Longavit B12 Ampoule
"Hydroxocobalamin acetate 1.045 mg. ( Equivalent to hydroxocobalamin 1.00 mg)
Company Name
Memphis
Therapeutic Group
VITAMIN B12 PLAIN
Pharmaceutical form
Ampoule
Package
"carton box containing one ampoule (1 ml) & other of 3 ampoules (1 ml)."
Indications
"1- Pernicious anemia, both uncomplicated and
accompanied by nervous system involvement.
2- Dietary deficiency of Vitamin B12, occurring in strict
vegetarians and in their breast-fed infants. (Isolated
vitamin B12 deficiency is very rare).
3- Malabsorption of vitamin B12, resulting from structural
or functional damage to the stomach, where intrinsic
factor is secreted or to the ileum, where intrinsic factor
facilitates vitamin B12 absorption. These conditions
include tropical sprue, and nontropical sprue
(idiopathic steatorrhea, gluten-induced enteropathy).
Folate deficiency in these patients is usually more severe
than vitamin B12 deficiency.
4- Inadequate secretion of intrinsic factor, resulting from
lesions that destroy the gastric mucosa (ingestion of
corrosives, extensive neoplasia), and a number of
conditions associated with a variable degree of gastric
atrophy (such as multiple sclerosis, certain endocrine
disorders, iron deficiency, and subtotal gastrectomy).
Total gastrectomy always produces vitamin B12
deficiency. Structural lesions leading to vitamin B12
deficiency include regional ileitis, ileal resections,
malignancies, etc.
5- Competition for vitamin B12 by intestinal parasites or
bacteria. The fish tapeworm (Diphyilobothrium latum)
absorbs huge quantities of vitamin B12 and infested
patients often have associated gastric atrophy. The
blind-loop syndrome may produce deficiency of
Vitamin B12 or folate.
6- Inadequate utilization of vitamin B12.
This may occur if antimetabolites for the vitamin are
employed in the treatment of neoplasia.
7- For the Schilling Test."
Warning & Precautions
"WARNINGS: - Avoid the intravenous route. - Folic acid is not a substitute for vitamin B12 although it may improve vitamin B12 deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B12 deficient megaloblastic anemia could result in progressive and irreversible neurologic damage. - Blunted or impeded therapeutic response to vitamin B12 may be due to such conditions as infection, uremia, drugs having bone marrow suppressant properties such as chloramphenicol, and concurrent iron or folic acid deficiency. PRECAUTIONS: General - The validity of diagnostic vitamin B12 or folic acid blood assays could be compromised by medications, and this should be considered before relying on such tests for therapy. - vitamin B12 is not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin B12 could mask the true diagnosis. - Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with B12 therapy. Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy. - vitamin B12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B12 may unmask this condition. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of carcinogenicity, mutagenesis, or impairment of fertility have not been performed with hydroxocobalamin. Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with hydroxocobalamin. It is also not known whether hydroxocobalamin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydroxocobalamin should be given to a pregnant woman only if clearly needed.
Product Type
Human
Dosage
"Protect from light.
- Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to
administration, whenever solution and container permit.
- Hydroxocobalamin injection should be given only
intramuscularly.
- In patients with Addisonian Pernicious Anemia,
parenteral therapy with vitamin B12 is the recommended
method of treatment and will be required for the
remainder of the patient's life. Oral therapy is not dependable.
In other patients with vitamin B12 deficiency, the duration of
therapy and route of administration will depend upon the
cause and whether or not it is reversible.
- Confirmatory diagnostic studies should be performed
prior to initiating therapy, if possible, and the patient
should be followed with appropriate studies to
demonstrate hematologic improvement (Hgb,
hematocrit, RBC, reticulocyte count). A diagnostic trial
utilizing physiologic doses of vitamin B12 (1 mcg daily)
and observing daily reticulocyte counts after establishing
a baseline may also be performed. The observation of
reticulocytosis which usually occurs between the third
and tenth day of therapy confirms the diagnosis of
vitamin B12 deficiency.
- In seriously ill patients it may be advisable to administer
both vitamin B12 and folic acid while waiting the results
of distinguishing laboratory studies. It is not necessary to
withhold vitamin B12 therapy until the precise cause of
B12 deficiency is established since absorption studies can
be performed at any time.
- Serum potassium should be closely observed the first 48
hours and potassium should be administered if necessary.
Treatment of Vitamin B12 Deficiency
- Thirty mcg daily for 5 to 10 days followed by 100 to 200
mcg monthly injected intramuscularly.
- If the patient is critically ill, or has neurologic disease, an
infectious disease or hyperthyroidism, considerably higher
doses may be indicated. However, current data indicate
that the optimum obtainable neurologic response may
be expected with a dosage of vitamin B12 sufficient to
produce good hematologic response.
- Children may be given a total of 1 to 5 mg over a period
of 2 or more weeks in doses of 100 mcg, then 30 to 50
mcg every 4 weeks for maintenance.
- Patients who have normal intestinal absorption may be
treated with an oral therapeutic multivitamins
preparation, containing 15 mcg vitamin B12 daily.
- Schilling Test : The flushing dose is 1000 mcg. "
Adverse Reactions
"Mild transient diarrhea, itching, transitory exanthema,
feeling of swelling of entire body, and anaphylaxis.
A few patients may experience pain after injection of
hydroxocobalamin."
Contra Indications
Hypersensitivity to any component of this medication.
Drug Interactions
NA.
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