Mylan-Clindamycin: Uses, Side Effects and Dosage

What is MYLAN-CLINDAMYCIN used for?

MYLAN-CLINDAMYCIN is used:

• To treat serious infections caused by germs
• To help prevent serious infections during and after surgery

How does MYLAN-CLINDAMYCIN work?

MYLAN-CLINDAMYCIN prevents the growth of germs(bacteria) causing your infection.

What are the ingredients in MYLAN-CLINDAMYCIN?

Medicinal ingredients: Clindamycin hydrochloride USP

Non-medicinal ingredients: Maize starch, lactose hydrous 100, talc, and magnesium stearate.

Capsule Shell: 150 mg capsule: Acid Red 27, FD&C Blue#1, Titanium Dioxide, Gelatin, FD&C

Red #3

300 mg capsule: FD&C Blue#1, Titanium Dioxide, Gelatin

Printing Ink: Opacode White S-1-7085 (Pharmaceutical glaze modified, titanium dioxide, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, and dimethylpolysiloxane)

MYLAN-CLINDAMYCIN comes in the following dosage forms:

150 mg and 300 mg capsules

Do not use MYLAN-CLINDAMYCIN if:

• You are allergic (hypersensitive) to

  o Clindamycin

  o Lincomycin

  o Other ingredients in the product (see list of non-medicinal ingredients)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MYLAN-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 MYLAN-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. MYLAN-CLINDAMYCIN capsules contain lactose.

• You are a pediatric patient. You should be assessed for your ability to swallow MYLAN-

  CLINDAMYCIN capsules. If the child is unable to reliably swallow a capsule, MYLAN-CLINDAMYCIN capsule should not be used and a suitable dosage formulation should be used.

Other warnings you should know about:

Long term use of MYLAN-CLINDAMYCIN

If you have to take MYLAN 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 clindamycin treatment.

Taking MYLAN-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.

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 MYLAN-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

How to take MYLAN-CLINDAMYCIN:

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:

Treatment of infection:

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 (6.5-8.0 mg/lb/day)
• 17-25 mg/kg/day (8.5-12.5 mg/lb/day)

*other appropriate dosage form may be used.

Keep taking this medicine for the full time of treatment, even if you (or your child) begin to feel better after a few days.

For Prevention of Endocarditis:

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): Refer to other dosage form, because the capsules may not be suitable. Use of the appropriate dosage form may be necessary.

If you stop taking MYLAN-CLINDAMYCIN

If you stop taking the medicine too soon your infection may come back again or get worse. Do not stop taking MYLAN-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:

If you think you have taken too much MYLAN-CLINDAMYCIN, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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.

What are possible side effects from using MYLAN-CLINDAMYCIN?

MYLAN-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

This may happen months after the last dose of medication. If this occurs, stop taking the medication and contact your doctor right away.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Keep out of the reach and sight of children.

Store at room temperature (15°C to 30°C), away from heat and direct light.

Do not store in the fridge or freezer.

Do not store in the bathroom as moisture and heat can cause damage.

If you want more information about MYLAN-CLINDAMYCIN:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this

  Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling 1-844 596-9526

• This document can be found at: www.mylan.ca.

Etobicoke, ON M8Z 2S6

Last Revised on: November 14, 2017

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-844 596-9526

www.mylan.ca