What is fosfomycin?

Fosfomycin is an antibiotic that fights infection caused by bacteria.

Fosfomycin is used to treat bladder infections.

Fosfomycin may also be used for purposes not listed in this medication guide.

Fosfomycin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Fosfomycin may cause serious side effects. Call your doctor at once if you have:

• diarrhea that is watery or bloody; or
• new or worsening bladder symptoms (burning, painful urination).

Common side effects of fosfomycin may include:

• nausea, upset stomach, stomach pain, diarrhea;
• headache, dizziness;
• weakness;
• rash;
• sore throat, runny nose;
• back pain; or
• menstrual pain, vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA.

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use fosfomycin if you are allergic to it.

Tell your doctor if you are pregnant or breastfeeding.

Fosfomycin should not be given to a child younger than 12 years old.

Do not share fosfomycin with another person, even if they have the same symptoms you have.

How should I take fosfomycin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Fosfomycin is usually given in only one dose. Do not take more than a single dose unless your doctor tells you to.

You may take fosfomycin with or without food.

Fosfomycin is a powder medicine that must be mixed with water before using it. Do not take the dry powder without adding water.

Dissolve the powder in 3 to 4 ounces (1/2 cup) of cold water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Do not mix fosfomycin oral powder with hot water.

It may take 2 or 3 days before your symptoms improve.

Call your doctor if your symptoms do not improve within 3 days after treatment, or if you have any other new symptoms.

To be sure fosfomycin is the right antibiotic for the type of infection you have, your urine may need to be tested before and after you take this medicine.

Store at room temperature away from moisture and heat. Keep the powder in its original package until you are ready to mix your dose.

Fosfomycin dosing information

Usual Adult Dose for Cystitis:

3 g (1 sachet) orally once as a single dose

Comments:
-This drug should not be used for the treatment of pyelonephritis or perinephric abscess.

Use: For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis

Usual Adult Dose for Urinary Tract Infection:

3 g (1 sachet) orally once as a single dose

Comments:
-This drug should not be used for the treatment of pyelonephritis or perinephric abscess.

Use: For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis

What happens if I miss a dose?

Fosfomycin is used as a single dose and does not have a daily dosing schedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include hearing problems and altered sense of taste.

What should I avoid while taking fosfomycin?

Antibiotic medicines can cause diarrhea. Tell your doctor if you have diarrhea that is watery or bloody.

What is fulvestrant?

Fulvestrant is a hormone therapy you may be prescribed if you have certain types of breast cancer. Fulvestrant is an estrogen receptor antagonist that binds to estrogen receptors in breast cancer cells. The hormone estrogen encourages breast cancer cells to grow, and fulvestrant works by binding and blocking the estrogen receptor, which slows the growth of cancer.

Fulvestrant was first approved by the FDA in 2002 after Phase 3 trials showed that the patients on fulvestrant took longer for their cancer to get worse, when compared to patients on Arimidex (anastrozole). It is approved to be used for certain types of breast cancer in women, so your doctor will only prescribe it for you if it has been shown to be effective for your type of cancer.

It is given as an injection into your buttock muscle once a month, but your dose may change depending on how well it is working for you and if you are having side effects. You may also be given other medicines with fulvestrant to treat your breast cancer.

What is fulvestrant used for?

Fulvestrant is a prescription medicine used to treat advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic).

Fulvestrant may be used alone, if you have gone through menopause, and your advanced breast cancer is:

• hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative and has not been previously treated with endocrine therapy
  or
• HR-positive and has progressed after endocrine therapy.

Fulvestrant may be used in combination with ribociclib, if you have gone through menopause, and your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has not been previously treated with endocrine therapy or has progressed after endocrine therapy.

Fulvestrant may be used in combination with palbociclib or abemaciclib if your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has progressed after endocrine therapy.

When fulvestrant is used in combination with palbociclib, abemaciclib, or ribociclib, also read the Patient Information for the prescribed product.

It is not known if this medicine; is safe and effective in children.

It is not known if fulvestrant is safe and effective in people with severe liver problems.

Who should not receive fulvestrant?

Do not receive fulvestrant if you have had an allergic reaction to it or any of the inactive ingredients. See the end of this page for a list of ingredients.

Symptoms of an allergic reaction to fulvestrant may include:

• itching or hives
• swelling of your face, lips, tongue, or throat
• trouble breathing

What should I tell my healthcare provider before taking fulvestrant?

Before receiving this medicine, tell your healthcare provider about all of your medical conditions, including if you:

• have a low level of platelets in your blood or bleed easily
• have liver problems
• are pregnant, or plan to become pregnant. See below for more information on fulvestrant and pregnancy, as it can harm your unborn baby
• are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with fulvestrant and for one year after the last dose. See below for more information on fulvestrant and breastfeeding.
• It is important to tell your healthcare provider if you take a blood thinner medicine.

How will I receive fulvestrant?

• Your healthcare provider will give you fulvestrant by injection into the muscle of each buttock.
• Your healthcare provider may change your dose if needed.

Dosing information

Fulvestrant is an intramuscular injection that is supplied as 5-mL single-dose prefilled syringes containing 250 mg/5 mL fulvestrant.

The recommended dose of fulvestrant is 500 mg to be administered intramuscularly into the buttocks (gluteal area) slowly (1 – 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29, and once monthly thereafter.

What are the possible side effects of fulvestrant?

Fulvestrant may cause serious side effects, including:

• Injection site related nerve damage. Call your healthcare provider if you develop any of the following symptoms in your legs following the injection:
  • numbness
  • tingling
  • weakness

The most common side effects of fulvestrant include:

• injection site pain
• nausea
• muscle, joint, and bone pain
• headache
• back pain
• tiredness
• pain in arms, hands, legs, or feet
• hot flashes
• vomiting
• loss of appetite
• weakness
• cough
• shortness of breath
• constipation
• increased liver enzymes
• diarrhea

Fulvestrant may cause fertility problems in males and females. Talk to your healthcare provider if you plan to become pregnant. See below for more information on fulvestrant and pregnancy.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects with this medicine. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA .

Interactions

Some medications interact with fulvestrant, so it is important to tell your doctor about any medicines that you are currently taking, or if you start or stop any medicine while you are having cancer treatment. Also tell your doctor about any over-the-counter medicines, vitamins, minerals or herbal products that you take.

Especially tell your healthcare provider if you take a blood thinner medicine.

To find out more about interactions with fulvestrant click the link below:

Does fulvestrant interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.Drug nameAdd a drug to check interactionsAdd

Pregnancy and breastfeeding

Pregnancy

You should not take fulvestrant if you are pregnant or planning a pregnancy, as it can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider may perform a pregnancy test within 7 days before you start this medicine.
• You should use effective birth control during treatment with fulvestrant and for one year after the last dose of fulvestrant.
• Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with this medicine.

If you are breastfeeding or plan to breastfeed

• It is not known if this medicine passes into your breast milk.
• Do not breastfeed during your treatment with fulvestrant and for one year after the final dose of fulvestrant.
• Talk to your healthcare provider about the best way to feed your baby during this time.

Storage

How should I store fulvestrant?

• Refrigerate, 2°- 8°c (36°- 46°f).
• Store in the original carton until time of use, to protect this medicine from light.

What are the ingredients in fulvestrant?

Active ingredient: fulvestrant.

Inactive ingredients:

Faslodex single-dose prefilled syringe: alcohol, benzyl alcohol, benzyl benzoate, and castor oil.

Faslodex single-dose prefilled syringe is Manufactured for AstraZeneca UK Limited, Macclesfield, Cheshire, England

What is Kratom?

Kratom is a herbal substance that has a stimulant and opioid-like effect. Kratom stimulant effects include alertness, rapid heart rate, and increased energy. Kratom can also cause effects such as relaxation, confusion, and pain relief similar to opioids and sedatives effect. How kratom affects each person depends on how much is taken, its strength or concentration, how it is taken ( capsules, powder, tea), and the person’s medical conditions and drug-taking history.

Kratom products are made from leaves from Mitragyna speciosa, a tree native to Southeast Asia. Kratom is usually taken as raw plant material either in a capsule, in powder form mixed into drinks or food, tea made with leaves, or as liquid kratom extract.Kratom’s common or street names are Thang, Krypton, Kakuam, Thom, Ketum, Biak-Biak (common name in Thailand), Mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa.

In the US, kratom has been used as an alternative agent for muscle pain relief, diarrhea, and as a treatment for opiate addiction (such as prescription narcotics or heroin), and withdrawal. However, its safety and effectiveness for these conditions has not been clinically determined.

Kratom and the FDA

The FDA notes it has no scientific data that would support the use of kratom for medical purposes. In addition, the FDA states that kratom should not be used as an alternative to prescription opioids, even if using it for opioid withdrawal symptoms. FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs. At this time FDA has said that Kratom is not appropriate for use as a  dietary supplement.

Effective, FDA-approved prescription medications, including buprenorphine (Sublocade), methadone, naltrexone (Vivitrol), and buprenorphine and naloxone (Suboxone) are available from a health care provider, to be used in conjunction with counseling, for opioid withdrawal. Also, they state there are also safer, non-opioid options for the treatment of pain.

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In 2018 the US Centers for Disease Control and Prevention (CDC) reported it was investigating a multistate outbreak of 28 salmonella infections in 20 states linked to kratom use. They noted that 11 people had been hospitalized with salmonella illness linked to kratom. Those who fell ill consumed kratom in pills, powder or tea.

Is kratom legal?

Kratom is not controlled under the Controlled Substances Act but there may be some regulations or prohibitions against the possession and use of kratom in some states. The American Kratom Association is a lobbying and advocacy group in support of kratom use. The American Kratom Association reports that there are a number of misconceptions, misunderstandings and lies floating around about Kratom. They advocate to “fight anti-kratom legislation across the United States.”

The FDA continues to seize adulterated dietary supplements containing kratom. Seized brand names have included: Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical, and El Diablo. There are no currently no FDA approved uses for kratom.

How does kratom work?

As reported in February 2018, the FDA has confirmed from analysis that kratom has opioid properties. More than 20 alkaloids in kratom have been identified in the laboratory, including those responsible for the majority of the pain-relieving action, the indole alkaloid mitragynine, structurally related to yohimbine. Mitragynine is classified as a kappa-opioid receptor agonist and is roughly 13 times more potent than morphine. Mitragynine is thought to be responsible for the opioid-like effects.

Kratom, due to its opioid-like action, has been used for treatment of pain and opioid withdrawal. Animal studies suggest that the primary mitragynine pharmacologic action occurs at the mu and delta-opioid receptors, as well as serotonergic and noradrenergic pathways in the spinal cord. Stimulation at post-synaptic alpha-2 adrenergic receptors, and receptor blocking at 5-hydroxytryptamine 2A may also occur. The 7-hydroxymitragynine may have a higher affinity for the opioid receptors. Partial agonist activity may be involved.

Additional animal studies have suggested that these opioid-receptor effects may be reversible with the opioid antagonist naloxone.

Time to peak concentration in animal studies is reported to be 1.26 hours, and elimination half-life is 3.85 hours. Effects are dose-dependent and occur rapidly, reportedly beginning within 10 minutes after consumption and lasting from one to five hours.

How does kratom make you feel?

Most of the psychoactive effects of kratom have evolved from anecdotal and case reports. Kratom has an unusual action of producing both stimulant effects at lower doses and more CNS depressant side effects at higher doses.

• Stimulant effects manifest as increased alertness, boosted physical energy, talkativeness, and a more social behavior.
• At higher doses, the opioid and CNS depressant effects predominate, but effects can be variable and unpredictable.

Reviews from consumers and the public who have used kratom report lessened anxiety, stress, and fatigue, pain relief, sharpened focus, and relief of withdrawal symptoms. Beside pain, other anecdotal uses include as an anti-inflammatory, antipyretic (to lower fever), antitussive (cough suppressant), antihypertensive (to lower blood pressure), as a local anesthetic, to lower blood sugar, and as an  antidiarrheal. It has also been promoted to enhance sexual function. It’s important to note that none of these uses have been studied clinically or are proven to be safe or effective.

It has been reported that opioid-addicted individuals use kratom to help avoid narcotic-like withdrawal side effects when other opioids are not available. Kratom withdrawal side effects may include irritability, anxiety, craving, yawning, runny nose, stomach cramps, sweating and diarrhea – all similar to opioid withdrawal.

Mixing kratom, other opioids, and other types of medication can be dangerous. Kratom has been shown to have opioid receptor activity, and mixing prescription opioids, or even over-the-counter medications such as loperamide, with kratom may lead to CNS depression and serious side effects.

Related: Kratom: Unsafe and Ineffective

How widely is kratom used?

On the Internet, kratom is marketed in a variety of forms, including kratom  capsules, kratom drinks, kratom tea, raw leaf, powder, gum, pressed into tablets, and as a concentrated extract. In the US and Europe, it appears its use is expanding, and recent reports note increasing use by the college-aged population.

The DEA states that drug abuse surveys have not monitored kratom use or abuse in the US, so its true demographic extent of use, abuse, addiction, or toxicity is not known. However, as reported by the DEA in 2016, there were 660 calls to U.S. poison centers related to kratom exposure from 2010 to 2015.

In 2019, the FDA warned several manufacturers over false claims that their products containing kratom can treat or cure opioid addiction. The companies also made unproven claims for treatment for pain, depression, anxiety and cancer.

What are kratom side effects?

Kratom side effects include sedation, nausea, sweating, dry mouth, increased urination, loss of appetite, itching, constipation, dizziness, and confusion.

Case reports also describe the following kratom side effects: addiction, withdrawal, hypothyroidism, liver injury, aching of muscles and bones, and jerky limb movements.

Kratom addiction and chronic use have led to cases of psychosis with hallucinations, delusion, and confusion. High-dose use may lead to fast heart rate (tachycardia) and low blood pressure (hypotension). Tremor, anorexia, and weight loss are other possible side effects of long-term use.

Seizures have been reported when kratom was combined with modafinil in at least one case report. The DEA has also reported seizure adverse events with recreational kratom use.

A case series (Kronstad and colleagues) described a fatal drug interaction with kratom. A substance dubbed “Krypton” – a mixture of mitragynine and a metabolite of tramadol – was found post-mortem in nine people in Sweden over a one-year period. Tramadol, an opioid-like prescription pain drug, was most likely added to kratom to boost its narcotic-like effect.

Does kratom cause liver injury?

In 2019, researchers published information that liver injury is a possible side effect of kratom use. They reviewed 404 cases of liver damage from  dietary supplements. Eight of the cases, which occurred between 2007 and 2017, were tied to kratom, and the product was used two to six weeks before signs of liver damage appeared. Five patients had jaundice (a yellowing of the skin); six had itching; five had abdominal pain, and three had fever. Six patients were hospitalized, and all got better without the need for a liver transplant.

Is kratom deadly?

In November 2017 and February 2018, the FDA issued a public health advisory about deadly risks associated with kratom. There have been at least 44 reports of kratom-related deaths, sometimes used in combination with other illicit drugs, prescription drugs, or over-the-counter agents such as loperamide (Imodium).

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• The FDA’s analysis from February 2018 included 44 reported deaths associated with the use of kratom. Deaths reported by the FDA have involved one person who had no historical or toxicologic evidence of opioid use, except for kratom.
• In addition, reports suggest kratom may be used in combination with other drugs that have action in the brain, including illicit drugs, prescription opioids, benzodiazepines and over-the-counter medications, like the  anti-diarrheal medicine, loperamide (Imodium AD).

As with many herbal alternatives, designer drugs, or illicit products sold on the Internet, the possibility exists that kratom may also be contaminated with illegal drugs, black market prescription medications, or even poisonous products. Consumers should avoid buying unknown drug products from the Internet. When combined with other drugs — recreational, prescription, or alcohol — the effects of kratom are unknown and may be dangerous.

Is kratom addictive?

Kratom is well-known to be addictive, as found with traditional use by natives over many years in Southeast Asian countries. Withdrawal effects similar to narcotic withdrawal and drug-seeking behaviors have been described in users in Southeast Asia. Many Southeast Asian countries have restricted the use of kratom due to the potential for abuse.

The fact that kratom is derived from a plant should not lead consumers to be believe it 100% safe and “all-natural”. While certainly not all botanicals have dangerous properties, drugs with dangerous effects can come from botanicals, for example, heroin (opium poppy), cocaine (coca leaves), and nicotine (tobacco).

Will a drug test identify kratom use?

Currently, kratom is not included in standard drug screens in the US. Kratom tests are available for screening but are not widely available.

Bottom Line

• Kratom, an herbal product that originated in Southeast Asia, is being used in the US to ease anxiety, treat chronic pain and to reverse opioid withdrawal symptoms; often purchased over the Internet. Recreational use may be on the rise, and it is legal in many US states, but illegal in others.
• Kratom has opioid properties. Mitragynine is classified as a kappa-opioid receptor agonist and is roughly 13 times more potent than morphine. Mitragynine is thought to be responsible for the opioid-like effects.
• According to the FDA, deaths with kratom use have occurred, the scientific literature has disclosed serious concerns regarding the toxicity of kratom in multiple organ systems, and kratom affects the same opioid receptors as morphine.
• The FDA continues warn consumers not to use any products labeled as containing kratom.