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Instructions for the medicinal product
T R A D M A D O L COP 50
(TRAMADOL 50)
International nonproprietary name-Tramadol
Dosage form - capsules 50 mg
Ingredients:
Active ingredient: Tramadol hydrochloride - 50 mg
Inactive ingredients: calcium hydrogen phosphate anhydrous, magnesium stearate,
colloidal silicon dioxide, gelatin capsule: body - red iron oxide,
titanium dioxide, yellow iron oxide, gelatin, cover - red iron oxide, silica
titanium, iron oxide yellow, gelatin.
Description: light yellow, hard gelatin capsules, size, number 3, containing
white or almost white powder.
Pharmacotherapeutic group - Analgesic, anodyne.
Code Axm [N02AX02]
Pharmacodynamics:
Refers to the means of the central analgesic action. A pronounced
analgesic effect.
Nonselective antagonist of opioid mu-, delta and kappa receptors in the CNS with the highest
affinity for mu-receptors. Inhibits the neuronal norepinephrine and enhances the capture of
release of serotonin. Also has antitussive action does not violate the motility
gastro - intestinal tract. Duration of action - about 4-8 hours.
Pharmacokinetics:
Absorption: After oral tramadol is rapidly and almost completely absorbed from the gastro -
intestinal tract (90%). The maximum concentration in plasma is determined
about 2 hours. The value of bioavailability is about 70%, independent of
food intake and increases with repeated use of the drug.
Raspredechenie. Plasma protein binding is about 20%. Tramadol crosses the
the blood-brain and placental barriers. Approximately 0.1% is excreted in breast
milk.
Metabolism: metabolized by demethylation and conjugation to 11 metabolites,
only one of which (O-demetiltramadol) has a pronounced pharmacological
activity (2-4 times greater activity than tramadol).
Excretion: Tramadol and its metabolites are excreted in the kidneys (90%) and through
intestine (10%). The half-life, regardless of the route is approximately b
hours. Patients in the POE / Shiloh age with liver cirrhosis and renal failure
vechichina half-life is increased.
Mode of action: Analgeziruyuschee.
Analgesic effect is due to agonistic effects on opioid receptors in
CNS. As a synthetic opioid, is a racemate (+) and (-) isomer is different
involved in the analgesic effect. Isomer (+) - pure agonist opioid
receptors isomer (-) inhibits the neuronal uptake of norepinephrine, activates the central
descending noradrenergic system, which violates the transmission of pain impulses and
gelatinous substance of the spinal cord, both isomers act synergistically. Cause
sedation.
Clinical Pharmacology: In therapeutic doses, has practically no effect on the
hemodynamics, does not inhibit the function of respiration. In a controlled application
addiction and drug dependence develops very rarely.
Indications: Moderate and marked acute and chronic pain of varying
etiology (trauma, cancer patients during painful
diagnostic or therapeutic interventions).
Contraindications: 1 iperchuvstvitelnost to opiates, state, accompanied by
respiratory depression or severe depression of the central nervous system (acute alcohol intoxication,
hypnotics or psychotropic drugs, opioid analgesics), severe renal (C1
less than 10 ml / min) and / or liver failure, childhood (up to 1 year), pregnancy,
breast-feeding.
Pregnancy and breast-feeding: It is possible only for health
indications, the application is limited to a single dose.
Side effects: the digestive tract: nausea, dry mouth, rarely - vomiting, constipation,
abdominal pain, bloating, and in rare cases - change in appetite.
The nervous system and sense organs: dizziness, fatigue, drowsiness,
confusion, rarely - headache, mood changes (mostly
improvement, at least - depression), activity (primarily the suppression, at least - increase)
violation of behavioral reactions, feelings, and in some cases - cerebral seizures
(At / in the administration of high doses or in combination with neuroleptics).
Cardio-vascular system and blood (blood, hemostasis) in isolated
cases - interruption of cardiac rhythm, tachycardia, syncope or collapse (especially if the patient
is in an upright position or during exercise).
For the skin: rare - redness, rash.
On the part of the musculoskeletal system: in rare cases - muscle weakness.
From the respiratory system: side-effects were not observed when using
capsules and rectal suppositories, but does not exclude the deterioration of respiratory function in
significantly exceeded the recommended dose or while taking other
drugs which depress the central nervous system.
Other: increased sweating (for rapid on / in the introduction), in rare cases -
difficulty in swallowing water.
Interaction: Enhances the action of CNS depressants and ethanol. Carbamazepine
reduces the analgesic effect and duration of action, anxiolytics - increase,
increased duration of anesthesia in combination with barbiturates. Long-term
use of opioids or barbiturates stimulate the development of cross-
tolerance. Naloxone activates respiration, eliminating analgesia. MAO inhibitors,
furazolidone, procarbazine, antipsychotic drugs increase the risk of seizures. Quinidine increases
concentration in plasma and reduces the amount of metabolite Ml due to competitive
Inhibition of cytochrome P450 isoenzyme 2D6.
Symptoms: characteristic of opiates - coma, epileptiform convulsions,
lowering blood pressure, tachycardia, narrowing or dilated pupils, difficulty breathing, until
stop. Treatment: An Introduction antagonists (naloxone), to eliminate seizures - drugs from
of benzodiazepines.
Dosage and administration:
Dose is determined by the physician individually depending on the intensity and nature of
pains.
Adults and adolescents over the age of 14 that le
Typically, the initial dose - one tablet or capsule (50 mg) orally with a small amount
fluid, regardless of meal times, with no effect within 30 - 60 minutes
You can even take a pill or capsule, with severe pain may be a single dose immediately
be 100 mg (2 tablets or capsules). The effect, depending on the severity of
pain persists for 4-8 hours. Do not exceed the daily dose of tramadol 400 mg (8
tablets or capsules).
Children. Do not take this dosage form for children weighing less than 25 kg and
aged less than 14 years. .
Elderly patients, patients with impaired fuiktsiiPygechten and I yaochek. *
If necessary, the reception should increase the interval between doses of the drug. ^
The duration and pattern of use are determined by the attending vrachosch)
The capsules should be swallowed without chewing, with neobhoyatgmtm
regardless of the meal.
Precautionary measures: With care and under the supervision of a physician prescribed for
functional disorders of kidney and liver, brain injury, increased intracranial
pressure, epilepsy, drug dependence on opioids, pain in the abdomen
unknown origin, unexplained confusion, disturbances of the respiratory
center or respiratory function. Patients with seizures of central origin should be
carefully controlled. Exclude the use of alcohol. It should not be used during
the drivers of vehicles and people skills are associated with increased
concentration.
Cautions: Long-term treatment of chronic pain to hold only
strict indications, in order to avoid the development of drug dependence.
Shelf life: 3 years.
The drug should not be taken after the expiration date!
Storage: List A. At temperatures below 25 ° C, protected from
moisture and light.
Method of production
In the blister 30 capsules of 50 mg.Z blisters of 10 capsules and a piece of loose leaf
packed in cartons.
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