COMPOSITION:
Each film coated tablet contains:
Spiramycin 1.5 M.I.U
Excipients q.s.
WHAT'S IN YOUR MEDICINE
Toxentra tablet contains Spiramycin, a macrolide antibiotic produced by Streptomyces ambofaciens. Effective against gram-positive aerobic pathogens, N. gonorrhoeae, and staphylococci. Used to treat infections caused by bacteria and Toxoplasma gondii.
ABOUT YOUR MEDICINE
- Treats many kinds of infections.
- Often used to treat toxoplasmosis in pregnant women (reduces chance of unborn baby infection).
- Not effective for colds, flu, or viral infections.
BEFORE TAKING YOUR MEDICINE
- Best taken on an empty stomach.
- Complete full course even if you feel better.
- Take doses at evenly spaced times.
- Discuss with healthcare provider if:
• Allergic to spiramycin or related antibiotics (erythromycin, azithromycin, clarithromycin, etc.)
• Pregnant or breastfeeding
• Children or older adults usage
• Liver disease or bile duct obstruction
• Taking other medicines
WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING TOXENTRA?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Spiramycin, the following should be considered:
Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to spiramycin, or any related medicines such as erythromycin, azithromycin, clarithromycin, troleandomycin, dirithromycin, or josamycin. Also tell your healthcare professional if you are allergic to any other substances such as foods, preservatives, or dyes.
Pregnancy: Toxentra is used to treat toxoplasmosis in pregnant women since this medicine decreases the chance that the unborn baby will get the infection. If the unborn baby is already infected with toxoplasmosis, Spiramac does not treat the infection. This medicine has not been found to cause birth defects or other problems in humans.
Breast-feeding: Toxentra passes into the breast milk. However, Toxentra has not been shown to cause problems in nursing babies to date.
Children: This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems in children than it does in adults.
Older adults: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of Toxentra in the elderly with use in other age groups.
Other medicines: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter) medicine.
Other medical problems: The presence of other medical problems may affect the use of Spiramac. Make sure you tell your doctor if you have any other medical problems, especially:
• Liver disease
• Obstruction of the bile ducts
These conditions may increase the chance of side effects.
TAKING YOUR MEDICINE
Adults:
- 6,000,000 to 9,000,000 M.I.U. (4-6 tablets Toxentra 500) per 24 hrs in 2 divided doses.
- Severe infections: up to 12,000,000-15,000,000 M.I.U. (8-10 tablets Toxentra 500/day).
- Gonorrhea: 12,000,000-13,500,000 M.I.U. (8-9 tablets) single dose.
Children:
- 150,000 U/kg body weight daily in 2–3 divided doses.
AFTER TAKING YOUR MEDICINE
If your symptoms do not improve within a few days, or if they become worse, check with your doctor. What are various side effects of Toxentra? Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common:
- Skin rash and itching
- Unusual bleeding or bruising
Rare:
- Bloody stools
- Chest pain
- Fever
- Heartburn
- Irregular heartbeat
- Nausea
- Recurrent fainting
- Stomach pain and tenderness
- Vomiting- Yellow eyes or skin
Other side effects may occur that usually do not need medical attention.
These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if the following side effect continues or is bothersome:
Less common: Diarrhea
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
What happens if i take an Overdose of Toxentra?
Symptoms:
- No case of accidental overdose has been reported.
- In oral doses over 4 g/day, abdominal discomfort, nausea or diarrhea may occur.
Treatment:
- No specific treatment has been proposed.
- Management should be symptomatic.
WHAT SHOULD I DO IF I MISS A DOSE?
If you miss a dose of this medicine, take it as soon as possible. This will help to keep a constant amount of medicine in the blood. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double your dose.
STORING YOUR MEDICINE
Do not use the tablets after the expiry date shown on the product packaging. Keep the tablets below 25°C in a dry place, protected from light and moisture. Store in the original packaging. Do not freeze. Keep them in a secure place where children cannot get them. Remember this medicine is for YOU only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need. Give them back to your pharmacist for safe disposal.