SOLUTION FOR INJECTION (Bisa di tetes kedalam air putih via oral )
Each ml solution for injection contains :
Ketamin hyrochloride 57.677 mg
(Corresponding to Ketamine 50 mg)
ACTION AND MORE OR MECHANISHMS OF ACTION
Ketamine hyrochloride is a racemix cyclohexanone derivate having strong analgesic action, simultaneously, it produces also a dissociatetive doses and survives the anaesthesia. The analgesic effect appears already with subdissociative doses and survives the anaesthesia. It is partly displaced by naloxone.
The sedative and hypnotic properties of ketamine hydrochloride are of secondary importance. Ketamine hydrochloride produces a profound local anaesthetic effect on the spinal cord and the peripheral nerves.
The electroencephalogram ( EEG ) under ketamin hydrochloride anaesthesia indicates the suppression of the bioelectrical actives of cerebrum, above all in the frontal areas, and demonstrates a stimulatory effect on the subcortical structures. The muscle tone remains normal or increases, and the protective reflexes are generally not impaired. The convulsive threshold is not lowered. Under spontaneous respiration, an increased intracranial pressure is created, which fails to appear with an adequate artificial respiration.
Due to the sympathicomimetic effect, ketamine hydrochloride increases the blood pressure as well as the frequency of the heart , consequently, the myocardial oxygen consumption is increased by reactive promotion of coronary circulation ( increased norardrenaline level ). On the heart itself, ketamine hydrochloride produces negative inotropic and antiarrhythmic actions. The peripheral resistance changes rarely in the patients having healthy coronary functions due to reciprocal influences. Afte the administration of ketamine hydrochloride a moderate hyperventilation is observed without significant impairment of blood gas concentration. Ketamine hydrochloride has an relaxing effect on bronchial musculature. Metabolism, endocrine system, and the function of liver, kidney and the intestinal tract as well as the blood coagulatory system are not influenced by ketamine hydrochloride.
Pharmacology (summary of pharmacodynamics and pharmacokinetics)
Ketamine hydrochloride is dissolved 1:4 in water and has a pKa of 7.5. The distribution quotient in heptane / water is 5.5. As a lipophile substance ketamine hydrochloride has and apparent volume of distibution of 200 l. After an intravenous bolus application ketamine hydrochloride rapidly diffuses into brain and reaches the highest concentration within one minute.The concentration in brain tissue is 6.5 times higher than in plasma. The duration of anaesthetic effect was determined by the distribution half life, 5.5 – 18 minutes, after single bolus administration. Ketamine hydrochloride crosses the placental barrier. Ketamine hydrochloride is rapidly absorbed after intramuscular administration (absorption half life, 2-17 minutes). On administration 0.5 mg ketamine hydrochloride / kg body weight and after a “lag-time” of less than 4 minutes, the maximal plasma concentration of 243 mg/ml (100 – 425 mg/ml) was measured in 6 probands after 22 minutes (5-30 minutes). 93% of ketamine hydrochloride are biologically available after intramuscular administration, and about 47% bind to the plasma proteins.
The metabolism of ketamine hydrochloride occurs rapidly and to a large extent quantitatively. It is converted among other metabolites to norketamine by N-demethylation, and to a cyclohexane-derivative by dehydration, which have the anaesthetic effects of 1/3 to 1/10 as well as 1/10 to 1/100 of ketamine hydrochloride, respectively.
The terminal elimination half-life is between 79 minutes (after continuous infusion) and 186 minutes (after a low dose i.v. administration) for ketamine hydrochloride, and 240 minutes for norketamine.
Ketamine hydrochloride and its metabolites are predominantly eliminated by renal excretion. After application of labelled 3H-ketamine hydrochloride, 91-97% of the total radioactivity were found in 120 hours urine and only 3% in the feces. In 72 hours only 2.3 % or 1.6 % of the total dose were eliminated in urine as free ketamine hydrochloride and norketamine, respectively and 16% of the dose as dehydronorketamine.
According to some occasional result, the pharmacokinetic of ketamine hydrochloride should not be significantly changed during a theraphy by continuous infusion.
Ketamine-hameln 50 mg/ml injection is recommended :
- As the sole anaesthetic agent for diagnostic and surgical procedures. When used by intravenous or intramuscular injection, ketamine-hameln 50 mg/ml injections is best suited for short procedures. With additional dose, or by intravenous infusion, ketamine-hameln 50 mg/ml injection can be used for longer procedures. If skeletal muscle relaxation is desired, a muscle relaxant should be used and respiration should be supported.
- For the induction of anaesthesia prior to the administration of other general anaesthetic agents.
- To supplement other anaesthetic agents.
Specific areas of applications or types of procedures :
- When the intramuscular route of administration is preferred.
- Debridement, painful dressings, and skin grafting in burned patients, as well as other superficial surgical procedures.
- Neurodiagnostic procedures such as pneumoencephalograms, ventriculograms, myelograms, and lumbar punctures.
- Diagnostic and operative procedures of the eye, ear, nose, and mouth,including dentalextractions. Note: Eye movements may persist during ophtalmological procedures.
- Anaesthesia in poor-risk patients with depression of vital functions or where depression of vital functions must be avoided,if at all possible.
- Orthopaedic procedures such as closed reductions, manipulations, femoral pinning, amputations, and biopsies.
- Sigmoidoscopy and minor surgery of the anus and rectum, circumcision and pilonidal sinus.
- Cardiac catheterization procedures.
- Caesarian section; as an induction agent in the absence of elevated blood pressure.
- Anaesthesia in the asthmatic patient, either to minimize the risks of an attack of bronchospasm developing, or in pressence of bronchospasm where anaesthesia cannot be delayed.
Ketamine-hameln 50 mg/ml injection is contra-indicated in persons in whom an evaluation of blood pressure would constitute a serious hazard (see Adverse Reactions section). And in those who have shown hipersensitivity to the drug. Ketamine-hameln 50 mg/ml injection should not be used in patients with eclampsia or pre-eclampsia. Severe coronary or myocardial disease, cerebral vascular accident or cerebro trauma.
SIDE EFFECTS / ADVERSE REACTIONS
Temporary elevation of blood pressure and pulse rate is frequently observed following
administration of ketamine hydrochloride. However, hypotension and bradycardia have been reported.
Arrhythmia has also occurred. The medium peak rise of blood pressure has ranged from 20 to 25 per cent of preanaesthetic values. Depending on the condition of the patient, this elevation of blood pressure may be considered an adverse reaction or a beneficial effect.
Depression and respiration or apnoea may occur following too rapid intravenous administration or high doses of ketamine hydrochloride.
Laryngospasm and other forms of airway obstruction have occured during ketamine hydrochloride anaesthesia.
Diplopia and nystagmus may occur following ketamine hydrochloride administration . A slight elevation in intraocular pressure may also occur.
During recovery from anaesthesia the patient may experience emergence delirium, characterised by vivid dreams (pleasant or unpleasant), with or without psychomotor activity, manifested by confusion and irrational behaviour. The fact that these reactions are observed less often in the young (15 years of age or less) makes ketamine-hameln 50 mg/ml injection especially useful in paediatric anaesthesia.
These reactions are also less frequent in the elderly (over 65 years of age) patient. The incidence of emergence reactions is reduced as experience with the drug is gained. No residual psychological effects are known to have resulted from the use of Ketamine-hameln 50 mg/ml injection.
In some patients, enhanced skeletal muscle tone may be manifested by tonic and clonic movements sometimes resembling seizures. These movements do not imply a light plane of anaesthesia and are not indicative of a need for additional doses of the anaesthetic.
Anorexia, nausea, and vomiting have been observed, however, these are minimal and are not ussually severe.
The great majority of patients are able to take liquids by mouth shortly after regaining consciousness.
Local pain and exanthema at the injection site have infrequently been reported. Transient erythema and/or morbiliform rash have also been reported. Increased salivation leading to respiratory difficulties may occur unless an antisialogogue is used.
Ketamine-hameln solution for Injection Box, 1 Vial @ 10 ml
Reg. No. DKI0403900243A 1
Ketamine-hameln Solution for Injection Box, 10 Vials @ 10 ml
Reg. No. DKI0403900243A 1
Ketamine-hameln Solution for Injection Box, 10 Vials @ 20 ml
Reg. No. DKI0403900243A 1
Ketamine diproduksi oleh ;
Untuk pemesanan – Segera hubungi (email)