What happens if I overdose Ocnil?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Ocnil:
Ocnil is handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.
Overdose of Ocnil in details
Serum levels of Ocnil are not appreciably affected by hemodialysis and peritoneal dialysis.
What should I avoid while taking Ocnil?
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.
Ocnil warnings
Clostridium difficile associated diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ocnil, 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.
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 antibacterial 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 antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Hypersensitivity
Serious hypersensitivity reactions, including anaphylaxis and erythema multiforme, have been reported with use of Ocnil. If an allergic reaction to Ocnil occurs, discontinue the drug.
Benzyl Alcohol Toxicity in Pediatric Patients (Gasping Syndrome")
This product contains benzyl alcohol as a preservative.
The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome", and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome", the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the hepatic capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity.
Use in Meningitis — Although Ocnil appears to diffuse into cerebrospinal fluid, levels of Ocnil in the CSF may be inadequate for the treatment of meningitis.
What should I discuss with my healthcare provider before taking Ocnil?
You should not receive this medication if you are allergic to Ocnil or clindamycin.
Antibiotic medicine can cause overgrowth of normally harmless bacteria in the intestines. This can lead to an infection that causes mild to severe diarrhea, even months after your last antibiotic dose. If left untreated this condition can lead to life-threatening intestinal problems. Before you receive Ocnil, tell your doctor if you have a history of intestinal disorder such as ulcerative colitis.
Older adults and those who are ill or debilitated may be more sensitive to the effects of diarrhea caused by this medication.
To make sure Ocnil is safe for you, also tell your doctor if you have:
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asthma;
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severe allergies; or
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liver or kidney disease.
FDA pregnancy category C. It is not known whether Ocnil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Ocnil can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
Ocnil precautions
General
Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When Ocnil is indicated in these patients, they should be carefully monitored for change in bowel frequency.
Ocnil should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Ocnil should be used with caution in patients with a history of asthma or significant allergies.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibacterial therapy.
The use of Ocnil may result in overgrowth of nonsusceptible organisms— particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. When patients with pre-existing monilial infections require therapy with Ocnil, concomitant antimonilial treatment should be given.
The serum half-life of Ocnil may be prolonged in patients with severe impairment of renal function compared to patients with normal renal function. In patients with abnormal hepatic function, serum half-life may be twofold longer than in patients with normal hepatic function.
Patients with severe impairment of renal function and/or abnormal hepatic function should be dosed with caution and serum Ocnil levels monitored during high-dose therapy.
Ocnil should not be injected intravenously undiluted as a bolus, but should be infused over at least 60 minutes as directed in the DOSAGE AND ADMINISTRATION Section.
Prescribing Ocnil in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Laboratory Tests
During prolonged therapy with Ocnil, periodic liver and kidney function tests and blood counts should be performed.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
The carcinogenic potential of Ocnil has not been evaluated.
Ocnil was not found to be mutagenic in the Ames Salmonella reversion assay or the V79 Chinese hamster lung cells at the HGPRT locus. It did not induce DNA strand breaks in V79 Chinese hamster lung cells as measured by alkaline elution or chromosomal abnormalities in cultured human lymphocytes. In vivo, Ocnil was negative in both the rat and mouse micronucleus assays and it did not induce sex-linked recessive lethal mutations in the offspring of male Drosophila. However, Ocnil did cause unscheduled DNA syntheses in freshly isolated rat hepatocytes.
Impairment of fertility was not observed in male or female rats given oral 300 mg/kg doses of Ocnil (0.36 times the highest recommended human dose based on mg/m²).
Pregnancy
Pregnancy Category C
Ocnil Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta. See WARNINGS.
Teratogenic Effects
There are no studies on the teratogenic potential of Ocnil in animals or adequate and well-controlled studies of pregnant women.
Nonteratogenic Effects
Reproduction studies have been performed in rats using oral doses of Ocnil up to 1000 mg/kg (1.2 times the maximum daily human dose based on mg/m²) and have revealed no adverse effects on survival of offspring from birth to weaning.
Nursing Mothers
Ocnil has been reported to appear in human milk in concentrations of 0.5 to 2.4 mcg/mL. Because of the potential for serious adverse reactions in nursing infants from Ocnil, a decision should be made whether to discontinue nursing, or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Ocnil Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with a fatal “Gasping Syndrome” in premature infants. See WARNINGS. Safety and effectiveness in pediatric patients below the age of one month have not been established.
What happens if I miss a dose of Ocnil?
Since Ocnil is usually given by a healthcare professional, it is not likely that you will miss a dose. If you are using Ocnil at home, call your doctor for instructions if you miss a dose.
References
- DrugBank. "lincomycin". http://www.drugbank.ca/drugs/DB01627 (accessed September 17, 2018).
- MeSH. "Protein Synthesis Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
