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Tribedoce Compuesto Complejo B (B1,B6,B12) Three 3 Injections
This is a GENERIC Medication
TRIBEDOCE COMPOUND
Solution for
injection
Diclofenac sodium
THIAMINE
VITAMIN B12
VITAMIN B6
Dosage form
The number 1 vial contains:
Thiamine Hydrochloride ..................... 100 mg
Pyridoxine Hydrochloride ................ 100 mg
Cyanocobalamin ............................... 5 mg
Vehicle cbp 1 ml.
The bulb number 2 contains:
Diclofenac sodium ......................... 75 mg
Vehicle cbp 2 ml.
INDICATIONS
Anti-inflammatory with analgesic action. Antineuritic.
Lumbago, cervical, brachialgia, radiculitis, peripheral neuropathies of
different etiology, facial neuralgia, trigeminal neuralgia, intercostal
neuralgia, herpetic neuralgia, alcoholic neuropathy, diabetic neuropathy,
carpal canal syndrome, fibromyalgia, spondylitis.
Exactly what is this
medication?
It is known as a Pharmacokinetics
Thiamine hydrochloride, pyridoxine hydrochloride,
cyanocobalamin and involved in the metabolism of all cells in the body, but
their main activity is exerted on nervous system cells, therefore they have
been termed neurotropic vitamins.
Thiamine (vitamin B 1): Gastrointestinal absorption of
thiamine is ingested with food going through an active transport mechanism, and
when administered in large doses, is absorbed by passive diffusion. The maximum
absorption limit of 8 to 15 mg per day, but this amount can be easily overcome
when ingested in divided doses with food. The total degradation fabrics made
​​from about 1 mg per day of thiamine.
When intake is less than this amount, thiamine is not
excreted in the urine, but when intake exceeds this amount, first saturate
tissue deposits and subsequently appears unchanged or with its catabolite, the
pyrimidine.
The functionally active form of thiamine is thiamine pyrophosphate
which is involved in the metabolism of carbohydrates as dehydrogenases factor
(ketoacidotic branched chain dehydrogenase complex piruvatodeshidrogenasa or
alpha-ketoglutarate dehydrogenase) and transcetolasas. Among metabolic
processes are affected thiamine deficiency during energy intake is inhibited
neuronal the degradation of carbohydrates, which prevents regeneration of the
axon membrane (J Nutr, 1995, 125: 189-194). In addition to participating in the
process of synthesis of acetylcholine, thiamine pyrophosphate involved in
neurotransmitter release this presynaptic membrane, since high concentrations
were found in the phosphorylated thiamine cholinergic nerve endings (Ann Neurol
1993; 34: 724-726).
Pyridoxine (vitamin B 6): pyridoxine, pyridoxal and
pyridoxamine are readily absorbed through the gastrointestinal system after its
hydrolysed products are phosphorylated.
At least 60% of circulating vitamin B 6 corresponds to
pyridoxal phosphate.
It is considered that the pyridoxal is the primary form that
crosses cell membranes. The main product of excretion is 4-pyridoxic acid,
formed by the action on the liver aldehidooxidasa free pyridoxal.
Cyanocobalamin (Vitamin B12): Vitamin B 12 is ingested with
food binds to intrinsic factor (glycoprotein with molecular mass of 59,000), in
the presence of gastric acid and pancreatic proteases. The vitamin B 12 complex
intrinsic factor reaches the distal ileum, where it interacts with a specific
receptor located on the iliac mucosal cells and from there, is transported to
the circulation.
Besides the intrinsic factor requires the presence of bile
and sodium carbonate (an appropriate pH) for the transport of vitamin B 12
through the ileum.
The development of vitamin B12 deficiency, commonly, not
from a lack in the diet if a defect in gastrointestinal absorption.
Once absorbed, vitamin B 12 binds to a plasma betaglobulina
called transcobalamin II, for transport to the tissues.
Vitamin B 12 linked to transcobalamin II is rapidly removed
from the plasma and stored in liver cells, so that up to 90% of body stores of
vitamin B 12 in the normal adult, or 1 to 10 mg are in the liver. Vitamin B 12
is stored as active coenzyme, with a turnover rate of 0.5 to 0.8 mcg per day
depending on the body shell capacity. The minimum requirement for the vitamin
per day is 1 mcg.
Approximately 3 mcg of vitamin B 12 are secreted each day
through the bile and 50 to 60% of that amount is not intended to re-sorption.
This prevents the enterohepatic cycle during bowel disease, it interferes with
the absorption, which can result in continuous depletion of hepatic stores of
vitamin. Metabolically active forms of vitamin B 12 are methylcobalamin and
5-deoxyadenosylcobalamin, which are critical for growth and cell replication.
Methylcobalamin involved in transforming homocysteine ​​to
methionine and its derivative, S-adenosinmetionina as well as the conversion of
5-methyltetrahydrofolate to tetrahydrofolate.
The 5-deoxyadenosylcobalamin intervenes in the isomerization
of L-metilmalonilcoenzima A succinilcoenzima A, which promotes the synthesis of
fatty acids.
These metabolic actions within the nervous system leading to
the generation of ATP that is necessary for a) the synthesis of mitochondrial
DNA neurons, b) for the formation of melanin axonal sheath, c) to provide the
biochemical components of neurotransmission d) to maintain the constancy of the
internal environment neuronal necessary to generate action potentials and allow
transmission at synapses (Neurology, 1995, 45: 11-16).
The combination of vitamins B 1, B 6 and B 12 has
contraceptive activity, according to recent clinical observations, resulting in
substantial analgesic (Klin Wochenschr, 1990, 68: 103-148).
Diclofenac Sodium: 20 minutes after intramuscular
application of 75 mg of diclofenac plasma concentration is reached 2.5 mcg / ml
(8 micromoles / liter).
Plasma concentrations are directly proportional to the dose.
The area under the concentration curve obtained when administered at the same
dose, corresponds approximately to twice that obtained when it is applied by
oral or rectal route, as the active principle is metabolized almost 50% during
its first passage through the liver (first pass effect), when administered by
the routes mentioned. The drug is extensively bound to plasma proteins (99.7%),
mainly albumin and plasma half-life is about one to two hours.
Diclofenac is widely distributed in the body so that
systemic bioavailability is only 50%, found in the highest concentrations in
liver and kidney.
The drug is metabolized in the liver by cytochrome P-450
isozyme subfamily 4-hidroxidiclofenaco CYP2C as a major metabolite, and other
hydroxylated forms.
After glucuronidation and sulfation, the metabolites are
excreted in the urine (65%) and bile (35%). Repeated doses produced no
accumulation of diclofenac in the normal adult. The excretion half-life is 1.2
to 2.0 hours.
Diclofenac is a cyclooxygenase inhibitor, which is the
enzyme that converts arachidonic acid into prostaglandins. Its power is
substantially greater than that of indomethacin, naproxen and other NSAIDs.
Prostaglandins are whose synthesis is inhibited PGE 2 (50%), thromboxane TXB 1
(60%) and PGF (30%).
Furthermore, the drug appears to reduce intracellular
concentrations of free arachidonate in leukocytes, possibly modifying the
release or uptake of the fatty acid.
In addition to its peripheral effect, diclofenac and other
nonsteroidal antiinflammatory analgesics may have a contraceptive effect
(analgesic) in the central nervous system acting on the release of
prostaglandins and / or through the neuronal systems which use and
catecholamines neurotransmitter serotonin (Pain, 1994, 57: 197-205).
WHEN NOT TO USE!
Hypersensitivity to the components of the
formula. Polycythemia vera. Vitamin B 12 is not to be used in early Leber's
disease (hereditary optic nerve atrophy).
Gastroduodenal peptic ulcer. In patients whose
attacks of bronchial asthma, urticaria or acute rhinitis are caused by aspirin
or its derivatives.
PRECAUTIONS
Diclofenac: diclofenac preparations can cause allergic
reactions such as swelling of the eyelids, lips, pharynx and larynx, urticaria,
asthma, and bronchospasm, sometimes increased blood pressure.
Diclofenac and other drugs in its class may rarely cause gastrointestinal
effects such as bleeding and rarely hepatotoxicity, which can lead to
hospitalization. Diclofenac is used in the maintenance of arthritis, but its
main effect is as an analgesic.
Thiamine: Occasionally, individually administered thiamine
can cause hypersensitivity, especially after repeated doses, cigarillo,
urticaria, nausea, cyanosis, have also been reported. Patients should be
advised that they should take proper diet, as there may be a relapse upon dose
reduction or to suspend it.
Pyridoxine: Pyridoxine should not be administered to
patients already receiving levodopa, because it is an antagonist of pyridoxine.
However, occasionally pyridoxine may be administered in patients receiving
carbodopa jointly and levodopa. The administration of preparations with
pyridoxine may cause drowsiness, paraesthesia and low levels of folic acid.
Cyanocobalamin: Patients with pernicious anemia should
receive monthly cyanocobalamin to maintain their levels, if it does not, can
cause anemia resubmit therefore develops a degeneration in the spinal nerves.
Patients should be advised that replacing vitamin B 12 folic
acid, which could cause a progressive subacute combined degeneration.
RESTRICTIONS OF USE
DURING PREGNANCY AND BREASTFEEDING
Do not take during pregnancy or breastfeeding. Before taking
this medicine, you should investigate the state of the digestive, liver and
kidney.
ADVERSE REACTIONS
There have been isolated reports of reactions by the
long-term parenteral administration of thiamine and vitamin B 12, which may be
due, probably, to rare cases of hypersensitivity. The mega-dose administration
of pyridoxine may cause certain sensory neuropathic syndromes, but no
histopathological studies have shown that these syndromes are associated with
some degree of neuronal degeneration. When stopping pyridoxine neuronal
spreading slowly improving, until patients recover completely. Rash and other hypersensitivity
reactions to any component of the formula.
DOSAGE AND
ADMINISTRATION
Intramuscular deep.
A light bulb and a bulb No. 1 No. 2, mixed in the same
syringe, once a day for 2 days.
STORAGE
RECOMMENDATIONS
Store at room temperature to not more than 30 ° C. Protect from light.
For more information, please contact your medical doctor.
