoule (I. M.) every other day until improvement is optimum.
Anemia {Proohylactic dosel and mild deficiencies:
1 ampoule (I.M.) every 2-3 months.
Contraindications:
Hypersensitivity to hydroxocobalamin or cobalt.
Pregnancy, Nursing Mothers & Pediatric Use:
Do not administer injections preserved with benzyl alcohol to premature infants, neonates, children below 13 years, pregnant w°lrl 01 nIl rthers Benzyl alcohol hasbeen associated with serious adverse events and death, particularly in pediatric patients (it may cause Gasping syndrome). Injections that are preservative free should be
used in these populations.
Side Effects:
Depovit B” is well tolerated. Hypersensitivity reactions including itching, diarrhea, urticaria or peripheral vascular thrombosis rarely occur.
Drug Interactions:
Chloramphenicol may interfere witlT the therapeutic response to hydroxocobalamin injection.
Precautions and Warnings:
Hypokalemia may occur on initial treatment of patients with severe megaloblastic anemia. Vitamin B” therapy may unmask the signs of polycythemia vera.
Warning of Benzyl alcohol:
This product contains benzyl alcohol which is potentially toxic When administered locally to neural tissue.
Package:
A carton box containing 3 ampoules (amber glass, type I), each of 1 ml + pamphlet.
Storage:
Store at temperature not exceeding 30 ‘C.
This is a medicament
– Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
– Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
– The doctors and the pharmacist are experts in medicine, its benefits and risks.
– Do not by yourself interrupt the period of treatment prescribed for you.
– Do not repeat the same prescription without consulting your doctor.
– Keep medicament out of reach of children.
PRODUCED BY :
AmRIYA PHARm FOR PHARMACEUTlCAL .INDUSTRIES
AlEXANDRIA· EGYPT
