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Tuesday, October 4, 2016

Mobimed

Mobimed may be available in the countries listed below.

Ingredient matches for Mobimed

Meloxicam

Meloxicam is reported as an ingredient of Mobimed in the following countries:

Vietnam

International Drug Name Search

Monday, October 3, 2016

Cipro XR Extended-Release Tablets

Pronunciation: SIP-roe-FLOX-a-sin
Generic Name: Ciprofloxacin
Brand Name: Generic only. No brands available.

Cipro XR Extended-Release Tablets are associated with an increased risk of tendon problems. These include pain, swelling, inflammation, and possible breakage of tendons. The risk of tendon problems is greater in patients who are older than 60 years, patients who take corticosteroids (eg, prednisone), and in those who have received kidney, heart, or lung transplants. The Achilles tendon in the back of the foot/ankle is most often affected. However, problems may also occur in other tendons (eg, in the shoulder, arm, hand). Problems may occur while you take Cipro XR Extended-Release Tablets or up to several months after you stop taking it.

Signs of tendon problems may include pain, soreness, redness, or swelling of a tendon or joint; bruising right after an injury in a tendon area; hearing or feeling a snap or pop in a joint or tendon area; or inability to move or bear weight on a joint or tendon area. Tell your doctor right away if you experience any of these symptoms while you take Cipro XR Extended-Release Tablets or within several months after you stop taking it.

Cipro XR Extended-Release Tablets may worsen muscle weakness and breathing problems in patients with myasthenia gravis. Do not take Cipro XR Extended-Release Tablets if you have a history of myasthenia gravis.

Cipro XR Extended-Release Tablets are used for:

Treating urinary tract infections caused by certain bacteria.

Cipro XR Extended-Release Tablets are a fluoroquinolone antibiotic. It works by killing sensitive bacteria.

Do NOT use Cipro XR Extended-Release Tablets if:

you are allergic to any ingredient in Cipro XR Extended-Release Tablets or to any other fluoroquinolone (eg, levofloxacin)

you have a history of myasthenia gravis

you are taking tizanidine or you have recently received a live oral typhoid vaccine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cipro XR Extended-Release Tablets:

Some medical conditions may interact with Cipro XR Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a stomach infection, liver problems, brain or nervous system problems, increased pressure in the brain, Alzheimer disease, brain blood vessel problems, muscle problems (eg, myasthenia gravis), or a history of seizures

if you have a history of severe or persistent diarrhea, skin sensitivity to the sun, low blood potassium levels, heart problems, or irregular heartbeat (eg, QT prolongation), or if you have a family member with a history of irregular heartbeat

if you have a history of joint or tendon problems; rheumatoid arthritis; kidney problems or decreased kidney function; or a heart, kidney, or lung transplant

if you take corticosteroids (eg, prednisone) or you participate in strenuous physical work or exercise

Some MEDICINES MAY INTERACT with Cipro XR Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Antiarrhythmics (eg, amiodarone, quinidine) because the risk of serious side effects, including irregular heartbeat, may be increased

Corticosteroids (eg, prednisone) because they may increase the risk of tendon problems

Diuretics (eg, furosemide, hydrochlorothiazide), metoclopramide, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or probenecid because they may increase the risk of Cipro XR Extended-Release Tablets's side effects

Anticoagulants (eg, warfarin), antipsychotics (eg, clozapine), cyclosporine, methotrexate, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), sulfonylureas (eg, glyburide), theophylline, tizanidine, tricyclic antidepressants (eg, amitriptyline), or xanthines (eg, caffeine) because the risk of their side effects may be increased by Cipro XR Extended-Release Tablets

Hydantoins (eg, phenytoin) or live oral typhoid vaccine because their effectiveness may be decreased by Cipro XR Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cipro XR Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cipro XR Extended-Release Tablets:

Use Cipro XR Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Cipro XR Extended-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Cipro XR Extended-Release Tablets refilled.

Take Cipro XR Extended-Release Tablets by mouth with or without food. The preferred dosing time is 2 hours after a meal.

Swallow Cipro XR Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.

Take Cipro XR Extended-Release Tablets with a full glass of water (8 oz/240 mL).

Drinking extra fluids while you are taking Cipro XR Extended-Release Tablets are recommended. Check with your doctor for instructions.

If you also take any products containing magnesium, aluminum, calcium, iron, or zinc (eg, antacids, quinapril, vitamins/minerals); didanosine; sucralfate; or bismuth subsalicylate, do not take them within 6 hours before or 2 hours after taking Cipro XR Extended-Release Tablets. Check with your doctor if you have questions.

If you also take sevelamer, do not take it within 4 hours before or after taking Cipro XR Extended-Release Tablets. Check with your doctor if you have questions.

To clear up your infection completely, take Cipro XR Extended-Release Tablets for the full course of treatment. Keep taking it even if you feel better in a few days.

Avoid taking Cipro XR Extended-Release Tablets with milk or milk products (eg, calcium-enriched juice, yogurt) by themselves. However, taking Cipro XR Extended-Release Tablets as part of a full meal that contains milk or milk products is permitted.

If you miss a dose of Cipro XR Extended-Release Tablets, take it as soon as possible if you remember on the same day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses on the same day.

Ask your health care provider any questions you may have about how to use Cipro XR Extended-Release Tablets.

Important safety information:

Cipro XR Extended-Release Tablets may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Cipro XR Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Be sure to use Cipro XR Extended-Release Tablets for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

Long-term or repeated use of Cipro XR Extended-Release Tablets may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

Cipro XR Extended-Release Tablets only works against bacteria; it does not treat viral infections (eg, the common cold).

Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate).

Tell your doctor right away if you experience pain or swelling of a tendon or weakness or loss of use of a joint area. Rest the area and avoid exercise until further instruction from your doctor.

Diabetes patients - Cipro XR Extended-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Cipro XR Extended-Release Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Cipro XR Extended-Release Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.

Use Cipro XR Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects (eg, tendon problems), especially if they take corticosteroids (eg, prednisone). They may also be more sensitive to other effects (eg, irregular heartbeat).

Cipro XR Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 18 years; they may be more sensitive to its effects, especially joint and tendon problems.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Cipro XR Extended-Release Tablets while you are pregnant. Cipro XR Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Cipro XR Extended-Release Tablets.

Possible side effects of Cipro XR Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine or unusual change in the amount of urine; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; loss of consciousness; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath or trouble breathing; stomach cramps or pain; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cipro XR side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Cipro XR Extended-Release Tablets:

Store Cipro XR Extended-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cipro XR Extended-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Cipro XR Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

Cipro XR Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cipro XR Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Cipro XR resources

Cipro XR Side Effects (in more detail)
Cipro XR Use in Pregnancy & Breastfeeding
Drug Images
Cipro XR Drug Interactions
Cipro XR Support Group
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Anthrax
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Delavirdine Mesylate

Delavirdine Mesylate may be available in the countries listed below.

Ingredient matches for Delavirdine Mesylate

Delavirdine

Delavirdine Mesylate (USAN) is known as Delavirdine in the US.

International Drug Name Search

Glossary

USAN

United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Lenalidomide

Class: Biologic Response Modifiers
Chemical Name: 2,6-Piperidinedione, 3-(4-amino-1-3-dihydro-1-oxo-2H-isoindol-2yl)-; 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione
Molecular Formula: C₁₃H₁₃N₃O₃
CAS Number: CAS-191732-72-6
Brands: Revlimid

Special Alerts:

[Posted 04/08/2011] ISSUE: FDA is informing the public that we are aware of results from clinical trials conducted inside and outside the United States that found that patients treated with lenalidomide (Revlimid) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.

BACKGROUND: Lenalidomide is used to treat a type of blood disorder known as myelodysplastic syndrome. Lenalidomide is also used along with other drugs to treat people with the cancer known as multiple myeloma.

RECOMMENDATION: At this time, there is no recommendation to delay, modify or restrict the use of lenalidomide for patients being treated according to the FDA-approved indications. FDA is currently reviewing all available information on this potential risks and will communicate any new recommendations once it has completed its review. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for lenalidomide to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of lenalidomide and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page () or the ASHP REMS Resource Center ().

Teratogenic Effects

Potential risk of teratogenicity and fetotoxicity due to structural similarity to thalidomide, a known human teratogen that can cause severe, life-threatening birth defects if administered during pregnancy.¹ ⁷ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Teratogenicity Precautions

Contraindicated in pregnant women; use in women of childbearing potential only when alternative treatments are not available and adequate precautions taken to prevent fetal exposure.¹ (See Contraindications and also Fetal/Neonatal Morbidity and Mortality under Cautions.)

Pregnancy must be excluded with 2 confirmed negative pregnancy tests (sensitivity to detect human serum chorionic gonadotropin [HCG] concentrations of ≥50 million IU/mL); one test within 10–14 days and another ≤24 hours prior to treatment initiation.¹ ^j Repeat pregnancy tests throughout therapy (i.e., once weekly during first month, then monthly or every 2 weeks in women with regular or irregular menstrual cycles, respectively).¹ ⁷ ^j

Pregnancy must be prevented (even in females with a history of infertility) by simultaneous use of 2 forms of reliable contraception for ≥4 weeks prior to, throughout, and for 4 weeks after completion of therapy.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.) Mandatory contraception not required for females who have undergone hysterectomy or bilateral oophorectomy, are postmenopausal and have had no menses for ≥24 consecutive months, or practice continuous abstinence from heterosexual contact.¹

Sexually mature males (including successfully vasectomized men) must completely avoid unprotected sexual contact with women of childbearing potential (i.e., use latex condom throughout and for ≥4 weeks after lenalidomide therapy) because it is unknown if drug distributes into semen.¹ ⁷

Provide pregnancy tests and counseling if a patient misses her period or has abnormalities in menstrual bleeding.¹

If pregnancy occurs, immediately discontinue treatment.¹ Refer patient to obstetrician-gynecologist experienced in reproductive toxicity for further evaluation and counseling.¹ Report any suspected fetal exposure to FDA MedWatch Program at 1-800-FDA-1088 and to manufacturer at 1-888-423-5436.¹

Restricted Distribution Program

Available only through restricted distribution program, the RevAssist program, designed because of potential teratogenicity and to help ensure that fetal exposure does not occur.¹ (See Restricted Distribution Program under Dosage and Administration.)

Limits access to lenalidomide to prescribing clinicians, pharmacies, and patients who are registered in program and mandates compliance with registration, education, and safety requirements.¹ ⁷ ^j

Registered prescribing clinicians must understand risks of teratogenicity if used during pregnancy and must not provide a prescription until a documented negative pregnancy test available.¹

Patient or parent/legal guardian (for minors 12–18 years of age) must be capable of understanding and complying with patient registration, education, patient survey, and safety requirements, including mandatory contraceptive measures and pregnancy testing.¹ ⁷

Provide oral and written warnings of risk of possible contraceptive failure, hazards of using drug during pregnancy, exposing fetus to drug, and possibility of drug in semen.¹ ⁷

Patient or parent/legal guardian must provide written acknowledgement of understanding of these warnings and need for mandatory contraceptive measures.¹ ⁷

Hematologic Toxicity

Risk of severe thrombocytopenia and neutropenia.¹ ⁷ (See Hematologic Effects under Cautions.)

Grade 3 or 4 neutropenia and/or thrombocytopenia reported in 80% of patients with myelodysplastic syndromes (MDS) with deletion 5q abnormality.¹ Dosage delay or reduction required in 80% of such patients; a second dosage delay or reduction required in 34% of patients.¹

Monitor CBCs weekly for the first 8 weeks of therapy for MDS and at least monthly thereafter.¹ Dosage interruption and/or reduction and supportive therapy (e.g., blood products) and/or hematopoietic agents (colony-stimulating factors) may be required.¹ (See Dosage Modification for Toxicity in Patients with MDS under Dosage and Administration.)

Thromboembolic Effects

Increased risk of venous thromboembolism (e.g., DVT, PE) in patients with multiple myeloma when used in combination with dexamethasone.¹ ⁷ ^c ^h ^k (See Thromboembolic Effects under Cautions.)

Monitor for signs and symptoms of thromboembolism.¹ ⁷

Introduction

Biologic response modifier; thalidomide analog with immunomodulatory, antineoplastic, and antiangiogenic activity.¹ ^a ^b ^c ^d ^e ⁱ

Uses for Lenalidomide

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Myelodysplastic Syndrome (MDS)

Treatment of RBC transfusion-dependent anemia associated with low- or intermediate-1-risk MDS in patients with a cytogenetic deletion abnormality involving the long arm of chromosome 5 (deletion 5q abnormality), with or without additional cytogenetic abnormalities¹ ³ ⁵ ⁷ ⁱ (designated an orphan drug by FDA for this use).⁶

Multiple Myeloma

Treatment of multiple myeloma (in combination with dexamethasone) in patients who have received at least one prior therapy¹ ⁷ (designated an orphan drug by FDA for this use).⁶

Combination therapy with dexamethasone substantially more effective than dexamethasone monotherapy in achieving overall, complete, and partial response in patients who have received at least one prior therapy.¹

Lenalidomide Dosage and Administration

General

Adjust dosage carefully according to individual response and laboratory parameters (e.g., blood cell counts).¹ ⁷

Carefully monitor CBCs (including differential and platelets) during therapy.¹ (See Hematologic Effects under Cautions.)

Administration

Restricted Distribution Program

Distribution of lenalidomide is restricted because it is an analog of thalidomide (a known teratogen that can cause severe birth defects).¹ (See Boxed Warning and see Fetal/Neonatal Morbidity and Mortality under Cautions.)

Must be obtained through a restricted distribution program (RevAssist) to ensure that fetal exposure to lenalidomide does not occur.¹ ^c ^j The program requires registration of clinicians, pharmacies, and patients; all must agree to accept specific responsibilities (e.g., mandatory contraceptive measures, pregnancy testing) designed to minimize pregnancy exposures in order to prescribe, dispense, or use lenalidomide.¹ ⁷ ^j

RevAssist program ensures appropriately timed and properly documented pregnancy testing and counseling of patients before, during, and following lenalidomide therapy.¹

Prior to initiation of therapy, females must certify that they are not pregnant or not of childbearing potential (i.e., have undergone hysterectomy or bilateral oophorectomy, postmenopausal [no menses for ≥24 consecutive months]).¹

Pharmacists registered with the restricted distribution program must offer counseling, provide educational materials (e.g., patient information guide), and confirm negative pregnancy test results (in women of childbearing potential) each time drug is dispensed.¹ ^c ^j

To facilitate pregnancy testing and counseling in accordance with RevAssist program, prescribe and dispense ≤28-day supply of drug.¹ ⁷ ^c ^j Patients and prescribers must participate in monthly telephone surveys to receive authorization for each prescription written.¹ ^c ^j

For additional details on program requirements, contact Celgene at 888-423-5436 or see RevAssist website at .¹ ⁷ ^j

Oral Administration

Administer orally with water once daily.¹ ⁷

Swallow capsules whole; do not break, chew, or open capsules.¹ ⁷

Administer as a single 25-mg capsule for treatment of multiple myeloma.¹ Effects of substituting lower-strength capsules to achieve a 25-mg dose not known.¹

If a dose is missed, take as soon as remembered; if a dose is missed for an entire day, skip dose and resume regular dosing schedule the following day.⁷ Do not double a dose.⁷

Manufacturer makes no specific recommendations regarding administration with meals; food may decrease peak plasma concentrations.¹ (See Food under Pharmacokinetics.)

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adults

Myelodysplastic Syndrome

Oral

Initially, 10 mg once daily.¹ Continue or adjust initial dosage based on clinical response and laboratory parameters (e.g., blood cell counts).¹ ⁷

If thrombocytopenia and/or neutropenia occur, reduce dosage or interrupt therapy based on degree of myelosuppression.¹ (See Dosage Modification for Toxicity in Patients with MDS under Dosage and Administration.)

Dosage Modification for Toxicity in Patients with MDS

Oral

Table 1. Dosage Adjustment for Thrombocytopenia Occurring ≤4 Weeks After Initiation of Therapy
Lenalidomide Daily Dosage	Platelet Count (per mm³)	Dosage Adjustment
10 mg	Baseline count ≥100,000 and then decreases to <50,000	Discontinue therapy.¹ When count returns to ≥50,000/mm³, resume therapy at 5 mg daily.¹
10 mg	Baseline count <100,000 and then decreases to 50% of baseline	Discontinue therapy.¹ When count returns to ≥50,000/mm³ (for baseline ≥60,000/mm³) or ≥30,000/mm³ (for baseline <60,000/mm³), resume therapy at 5 mg daily.¹
5 mg	<30,000 or <50,000 (with platelet transfusions)	Discontinue therapy.¹ When count returns to ≥30,000/mm³ (without hemostatic failure), resume therapy at 5 mg every other day.¹

Table 2. Dosage Adjustment for Thrombocytopenia Occurring >4 Weeks After Initiation of Therapy
Lenalidomide Daily Dosage	Platelet Count (per mm³)	Dosage Adjustment
10 mg	<30,000 or <50,000 (with platelet transfusions)	Discontinue therapy.¹ When count returns to ≥30,000/mm³ (without hemostatic failure), resume therapy at 5 mg daily.¹
5 mg	<30,000 or <50,000 (with platelet transfusions)	Discontinue therapy. When count returns to ≥30,000/mm³ (without hemostatic failure), resume therapy at 5 mg every other day.¹

Table 3. Dosage Adjustment for Neutropenia Occurring ≤4 Weeks After Initiation of Therapy
Lenalidomide Daily Dosage	ANC (per mm³)	Dosage Adjustment
10 mg	Baseline ≥1000 and then decreases to <750	Discontinue therapy.¹ When ANC returns to ≥1000/mm³, resume therapy at 5 mg daily. ¹
10 mg	Baseline ANC <1000 and then decreases to <500	Discontinue therapy.¹ When ANC returns to ≥500/mm³, resume therapy at 5 mg daily. ¹
5 mg	If ANC decreases to <500 for ≥7 days or decreases to <500 associated with fever (≥38.5°C)	Discontinue therapy.¹ When ANC returns to ≥500/mm³, resume therapy at 5 mg every other day. ¹

Table 4. Dosage Adjustment for Neutropenia Occurring >4 Weeks After Initiation of Therapy
Lenalidomide Daily Dosage	ANC (per mm³)	Dosage Adjustment
10 mg	If ANC decreases to <500 for ≥7 days or decreases to <500 associated with fever (≥38.5°C)	Discontinue therapy.¹ When ANC returns to ≥500/mm³, resume therapy at 5 mg daily. ¹
5 mg	If ANC decreases to <500 for ≥7 days or decreases to <500 associated with fever (≥38.5°C)	Discontinue therapy.¹ When ANC returns to ≥500/mm³, resume therapy at 5 mg every other day. ¹

Multiple Myeloma

Oral

Initially, 25 mg once daily given on days 1–21 of each 28-day cycle.¹ ^d ^e Administer with oral dexamethasone 40 mg daily on days 1–4, 9–12, and 17–20 of each 28-day cycle for the first 4 cycles of therapy, then reduce to 40 mg daily on days 1–4 of subsequent cycles.¹ ^d ^e

Continue or adjust initial dosage based on clinical response and laboratory parameters (e.g., blood cell counts).¹ ⁷ (See Dosage Modification for Toxicity in Patients with Multiple Myeloma Under Dosage and Administration.)

Dosage Modification for Toxicity in Patients with Multiple Myeloma

Hematologic Toxicity.

Oral

Continue at reduced dosage for remainder (up to 21 days) of treatment cycle.

Table 5. Dosage Adjustment for Thrombocytopenia During Therapy
Platelet Count (per mm³)	Dosage Adjustment
<30,000	Discontinue therapy and monitor CBCs weekly.¹ When count returns to ≥30,000/mm³, reduce dosage to 15 mg daily.
For each subsequent decrease to <30,000	Discontinue therapy.¹ When count returns to ≥30,000, resume at a dosage 5 mg less than previous dose; do not administer <5 mg daily.

Continue at reduced dosage for remainder (up to 21 days) of a 28-day treatment cycle.

Table 6. Dosage Adjustment for Neutropenia During Therapy
ANC (per mm³)	Dosage Adjustment
<1000	Discontinue therapy, add a granulocyte colony-stimulating factor (G-CSF), and monitor CBCs weekly.¹
≥1000 (following discontinuation of therapy ) and no other toxicity present	Resume at 25 mg daily.¹
≥1000 (following discontinuation of therapy) and other toxicity present	Reduce dosage to 15 mg daily.¹
For each subsequent decrease to <1000	Discontinue therapy.¹ When count returns to ≥1000/mm³, resume at a dosage 5 mg less than previous dose; do not administer <5 mg daily.¹

Other Grade 3/4 Toxicities.

If patient experiences other grade 3 or 4 nonhematologic toxicities, interrupt therapy and resume at next lower dosage level when toxicity resolves or decreases to ≤grade 2 (i.e., reduce to 15 mg; if necessary, further reduce dosage 5 mg less than previous dose [not <5 mg daily given on days 1–21 of each 28-day cycle]).¹ ⁸

Prescribing Limits

Adults

Multiple Myeloma

Oral

Minimum 5 mg daily given on days 1–21 of each 28-day cycle.¹

Special Populations

Renal Impairment

Myelodysplastic Syndrome

Oral

Dosage for Treatment of MDS in Adults with Renal Impairment8f
Cl_cr (mL/min)	Dosage
≥50	10 mg once daily
30–49	5 mg once daily
<30 (not requiring dialysis)	5 mg every 48 hours
End stage renal disease (requiring dialysis)	5 mg 3 times a week following each dialysis

Multiple Myeloma

Oral

Dosage may be increased to 15 mg once daily after 2 cycles in patients who have not responded to therapy.

Based on dosing for 21 days of a 28-day cycle.

Dosage for Multiple Myeloma in Adults with Renal Impairment8f
Cl_cr (mL/min)	Dosage
≥50	25 mg once daily
30–49	10 mg once daily^,
<30 (not requiring dialysis)	15 mg every 48 hours
End stage renal disease (requiring dialysis)	15 mg 3 times a week following each dialysis

Geriatric Patients

Select dosage with caution because of age-related decreases in renal function; reduced dosages may be required.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Lenalidomide

Contraindications

Pregnancy.¹ ⁷ (See Boxed Warning and see Fetal/Neonatal Morbidity and Mortality under Cautions.)

Females of childbearing potential, unless they comply with all special conditions required by manufacturer and RevAssist program.¹ (See Boxed Warning and see Restricted Distribution Program under Dosage and Administration.)

Known hypersensitivity to lenalidomide or any ingredient in the formulation.¹ ⁷

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.¹ ⁷ Teratogenic effects of lenalidomide not fully established, but considered a potential teratogen due to structural similarity to thalidomide, a known human teratogen associated with severe birth defects and fetal death.¹ ⁷ ^g (See Boxed Warning.)

Contraindicated in female patients who are or may become pregnant unless alternative therapies not available and adequate precautions taken to avoid pregnancy.¹

Women of childbearing potential must use 2 forms of effective contraception ≥4 weeks prior to, throughout, and for 4 weeks following completion of therapy.¹ ⁷ Use a highly effective birth control method (e.g., intrauterine device [IUD]; oral, injectable, or implanted hormonal contraceptive; tubal ligation; vasectomized partner) and an effective barrier method (e.g., latex condom, diaphragm, cervical cap).¹ If either IUD or hormonal contraceptive use contraindicated, may use another highly effective method or 2 simultaneous effective barrier methods.¹

If clinician not available, information about emergency contraception (including information regarding clinicians who provide emergency contraceptive services) can be obtained by calling 1-888-668-2528.¹

Not known whether lenalidomide is present in semen; sexually mature males (including those who have undergone successful vasectomy) receiving lenalidomide must use a latex condom each time they have sexual contact with a woman of childbearing potential during therapy and for 4 weeks following completion of therapy.¹ ⁷

Hematologic Effects

Risk of severe (grade 3 or 4) neutropenia and/or thrombocytopenia.¹ ³ ⁷ ^a ⁱ

Grade 3/4 hematologic toxicities reported in about 80% of patients with MDS associated with deletion 5q abnormality.¹ Generally occurs during initial weeks (approximately 6 weeks for neutropenia and 4 weeks for thrombocytopenia) of treatment and reverses with dosage reduction or discontinuance.¹ ³ ⁵

Higher frequency of grade 3/4 hematologic toxicities reported in patients with multiple myeloma receiving combination therapy with dexamethasone compared with those receiving dexamethasone alone.¹

Carefully monitor hematologic status during therapy.¹ Obtain baseline CBCs.^j In patients with MDS, perform weekly CBCs during first 8 weeks of therapy, and at least monthly thereafter.¹ In patients with multiple myeloma, perform CBCs every 2 weeks for the first 12 weeks of therapy, and at least monthly thereafter.¹

If hematologic toxicity occurs, interrupt therapy and/or reduce dosage according to degree of myelosuppression.¹ (See Dosage Modification for Toxicity in Patients with MDS and also Dosage Modification for Toxicity in Patients with Multiple Myeloma under Dosage and Administration.) Initiate supportive therapy with blood product transfusions or growth factors (e.g., G-CSF) if indicated.¹ ⁵

Thromboembolic Events

Risk of venous thromboembolism (e.g., DVT, PE) in patients with multiple myeloma, especially when used in combination therapy with dexamethasone.¹ ⁷ ^c ^h ^k

Monitor for signs and symptoms of thromboembolism (e.g., shortness of breath, chest pain, arm or leg swelling).¹ Carefully assess preexisting risk factors (e.g., age, recent surgery, trauma, immobility) and consider prophylactic antiplatelet or anticoagulation treatment. ¹ ^c ^d ^h ^k Based on limited data, some experts recommend prophylaxis in all patients receiving lenalidomide for multiple myeloma.^c ^k

Specific Populations

Pregnancy

Category X.¹ (See Contraindications and also Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether lenalidomide is distributed into milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹ ⁷

Geriatric Use

No substantial differences in efficacy relative to younger adults; however, increased incidence of serious adverse effects reported in patients >65 years of age compared with younger patients.¹ ⁸

Principally eliminated by kidneys.¹ Assess renal function and select dosage carefully due to greater frequency of decreased renal function in geriatric patients.¹ (See Geriatric Patients under Dosage and Administration.)

Renal Impairment

Substantially eliminated by kidneys; possible increased toxicity in patients with renal impairment.¹

Monitor renal function; adjust dosage if necessary based on degree of renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

MDS: Thrombocytopenia,¹ ³ ⁵ ^b ⁱ neutropenia,¹ ³ ⁵ ^b ^c ⁱ diarrhea,¹ ³ ⁷ ⁱ pruritus,¹ ³ ⁷ ⁱ rash,¹ ⁷ ⁱ fatigue,¹ ³ ⁷ ⁱ constipation,¹ ⁱ nausea,¹ ⁱ nasopharyngitis,¹ arthralgia,¹ back pain,¹ fever,¹ peripheral edema,¹ ⁱ cough,¹ dizziness,¹ headache,¹ muscle cramps,¹ dyspnea,¹ pharyngitis,¹ asthenia,¹ epistaxis,¹ upper respiratory tract infection,¹ dry skin,¹ abdominal pain,¹ anemia,¹ pneumonia,¹ hypokalemia,¹ limb pain,¹ urinary tract infection,¹ anorexia,¹ edema,¹ ³ insomnia,¹ vomiting.¹

Multiple myeloma: Constipation,¹ ^d fatigue,¹ ^d insomnia,¹ muscle cramps,¹ diarrhea,¹ neutropenia,¹ anemia,¹ asthenia,¹ fever,¹ nausea,¹ headache,¹ peripheral edema,¹ dizziness,¹ dyspnea,¹ tremor,¹ weight loss,¹ thrombocytopenia,¹ rash,¹ ^d back pain,¹ hyperglycemia,¹ muscle weakness,¹ blurred vision,¹ cough,¹ dyspepsia,¹ anorexia,¹ upper respiratory tract infection,¹ dysgeusia,¹ paresthesia,¹ hypokalemia,¹ pneumonia,¹ arthralgia,¹ vomiting.¹

Interactions for Lenalidomide

Not metabolized by CYP isoenzymes.¹ Does not inhibit or induce CYP isoenzymes.¹

Specific Drugs

Drug	Interaction	Comments
Digoxin	Increased peak plasma digoxin concentrations¹	Monitor plasma digoxin concentrations¹
Warfarin	No pharmacokinetic interaction observed with single dose of warfarin¹

Lenalidomide Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration.¹ ^f

In healthy patients, peak plasma concentrations attained within approximately 0.625–1.5 hours following oral administration.¹ ^c ^f

In patients with multiple myeloma, peak plasma concentrations attained within 0.5–4 hours following oral administration.¹ AUC is 57% higher than in healthy male volunteers.¹

Food

Food decreases peak plasma concentrations by 36%,¹ but does not alter extent of absorption.¹ ^f

Special Populations

In multiple myeloma patients with mild renal impairment, AUC increased by 56% compared with those with normal renal function.¹

Distribution

Extent

Not known whether distributed into human milk.¹

Not known whether crosses placenta in humans; embryocidal effects observed in rabbits.¹ ^l

Not known whether distributed into semen.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Plasma Protein Binding

Approximately 30–40%.¹ ^f

Elimination

Metabolism

Metabolic fate not known.¹ In vitro studies indicate that lenalidomide does not undergo metabolism via CYP isoenzymes.¹

Elimination Route

Primarily excreted in urine (67%) as unchanged drug via glomerular filtration and tubular secretion.¹ ^f

Partially (about 30%) removed by hemodialysis.^f

Half-life

Approximately 3–4 hours.¹ ^c ^f

No evidence of drug accumulation with multiple dosing.¹ ^f

Special Populations

In patients with renal impairment (Cl_cr <50 mL/minute), clearance reduced, systemic exposure increased, and half-life prolonged.^f

Stability

Storage

Oral

Capsules

25°C (may be exposed to 15–30°C).¹ ⁷

Actions

A thalidomide analog; similar in structure, but functionally distinct.^b ^c ^h Exhibits more potent immunomodulating effects^a ^c ^d and lack of CNS effects compared with thalidomide.³ ^b Insufficient information regarding teratogenic potential of lenalidomide.¹

Exact mechanism of action not fully elucidated.¹ ^a ^b Affects a broad range of ligand-induced responses, including angiogenesis, inflammation, immune response, and cell adhesion.¹ ³ ^c

Antiangiogenic effects include inhibition of vascular endothelial growth factor (VEGF), an angiogenic cytokine secreted by bone marrow stromal cells and myeloma cells.^c

Enhances cell-mediated immunity by inhibiting secretion of proinflammatory cytokines (e.g., tumor necrosis factor [TNF; TNF-α]), and stimulating interleukin-2, interferon gamma, cytolytic T-cell and natural killer (NK) cell responses.¹ ³ ^a ^c ⁱ

Interferes with growth signaling between myeloma cells and bone marrow stromal cells by modulating expression of cell surface adhesion molecules.^c

Exhibits direct antitumor effects by inducing cell cycle arrest and apoptosis in certain myeloma cell lines.¹ ⁸ ^a ^b ^c

Improves erythropoiesis in patients with low- or intermediate-1-risk MDS associated with a deletion 5q abnormality alone or with additional chromosomal abnormalities.¹ ⁱ May have direct antiproliferative activity against deletion 5q cell lines.³ ⁵ ^b

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Importance of comprehensive counseling (i.e., orally and in writing) on benefits and risks (i.e., severe, potentially life-threatening birth defects) of drug.¹ (See Boxed Warning.)

Importance of taking lenalidomide only as prescribed, and in compliance with requirements of RevAssist program.¹ (See Restricted Distribution Program under Dosage and Administration.)

Importance of providing patients with a copy of manufacturer’s patient information (medication guide) each time drug is dispensed.¹ ⁷ ^c ^j

Importance of warning women of childbearing potential not to take drug if pregnant, breast-feeding, or able to get pregnant (e.g., not using required methods of birth control).¹

Necessity of advising any woman of childbearing potential to avoid pregnancy by using mandatory contraceptive measures, unless she abstains from heterosexual contact.¹ (See Boxed Warning and see Fetal/Neonatal Morbidity and Mortality under Cautions.)

Importance of mandatory pregnancy testing prior to and during therapy.¹

Importance of immediately discontinuing therapy if pregnancy suspected.¹

Importance of women of childbearing potential informing clinicians of pregnancy, suspected pregnancy, missed menstrual period, unusual menstrual bleeding, or cessation of using contraceptive measures.¹

Importance of informing patient how to obtain information about emergency contraception (including information regarding clinicians who provide emergency contraceptive services) if clinician not available.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Importance of informing sexually mature male patients (including those who have undergone a vasectomy) of necessity of using a latex condom when engaging in sexual contact with a woman of childbearing potential or a pregnant woman.¹ ⁷ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Importance of male patients informing clinicians of unprotected heterosexual sexual contact during therapy and for first 4 weeks after drug discontinuance.¹ Importance of male patients informing clinician of suspected pregnancy of their sexual partner.¹

Importance of informing patients not to share drug with anyone else (even if the other individual has similar symptoms) and of not donating blood or semen while receiving drug and for 4 weeks afterward.¹ ⁷ ^j

Importance of advising patients to swallow capsules whole with water, and not to break, chew, or open capsules.¹ ⁷

Importance of taking a missed dose as soon as possible, and not doubling the next dose.⁷

Risk of hematologic toxicities; importance of periodic monitoring of blood cell counts during treatment.¹

Risk of venous thromboembolic events; importance of advising patients to immediately inform clinician if they develop symptoms of shortness of breath, chest pain, or swelling of the arms or legs.¹ ⁷ ^c

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹ ⁷

Importance of informing patients of other important precautionary information.¹ ⁷ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Distribution of lenalidomide is restricted.¹ (See Restricted Distribution Program under Dosage and Administration.)

Lenalidomide
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	5 mg	Revlimid	Celgene
		10 mg	Revlimid	Celgene
		15 mg	Revlimid	Celgene
		25 mg	Revlimid	Celgene

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's ac

Lacrisert

Generic Name: hydroxypropyl cellulose (Ophthalmic route)

hye-drox-ee-PROE-pil SEL-ue-lose

Commonly used brand name(s)

In the U.S.

Lacrisert

Available Dosage Forms:

Device

Therapeutic Class: Lubricant, Ocular

Uses For Lacrisert

Hydroxypropyl cellulose belongs to the group of medicines known as artificial tears. It is inserted in the eye to relieve dryness and irritation caused by reduced tear flow that occurs in certain eye diseases.

This medicine is available only with your doctor's prescription.

Before Using Lacrisert

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of this medicine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of this medicine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Lacrisert

To use:

This medicine usually comes with patient directions. Read them carefully before using this medicine. It is very important that you understand how to insert this eye system properly. If you have any questions about this, check with your doctor.

Before opening the package containing this medicine, wash your hands thoroughly with soap and water.

If the eye system accidentally comes out of your eye, as sometimes occurs when the eye is rubbed, do not put it back in the eye, since it may be contaminated. Instead, insert another eye system if needed.

You may have to use this medicine for several weeks before your eye symptoms get better.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For eye system dosage form:
- For dry eyes or eye irritation:
  - Adults and children—Place one insert in the eye each day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Lacrisert

This medicine may cause blurred vision for a short time after each dose is applied. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well .

This medicine may also cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

If your eye symptoms get worse or if you get new eye symptoms, remove the eye system and check with your doctor as soon as possible.

Lacrisert Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Blurred vision

eye redness or discomfort or other irritation not present before use of this medicine

increased sensitivity of eyes to light

matting or stickiness of eyelashes

swelling of eyelids

watering of eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Lacrisert side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Lacrisert resources

Lacrisert Side Effects (in more detail)
Lacrisert Use in Pregnancy & Breastfeeding
Lacrisert Support Group
0 Reviews for Lacrisert - Add your own review/rating

Lacrisert Prescribing Information (FDA)

Lacrisert Concise Consumer Information (Cerner Multum)

Lacrisert Insert MedFacts Consumer Leaflet (Wolters Kluwer)

FreshKote Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Lacri-Lube S.O.P. Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

Murine Tears Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Murocel Eye Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Refresh Redness Relief Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Refresh liquigel

Compare Lacrisert with other medications

Eye Dryness/Redness

Andehist NR Syrup

Generic Name: brompheniramine and pseudoephedrine (BROM fen EER a meen and SOO doe ed FED rin)

Brand Names: Andehist NR Syrup, Bidhist-D, Bromaline, Bromhist Pediatric Drops, Bromhist-NR, BroveX PD, BroveX PSE, Brovex SR, Di-Bromm, Histex SR, J-TanD PD, Lodrane 12D, Lodrane 24D, Lodrane D, Lodrane Liquid, LoHist-12D, LoHist-PD, Q-Tapp, Sildec, Touro Allergy, Ultrabrom, Ultrabrom PD

What is Andehist NR Syrup (brompheniramine and pseudoephedrine)?

Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Brompheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Andehist NR Syrup (brompheniramine and pseudoephedrine)?

There are many brands and forms of this medicine available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Brompheniramine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking Andehist NR Syrup (brompheniramine and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine and pseudoephedrine if you have:

kidney disease;

diabetes;

glaucoma;

heart disease or high blood pressure;

diabetes;

a thyroid disorder;

an enlarged prostate; or

problems with urination.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Brompheniramine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Andehist NR Syrup (brompheniramine and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Andehist NR Syrup (brompheniramine and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Andehist NR Syrup (brompheniramine and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heartbeat;

confusion, hallucinations, unusual thoughts or behavior;

severe dizziness, anxiety, restless feeling, or nervousness;

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

confusion, hallucinations, unusual thoughts or behavior;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

urinating less than usual or not at all.

Less serious side effects may include:

blurred vision;

dry mouth;

nausea, stomach pain, constipation;

mild loss of appetite, stomach upset;

warmth, tingling, or redness under your skin;

sleep problems (insomnia);

restless or excitability (especially in children);

skin rash or itching;

dizziness, drowsiness;

problems with memory or concentration; or

ringing in your ears.

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 at 1-800-FDA-1088.

What other drugs will affect Andehist NR Syrup (brompheniramine and pseudoephedrine)?

Sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by brompheniramine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications..

Tell your doctor about all other medications you use, especially:

medicines to treat high blood pressure;

a diuretic (water pill);

medication to treat irritable bowel syndrome;

bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with brompheniramine and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Andehist NR Syrup resources

Andehist NR Syrup Side Effects (in more detail)
Andehist NR Syrup Use in Pregnancy & Breastfeeding
Andehist NR Syrup Drug Interactions
Andehist NR Syrup Support Group
0 Reviews for Andehist NR - Add your own review/rating

Bidhist-D Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Bromfenex Controlled-Release and Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Lodrane D MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Andehist NR Syrup with other medications

Hay Fever
Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about brompheniramine and pseudoephedrine.

See also: Andehist NR side effects (in more detail)

Zomig Nasal

Zomig Nasal may be available in the countries listed below.

Ingredient matches for Zomig Nasal

Zolmitriptan

Zolmitriptan is reported as an ingredient of Zomig Nasal in the following countries:

Czech Republic

Iceland

Luxembourg

Norway

Sweden

Switzerland

International Drug Name Search