Cleocin HCl Oral

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clindamycin in children.

Geriatric

Although appropriate studies on the relationship of age to the effects of clindamycin have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have colitis, which may require caution in patients receiving clindamycin.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cholera Vaccine, Live
• Erythromycin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atracurium
• Cyclosporine
• Metocurine
• Tubocurarine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Atopic syndrome or
• Diarrhea or
• Liver disease, severe or
• Stomach or bowel problems, history of—Use with caution. May make these conditions worse.

• Meningitis—Should not be used in patients with this condition.

It is important that your doctor check your or your child's progress after treatment. This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects. Blood tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve, or if they become worse, check with your doctor.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you or your child are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you or your child are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Clindamycin can cause diarrhea, which may be severe or lead to serious, life-threatening intestinal problems. If you have diarrhea that is watery or bloody, stop using clindamycin and call your doctor.

You should not use this medicine if you are allergic to clindamycin or lincomycin.

To make sure clindamycin is safe for you, tell your doctor if you have ever had:

• colitis, Crohn's disease, or other intestinal disorder;

• eczema, or allergic skin reaction;

• liver disease;

• asthma or a severe allergic reaction to aspirin;

• if you also take erythromycin; or

• if you are allergic to yellow food dye.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Clindamycin can pass into breast milk and may cause side effects in the nursing baby. Tell your doctor if you are breast-feeding.

Do not give a clindamycin injection to a child without medical advice. Injectable clindamycin contains an ingredient that can cause serious side effects or death in very young infants or premature babies. Do not allow an older child to use this medicine without supervision of an adult.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take the capsule with a full glass of water to keep it from irritating your throat.

Measure the oral liquid with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Clindamycin is sometimes given as an injection into a muscle, or injected into a vein through an IV. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

To make sure this medicine is not causing harmful effects, you may need frequent medical tests during treatment.

If you need surgery, tell the surgeon ahead of time that you are using clindamycin.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Clindamycin will not treat a viral infection such as the flu or a common cold.

Store at room temperature away from moisture and heat. Protect the injectable medicine from high heat.

Do not store the oral liquid in the refrigerator. Throw away any unused oral liquid after 2 weeks.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, clindamycin may cause a severe drug reaction that can affect many parts of the body. This type of reaction can start several weeks after you begin using this medicine. Seek medical treatment if you have new or worsening symptoms of fever, facial swelling, a red or blistering skin rash, flu symptoms, swollen glands, feeling weak or tired, severe tingling or numbness, upper stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes), weight loss, pain or burning when you urinate, lower back pain, swelling in your legs or feet, cough, chest pain, or trouble breathing.

Clindamycin can cause diarrhea, which may be severe or lead to serious, life-threatening intestinal problems. If you have diarrhea that is watery or bloody, stop using clindamycin and call your doctor.

Call your doctor at once if you have:

• any change in bowel habits;

• severe stomach pain, diarrhea that is watery or bloody;

• little or no urination;

• a metallic taste in your mouth (after clindamycin injection);

• signs of inflammation in your body--swollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness, upper stomach pain, jaundice (yellowing of the skin or eyes), chest pain, new or worsening cough with fever, trouble breathing; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, stomach pain;

• mild skin rash; or

• vaginal itching or discharge;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Oral:
Serious infection: 150 to 300 mg orally every 6 hours
More severe infection: 300 to 450 mg orally every 6 hours

Parenteral:
Serious infection: 600 to 1,200 mg via IV infusion or IM injection per day, in 2 to 4 equally divided doses
Severe infection: 1,200 to 2,700 mg via IV infusion or IM injection per day, in 2 to 4 equally divided doses
More severe infection: Up to 4,800 mg via IV infusion per day

Comments:
-A single IM injection greater than 600 mg is not recommended
-A single 1 hour IV infusion greater than 1,200 mg is not recommended
-In the treatment of anaerobic infections, parenteral clindamycin should be used initially and then patients changed to oral therapy when clinically appropriate.
-Clindamycin should be reserved for penicillin-allergic patients or other patients for whom a penicillin is not appropriate.
-Combination therapy with additional antibiotics may be required according to standard treatment protocols. Treatment should be guided by culture and susceptibility studies.

Uses:
Serious infections caused by susceptible organisms:
-Staphylococci, streptococci, and pneumococci, including serious respiratory tract infections and skin and soft tissue infections
-Anaerobes, including serious respiratory tract infections, serious skin and soft tissue infections, septicemia, intraabdominal infections, and infections of the female pelvis and genital tract.
-Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections

US BOXED WARNING(S):
-Clostridium difficile associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including clindamycin and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C difficile.
-Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.
-C difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.
-Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation should be instituted as clinically indicated.

Consult WARNINGS section for additional precautions.