Daptomycin (Intravenous)

Daptomycin is an antibiotic that kills certain strains of bacteria in the bloodstream and in cases of complicated skin and skin structure infections.

Overview

Daptomycin is an antibiotic intended for complicated skin and skin structure snfections (cSSSI). There are many other applications in which daptomycin may prove useful; for example, daptomycin is also prescribed for certain bloodstream infections.

As a potent antibiotic, it wipes out and prevents the growth of bacteria. However, this treatment has zero effect on treating viral infections, such as the common cold or flu. In order to prevent antibacterial resistance, doctors will test the patient to determine if this treatment is appropriate. Daptomycin is proven to kill various streptococcus strains of bacteria, including streptococcus pyogenes, streptococcus agalactiae and streptococcus dysgalactiae subspecies equisimilis, as well as staphylococcus aureus and enterococcus faecalis.

Daptomycin is produced by fermenting streptomyces roseosporus, sourced predominantly from soils. It is considered to be a highly effective cyclic lipopeptide antibacterial agent that can stop and prevent the growth of the aforementioned strains of bacteria. It quickly attaches itself to predetermined bacterial membranes and effectively annihilates the possibility of growth.

Daptomycin also goes by the US trade name Cubicin and it is only available on prescription by a certified physician. A trained nurse administers treatment at all times in a hospital or clinical facility through the intravenous route, or a needle placed in the veins.

Condition(s) treated

  • Complicated skin and skin structure infections (cSSSI)
  • Right-sided infective endocarditis
  • Bacteremia

Type of medicine

  • Cyclic lipopeptide antibiotic

Side effects

A number of side effects have been reported in patients who have undergone treatment with daptomycin.

  • The most common side effects of daptomycin:
  • style="font-weight: 400;">Edema or bloating
  • Changes in weight
  • A tingling or pins and needles sensation

The less common side effects of daptomycin:

  • Stomach pain
  • Feeling irritable
  • Changes in stool color
  • Pain in the bladder
  • Color changes in urine (bloody or cloudy)
  • Vision changes
  • Chest tightness
  • Feeling confused
  • Changes in urinary output
  • Difficulty urinating
  • Distended veins in the neck
  • Mood swings
  • Diarrhea
  • Dehydration or dry mouth
  • Extreme drowsiness or lethargy
  • Feeling faint or dizzy
  • Irregular heartbeat
  • Headaches
  • Fevers or chills
  • High blood pressure
  • Trouble breathing
  • Skin irritations
  • Appetite loss
  • Pain in the back or aide
  • Muscle aches and pain
  • Twitching
  • Feeling nervous
  • Ringing ears
  • Convulsions
  • Sneezing, coughs or a sore throat
  • Feeling limp
  • Perspiration
  • Skin that bruises or looks pale
  • Unsettled stomach (regurgitating coffee grounds)

The rare side effects of daptomycin:

  • A pins and needles sensation
  • Belching
  • Bloody vomit
  • Bloody stools or urine
  • Blurred vision
  • Coma
  • Dry coughing
  • Enlarged glands and lymph nodes
  • Feeling hoarse
  • Feeling irritable
  • Feeling sleepy
  • Feeling too warm or too cold
  • Gums that bleed
  • Hallucinations
  • Hearing loss
  • Hives and rashes
  • Itching
  • Loss of consciousness
  • Loss of mobility
  • Low or no pulse
  • Muscle spasms
  • Pain and tenderness in the abdomen
  • Pain in the eyes
  • Pain the joints or bones
  • Red dots on skin
  • Scaling
  • Trouble swallowing
  • Ulcers
  • Voice changes
  • Yellow eyes

Dosage

The dosage amounts for daptomycin vary from one patient to another. Generally speaking, however, this is dependent on a range of factors, including:

  • the diagnosis
  • the age and weight of the patient
  • underlying medical conditions

The mean dose for cSSSI

4 mg infused over 30-60 minutes for 7-14 days

The mean dose for staphylococcus aureus bacteremia:

6 mg infused over 30-60 minutes for two to six weeks

The intravenous route of application is sometimes administered as a 30 minute treatment, depending on the patient. The FDA warns against dosing pediatric patients in two minute timeframes, as this could increase the risks of serious adverse effects.

Altered doses may furthermore be required in certain high-risk groups that are more predisposed to developing complications from the treatment.

Reconstitution

The instructions for reconstituting daptomycin are dependent on the strength and model of the medicine. Daptomycin may be supplied in three different formats of lyophilized powder indicated for reconstitution. These include:

  • 500 mg vials of Cubicin
  • 500 mg vials of Cubicin RF
  • 350 mg vials of daptomycin

Instructions for reconstituting Cubicin

The listed protocols for reconstituting Cubincin include:

1. Mix one vial with 10 ml of 0.9% NaCl (sodium chloride).
2. Shake, but do not over mix, as this causes foaming. Rotate back and forth in a non-aggressive motion.
3. Rest by allowing the solution to be left as is for roughly 10 minutes.
4. Transfer to the needle. 21 gauge needles or smaller varieties are recommended for transfer.

Instructions for reconstituting Cubicin RF:

1. Mix in the supplied vial. Unlike Cubincin, which uses 0.9% NaCl during reconstitution, this hybrid should only be mixed with sterile water reserved for intravenous applications. Additionally, bacteriostatic water may also be used. The indicated amount of sterile water or bacteriostatic water for reconstitution with Cubincin RF is 10 ml.
2. Rotate and use a gentle motion to mix the solution - watch for even distribution. If discolorations or particles are observed, check with a supervisor before use.
3. Transfer by using a 21 gauge needle or a smaller variety.

Instructions for reconstituting daptomycin 350 mg vials:

1. Mix 7 mL of 0.9% NaCl (sodium chloride) into the vial.
2. Dilute and leave the diluted mix for roughly 10 minutes. This means that you should let it sit undisturbed before mixing.
3. Swirl and use a gentle motion to reconstitute the mix.
4. Transfer to the needle. As with both Cubincin and Cubincin RF, a 21 gauge needle or smaller hybrid should be used to complete the transfer.

Other important things to note:

  • Correct dosing: This mixture is not the correct dosage amount for patients. Refer to the acting physician's prescriptions to determine the amount that is prescribed for transfer to the infusion bag. The mix must be further diluted to accomplish the right measurements.
  • Read insert labels: Read the full instructions enclosed in each pack to ensure best results and patients' safety. The reconstitution instructions outlined above do not replace the guidelines provided by an authoritative figure.
  • Follow safety protocols:nTo prevent the risk of transmitting infectious diseases, adhere to safety protocols by never reusing disposable needles. Used needles should be discarded safely in a biohazardous waste container. Moreover, medical-grade gloves should be worn at all times during reconstitution and administration.

Interactions

Negative adverse effects have been reported when daptomycin is used in conjunction with certain other medications. A few are outlined below, but this is not an all inclusive list. Doctors generally investigate patient's medical history before commencing treatment with any medication, so patients are advised to disclose their full medical background, including past allergies, current medicines, lifestyle habits, underlying ailments and more.

Drug interactions

The most commonly reported negative drug interactions with daptomycin include:

  • Atorvastatin
  • Fluvastatin
  • Lescol
  • Lipitor
  • Lovastatin
  • Pravastatin
  • Rosuvastatin
  • Simvastatin

In the event that concomitant use is necessary, a modified dose may be required.

Over the counter drugs

Inform your medical provider if you're currently using any medicine, including over the counter drugs, such as herbal supplements and vitamins.

Warnings

Read all precautions before commencing treatment:

Vaccinations

This drug should not be given to patients who have recently received the cholera vaccine, as serious negative interactions can result from concomitant use.

Underlying medical conditions

The presence of certain pre-existing conditions can cause complications to arise. Tell your doctor if you have been diagnosed with:

  • Diarrhea
  • Infections
  • Kidney disease
  • Muscle issues
  • Neuropathic issues

In these cases, an adjusted dosage may be required in order to prevent the condition or conditions from becoming worse.

Eosinophilic pneumonia

In rare cases, eosinophilic pneumonia may develop following daptomycin treatments. This is a serious condition that requires immediate medical intervention. Some of the main warning signs of eosinophilic pneumonia include:

  • Chest tightness
  • Lethargy
  • Quick breaths
  • Rashes
  • Wheezing

Peripheral neuropathy

There is also a risk of developing peripheral neuropathy with daptomycin treatments. The warning signs include:

  • A burning or tingling sensation
  •  Numbness
  • Pain in the hands and feet

If these symptoms are noticed, consult your doctor right away.

Patients who have existing peripheral neuropathies and myopathy disorders should be monitored closely. To reduce the risks of side effects, physicians may order statin treatments during the infusion process while monitoring renal function.

Persisting or relapsing bacteremia

In some patients, the response to this treatment may be poor. If your symptoms persist or get worse even after treatment, contact your healthcare provider. Blood cultures can be taken to determine if the infection is reoccurring and whether an alternate treatment is required.

As a general rule of thumb, if you do not feel better within a few days of treatment, consult your medical provider right away.

Diarrhea

One complication that is often reported with intravenous antibiotic treatments is persistent diarrhea, which could happen well past the treatment date. Patients could develop this discomforting condition two months or more after the initial treatment with daptomycin. In the event this occurs, patients are advised to avoid taking over the counter medicines and contact a medical provider.

Special note: The development of diarrhea post-treatment is classified as clostridium difficile-associated diarrhea (CDAD), which can be fatal if left as is. It is, therefore, important to seek medical help if you suspect CDAD. In order to treat this condition, doctors may use a number of combination treatments, including:

  • Antibiotic agents targeted to treat C. Difficile
  • Fluid and electrolyte management
  • Protein replacement therapy
  • Surgery

Due to these risks, doctors generally complete an overview of risks versus benefits before commencing treatment with daptomycin.

Effects on medical tests

Daptomycin could possibly affect the results of certain medical tests. If you have an upcoming appointment scheduled with a healthcare facility, inform medical workers about recent daptomycin use.

Pediatric use

Daptomycin is considered safe for use in children over the age of one. Based on clinical trials, this medicine can affect the following areas of development and function in neonates or infants younger than 12 months old:

  • Central nervous system
  • Muscular functions
  • Neuromuscular functions
  • Peripheral nervous system

Warnings for healthcare professionals

Indications for use ' daptomycin is a potent antibiotic. However, it is not intended for certain conditions, including:

  • Cold and flu viruses
  • Pneumonia
  • Left-sided infective endocarditis

In clinical trials, the outcomes for use in these respects proved to be unfavorable.

Storage

The storage instructions vary depending on whether the vial is sealed or reconstituted.

Sealed vials

As a general rule of thumb, unopened vials should be stored at the following temperatures to maintain quality and efficacy:

  • Cubicin: store sealed vials in a refrigerator at temperatures ranging from 2-8°C (36-46°F).
  • Cubicin RF - store the unopened vial at a room temperature of 20-25°C (68-77°F). Ensure the temperatures in this area are controlled and monitored at all times.
  • Daptomycin 350 mg vials - store the sealed container or vial in a refrigerator at temperatures ranging from 2-8°C (36-46°F).

Note: In all cases, the unopened vials should never be kept in areas of excessive heat. Doing so could result in the risk of killing the antibacterial agent.

Reconstituted solutions

The storage instructions for storing reconstituted solutions are also based on the formation of daptomycin:

  • Cubicin: The reconstituted solution can be stored for up to 12 hours at room temperatures ranging from 20-25°C (68-77°F). Alternatively, the shelf life can be expanded by placing this at refrigerated temperatures of 2-8°C (36-46°F) for up to 48 hours.
  • Cubicin RF - There are two specific guidelines for storing reconstituted Cubincin RF and it is primarily based on the diluent used. For reconstituted Cubicin RF mixed with sterile water used for injection, the vial can be kept at controlled room temperatures of 20-25°C (68-77°F) for a period of 24 hours. The shelf life can also be extended by storing at refrigerated temperatures of 2-8°C (36-46°F) for up to 72 hours. Cubincin RF reconstituted with bacteriostatic water for injection tends to last a little longer. This mix can be safely stored at room temperatures of 20-25°C (68-77°F) for up to two days and at refrigerated temperatures of 2-8°C (36-46°F) for up to five days.

Summary

Daptomycin is an antibacterial agent intended for treating complicated skin and skin structure infections, as well as right-sided infective endocarditis. It is otherwise known as a cyclic lipopeptide antibacterial agent that is approved for use in adults and children over the age of one years old.

To reduce incidences of antibiotic resistance, medical researchers suggest only prescribing daptomycin for strains of bacteria that have proven to be responsive to the treatment. To help determine this, skin or soft tissue tests are performed for patients suspected of having a cSSSI.

Generally speaking, the medicine is administered by a nurse in a hospital setting. Daptomycin permeates the bloodstream through intravenous injections, which take place over the course of 30 - 60 minutes. There are some exceptions, however, where infusion happens as quickly in two minutes or less.

Daptomycin is usually well-tolerated by most patients and boasts a high success rating based on clinical trials. Nevertheless, complications may arise from using this medicine, including anaphylactic shock, chronic diarrhea and antibiotic resistance. Patients should pay attention to precautions outlined by a healthcare provider and know when to call 911.