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Bactonorin vial

 

 Bactonorin  vial.

Generic name:- Cefotiam Hydrochloride for Injection.

Ingredient:- The chief ingredient of the drug is Cefotiam Hydrochloride .Its chemical name is (6R, 7R)-[[(2-amino-4- thiazolyl) acetyl] amino]-3-[[1-[2-(dimethylamino) ethyl]-1H- tetrazol-5-yl] sulfanylmethyl]-8-oxo-5-thia-1- azabicyclo [4.2.0] otc-2-ene-2-carboxylic acid dihydrochloride
Its empirical formula is C18H23N9O4S3· 2HCl and its molecular weight is 598.54.
The excipient is sodium carbonate.
Description:-
The drug occurs as a white to light yellow crystalline powder.

Indications:-
It is indicated for the following infections caused by staphylococcus, streptococcus (except enterococcus), pneumococcus, hemophilus influenzae, Escherichia coli, Klebsiella, enterbacter, citrobacter, proteus mirabilis, proteus rulgaris, proteus rettgeri, and Morgan's bacillus, which are sensitive to the drug.
These infections include: septicemia, postoperative infection, infection of burn, subcutaneous abscess, swelling, furuncle, osteomyelitis, suppurative arthritis, tonsillitis (periodontitis of tonsil, peritonsillar abscess), bronchitis, bronchiectasis coinfection, pneumonia, pyosis of the lung, pyothorax, cholangitis, cholecystitis, peritonitis, pyelonephritis, cystitis, urethritis, prostatitis, meningitis, endometritis, pelvic inflammatory disease, parametritis, adnexitis, bartholinitis, otitis media, and sinusitis.
Dosage and Administration:-
oUsually, the dose to adults is 0.5g-2g, two to four times daily; while the dose to children is 40-80mg, three to four times daily, both through IM\IV injection. Dosage adjustment may be needed according to patients’ age and different symptoms. To adult patients with septicemia, the daily dose can be increased to 4g, while to pediatric patients with critical illness or incurable infections like septicemia, cerebrospinal meningitis, the daily dose can be increased to 160mg/kg. Dissolve the drug in sodium chloride or dextrose infusion before intravenous injection. In addition, add 0.25-2g of the drug to sugar, electrolyte and amino acid solution and intravenous drip within 30 minutes to 2 hours, while dosage administrated to children can refer to the above-mentioned dosage above. When added to fluid infusion, the period of intravenous injection is within 30 minutes to 1 hour.
The preparation method of injection: because the drug contains sodium carbonate anhydrous, a buffer, which may generate CO2 when dissolved, and the pressure in the bottle is negative. When dissolving 1g, inject 5mL solvent into the bottle. (If 1g of the drug is used for intravenous injection, inject 100mL solvent.)
Usually 1g is diluted to 20mL for intravenous injection.
Water for injection is not recommended for dilution because it cannot form isotonic solution on intravenous dripping.
When dissolving the drug, please read through the dissolving method directions attached to it.
Contacting measles may occur when preparing for the injection. If the hands swell, itch or redden, general appearance of rash, itching, bellyache, nausea, and vomiting, please avoid touching the drug afterwards.
Adverse Reactions:-
Shock:Because shock symptom occasionally occurs, attention should be paid to observe after administration. If symptoms such as discomfort, paresthesia in the oral cavity, stridor, dizziness, sense of defecation, tinnitus, sweating occur, stop administrating.
Anaphylaxis: If anaphylaxis such as rash, urticaria, erythema, itching, fever, enlargement of lymph glands, and arthralgia occur, stop administrating and deal with them properly.
Kidney: Because severe renal dysfunction like acute renal failure occasionally occurs, conduct regular body check and sufficient observation. When abnormal conditions occur, stop administrating and deal with them properly.
Blood: Decrease in erythrocytes, granulocytes, platelets and increase in eosinophilic leukocytes occur sometimes, while hemolytic anemia occasionally occurs.
Liver: Increase in AST, ALT, Alkaline Phosphatase (ALP) occurs sometimes, and increase in bilirubin, lactate dehydrogenase and γ-glutamyl transpeptidase occasionally occurs.
Digestive system: Severe colitis with bloody stool symptoms such as pseudomembraneous colitis occasionally occurs. If bellyache or repeated diarrhea occurs because of taking the drug, stop administrating immediately and deal with them properly. Sometimes nausea and diarrhea are caused; occasionally symptoms such as vomiting, inappetence and bellyache occur.
Respiratory system: Interstitial pneumonia with symptoms such as fever, cough, dyspnea, abnormal chest x-ray, and increase in eosinophilic leukocyte occasionally occur. If the above mentioned symptoms occur, stop administrating and inject adrenocortical hormones to deal with them properly.
Central nervous system: Neurological symptoms like spasm may sometimes occur when patients with renal failure are given a large dose.
Superinfection: Stomatitis and candidiasis occasionally occur.
Avitaminosis: Vitamin K deficiency (such as hypoprothrombinemia, bleeding tendency), and vitamin B deficiency (glossitis, stomatitis, inappetence and neuritis) occasionally occur.
Others: Dizziness, headache, lethargy and numbness occasionally occur.
Contraindications:- 
History of shock due to the drug.
History of hypersensitivity to the drug, cephalosporins, and antibiotics.
Precautions
1. The following patients should take the drug carefully:
(1) With history of hypersensitivity to penicillin antibiotics.
(2) The patients or their parents and brothers have the physique that is prone to contract allergic diseases like bronchial asthma, rash, and urticaria.
(3) Patients with severe renal dysfunction
(4) Because patients who may inadequately intake through oral route or who adopt non-oral feeding, who are senile, or who are in poor general body state may acquire vitamin K deficiency, sufficient observation is needed.
2. General precautions
(1) Because the possibility of shock exists, detailed interrogation is needed before administration, it would be best to do dermal sensitivity test before injection.
(2) Prepare to give emergency treatment to patients with shock in advance. In addition, keep the patients using the drug in tranquil state and observe sufficiently.
3. Effect on clinical laboratory value
(1) Except Tes-Tape, false positive reactions sometimes occur when using Benedict reagent, and Flint test to examine sugar in urine.
(2) Pay attention to the fact that direct Coombs test may sometimes have positive results.
4. Precautions in administration
(1) The drug can only be administrated through IM\IV injection.
(2) To avoid occasional angiodynia and thrombophlebitis caused by large dose of intravenous injection, attention should be paid to injection preparation, injection sites and injection method, and also to slowing down the injection rate as much as possible.
(3) The liquid medicine after dissolving should be used quickly, and must be used up within 8 hours if it must be stored. Meanwhile, the color of the yellowish liquid medicine may be darkened over time.
5. Others
When taking this drug, examine the liver function, kidney function and blood regularly.
The drugs for pregnant women and breast-feeding women
The drug safety is unclear when pregnant women take it. Only when benefit overweighs risk in treatment can the drug be used in women who are or may have become pregnant.
Pediatric use
The drug safety is unclear in premature infants or neonates.
Geriatric use
The dosage adjustment of elderly patients is based on their renal impairment. Adjust the drug dosage and dosing interval to prevent adverse reactions in senile patients.
Drug Interactions:-
Concomitant use of compounds resembling the drugs (other cephalosporin type antibiotics) and diuretics like furosemide can intensify nephrotoxicity, so coadministration of diuretics like furosemide needs to monitor the renal function.
Overdosage:-
If overdosage occurs, stop taking the drug and conduct hemodialysis or peritoneal dialysis if needed. 

Drug Directions:-
Please read through the drug directions and take the drug under the physician’s guidance .

Storage:-
Store in a cool, dark and dry place (the temperature is below 20℃), tightly closed

Dosage form:-

 0.5g/1.0g IM/IV.

Packaging:-

(1) 1 vial per box; 

(2) 6 vials per box.