Curam Injection

Co-amoxiclav: Amoxicillin, clavulanic acid.

The active substances are amoxicillin (as the sodium salt) and clavulanic acid (as the potassium salt). Each vial contains 500mg amoxicillin (as the sodium salt) and 100mg clavulanic acid (as the potassium salt) or 1000mg amoxicillin (as the sodium salt) and 200 mg clavulanic acid (as the potassium salt), respectively.
Excipients/Inactive Ingredients: There are no other ingredients. However, see Precautions for further important information about sodium and potassium in Curam.

Curam is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins" that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening.

Curam is used in adults and children to treat the following infections: severe ear, nose and throat infections, respiratory tract infections, urinary tract infections, skin and soft tissue infections including dental infections, bone and joint infections, intra-abdominal infections, genital organ infections in women.
Curam is used in adults and children to prevent infections associated with major surgical procedures.

The patient will never give themselves this medicine. A qualified person, like a doctor or a nurse, will give the patient this medicine.
The recommended doses are: Adults, and children weighing 40 kg and over: See Table 1.

Click on icon to see table/diagram/image

Children weighing less than 40kg: All doses are worked out depending on the child's bodyweight in kilograms. (See Table 2.)

Click on icon to see table/diagram/image

Patients with kidney and liver problems: If the patient has kidney problems they may be given a different dose. A different strength or a different medicine may be chosen by the doctor.
If the patient has liver problems their doctor will keep a close check on them and they may have more regular liver functions tests.
How Curam will be given to the patient: Curam will be given as an injection into a vein or by intravenous infusion.
Make sure the patient drinks plenty of fluids while having Curam.
The patient will not normally be given Curam for longer than 2 weeks without the doctor reviewing their treatment.
If more Curam is given to the patient than recommended: It is unlikely the patient will be given too much, but if they think they have been given too much Curam, tell the doctor, pharmacist or nurse immediately. Signs may be an upset stomach (feeling sick, being sick or diarrhoea) or convulsions.
If the patient has any further questions about how this medicine is given, ask the doctor, pharmacist or nurse.
METHOD OF ADMINISTRATION: Curam may be administered either by slow intravenous injection over 0 period of 3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min. Amoxicillin/clavulanic acid is not suitable for intramuscular administration.

Do not take Curam: if the patient is allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in Description); if the patient has ever had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face or throat; if the patient has ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
Do not take Curam if any of the previously mentioned apply to the patient. If the patient is not sure, talk to the doctor, pharmacist or nurse before having Curam.

Talk to the doctor, pharmacist or nurse before taking Curam if the patient: has glandular fever; is being treated for liver or kidney problems; is not passing water regularly.
If the patient is not sure if any of the previously mentioned apply to them, talk to the doctor, pharmacist or nurse before taking Curam.
In some cases, the doctor may investigate the type of bacteria that is causing the infection. Depending on the results, the patient may be given a different strength of Curam or a different medicine.
Conditions the patient needs to look out for: Curam can make some existing conditions worse, or cause serious side effects. These include allergic reactions, convulsions (fits) and inflammation of the large intestine. The patient must look out for certain symptoms while they are taking Curam, to reduce the risk of any problems. See "Conditions the patient needs to look out for" under Side Effects.
Blood and urine tests: If the patient is having blood tests (such as red blood cell status tests or liver function tests) or urine tests (for glucose), let the doctor or nurse know that they are taking Curam. This is because Curam can affect the results of these types of tests.
500 mg/100 mg powder for injection or infusion: Curam contains approximately 31.4 mg (1.4 mmol) of sodium. This is equivalent to 1.57% of the recommended maximum daily dietary intake of sodium for an adult. Curam contains approximately 19.6mg (0.5 mmol) of potassium i.e. essentially "potassium-free".
1000 mg/200 mg powder for injection or infusion: Curam, 1000mg/200mg contains approximately 62.9mg (2.7 mmol) of sodium. This is equivalent to 3.145% of the recommended maximum daily dietary intake of sodium for an adult.
Curam, 1000 mg/200mg contains approximately 39.3 mg (1.0 mmol) of potassium. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Driving and using machines: Curam can have side effects and the symptoms may make the patient unfit to drive. Do not drive or operate machinery unless the patient is feeling well.

If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor, pharmacist or nurse for advice before taking this medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects as follows may happen with this medicine.
Conditions the patient needs to look out for: Allergic reactions: skin rash; inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body; fever, joint pain, swollen glands in the neck, armpit or groin; swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing; collapse.
Contact a doctor immediately if the patient gets any of these symptoms. Stop taking Curam.
Inflammation of large intestine: Inflammation of the large intestine, causing watery diarrhea usually with blood and mucus, stomach pain and/or fever.
Contact the doctor as soon as possible for advice if the patient gets these symptoms.
Common side effects (may affect up to 1 in 10 people): thrush (candida - a yeast infection of the vagina, mouth or skin folds); diarrhoea.
Uncommon side effects (may affect up to 1 in 100 people): skin rash, itching; raised itchy rash (hives); Feeling sick (nausea), especially when taking high doses; vomiting; indigestion; dizziness; headache.
Uncommon side effects that may show up in the blood tests: increase in some substances (enzymes) product by the liver.
Rare side effects (may affect up to 1 in 1,000 people): skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge - erythema multiforme).
If the patient notices any of these symptoms contact a doctor urgently: swelling and redness along a vein which is extremely tender when touched.
Rare side effects that may show up in the blood tests: low number of cells involved in blood clotting; low number of white blood cells.
Other side effects: Other side effect have occurred in a very small number of people but their exact frequency is unknown.
Allergic reactions (see previously mentioned).
Inflammation of the large intestine (see previously mentioned).
Inflammation of the protective membrane surrounding the brain (aseptic meningitis).
Serious skin reactions: a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis); widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis); a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis); flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increase white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
Contact a doctor immediately if the patient gets any of these symptoms: inflammation of the liver (hepatitis); jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make the skin and whites of the eyes appear yellow; inflammation of tubes in the kidney; blood takes longer to clot; convulsions (in people taking high doses of Curam or who have kidney problems).
Side effects that may show up in the blood or urine tests: severe reduction in the number of white blood cells; low number of red blood cells (haemolytic anaemia); crystals in urine.
Reporting of side effects: If the patient gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monograph. The patient can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects the patient can help provide more information on the safety of this medicine.

Other medicines and Curam: Tell the doctor, pharmacist or nurse if they are using, has recently used or might use any other medicines. This includes medicines that can be bought without a prescription and herbal medicines.
If the patient is taking allopurinol (used for gout) with Curam, it may be more likely that they'll have an allergic skin reaction.
If the patient is taking probenecid (used for gout), the doctor may decide to adjust the dose of Curam.
If medicines to help stop blood clots (such as warfarin) are taken with Curam then extra blood tests may be needed.
Curam can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Curam may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.

The following information is intended for medical or healthcare professionals only:
INCOMPATIBILITIES WITH DILUENTS AND OTHER MEDICINAL PRODUCTS: Amoxicillin/Clavulanic acid 500/100mg or 1000/200mg Powder for solution for injection/infusion must not be mixed with amino acid solutions, lipid emulsions, blood and glucose solutions.
Amoxicillin/Clavulanic Acid 500/100mg or 1000/200mg Powder for solution for injection/infusion is less stable in infusions containing dextran or bicarbonate. Reconstituted solution should, therefore, not be added to such infusions but may be injected into the drip tubing over a period three to four minutes.
Because of the inactivation of aminoglycosides by amoxicillin, in-vitro mixing should be avoided.
INSTRUCTIONS FOR USE AND HANDLING: The reconstitution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter prior to administration. The solution should only be used if the solution is clear and free from particles. Any unused solution should be discarded.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the injection and infusion solutions should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. For single use only.
600 mg vial: Preparation of intravenous injections: Vials of 500/100mg are diluted with 10ml or up to 20ml of water injections. (See Table 3).

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Preparation of intravenous infusions: The reconstitution of the ready to use solution for infusion has to take place in two steps in order to allow the reconstitution of the necessary volume for solution for infusion: The vial of 500/100mg is first reconstituted with one of the compatible intravenous fluids in its vial. This solution has then to be transferred into a suitable infusion bag which should contain the same compatible fluid as used for reconstitution. Controlled and validated aseptic conditions have to be observed.
Vials of 500/100mg are diluted with 25ml or up to 50ml of water for injection or of the following fluids: Physiological saline, Sodium lactate 167mmol/l, Ringer's solution, Hartmann's solution.
If the product is dissolved in water for injection as specified, this solution may be mixed with the following solvents: Water for injection, Physiological saline, Sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.
1,200 mg vial: Preparation of intravenous injections: Vials of 1000/200mg are diluted with 20 ml of water for injections. (See Table 4.)

Click on icon to see table/diagram/image

Preparation of intravenous infusions: Vials of 1000/200 mg are diluted with 20 ml of water for injections or of the following fluids: Physiological saline, Sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.
The reconstitution of the ready to use solution for infusion has to take place in two steps in order to allow the reconstitution of the necessary volume for solution for infusion.
The vial of 1000/200mg is first reconstituted with one of the compatible intravenous fluids in its vial. This solution has then to be transferred into a suitable infusion bag which should contain the some compatible fluid as used for reconstitution, with a volume of 50ml or up to 100 ml.
Controlled and validated aseptic conditions have to be observed.
Bottles of 1000/200 mg are diluted with 50 ml of water for injections or of the following fluids: Physiological saline, Sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.
If the product is dissolved in water for injection as specified, this solution may be mixed with the following solvents: Water for injection, Physiological saline, Sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.
Solutions for intravenous infusion should be administered in full within 60 min of preparation.
After dissolution in water for injection, transient pink color may occur, the solution will become clear again rapidly afterwards.

Do not store above 25°C.
Keep the container in the outer carton.
Reconstituted solution: Chemical and physical in-use stability has been demonstrated for the reconstituted solution for injection for 15 minutes if stored at 25°C and for the reconstituted solution for infusion 60 minutes if stored at 25°C.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the injection and infusion solutions should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. This measure will help protect the environment.

Penicillins

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

POM

Powd for soln for inj/infusion (vial) 600 mg x 1's. 1,200 mg x 1's.