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Lincocin

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Overview

What is Lincocin?

LINCOCIN Sterile Solution contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance produced by the growth of a member of the group of (Fam. ). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is CHNOS.HCl.HO and the molecular weight is 461.01.

The structural formula is represented below:

Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone.



What does Lincocin look like?



What are the available doses of Lincocin?

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What should I talk to my health care provider before I take Lincocin?

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How should I use Lincocin?

LINCOCIN Sterile Solution is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibacterial associated pseudomembranous colitis, as described in the box, before selecting lincomycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).

Indicated surgical procedures should be performed in conjunction with antibacterial therapy.

The drug may be administered concomitantly with other antimicrobial agents when indicated.

Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of LINCOCIN and other antibacterial drugs, LINCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

If significant diarrhea occurs during therapy, this antibacterial should be discontinued. (see box.)


What interacts with Lincocin?

This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.



What are the warnings of Lincocin?

There are no adequate and well-controlled clinical trials  of fluconazole in pregnant women. Case reports describe a pattern of distinct congenital anomalies in infants exposed to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If fluconazole is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus. Effective contraceptive measures should be considered in women of child-bearing potential who are being treated with fluconazole 400 to 800 mg/day and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose. Epidemiological studies suggest a potential risk of spontaneous abortion and congenital abnormalities in infants whose mothers were treated with 150 mg of fluconazole as a single or repeated dose in the first trimester, but these epidemiological studies have limitations and these findings have not been confirmed in controlled clinical trials  (See )

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Clostridium difficile

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If CDAD is suspected or confirmed, ongoing antibacterial use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of , and surgical evaluation should be instituted as clinically indicated.

Hypersensitivity

Severe hypersensitivity reactions, including anaphylactic reactions and severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and erythema multiforme (EM) have been reported in patients receiving LINCOCIN therapy. If an anaphylactic reaction or severe skin reaction occurs, LINCOCIN should be discontinued and appropriate therapy should be initiated. (see )

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 liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity.

Use in Meningitis — Although lincomycin appears to diffuse into cerebrospinal fluid, levels of lincomycin in the CSF may be inadequate for the treatment of meningitis.


What are the precautions of Lincocin?

General

Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When LINCOCIN is indicated in these patients, they should be carefully monitored for change in bowel frequency.

LINCOCIN should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

LINCOCIN 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 LINCOCIN 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 LINCOCIN, concomitant antimonilial treatment should be given.

The serum half-life of lincomycin 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 lincomycin levels monitored during high-dose therapy. (see )

Lincomycin should not be injected intravenously undiluted as a bolus, but should be infused over at least 60 minutes as directed in the Section.

Prescribing LINCOCIN 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.

Information for Patients

Patients should be counseled that antibacterial drugs including LINCOCIN should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When LINCOCIN is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by LINCOCIN or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibacterial which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterial, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible

Laboratory Tests

During prolonged therapy with LINCOCIN, periodic liver and kidney function tests and blood counts should be performed.

Drug Interactions

Lincomycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used in caution in patients receiving such agents.

Antagonism between lincomycin and erythromycin has been demonstrated. Because of possible clinical significance, the two drugs should not be administered concurrently.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of lincomycin has not been evaluated.

Lincomycin was not found to be mutagenic in the Ames 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. , lincomycin 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 . However, lincomycin 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 lincomycin (0.36 times the highest recommended human dose based on mg/m).

Pregnancy

LINCOCIN Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta. See.

Nursing Mothers

Lincomycin has been reported to appear in human milk in concentrations of 0.5 to 2.4 µg/mL. Because of the potential for serious adverse reactions in nursing infants from LINCOCIN, 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

LINCOCIN Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature infants. See. Safety and effectiveness in pediatric patients below the age of one month have not been established. (see )


What are the side effects of Lincocin?

The following reactions have been reported with the use of lincomycin and are listed by System Organ Class.

Gastrointestinal disorders

Diarrhea, nausea, vomiting, glossitis, stomatitis, abdominal pain, abdominal discomfort, anal pruritus

Skin and subcutaneous tissue disorders

Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, dermatitis bullous, dermatitis exfoliative, erythema multiforme (see rash, urticaria, pruritus

Infections and infestations

Vaginal infection, pseudomembranous colitis, colitis (see )

Blood and lymphatic system disorders

Pancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura

Immune system disorders

Anaphylactic reaction (see ), angioedema, serum sickness

Hepatobiliary disorders

Jaundice, liver function test abnormal, transaminases increased

Renal and urinary disorders

Renal impairment, oliguria, proteinuria, azotemia

Cardiac disorders

Cardio-respiratory arrest (see )

Vascular disorders

Hypotension (see ), thrombophlebitis

Ear and labyrinth disorders

Vertigo, tinnitus

Neurologic disorders

Headache, dizziness, somnolence

General disorders and administration site conditions

Injection site abscess sterile, injection site induration, injection site pain, injection site irritation


What should I look out for while using Lincocin?

This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.

See box.


What might happen if I take too much Lincocin?

Serum levels of lincomycin are not appreciably affected by hemodialysis and peritoneal dialysis.


How should I store and handle Lincocin?

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.LINCOCIN Sterile Solution is available in the following strength and package sizes:300 mgEach mL of LINCOCIN Sterile Solution contains lincomycin hydrochloride equivalent to lincomycin 300 mg; also benzyl alcohol, 9.45 mg added as preservative.LINCOCIN Sterile Solution is available in the following strength and package sizes:300 mgEach mL of LINCOCIN Sterile Solution contains lincomycin hydrochloride equivalent to lincomycin 300 mg; also benzyl alcohol, 9.45 mg added as preservative.LINCOCIN Sterile Solution is available in the following strength and package sizes:300 mgEach mL of LINCOCIN Sterile Solution contains lincomycin hydrochloride equivalent to lincomycin 300 mg; also benzyl alcohol, 9.45 mg added as preservative.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Intramuscular administration of a single dose of 600 mg of lincomycin produces average peak serum levels of 11.6 µg/mL at 60 minutes and maintains therapeutic levels for 17 to 20 hours for most susceptible gram-positive organisms. Urinary excretion after this dose ranges from 1.8 to 24.8 percent (mean: 17.3 percent).

A two hour intravenous infusion of 600 mg of lincomycin achieves average peak serum levels of 15.9 µg/mL and yields therapeutic levels for 14 hours for most susceptible gram-positive organisms. Urinary excretion ranges from 4.9 to 30.3 percent (mean: 13.8 percent).

The biological half-life after intramuscular or intravenous administration is 5.4 ± 1.0 hours. The serum half-life of lincomycin 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. Hemodialysis and peritoneal dialysis are not effective in removing lincomycin from the serum.

Tissue level studies indicate that bile is an important route of excretion. Significant levels have been demonstrated in the majority of body tissues. Although lincomycin appears to diffuse into cerebrospinal fluid (CSF), levels of lincomycin in the CSF appear inadequate for the treatment of meningitis.

Non-Clinical Toxicology
This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.

See box.

Lincomycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used in caution in patients receiving such agents.

Antagonism between lincomycin and erythromycin has been demonstrated. Because of possible clinical significance, the two drugs should not be administered concurrently.

Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When LINCOCIN is indicated in these patients, they should be carefully monitored for change in bowel frequency.

LINCOCIN should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

LINCOCIN 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 LINCOCIN 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 LINCOCIN, concomitant antimonilial treatment should be given.

The serum half-life of lincomycin 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 lincomycin levels monitored during high-dose therapy. (see )

Lincomycin should not be injected intravenously undiluted as a bolus, but should be infused over at least 60 minutes as directed in the Section.

Prescribing LINCOCIN 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.

The following reactions have been reported with the use of lincomycin and are listed by System Organ Class.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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