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1 Benzylpenicillin apollo Benzylpenicillin apollo Benzylpenicillin CAS Number : Molecular Weight : g/mol Molecular Formula :C16H18N2O4S Systematic (IUPAC) : (2S,5R,6R)-3,3-dimethyl-7- oxo-6-(2-phenylacetamido)-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic acid How does it work? Crystapen injection contains the active ingredient benzylpenicillin, which is a type of medicine called an antibiotic. It is used to treat infections caused by bacteria.

2 Benzylpenicillin works by interfering with the ability of bacteria to form cell walls. The cell walls of bacteria are vital for their survival. They keep unwanted substances from entering their cells and stop the contents of their cells from leaking out. Benzylpenicillin impairs the bonds that hold the bacterial cell wall together. This allows holes to appear in the cell walls and kills the bacteria. Benzylpenicillin is a broad-spectrum antibiotic that kills a wide variety of bacteria that cause a wide variety of commonly-occuring infections. Benzylpenicillin may be used to treat infections of the lungs and airways, mouth and throat, skin or soft tissue, or ears, as well as other more rare infections. To make sure the bacteria causing an infection are susceptible to benzylpenicillin your doctor may take a tissue sample, for example a swab from the throat or skin, or a blood sample. Benzylpenicillin is given by injection into a vein or muscle, or via a drip into a vein. What is it used for? Bacterial infections of the middle ear (otitis media). Bacterial infections of the throat. Bacterial infections of the nasal passages or sinuses. Bacterial infections of the skin and soft tissue, eg cellulitis. Inflammation of the lining of the heart cavity and heart valves due to infection with the bacterium streptococcus (endocarditis). Pneumonia. Meningitis. Bacterial infections of the blood (septicaemia). Bacterial infections of the bones (osteomyelitis).

3 Tetanus. Lyme disease. Leptospirosis (Weil's disease). Diphtheria. Anthrax. Gas gangrene. Crystapen injection is also given during labour to mothers who have tested positive for group B streptococcal bacteria, to prevent this bacteria infecting the baby during the birth. Warning! Broad-spectrum antibiotics can sometimes cause inflammation of the bowel (colitis). For this reason, if you get diarrhoea that becomes severe or persistent or contains blood or mucus, either during or after treatment with this medicine, you should tell your doctor immediately. Not to be used in People allergic to penicillin-type antibiotics. This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately. Use with caution in History of allergies. Decreased kidney function. Pregnancy and breastfeeding Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn

4 baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. There are no known harmful effects when this medicine is used during pregnancy. The medicine passes into the breast milk, but at normal doses it is unlikely to harm the baby. Discuss with your doctor. Side effects Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. Allergic reaction to active ingredient. Symptoms may include itching, hives, fever (high temperature), joint pains, swelling of the tongue, throat or face, difficulty breathing or collapse. If you experience any of these symptoms tell your doctor immediately. Overgrowth of non-susceptible organisms such as the yeast Candida, which may cause infection such as thrush. Tell your doctor if you think you have developed any new infections either during or after treatment with this medicine. Inflammation of the large intestine (colitis). This is rare - see warning section above. Convulsions - rare. Blood disorders - rare. The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the

5 information provided with the medicine or consult your doctor or pharmacist. How can this medicine affect other medicines? It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to make sure that the combination is safe. If you are taking the contraceptive pill and experience vomiting or diarrhoea as a result of treatment with this antibiotic, you should follow the instructions for vomiting and diarrhoea described in the leaflet provided with your pills. Benzylpenicillin may decrease the removal of the medicine methotrexate from the body, which could increase the risk of its side effects. If you are taking methotrexate your doctor may want you to have extra check-ups and blood tests while you are having a course of this antibiotic. Benzylpenicillin may rarely alter the anti-blood-clotting effects of anticoagulant medicines such as warfarin. Your doctor may wish to monitor your blood clotting time (INR) more frequently while you are being treated with both medicines. Oral typhoid vaccine (Vivotif) should not be taken until at least three days after you have finished a course of this antibiotic, because the antibiotic could make this vaccine less effective. Probenecid may increase the blood level of benzylpenicillin, and people taking probenecid may be prescribed a lower than normal dose of this antibiotic.

6 Presentation And Administration ICU stocks 600mg (=1 mega unit) vials of Pencillin G Sodium (Novartis). Add 1.6ml of water for injection to each 600mg vial (using 1.6ml of water for injection in a vial will give a concentration of 300mg/ml) Store at room temperature. Protect from light. Benzylpenicillin is not stable in glucose and glucose/saline combination IV fluids. Compatible with: water for injection, normal saline Administer by either IV injection or intermittent infusion. To administer by IV injection dilute to 10ml with water for injection and inject slowly at a rate not greater than 300mg/min To administer by intermittent infusion add to ml of compatible IV fluid and infuse over minutes. The dry powder is relatively stable and may be stored at room temperature without significant loss of potency. Sterile solutions may be kept in the refrigerator one week without significant loss of potency. Solutions prepared for intravenous infusion are stable at room temperature for at least 24 hours. Dosage Usually in ICU patients higher dose penicillin is preferred. Use 1.2gm-2.4gm Q4-6hrly. In patients with meningitis use 2.4gm 4hrly. Precaution General: Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma. Haemolytic anaemia, leukopaenia, thrombocytopaenia, neuropathy, and nephropathy are rarely observed

7 adverse reactions and are usually associated with high intravenous dosage. High dosage of penicillin G sodium may result in congestive heart failure due to high sodium intake Laboratory Tests: No tests in addition to routine ICU tests are required Drug/Laboratory Test Interactions: IMPORTANT DRUG INTERACTIONS FOR THE ICU Fusidic Acid: May diminish the therapeutic effect of Penicillins. Methotrexate: Penicillins may decrease the excretion of Methotrexate. Mycophenolate: Penicillins may decrease serum concentrations of the active metabolite(s) of Mycophenolate. This effect appears to be the result of impaired enterohepatic recirculation. Tetracycline Derivatives: May diminish the therapeutic effect of Penicillins. Adverse Reactions Body as a Whole:Anaphylaxis, serum sickness Nervous System:Coma (high doses), hyperreflexia (high doses), seizures (high doses) Digestive System:Pseudomembranous colitis, hepatitis Hematological system:neutropaenia, haemolytic anaemia (rare, high doses) Metabolic:Hypernatraemia Renal System:Acute interstitial nephritis (high doses), renal tubular damage (high doses) Skin:Rash apollo asia Division

8 APOLLO Pharmaceuticals API Manufacturer INDIA [P] Ltd. asia Division Mr.Vipin Saxena CEO Cellular: Cellular: Direct : FAX : Wireline Purchase HELPDESK: Wireline Sales HELPDESK: Wireless 24x7 HELPDESK: Blackberry Pin : 32E6500D 32E C58 apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in purchase@apollopharma.in Chat: MSN Hotmail:VipinrSaxena Skype NAME:VipinrSaxena Rocketmail:VipinrSaxena Google mail:vipinrsaxena

9 BlackBerry:28415C58 Regd. Office :- 1104, Maker Chamber V, Nariman Point Mumbai, INDIA Pin: Industrial Office D-62, OIC India Oshiwara Industrial Centre, New Link Road, Goregoan West, Mumbai, INDIA Pin: Manufacturing Unit Address: Plot No. 117A, Village: Chamble Near MonaTona Limited.Wada, Maharashtra, PIN : INDIA apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in purchase@apollopharma.in

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