tigecycline (Rx)

Brand and Other Names:Tygacil
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 50mg/vial

Complicated Intra-abdominal Infections

Initial: 100 mg IV infusion, THEN

50 mg IV infusion q12hr for 5-14 days

Complicated Skin Infections

Initial: 100 mg IV infusion, THEN

50 mg IV infusion q12hr for 5-14 days

Community-Acquired Pneumonia

Initial: 100 mg IV infusion, THEN

50 mg IV infusion q12hr for 7-14 days

Dosage Modifications

Renal impairment: Dose adjustment not necessary (minimum dialyzed through hemodialysis or peritoneal dialysis)

Hepatic impairment

  • Severe (Child-Pugh C): Maintenance 25 mg IV q12hr (following initial 100 mg)

Dosing Considerations

Not indicated for the treatment of diabetic foot infections; a clinical trial failed to demonstrate noninferiority

Not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia; in a comparative clinical trial, greater mortality and decreased efficacy were reported in tigecycline-treated patients

Susceptible organisms

  • Complicated skin infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible only), Staphylococcus aureus (MRSA and methicillin-susceptible), Streptococcus pyogenes, Streptococcus anginosus grp, Streptococcus agalactiae, or Bacteroides fragilis
  • Complicated intra-abdominal infections caused by E coli, Enterococcus faecalis (vancomycin-susceptible only), S aureus (methicillin-susceptible only), Citrobacter freundii, Enterobacter cloacae, Klebsiella pneumoniae, K oxytoca, B thetaiotaomicron, B uniformis, B vulgatus, Clostridium perfringens, Peptostreptococcus micros
  • Community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Legionella pneumophila

Acute Myeloid Leukemia (Orphan)

Orphan designation for treatment of acute myeloid leukemia

Tigecycline selectively targets leukemia cells and leukemic stem cells by inhibiting mitochondrial protein synthesis

Orphan sponsor

  • Stem Cell Therapeutics Corporation; 96 Skyway Avenue; Toronto, ON M9W 4Y9, Canada

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and tigecycline

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (0)

              Serious - Use Alternative (3)

              • BCG vaccine live

                tigecycline decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.

              • cholera vaccine

                tigecycline, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

              • typhoid vaccine live

                tigecycline decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.

              Monitor Closely (13)

              • bazedoxifene/conjugated estrogens

                tigecycline will decrease the level or effect of bazedoxifene/conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • conjugated estrogens

                tigecycline will decrease the level or effect of conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • dichlorphenamide

                dichlorphenamide, tigecycline. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis.

              • digoxin

                tigecycline will increase the level or effect of digoxin by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • estradiol

                tigecycline will decrease the level or effect of estradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • estrogens conjugated synthetic

                tigecycline will decrease the level or effect of estrogens conjugated synthetic by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • estropipate

                tigecycline will decrease the level or effect of estropipate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • ethinylestradiol

                tigecycline will decrease the level or effect of ethinylestradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate

                tigecycline will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.

              • mestranol

                tigecycline will decrease the level or effect of mestranol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • mipomersen

                mipomersen, tigecycline. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Both drugs have potential to increase hepatic enzymes; monitor LFTs.

              • sodium picosulfate/magnesium oxide/anhydrous citric acid

                tigecycline decreases effects of sodium picosulfate/magnesium oxide/anhydrous citric acid by altering metabolism. Use Caution/Monitor. Coadministration with antibiotics decreases efficacy by altering colonic bacterial flora needed to convert sodium picosulfate to active drug.

                sodium picosulfate/magnesium oxide/anhydrous citric acid decreases levels of tigecycline by cation binding in GI tract. Use Caution/Monitor. Take at least 2 hours before and not less than 6 hours after administration of sodium picosulfate, magnesium oxide and anhydrous citric acid to avoid magnesium chelation.

              • warfarin

                tigecycline increases levels of warfarin by decreasing elimination. Use Caution/Monitor. Minimal effect on INR; monitor.

              Minor (7)

              • balsalazide

                tigecycline will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • biotin

                tigecycline will decrease the level or effect of biotin by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • digoxin

                tigecycline decreases levels of digoxin by unspecified interaction mechanism. Minor/Significance Unknown.

              • pantothenic acid

                tigecycline will decrease the level or effect of pantothenic acid by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • pyridoxine

                tigecycline will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • pyridoxine (Antidote)

                tigecycline will decrease the level or effect of pyridoxine (Antidote) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • thiamine

                tigecycline will decrease the level or effect of thiamine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Nausea (29.5%)

              Vomiting (19.7%)

              Diarrhea (12.7%)

              1-10%

              Infection (8.3%)

              Fever (7.1%)

              Abd pain (6.8%)

              Headache (5.9%

              HTN (4.9%)

              Anemia (4.2%)

              Dizziness (3.5%)

              Dyspnea (2.9%)

              Pruritus (2.6%)

              Rash (2.4%)

              Hypotension (2.3%)

              Insomnia (2.3%)

              Postmarketing Reports

              Anaphylaxis/anaphylactoid reactions

              Acute pancreatitis

              Hypofibrinogenemia

              Hepatic cholestasis and jaundice

              Severe skin reactions, including Stevens-Johnson Syndrome

              Symptomatic hypoglycemia in patients with or without diabetes mellitus

              Prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia

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              Warnings

              Black Box Warnings

              Increased mortality with use of tigecycline for FDA-approved indications, as well as for nonapproved indications, compared with other antibiotics

              FDA approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP); it is not approved for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia

              Analysis from 10 clinical trials for FDA-approved uses (cSSSI, cIAI, CABP), including trials conducted after the drug was approved, showed a higher risk of death among patients receiving tigecycline, compared with other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively; the adjusted risk difference for death was 0.6%, with a corresponding 95% confidence interval (0.0%, 1.2%)

              Contraindications

              Documented hypersensitivity

              Cautions

              Severe hepatic impairment

              Pregnancy

              Caution in severe hepatic impairment (reduce dose); patients who develop abnormal liver function tests during therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing tigecycline therapy

              Use during tooth development may cause permanent discoloration of teeth; adverse reaction is more common during long-term use but has been observed following repeated short-term courses; enamel hypoplasia has also been reported

              Use during second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth; tetracyclines form a stable calcium complex in any bone-forming tissue; a decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours; effect was shown to be reversible when therapy was discontinued; advise patient of potential risk to fetus if drug is used during second or third trimester of pregnancy

              Hypofibrinogenemia reported; obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment

              May permit clostridia overgrowth, resulting in antibiotic-associated colitis; evaluate for Clostridium difficile if diarrhea occurs

              Avoid use in patients with known hypersensitivity to tetracyclines

              May have adverse effects similar to those of tetracyclines (eg, photosensitivity, pseudotumor cerebri, antianabolic action)

              Pancreatitis, including fatalities, reported; if pancreatitis suspected, consider stopping treatment

              Increased mortality risk with use of IV tigecycline (see Black Box Warnings)

              May cause fetal harm when administered to a pregnant woman

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              Pregnancy & Lactation

              Pregnancy

              May cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during second and third trimesters of pregnancy

              There are no available data on risk of major birth defects or miscarriage following use during pregnancy

              Advise patients of potential risk to fetus if drug is used during second or third trimester

              Animal data

              • Administration of intravenous tigecycline in pregnant rats and rabbits during period of organogenesis was associated with reduction in fetal weights and an increased incidence of skeletal anomalies (delays in bone ossification) at exposures of 5 and 1 times the human exposure at recommended clinical dose in rats and rabbits, respectively

              Lactation

              There are no data on presence of drug in human milk; however, tetracycline-class antibacterial drugs are present in breast milk

              Not known whether drug has an effect on breastfed infant or on milk production

              Drug has low oral bioavailability; therefore, infant exposure is expected to be low

              Drug is present in rat milk with little or no systemic exposure to drug in nursing pups as a result of exposure via maternal milk; when drug is present in animal milk, it is likely that the drug will be present in human milk

              Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition

              Because of theoretical risk of dental discoloration and inhibition of bone growth, avoid breastfeeding if receiving therapy for longer than three weeks

              A lactating woman may consider interrupting breastfeeding and pumping and discarding breastmilk during administration of therapy and for 9 days (approximately 5 half-lives) after last dose in order to minimize drug exposure to a breastfed infant

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              A glycylcycline antibiotic that is structurally similar to tetracycline antibiotics; inhibits bacterial protein translation by binding to 30S ribosomal subunit, and blocks entry of amino-acyl tRNA molecules in ribosome A site.

              Distribution

              Protein bound: 71-89%

              Vdss: 500-700 L

              Metabolism

              Not extensive

              Elimination

              Half-life: (single dose) 27 hr; (multiple dose) 42 hr

              Excretion: urine (33%); feces (59%)

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              Administration

              IV Incompatibilities

              Y-site: amphotericin B, chlorpromazine, methylprednisolone, voriconazole

              IV Compatibilities

              Solution: NS, D5W

              Y-site: dobutamine, dopamine, LR, KCl, theophylline, ranitidine, lidocaine

              IV Preparation

              Reconstitute each vial with 5.3 mL NS or D5W to achieve a conc of 10 mg/mL

              Gently swirl to dissolve

              Immediately withdraw 5 mL and add to a 100-mL infusion bag

              IV Administration

              Infuse over 30-60 min

              Through dedicated line or Y-site

              Storage

              Store vials at 20-25°C (68-77°F)

              May be stored in IV bag at room temp for up to 6 hr or refrigerated at 2-8°C for up to 24 hr

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              tigecycline intravenous
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              50 mg vial
              tigecycline intravenous
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              tigecycline intravenous
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              tigecycline intravenous
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              tigecycline intravenous
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              tigecycline intravenous
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              tigecycline intravenous
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              Tygacil intravenous
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              50 mg vial
              Tygacil intravenous
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              50 mg vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              tigecycline intravenous

              TIGECYCLINE - INJECTION

              (TYE-ge-SYE-kleen)

              COMMON BRAND NAME(S): Tygacil

              WARNING: This medication may increase the risk of death. It should only be used when other treatments have not worked. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for your infection, with your doctor.

              USES: Tigecycline is used to treat certain serious bacterial infections when other antibiotics may not work. It is related to a class of drugs known as tetracycline antibiotics. It works by stopping the growth of bacteria.This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

              HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using tigecycline and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein over 30 to 60 minutes by a healthcare professional. It is given as directed by your doctor, usually every 12 hours. The dosage is based on your medical condition and response to treatment.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Swirl the medication gently to mix. Do not shake. The mixed medication should be yellow to orange in color. Before using, check this product visually for particles or green/black discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same times every day.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition lasts or gets worse.

              SIDE EFFECTS: Nausea, vomiting, headache, dizziness, or pain/swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), unusual fatigue, severe stomach/abdominal pain, hearing changes (such as ringing in the ears, decreased hearing), irregular heartbeat, easy bleeding/bruising, yellowing of the eyes or skin, dark urine.Tetracycline drugs such as tigecycline may rarely cause a serious increase in pressure inside the skull (intracranial hypertension-IH). The risk of this side effect is greater for women of childbearing age who are overweight or who have had IH in the past. If IH develops, it usually goes away after tigecycline is stopped; however, there is a chance of permanent vision loss or blindness. Get medical help right away if you have: headaches that are severe or don't go away, nausea/vomiting that doesn't stop, vision changes (such as blurred/double vision, decreased vision, sudden blindness).This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: See also Side Effects section.Before using tigecycline, tell your doctor or pharmacist if you are allergic to it; or to tetracyclines (such as doxycycline, minocycline, tetracycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Tigecycline may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Children younger than 8 years may be more sensitive to the side effects of tigecycline, especially tooth discoloration. Tooth discoloration has also occurred in older children and in young adults. Discuss the risks and benefits of this medication with the doctor.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using tigecycline. Tigecycline may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: retinoid medications taken by mouth (such as acitretin, isotretinoin).

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.Lab and/or medical tests (such as liver function, fibrinogen levels, blood counts, cultures) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

              STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.