| Customization: | Available |
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| Application: | Internal Medicine |
| Usage Mode: | for Injection |
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| PRODUCT NAME: | Lyophilized Amikacin Sulfate Powder for Injection |
| STRENGTH: | 0.2g, 0.4g, 0.6g |
| PACKING DETAILS: | 10 vials/tray/box;1 vial +1 solvent/tray/box |
| STORAGE: | Store in a cool and dry place below 25ºC, protected from light. |
| SHELF LIFE: | 36 months |
| REGISTRATION DOSSIERS ARE AVAILABLE. | |
| CONSIGNMENT MANUFACTURING, BRAND OEM/ODM SERVICE IS AVAILABLE. | |
Amikacin Injection is a semi-synthetic, aminoglycoside antibiotic which is active against a broad spectrum of Gram-negative organisms, including pseudomonas and some Gram-positive organisms.
Sensitive Gram-negative organisms include; Pseudomonas aeruginosa, Escherichia coli., indole-positive and indole-negative Proteus spp., Klebsiella, Enterobacter and Serratia spp., Minea-Herralae, Citrobacter freundii, Salmonella, Shigella, Acinetobacter and Providencia spp.
The principal Gram-positive organism sensitive to amikacin is Staphylococcus aureus, including some methicillin-resistant strains. Amikacin has some activity against other Gram-positive organisms including certain strains of Streptococcus pyogenes, Enterococci and Diplococcus pneumoniae.
Amikacin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species. Although amikacin is not the drug of choice for infections due to staphylococci, at times it may be indicated for the treatment of known or suspected staphylococcal disease. These situations include: the initiation of therapy for severe infections when the organisms suspected are either Gram-negative or staphylococci, patients allergic to other antibiotics, and mixed staphylococcal/Gram-negative infections.
Therapy with amikacin may be instituted prior to obtaining the results of sensitivity testing. Surgical procedures should be performed where indicated.
Consideration should be given to official guidance on the appropriate use of antibacterial Agents.
2. Posology and method of administration
Amikacin sulphate injection may be given intramuscularly or intravenously.
Amikacin should not be physically premixed with other drugs, but should be administered separately according to the recommended dose and route.
The patient's pre-treatment bodyweight should be obtained for calculation of correct dosage.
The status of renal function should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate. The blood urea nitrogen (BUN) is much less reliable for this purpose. Reassessment of renal function should be made periodically during therapy.
Whenever possible, amikacin concentrations in serum should be measured to assure adequate, but not excessive levels. It is desirable to measure both peak and trough serum concentrations intermittently during therapy. Peak concentrations (30-90 minutes after injection) above 35 mcg/ml and trough concentrations (just prior to the next dose) above 10 mcg/ml should be avoided. Dosage should be adjusted as indicated. In patients with normal renal function, once-daily dosing may be used; peak concentrations in these cases may exceed 35 mcg/ml.
For most infections the intramuscular route is preferred, but in life-threatening infections, or in patients in whom intramuscular injection is not feasible, the intravenous route, either slow bolus (2 to 3 minutes) or infusion (0.25% over 30 minutes) may be used.
3. Contraindications
Amikacin sulphate injection is contraindicated in patients with known allergy to amikacin or any component of the formulation.
A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any aminoglycoside because of the known cross sensitivities of patients to drugs in this class.
Aminoglycosides may impair neuromuscular transmission, and should not be given to patients with myasthenia gravis.
4. Undesirable effects
All aminoglycosides have the potential to induce ototoxicity, renal toxicity, and neuromuscular blockade. These toxicities occur more frequently in patients with renal impairment, in patients treated with other ototoxic or nephrotoxic drugs, and in patients treated for longer periods and/or with higher doses than recommended (see section 4.4)
Renal function changes are usually reversible when the drug is discontinued.
Toxic effects on the eighth cranial nerve can result in hearing loss, loss of balance, or both. Amikacin primarily affects auditory function. Cochlear damage includes high frequency deafness and usually occurs before clinical hearing loss can be detected by audiometric testing (see section 4.4).
Macular infarction sometimes leading to permanent loss of vision has been reported following intravitreous administration (injection into the eye) of amikacin.
When the recommended precautions and dosages are followed the incidence of toxic reactions, such as tinnitus, vertigo, and partial reversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting is low. Urinary signs of renal irritation (albumin, casts, and red or white cells), azotaemia and oliguria have been reported although they are rare.
5.Overdose
In case of overdosage there is a general risk for nephro-, oto- and neurotoxic (neuromuscular blockage) reactions. Neuromuscular blockage with respiratory arrest needs appropriate treatment including application of ionic calcium (e.g. as gluconat or lactobionat in 10-20% solution) (see section 4.4). In the event of overdosage or toxic reaction, peritoneal dialysis or haemodialysis will aid in the removal of amikacin from the blood. Amikacin levels are also reduced during continuous arteriovenous hemofiltration. In the newborn infant, exchange transfusion may also be considered.
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Brief Introduction to Our Company:
Shandong Sino Pharmaceutical Technology Co., Ltd. (S.S.P.T.) is a different kind of pharmaceuticals (both finished medicine products and raw materials), health products, cosmetics and medical supplies company for human needs, focusing on global markets, especially the developing world. Working with the highest levels of government and local distributors alike, we aim to not only expand our business scale and scope but also have a special interest in serving the needs of the end consumer that requires our products the most. To this end, we have a presence in 5 continents with an expanding product range to meet the demand of our main markets.
Moreover, our manufacturing facilities follow strict GMP rules and regulations. We have intergraded all GMP guidelines into internal procedures improving the degree to which results are consistently exceeding expectations. As one of the best pharmaceutical companies in China, we take our ethical obligation to improving access to high quality and affordable WHO essential drugs seriously. This is the ethical basis our company was founded on.
Consignment Manufacturing, Brand OEM/ODM Service are available.
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