Properties
What is it?
Sulcidi 1g/0.5g Powder and Solvent for IM Injection. Sterile Active Substance: Each vial contains 1000mg Ampicillin (as 1,062.92mg Ampicillin Sodium) and 500mg Sulbactam (as 547.17mg Sulbactam Sodium). It also contains 3.5ml of 0.5% Lidocaine Hydrochloride as a solvent. Excipients: Do not take this medicine before carefully reading this leaflet as it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine is for you only. Do not give it to others. When using this medicine, if you have a doctor's appointment or go to the hospital, tell your doctor that you are using this medicine. Follow the instructions in this leaflet exactly. Do not use a dose higher or lower than recommended. This leaflet contains the following information: 1. What Sulcidi is and what it is used for 2. What you need to know before using Sulcidi 3. How to use Sulcidi 4. Possible side effects 5. How to store Sulcidi 1. What Sulcidi is and what it is used for Sulcidi belongs to a group of medicines called penicillin group antibiotics. It consists of active substances called ampicillin and sulbactam. Sulbactam makes ampicillin effective against bacteria resistant to penicillin. Sulcidi is presented in 1 vial containing white or cream-colored powder for injection. Sulcidi is used to treat infections of the upper and lower respiratory tract, sinusitis (inflammation of the air-filled spaces in the facial bones), otitis media (inflammation of the middle ear), epiglottitis (inflammation of the tracheal tubes), pneumonia (inflammation of the lungs); urinary tract infections and pyelonephritis (inflammation developed in the urinary tract and kidneys); intra-abdominal infections, including peritonitis (inflammation of the peritoneum), cholecystitis (inflammation of the gallbladder), endometritis (inflammation of the uterine lining) and pelvic cellulitis; bacterial septicemia (a disease causing fever and chills due to bacteria entering the bloodstream); infections of the skin, soft tissues, bones, and joints, including gonococcal (microorganism causing gonorrhea) infections. Sulcidi may also be used to reduce surgical wound infections before, during, and after surgery in patients undergoing abdominal or pelvic surgery (area of internal female reproductive organs) and with possible peritoneal contamination (inflammation of the peritoneum). Sulcidi may be used prophylactically to reduce infectious diseases after termination of pregnancy or cesarean section. 2. What you need to know before using Sulcidi Do not use Sulcidi if: · You are hypersensitive to ampicillin and/or sulbactam; you have had an allergic reaction to penicillins before; you are pregnant or breastfeeding; you have infectious mononucleosis (a viral disease) and herpes virus infections. Use Sulcidi with caution if: · You have had hypersensitivity reactions to cephalosporins and other allergens before; · You develop an infection in any part of your body during treatment; · You develop diarrhea during treatment; · It is used to treat newborns; · You have kidney, liver, or blood disorders. Consult your doctor if these warnings apply to you or have applied to you in the past. Use of Sulcidi with food and drink This medicinal product has no interaction with food and drink in terms of administration. Pregnancy Before using the medicine, consult your doctor or pharmacist. If you are pregnant, do not use Sulcidi without your doctor's recommendation. If you discover you are pregnant during treatment, consult your doctor or pharmacist immediately. Breastfeeding Before using this medicine, consult your doctor or pharmacist. Do not use Sulcidi during breastfeeding without your doctor's recommendation. Driving and using machinery No effect on the ability to drive or use machinery has been observed. Important information about some of the ingredients in Sulcidi Each dose of this product contains approximately 5.23 mmol (120.89 mg/vial) of sodium. This should be taken into account by patients on controlled sodium diets. Use with other medicines When taken with allopurinol (a medicine that reduces uric acid levels), you may develop a rash. If used with aminoglycosides, they should be administered at different sites with an interval of at least one hour. When used with anticoagulants (medicines that prevent clotting), penicillins can cause changes in platelet function and tests and may increase bleeding. · Antibiotics such as chloramphenicol, erythromycin, sulfonamides, and tetracyclines may suppress the bactericidal effect of penicillins, so parallel therapy is best avoided. · If you are taking methotrexate (a drug used for cancer and rheumatoid arthritis) with Sulcidi, you need to be closely monitored, as the effectiveness of other medications may increase. When ampicillin is taken with estrogen-containing oral contraceptives, the effectiveness of your contraceptive method may be reduced, and therefore, an alternative or additional method of contraception should be used. Probenecid (a medicine that increases uric acid excretion) may increase the risk of toxicity from oral Sulcidi; do not use together unless specifically prescribed by your doctor. Sulcidi may affect some laboratory tests, and false-positive glycosuria (sugar in the urine) may be observed in tests performed. If you are currently taking or have recently taken any prescription or over-the-counter medicines, tell your doctor or pharmacist. 3. How to use Sulcidi Instructions for proper use and dose/frequency of use: Always use Sulcidi exactly as prescribed by your doctor. If you are unsure, ask your doctor or pharmacist. Your doctor will determine the dose and frequency of administration based on the type of infection you have or need to prevent. The usual dose is: For adults: 1.5-12g per day divided into doses every 6-8 hours. Treatment of non-severe infections may be with a single dose every 12 hours. The frequency of administration also depends on kidney function. To prevent surgical infections, 1.5-3g of Sulcidi should be administered during anesthesia. The dose may be repeated every 6-8 hours and should be discontinued 24 hours after surgery if no longer needed. For the treatment of uncomplicated gonorrhea, 1.5g of Sulcidi (1 vial) can be used as a single dose, along with 1g of oral probenecid. Method of administration: After preparation of the solution for injection, Sulcidi is administered by deep intramuscular injection by a doctor or nurse. Lidocaine solution must not be administered intravenously. Different age groups: Use in children: The dose also depends on the child's weight. The usual dose is 150mg/kg per day, divided into doses every 6-8 hours. For newborns (especially premature infants) in the first week of life, the recommended dose is 75 mg/kg per day, divided into doses every 12 hours. Special conditions of use: Kidney/liver failure If you have acute kidney failure, your doctor will prescribe the medication less frequently. If you feel that the effect of Sulcidi is too strong or too weak, tell your doctor or pharmacist. If you have used more Sulcidi than recommended: Overdose of Sulcidi is unlikely as it is administered under medical supervision. However, if you think you have taken an overdose of Sulcidi, inform your doctor or nurse. If you have taken an overdose of Sulcidi, inform your doctor or pharmacist. If you forget to use Sulcidi: Since Sulcidi is administered by a healthcare professional, missing a dose is not expected. However, if you think a dose has been missed, inform your doctor or nurse. Do not take a double dose to make up for a missed dose. Possible events that may occur upon discontinuation of Sulcidi treatment: Treatment should be continued for the period prescribed by your doctor. If treatment is stopped prematurely, the infection may recur or worsen. 4. Possible side effects Like other medicines, Sulcidi may cause side effects in patients who are sensitive to its ingredients. As with other injectable antibiotics, the main side effect is pain at the injection site; it is particularly associated with the intramuscular administration method. A small number of patients develop phlebitis (inflammation of a vein) or reactions at the injection site after intravenous administration. The most frequently observed side effects are: abnormal liver enzymes, bilirubin test results in blood and urine. Anemia, coagulation disorders, abnormal blood levels; difficulty breathing; chest tightness; swelling of eyelids, face, and lips; red spots all over the body, accompanied by itching; skin swelling; hypersensitivity reactions and shock associated with hypersensitivity reactions; dizziness/drowsiness; nausea, vomiting, diarrhea, inflammation of the small and large intestine, enteritis, accompanied by bloody, watery diarrhea associated with prolonged use of antibiotics; jaundice, abnormal liver function; rash, itching, and other skin reactions; bloody blisters on the skin and around the eyes, inflammation accompanied by swelling and redness (Stevens-Johnson syndrome, epidermal necrolysis) in rare cases; loss of appetite, excessive thirst, kidney inflammation accompanied by vomiting (interstitial nephritis); changes in liver enzymes and blood laboratory parameters. Some of these side effects return to normal after discontinuation of treatment. Convulsions and kidney inflammation are rarely observed. If you experience any side effects not listed in this leaflet, contact your doctor or pharmacist. Reporting of side effects: If you experience any side effects, or any side effects not listed in this patient information leaflet, consult your doctor, pharmacist, or nurse. By reporting side effects, you will help provide more information about the safety of the medicine. 5. How to store Sulcidi Store Sulcidi out of reach of children and in its original packaging. Store at room temperature below 30°C. Use Sulcidi according to the expiry date. For intramuscular injections, the concentrated solution should be used within one hour of preparation. Do not use Sulcidi if you notice any damage to the product and/or its packaging. Do not use Sulcidi after the expiry date indicated on the packaging. Do not dispose of expired or unused medicines. Hand them over to the medicine return system determined by the Ministry of Environment and Urban Planning. Dispensing category: Pharmaceutical product group II, dispensed with prescription form №3