Unipen

How old is patient? < 1 1-5 6-15 16-29 30-45 46-60 > 60

Unipen uses

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• Directions for use
• How supplied
• References
• Unipen reviews

INDICATIONS AND USAGE

Unipen is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug [see Clinical

Pharmacology: Susceptibility Test Methods ].

Unipen should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant Staphylococcus sp., therapy with Unipen for Injection, USP should be discontinued and alternative therapy provided.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Unipen for Injection, USP and other antibacterial drugs, Unipen for Injection, USP 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.

CONTRAINDICATIONS

A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.

WARNINGS

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with Unipen, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Unipen should be discontinued and appropriate therapy instituted.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Unipen for Injection, USP, 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 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.

PRECAUTIONS

General

Unipen should generally not be administered to patients with a history of sensitivity to any penicillin.

Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma. Whenever allergic reactions occur, penicillin should be withdrawn unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to penicillin therapy.

The use of antibiotics may result in overgrowth of nonsusceptible organisms. If new infections due to bacteria or fungi occur, the drug should be discontinued and appropriate measures taken.

The liver/biliary tract is the primary route of Unipen clearance. Caution should be exercised when patients with concomitant hepatic insufficiency and renal dysfunction are treated with Unipen.

Prescribing Unipen for Injection 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

Bacteriologic studies to determine the causative organisms and their susceptibility to the penicillinase-resistant penicillins should be performed [see Clinical

Pharmacology: Microbiology ]. In the treatment of suspected staphylococcal infections, therapy should be changed to another active agent if culture tests fail to demonstrate the presence of staphylococci.

Periodic assessment of organ system function including renal, hepatic, and hematopoietic should be made during prolonged therapy with Unipen. White blood cell and differential cell counts should be obtained prior to initiation of therapy and periodically during therapy with Unipen. Urinalysis, serum blood urea nitrogen, and creatinine determinations should be performed at baseline and periodically during therapy with Unipen. Serum bilirubin, SGOT, SGPT, alkaline phosphatase, and gamma glutamyl transferase should be obtained at baseline and periodically during therapy, especially when using high Unipen doses. In patients with worsening hepatic function, the risk versus benefit of continued Unipen use should be re-evaluated.

Drug Interactions

Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided.

Unipen in high dosage regimens, i.e., 2 grams every 4 hours, has been reported to decrease the effects of warfarin. When Unipen and warfarin are used concomitantly, the prothrombin time should be closely monitored and the dose of warfarin adjusted as necessary. This effect may persist for up to 30 days after Unipen has been discontinued.

Unipen when administered concomitantly with cyclosporine has been reported to result in subtherapeutic cyclosporine levels. The nafcillin-cyclosporine interaction was documented in a patient during two separate courses of therapy. When cyclosporine and Unipen are used concomitantly in organ transplant patients, the cyclosporine levels should be monitored.

Drug/Laboratory Test Interactions

Unipen in the urine can cause a false-positive urine reaction for protein when the sulfosalicyclic acid test is used, but not with the dipstick.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long term animal studies have been conducted with these drugs.

Studies on reproduction in rats and mice reveal no fetal or maternal abnormalities before conception and continuously through weaning (one generation).

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in the mouse with oral doses up to 20 times the human dose and orally in the rat at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the rodent fetus due to Unipen. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Unipen should be used during pregnancy only if clearly needed.

Nursing Mothers

Penicillins are excreted in human milk. Caution should be exercised when penicillins are administered to a nursing woman.

Pediatric Use

The liver/biliary tract is the principal route of Unipen elimination. Because of immature hepatic and renal function in pediatric patients, Unipen excretion may be impaired. Safety and effectiveness in pediatric patients have not been established for the use of intravenous Unipen. Safety and effectiveness in pediatric patients have been established for the use of intramuscular Unipen.

Geriatric Use

Clinical studies of Unipen for Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Unipen for Injection contains 66.1 mg [2.9 mEq] of sodium per gram of Unipen. At the usual recommended doses, patients would receive between 132.2 and 396.6 mg/day [5.8 and 17.4 mEq] of sodium. The geriatric population may respond with a blunted natriuresis to salt loading. This may be clinically important with regard to such diseases as congestive heart failure.

Information for Patients

Patients should be counseled that antibacterial drugs including Unipen for Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Unipen for Injection 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 Unipen for Injection or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic. If this occurs, patients should contact their physician as soon as possible.

ADVERSE REACTIONS

Body as a Whole

The reported incidence of allergic reactions to penicillin ranges from 0.7 to 10 percent [see Warnings ]. Sensitization is usually the result of treatment, but some individuals have had immediate reactions to penicillin when first treated. In such cases, it is thought that the patients may have had prior exposure to the drug via trace amounts present in milk or vaccines. Two types of allergic reactions to penicillins are noted clinically, immediate and delayed.

Immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioedema, laryngospasm, bronchospasm, hypotension, vascular collapse, and death. Such immediate anaphylactic reactions are very rare [see Warnings ] and usually occur after parenteral therapy but have occurred in patients receiving oral therapy. Another type of immediate reaction, an accelerated reaction, may occur between 20 minutes and 48 hours after administration and may include urticaria, pruritus, and fever.

Although laryngeal edema, laryngospasm, and hypotension occasionally occur, fatality is uncommon. Delayed allergic reactions to penicillin therapy usually occur after 48 hours and sometimes as late as 2 to 4 weeks after initiation of therapy. Manifestations of this type of reaction include serum sickness-like symptoms and various skin rashes. Nausea, vomiting, diarrhea, stomatitis, black or hairy tongue, and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy.

Local Reactions

Pain, swelling, inflammation, phlebitis, thrombophlebitis, and occasional skin sloughing at the injection site have occurred with intravenous administration of Unipen [see Dosage and Administration ]. Severe tissue necrosis with sloughing secondary to subcutaneous extravasation of Unipen has been reported.

Nervous System Reactions

Neurotoxic reactions similar to those observed with penicillin G could occur with large intravenous or intraventricular doses of Unipen especially in patients with concomitant hepatic insufficiency and renal dysfunction [see Precautions ].

Urogenital Reactions

Renal tubular damage and interstitial nephritis have been associated with the administration of Unipen. Manifestations of this reaction may include rash, fever, eosinophilia, hematuria, proteinuria, and renal insufficiency.

Hepatic Reactions

Elevation of liver transaminases and/or cholestasis may occur, especially with administration of high doses of Unipen.

Gastrointestinal Reactions

Pseudomembranous colitis has been reported with the use of Unipen. The onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment [see Warnings ].

Metabolic Reactions

Agranulocytosis, neutropenia, and bone marrow depression have been associated with the use of Unipen.

To report SUSPECTED ADVERSE EVENTS, contact FDA at 1-800-FDA-1088 or www.fda.gov.

OVERDOSAGE

Neurotoxic reactions similar to those observed with penicillin G may arise with intravenous doses of Unipen especially in patients with concomitant hepatic insufficiency and renal dysfunction [see Pr ecautions].

In the case of overdosage, discontinue Unipen, treat symptomatically and institute supportive measures as required. Hemodialysis does not increase the rate of clearance of Unipen from the blood.

DOSAGE AND ADMINISTRATION

Unipen for Injection is available for intramuscular and intravenous use.

The usual I.V. dosage for adults is 500 mg every 4 hours. For severe infections, 1 gram every 4 hours is recommended. Administer slowly over at least 30 to 60 minutes to minimize the risk of vein irritation and extravasation.

Drug	Adults	Infants and Children <40 kg (88 lbs)	Other Recommendations
Unipen	500 mg IM every 4 to 6 hours IV every 4 hours	25 mg/kg IM twice daily	Neonates 10 mg/kg IM twice daily
Unipen	1 gram IM or IV every 4 hours (severe infections)

Bacteriologic studies to determine the causative organisms and their susceptibility to Unipen should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with Unipen should be continued for at least 14 days. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

No dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis. Hemodialysis does not accelerate Unipen clearance from the blood.

With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Do not add supplementary medication to Unipen.

DIRECTIONS FOR USE

For Intramuscular Use

Reconstitute with Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP or Bacteriostatic Water for Injection, USP ; add 3.4 mL to the 1 g vial for 4 mL resulting solution and 6.5 mL to the 2 g vial for 8 mL resulting solution. All reconstituted vials have a concentration of 250 mg per mL.

The clear solution should be administered by deep intragluteal injection immediately after reconstitution.

Reconstituted Stability

Reconstitute with the required amount of Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP or Bacteriostatic Water for Injection, USP (with benzyl alcohol or parabens). The resulting solutions are stable for 3 days at room temperature or 7 days under refrigeration and 90 days frozen.

For Direct Intravenous Use

The required amount of drug should be diluted in 15 to 30 mL of Sterile Water for Injection, USP or Sodium Chloride Injection, USP and injected over a 5- to 10- minute period. This may be accomplished through the tubing of an intravenous infusion if desirable.

For Administration by Intravenous Drip

Reconstitute as directed above (For Intravenous Use) prior to diluting with intravenous solutions.

Concentration mg/mL	Sterile Water for Injection, USP		Sodium Chloride Injection, USP (0.9%)		Sodium Lactate Solution, USP (M/6 Molar)	Dextrose Injection, USP (5%)	Dextrose and Sodium Chloride Injection, USP (5% Dextrose and 0.45% Sodium Chloride)	Invert Sugar Injection, USP (10%)	Lactated Ringers Injection, USP
ROOM TEMPERATURE (25° C)
10-200		24 Hrs		24 Hrs
30					24 Hrs
2-30						24 Hrs	24 Hrs
10-30								24 Hrs	24 Hrs
REFRIGERATION (4° C)
10-200		7 Days		7 Days
10-30					7 Days	7 Days	7 Days	7 Days	7 Days
FROZEN (-15° C)
250		90 Days		90 Days
10-250					90 Days	90 Days	90 Days	90 Days	90 Days

• * IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that a product should be used as soon after preparation as feasible.

Only those solutions listed above should be used for the intravenous infusion of Unipen sodium, USP. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of Unipen is administered before the drug loses its stability in the solution in use.

There is no clinical experience available on the use of this agent in neonates or infants for this route of administration.

This route of administration should be used for relatively short-term therapy (24 to 48 hours) because of the occasional occurrence of thrombophlebitis particularly in elderly patients.

If another agent is used in conjuction with Unipen therapy, it should not be physically mixed with Unipen but should be administered separately.

HOW SUPPLIED

Unipen for Injection, USP contains Unipen sodium as the monohydrate equivalent to 1 gram or 2 grams Unipen per vial.

NDC 0781-3124-95 1 gram vial packaged in 10s

NDC 0781-3125-95 2 gram vial packaged in 10s

Other package sizes available:

NDC 0781-3126-95 Pharmacy Bulk Package bottle containing Unipen sodium as the monohydrate equivalent to 10 grams of Unipen, supplied in cartons of ten

Store dry powder at 20° to 25°C (68° to 77°F).

REFERENCES

• Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; 26th ed., CLSI supplement M100-S. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2016.

Revised: February 2017

46200748

Manufactured in Austria by Sandoz GmbH for

Sandoz Inc., Princeton, NJ 08540

Product of Italy

NDC 0781-3124-85

Unipen

for Injection,

USP

Sterile

1 g/Vial

Rx only

Buffered - for IM or IV use

Vial contains Unipen sodium,

as the monohydrate,

equivalent to 1 g Unipen.

1g-vial Unipen

NDC 0781-3125-85

Unipen

for Injection,

USP

Sterile

2 g/Vial

Rx only

Buffered - for IM or IV use

Vial contains Unipen sodium,

as the monohydrate,

equivalent to 2 g Unipen.

2g-vial Nafcillin

Unipen pharmaceutical active ingredients containing related brand and generic drugs:

• Nafcillin Sodium

Unipen available forms, composition, doses:

• Capsules; Oral; Nafcillin Sodium 250 mg
• For Solution; Oral; Nafcillin Sodium 250 mg / 5 ml
• Injectable; Injection; Nafcillin Sodium 1 g
• Injectable; Injection; Nafcillin Sodium 2 g
• Injectable; Injection; Nafcillin Sodium 20 g
• Injectable; Injection; Nafcillin Sodium 4 g
• Injectable; Injection; Nafcillin Sodium 500 mg
• Tablets; Oral; Nafcillin Sodium 500 mg

Unipen destination | category:

• Human:
• Beta-lactam antibiotics

Unipen Anatomical Therapeutic Chemical codes:

• J01C - Beta

Unipen pharmaceutical companies:

• Wyeth

References

1. Dailymed."NAFCILLIN SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. "nafcillin". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
3. "nafcillin". http://www.drugbank.ca/drugs/DB0060... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Unipen?

Depending on the reaction of the Unipen after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Unipen not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Unipen addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Unipen, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Unipen consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology