Snorting Tramadol: Tramadol solution for injection 5 2.0 5

Snorting Tramadol: Tramadol solution for injection 5 2.0 5

Content:

Snorting Tramadol: Tramadol solution for injection 5 2.0 5

Tramadol solution for injection 5% 2.0 No. 5

Instructions for medical use

medicinal product

Tramadol

Tradename

Tramadol

International non-proprietary name

Tramadol

Dosage Form

Solution for injection 5%, 1 ml and 2 ml

Composition

1 ml of the preparation contains

active ingredient – tramadol hydrochloride

(in terms of 100% substance) 50.0 mg,

excipients: sodium acetate trihydrate, water for injection.

Description

Colorless or slightly colored clear liquid.

Pharmacotherapeutic group

Analgesics. Opioids. Other opioids.

ATC code N02AX02

Pharmacological properties

Pharmacokinetics

Absolute bioavailability with intramuscular tramadol is 100%. Binding to protein is 20%. Tramadol penetrates the blood-brain barrier and the placenta. The drug is found in breast milk only in very small quantities (0.1%).

Tramadol and its metabolites are excreted through the kidneys. Eleven metabolites have been identified, of which only O-desmethyltramadol is pharmacologically active.

The elimination half-life is approximately 6 hours, regardless of the route of administration. In the event of impaired liver or kidney function, a slight increase in the half-life is expected. In cases of more severe disorders (cirrhosis, creatinine clearance lt; 5 ml / min.) A 2-3-fold increase in elimination time is expected.

Excreted by the kidneys – 90% and through the intestines – ten%.

Pharmacodynamics

Analgesic agent of central action (opioid + non-opioid). Non-selective agonist of mu, delta and kappa receptors in the central nervous system with the highest affinity for mu receptors. It inhibits nociceptive activity and activates the antinociceptive system. It promotes the opening of potassium and calcium channels, causes hyperpolarization of the membranes and inhibits the conduction of nerve impulses.

Stimulates the adrenergic system, inhibiting the reverse neuronal seizure of norepinephrine. Enhances the release of serotonin. It has sedative and antitussive effects. In therapeutic doses, it practically does not inhibit respiration and does not violate cardiovascular activity.

With parenteral administration, the analgesic effect develops in 5–10 minutes and lasts for 3–5 hours.

Indications for use

Pain syndrome of medium and strong intensity:

– postoperative period

– injuries, burns

– myocardial infarction

– oncological diseases

– pain relief during painful diagnostic and therapeutic procedures

Dosage and administration

Tramadol is used as prescribed by a doctor, the dosage regimen of the drug is selected individually, depending on the severity of pain and sensitivity of the patient.

The duration of treatment is determined individually, you should not prescribe the drug over a period justified from a therapeutic point of view.

Tramadol is intended for snorting tramadol: for intravenous (inject slowly!), Intramuscular or subcutaneous. The usual single dose for intravenous administration in adults and children over 14 is 50-100 mg of tramadol hydrochloride. If necessary, in case of insufficient effect, after 30-60 minutes, you can assign a single dose of 50 mg. The maximum daily dose should not exceed 400 mg. When an intravenous drip infusion is performed, the initial dose of 50-100 mg of tramadol hydrochloride is administered intravenously for 20 minutes, then the supporting drop infusion is started at a rate of 12 mg of tramadol hydrochloride per hour up to the maximum possible daily dose of 400 mg.

Compatible solutions for tramadol infusion are: 0.9% sodium chloride solution, Ringer’s solution or 5% glucose solution.

For intramuscular or subcutaneous administration, the initial dose is usually 50-100 mg, further injections are possible, if necessary, at a dose of 50 mg to the maximum possible daily dose.

The maximum daily dose of the drug should not exceed 400 mg.

In elderly patients, as well as in patients with impaired liver and / or kidney function, a dosing regimen needs adjustment: a reduction in the dose and frequency of drug administration. The highest daily dose for patients over 75 should not exceed 300 mg (6 ml).

Children aged 2 to 14 years old tramadol hydrochloride snorting tramadol: it is recommended to administer in a single dose at the rate of 1-2 mg per 1 kg of body weight of the child, the maximum daily dose should not exceed 4-8 snorting tramadol: mg per 1 kg body weight of the child.

Side effects

– sweating, dizziness, headache, weakness, fatigue, lethargy, drowsiness, sleep disturbance, confusion, loss of motor coordination

– paradoxical CNS stimulation (nervousness, agitation, anxiety, tremor, muscle spasms, euphoria, sometimes – dysphoria, emotional lability, hallucinations)

– convulsions of central genesis (with intravenous administration in high doses or with simultaneous prescription of antipsychotic drugs)

– depression, amnesia, cognitive impairment, paresthesia, gait imbalance, muscle weakness, involuntary muscle contraction, epileptiform seizures

– change in appetite, dry mouth, nausea, vomiting, difficulty in swallowing, flatulence, abdominal pain, constipation, diarrhea, increased activity of liver enzymes

– tachycardia, orthostatic hypotension, syncope, collapse, bradycardia, vasodilation, cardiac arrhythmia

– urticaria, pruritus, rash, bullous rash, Stevens syndrome – Johnson Lyell Syndrome

– difficulty urinating, dysuria, urinary retention

– hypoglycemia

– blurred vision

– dyspnea, bronchospasm, wheezing, angioedema, anaphylaxis

– respiratory depression, shortness of breath

– menstrual disorders

– development of drug dependence is possible with long-term use

– syndrome "cancellations" possible with abrupt drug withdrawal

Contraindications

– hypersensitivity to tramadol hydrochloride or other opiates

– conditions accompanied by respiratory depression or marked depression of the central nervous system (alcohol poisoning, sedatives, sleeping pills, narcotic analgesics, psychotropic drugs)

– simultaneous use of monoamine oxidase inhibitors and a two-week period after their withdrawal

– impaired consciousness of unknown origin

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– dysfunction of the respiratory center, impaired respiratory function

– conditions accompanied by elevated cranial pressure without artificial respiration

– drug addiction

– insufficiency of renal function of severe degree (CC less than 10 ml / min)

– severe liver failure

– patients with epilepsy, the course of which can not be adequately controlled

– pregnancy and lactation

– children up to 2 years

Drug interactions

Tramadol solution is incompatible in one syringe with solutions of diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, nitroglycerin, midazolone.

Tramadol is not prescribed simultaneously with monoamine oxidase inhibitors, its use is possible 2 weeks after their cancellation.

Combined use with neuroleptics, furazolidone, procarbazine, serotonin reuptake inhibitors, tricyclic antidepressants is not recommended due to the possible risk of seizures.

Tramadol enhances (mutually) the effects of tranquilizers, hypnotics, sedatives, alcohol and other substances that depress the central nervous system. Prolonged use of opioid analgesics or barbiturates stimulates the development of cross-tolerance. When combined with carbamazepine, analeptics and psychostimulants, the analgesic effect of the drug is weakened.

The direct antagonists of Tramadol that completely block its action are naloxone and naltrexone.

The drug is not prescribed for the treatment of drug withdrawal syndrome.

Quinidine increases the plasma concentration of tramadol and reduces the metabolite of mono-O-desmethyltramadol due to competitive inhibition of the isoenzyme CYP2D6.

The combination of opioid receptor agonists / antagonists (for example, buprenofine, nalbuphine, pentazocine) and tramadol is not recommended because the analgesic effect of a pure agonist is reduced under these conditions. Perhaps the development of serotonin syndrome associated with the use of tramadol in combination with other serotonergic substances, such as selective serotonin reuptake inhibitors. Symptoms of serotonin syndrome: confusion, dysphoria, hyperthermia, sweating, ataxia, hyperreflexia, myoclonus and diarrhea. Cancellation of serotonergic drugs causes rapid relief of symptoms.

With the simultaneous administration of tramadol and coumarin derivatives (for example, warfarin), careful monitoring of patients is necessary, since in some patients prothrombin time decreases with the development of bleeding and ecchymosis. Other inhibitors of CYP3A4, for example, ketoconazole and erythromycin, can inhibit the metabolism of tramadol (N-demethylation) and the active metabolite O-desmethyltramadol.

CYP2D6 isoenzyme inhibitors (such as fluoxetine, paroxetine, and aminotriptilline) reduce tramadol metabolism.

In a limited number of studies, it was found that pre-or postoperative use of the anti-emetic agent 5-NTZ ondansetron antagonist increased the need for tramadol for postoperative pain.

special instructions

In the case of the use of Tramadol in conjunction with other drugs, the patient must inform the doctor.

Observe precautions when taking the drug in the following conditions:

– with convulsions of central genesis

– with head injuries

– in patients with impaired liver and kidney function

– with shock

– with abdominal pain of unknown origin («sharp belly snorting tramadol:»)

– for disorders of the respiratory center and respiratory function

Tramadol should not be used for longer than the period justified from a therapeutic point of view. In the case of long-term treatment can not exclude the possibility of drug dependence. The patient should be warned about the need to strictly adhere to the dose and duration of treatment prescribed by the doctor and not transfer the drug to other persons. Long-term treatment for chronic pain syndrome should be carried out only under strict indications.

With extended time intervals, Tramadol is used in elderly patients. Under close medical supervision and in reduced doses, tramadol hydrochloride should be used against the background of the action of anesthesia, sleeping pills and psychotropic drugs. The drug should not be combined with narcotic analgesics because of the poor predictability of the interaction effects. Not recommended for the treatment of drug withdrawal syndrome. Combination with monoamine oxidase inhibitors should be avoided. Patients with epilepsy or prone to seizures should take Tramadol only for health reasons. During the period of drug treatment is not allowed to use alcohol.

The incidence of side effects increases with increasing duration of the drug.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery

It is not recommended to engage in activities that require increased attention and high speed of psychomotor reactions (driving vehicles and driving machinery) due to the possible occurrence of adverse reactions.

Overdose

Symptoms: nausea, vomiting, constriction of the pupils, dilated pupils, depression of consciousness, up to a coma, a drop in blood pressure. The most dangerous consequences of an overdose of tramadol hydrochloride are respiratory depression and up to a stop, convulsions.

Treatment: maintaining adequate pulmonary ventilation and symptomatic therapy in the intensive care unit. An antidote in the case of respiratory depression is naloxone, for convulsions it is advisable to use diazepam.

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Hemodialysis is ineffective.

Release form and packaging

On 1 ml or 2 ml in ampoules of neutral glass.

On 5 ampoules pack into a blister strip packaging from a film of polyvinyl chloride and aluminum foil.

2 contour packages together with the approved instructions for medical use in the state and Russian languages ​​are placed in a pack of cardboard. An ampoule scarifier is placed in each pack. When packing ampoules with notches, rings and dots, the scarifiers are not inserted.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 30°WITH.

Keep out of the reach of children!

Shelf life

3 years

Do not use the drug after the expiration date.

Pharmacy sales terms

On prescription

Manufacturer

AO «Himfarm», THE REPUBLIC OF KAZAKHSTAN,

Shymkent, st. Rashidova, b / n, t / f: 561342

Registration Certificate Holder

AO «Himfarm», THE REPUBLIC OF KAZAKHSTAN

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