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Dalacin-C (150 Mg) Capsule
 

Active ingredient: 
Clindamycin HCl hydrate
Dosage Form: 
Oral capsule. The opaque, purple capsules are marked with "Clin 150" and "Pfizer" in black.
Therapeutic category: 
Antibiotic, Lincosamides
 

 


What is the medicine prescribed for? 

 
Adult Formulation:

Treatment of susceptible bacterial infections, mainly those caused by anaerobes, streptococci, pneumococci, and staphylococci; pelvic inflammatory disease (I.V.)

Use: Dental

Alternate oral antibiotic for prevention of infective endocarditis in individuals allergic to penicillins or ampicillin, when amoxicillin cannot be used; alternate I.M. or I.V. antibiotic for prevention of infective endocarditis in patients allergic to penicillins or ampicillin and unable to take oral medication; alternate oral antibiotic for prophylaxis for dental patients with total joint replacement who are allergic to penicillin; alternate I.V. antibiotic for prophylaxis for dental patients with total joint replacement who are allergic to penicillin and unable to take oral medications; alternate antibiotic in the treatment of common orofacial infections caused by aerobic gram-positive cocci and susceptible anaerobes; treatment of periodontal disease

Medicines are sometimes prescribed for purposes other than those listed above. Use only for the condition for which it was prescribed. Do not give this medicine to other people even if they have the same symptoms you have, as it may not be right for them.

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How to take medication? 

 

The suitable dosage for each patient should be prescribed by a doctor.

Method of Administration:

Administration: Oral
Administer oral dosage form with a full glass of water to minimize esophageal ulceration. Give around-the-clock to promote less variation in peak and trough serum levels.

Dietary Consideration:

Food: Peak concentrations may be delayed with food. May be taken with food.

Adult Dosage:

Oral: 150-450 mg/dose every 6-8 hours; maximum dose: 1.8 g/day
I.M., I.V.: 1.2-2.7 g/day in 2-4 divided doses; maximum dose: 4.8 g/day

Indication-specific dosing:
Amnionitis: I.V.: 450-900 mg every 8 hours
Anthrax (unlabeled use): I.V.: 900 mg every 8 hours with ciprofloxacin or doxycycline

Babesiosis (unlabeled use):
Oral: 600 mg 3 times/day for 7-10 days with quinine (Medical Letter, 2007)
I.V.: 1.2 g twice daily for 7-10 days with quinine (Medical Letter, 2007)
Bacterial vaginosis (unlabeled use): Oral: 300 mg twice daily for 7 days (CDC, 2010)
Bite wounds (canine): Oral: 300 mg 4 times/day with a fluoroquinolone
Cellulitis due to MRSA (unlabeled use): Oral: 300-450 mg 3 times/day for 5-10 days (Liu, 2011)
Complicated skin/soft tissue infection due to MRSA (unlabeled use): I.V., Oral: 600 mg 3 times/day for 7-14 days (Liu, 2011)
Gangrenous pyomyositis: I.V.: 900 mg every 8 hours with penicillin G
Group B streptococcus (neonatal prophylaxis): I.V.: 900 mg every 8 hours until delivery

Orofacial/parapharyngeal space infections:
Oral: 150-450 mg every 6 hours for 7 days, maximum 1.8 g/day
I.V.: 600-900 mg every 8 hours
Osteomyelitis due to MRSA (unlabeled use): I.V., Oral: 600 mg 3 times/day for a minimum of 8 weeks (some experts combine with rifampin) (Liu, 2011)
Pelvic inflammatory disease: I.V.: 900 mg every 8 hours with gentamicin (conventional or single daily dosing); 24 hours after clinical improvement may convert to oral doxycycline 100 mg twice daily or clindamycin 450 mg 4 times/day to complete 14 days of total therapy. Avoid doxycycline if tubo-ovarian abscess is present. (CDC, 2010)

Pneumocystis jiroveci pneumonia (unlabeled use):
I.V.: 600-900 mg every 6-8 hours with primaquine for 21 days (CDC, 2009)
Oral: 300-450 mg every 6-8 hours with primaquine for 21 days (CDC,2009)
Pneumonia due to MRSA (unlabeled use): I.V., Oral: 600 mg 3 times/day for 7-21 days (Liu, 2011)

Prophylaxis against infective endocarditis (unlabeled use):
Oral: 600 mg 30-60 minutes before procedure (Wilson, 2007)
I.M., I.V.: 600 mg 30-60 minutes before procedure. Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications. (Wilson, 2007)
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.

Prophylaxis in total joint replacement patients undergoing dental procedures which produce bacteremia (unlabeled use):
Oral: 600 mg 1 hour prior to procedure (ADA, 2003)
I.V.: 600 mg 1 hour prior to procedure (for patients unable to take oral medication) (ADA, 2003)
Septic arthritis due to MRSA (unlabeled use): I.V., Oral: 600 mg 3 times/day for 3-4 weeks (Liu, 2011)
Toxic shock syndrome: I.V.: 900 mg every 8 hours with penicillin G or ceftriaxone

Toxoplasmosis (HIV-exposed/positive; secondary prevention [unlabeled use]):
Oral: 600 mg every 8 hours (with pyrimethamine and leucovorin calcium) (CDC, 2009)

Dental Usual Dosing
Orofacial infection:
Adults:  Oral: 150-450 mg/dose for 7 days; maximum dose: 1.8 g/day
I.V.: 600-900 mg every 8 hours
Treatment of periodontal disease: Oral: 300 mg every 8 hours for 8 days

Infective endocarditis prophylaxis:
Adults:  Oral: 600 mg 30-60 minutes before procedure
I.M., I.V.: 600 mg 30-60 minutes before procedure. Note: Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications.

Prophylaxis in total joint replacement patients undergoing dental procedures which produce bacteremia:
Adults:  Oral: 600 mg 1 hour prior to procedure
I.V.: 600 mg 1 hour prior to procedure (for patients unable to take oral medication)


Children Dosage:

Infants and Children:
Oral: 8-20 mg/kg/day as hydrochloride; 8-25 mg/kg/day as palmitate in 3-4 divided doses (minimum dose of palmitate: 37.5 mg 3 times/day)
I.M., I.V.:   <1 month: 15-20 mg/kg/day in 3-4 divided doses
                 >1 month: 20-40 mg/kg/day in 3-4 divided doses

Indication-specific dosing:
Children:
Anthrax (unlabeled use): I.V.: 7.5 mg/kg every 6 hours
Babesiosis (unlabeled use): Oral: 20-40 mg/kg/day divided every 8 hours for 7-10 days plus quinine (Medical Letter, 2007)

Cellulitis due to MRSA (unlabeled use):
Oral: 10-13 mg/kg/dose every 6-8 hours for 5-10 days (maximum: 40 mg/kg/day) (Liu, 2011)
Complicated skin/soft tissue infection due to MRSA (unlabeled use):
I.V., Oral: 10-13 mg/kg/dose every 6-8 hours for 7-14 days (maximum: 40 mg/kg/day) (Liu, 2011)

Orofacial infections:
Oral: 10-20 mg/kg/day in 3-4 equally divided doses
I.V.: 15-25 mg/kg/day in 3-4 equally divided doses

Osteomyelitis due to MRSA (unlabeled use):
I.V., Oral: 10-13 mg/kg/dose every 6-8 hours for a minimum of 4-6 weeks (maximum: 40 mg/kg/day) (Liu, 2011)

Pneumonia due to MRSA (unlabeled use):
I.V., Oral: 10-13 mg/kg/dose every 6-8 hours for 7-21 days (maximum: 40 mg/kg/day) (Liu, 2011)

Prophylaxis against infective endocarditis (unlabeled use):
Oral: 20 mg/kg 30-60 minutes before procedure (Wilson, 2007)
I.M., I.V.: 20 mg/kg 30-60 minutes before procedure. Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications. (Wilson, 2007)
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.

Septic arthritis due to MRSA (unlabeled use):
I.V., Oral: 10-13 mg/kg/dose every 6-8 hours for minimum of 3-4 weeks (maximum: 40 mg/kg/day) (Liu, 2011)

Toxoplasmosis (HIV-exposed/-positive; secondary prevention [unlabeled use]):
Oral: 20-30 mg/kg/day divided every 6-8 hours (plus pyrimethamine and leucovorin calcium) (CDC, 2009)

Dental Usual Dosing
Orofacial infection:
Children:  Oral: 10-20 mg/kg/day in 3-4 equally divided doses
                   I.V.: 15-25 mg/kg/day in 3-4 equally divided doses

Infective endocarditis prophylaxis:
Children:  Oral: 20 mg/kg 30-60 minutes before procedure
I.M., I.V.: 20 mg/kg 30-60 minutes before procedure. Note: Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications.

How does it work? 

Amoxicillin:

Reversibly binds to 50S ribosomal subunits preventing peptide bond formation thus inhibiting bacterial protein synthesis; bacteriostatic or bactericidal depending on drug concentration, infection site, and organism
 

Contraindications

 

Hypersensitivity to clindamycin, lincomycin, or any component of the formulation

 
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
 
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
 
 

Important safety information

Boxed warnings:

• Colitis: See “Concerns related to adverse effects” below.

Concerns related to adverse effects:

• Colitis: [U.S. Boxed Warning]: Can cause severe and possibly fatal colitis. Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment. Use with caution in patients with a history of gastrointestinal disease. Discontinue drug if significant diarrhea, abdominal cramps, or passage of blood and mucus occurs.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment; monitor hepatic enzymes periodically as dosage adjustments may be necessary in patients with severe impairment.

Special populations:

• Atopic patients: Use with caution in atopic patients.

Dosage form specific issues:

• Benzyl alcohol: Some products may contain benzyl alcohol which has been associated with "gasping syndrome" in neonates.

• Tartrazine: Some products may contain tartrazine, which may cause allergic reactions in certain individuals.

Other warnings/precautions:

• Appropriate use: Not appropriate for use in the treatment of meningitis due to inadequate penetration into the CSF.

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If you miss a dose

 
Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.
 
 

Pregnancy and breastfeeding

 
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
 
Pregnancy considerations
 

Pregnancy Category B

Because adverse effects were not observed in animals, clindamycin is classified as pregnancy category B. Clindamycin crosses the placenta throughout pregnancy and at term, but use during pregnancy has not been shown to cause adverse fetal effects. Clindamycin pharmacokinetics are not affected by pregnancy. Clindamycin therapy is recommended in certain pregnant patients for prophylaxis of group B streptococcal disease in newborns, prophylaxis and treatment of Toxoplasma gondii encephalitis, or for the treatment of Pneumocystis pneumonia (PCP), bacterial vaginosis, or malaria.

Breastfeeding considerations

Enters breast milk/not recommended (AAP rates “compatible”; AAP 2001 update pending)


Small amounts of clindamycin transfer to human milk. The manufacturer does not recommend the use of clindamycin during breast-feeding. Nondose-related effects could include modification of bowel flora. There has been one published case of bloody stools in a nursing infant, but a causal relationship was not proven.

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Possible side effects

 
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
 
Side effects may include:
 
Very common (≥10%) 
Frequency not defined.
 
Common (1%-10%) 

Cardiovascular: Cardiac arrest (rare; I.V. administration), hypotension (rare; I.V. administration)

Dermatologic: Erythema multiforme (rare), exfoliative dermatitis (rare), pruritus, rash, Stevens-Johnson syndrome (rare), urticaria

Gastrointestinal: Abdominal pain, diarrhea, esophagitis, nausea, pseudomembranous colitis, vomiting

Genitourinary: Vaginitis

Hematologic: Agranulocytosis, eosinophilia (transient), neutropenia (transient), thrombocytopenia

Hepatic: Jaundice, liver function test abnormalities

Local: Induration/pain/sterile abscess (I.M.), thrombophlebitis (I.V.)

Neuromuscular & skeletal: Polyarthritis (rare)

Renal: Renal dysfunction (rare)

Miscellaneous: Anaphylactoid reactions (rare)


Serious ADR (<1%) 

Frequency not defined.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
 
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
 
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
 
 

Interaction with other medication 

BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination

Erythromycin: May diminish the therapeutic effect of Lincosamide Antibiotics. Risk X: Avoid combination

Erythromycin (Systemic): Lincosamide Antibiotics may diminish the therapeutic effect of Erythromycin (Systemic). Risk X: Avoid combination

Kaolin: May decrease the absorption of Lincosamide Antibiotics. Risk D: Consider therapy modification

Neuromuscular-Blocking Agents: Lincosamide Antibiotics may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
 
Herb/Nutraceutical: St John's wort may decrease clindamycin levels.
 
Not provided information.
 
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to ensure that the combination is safe. 
 
 

Storage

 
Store below 30°C (86°F).
 
 

This information is a merely a general guideline and is not a substitute for a consultation with your doctor. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
 
 
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