Consumer Information for: AG-CLINDAMYCIN
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
AG-Clindamycin is used:
- To treat serious infections caused by germs.
- To help prevent serious infections during and after surgery.
What it does
AG-Clindamycin prevents the growth of germs (bacteria) causing your infection.
When it should not be used
- You are allergic (hypersensitive) to
- Clindamycin
- Lincomycin
- Other ingredients in the product (see list of non-medicinal ingredients)
What the medicinal ingredient is
Medicinal ingredients: Clindamycin hydrochloride.
What the non-medicinal ingredients are
Non-medicinal ingredients: cornstarch, lactose, magnesium stearate, talc and titanium dioxide.
What dosage form it comes in
150 mg and 300 mg capsules
Warnings and precautions
Serious Warnings and Precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-Clindamycin. Talk about any health conditions or problems you may have, including if:
- You have a history of intestinal disorders such as colitis (inflammation of the colon), or inflammatory bowel disease.
- You have diarrhea or usually get diarrhea when you take antibiotics or have ever suffered from problems with your stomach or intestines (e.g. bowel disease, colitis).
- You suffer from problems with your kidneys or liver.
- You have glucose-6-phosphate dehydrogenase (G-6-PD) deficiency and taking primaquine. You need to have routine blood tests while taking AG-Clindamycin with primaquine to monitor for potential blood cell changes.
- You are pregnant or planning to become pregnant. Clindamycin passes to the human fetus.
- You are breastfeeding or planning to breastfeed. Clindamycin is passed to the infant through human breast milk. Because of the potential for serious adverse reactions in nursing infants, clindamycin should not be taken by nursing mothers.
- You have intolerance to some milk sugars. AG-Clindamycin capsules contain lactose.
Other warnings you should know about: Long term use of AG-Clindamycin If you have to take AG--Clindamycin for a long time, your doctor may arrange regular liver, kidney and blood tests. Do not miss these check-ups with your doctor. Long term use can also make you more likely to get other infections that do not respond to AG-Clindamycin treatment.
Taking AG-Clindamycin with primaquine Patients with G-6-PD deficiency taking the combination of clindamycin and primaquine should have routine blood examinations during therapy with primaquine to monitor for potential blood cell changes. REMEMBER: This medication is for YOU. Never give it to others. It may harm them even if their symptoms are the same as yours.
Interactions with this medication
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. The following may interact with AG-Clindamycin:
- Erythromycin (an antibiotic)
- Rifampin (an antibiotic)
- Muscle relaxants used for operations
- Aminoglycosides (a class of antibiotics)
- Primaquine (antimalarial)
- St. John’s Wort (Hypericum perforatum)
Tell your doctor if you are taking or being administered any other topical or oral medication, including erythromycin or neuromuscular blocking agents.
Proper use of this medication
How to take AG-Clindamycin: Your doctor will assess for your child’s ability to swallow AG-Clindamycin capsules. If the child is unable to reliably swallow a capsule, AG-Clindamycin capsule should not be used. Your doctor will recommend a suitable dosage form for your child. Take your medicine (or give the medicine to your child) as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The capsules should be taken with a full glass of water to avoid throat irritation. The capsules can be taken with or without food.
Usual Dose
Adult dose: 150 mg to 450 mg by mouth every 6 hours depending on the severity of infection.
Child dose (for children weighing ≥ 40 pounds (18.2 kg) and able to swallow): One of the following dosage ranges should be selected depending on the severity of the infection:
- 8-12 mg/kg/day (4-6 mg/lb/day)
- 13-16 mg/kg/day (6.5-8 mg/lb/day)
- 17-25 mg/kg/day (8.5-12.5 mg/lb/day)
| Severity of the infection | Mild | Moderate | Severe |
|---|---|---|---|
| Weight in pounds (weight in kg) | 4-6 mg/lb/day (8- 12 mg/kg/day) | 6.5-8 mg/lb/day (13- 16 mg/kg/day) | 8.5-12.5 mg/lb/day (17-25 mg/kg/day) |
| 22-40 (10-18.2 kg) | * | * | * |
| >40-55 (>18.2-25 kg) | * | * | 150 mg q. 8h |
| >55-75 (>25-34 kg) | * | 150 mg q. 8h | 150 mg q. 6h |
| >75-100 (34-45.5 kg) | 150 mg q. 8h | 150 mg q. 6h | 300 mg q. 8h |
| >100 (>45.5 kg) use adult dosage | 150 mg q. 6h | 300 mg q. 6h | 450 mg q. 6h |
Prevention of infection (patients undergoing surgery):
Adult dose: 300 mg by mouth at 1 hour before procedure; then 150 mg at 6 hours after the first dose. Child dose (for children weighing ≥ 40 pounds (18.2 kg) and able to swallow): 10 mg per kg by mouth at 1 hour before procedure; then 5 mg/kg at 6 hours after the first dose.
If you stop taking AG-Clindamycin If you stop taking the medicine too soon your infection may come back again or get worse. Do not stop taking AG-Clindamycin unless your doctor tells you to. If you have any further questions on how to take this product, ask your doctor or pharmacist.
Overdose
Missed Dose
If you missed a dose of this medication, take it as soon as you remember. This will help to keep a constant amount of medication in your blood. But, if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
Side effects and what to do about them
What are possible side effects from using AG-Clindamycin? AG-Clindamycin can cause side effects such as:
- skin reddening, rash, itching, hives
- feeling sick, vomiting, diarrhea, stomach pain
- sore throat, throat sores
- low red blood cells (anemia) with symptoms such as bruising, bleeding
- low white blood cells (neutropenia) which can lead to more infections
- vaginal infection or vaginitis (inflamed vagina) Contact your doctor immediately if the following happens:
- You have a severe allergic reaction with symptoms such as:
- sudden wheeziness
- difficulty in breathing
- swelling of eyelids, face or lips
- rash or itching (especially affecting the whole body)
- Blistering and peeling of large areas of skin
- Fever
- Cough
- Feeling unwell
- Swelling of the gums, tongue or lips
- You have liver problems with symptoms such as:
- yellowing of the skin and whites of the eyes (jaundice).
- You have Clostridium difficile colitis (bowel inflammation) with symptoms such as:
- severe, persistent watery or bloody diarrhea (watery or bloody) with or without
- abdominal pain
- nausea
- fever
- vomiting
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Very Common | |||
| Liver problem | ✔ | ✔ | |
| Common | |||
| Diarrhea | ✔ | ||
| Rash | ✔ | ||
| Rare | |||
| Nausea, abdominal pain | ✔ | ||
| Vomiting | ✔ | ||
| Skin reactions : itching | ✔ | ||
| Signs of a severe allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body) | ✔ | ||
| NOT KNOWN | |||
| Clostridium difficile colitis (bowel inflammation) with symptoms such as severe or persistent diarrhea, abdominal pain, nausea and vomiting | ✔ | ||
How to store
Keep in a safe place out of the reach and sight of children. Store at room temperature (15°C to 30°C) in tightly closed container, away from heat and direct light. Protect from moisture. Do not store in the fridge or freezer. Do not store in the bathroom as moisture and heat can cause damage.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at MedEffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***
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